Moleculin Reports Full Year 2023 Financial Results
- Positive clinical data for Annamycin supporting advancement into a pivotal study for AML.
- Closed a direct offering and private placement, raising gross proceeds of $4.5 million.
- Net loss for 2023 was $29.8 million, with cash and cash equivalents of $23.6 million as of December 31, 2023.
- Increase in R&D expenses from the previous year due to WPD sublicense termination.
- Non-cash loss of $1.0 million on warrants in 2023.
- Stock-based compensation expense of approximately $2.0 million in 2023.
Insights
Annamycin's progression to a pivotal study for Acute Myeloid Leukemia (AML) signifies a critical juncture in oncology drug development, particularly for treatments targeting hard-to-treat cancers. The data indicating non-cardiotoxicity is notable, as cardiotoxicity is a significant concern with current anthracyclines used in chemotherapy. The implications for patients could be profound, potentially offering a safer treatment alternative. For investors, the transition of Annamycin into late-stage trials is a key indicator of Moleculin's pipeline maturity and could influence the company's valuation. The financial commitment to R&D, despite a modest increase, reflects a strategic focus on advancing their lead compounds. However, the net loss and cash runway projections warrant attention, as they suggest a potential need for additional capital in the near future, which could lead to dilution for current shareholders.
The direct offering priced at-the-market, involving institutional and executive participation, provides a short-term cash infusion and demonstrates a degree of confidence in Moleculin's prospects. However, the $4.5 million raised extends the cash runway only into Q4 2024, suggesting a limited financial cushion. This could potentially pressure the stock if the market anticipates further capital raises. The reported net loss is also a concern, though not uncommon for clinical-stage biotech firms. The decrease in G&A expenses is a positive sign of cost management, but the R&D expenses will likely increase as the company approaches pivotal trials. The cash position of $23.6 million, while sufficient for the near term, needs to be considered in the context of future clinical trial costs and potential commercialization expenses.
The market for AML treatments is competitive, with several players working on new therapies. Annamycin's potential non-cardiotoxic profile could differentiate it in the marketplace and offer a competitive advantage. The presentation of interim data at the ASH meeting is a strategic move to garner interest among key opinion leaders, which could facilitate future adoption and partnerships. The biotech sector is driven by data and multiple data readouts in 2024 will likely be pivotal for Moleculin's stock performance. The company’s strategic focus on advancing Annamycin is clear, but the market will closely watch the data readouts for efficacy and safety to assess the drug's commercial potential and impact on Moleculin's long-term growth.
– Year marked by growing body of positive Annamycin efficacy and safety clinical data expected to support advancement into a pivotal study for AML
– Company to host conference call and webcast Monday, March 25th at 8:30 AM ET
– Company to issue separate clinical trial update press release Monday prior to the conference call
"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 - 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 Meeting and Exposition (ASH) in
San Diego, CA.
Summary of Financial Results for the Full Year 2023
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
The net loss for the year ended December 31, 2023 was
As of December 31, 2023, the Company had cash and cash equivalents of
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.
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. Annamycin is currently in development for the treatment of 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
Moleculin Biotech, Inc. | ||||
Unaudited Condensed Consolidated Balance Sheets | ||||
(in thousands) | December 31, 2023 | December 31, 2022 | ||
Current assets: | ||||
Cash and cash equivalents | $ 23,550 | $ 43,145 | ||
Prepaid expenses and other current assets | 2,723 | 2,451 | ||
Total current assets | 26,273 | 45,596 | ||
Furniture and equipment, net | 272 | 275 | ||
Intangible assets | 11,148 | 11,148 | ||
Operating lease right-of-use asset | 524 | 403 | ||
Total assets | $ 38,217 | $ 57,422 | ||
Current liabilities: | ||||
Accounts payable and accrued expenses and other current liabilities | $ 6,815 | $ 4,819 | ||
Total current liabilities | 6,815 | 4,819 | ||
Operating lease liability - long-term, net of current portion | 474 | 335 | ||
Warrant liability - long term | 4,855 | 77 | ||
Total liabilities | 12,144 | 5,231 | ||
Total stockholders' equity | 26,073 | 52,191 | ||
Total liabilities and stockholders' equity | $ 38,217 | $ 57,422 | ||
Unaudited Condensed Consolidated Statements of Operations | ||||
Year Ended December 31, | ||||
(in thousands, except share and per share amounts) | 2023 | 2022 | ||
Revenues | $ - | $ - | ||
Operating expenses: | ||||
Research and development | 19,487 | 18,968 | ||
General and administrative and depreciation and amortization | 10,144 | 11,672 | ||
Total operating expenses | 29,631 | 30,640 | ||
Loss from operations | (29,631) | (30,640) | ||
Other income: | ||||
(Loss) gain from change in fair value of warrant liability | (1,044) | 1,335 | ||
Transaction costs allocated to warrant liabilities | (510) | - | ||
Other income, net | 48 | 40 | ||
Interest income, net | 1,368 | 240 | ||
Net loss | $ (29,769) | $ (29,025) | ||
Net loss per common share - basic and diluted | $ (15.07) | $ (15.22) | ||
Weighted average common shares outstanding - basic and diluted | 1,975,610 | 1,906,960 | ||
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SOURCE Moleculin Biotech, Inc.
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