UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): March 16, 2020
MOLECULIN-LOGO_HORIZA27.JPG
MOLECULIN BIOTECH, INC.
(Exact Name of Registrant as Specified in its Charter)
DELAWARE
001-37758
47-4671997
(State or Other Jurisdiction of Incorporation or Organization)
(Commission File No.)
(I.R.S. Employer Identification No.)

5300 Memorial Drive, Suite 950, Houston ,TX 77007
(Address of principal executive offices and zip code)

(713) 300-5160
(Registrant’s telephone number, including area code)
(Former name or former address, if changed from last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c)).
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).                Emerging growth company [X]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [X] Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol (s)
Name of each exchange on which registered
Common Stock, par value $.001 per share
MBRX
The NASDAQ Stock Market LLC


Item 1.01    Entry into a Material Definitive Agreement.
    
On March 16, 2020, Moleculin Biotech, Inc. (the "Company") entered into a material transfer agreement with The University of Texas Medical Branch at Galveston, d/b/a UTMB Health ("UTMB"), a health institution of The University of Texas System ("System"), an agency of the State of Texas (the "Agreement"). Pursuant to the Agreement, the Company agreed to provide research material(s) to UTMB. The materials will be used by UTMB to conduct research, specifically to test the effects of 2 deoxyglucose (2DG) and analogues thereof on the infectivity of viruses. The materials to be provided pursuant to the Agreement are subject to patent and technology license agreements the Company has with M.D. Anderson Cancer Center.
In the event that use of the materials results in an invention, improvement, substance, or information, whether or not patentable, and patent applications and patents, if any, which result therefrom (the "Developed Technology"), UTMB has agreed to disclose such Developed Technology, in confidence, to the Company. At the Company’s expense, the Company has the right to file for and obtain patent protection in the name of UTMB, if solely invented by UTMB, or in the name of both parties if jointly invented, for Developed Technology or request UTMB to do so. Any Developed Technology conceived, invented, expressed and/or reduced to practice solely by UTMB in accordance with UTMB’s research shall be solely owned by UTMB. For those inventions determined to be solely owned by UTMB, the Company has been granted an option to negotiate a license in such Developed Technology on a worldwide, exclusive basis the terms of which shall be negotiated by and between the parties in good faith. Any Developed Technology conceived, invented, expressed and/or reduced to practice jointly by UTMB and the Company in accordance with the research performed hereunder shall be deemed Jointly Developed Technology and shall be owned jointly the Company and UTMB.
    
Item 9.01     Financial Statements and Exhibits.

(d)    Exhibits.

Exhibit No.    Description

1.1        Material Transfer Agreement

99.1        Press Release dated March 17, 2020

    
SIGNATURE
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
MOLECULIN BIOTECH, INC.
DATED: March 17, 2020
By: /s/ Jonathan P. Foster
Jonathan P. Foster
Chief Financial Officer    

2


EXHIBIT INDEX

Exhibit No. Description

1.1        Material Transfer Agreement

99.1        Press Release dated March 17, 2020





3


MATERIAL TRANSFER AGREEMENT

THIS AGREEMENT entered into this 23rd day of February, 2020 ("the Effective Date") by and between Moleculin Biotech, Inc., located at 5300 Memorial Drive, Suite 950, Houston, TX 77007("MOLECULIN") and The University of Texas Medical Branch at Galveston, d/b/a UTMB Health (“UTMB”), a health institution of The University of Texas System (“System”), an agency of the State of Texas, located at 301 University Blvd., Galveston, TX 77555-0926, _("Recipient").

Subject to availability, MOLECULIN agrees to provide research material(s) to Recipient. Such material and any related biological material or associated know-how and data that will be received by Recipient from MOLECULIN; and any substance that is replicated or is an unmodified derivative or progeny derived or produced therefrom are covered by this Agreement. All such materials and written information provided to the Recipient shall hereinafter be referred to as the "Material(s)."

1.The Materials will be used by Recipient only in conjunction with the research described in Appendix A and only for non-commercial research purposes. The Materials shall not be used in research that is subject to consulting or licensing obligations to another institution, corporation or business entity, unless written permission is obtained in advance from MOLECULIN.

