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): April 16, 2020
moleculin-logo_horiza33.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 7.01 Regulation FD Disclosure.

On April 16, 2020, Moleculin Biotech, Inc. (the "Company") conducted an investor webinar using the presentation set forth as Exhibit 99.1 herein. The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed to be "filed" for the purpose of the Securities Exchange Act of 1934, as amended ("Exchange Act"), nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended ("Securities Act"), unless specifically identified therein as being incorporated by reference.

Item 8.01 Other Events.

As previously reported, on July 23, 2019, the Company entered into an At Market Issuance Sales Agreement (the "Agreement") with Oppenheimer & Co. Inc. (the "Oppenheimer"). Pursuant to the terms of the Agreement, the Company may offer and sell, from time to time, Company common stock through Oppenheimer, acting as agent, through an "at the market offering" as defined in Rule 415(a)(4) (the "ATM Offering") promulgated under the Securities Act. On July 24, 2019, pursuant to the ATM Offering, the Company filed a prospectus supplement pursuant to which the Company may offer and sell, from time to time, Company common stock having an aggregate offering price of up to $15.0 million through Oppenheimer (the "ATM Prospectus Supplement"). From April 8, 2020 to April 16, 2020, the Company issued shares of common stock through the ATM Prospectus Supplement. Additionally, the Company has received notice that certain warrants, previously issued, are being exercised. During this period of time, the Company has issued, including shares issuable under the above transactions, approximately 7.2 million shares at an average price of $1.44 for gross and net proceeds of approximately $10.3 million and $10.0 million, respectively. The Company paid fees and commissions of approximately $0.3 million to Oppenheimer on the gross proceeds from the sale of its common stock under the ATM Prospectus Supplement. After the completion of the foregoing issuances, the Company will have 60,403,164 shares of common stock outstanding. The Company has publicly stated in the conference call mentioned above that the Company estimates that such transactions, when joined with cash on hand, will support the Company's planned operations into the first quarter of 2021.


Item 9.01 Financial Statements and Exhibits.

(d)    Exhibits.

Exhibit No.    Description

99.1        Investor Presentation dated April 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.

Date: April 17, 2020

By:    /s/ Jonathan P. Foster
Jonathan P. Foster
Chief Financial Officer


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EXHIBIT INDEX
Exhibit No.    Description

99.1        Investor Presentation dated April 2020



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mbrxconferencecallslides
Developing ground-breaking therapies for highly challenging diseases April 16, 2020 Investor Conference Call to Discuss the COVID-19 Potential for our Drug Candidate WP1122 (Nasdaq: MBRX)

 
Disclaimer All statements contained herein other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. 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. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. More detailed information about Moleculin is set forth in our filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. 2

 
WP1122 COVID-19 Opportunity • Viruses depend on glycolysis and glycosylation for infectivity and replication • Glycolysis and glycosylation can be disrupted by using a glucose decoy known as 2-DG • While 2-DG has been shown to be effective in vitro, its lack of drug-like properties makes it ineffective as a drug in humans • WP1122 appears to solve 2-DG’s problem by creating a prodrug of 2-DG that reaches much higher tissue/organ concentrations than 2-DG alone 3

 
Viruses are Highly Dependent on Glucose Glycan Glycoprotein 2 Different Processes Glucose provides energy in the form of adenosine tri-phosphate (ATP) to viral host cells via glycolysis, as well as enabling glycan formation supporting creation of glycoproteins during glycosylation. 4

 
Glucose Plays a Critical Role in Glycosylation Enveloped viruses depend on glycosylation, which begins by hijacking the host cell secretory pathway, where combinations of sugar molecules (including glucose and mannose) called “glycans” are combined with proteins, as “folding” provides 3- dimensional structure. These viral “glycoproteins” mediate the assembly and budding of new virions. The host’s immune system can be evaded through “shedding” of these glycoproteins (* for some viruses, not yet confirmed for coronaviruses) and through “glycan shielding.” Glycans are crucial for viral attachment and infection of host cells. – Bagdonaite I., et al. Global aspects of viral glycosylation. Glycobiology. 2018, vol. 28, no. 7, 443–467 doi: 10.1093/glycob/cwy021. 5

 
Viruses Upregulate Host Cell’s Glycolysis Viruses induce an anabolic state in host cells, which in turn makes them highly dependent upon glycolysis for adequate energy production – Gualdoni G. et al. Rhinovirus induces an anabolic reprogramming in host cell metabolism essential for viral replication. PNAS. 2018, E7158–E7165, vol. 115, no. 30 6

 
2-DG is a Glucose Decoy 2-DG appears to the body to be natural glucose, but its lack of one hydroxyl group (shown in red on D- (2-DG) Glucose above) means that 2-DG will not convert into energy via glycolysis and it will not form the proper building-blocks for glycan formation during glycosylation. 7

 
2-DG Disrupts Both Glycosylation and Glycolysis Both Processes Disrupted The inhibition by 2-DG of glycosylation and glycolysis are both believed to play a role in limiting viral infectivity and replication. 8

