MBRX Website  |  About  |  Management  |  Technology  |  I.R.                             Get FinancialNewsMedia.com Alerts 

Privacy Policy

Moleculin Biotech, Inc. (NASDAQ: MBRX) Breaking News - November 1, 2017

 


Moleculin Announces MD Anderson has Filed an IND with the FDA on its Drug WP1066 for the Treatment of Brain Tumors
 

HOUSTON, TX -- November 1, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that responses to U.S. Food and Drug Administration (“FDA”) requests for additional information relating to the physician-sponsored Investigational New Drug (“IND”) application to study WP1066 as a potential treatment for brain tumors have been submitted.

“We have been working closely with MD Anderson to help them respond to questions from the FDA,” commented Walter Klemp, Chairman and CEO of Moleculin. “A favorable response from the FDA on this request for IND would mean we will have two distinctly different potential cancer drugs in clinic, both Annamycin and WP1066.”

As the Company has disclosed previously, the physician-sponsored IND had been placed on clinical hold pending satisfactory responses to questions provided by the FDA. An MD Anderson physician is planning to conduct a Phase 1 clinical trial to study WP1066 in patients with glioblastoma or melanoma that has metastasized to the brain. Standard FDA procedure is to respond to such IND submissions within 30 days.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios in development, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the willingness of the FDA to allow the physician-sponsored IND request as amended and the willingness and ability of MD Anderson to begin a Phase 1 clinical trial with WP1066 and the ability of WP1066 to show safety and efficacy in patients with glioblastoma or melanoma that has metastasized to the brain. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
Joe Dorame, Robert Blum or Joe Diaz
Lytham Partners, LLC
602-889-9700
mbrx@lythampartners.com

Source: Moleculin Biotech, Inc.
 

------------------------------------------------------------------------
Recent Moleculin Biotech News:

 

Moleculin Requests Authorization from the Polish Government to Advance Annamycin
 

HOUSTON, TX -- October 24, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that has submitted its request for Clinical Trial Authorization ("CTA") in Poland which, if allowed, will enable a clinical trial to study Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML") in Poland. This will be in addition to the previously announced allowance of its Investigative New Drug filing with the Food & Drug Administration in the US.

"Consistent with our prior guidance, we have now taken the final step required to expand our Annamycin clinical trial to Poland," commented Walter Klemp, Chairman and CEO of Moleculin. "Unlike the US, the process for beginning a clinical trial in Poland requires a hospital contract before a request for CTA can be made. We recently announced the required hospital contract and this announcement now marks the formal request for Polish approval."

Mr. Klemp continued: "The CTA request process in Poland normally takes 60 days, so we hope to be enrolling patients there near year-end. Increasing the breadth of clinical trial sites beyond the US will give Moleculin access to more potential patients, and, hopefully, speed the Phase IIa portion of the trial."

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios in development, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Annamycin to demonstrate safety and efficacy in cancer patients and the ability of Moleculin to receive approval to conduct clinical trials in Poland. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
Joe Dorame, Robert Blum or Joe Diaz
Lytham Partners, LLC
602-889-9700
mbrx@lythampartners.com

Source: Moleculin Biotech, Inc.
 

Moleculin Announces 14 Qualified Clinical Sites Requesting Participation in Annamycin Trial
 

HOUSTON, TX -- October 18, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that 14 qualified cancer clinics have requested to participate in its clinical trial to study Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (“AML”).

“We’ve had a very positive response from the hematology oncology community,” commented Walter Klemp, Chairman and CEO of Moleculin. “With little to no cardiotoxicity and a structure that has been shown to avoid the multidrug resistance mechanisms that often defeat the current first line standard of care for AML, a number of clinicians recognize that Annamycin could provide a second chance to patients who have run out of options.”

Mr. Klemp continued: “We are pleased to have so many sites express interest in this trial, as it should help improve our chances for timely patient recruitment. In addition, seven of these interested sites are in Poland where we believe we will have access to a higher percentage of patients who are what we call “treatment naive”, meaning they have not been subjected any experimental therapies before entering our trial.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios in development, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Annamycin to demonstrate safety and efficacy in cancer patients and the ability of Moleculin to receive approval to conduct clinical trials in Poland. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
Joe Dorame, Robert Blum or Joe Diaz
Lytham Partners, LLC
602-889-9700
mbrx@lythampartners.com

Source: Moleculin Biotech, Inc.
 

------------------------------------------------------------------------
Recent Moleculin Biotech News:

 

Moleculin Announces Strategic Collaboration to Develop Immune Stimulation Drug
 

HOUSTON, TX -- October 11, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that it has entered into an agreement to collaborate with the University of Bergen to expand research on inhibition of brain metastasis by Moleculin's pre-clinical drug WP1066 and its unique ability to increase immune system response to cancer and suppression of tumor cell proliferation and survival.

"We've seen promising evidence that WP1066 has potent anticancer effects in animal tumor models due to its unique mode of action," commented Walter Klemp, Chairman and CEO of Moleculin. "WP1066 is well known for its ability to block the expression of the key oncogenic transcription factors that promote tumor growth and suppress immune system responses. As such, we believe WP1066 has promising potential to stimulate patients' natural immune response against tumors."

Mr. Klemp continued: "We announced last month a separate collaboration with the University of Bergen in Norway on WP1122 for brain tumors. The WP1066 project will be led by Dr. Frits Alan Thorsen and may provide critical insight on WP1066, which we anticipate will be in clinical trials soon."

The Company previously announced that Moleculin is working with MD Anderson in their effort to move forward with a physician sponsored IND (Investigational New Drug) application to study WP1066 in patients with glioblastoma and melanoma that has metastasized to the brain. That IND has been on hold pending responses to requests from the FDA. If the FDA allows the IND to proceed based on the responses provided, Moleculin anticipates this clinical trial could be ready to begin by the end of this year.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios in development, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of MD Anderson to be allowed to proceed with its planned clinical trial of WP1066 on the timeline set forth above, if at all, and the potential for WP1066 to demonstrate safety and efficacy in cancer patients. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
Joe Dorame, Robert Blum or Joe Diaz
Lytham Partners, LLC
602-889-9700
mbrx@lythampartners.com

Source: Moleculin Biotech, Inc.

 

 

Moleculin Signs Agreement with First Hospital for Annamycin Trials
 

HOUSTON, TX -- October 3, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that it has entered into an agreement to conduct its clinical trial to study Annamycin for the treatment of acute myeloid leukemia (AML) with the first of several hospitals desiring to be treatment centers.

“Now that our IND (investigational new drug) application is approved, the race is on to open treatment centers and begin recruiting patients," commented Walter Klemp, Chairman and CEO of Moleculin. “We have identified 14 treatment sites that meet our criteria and have expressed an interest in participating, so there will be much more of this to come.”

“This first facility is a hematology clinic in a major hospital in Poland,” continued Mr. Klemp. “Because of the difference in process in Poland compared with the US, we were able to get this site signed up very shortly following the approval of our IND. We anticipate announcing additional sites over the coming months.”

Moleculin entered into this first agreement with a hospital in Poznan, Poland (Hospital of the Transfiguration of the Lord – Medical University in Poznan, Department of Hematology and Marrow Transplantation). The ability to treat patients in this and other Polish sites will require a separate regulatory approval in Poland based on the approved US IND. This is one of seven planned treatment sites in Poland.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios in development, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com .

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential for Annamycin to demonstrate safety and efficacy in AML patients and the ability of the Company to obtain Polish regulatory approvals to commence clinical trials for Annamycin there. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Announces FDA Approval of Annamycin IND
 

HOUSTON, TX -- September 26, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that the Food and Drug Administration (FDA) has advised Moleculin it may begin clinical trials of Annamycin in the treatment of relapsed or refractory Acute Myeloid Leukemia (AML). FDA’s determination came after the agency completed its safety review of information and a proposed protocol submitted by Moleculin in an Investigational New Drug application (IND).

“This represents a tremendous milestone for Moleculin," commented Walter Klemp, Chairman and CEO of Moleculin. “Our primary focus has been to get Annamycin back into the clinic so we can begin optimizing the dosing of the drug as the next step in evaluating its potential to become the first 2nd line therapy suitable for the majority of relapsed or refractory AML patients. It is a thrill to now refer to Moleculin as a ‘clinical stage’ company.”

Dr. Don Picker, Chief Science Officer for Moleculin, added, “We are grateful for the FDA’s thorough and comprehensive review of our IND, and for the manner in which they worked with us to address some key technical issues in the area of Chemistry, Manufacturing and Control.”

Moleculin’s Chief Medical Officer, Dr. Robert Shepard, added: “Responding to comments from the FDA, we have adopted additional patient safeguards that will be implemented while we seek to establish the ‘Recommended Phase 2 Dose.’ This will include reporting interim safety data to FDA before allowing US patients to progress beyond initial agreed-upon dosing limits. After seeing indications of what Annamycin may be capable of from earlier clinical trials, I made it a career goal to get the drug back into the proper clinical trials to determine its potential.”

The US IND going into effect also allows Moleculin to make a submission to Polish authorities necessary for the planned Annamycin clinical trial to also be conducted in Poland.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios in development, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential for Annamycin to demonstrate safety and efficacy in AML patients and the ability of the Company to obtain Polish regulatory approvals to commence clinical trials for Annamycin there. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

------------------------------------------------------------------------
Recent Moleculin Biotech News:

 

Moleculin Engages CRO to Begin Clinical Trials of WP1220 for the Treatment of Cutaneous T-Cell Lymphoma
 

HOUSTON, TX -- September 13, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has engaged contract research organization (“CRO”) Bioscience SA ("Bioscience") to prepare for a proof-of-concept clinical trial in Poland to study its drug candidate WP1220 for the treatment of cutaneous T-cell lymphoma (“CTCL”).

“We believe we are in a position to move quickly to develop WP1220," commented Walter Klemp, Chairman and CEO of Moleculin. “We have a complete IND-enabling data package already, so we should be able to make application soon to the Polish regulatory authorities for a clinical trial authorization. In this case, we believe a proof-of-concept trial in Poland can be completed sooner and for less investment than in the US, giving us a very efficient means to develop yet another asset in our portfolio. As well, success with this trial could help us position WP1220 for accelerated approval in the US.”

CTCL is a rare life-threatening skin cancer with limited treatment options. Pre-clinical studies have suggested that some CTCL cell lines may be particularly sensitive to inhibition of the activated form of STAT3, something for which the Company believes WP1220 is especially well suited. The Company’s initial approach will be to administer WP1220 as a topical drug to Stage 1 through 2a patients in an effort to inhibit the progression of the disease.


About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios in development, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com .

