false
0001659617
0001659617
2022-08-19
2022-08-19
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): August 19, 2022
MOLECULIN BIOTECH, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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001-37758
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47-4671997
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(State or Other Jurisdiction of
Incorporation or Organization)
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(Commission File No.)
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(I.R.S. Employer Identification
No.)
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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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c))
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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:
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Title of each class
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Trading Symbol (s)
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Name of each exchange on which registered
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Common Stock, par value $.001 per share
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MBRX
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The NASDAQ Stock Market LLC
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Item 7.01
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Regulation FD Disclosure
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On August 19, 2022, Moleculin Biotech, Inc. (the “Company”), issued a press release announcing preliminary results from the third cohort of the Company’s first-in-human Phase 1a study of WP1122. This cohort consisted of 10 subjects dosed with 32 mg/kg or placebo in the dose escalation trial evaluating the safety and pharmacokinetics (PK) of WP1122 in healthy volunteers in the United Kingdom (UK). Based on the overall results in Cohort 3, the Safety Review Committee (SRC) for the study deemed the third single ascending dose (SAD) cohort dose safe and well-tolerated, allowing the Company to begin its fourth SAD Cohort with a dose escalation to 64 mg/kg. Additionally, dosing of WP1122 in the multiple ascending dose (MAD) cohorts will commence at a total daily dose of 32 mg/kg, which has been shown to be safe in the single dose cohort.
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.
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Item 9.01
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Financial Statements and Exhibits.
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104
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Cover page Interactive Data File (formatted as Inline XBRL document)
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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.
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MOLECULIN BIOTECH, INC.
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Date:
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August 19, 2022
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By:
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/s/ Jonathan P. Foster
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Jonathan P. Foster
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