 
2-DG Has Well-Documented Anti-Viral Properties • Gualdoni G. et al. Rhinovirus induces an anabolic reprogramming in host cell metabolism essential for viral replication. PNAS. 2018, • Rhinovirus E7158–E7165, vol. 115, no. 30 • Schmidt M. et al. Interference of Nucleoside Diphosphate • Herpesvirus Derivatives of 2-Deoxy-D-glucose with the Glycosylation of Virus- Specific Glycoproteins in vivo. Eur. J. Biochem. 70, 55-62 (1976). • Leung H. J., Duran, E. M., Kurtoglu, M., Andreansky, S., • Papillomavirus 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. • Semliki Forest virus Antimicrob. Agents Chemother. 56, 5794–5803 • Maehama, T., Patzelt, A., Lengert, M., Hutter, K. J., Kanazawa, K., et al. (1998) Selective down-regulation of human • Dengue virus papillomavirus transcription by 2-deoxyglucose. Int. J. Cancer. 76, 639–646. • Porcine epidemic diarrhea • Fontaine K, et al. Dengue Virus Induces and Requires Glycolysis for Optimal Replication. Journal of Virology Jan 2015, 89 (4) 2358- virus 2366. DOI: 10.1128/JVI.02309-14 • 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. 9

 
2-DG Inhibition Now Demonstrated in SARS-CoV-2 2-DG completely stops replication of SARS-CoV-2 in vitro in human Caco-2 cells. Based on research conducted at The Institute of Biochemistry at Goethe Effect of in vitro incubation of non- University Frankfurt reported in an unreviewed article recently submitted to NatureResearch (https://www.researchsquare.com /article/rs- cytotoxic levels of 2-DG in Caco-2 cells 17218/v1) by Bojkova, D et al. March 11, 2020; DOI: 10.21203/rs.3.rs- on viral replication of SARS-CoV-2 17218/v1. 10

 
2-DG Is Considered Safe and Well-Tolerated in Humans • Raez L.E., et al. “A phase I dose-escalation trial of 2-deoxy-D-glucose alone • Tested in over 100 patients in multiple or combined with docetaxel in patients with advanced solid tumors.” Cancer Chemother Pharmacol. 2013 Feb;71(2):523-30. doi: 10.1007/s00280-012- clinical trials (7 cited here) 2045-1. • Laszalo J, et al. “The effect of 2-DG infusions on lipid and carbohydrate • Phase 2 clinical trial conducted at 63 mg/kg metabolism in man.” J Clin Invest 1960;40:171-6. • Thompson DA, et al. “Thermoregulatory and related responses to 2-deoxy- • The most common adverse events were D-glucose administration in humans.” Am J Physiol. 1980 Sep;239(3):R291- 5. fatigue, sweating, dizziness and nausea • Mohanti BK, et al. “Improving cancer radiotherapy with 2-deoxy-D-glucose: mimicking the hypoglycemic symptoms phase I/II clinical trials on human cerebral gliomas.” Int J Radiat Oncol Biol Phys. 1996 Apr 1;35(1):103-11. expected from 2-DG administration • Singh D, et al. “Optimizing Cancer Radiotherapy with 2-DeoxyD-Glucose.” Strahlenther Onkol (2005) 181: 507. • The most significant adverse effects noted • Murugesan K, et al. “Phase I trial of 2-deoxyglucose for treatment of advanced solid tumors and hormone refractory prostate cancer: A at 63-88 mg/kg doses were reversible pharmacokinetics (PK) assessment.” Proceedings: AACR 101st Annual hyperglycemia, gastrointestinal bleeding Meeting 2010‐‐ Apr 17‐21, 2010; Washington, DC. • Stein M, et al. “Targeting tumor metabolism with 2-deoxyglucose in patients and reversible QTc prolongation with castrate-resistant prostate cancer and advanced malignancies.” Prostate. 2010 Sep 15;70(13):1388-94. 11

 
Unfortunately, 2-DG Lacks Drug-Like Properties 2-DG’s lack of drug-like properties limits its in vivo performance. Short half-life, Rapidly metabolized, Poor tissue/organ uptake and retention 2-DG We believe 2-DG’s performance in humans is limited by its lack of drug-like properties. Because it is rapidly metabolized, it has inadequate tissue/organ distribution and retention. 12

 
WP1122 is a Prodrug of 2-DG 6 5 WP1122 4 1 metabolizes 3 2 to 2-DG (2-DG) The presence of two acetyl groups (in blue) in WP1122 forms esters with hydroxyl groups at positions C-3 and C-6 and greatly enhances its tissue/organ uptake and retention. 13

 
WP1122 Significantly Outperforms 2-DG in animal models 2-DG Generated from WP1122 10x 10x Up Up To To 2.6x 2-DG 1.8x Half-Life Plasma Organ Uptake Tumor Concentration Potency Zielinski R, et al. “Preclinical evaluation of WP1122, a 2-DG prodrug and inhibitor of glycolysis.” Proceedings: Symposia on Cancer Research 2017 Cancer Metabolism, Houston, TX, 10/2017. 14

 
Summary • Viruses depend on glycolysis and glycosylation for infectivity and replication • Glycolysis and glycosylation can be disrupted by using a glucose decoy known as 2-DG • While 2-DG has been shown to be effective in vitro, its lack of drug-like properties makes it ineffective as a drug in humans • WP1122 appears to solve 2-DG’s problem by creating a prodrug of 2-DG that reaches much higher tissue/organ concentrations than 2-DG alone 15

 
Developing ground-breaking therapies for highly challenging diseases April 16, 2020 Investor Conference Call to Discuss the COVID-19 Potential for our Drug Candidate WP1122 (Nasdaq: MBRX)