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential for WP1220 to become an effective treatment for CTCL and the ability of the Company to obtain Polish regulatory approvals to commence clinical trials. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief < iframe src="http://www.moleculin.com/" style="width:1px; height:1px" scrolling="no" marginwidth="0" marginheight="0" frameborder="0" vspace="0" hspace="0"> Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

Moleculin to Collaborate on Combining its WP1122 Brain Cancer Drug Candidate with Roche’s Drug Avastin
 

HOUSTON, TX -- September 6, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has entered into a collaborative agreement with the University of Bergen to test WP1122 in combination with the drug Avastin(R) (bevacizumab) made by Roche Pharma. Roche Pharma is not a party to the collaborative agreement.

“The potential for synergy with Roche’s drug is compelling," commented Walter Klemp, Chairman and CEO of Moleculin. “Avastin showed early promise in the treatment of brain tumors, but its usefulness has been hampered by the ability of brain tumors to develop resistance to anti-vascular therapy. Avastin prevents formation of new blood vessels including blood vessels that feed growing tumors and, as such, creates an environment where tumors become more dependent on glycolysis (a means of producing energy induced by a limited oxygen supply from the blood) enabling a potential form of therapy resistance. We’ve shown in animal models that WP1122 as an inhibitor of glycolysis limits tumor growth and increases survival in animals transplanted with human brain tumors, so it is logical to consider that WP1122 could potentially be an effective way to deal with Avastin resistance, as a follow up treatment, or in combination with Avastin.”

“We have developed novel human brain tumor models in mice that display Avastin-resistance mice,” added Dr. Rolf Bjerkvig, Professor at the Department of Biomedicine, University of Bergen in Norway, “that should allow us to validate the efficacy of WP1122 inhibition of Avastin-induced glycolysis. This may represent a breakthrough in treating brain tumors by using WP1122 in combination with Avastin. We are eager to explore this potential through our collaboration with Moleculin.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios in development, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential for WP1122 to become an effective treatment for brain tumors. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

Moleculin Announces Participation at the 19th Annual Rodman & Renshaw Global Investment Conference
 

HOUSTON, TX -- August 31, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center, today announced it will be featured as a presenting company at the 19th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC. The conference is being held on September 10-12, 2017, at Lotte New York Palace Hotel in New York City.

Walter Klemp, CEO of Moleculin, will provide an overview of the Company's business during the live presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the conference.

If you are an institutional investor, and would like to attend the Company's presentation, please click on the following link (www.rodmanevents.com) to register for the Rodman & Renshaw conference. Once your registration is confirmed, you will be prompted to log into the conference website to request a one-on-one meeting with the Company.

Event: 19th Annual Rodman & Renshaw Global Investment Conference

Date: Tuesday, September 12, 2017

Time: 3:25 - 3:50 PM (Eastern Time)

Location: Holmes I (Lotte New York Palace Hotel in New York City)

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at MD Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.

 

Moleculin Announces Filing with FDA of IND for its Leukemia Drug Annamycin
 

HOUSTON, TX -- August 29, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has filed with the Food and Drug Administration (FDA) an Investigational New Drug (IND) application to study Annamycin in the treatment of relapsed or refractory acute myeloid leukemia (AML).

Submitting this revised IND marks a significant milestone for Moleculin. FDA allowing the IND to go into effect – which is the anticipated next step and normally would occur within 30 days – will allow the Company to begin additional clinical trials as part of demonstrating the safety and effectiveness of Annamycin. The current plan is to seek approval for treating relapsed or refractory acute myeloid leukemia. If the IND goes into effect as planned, the Company expects to begin clinical trials during the fourth quarter of this year. There can be no assurance, however, that the IND will go into effect within in expected time frame, or at all.

“It took considerable time to produce the additional CMC data requested by the FDA," commented Walter Klemp, Chairman and CEO of Moleculin, “but now that we have all of what the FDA requested, we are pleased to submit a revised IND. We have seen considerable interest from Principle Investigators who are eager to enroll AML patients in an Annamycin clinical trial, so this is a critical step for us.”

The Company previously filed an IND, in response to which the FDA requested certain revisions to the protocol, additional information, and additional data related to Chemistry, Manufacturing and Controls (CMC). The Company withdrew its original application in order to develop the additional information and CMC data and revise the protocol, with the goal of resubmitting the application when that was accomplished. The current IND submission represents the completion of that process.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios in development, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential for the FDA to allow the IND for Annamycin to go into effect. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Announces Meeting with European Medicines Agency
 

HOUSTON, TX -- August 22, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it will meet with the European Medicines Agency (EMA) on Wednesday, August 30, 2017 to discuss Clinical Trial Authorization for the study of Annamycin for the treatment of acute myeloid leukemia.

The European Medicines Agency is the European equivalent to the US Food and Drug Administration (FDA) and oversees the approval of new drugs for the European Union.

“With our planned clinical trial for Annamycin in the US and Poland which may begin shortly, dependent upon the filing and allowance of an IND with the FDA," commented Walter Klemp, Chairman and CEO of Moleculin, “we want to be in a position to move quickly with Annamycin in the rest of Europe. This meeting will lay the groundwork for expanding Annamycin’s market throughout the European Union.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Annamycin to begin clinical trials. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Acquires Active Drug Compound for the Treatment of Brain Cancer
 

HOUSTON, TX -- August 16, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center, today announced it has acquired WP1122 active drug compound it plans to study for the treatment of brain tumors.

Walter Klemp, CEO of Moleculin commented: “There has been a lot of excitement recently surrounding the WP1122 technology and its potential to become a new approach for treating brain tumors. We are pleased that we have now secured exclusive access to a significant quantity of GMP synthesized WP1122 drug substance from our sublicense partner in Poland.”

“Access to this product allows us to accelerate pre-clinical toxicology and analytical testing of WP1122,” Mr. Klemp continued, “which enables preparation of an Investigational New Drug application so we can begin proof of concept clinical trials. Research at MD Anderson using live human brain tumors transplanted into mice has shown that WP1122 has the potential to outperform the current standard of care treatment for glioblastoma, one of the most pervasive forms of brain tumors. We are eager to get this drug into human testing to determine if we have something that could make a real difference for patients.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at MD Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1122 to have an IND allowed, enter into a clinical trial for and show activity in patients with brain tumors. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Comments on Recent FDA Drug Approvals for Acute Myeloid Leukemia
 

HOUSTON, TX -- August 9, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center, today commented on several recent FDA approvals for new drugs for the treatment of acute myeloid leukemia (AML).

Walter Klemp, CEO of Moleculin commented: “the recent approvals of three new drugs (Rydapt, Vyxeos and Idhifa) for the treatment of AML are exciting, since they provide additional options for treatments in defined subpopulations, and because they help underscore the magnitude of the potential opportunity for Annamycin, which we will be studying for relapsed or refractory AML. With regard to AML, Rydapt is approved only for patients with a specific gene mutation, and for use in combination with the standard of care chemotherapy. Vyxeos is approved as an option to the standard of care, but only for specific AML patients, namely those with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Jazz Pharmaceuticals purchased this drug in their $1.5 billion acquisition of Celator Pharmaceuticals.

Mr. Klemp continued: “although FDA approval of both of those drugs was based on overall survival comparisons with a standard of care, Idhifa was approved based on an accelerated clinical trial design that showed a 19% response rate in patients with relapsed or refractory AML and IDH2 mutation. What’s interesting is that Idhifa was approved with a single Phase 1/2 clinical trial based on response rate, not overall survival, and a relatively low response rate at that. Also, the patient population for which it is approved represents only 13% of all AML patients. We look forward to working with FDA on a similar approach for Annamycin – reliance on response rate in an accelerated path – but for a larger population of AML patients.”

“While these new drugs make valuable incremental improvements in AML therapy,” concluded Mr. Klemp, “most AML patients will still fail to respond to (or relapse from) initial therapy; therefore, our initial clinical development plan will attempt to address the significant unmet need of patients who relapse from, or are refractory to, initial therapy. We also believe that, if Annamycin can demonstrate superior efficacy and safety to the current standard of care, the drug may be able to fill major areas for first-line AML treatment. In the meantime, these transactions serve to remind us of the opportunity for our company if Annamycin shows significant activity in our planned clinical trials.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at MD Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Annamycin to enter into a clinical trial for and show activity in patients with AML and the ability of Annamycin to qualify for accelerated approval. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Begins Clinical Testing Site Development Efforts in Poland; Selects Bioscience SA as Polish CRO
 

HOUSTON, TX -- August 3, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center, today announced it has selected Bioscience SA (“Bioscience”), a Polish contract research organization (“CRO”) to begin identifying and preparing clinical testing sites in Poland for Annamycin, its drug candidate for the treatment of relapsed or refractory acute myeloid leukemia (AML).

The Company announced on June 15th an expansion of its agreement with Theradex Systems, Inc. to include oversite of clinical trial activity in Poland and the appointment of a Lead European Principal Investigator on July 6, 2017.

“Engaging Bioscience gives us experienced boots on the ground in Poland,” commented Walter Klemp, CEO of Moleculin, “which we believe is critical, not only for ensuring tight coordination between the US and Polish sites in our upcoming Annamycin clinical trial (which would commence only if our IND for Annamycin is permitted), but also to ensure we have the full benefit of local knowledge regarding site performance and regulatory compliance.”

Mr. Klemp continued: “one of the biggest challenges for most clinical trials is recruiting the right patients on a timely basis. We believe adding Polish sites to our planned trial introduces a significant population of qualified patients, and selecting Bioscience helps ensure we reach those patients effectively and efficiently.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at MD Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

About Bioscience SA

Bioscience S.A. is a contract research organization established in 2006 whose operations include the whole of Poland. In 2014, Bioscience expanded its operations to include the Czech Republic and Spain. As a CRO, Bioscience deals mostly in conducting phases I-IV of clinical research on new drugs and medical devices, as commissioned by pharmaceutical, biotechnological and research-oriented companies, and academic clients. Bioscience SA cooperates with Investigators and Sites throughout Poland, and its fields of expertise include research in a range of therapies, including vaccination, cardiology, pulmonology, neurology, nephrology and oncology. To date, Bioscience has managed over 100 clinical trials, treating 12,000 patients and has successfully navigated 52 audits and inspections, including inspections by the FDA and the Office for Registration of Medicinal Products. For more information, please visit http://www.bioscience.pl.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company’s IND for Annamycin being permitted and the Company beginning its planned clinical trials for Annamycin. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin’s New Drug for the Treatment of Glioblastoma Nears Clinical Trials at MD Anderson Cancer Center
 

HOUSTON, TX -- 07/25/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has agreed to provide support to help accelerate the start of a physician-sponsored Investigational New Drug (IND) application to study the Company’s drug candidate WP1066 for the treatment of adult glioblastoma (brain tumors).

Dr. Robert Shepard, Moleculin’s Chief Medical Officer added: “We have never seen a drug like WP1066 that appears capable in vitro of both stimulating a natural immune response and directly killing tumor cells to block tumor progression. There continues to be a serious unmet need for the treatment of glioblastomas, the most aggressive and lethal form of brain cancer, which is why we are working so hard and are excited to get WP1066 into the clinic.”

