On March 22, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported its financial results for the fiscal year ended December 31, 2023 (Press release, Moleculin, MAR 22, 2024, View Source [SID1234641389]). As previously announced, the Company will host a conference call and live audio webcast, Monday, March 25, 2024, at 8:30 AM ET (details below), issuing a separate clinical trial update press release just prior.
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"Over the course of 2023 we established a significant growing body of positive clinical and encouraging safety data for Annamycin that continues to strengthen our confidence in the potential of our next generation, non-cardiotoxic chemotherapy in the treatment landscape for hard-to-treat cancers and viruses," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Building off of our momentum, we are laser focused on driving our priority pipeline programs toward key data milestones in the near term and believe we are well-positioned to achieve clinical and regulatory milestones that will translate into significant value creation for all of our stakeholders."
Recent Highlights
Announced 2023 year-end Annamycin clinical trials preliminary data and 2024 expectations for multiple data readouts and transition to pivotal Phase 2B/3;
Closed a registered direct offering priced at-the-market under Nasdaq rules with a single healthcare-focused institutional investor and certain of the Company’s executive officers, a board member and concurrent private placement for gross proceeds of $4.5 million before deducting the placement agent’s fees and other estimated offering expenses payable by the Company pushing the Company’s cash runway into the fourth quarter of 2024; and
Presented positive interim data from the Company’s ongoing European Phase 1B/2 clinical trial evaluating Annamycin for the treatment of AML (MB-106) to key opinion leaders and current investigators at a meeting held in conjunction with the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting and Exposition (ASH) (Free ASH Whitepaper) in San Diego, CA.
Summary of Financial Results for the Full Year 2023
Research and development (R&D) expenses were $19.5 million and $19.0 million for the years ended December 31, 2023 and 2022, respectively. The increase in R&D of $0.5 million is mainly related to the $1.5 million WPD sublicense termination, which enabled the reacquisition of the Company’s intellectual property rights in certain territories, including parts of the European Union. This was offset by $1.0 million in costs related to the timing of costs incurred for clinical trials and sponsored research.
General and administrative (G&A) expenses were $10.0 million and $11.5 million for the years ended December 31, 2023 and 2022, respectively. The decrease in G&A of $1.5 million was mainly attributable to a decrease in regulatory and legal services, and consulting & advisory fees.
The net loss for the year ended December 31, 2023 was $29.8 million, which included a non-cash loss of $1.0 million on warrants in 2023 as compared to a gain of $1.3 million in the prior year and approximately $2.0 million of stock-based compensation expense in 2023 as compared to $2.3 million in 2022.
As of December 31, 2023, the Company had cash and cash equivalents of $23.6 million. The Company believes that this cash is sufficient to meet its projected operating requirements into the fourth quarter of 2024.
Conference Call and Webcast
Moleculin management will host its quarterly conference call and webcast for investors, analysts, and other interested parties Monday, March 25, 2024, 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.