On April 16, 2025 Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a developer of treatments for rare and orphan indications, including Parkinson’s Disease, pancreatic ductal adenocarcinoma ("PDAC"), diffuse intrinsic pontine glioma ("DIPG"), and various other cancers, reported its financial results for the fiscal year ended December 31, 2024 ("FY 2024"), as compared to the fiscal year ended December 31, 2023 ("FY 2023") (Press release, Oncotelic, APR 16, 2025, View Source [SID1234651963]). The financial results are based on the Annual Report on Form 10-K ("Form 10-K") as filed with the Securities and Exchange Commission ("SEC") on April 15, 2025.
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Highlights for FY 2024 and thereafter:
2024 has been a transformational year for us. We made great progress on multiple fronts and this momentum continues in 2025. We individually discuss each of these areas below:
San Diego Facility
Our joint venture ("JV"), GPM Biotechnology Limited, with Dragon Capital Overseas Limited has continued the development of its nanoparticle pipeline at its facility in San Diego ("Facility") since late 2023 / early 2024. In late 2024, just over a year after breaking ground, the Facility became good manufacturing practices certified and was issued a Drug Manufacturing License by the State of California Department of Public Health and Food and Drug Branch. The Facility is planned to primarily manufacture our drug product, including the clinical trial materials, for the clinical programs for each of our compounds.
Nanoparticle Platform
At the Facility, the JV initially identified 5 compounds, including OT-101, for development as nanoparticles. Subsequently, the JV identified an additional compound, bringing the total to 5 new compounds, not including OT-101. Each of the nanoparticle compounds is designed as a next-generation anticancer agents. We believe that each of these new compounds can potentially lead to significant revenue and value for the JV, which in turn could lead to significant value to the Company due to our investment in the JV. Two of the 6 compounds are in late stages of manufacturing, and the Company plans to file INDs for both before the end of the year. Our proprietary nanoparticle platform enables the development of multiple therapeutic candidates, to address various oncology indications.
Investigational New Drug Filing Platform with Shanghai Medicilon
We recently announced that we entered into an agreement to utilize the proprietary rapid investigational new drug ("IND") platform created and owned by Shanghai Medicilon Inc. ("Medicilon") to file up to 20 new INDs. We, and the JV, plan to utilize it to file the 6 compounds identified utilizing the Medicilon IND platform, among and upto 20 total filings.
OT-101 Clinical Program
The primary candidate of our JV, OT-101, which has previously completed multiple clinical trials, is currently undergoing a Phase 3 trial in pancreatic cancer. OT-101 also completed a phase 1 combination trial with IL-2. This will allow us to pursue OT-101 in combination with various checkpoint inhibitors, such as PD-1 blockers.
Artificial Intelligence Platform
Our artificial intelligence ("AI") team has played an increasingly important role in the development of the Company and the Facility. Our proprietary AI technology has been used by our scientists in writing research papers, development reports, and regulatory documents from the data gathered from our Facility and elsewhere. As announced in December 2024, we are leveraging our AI Platform, "PDAOAI", to allow third party researchers and individuals to utilize our platform in their workflow. Unlike standard AI tools, PDAOAI is specifically designed for pharmaceutical regulatory processes and research documentation, streamlining workflows and potentially accelerating development timelines.
Results of Operations
Below is a presentation of our financial results comparing FY 2024 to FY 2023, and are based on our results published in our Form 10-K filed with the SEC on April 15, 2025.
FY 2024 compared to FY 2023 Financial Results Overview
ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Year Ended December 31,
2024 2023
Service Revenue $ - $ 70,000
Total Revenue - 70,000
Operating expenses:
Research and development $ - $ 61,143
General and administrative 376,013 573,726
Goodwill impairment (See note 2 and 3) 3,200,000 6,083,146
Total operating expenses 3,576,013 6,718,015
Income/(Loss) from operations (3,576,013 ) (6,648,015 )
Other income (expense):
Interest expense, net (857,723 ) (1,044,786 )
Reimbursement for expenses – related party 22,937 72,246
Change in fair value of investment in GMP Bio - 12,706
Change in fair value of derivative on debt (280,402 ) (225,074 )
Loss on debt conversion (88,258 ) (373,142 )
Total other income (expense) (1,203,446 ) (1,558,050 )
Net income (loss) before non-controlling interests (4,779,459 ) (8,206,065 )
Net loss attributable to non-controlling interests (255,527 ) (302,972 )
Net income (loss) attributable to Oncotelic Therapeutics, Inc. $ (4,523,932 ) $ (7,903,093 )
Basic net loss per share attributable to common stock $ (0.01 ) $ (0.02 )
Basic weighted average common stock outstanding 404,396,473 384,075,369
We incurred a lower net loss per basic share of $0.01 for the year ended December 31, 2024 as compared to net loss per basic share of $0.02 for the year ended December 31, 2023. We incurred a significantly lower net loss of approximately $3.4 million between December 31, 2024 and 2023, respectively. The lower net loss was primarily due to lower impairment of goodwill by approximately $2.9 million, lower general and administrative expenses of approximately $0.2 million and lower other expenses, including interest cost, or approximately $0.3 million. All operational costs associated with OT-101 and the nanoparticle platform are substantially covered by the JV, significantly reducing our direct financial burden till such time we make a determination to commence development of our own compounds.
"Our JV is growing rapidly and is moving towards a potential initial public offering, the timing of which is under evaluation. The JV’s product portfolio has the potential to generate significant revenues and value for itself and, consequently, the Company and its shareholders due to our ownership in the JV. That has been the plan for the Company, since we entered into the JV. As reported in our Form 10-K, while we believe that the valuation of the JV has increased, we have opted to revise the fair value of our investment in the JV only upon a triggering event occurring, and justifying the revision to our fair value, such as, but not limited to, a financing, licensing, an IPO, or results of late stage clinical trials such as our Phase 3 pancreatic cancer trial", said Amit Shah, CFO for Oncotelic.