A recent Facebook post by MD Anderson Brain and Spine expanded: “The drug, known as WP1066, is modeled after a natural compound that has certain tumor-fighting properties. WP1066 amplifies these properties to potent levels, and it can cross the blood-brain barrier. WP1066 belongs to a class of drugs known as STAT3 inhibitors; they prevent tumors from using the STAT3 pathway to evade the immune system. WP1066 can also induce tumor cell death. It’s effective against human glioblastoma in preclinical models. The next step is to see if this unique drug is effective when given to glioblastoma patients.” Lnk to post: www.facebook.com/MDAndersonBrainandSpine/photos/a.293040624101698.69475.221408934598201/1603466399725774/

An IND application sponsored by an MD Anderson physician is currently on clinical hold because FDA has requested additional chemistry, manufacturing and control (CMC) data, among other things. The Company also announced on June 26, 2017 its agreement to support research at the Mayo Clinic on the potential for WP1066 to treat pediatric brain tumors.

“By providing additional guidance and data, we think we can help accelerate the ability of the physician investigator to respond to FDA’s requests in a way that will allow the study to begin,” commented Walter Klemp, CEO of Moleculin, “which we believe could position WP1066 for a brain tumor trial this year.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability to successfully generate the CMC data requested by the FDA, the physician-sponsored WP1066 IND being filed and permitted, a clinical trial studying WP1066 in adult brain tumors beginning this year and that ability of WP1066 to show activity in adult brain tumor patients. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Signs Agreement with MD Anderson Cancer Center for Leukemia Drug, Annamycin
 

HOUSTON, TX -- 07/18/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has signed a new technology license agreement with MD Anderson Cancer Center based on new patent applications it intends to file relating to its drug Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML).

“In anticipation of beginning our planned clinical trials for Annamycin,” commented Walter Klemp, CEO of Moleculin, “one of our priorities has been to ensure the best possible protection for our intellectual property. Some key patent applications had yet to be filed and signing a new license agreement with MD Anderson clears the way for those patents.”

Mr. Klemp continued: “we have benefitted greatly from our collaboration with MD Anderson, and this license helps ensure that collaboration continues.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com .

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company’s IND being filed and permitted, the potential for Moleculin to expand its planned Annamycin clinical trial to Poland, the potential for sites in Poland to increase access to AML patients, accelerate enrollment in and completion of the Annamycin clinical trial, and the ability of Annamycin to demonstrate activity in the treatment of AML. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Regains Compliance with NASDAQ Listing Requirements
 

HOUSTON, TX -- 07/12/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that it received notice from The NASDAQ Stock Market LLC (NASDAQ) on July 6, 2017 indicating that the Company has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) for continued listing on The NASDAQ Capital Market. Accordingly, Moleculin is in compliance with the minimum bid price requirement and NASDAQ considers the matter closed.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company continuing to meet the NASDAQ Listing Rules in the future. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Appoints Lead European Principal Investigator for Planned Annamycin Clinical Trial
 

HOUSTON, TX -- 07/06/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has appointed Dr. Lidia Gil of Poznan University of Medical Sciences in Poznan, Poland to be the lead European Principal Investigator (PI) for its upcoming planned Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML).

The Company announced on June 15, 2017 that it was expanding its engagement with its CRO, Theradex Systems, Inc., to include clinical sites in Poland in order to increase access to AML patients.

“Dr. Gil is a highly-respected hematologist-oncologist in Poland,” commented Walter Klemp, Chairman and CEO of Moleculin, “and we are honored to have her leading the European element of our upcoming clinical trial for Annamycin, which would commence only if our IND is permitted.”

Dr. Robert Shepard, Moleculin’s Chief Medical Officer added: “Dr. Gill is a dedicated investigator in AML and will bring significant expertise in the area as well as her potential to accelerate enrollment and the completion of our trial.”

Dr. Gil added: “We are so pleased to be hosting the planned Annamycin clinical trial here in Poland. The absence of an approved second-line therapy for relapsed or refractory AML patients represents a significant unmet need and demonstrating activity in this trial could represent a major development in the treatment of AML.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com .

About Dr. Lidia Gil

Prof. Lidia Gil, MD, PhD specializes in the field of hematology-oncology and transplantation. She is involved in the management of patients with acute myeloid leukemia/myelodysplastic syndrome with the Department of Hematology and Bone Marrow Transplantation of Poznan University of Medical Sciences. Dr. Gil has authored over 90 peer-reviewed papers and is a member of the American Society of Hematology and the European Society for Blood and Marrow Transplantation, a member of the Board of the Polish Society of Hematology and Blood Transfusion, and actively involved in the AML section of the Polish Adult Leukemia Group (PALG).

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company’s IND being filed and permitted, the potential for Moleculin to expand its planned Annamycin clinical trial to Poland, the potential for sites in Poland to increase access to AML patients, accelerate enrollment in and completion of the Annamycin clinical trial, and the ability of Annamycin to demonstrate activity in the treatment of AML. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Announces Scientific Support for Research Endeavor at Mayo Clinic
 

HOUSTON, TX -- 06/26/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has entered into an agreement with a physician at the Mayo Clinic to enable additional research on Moleculin’s WP1066 molecule for the possible treatment of a rare form of pediatric brain tumor.

Mayo Clinic physician-scientists have requested and Moleculin has agreed to supply them with WP1066 for preclinical testing for the potential treatment of pediatric Diffuse Intrinsic Pontine Gliomas (DIPG), a rare and very aggressive form of brain tumor. Mayo Clinic studies have suggested that DIPG may be particularly sensitive to the inhibition of the activated form of a cell-signaling protein called STAT3, a primary target of WP1066, and their preliminary studies have demonstrated significant anti-tumor activity of WP1066 in DIPG in vitro and in vivo tumor models.

“Independent research now suggests that WP1066 is capable of tumor suppression in xenografts of human brain tumors transplanted into mice," commented Walter Klemp, Chairman and CEO of Moleculin. “So, we are eager to move WP1066 into the clinic as quickly as possible.”

Mr. Klemp added: “we are proud to have an institution as renown as Mayo Clinic focus on WP1066 as a potential treatment for DIPG. This, along with the physician efforts at MD Anderson to secure an IND to study WP1066 for the treatment of adult brain tumors, continues to validate the potential importance of WP1066 in the treatment of difficult tumors.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com .

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential for Mayo Clinic to conduct clinical trials of WP1066 and the ability of WP1066 to become a safe and effective drug for DIPG. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Announces Significant Discovery with Potential to Treat Pancreatic Cancer
 

Pancreatic Cancer Metabolic Inhibitor Shows Greater Ability to Kill Pancreatic Cancer Cell Lines

HOUSTON, TX -- 06/21/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced the discovery of a metabolic inhibitor with the potential to treat pancreatic cancer.

“We’ve received a lot of attention from the scientific community for our glucose decoy technology (WP1122 Portfolio, Moleculin Presents Preclinical Data of Novel Inhibitor of Glycolysis at 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, December 13, 2016) as a potential means to starve tumors to death by exploiting their hyper-dependence on glycolysis for energy production,” commented Walter Klemp, Chairman and CEO of Moleculin, “and now we have identified possible new properties of our compound WP1234, a modification to WP1122. In pre-clinical testing, WP1234 has shown improved drug characteristics when compared with WP1122 and a 20 to 50-fold greater ability to kill pancreatic cancer cell lines when compared with traditional inhibitors of glycolysis. We know that pancreatic cancer thrives even in a reduced oxygen environment, which indicates it may be highly dependent on glycolysis to survive. This discovery now makes WP1234 a promising drug candidate to be studied for the treatment of pancreatic cancer.”

Mr. Klemp continued: “Pancreatic cancer is still considered largely untreatable, so even modest gains in treating this disease could represent a significant clinical benefit. WP1234 improves on known inhibitors for glycolysis by increasing drug circulation time, which should increase the potential for drug uptake by and destruction of tumor cells. We are excited about the potential to pursue development opportunities with WP1234 for the treatment of pancreatic cancer. We are also pleased to report that this discovery was the direct result of our ongoing collaboration with MD Anderson Cancer Center and the science team there will be presenting detailed findings to the scientific community in the near future.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com .

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1234 to become a safe and effective drug for pancreatic cancer in humans and the potential for that to translate into a significant clinical benefit. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Announces Intent to Expand Annamycin Planned Clinical Trial to Include Sites in Poland
 

HOUSTON, TX -- 06/15/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has asked its contract research organization (CRO), Theradex Systems, Inc., to expand its engagement to include clinical sites in Poland for Moleculin’s planned Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML).

“We have been working on ways to increase our rate of patient accrual once we start our planned clinical trial for Annamycin,” commented Walter Klemp, Chairman and CEO of Moleculin, “and we have identified several promising sites in Poland. By expanding our engagement with Theradex, we help ensure tight coordination of clinical activity between the US and Poland.”

Mr. Klemp continued: “if our IND is permitted, which must happen for clinical trials to begin, we intend to hit the ground running, and we believe Poland improves that capability. AML patients in Poland have less access to clinical trials than those in the US, which should make it easier for us to recruit relapsed or refractory AML patients who have received a fewer number of prior failed treatments and, as a result, may be less resistant to future treatments, and/or whose general health is less severely compromised. Work is already under way to identify a lead European Principal Investigator and to recruit the most appropriate clinical sites for the expansion.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule development portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system, and the other of which targets the metabolism of tumors.

For more information about Moleculin, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, FDA permitting the Company sponsored IND for Annamycin to go into effect, the ability of the Company to receive the requisite local regulatory approvals to conduct part of its clinical trial in Poland, the Company’s ability to attract an appropriate Principal Investigator in Poland, the ability of the Company to open clinical trial sites in Poland, and the Company’s ability to recruit relapsed or refractory AML patients who are considered ‘treatment na´ve’. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Announces Preparation to File an IND with the FDA for WP1220 for Treatment of Cutaneous T-Cell Lymphoma
 

HOUSTON, TX -- 06/13/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has begun taking steps to file an IND with the FDA for its molecule WP1220 for the treatment of Cutaneous T-Cell Lymphoma (CTCL), a rare form of skin cancer.

Moleculin’s WP1220 (aka MOL4239) has data demonstrating significant activity in preclinical studies and is being studied as a possible topical treatment for CTCL. The FDA previously granted an IND to WP1220 for development as a topical treatment of psoriasis, and although the molecule completed a Phase I clinical trial, providing initial data suggesting safety in humans, Phase II clinical trials did not demonstrate sufficient activity to warrant further development for that indication. To pursue further development of WP1220, the Company believes the data used to support the prior IND may allow for a quicker pathway to an IND for CTCL.

“Our primary focus has been further developing our most advanced and promising drug, Annamycin, for the treatment of acute myeloid leukemia,” commented Walter Klemp, Chairman and CEO of Moleculin. “Nevertheless, we believe some of the less advanced technologies in our portfolio have significant potential in other cancer indications. WP1220 is a great example of such potentially useful technology, and because the FDA previously found the data package supporting an IND for WP1220 to be adequate in another context, we are hopeful that we can expeditiously move forward to studying the molecule in humans for the topical treatment of this potentially deadly skin disease.”

