mbrx20220926_8k.htm
false 0001659617 0001659617 2022-09-27 2022-09-27
 
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): September 27, 2022
 
 
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 
 
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. ☐
 
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 September 27, 2022, Moleculin Biotech, Inc. (the “Company”), issued a press release announcing that its WP1096 molecule (a part of its WP1122 portfolio of D-glucose and D-mannose antimetabolites) will be evaluated in animal studies through the preclinical services offered by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. WP1096 is being studied by Moleculin as a novel potential therapy for a broad spectrum of viruses, including arenaviruses.
 
A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated by reference 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 “filed” for the purpose of the Securities Exchange Act of 1934, as amended (“Exchange Act”), nor shall it be 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 9.01
Financial Statements and Exhibits.
 
(d)
Exhibits.
 
Exhibit
No.
Description
 
99.1
 
104
Cover page Interactive Data File (formatted as Inline XBRL document)
 
 
 
 
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:
September 27, 2022
 
       
 
By:
/s/ Jonathan P. Foster
 
   
Jonathan P. Foster
 
 
 
 

Exhibit 99.1

      

Moleculin Biotech WP1122 Portfolio Compound, WP1096, Selected for NIAID-Funded Animal Studies as Novel Potential Antiviral

 

– Preclinical work being conducted is intended to validate in vitro findings in established animal models to determine if further preclinical development and human clinical trials are warranted

 

– Hemorrhagic fever arenaviruses (HFA) represent area of significant unmet need with no FDA-approved arenavirus vaccines or therapies

 

HOUSTON, September 27, 2022 /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 and viruses, today announced its WP1096 molecule (a part of its WP1122 portfolio of D-glucose and D-mannose antimetabolites) will be evaluated in animal studies through the preclinical services offered by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. WP1096 is being studied by Moleculin as a novel potential therapy for a broad spectrum of viruses, including arenaviruses.

 

WP1096 is a compound within the WP1122 portfolio, which is designed to exploit, amongst other uses, the potential uses of monosaccharide (such as glucose or mannose) decoys as a means to inhibit glycolysis and alter glycosylation. As an example, the Company’s WP1122 molecule is a prodrug of 2-deoxy-D-glucose (2-DG), and 2-DG has been approved outside the US for use as a treatment for COVID-19. The Company believes WP1096 may target and therapeutically impact glycolysis and glycosylation processes in host cells and viruses.

 

“We are encouraged by the data WP1096 has demonstrated in preliminary studies and look forward to further evaluating its potential as a much-needed anti-arenaviral therapy. The results of WP1096 preliminary studies show a broader spectrum of antiviral activity than 2-DG against hemorrhagic fever viruses (i.e., Argentine hemorrhagic fever, Marburg, Ebola and others), an area of significant unmet need, thus encouraging us to pursue advancing its development. We are grateful for this opportunity to take a step forward in unlocking further potential of the compounds within our WP1122 portfolio,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

 

Moleculin is currently conducting a Phase 1 trial of analog WP1122 (a prodrug of 2-DG) in healthy volunteers in preparation for a Phase 2 trial in COVID-19 patients. Between its antiviral effort with WP1122 and a range of oncology focused initiatives, Moleculin is not currently able to allocate significant resources to the development of WP1096. However, considering the promising WP1096 in vitro activity in a range of potentially deadly viruses previously demonstrated, Moleculin believes that WP1096 would be a good candidate for animal testing in arenavirus models where there is a significant unmet need.

 

The NIAID-funded animal studies will be with the Tacaribe arenavirus, a BSL-2 (bio safety level 2) virus and will be used as an indication of activity and as a means to optimize the animal testing protocol. Given the significant need for treatment alternatives in arenaviruses (and other hemorrhagic fever viruses), if WP1096 demonstrates significant efficacy in the requested animal studies, Moleculin intends to revise its current development strategy to accelerate development work on WP1096.

 

About Moleculin Biotech, Inc.

 

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of drug candidates for the treatment of highly resistant tumors and viruses. The Company’s lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

 

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator designed to be capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers; and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122, for the potential treatment of COVID-19 and other viruses, as well as cancer indications including brain tumors, pancreatic and other cancers.

 

For more information about the Company, please visit www.moleculin.com and connect on Twitter, LinkedIn and Facebook. 

 

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, whether the results of in vitro testing of WP1096 can be replicated in animal models and, eventually, in human trials, the ability of WP1096 to be successfully tested in animals and Moleculin’s ability to secure additional support for development of WP1096. 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.

 

Investor Contact:

 

JTC Team, LLC

Jenene Thomas

(833) 475-8247

[email protected]