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Moleculin Biotech, Inc. (MBRX) SEC Filing 10-K Annual report for the fiscal year ending Sunday, December 31, 2017

Moleculin Biotech, Inc.

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CIK: 1659617 Ticker: MBRX
Exhibit 99.1

Moleculin Biotech, Inc. Reports Financial Results for the Year Ended December 31, 2017

HOUSTON - March 28, 2018 - Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced its financial results for the year ended December 31, 2017. Additionally, the Company announced potential upcoming milestones and recent corporate developments.

Management Discussion
Walter Klemp, Chairman and CEO of Moleculin, said, “We continued to make significant progress in developing Moleculin’s distinctive cancer treatment technologies during 2017. We firmly believe that all three of our highly differentiated technologies have breakthrough potential in effectively treating various cancers. From those three core technologies, we now have six potential drug candidates, two of which we expect will commence clinical trials in 2018, with the possibility of a third before the end of the year.

“Our potentially disruptive technologies include Annamycin, a chemotherapy agent that is active against multidrug resistant tumor cells and has been designed to be non-cardio toxic (unlike currently approved drugs in this class); immuno-stimulating STAT3 inhibitors WP1066 and WP1732 that target glioblastoma and pancreatic cancer; and WP1122, an inhibitor of glycolysis that has been shown in preclinical testing to effectively block the energy supply required by cancer cells and effectively starves the cancer cells to death. Our diverse development portfolio gives Moleculin what I like to call multiple shots on goal."

The Company submitted an application in October 2017 for a Clinical Trial Authorization (“CTA”) for Annamycin in Poland. Having met all the requirements, the Ethics Committee in Poland approved the Phase I/II trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (“AML”) in December 2017. In March the Company received requests for and provided additional information to the Polish National Office. It expects a response from the Polish National Office in the first half of 2018 and at the earliest mid-April 2018. The start of clinical trials in Poland remains subject to confirmation and approval of the CTA by the Polish National Office. The Company can provide no assurance that it will receive such confirmation on a timely basis, if at all.
 
In addition, the Company continues to recruit and contract clinics both in the United States and Poland. In the US, the Company has one site - University Hospitals Cleveland Medical Center (“UHCMC”) - recruiting patients and enrollment has begun. The Company can provide no assurance that it will continue enrollments or begin treatment on a timely basis, if at all.

Mr. Klemp continued, “Additionally, this past December we announced that a physician-sponsored Investigational New Drug ("IND") application for a Phase I trial of Moleculin's WP1066 in patients with recurrent malignant glioma and brain metastasis from melanoma was allowed by the U.S. Food and Drug Administration ("FDA"). This will be our second drug in clinical trials. The trial will be conducted at the MD Anderson Cancer center to evaluate safety and efficacy. We believe WP1066 represents a new class of anticancer drugs able to fight tumors on two fronts by directly inhibiting cell signaling supporting tumor activity, and independently stimulating a natural immune response. This constitutes a new approach to treating brain tumors and tumor metastasis to the brain.


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The following information was filed by Moleculin Biotech, Inc. (MBRX) on Wednesday, March 28, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Moleculin Biotech, Inc.'s 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Balance Sheets
Balance Sheets (parenthetical)
Statements Of Cash Flows
Statements Of Operations
Statements Of Stockholders??? Equity
Statements Of Stockholders??? Equity (parenthetical)
Accrued Expenses And Other Accrued Liabilities
Accrued Expenses And Other Accrued Liabilities (details)
Accrued Expenses And Other Accrued Liabilities (tables)
Commitments And Contingencies
Commitments And Contingencies (details)
Convertible Notes Payable
Convertible Notes Payable - Narrative (details)
Convertible Notes Payable - Schedule Of Convertible Notes Payable (details)
Convertible Notes Payable (tables)
Equity
Equity - Narrative (details)
Equity - Schedule Of Assumptions (details)
Equity - Schedule Of Stock Based Compensation (details)
Equity - Summary Of Option Activities (details)
Equity (tables)
Income Taxes
Income Taxes - Narrative (details)
Income Taxes - Schedule Of Components Of Income Tax Expense (benefit) (details)
Income Taxes - Schedule Of Deferred Tax Assets And Liabilities (details)
Income Taxes - Schedule Of Effective Income Tax Rate Reconciliation (details)
Income Taxes - Summary Of Valuation Allowance (details)
Income Taxes (tables)
Intangible Assets
Intangible Assets - Narrative (details)
Intangible Assets - Schedule Of Intangible Assets (details)
Intangible Assets - Schedule Of Pro Forma Results Of Operations (details)
Intangible Assets - Summary Of Estimated Fair Values Of Assets Acquired And Liabilities Assumed (details)
Intangible Assets (tables)
Nature Of Business And Liquidity
Nature Of Business And Liquidity (details)
Subsequent Events
Subsequent Events (details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies - Fair Value Measurements (details)
Summary Of Significant Accounting Policies - Fair Value Of Warrant Liability (details)
Summary Of Significant Accounting Policies - Narrative (details)
Summary Of Significant Accounting Policies (policies)
Summary Of Significant Accounting Policies (tables)
Warrant Liability
Warrant Liability - Narrative (details)
Warrant Liability - Schedule Of Assumptions (details)
Warrant Liability - Schedule Of Warrant Activity (details)
Warrant Liability (tables)
Ticker: MBRX
CIK: 1659617
Form Type: 10-K Annual Report
Accession Number: 0001659617-18-000027
Submitted to the SEC: Wed Mar 28 2018 8:17:06 AM EST
Accepted by the SEC: Wed Mar 28 2018
Period: Sunday, December 31, 2017
Industry: Pharmaceutical Preparations

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