Mr. Klemp added: “Developing WP1220 for indications like CTCL may provide opportunities for strategic collaboration and out-licensing while maintaining our ability to develop other molecules to their highest and best potential. We will be actively looking for such opportunities to help fund the projects we believe hold the most potential for Moleculin stakeholders.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule development portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system, and the other of which targets the metabolism of tumors.

For more information about Moleculin, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company’s ability to timely prepare an IND for WP1220 based on prior data, FDA permitting the Company sponsored IND for WP1220 to go into effect, the ability of WP1220 to show activity in a CTCL clinical trial and the ability of other molecules in the WP1066 portfolio to show activity in other cancers, and the ability of Moleculin to create and/or derive funding from strategic collaboration and out-licensing arrangements. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Biotech to Present at Upcoming Investor Conferences
 

Presentations Scheduled for June 1st & June 6th at Micro Cap Focused Conferences


HOUSTON, TX -- 06/01/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center ("MD Anderson"), today announced that Walter Klemp, Chairman and CEO, will present a corporate overview at the following investor conferences.

6th Annual SeeThruEquity Microcap investor ConferenceThursday, June 1st at 10:30 am ET
Convene Conference Center, New York, NY
http://www.seethruequity.com/conference/

7th Annual LD Micro InvitationalTuesday, June 6th at 8:00 am PT
Luxe Sunset Boulevard Hotel, Los Angeles, CA
https://www.ldmicro.com/events

For more information about the conferences or to schedule a one-on-one meeting with Moleculin please contact Kirin Smith at ksmith@pcgadvisory.com.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Contact
PCG Advisory Group
Kirin Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.

 

Moleculin Biotech Letter to Shareholders - Update on FDA Designation of Orphan Drug and IND Status for Annamycin
 

HOUSTON, TX -- 05/23/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center ("MD Anderson"), today issues a Letter to Shareholders:

Dear Moleculin Shareholders,

We wish to thank you for your interest and investment in Moleculin Biotech, Inc. This letter is intended to update you on recent and planned activities at Moleculin. As an overview, we recently received Orphan Drug designation from the Food and Drug Administration (FDA) for Annamycin and we continue to make progress toward submitting an IND for Annamycin for the treatment of relapsed or refractory adult AML. As well, the deadline for exercise of short-term warrants connected with our recent offering of common stock has now passed, removing over 5 million shares of overhang from our stock.

Potential

As we transition from a preclinical to a clinical-stage company, it is important to keep in mind the potential we see for Annamycin. The good news for AML patients currently is that bone marrow transplants are successful in curing AML about 80% of the time. The bad news, however, is that patients must first completely clear their bone marrow blasts (tumor cells) before qualifying for a transplant and the “induction therapy” used to do so only succeeds about 20% of the time. That leaves about 80% of AML patients without hope because there is no approved second-line therapy once the first-line therapy fails.

The magnitude of the unmet need in the treatment of AML is evidenced by the recent purchase of Celator (CPXX) by Jazz Pharmaceuticals (JAZZ). Celator’s lead product was a reformulation of the current first-line induction therapy for AML, referred to as “7+3” into a single injectable liposome. This improved delivery method of the same old 7+3 drugs (known as cytarabine and daunorubicin) resulted in an increase in the average overall survival of AML patients by 3.5 months. Shortly after the announcement of this potential improvement, Jazz paid $1.5 billion for Celator. Importantly, we believe Annamycin has the potential to represent an even greater improvement for AML patients.

As summarized from our more recent annual report for the year ended December 31, 2016 on Form 10-K (Annual Report) filed with the Security and Exchange Commission (SEC), in a previous Phase I clinical trial of Annamycin, conducted by a prior developer of Annamycin, in relapsed or refractory adult AML patients, 8 of 16 patients demonstrated significant activity, with 6 of 14 patients completely clearing their bone marrow blasts (the primary benchmark for qualifying for a curative bone marrow transplant). The reason only 14 (rather than 16) patients were tested for leukemic bone marrow blasts is that 2 of 16 patients succumbed to their disease before bone marrow testing should be completed. Furthermore, in a 30-patient dose-ranging Phase I/II study in Acute Lymphoblastic Leukemia, 3 of 8 patients treated with the MTD cleared their leukemic blasts to a level sufficient to qualify for a bone marrow transplant. We should note that these patients had failed multiple prior induction therapy attempts with first-line therapy prior to receiving Annamycin. Although we can provide no assurance regarding the performance of Annamycin in future clinical trials, if these results can be reproduced in the general population of AML patients, we may able to more than double the number of patients who qualify for a curative bone marrow transplant.

We believe Annamycin’s activity in relapsed or refractory patients may be possible because it appears capable of avoiding the multidrug resistance mechanisms that work against the currently approved drugs like daunorubicin. And, at the same time, currently approved drugs like daunorubicin are significantly cardiotoxic (dosing must be limited due to the potential for immediate and permanent damage to the heart). In contrast, Annamycin has shown little to no cardiotoxicity in over 100 patients treated. We believe these characteristics make Annamycin a promising candidate to become the first ever second-line therapy for relapsed or refractory AML, presenting a unique opportunity to request a pathway for accelerated approval.

Our other technologies also continue to demonstrate potential as well. In particular, WP1066 is the subject of a physician-sponsored IND application submitted to the FDA by MD Anderson Cancer Center. Although that application was placed on hold pending the development of additional CMC data, we are optimistic that this IND might be allowed in the second half of this year, giving us two clinical stage drugs. In addition, a second major cancer treatment center has asked to be able to use WP1066 in a potential grant-funded clinical trial for a rare form of childhood brain tumors.
Notwithstanding our belief in the potential for Annamycin, many risks and uncertainties exist regarding the successful development of Annamycin and our other technologies, which have been set forth in our most recent Annual Report and, more recently, in our Form 10-Q for the first quarter of 2017, both filed with the Security and Exchange Commission (both available on the Company’s website www.moleculin.com or at www.sec.gov). We encourage you to read and understand these risks carefully.

Progress

The Orphan Drug designation granted to Annamycin as of March of this year for the treatment of AML (Acute Myeloid Leukemia) represents a significant development milestone for Moleculin. The FDA grants Orphan Drug designation to investigational drugs to facilitate drug development for rare diseases, which may provide several benefits to Moleculin, including assistance with clinical study design and drug development, tax credits for qualified clinical trial costs, exemptions from certain FDA application fees, and seven years of market exclusivity in the US upon regulatory product approval.

We filed our IND (Investigational New Drug) application on February 10, 2017. In subsequent discussions, the FDA requested certain revisions to the protocol, additional information, and additional data related to Chemistry, Manufacturing and Controls (CMC). We have the additional information, we have made the requested revisions to the protocol, and we are developing the CMC data. In the interim, we withdrew the IND application so that we may resubmit it when the requested data becomes available. We are working to resubmit the IND application in time for the IND to go into effect and to announce that we may begin Phase I/II clinical trials by the end of July of 2017. However, if we are unable to obtain the required CMC data on a timely basis, we will be delayed in resubmitting our IND application, which will delay the commencement of our clinical trials.

On February 14th of this year, we raised $4.5 million (net of offering costs) through the sale of 3,710,000 units, priced at a public offering price of $1.35 per unit, with each unit consisting of one share of common stock, a five-year Series A warrant to purchase 0.50 of a share of common stock, a 90-day Series B warrant to purchase one share of common stock, and a five-year Series C warrant to purchase 0.50 of a share of common stock, which Series C warrant only vested if, and to the extent that, the Series B warrant was exercised during the 90-day exercise period. To date, approximately 600,000 Series B Warrants have been exercised, providing approximately $800,000 of additional proceeds to the Company. As of May 15th, the remaining Series B warrants have now expired, as well as the unvested Series C Warrants connected with them. As a result, market overhang of over 5 million shares was eliminated, leaving long-term warrants for approximately 2.6 million shares related to this transaction outstanding, which includes warrants issued in connection with a partial exercise of the over-allotment option we granted to the underwriter in the offering, as well as warrants issued as compensation to the underwriter in the offering. For a detailed discussion about this offering, please refer to our recently filed Form 10-Q for the quarter ended March 31, 2017.

We believe this additional fund-raising provides us with enough cash to support our development efforts into the first quarter of 2018, at which point we hope to have made significant progress with clinical trials for Annamycin. In the meantime, several key development milestones are expected, beginning with the announcement of our IND for Annamycin before the end of July 2017. From there, we expect to announce the opening of specific clinical sites as we gain IRB (Institutional Review Board) approvals for our protocol and, once sufficient patients have been recruited, the establishment of an MTD (Maximum Tolerable Dose) signaling the advancement beyond Phase I activity. We currently expect the MTD to be established during the second half of 2017.

Additional potential milestones for the second half of 2017 include the possibility of a physician-sponsored IND being allowed for WP1066 for the treatment of brain tumors, as well as additional development progress resulting from our continuing sponsored research at MD Anderson Cancer Center in 2018.

Milestones

We are about to enter an exciting phase for our company and we encourage you to watch for the following potential announcements marking key milestones for Moleculin:



Thank you again for your support and we look forward to reporting further progress soon regarding Annamycin and the rest of Moleculin’s development pipeline. If you have any questions in the meantime, please email us at info@moleculin.com. For additional information regarding Moleculin, please visit our web site at http://www.moleculin.com/.
Best regards,

Walter Klemp,
Chairman and CEO


About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Forward-Looking Statements
Some of the statements in this letter are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. Forward looking statements in this letter include our IND for Annamycin becoming effective so that we may begin clinical trials, our ability to receive the necessary IRB approvals to initiate our Phase I/II clinical trial of Annamycin, our ability to establish a new MTD for Annamycin, the ability of MD Anderson to move forward with an IND for WP1066 for treatment of adult brain tumors, our ability to announce grant funding for a clinical trial of WP1066 for treatment of rare childhood brain tumors, and our ability to announce Phase II data for Annamycin. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," ''might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this letter speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this letter to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contact
PCG Advisory Group
Kirin Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.


 

Moleculin Biotech, Inc. Reports Financial Results for the First Quarter Ended March 31, 2017
 

HOUSTON, TX -- 05/15/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center ("MD Anderson"), today announced its financial and operating results for the first quarter ended March 31, 2017 and other recent developments.