2.Recipient shall not distribute, release, or disclose the Materials to any other person or entity and shall ensure that no one will be allowed to take or send the Materials to any other location, unless written permission is obtained in advance from MOLECULIN. Subject to section 5 below, Recipient agrees to maintain the confidentiality of this Agreement, the Materials, and any written information of MOLECULIN regarding the Materials, except to the extent such information of MOLECULIN, this Agreement, or the Materials:

(a)    can be demonstrated to have been in the public domain or publicly known and readily available to the trade or the public prior to the date of disclosure; or

(b)    can be demonstrated, from written records, to have been in Recipient's possession or readily available to
Recipient from another source not under obligation of secrecy to MOLECULIN prior to the disclosure; or becomes part of the public domain or publicly known by publication or otherwise, not due to any unauthorized act by Recipient; or

(c)    is independently developed by Recipient without reference to information or material(s) provided by MOLECULIN; or

(d)    is required to be disclosed by law or regulation.

All tangible confidential information provided to the Recipient shall be clearly marked by MOLECULIN, in writing, as confidential. Any information that is transmitted orally or visually, in order to be protected hereunder, shall be identified as such by MOLECULIN at the time of disclosure, and identified in writing to the Recipient, as Confidential Information, within thirty (30) days after such oral or visual disclosure. Except as required by law or with permission from MOLECULIN, the Recipient will not disclose confidential information for a period of five(5) years from the date of disclosure.

3.The Materials are supplied solely for scientific research purposes, for use in animals and/or in vitro. THE MATERIALS SHALL NOT BE USED IN HUMANS.

4.No right or license is granted under this Agreement either expressly or by implication. It is understood that any and all proprietary rights, including but not limited to patent rights, in and to the Materials shall be and remain with MOLECULIN.




5.Subject to the conditions set forth herein, Recipient shall have the right to publish the results of the research performed utilizing the Materials provided hereunder. The transfer of Material and/or written information under this Agreement, including but not limited to, information related to mode of action, dosage and/or any other distinctive property arising from work performed at MOLECULIN, is provided to Recipient within the context of a scientific collaboration. Therefore, the authorship of any scientific publication or presentation arising from work performed pursuant to this Agreement should take this into consideration. Recipient agrees to provide, MOLECULIN with an advance copy at least thirty (30) days in advance of any written submission (abstract or paper) or oral presentation that makes reference to the Materials. If any such submission or presentation discloses MOLECULIN proprietary information which Recipient is obligated to maintain as confidential under Paragraph 2 hereof, MOLECULIN shall notify Recipient within ten (10) working days of receipt thereof and Recipient shall delete such proprietary information from such submission or presentation and if requested by MOLECULIN will withhold such submission or presentation an additional sixty (60) days to allow MOLECULIN the opportunity to assess the patentability of developed technology disclosed in the submission or presentation and to file for patent(s) should MOLECULIN elect to do so.

6.In the event that use of the Material(s) results in an invention, improvement, substance, or information, whether or not patentable, and patent applications and patents, if any, which result therefrom (individually or collectively "Developed Technology"), Recipient agrees to disclose promptly, and in confidence, to MOLECULIN all Developed Technology. At the expense of MOLECULIN, MOLECULIN shall have the right to file for and obtain patent protection in the name of Recipient, if solely invented by Recipient, or in the name of both parties if jointly invented, for Developed Technology or request Recipient to do so. Recipient agrees to cooperate and assist MOLECULIN in obtaining patent protection for Developed Technology, and to sign all papers reasonably required for such purpose. Any Developed Technology conceived, invented, expressed and/or reduced to practice solely by Recipient in accordance with Recipient’s research shall be deemed Recipient Developed Technology and shall be solely owned by Recipient. For those inventions determined to be solely owned by Recipient (“Recipient Developed Technology”), MOLECULIN is hereby granted an option to negotiate a license in Recipient Developed Technology on a worldwide, exclusive basis the terms of which shall be negotiated by and between the parties in good faith. Such option shall be exercised within six (6) months of notification by either party to the other of the invention. Any Developed Technology conceived, invented, expressed and/or reduced to practice jointly by Recipient and MOLECULIN in accordance with the research performed hereunder shall be deemed Jointly Developed Technology and shall be solely owned jointly by MOLECULIN and Recipient. MOLECULIN and Recipient each agree to promptly disclose to the other, any such Jointly Developed Technology to the other party, and to execute such documents and perform such other acts as may be reasonably requested by the other party to obtain, perfect and enforce such rights therein and the assignment thereof. Recipient and Company shall work together in good faith regarding any protection and/or commercialization strategy in filing any patent applications that contain any Jointly Developed Technology. For those inventions determined to be solely owned by MOLECULIN, Recipient shall claim no rights.

