On March 23, 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 fiscal year ended December 31, 2022 and provided a pipeline update. As previously reported, the Company will host a conference call and live audio webcast, today, Thursday, March 23, 2023, at 8:30 AM ET (details below) (Press release, Moleculin, MAR 23, 2023, View Source [SID1234629246]).

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"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.