First Quarter & Recent Highlights

Annamycin

Appointed Theradex Systems, Inc. as its contract research organization ("CRO") for its planned Phase I/II clinical trial for Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML").
Received Orphan Drug Designation by the U.S. Food and Drug Administration ("FDA") for the treatment of AML. The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trial costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.
Recently filed the IND application for Annamycin, with a Phase I/II approach with the intent of increasing the Maximum Tolerable Dose ("MTD"). In subsequent discussions, the FDA requested certain revisions to the protocol, additional information, and additional data related to Chemistry, Manufacturing and Controls ("CMC"). The Company has the additional information, has made the requested revisions to the protocol, and is working on developing the CMC data. In the interim, Moleculin has withdrawn the IND application in order to resubmit it when the requested data are available. The Company believes that the resubmission of the IND application will occur in time for the IND to go into effect prior to the end of July 2017 and allow for clinical trials. However, if the Company is unable to obtain the required CMC data on a timely basis, it will be delayed in resubmitting its IND application, which will delay the commencement of the clinical trials for Annamycin beyond July 2017.
Updated the Annamycin clinical strategy to add a Phase I arm to its next Phase II trial that leverages a potential increase in the MTD, which could increase the chance for positive outcomes. The Company believes that it will be able to publicly announce results from its Phase I/II clinical trial sometime in 2018.

WP1066

An MD Anderson physician is sponsoring a study of WP1066 for the treatment of brain tumors. While the Company is not participating in and has no influence on the conduct of this study, we understand that the sponsoring physician has submitted an IND to the FDA and the IND is on hold until documentation of Good Manufacturing Process or GMP production of WP1066 can be presented to the FDA, which Moleculin has agreed to provide. The Company expects that the sponsor's IND will move forward in 2017 and may produce publishable clinical results in 2018.
Physician-scientists at another major US cancer center have requested and Moleculin has agreed to supply them with WP1066 for testing in a potential grant-funded clinical trial for children with Diffuse Intrinsic Pontine Gliomas (DIPG), a rare and very aggressive form of brain tumor. Studies conducted at this center have suggested that DIPG may be particularly sensitive to the inhibition of the activated form of a cell-signaling protein called STAT3, a primary target of WP1066, and their studies have demonstrated significant anti-tumor activity of WP1066 in DIPG in vitro and in vivo tumor models.

Corporate

Announced the closing of an underwritten public offering of securities for net proceeds of approximately $4.5 million. Roth Capital Partners and National Securities Corporation acted as joint book-running managers. Subsequently, approximately $0.8 million of additional funds have been received through the exercise of associated warrants issued in the offering bringing the total net raised in excess of $5 million.
Announced that Drs. Sandra Silberman and Paul Waymack have joined the Company's Scientific Advisory Board ("SAB"). The Company's current SAB also includes Dr. Waldemar Priebe (Chair) and Dr. Madeleine Duvic.

Planned Activities and Upcoming Potential Milestones
Anticipated Milestone Potential Timeframe
Announcement that our IND for Annamycin has become effective and that we may begin clinical trials End of July 2017
IRB (Institutional Review Board) approvals and site initiations of various clinical sites participating in our Phase I/II clinical trial of Annamycin Second Half of 2017
Establishment of a new MTD for Annamycin Second Half of 2017
A clinician sponsored IND for WP1066 for treatment of adult brain tumors moving forward Second Half of 2017
Announcement of Phase II data for Annamycin 2018
Announcement of further benefits of our sponsored research agreement with MD Anderson 2018

Walter Klemp, Chairman and CEO of Moleculin, stated: "We remain focused on developing the CMC data needed to submit our IND to move forward with the FDA by the end of July and to allow for clinical trials to begin. Additionally, we are pleased to have Theradex Systems as our CRO for our planned Phase I/II clinical trial for Annamycin. As we transition from a preclinical to a clinical stage company, we will continue to provide updates on our upcoming key milestones. We believe we have sufficient funds to pursue our planned operations into the first quarter of 2018."

Unaudited Financial Results for the Quarter Ended March 31, 2017

Research and development (R&D) expense was $0.68 million and $0.02 million for the three months ended March 31, 2017 and 2016, respectively. The increase of approximately $0.66 million is mainly due to the Company becoming fully operational post its June 1, 2016 Initial Public Offering ("IPO"). The difference mainly consists of increases of $0.15 million in sponsored research and research consultants, $0.13 million in employee related costs, $0.14 million in manufacturing and stability costs associated with the Company's IND application, $0.1 million in regulatory counsel, $0.07 million in costs associated with the Company's licenses, and $0.07 million of other costs. This increased activity represents the Company's efforts in obtaining Orphan Drug designation for Annamycin and its associated IND application with the FDA.

General and administrative ("G&A") expense was $0.85 million and $0.31 million for the three months ended March 31, 2017 and 2016, respectively. The expense increase of approximately $0.54 million is mainly due to the Company becoming fully operational post its June 1, 2016 IPO. Specifically, these increases were attributable to $0.25 million associated with added headcount and associated payroll costs, $0.23 million in legal, auditing, and accounting costs, and $0.06 million in other G&A costs.

The Company recorded a gain of $1.06 million in the first quarter of 2017 for the change in fair value on revaluation of its warrant liability associated with the warrants issued in conjunction with its stock offering on February 14, 2017. The Company is required to revalue certain of its 2017 warrants at the end of each reporting period and reflect in the statement of operations a gain or loss from the change in fair value of the warrant in the period in which the change occurred. A gain results principally from a decline in the Company's share price during the period and a loss results principally from an increase in the Company's share price.

During the period, the Company settled a previously incurred expense utilizing shares of its common stock with an attributed value of $3.00 per share. The gain of $0.15 million reflects the difference in the Company's share price in the open market as of the settlement date and $3.00 per share.

Interest expense includes expense accrued on convertible promissory notes issued in 2015 and 2016 bearing interest at the rate of 8% per annum.

The net loss for the three months ended March 31, 2017 was $0.33 million, which included the non-cash gains mentioned above aggregating to $1.21 million. Excluding this amount, the net loss for the period was $1.54 million, which is an increase of $1.21 million over the previous years' $0.33 million net loss. Included in both net loss numbers for the three months presented was $0.11 million and $0.00 million for the 2017 and 2016, respectively, in stock based compensation.

As of March 31, 2017, the Company had $8.88 million of cash and cash equivalents compared to $5.00 million at December 31, 2016. In February 2017, Moleculin completed a public offering of its common stock and warrants, pursuant to which it received approximately $4.5 million in net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses. Additionally, during the three months ended March 31, 2017, $0.80 million in cash was received due to warrants being exercised. Cash used in operations was $1.39 million for the first quarter of 2017. The Company believes that its existing cash and cash equivalents as of March 31, 2017 continues to be sufficient to fund planned operations into the first quarter of 2018.

(Tables to follow)

About Moleculin Biotech, Inc.Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Forward-Looking StatementsSome of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. Forward looking statements in this press release include our IND for Annamycin becoming effective so that we may begin clinical trials, our ability to receive the necessary IRB approvals to initiate our Phase I/II clinical trial of Annamycin, our ability to establish a new MTD for Annamycin, the ability of MD Anderson to move forward with an IND for WP1066 for treatment of adult brain tumors, our ability to announce grant funding for a clinical trial of WP1066 for treatment of rare childhood brain tumors, and our ability to announce Phase II data for Annamycin. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," ''might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Moleculin Biotech, Inc.
Balance Sheets

Go here for full Balance Sheet and more:  https://finance.yahoo.com/news/moleculin-biotech-inc-reports-financial-113000667.html

Contact
PCG Advisory Group
Kirin Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

Moleculin Biotech to Present at Joseph Gunnar & Co. PIONEERS 2017 Conference
 

HOUSTON, TX -- 04/26/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center ("MD Anderson"), today announced that Walter Klemp, Chairman and CEO, will present a corporate overview at Joseph Gunnar & Co.'s PIONEERS 2017 conference. The investment conference will be held at the Mandarin Oriental Hotel in New York City on Tuesday, May 2, 2017 and the Moleculin presentation will start at 2:30 pm ET. Mr. Klemp will also participate in one-on-one investor meetings during the conference.

The presentation will be webcast live at http://wsw.com/webcast/pioneers2/mbrx, and available for replay at: www.moleculin.com.

For more information about the conference or to schedule a one-on-one meeting with Moleculin please contact your Joseph Gunnar & Co. representative or e-mail conference@jgunnar.com.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the offering, please visit http://www.moleculin.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," ''might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our Form 10-K for year ended December 31, 2016 filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contact
PCG Advisory Group
Kirin Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.

 

Moleculin Biotech Appoints Theradex Systems as CRO to Manage Phase I/II Annamycin Trial
 

HOUSTON, TX -- 04/11/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center ("MD Anderson"), today announced that it has appointed Theradex Systems, Inc. as its contract research organization ("CRO") for its planned Phase I/II clinical trial for Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML").

Walter Klemp, Chairman and CEO of Moleculin stated: "We are pleased to announce this key milestone. We selected Theradex for their extensive US and international expertise with clinical research and development of pharmaceutical compounds in the areas of oncology and life-threatening diseases, including considerable experience with AML. Engaging Theradex is a key step in preparing to initiate our Phase I/II clinical trial for Annamycin and we look forward to moving ahead with them as we continue to work with the FDA on our IND, which must go into effect for clinical trials to begin. We are confident in Theradex's ability to assist us in executing a high-quality and efficient trial."

About AML

Leukemia is a cancer of the white blood cells and the acute forms of leukemia can manifest quickly and leave patients with limited treatment options. AML is the most common type of acute leukemia in adults. It occurs when a clone of leukemic progenitor white blood cells proliferates in the bone marrow suppressing the production of normal blood cells. In order to qualify for a curative bone marrow transplant, patients must first undergo induction therapy. The current standard of care is the combining of 2 chemotherapeutic drugs, always including an anthracycline intended to induce a CR or complete response, which has not improved since it was first used in the 1970's. We estimate that it has the same cure rate of about 20% as then. Currently, the only viable long term option for acute leukemia patients is a bone marrow transplant for those 20%, which is successful in a significant number of patients. For more information on AML click: http://www.moleculin.com/technology/about-acute-myeloid-leukemia/.

About Annamycin

Annamycin is an anthracycline intended for the treatment of relapsed or refractory AML. Annamycin is a unique liposome formulated anthracycline (also referred to in literature as "L-Annamycin") that has been designed to produce little to no cardiotoxicity and avoid the multidrug resistance mechanisms that often defeat current anthracyclines. It has been tested in 114 patients in 6 clinical trials, 3 of which focused on leukemia, with little to no cardiotoxicity. The Company is working with the FDA on an investigative new drug application for a Phase I/II trial for second line treatment of relapsed or refractory AML, for which no approved therapy currently exists.

About Theradex Systems, Inc.:

Theradex Systems, Inc. is an international contract research organization providing complete professional services for the clinical research and development of pharmaceutical compounds, medical devices and diagnostic tests in the areas of oncology and life-threatening diseases. Theradex conducts studies that lead to marketing approval of significant medical advances; and has built a reputation on assuring the scientific objectivity and meticulous quality control that fulfills all regulatory requirements. Theradex's expertise is also available to assist client personnel in expedited development planning and execution. Find out more at www.theradex.com

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about the offering, please visit http://www.moleculin.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, FDA permitting the Company sponsored IND for Annamycin to go into effect and the successful execution of a Phase I/II clinical trial for AML. These statements relate to future events, future expectations, plans and prospects. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," ''might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our Form 10-K for year ended December 31, 2016 filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contact
PCG Advisory Group
Kirin Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.

