mbrx20200908_8k.htm
false 0001659617 0001659617 2020-09-09 2020-09-09
 
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 9, 2020
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 9, 2020, Moleculin Biotech, Inc. (the “Company”) issued a press release announcing the successful completion of a pre-IND meeting with the FDA.
 
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 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, unless specifically identified therein as being incorporated by reference.
 
Item 9.01
Financial Statements and Exhibits.
 
(d)     Exhibits.
 
Exhibit No.
Description
 
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
 
 
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 9, 2020  
By:
/s/ Jonathan P. Foster
Jonathan P. Foster
Chief Financial Officer
 
2

 
EXHIBIT INDEX
 
Exhibit No.
Description
 
99.1
Press Release dated September 9, 2020
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
 
 
3
ex_203212.htm

Exhibit 99.1

 

Moleculin Announces Successful Completion of Pre-IND Meeting with the FDA

 

Intends to file an IND using Annamycin for the Treatment of Soft Tissue Sarcomas with Lung Metastases by Year-End

 

HOUSTON, September 09, 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 and viruses, today announced that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan for Annamycin, including the clinical study design and dosing strategy for the initial phase 1b/2 protocol for soft tissue sarcomas with lung metastases.

 

Moleculin submitted a proposed clinical protocol for FDA review entitled, “Phase 1b/2 Study of Liposomal Annamycin (Annamycin) in Subjects with Previously Treated Soft-Tissue Sarcomas with Pulmonary Metastases.” The proposed study is an open-label, multicenter, single-arm, dose escalation and expansion study to evaluate single-agent Annamycin in up to 55 patients with soft tissue sarcoma (STS) with lung metastases for whom chemotherapy is considered appropriate. The primary objectives of the dose escalation phase are to evaluate the safety of Annamycin and identify the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D).

 

In summary, the FDA, among other items:

 

 

did not object to the proposed clinical study design while providing guidance on additional assessments

 

agreed the proposed dose escalation schedule appeared reasonable

 

commented regarding the consideration for including adolescents in oncology clinical trials

 

stated that a repeat dose toxicology study of 3 months is required before initiating a registration study

 

recommended an EOP1 meeting after completion of the RP2D.

 

“We are pleased to complete the pre-IND meeting with the FDA, and will move forward with our plans to file the IND by the end of 2020 and initiate a Phase 1b/2 trial of Annamycin for the treatment of soft tissue sarcomas metastasized to the lungs,” said Wally Klemp, Chief Executive Officer of Moleculin. “We appreciate the FDA’s guidance as we endeavor to find a cure for certain cancers metastasized to the lungs.”

 

 

 

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 and viruses. 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, being studied for brain tumors, pancreatic cancer and hematologic malignancies; and WP1220, an analog to WP1066, being studied 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 capable of Metabolism/Glycosylation Inhibition, such as WP1122. Moleculin has the exclusive worldwide rights (subject to certain territories for which it has issued sublicenses) to all of the above technologies.

 

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 ability to obtain an IND for Annamycin and the ability of Annamycin to be shown safe and effective for the treatment of STS with lung metastases. 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

 

 

 

 
v3.20.2
Document And Entity Information
Sep. 09, 2020
Document Information [Line Items]  
Entity, Registrant Name MOLECULIN BIOTECH, INC.
Document, Type 8-K
Document, Period End Date Sep. 09, 2020
Entity, Incorporation, State or Country Code DE
Entity, File Number 001-37758
Entity, Tax Identification Number 47-4671997
Entity, Address, Address Line One 5300 Memorial Drive
Entity, Address, Address Line Two Suite 950
Entity, Address, City or Town Houston
Entity, Address, State or Province TX
Entity, Address, Postal Zip Code 77007
City Area Code 713
Local Phone Number 300-5160
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity, Emerging Growth Company true
Entity, Ex Transition Period true
Title of 12(b) Security Common Stock
Trading Symbol MBRX
Security Exchange Name NASDAQ
Amendment Flag false
Entity, Central Index Key 0001659617