If such Recipient Developed Technology, if patented, infringes any patent claims of MOLECULIN, the Recipient shall provide MOLECULIN a non-exclusive, royalty-free right to use such Developed Technology.

7.Recipient acknowledges that the Materials are provided WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. MOLECULIN MAKES NO REPRESENTATION THAT THE USE OF THE MATERIALS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER PROPRIETARY RIGHT.

8.In no event shall MOLECULIN be liable for any use of the Materials by Recipient. Recipient hereby agrees that to the extent permitted under the Laws and the Constitution of the State of Texas, that Recipient shall defend, indemnify and hold harmless MOLECULIN, its directors, officers, employees, shareholders and agents from any loss, claim, damage, expense or liability of whatsoever kind or nature (including reasonable attorney's fees), which may arise from or in connection with this Agreement or the use, handling or storage of the Materials.

9.Recipient will provide to MOLECULIN, throughout the progress of the collaboration, a summary of the results of the work utilizing the Materials. MOLECULIN shall defend, indemnify and hold harmless Recipient, System, its Regents, officers, agents and employees from any loss, claim, damage, expense or liability of whatsoever kind or


nature (including reasonable attorney's fees), which may arise from or in connection with MOLECULIN’s use of the results provided hereunder by Recipient.

10.Upon the request of MOLECULIN, Recipient shall promptly return to MOLECULIN the Materials furnished to Recipient under this Agreement or provide evidence to MOLECULIN that the Materials have been destroyed. The Recipient may retain one (1) copy of written confidential information for archival purposes only.

11.Recipient agrees to comply with all government and National Institutes of Health regulations and guidelines which are applicable to the Recipient's use of the Materials.

12.Each of Recipient and MOLECULIN represents to the other that it has the full right and authority to enter into this Agreement, and that it is not aware of any impediment which would inhibit its ability to perform the terms and conditions imposed upon it by this Agreement.

13.This Agreement is not assignable, whether by operation of law or otherwise, without the prior written consent of the other party.


IN WITNESS WHEREOF, the parties, intending to be legally bound, have caused this Agreement to be executed by their respective duly authorized representations,

                            
MOLECULIN:
/s/ Walter V. Klemp
 
Recipient:
/s/ Carolee A. King, JD
 
 
 
 
 
By:
Walter V. Klemp
 
By:
Carolee A. King, JD
 
 
 
 
(Printed Name)
Title:
CEO
 
Title:
Senior VP and General Counsel
 
 
 
 
 
Date:
March 16, 2020
 
Date:
March 13, 2020

Acknowledged by: /s/Mark R. Emmett, Ph D.                                      UTMB Investigator
























APPENDIX A

The research that is proposed is to test the effects of 2 deoxyglucose (2DG) and analogues thereof on the infectivity of viruses. Preliminary data demonstrated that commercially available 2DG dose dependently reduced the infectivity of Severe Fever with Thrombocytopenia Syndrome virus (strain YL-1) in Huh-7 cell culture (human liver cell line used in Hepatitis C and viral research). Three concentrations of 2DG in the media (1.0, 0.5 and 0.25 mM) were used.

We propose to test other 2DG analogues on specific human viruses to inhibit viral replication in both cell culture and animal models. Of specific interest is the effectiveness of 2DG analogues and prodrugs on the reduction of infectivity of encephalytic viruses in vivo in animal models. Global N-glycosylation of viral capsids will be monitored as an indicator of effectiveness of 2DG incorporation.

All data will be used for preliminary data to apply for external research funding to further fund this research. All data will be published in peer reviewed journals and presented at select international conference venues.