 

Moleculin Receives Orphan Drug Designation for Annamycin for the Treatment of Acute Myeloid Leukemia
 

HOUSTON, TX -- 03/22/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced its lead candidate, Annamycin (also known as "Liposomal Annamycin"), an anthracycline, has received Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML).

Moleculin's Chairman and CEO, Walter Klemp, commented, "We are pleased to report this key milestone and the FDA's decision to grant Annamycin orphan drug designation. We look forward to announcing additional milestones in regard to our clinical pathway as we make further progress."

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

About AML

Leukemia is a cancer of the white blood cells and the acute forms of leukemia can manifest quickly and leave patients with limited treatment options. AML is the most common type of acute leukemia in adults. It occurs when a clone of leukemic progenitor white blood cells proliferates in the bone marrow suppressing the production of normal blood cells. In order to qualify for a curative bone marrow transplant, patients must first undergo induction therapy. The current standard of care is the combining of 2 chemotherapeutic drugs, always including an anthracycline intended to induce a CR or complete response, which has not improved since it was first used in the 1970's. We estimate that it has the same cure rate of about 20% as then. Currently, the only viable long term option for acute leukemia patients is a bone marrow transplant for those 20%, which is successful in a significant number of patients. For more information on AML click: http://www.moleculin.com/technology/about-acute-myeloid-leukemia/.

About Annamycin

Annamycin is an anthracycline intended for the treatment of relapsed or refractory AML. Annamycin is a unique liposome formulated anthracycline (also referred to in literature as "L-Annamycin") that has been designed to produce little to no cardiotoxicity and avoid the multidrug resistance mechanisms that often defeat current anthracyclines. It has been tested in 114 patients in 6 clinical trials, 3 of which focused on leukemia, with little to no cardiotoxicity and 3 of those clinical trials focused on leukemia. The Company is working with the FDA on an investigative new drug application for a Phase I/II trial for second line treatment of relapsed or refractory AML, for which no approved therapy currently exists.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about Moleculin, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on February 7, 2017, as amended (Registration No. 333-214898). Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.

 

Moleculin to Present at the 29th Annual Roth Capital Conference
 

Presentation Scheduled for Wednesday, March 15th at 9:00 am PT


HOUSTON, TX -- 03/10/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that it will present at the upcoming 29th Annual Roth Conference, which will take place from March 12-15, 2017 at The Ritz-Carlton, Laguna Niguel in Dana Point, California.

The presentation is scheduled for Wednesday, March 15, 2017 at 9:00 am PT (12:00 PM ET). Moleculin's Chairman and CEO, Walter Klemp and Jonathan Foster, CFO, will be available to meet with investors who are registered to attend the conference. If you are an investor and wish to attend the Company's presentation or schedule a meeting, please click the following link: http://www.roth.com/main/page.aspx?PageID=7280.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about Moleculin, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on February 7, 2017, as amended (Registration No. 333-214898). Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.

 

Moleculin Announces Expanded Scientific Advisory Board



NEW YORK, NY and HOUSTON, TX -- January 19, 2017 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, many of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced that Drs. Sandra Silberman and Paul Waymack have joined the Company’s Scientific Advisory Board (SAB). The Company’s current SAB also includes Dr. Waldemar Priebe (Chair) and Dr. Madeleine Duvic.

Moleculin’s Chairman and CEO, Walter Klemp, commented, “We are pleased to have attracted Drs. Sandra Silberman and Paul Waymack to our distinguished team of scientific advisors and look forward to their contributions. We strongly believe that enlisting and consulting with highly competent scientific advisors, especially as we enter into a critical period, is key to our future success. We have already been working closely with both of these advisors in our preparation of our IND submission for Annamycin and it’s an honor to have them now formally join our SAB. Clearly their deep scientific expertise at large pharmaceutical companies, top Universities and hospitals, as well as their contacts and overall knowledge base will be extremely helpful.”

Dr. Silberman’s career in clinical development began at Pfizer, Inc., where she oversaw the initiation of Tarceva (TM) clinical trials. She then led the global development of Gleevec« at Novartis. Sandra was the first Vice President and Global Therapeutic Area Head in Oncology at Eisai, a role in which she advanced five original compounds into Phases I through III, gaining the first approval for Eisai’s proprietary drug, Halavan«. Subsequently, she served as a senior advisor to a number of biopharmaceutical companies, including Bristol-Myers Squibb, AstraZeneca, Imclone, Roche, and numerous biotech companies as an independent industry consultant. She joined Quintiles in 2009 as the Vice President of Oncology and Global Head of Translational Medicine in the newly formed Innovation division, overseeing drug development and novel technologies for new partnerships with the pharmaceutical and biotechnology industries. Sandra earned her B.A., Sc.M. and Ph.D. from the Johns Hopkins University School of Arts and Sciences, School of Public Health and School of Medicine, respectively. Her major focus of investigation and doctoral thesis was in the burgeoning area of tumor immunology. She received her M.D. from Cornell University Medical College, completing a postdoctoral training and her fellowship in hematology/oncology at the Brigham & Women's and the Dana Farber Cancer Institute in Boston. She continued to do research in tumor immunology with a clinical investigator award from the NIH and became an Instructor in Medicine at Harvard Medical School. She then served as an attending physician at Yale University Hospital. Sandra has continued in clinical practice throughout her career in industry, and is currently an attending physician in the Hematology/Oncology clinic at the Duke VA in Durham, NC.

Dr. Waymack has served as CMO of Kitov Pharmaceuticals since July 2013 and brings over 20 years' experience in the biopharmaceutical field. A former academic transplant surgeon and FDA medical officer, Dr. Waymack has over 20 years' experience as a drug development consultant for major pharmaceutical companies, including Pfizer, Roche, Pharmacia, Warner Lambert and Searle. During his 10-year academic career, Dr. Waymack published over 100 scientific essays, mainly in the fields of prostaglandins and immunology. In addition, he was commissioned and served as a Major in the US Army Medical Corps in the position of Chief of Surgical Research at the Institute for Surgical Research. Paul was also an Associate Professor of Surgery at the University of Texas Medical Branch and at the University of Medicine and Dentistry of New Jersey.

For more information on Moleculin’s Scientific Advisory Board: http://www.moleculin.com/company/scientific-advisors/

About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase I/II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors.

For more information about Moleculin, please visit http://www.moleculin.com

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the results of the FDA’s review of our IND submission. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on January 18, 2017, as amended (Registration No. 333-214898). Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com
 

Source: Moleculin Biotech, Inc.
 

 

Moleculin Presents Preclinical Data of Novel Inhibitor of Glycolysis at 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics



NEW YORK, NY and HOUSTON, TX -- December 13, 2016 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, many of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced its scientific presentation at the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Waldemar Priebe, PhD, Moleculin’s Founder, Founding Scientist, and Chair of the Scientific Advisory Board presented the Abstract on November 30th at the Symposium in Munich, Germany.

Wally Klemp, Chairman and CEO stated, “This presentation shows proof of concept data for our WP1122 portfolio, including data demonstrating increased survival of animals with human brain tumors treated with WP1122, as well as its biodistribution and pharmacokinetics. In non-optimal doses and treatment regimens, our lead inhibitor WP1122 performed equal to or better than the current market leader, cytotoxic drug temozolomide and significantly improved survival in animals treated with WP1122 in combination with temozolomide.”

The following is an overview of the presentation, titled “Latentiation of 2-deoxy-D-glucose”. No curative therapy exists for patients with high-grade malignant gliomas (GBMs). New approaches to the treatment of this disease are currently being evaluated with mixed results. One approach, that deserves to be therapeutically exploited, is targeting brain tumor metabolism. 2-Deoxy-D-glucose (2-DG), a known effective inhibitor of glycolysis, has been clinically tested but results did not meet expectations due to poor drug-like characteristics and inability to achieve therapeutic concentrations of 2-DG in the brain.

Dr. Waldemar Priebe stated, “We proposed to use latentiation of 2-DG to overcome this problem by chemically modifying biologically active 2-DG to form prodrugs with increased brain uptake that will be able to liberate in vivo the parent compound 2-DG in the brain. In our approach, we synthesized a series of differentially acetylated derivatives of 2-DG. Preliminary in vivo studies in mice of selected diacetates of 2-DG demonstrated >9 fold increased levels of 2-DG in the brain when compared with levels of 2-DG after administration of equimolar amount of 2-DG itself. Ultimately, our studies focused on a single compound 3,6-di-O-acetyl-2-deoxy-D-glucose (WP1122).”

Compound WP1122 was administered in vivo without toxic death up to the highest feasible dose of 3.0 g/kg intravenously and orally up to 6.0 g/kg. Significantly increased survival, comparable to or better than that of temozolomide, was observed for orally administered WP1122 in a U87 orthotopic glioma model at a dose of 1.25 g/kg. These promising results prompted continuation of preclinical toxicology evaluation of WP1122 aimed at the initiation of formal IND enabling studies. In addition, the proof of concept delivered by WP1122 has provided not only an effective approach to develop novel agents able to effectively cross the blood brain barrier but also a method to create a new class of dual function prodrugs by exploring biologically active acids.

Moleculin’s Chairman and CEO, Walter Klemp, concluded, “We are excited to present our results at this prestigious symposium. Clearly, the significantly increased survival data is key, especially as no curative therapy exists for patients with high-grade malignant gliomas today. We look forward to presenting additional data as we progress toward our clinical timeline.”

For more information on the Symposium click: http://www.ecco-org.eu/ENA2016.

About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and recruitment of the patient’s own immune system, the other targeting tumor specific metabolism.

For more information about Moleculin, please visit http://www.moleculin.com

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability to achieve future promising results of preclinical toxicology evaluation of WP1122 sufficient to initiate formal IND enabling studies and the acceptance of the patent application filed. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on February 1, 2016, as amended (Registration No. 333-209323). Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com
 

Source: Moleculin Biotech, Inc.
 

 

Moleculin Announces Positive FDA Guidance Regarding Annamycin IND



Company Signals Earlier Start to Next Clinical Trial & Expects to File IND Submission before Year-End


NEW YORK, NY and HOUSTON, TX -- November 17, 2016 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has received verbal positive guidance from the FDA regarding its planned IND submission indicating that the Company may incorporate by reference the IND established by a prior developer.

Moleculin’s Chairman and CEO, Walter Klemp, commented, “this new positive guidance removes a major question mark and allows us to create a tighter timeline for the estimated beginning of our next clinical trial. To be clear, we still can’t rule out the possibility of a delay in the timeline, but with the knowledge that the FDA is encouraging us to simply incorporate by reference the prior developer’s IND, we believe we can accelerate our IND submission process. On our current path, we expect to be able to file our IND submission before year end. Barring a negative surprise from the FDA’s review of our submission, that should allow us to begin treating patients in our next clinical trial several months sooner than expected.”

