Moleculin Reports Full Year 2022 Financial Results and Provides Pipeline Update

Rhea-AI Summary

Moleculin Biotech (NASDAQ: MBRX) reported its financial results for 2022, showing a net loss of $29.0 million, up from $6.7 million in 2021. R&D expenses increased to $19.0 million, driven by heightened clinical trial activities. The company has sufficient cash, totaling $43.1 million, to fund operations into the third quarter of 2024. Recent highlights include positive data from Annamycin's trials, an 80% overall response rate for refractory AML, and Fast Track Designation from the FDA for WP1122. A conference call to discuss results will be held on March 23, 2023, at 8:30 AM ET.

Positive

• 80% overall response rate in final cohort of Annamycin trial for Refractory AML.
• Received FDA Fast Track Designation for WP1122 in treating Glioblastoma Multiforme.
• Sufficient capital of $43.1 million to fund operations through Q3 2024.

Negative

• Net loss increased to $29.0 million from $6.7 million in 2021.
• R&D expenses rose to $19.0 million due to increased clinical trial costs.

– 2022 marked by continued execution and growing body of positive data across clinical and preclinical development programs

– Sufficient capital to fund operations into the third quarter of 2024

– Company to host conference call and webcast today at 8:30 AM ET

HOUSTON, March 23, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today reported its financial results for the fiscal year ended December 31, 2022 and provided a pipeline update. As previously announced, the Company will host a conference call and live audio webcast, today, Thursday, March 23, 2023, at 8:30 AM ET (details below).

"I am extremely proud of our team's solid execution of our strategy in 2022, resulting in significant progress on multiple fronts. We fully expect to build on the momentum from our positive and highly encouraging data to date and believe Moleculin is well positioned for an exciting 2023. Specifically, we look forward to multiple data readouts with Annamycin as well as across our pipeline over the course of this year, which we hope will unlock value in the near and long term," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

Recent Highlights

• Announced the publication of data evaluating Annamycin's performance as an anthracycline designed to avoid the cardiotoxicity typically associated with currently prescribed anthracyclines, in a manuscript titled, "Anthracycline-induced cardiotoxicity – are we about to clear this hurdle?," published in the peer-reviewed European Journal of Cancer.
• Received approval in Italy to conduct and dosed first subjects for Phase 1/2 trial evaluating Annamycin in combination with cytarabine (Ara-C) for the treatment of acute myeloid leukemia (AML).
• Announced final topline successful safety data – setting a recommended Phase 2 dose - and reported 80% overall response rate in final cohort from the European Phase 1 trial evaluating Annamycin as a single agent treatment of Refractory AML.
• Granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) of WP1122 for the treatment of Glioblastoma Multiforme (GBM).

Summary of Financial Results for the Full Year 2022 

Research and development (R&D) expense was $19.0 million and $14.4 million for the years ended December 31, 2022 and 2021, respectively. The increase in R&D of $4.6 million is mainly related to increased clinical trial activity, and costs related to manufacturing of additional drug product.

General and administrative (G&A) expense was $11.5 million and $8.4 million for the years ended December 31, 2022 and 2021, respectively. The increase in G&A of $3.1 million was mainly attributable to an increase in regulatory and legal services, and consulting & advisory fees.

The net loss for the year ended December 31, 2022 was $29.0 million, which included non-cash gains of $1.3 million on warrants in 2022 as compared to $6.7 million in the prior year and approximately $2.3 million of stock-based compensation expense in 2022 as compared to $2.4 million in 2021.

As of December 31, 2022, we had cash and cash equivalents of $43.1 million and prepaid expenses and other current assets of $2.5 million. The Company believes that this cash is sufficient to meet its projected operating requirements into the third quarter of 2024.

Conference Call and Webcast

Moleculin management will host its quarterly conference call and live audio webcast for investors, analysts, and other interested parties today, Thursday, March 23, 2023, at 8:30 AM ET.

Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat 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 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, the Company's forecasted cash burn rate (including its estimate of  cash sufficient to meet its projected operating requirements). 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
MBRX@jtcir.com 

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SOURCE Moleculin Biotech, Inc.

FAQ

What were Moleculin's financial results for 2022?

Moleculin reported a net loss of $29.0 million for 2022, compared to $6.7 million in 2021.

What is the cash position of Moleculin?

Moleculin has cash and cash equivalents of $43.1 million, sufficient to fund operations into the third quarter of 2024.

What recent achievements has Moleculin made in clinical trials?

Moleculin reported an 80% overall response rate in its final cohort for Annamycin in treating Refractory AML.

When is Moleculin's conference call to discuss financial results?

The conference call is scheduled for March 23, 2023, at 8:30 AM ET.

What FDA designation did Moleculin receive recently?

Moleculin received Fast Track Designation for WP1122 for the treatment of Glioblastoma Multiforme.