DC\82177016.2

MOLECULINLOGOA34.JPG
Exhibit 99.1
Moleculin Signs Agreement with UTMB to Test WP1122 on a Range of Viruses, including Coronavirus
Independent research suggests new approach to inhibiting the viral replication capability of a range of viruses, including Coronavirus

HOUSTON, March 17, 2020 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, announced that it has entered into an agreement with the University of Texas Medical Branch at Galveston (UTMB) to conduct research on Moleculin’s patented portfolio of molecular inhibitors, including drug candidate, WP1122, for antiviral properties against a range of viruses, including Coronavirus. UTMB’s Center for Biodefense and Emerging Infectious Diseases collaborates with the Galveston National Laboratory, which is funded by NIAID, the U.S. Department of Defense, the U.S. Centers for Disease Control & Prevention and other federal agencies, as well as academic partners, private foundations, and the biopharmaceutical industry.

"Published research has revealed that viral replication can be highly dependent on specific monosaccharides and has demonstrated the effectiveness of a compound known as ‘2-DG,’ a dual decoy of glucose and mannose, in the treatment of certain viruses1," commented Walter Klemp, Moleculin’s Chairman and CEO. "And, this is rooted in an emerging field of research focused on the role of glycolysis and glycosylation, or more specifically, on glucose and mannose metabolism in viral activity, including the coronavirus2. Importantly, although 2-DG has shown promise in the laboratory in relevant in vivo models, its potential as a therapy is severely limited by its lack of drug-like properties, including circulation time and organ uptake. Our drug candidate, WP1122, is a prodrug of 2-DG (2-deoxy-D-glucose) that, based on recently developed preclinical data appears to overcome 2-DG’s lack of drug-like properties and is able to significantly increase tissue/organ concentration."
Dr. Donald Picker, Chief Science Officer for Moleculin added: "the in vivo research supporting the use of 2-DG as dual inhibitor of glycolysis and glycosylation to defeat viruses like Coronavirus through multiple effects critical to the progression of viral infection is promising. And, with the improved drug-like properties of WP1122 and an apparent ability to increase concentration of the drug in the infected organs, we are excited to begin testing against coronavirus, as well as others. Our hope for this kind of therapeutic approach is not only as a potential treatment for infected patients, but even as a possible preventative measure."

   
 

(1) Wang Y., et al. Triggering unfolded protein response by 2-Deoxy-D-glucose inhibits porcine epidemic diarrhea virus propagation. Antiviral Research 106 (2014) 33-41.
Schmidt M., et al. Interference of Nucleoside Diphosphate Derivatives of 2-Deoxy-D-glucose with the Glycosylation of Virus-Specific Glycoproteins in vivo. Eur. J. Biochem. 70, 55-62 (1976).

Maehama, T., Patzelt, A., Lengert, M., Hutter, K. J., Kanazawa, K., et al.
(1998) Selective down-regulation of human papillomavirus transcription by
2-deoxyglucose. Int. J. Cancer 76, 639-646.

Leung, H. J., Duran, E. M., Kurtoglu, M., Andreansky, S., Lampidis, T. J., et al. (2012) Activation of the unfolded protein response by 2-deoxy-D-glucose inhibits kaposi’s sarcoma-associated herpesvirus replication and gene expression. Antimicrob. Agents Chemother. 56, 5794-5803

(2) Bagdonaite I., et al. Global aspects of viral glycosylation. Glycobiology. 2018, vol. 28, no. 7, 443-467 doi: 10.1093/ glycob/cwy021.
Under the agreement, Moleculin will supply the lead drug candidate, WP1122, and related inhibitors, as well as technical support and UTMB will begin testing these candidates against various viral disease models, including COVID-19, in connection with the UTMB Center for Biodefense and Emerging Infectious Diseases.
The UTMB Center for Biodefense and Emerging Infectious Diseases (CBEID) was established in 2003, the same year the National Institutes of Health (NIH), National Institute for Allergy and Infectious Diseases (NIAID) selected UTMB as one of eight institutions to lead a Regional Center of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) and to receive a grant to construct on the UTMB campus one of two National Biocontainment Laboratories, now known as the Galveston National Laboratory.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. The Company's clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including additional Immune/Transcription Modulators, as well as compounds like WP1122, capable of Metabolism/Glycosylation Inhibition.
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 prove safe and effective viruses, including Coronavirus and COVID-19. 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 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
James Salierno / Carol Ruth
The Ruth Group
646-536-7028 / 7000
jsalierno@theruthgroup.com 
cruth@theruthgroup.com