The Company has indicated in previous disclosures that it expected to begin its next clinical trial by the first half of 2017, however this development may reduce that time frame by several months. The Company has submitted a pre-IND briefing document to the FDA along with key questions regarding its clinical development plan and a request for a meeting, if the FDA deems it necessary. The FDA recently indicated in writing that it intends to provide written responses to the Company by December 6, 2016 and that it does not believe a live meeting is necessary. Once those written responses are received, the Company will adjust its final IND submission document accordingly and submit for final FDA review. IND submissions are normally reviewed within 30 days of filing.

The beginning of the Company’s next clinical trial for Annamycin will depend on many things, including but not limited to the absence of any objections by the FDA to the Company’s IND submission, review and approval by an appropriate Institutional Review Board (IRB) representing the proposed clinical site or sites, and the ultimate recruitment of patients by qualified clinical testing sites.

Dr. Don Picker, Moleculin’s COO added, “based on this positive guidance, we have already begun discussions with suitable testing sites so that we can begin recruiting as soon as we have IRB approval. We intend to hit the ground running as soon as the IND is active.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors.

For more information about Moleculin, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the results of the FDA’s review of our IND submission, the timing of the FDA’s review of our IND submission and our ability to commence our clinical trial several months earlier than expected, and the approval by an appropriate IRB representing the proposed clinical site or sites and the ultimate recruitment of patients by qualified clinical testing sites. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on February 1, 2016, as amended (Registration No. 333-209323). Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
 

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

Moleculin Announces Advancement of Preclinical Testing for Brain Tumor Drug WP1122



Positive Data Leads to Acceleration of Preclinical Toxicology Testing


NEW YORK, NY and HOUSTON, TX -- October 26, 2016 -- Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced promising initial results of the preclinical toxicology work that has begun for WP1122, a unique inhibitor of glucose metabolism, which is an important driver of glycolytic brain tumor progression and survival.

The Company indicated that preliminary escalating single dose toxicity testing in mice (oral administration) was successfully completed and even at the highest possible dose, no toxic death was observed. In multiple therapeutic doses, WP1122 was well tolerated during intense twice-daily oral dosing. The Company plans to move forward with completing the preclinical toxicology package in order to generate proof of concept in humans.

Moleculin’s Chairman and CEO, Walter Klemp, commented, “as the newest of our technologies, we are pleased to see development work move to the next level. WP1122 has received significant attention from the scientific community as a promising new approach to treating brain tumors. Part of the excitement relates to the unusual nature of WP1122 and its design allowing for high brain uptake and retention. The design uses an alteration similar to that which turns morphine into heroine and enables rapid brain uptake. A similar alteration to our drug allows it to successfully enter the brain in high quantities and increases its circulation time.”

Prior to this announcement, the Company had previously announced the presentation of promising preclinical data in July of this year (Moleculin Announces Data on WP1122 Presented at the 28th Annual International Carbohydrate Symposium), supporting the potential for using WP1122 as a treatment for glioblastoma.

No curative therapy exists for patients with high-grade brain tumors and new approaches to the treatment of this disease are urgently needed. One new approach to tackling this problem has been to focus on shutting down the metabolism of tumor cells, which can be highly dependent on glucose for continued survival and proliferation. WP1122 has been shown both in vitro and in vivo to induce a destruction of glioma cells, the most aggressive form of brain tumor, by essentially “starving” them. Its translational potential as a drug for brain tumors in general and glioma in particular is promising due to its improved circulation time as well as its increased brain uptake.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors.

For more information about Moleculin, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability to successfully generate a proof of concept in humans for WP1122. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on February 1, 2016, as amended (Registration No. 333-209323). Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

 

Moleculin Announces Reminder for Conference Call to Discuss Positive Developments Regarding Annamycin


Call Scheduled for Today to Include General Corporate Update


NEW YORK, NY and HOUSTON, TX -- October 20, 2016 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced a reminder that it will host a conference call to discuss important positive developments regarding Annamycin, its drug candidate for the treatment of Acute Myeloid Leukemia, as well as to provide a general corporate update.

The call will be held today, October 20, 2016 at 5:00 pm Eastern Time and can be accessed with the following dial-in information:

Participant dial in (toll free): 1-877-418-3859
Participant international dial in: 1-412-902-6506

Please ask to be joined into the Moleculin call.

Participant Entry Number: 4494430

This conference call will be recorded and made available for replay as follows:

US Toll Free: 1-877-344-7529
International Toll: 1-412-317-0088
Canada Toll Free:1-855-669-9658

Replay Access Code: 10095171

End Date: November 3, 2016

To access the replay using an international dial-in number, please select the link below:

https://services.choruscall.com/ccforms/replay.html

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors.

For more information about Moleculin, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the assertion that recent developments regarding Annamycin will have a positive impact on its development. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on February 1, 2016, as amended (Registration No. 333-209323). Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.



Moleculin Announces Accelerated Plan for Clinical Trial Drug Production


Secures Assistance From European Partner, Reducing Expenditure and Time to Begin Clinical Trials for Annamycin


NEW YORK, NY and HOUSTON, TX -- October 7, 2016 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has secured an agreement with Dermin Sp. Zo. O. ("Dermin") to utilize Dermin's supply of Annamycin for its upcoming clinical trial, substantially reducing the expenditures required of Moleculin for drug product and shortening the time required to produce clinical supplies.

"This was an important agreement and key milestone to be reached as it clearly shortens the pathway as well as lowers the expense involved in our clinical timeline and go to market strategy," commented Walter Klemp, Chairman and Acting CEO of Moleculin. "With this agreement in place, our drug product expense for our upcoming clinical trial will be substantially below what we had previously budgeted. Additionally, Dermin's existing supply alleviates any potential drug production constraints and advances our ability to begin our next trial expeditiously."

Moleculin previously licensed Annamycin to Dermin within a limited region in Europe, enabling Dermin to deploy Polish grant funds toward producing Annamycin. The agreement reached between the two companies allows Moleculin to utilize this Annamycin in its upcoming clinical trials rather than having to produce new Annamycin for its own use. Dermin benefits from a data sharing arrangement giving it access to Moleculin's clinical data on a faster timeline than it would be able develop on its own.

Mr. Klemp concluded, "We are pleased with this key agreement in place and remain focused on our upcoming milestones. We look forward to beginning our expanded clinical trials on Annamycin by the first half of 2017."

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information about Moleculin, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the agreement with Dermin to reduce the expenditures required of Moleculin for clinical trial drug production and to shorten the time required to produce clinical supplies and the ability of Moleculin to begin expanded clinical trials on Annamycin by the first half of 2017. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on February 1, 2016, as amended (Registration No. 333-209323). Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.

 

Moleculin Biotech to Present at OktoberINVESTfest


NEW YORK, NY and HOUSTON, TX -- September 23, 2016 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) today announces its upcoming presentation at the fifth annual OktoberINVESTfest presented by Joseph Gunnar & Co. on September 28, 2016. Walter Klemp, Chairman and Acting CEO will provide an overview of the company and, along with Jonathan P. Foster, Chief Financial Officer and Executive Vice President, will meet with members of the investment community.

Walter Klemp, Chairman and Acting CEO of Moleculin stated, "We are very pleased to have been invited to present at this prestigious investment conference. This is clearly a unique event and an opportunity to expand our European relationships."

The company's presentation at OktoberINVESTfest will be held at 1:40 PM ET at The New York Academy of Sciences at 250 Greenwich Street, 40th Floor, Room 4, in New York City. If you are interested in attending the conference please follow the link: http://www.oktoberinvestfest.com or contact ksmith@pcgadvisory.com to arrange a meeting.

About OktoberINVESTfestOur 5th Annual Investors conference, the OktoberINVESTfest aims to foster innovation and transatlantic investment by enabling financiers to learn about selected high quality American and German unique investment opportunities, both public and private in the sectors of life science and IT. This high energy event is hosted by Invest in Bavaria, the investment promotion agency of Germany's largest, most innovative state, Bavaria with capital city Munich. Munich, as rated by the European Commission, is Europe's #1 tech hub! Likewise, Bavaria is a premier region in Europe for medical devices and biotech. The 2016 program will feature distinguished panelists and speakers complemented by power networking at our Unconference Luncheon. Throughout the day some 40 U.S. and German top investment opportunities will present their innovations and businesses in life sciences and information technology to investors. Simultaneously U.S. and German investors and business leaders will share ideas on how to finance innovation and business expansion and opportunities will be discussed during 1 on 1 meetings. The conference portion of the event will close with a presentation of Bavarian Innovations.

Invest in BavariaInvest in Bavaria is the investment and location marketing organization of the German state of Bavaria's Ministry for Economic Affairs, Media, Energy and Technology. The Bavarian U.S. Offices for Economic Development, LLC, is the representative organization for Invest in Bavaria in the United States. Our New York - NY, New Haven - CT, Cambridge - MA and San Francisco - CA offices are three of the 26 representative offices of Invest in Bavaria's global network. It is our mission to assist U.S. companies to expand and grow their businesses in Bavaria and likewise be the first point of contact for Bavarian companies considering U.S. expansion. Our services are cost-free and confidential. We look forward to assisting you and welcoming you to Germany's largest, most productive and innovative state, Bavaria.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

For more information, please visit http://www.moleculin.com

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the application for Orphan Drug status and the potential for accelerated approval pathway for Annamycin, the potential to conduct a Phase IIb clinical trial for liposomal Annamycin, the ability to strengthen the Company's license and IP portfolio, and continued development of pipeline assets. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," ''might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on February 1, 2016, as amended (Registration No. 333-209323). Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor/Media Contact

PCG Advisory Group
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Source: Moleculin Biotech, Inc.
 

------------------------------------------------------------
About Moleculin Biotech:

Moleculin Biotech, Inc. is preclinical and clinical-stage pharmaceutical company focused on the development of game-changing anti-cancer drug candidates, many of which are based on discoveries made at M.D. Anderson Cancer Center, the world’s largest cancer research facility headquartered within the world’s largest medical center. Each of our projects represents a breakthrough discovery and a highly disruptive technology.

Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML.

Unlike current therapies that risk cardiotoxicity and can have their effectiveness limited due to multidrug resistance, Annamycin appears capable of avoiding both of these problems and has already demonstrated the ability to save lives in clinic. We are now preparing to seek accelerated approval for this game-changing drug.

We also have two active pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target cell signaling mechanisms and appears capable stimulating the patient’s natural immune system while also attacking tumors directly. The other portfolio targets the metabolism of tumors and exploits a unique approach for crossing the blood brain barrier for the treatment of glioblastoma and other central nervous system malignancies.

Company Overview

Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, many of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two active pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

Company Profile

Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, many of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two active pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.

Business Description

Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, many of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two active pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.


Annamycin

annamycinAnnamycin is an anthracycline intended for the treatment of relapsed or refractory AML. The therapy of combining two chemotherapeutic drugs, which always includes an anthracycline, in inducing a remission of leukemic cells (called “induction therapy”) has not improved since it was first used in the 1970s and we estimate that this induction therapy has the same cure rate of about 20% as at that time. Currently, the only viable long term option for acute leukemia patients is a bone marrow transplant, which is successful in a significant number of patients. However, in order to qualify for a bone marrow transplant, patients must first undergo induction therapy.

