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): June 21, 2017
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.) |
2575 WEST BELLFORT, SUITE 333, HOUSTON TX 77054
(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. ☒
| Item 3.02 | Unregistered Sales of Equity Securities. |
As previously disclosed in its public filings, Moleculin Biotech, Inc. (the “Company”) had on various dates from August 31, 2015 through January 19, 2016, issued 8% unsecured promissory notes to certain accredited investors pursuant to an exemption from registration under the Securities Act of 1933, as amended, in reliance on Section 4(a)(2) thereof. Upon the completion of the Company’s initial public offering, these notes provided that they be converted into shares of common stock at their applicable conversion prices, to the extent and provided that no holder of these notes was permitted to convert such notes to the extent that the holder or any of its affiliates would beneficially own in excess of 4.99% of the Company’s common stock after such conversion. Due to this 4.99% limitation, certain portions of the issued notes remained outstanding subsequent to the Company’s initial public offering. As of March 31, 2017, the Company had outstanding convertible notes in principal amount of approximately $22,000, convertible at $0.20 per share, and convertible notes in principal amount of approximately $86,000, convertible at $0.1299 per share. On June 23, 2017, the foregoing convertible notes of approximately $108,000 in principal amount, plus accrued interest of approximately $4,000, was converted into an aggregate of 804,037 shares of Company common stock. After the completion of these conversion, the Company no longer has any outstanding convertible notes.
| Item 7.01. | Regulation FD Disclosure. |
On June 21, 2017, the Company issued a press release announcing the discovery of a metabolic inhibitor with the potential to treat pancreatic cancer. A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated by reference herein.
On June 26, 2017, the Company issued a press release announcing that it had entered into an agreement with a physician at the Mayo Clinic to enable additional research on Moleculin's WP1066 molecule for the possible treatment of a rare form of pediatric brain tumor. A copy of the press release is attached to this report as Exhibit 99.2 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 |
| 99.1 | Moleculin Biotech, Inc. press release dated June 21, 2017 |
| 99.2 | Moleculin Biotech, Inc. press release dated June 26, 2017 |
| 2 |
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: June 27, 2017 | |||
| By: | /s/ Jonathan Foster | ||
| Jonathan Foster | |||
| Chief Financial Officer | |||
| 3 |
EXHIBIT INDEX
| Exhibit No. | Description |
| 99.1 | Moleculin Biotech, Inc. press release dated June 21, 2017 |
| 99.2 | Moleculin Biotech, Inc. press release dated June 26, 2017 |
| 4 |
Exhibit 99.1
Moleculin Announces Significant Discovery with Potential to Treat Pancreatic Cancer
Metabolic Inhibitor Shows Greater Ability to Kill Pancreatic Cancer Cell Lines
HOUSTON – June 21, 2017 – Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced the discovery of a metabolic inhibitor with the potential to treat pancreatic cancer.
“We’ve received a lot of attention from the scientific community for our glucose decoy technology (WP1122 Portfolio, Moleculin Presents Preclinical Data of Novel Inhibitor of Glycolysis at 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics , December 13, 2016) as a potential means to starve tumors to death by exploiting their hyper-dependence on glycolysis for energy production,” commented Walter Klemp, Chairman and CEO of Moleculin, “and now we have identified possible new properties of our compound WP1234, a modification to WP1122. In pre-clinical testing, WP1234 has shown improved drug characteristics when compared with WP1122 and a 20 to 50-fold greater ability to kill pancreatic cancer cell lines when compared with traditional inhibitors of glycolysis. We know that pancreatic cancer thrives even in a reduced oxygen environment, which indicates it may be highly dependent on glycolysis to survive. This discovery now makes WP1234 a promising drug candidate to be studied for the treatment of pancreatic cancer.”
Mr. Klemp continued: “Pancreatic cancer is still considered largely untreatable, so even modest gains in treating this disease could represent a significant clinical benefit. WP1234 improves on known inhibitors for glycolysis by increasing drug circulation time, which should increase the potential for drug uptake by and destruction of tumor cells. We are excited about the potential to pursue development opportunities with WP1234 for the treatment of pancreatic cancer. We are also pleased to report that this discovery was the direct result of our ongoing collaboration with MD Anderson Cancer Center and the science team there will be presenting detailed findings to the scientific community in the near future.”
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.
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 WP1234 to become a safe and effective drug for pancreatic cancer in humans and the potential for that to translate into a significant clinical benefit. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech 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
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com
Exhibit 99.2
Moleculin Announces Scientific Support for Research Endeavor at
Mayo Clinic
HOUSTON – June 26, 2017 – Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has entered into an agreement with a physician at the Mayo Clinic to enable additional research on Moleculin’s WP1066 molecule for the possible treatment of a rare form of pediatric brain tumor.
Mayo Clinic physician-scientists have requested and Moleculin has agreed to supply them with WP1066 for preclinical testing for the potential treatment of pediatric Diffuse Intrinsic Pontine Gliomas (DIPG), a rare and very aggressive form of brain tumor. Mayo Clinic studies have suggested that DIPG may be particularly sensitive to the inhibition of the activated form of a cell-signaling protein called STAT3, a primary target of WP1066, and their preliminary studies have demonstrated significant anti-tumor activity of WP1066 in DIPG in vitro and in vivo tumor models.
“Independent research now suggests that WP1066 is capable of tumor suppression in xenografts of human brain tumors transplanted into mice," commented Walter Klemp, Chairman and CEO of Moleculin. “So, we are eager to move WP1066 into the clinic as quickly as possible.”
Mr. Klemp added: “we are proud to have an institution as renown as Mayo Clinic focus on WP1066 as a potential treatment for DIPG. This, along with the physician efforts at MD Anderson to secure an IND to study WP1066 for the treatment of adult brain tumors, continues to validate the potential importance of WP1066 in the treatment of difficult tumors.”
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.
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 potential for Mayo Clinic to conduct clinical trials of WP1066 and the ability of WP1066 to become a safe and effective drug for DIPG. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech 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
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com