On November 13, 2023 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, reported its financial results for the quarter ended September 30, 2023 (Press release, Moleculin, NOV 13, 2023, View Source [SID1234637552]). As previously announced, the Company will host a conference call and live audio webcast, today, November 13, 2023, at 8:30 AM ET (details below).
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"There remains a dire unmet need in AML and STS for a safer, non-cardiotoxic chemotherapy for elderly and frail patients," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Our growing body of positive clinical and encouraging safety data for Annamycin continues to bolster our confidence that our next generation chemotherapy can make a significant impact in the treatment landscape for these high value indications. We remain focused on advancing our priority pipeline programs to key data milestones in the near term, which we be believe will support advancement into pivotal, registration studies in both AML and STS. We believe our year of continued data and the achievement of clinical and regulatory milestones will translate into significant value creation for all of our stakeholders."
Recent Highlights
Dosed first subjects in Phase 2 portion of the clinical trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of Acute Myeloid Leukemia (AML) (MB106);
Completed enrollment in U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of Soft Tissue Sarcoma (STS) Lung Metastases (MB107);
Announced a new positive independent assessment report was published confirming the absence of cardiotoxicity in subjects treated with Annamycin;
Presented poster titled, "A Phase 1b/2 Study of Liposomal Annamycin (ANN) in Subjects with Previously Treated Soft-Tissue Sarcomas (STS) with Pulmonary Metastases" at the 2023 Connective Tissue Oncology Society Annual Meeting in Dublin, Ireland;
Participated in the Virtual Investor Ask the CEO Conference, the webcast replay can be found here; and
The Company will release a more detailed Clinical Trial Update press release later this morning.
Summary of Financial Results for the Third Quarter 2023
Research and development (R&D) expense was $3.3 million and $6.0 million for the three months ended September 30, 2023 and 2022, respectively. The decrease of $2.7 million is mainly related to the timing of costs incurred for clinical trials and timing of sponsored research payments.
General and administrative expense was $2.6 million and $3.1 million for the three months ended September 30, 2023 and 2022, respectively. The decrease of $0.5 million is mainly related to a decrease in regulatory and legal services, and consulting & advisory fees.
As of September 30, 2023, the Company had cash and cash equivalents of $24.6 million and believes that this cash is sufficient to meet its planned operations, which include the current Phase 2 clinical programs and preparations for future clinical trials, into the third quarter of 2024.
Conference Call and Webcast
Moleculin management will host its quarterly conference call and webcast for investors, analysts, and other interested parties today, November 13, 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.