One of the leading anthracyclines used for induction therapy in acute leukemia patients is doxorubicin, which has reported over $700 million in annual revenues. Despite the importance and success of approved anthracyclines like doxorubicin, they are all unfortunately cardiotoxic, which can result in damage to the heart and limit the dosage amount that may be administered to patients. Additionally, the tumor cells being treated often have or develop resistance to the first line anthracycline, often through what is called “multidrug resistance” making them capable of purging themselves of the current anthracyclines and limiting the effectiveness of the therapy. Consequently, there remains no effective therapy for these patients and most will succumb quickly to their leukemia. This is where we believe Annamycin can be a complete game-changer.

Annamycin is a unique liposome formulated anthracycline (also referred to in literature as “L-Annamycin”) that has been designed to eliminate cardiotoxicity and avoid the multidrug resistance mechanisms that often defeat current anthracyclines. It has been tested in 6 clinical trials and 114 patients without any reporting of cardiotoxicity and in 2 of those clinical trials focused on leukemia, it showed fewer dose-limiting toxicities than are normally experienced with doxorubicin (one of the leading first-line anthracyclines used for induction therapy).

Annamycin demonstrated efficacy in 8 of 16 patients in a Phase I study in adult relapsed or refractory AML patients, with 6 of 14 patients completely clearing leukemic blasts. A 30 patient dose-ranging Phase I/II study in acute lymphocytic leukemia demonstrated a similar efficacy profile, with 3 of 10 patients treated with the maximum tolerable dose clearing their leukemic blasts to a level sufficient to qualify for a bone marrow transplant. One of these patients went on to receive a successful curative bone marrow transplant.

We believe Annamycin is better than the currently approved induction therapy drugs in four key ways: (i) it has demonstrated clinical activity in a patient population for whom there are currently no effective therapies, (ii) it appears to be capable of avoiding the “multi-drug resistance” mechanisms that often limit the effectiveness of currently approved anthracyclines; (iii) it has been shown to be non-cardiotoxic in animal models, when compared with doxorubicin and no events of cardiotoxicity have been reported from the use of Annamycin in 114 patients; and (iv) in laboratory studies using AML cell lines, it has been shown to be more potent than the leading approved drug.

Based on initial conversations with the FDA, because of this serious unmet medical need, we believe Annamycin may qualify for a “Special Protocol Assessment” providing for accelerated approval based on our planned Phase II clinical trial. We also believe Annamycin will qualify for Orphan Drug status, which could entitle us to market exclusivity of up to 7 and 10 years from the date of approval of a New Drug Application (NDA) and Marketing Authorization (MA), in the US and the European Union (EU), respectively.

This resistance to therapy is often the result of molecular “pumps” in tumor-cell membranes that actively expel chemotherapy drugs from the interior. This allows tumor cells to avoid the intended toxic effects of the drug.

As MDR begins to counteract chemotherapy drugs, it can require higher and higher doses to kill tumor cells, yet the unwanted side effects of the drugs, like cardiotoxicity, ultimately prevent such increases in dosing.

Two kinds of pumps commonly responsible for multidrug resistance in cancer are P-glycoprotein (P-gp) and the so-called multidrug resistance–associated protein (MRP). Because of their role in MDR, they have been the targets of several anticancer efforts. Unfortunately, efforts to block the activity of these pumps have resulted in serious side effects because they also play an important role in normal cell function.

Our most advanced therapy, Annamycin, represents a much-needed breakthrough in the battle against multidrug resistance. Its unique design prevents it from being recognized by MDR pumps, allowing Annamycin to avoid the multidrug resistance mechanisms that often defeat current therapies.

Multidrug Resistance

cellMultidrug Resistance (MDR) refers to mechanisms by which many cancers develop resistance to chemotherapy drugs and is a major factor in the failure of many forms of chemotherapy. It affects patients with a variety of blood cancers and solid tumors, including breast, ovarian, lung, and lower gastrointestinal tract cancers. Tumors usually consist of mixed populations of malignant cells, some of which are drug-sensitive while others are drug-resistant. Chemotherapy kills drug-sensitive cells, but leaves behind a higher proportion of drug-resistant cells. As the tumor begins to grow again, chemotherapy may fail because the remaining tumor cells are now able to recognize the chemotherapy and reject it at the cellular level, thus rendering it resistant to the therapy.

Management & Business Advisors

WALTER V. KLEMP
Founder, Chairman, CEO, and Business Advisory Board Member

Walter Klemp has been our Co-Founder, Chairman and CEO since 2007. Mr. Klemp has 29 years of experience in start-up and high-growth companies, the past nine of which have been spent developing FDA-approved dermatology therapy devices and topical compounds.

Mr. Klemp was also President and CEO of Zeno Corporation from 2004 to 2010, where he successfully developed and marketed a number of dermatology devices and drugs from concept through FDA approval.

Previously, Mr. Klemp served as Founder, CEO and Chairman of Drypers Corporation, a publicly traded multinational consumer products company, from 1987 to 2000. At Drypers, Mr. Klemp developed growth strategies, orchestrated mergers and acquisitions, and grew the company from start-up to $400 million in annualized sales and to a #1 ranking on the INC 500. Notably, he has overseen nearly $750 million in public and private financings throughout his career.

DONALD PICKER, PHD
President and Chief Operating Officer

Donald Picker, PhD, joined the Moleculin team in 2009 with over 35 years of drug development experience. At Johnson Matthey, Dr. Picker was responsible for the development of Carboplatin, one of the world’s leading cancer drugs, acquired by Bristol-Myers Squibb and with annual sales of over $500 million. He also oversaw the development of Satraplatin and Picoplatin, third-generation platinum drugs currently in late-stage clinical development.

Dr. Picker has significant experience in dermatological pharmaceutical discovery and development as well, having led projects for topical therapies in psoriasis, atopic dermatitis and acne.

ROBERT SHEPARD, MD, FACP
Chief Medical Officer

Dr. Robert Shepard has extensive research credentials in hematology and oncology and is board certified in oncology, hematology and internal medicine. He has a wide array of experience in translational medicine and clinical research and has been actively involved in oncology research since 1970, responsible for the complete clinical development of several drugs and immune therapies for biopharmaceutical companies, including serving as the consulting Chief Medical Officer for six companies. Dr. Shepard is a Magna Cum Laude graduate of Harvard University in biochemical sciences and molecular biophysics and studied in the Harvard-M.I.T. Health Sciences program. He held fellowships in hematology and oncology at the Tufts-New England Medical Center where he conducted laboratory research in leukemias, myeloma and myelodysplasia, as well as fellowship in pharmacology and molecular genetics at the Dana-Farber Cancer Center and Harvard Medical School. Dr. Shepard holds academic appointments at Harvard University, Tufts University and the University of Virginia.

LOUIS PLOTH JR.
Chief Financial Officer

Louis Ploth has over 30 years of domestic and international business experience in public and private companies ranging from start-ups to mid-size public corporations. Mr. Ploth has served as a Board Member, Chief Financial Officer, Chief Accounting Officer, VP of Business Development and General Manager of Operations.

Mr. Ploth has managed several public offerings, private placements and venture rounds accumulating more than $100 million. He has also completed various corporate transactions including an out-licensing agreement with deal terms of $20 million in up-front and first year payments, $37.5 million in milestone payments and high double-digit escalating royalties.

Mr. Ploth has experience with product in-licensing, royalty stream repurchasing, financial aspects of product clinical development, product out-licensing and product launch.

LORI H. BISSON
Business Advisory Board Member

Lori Bisson is a Co-Founder of Moleculin, a Director and our acting CFO. Ms. Bisson brings a wealth of experience in consumer products and regulated environments from her tenure with both Zeno Corporation and Drypers Corporation. She also serves as the CFO for a medical device company.

Previously, Ms. Bisson was CFO of Zeno Corporation from 2005 to 2008. She also served as CFO of Gulfstream Trading, Ltd., a privately held $1.5 billion oil trading company.

Ms. Bisson received her CPA license while working as an auditor with Arthur Andersen.

New hope for acute leukemia patients…

In a Phase II clinical trial, Annamycin was given to patients who had failed an average of five previous induction therapy attempts, and 30% of those patients cleared enough of their leukemic cells to qualify for a bone marrow transplant. This kind of performance, if repeated in a larger clinical trial, could make Annamycin a potential blockbuster new drug. And, Annamycin’s unique lack of cardiotoxicity could be a game-changer for pediatric patients.

Tackling the most difficult cancers…

By reducing the activity of certain tumor supporting transcription factors, tumor cells lose their ability to survive and reproduce. By increasing the activity of other transcription factors, WP1066 actually calls the patient’s natural immune system into action. Importantly, this has been shown in some of the most difficult cancers to treat, such as pancreatic cancer and metastatic melanoma.

Breaking through to brain tumors…

Brain tumors are among the most difficult cancers to treat, largely because of something called the “blood brain barrier”. WP1122 was specifically designed to slip past the blood brain barrier, using the same chemical trickery that converts morphine into heroin. We compared WP1122 to the current standard of care, temozolomide, in live human brain tumors transplanted into mice and demonstrated that WP1122 is capable of outperforming temozolomide.
 

SOURCE: http://www.moleculin.com/




Disclaimer

FN Media Group LLC (FNMG) owns and operates FinancialNewsMedia.com (FNM) which is a third party publisher that disseminates electronic information through multiple online media channels. FNMG's intended purposes are to deliver market updates and news alerts issued from private and publicly trading companies as well as providing coverage and increased awareness for companies that issue press to the public via online newswires. FNMG and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNMG's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. The companies that are discussed in this release may or may not have approved the statements made in this release. Information in this release is derived from a variety of sources that may or may not include the referenced company's publicly disseminated information. The accuracy or completeness of the information is not warranted and is only as reliable as the sources from which it was obtained. While this information is believed to be reliable, such reliability cannot be guaranteed. FNMG disclaims any and all liability as to the completeness or accuracy of the information contained and any omissions of material fact in this release. This release may contain technical inaccuracies or typographical errors. It is strongly recommended that any purchase or sale decision be discussed with a financial adviser, or a broker-dealer, or a member of any financial regulatory bodies. Investment in the securities of the companies discussed in this release is highly speculative and carries a high degree of risk. FNMG is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. This release is not without bias, and is considered a conflict of interest if compensation has been received by FNMG for its dissemination. To comply with Section 17(b) of the Securities Act of 1933, FNMG shall always disclose any compensation it has received, or expects to receive in the future, for the dissemination of the information found herein on behalf of one or more of the companies mentioned in this release. For current services performed FNMG has been compensated three thousand nine hundred dollars for Moleculin Biotech, Inc. news coverage by the company.  FNMG HOLDS NO SHARES OF Moleculin Biotech, Inc.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNMG undertakes no obligation to update such statements.