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AGOURA HILLS, Calif., April 16, 2025 (GLOBE NEWSWIRE) -- 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, today announced 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”). 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. 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 SUBSIDIARIESCONSOLIDATED 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. About Oncotelic Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma “DIPG” (through OT-101) through its 45% joint venture, melanoma (through CA4P), and Acute Myeloid Leukemia “AML” (through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019. Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease ("PD"). Over 60,000 new patients are being diagnosed with PD in the United States and currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030. In addition, approximately 10 million suffer from this disease globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics. AL-101 is also being developed for Erectile Dysfunction ("ED"). ED is the most prevalent male sexual disorder globally. The percentages of men affected by ED are as follows: 14.3-70% of men aged 60 years, 6.7-48% of men aged 70 years, and 38% of men aged 80 years (Geerkens MJM et al. (2019). Eur Urol Focus. pii: S2405-4569(19)30079-3). However, with the increasing administration of PDE5 inhibitors in clinical practice, it was found that approximately 30-35% of ED patients are treatment failures (McMahon CN et al. (2006). BMJ, 332: 589-92). AL-101 is designed to target treatment failure ED patients who do not respond to PDE5 inhibitors. Through similar mechanism of action, AL-101 is being developed for Female Sexual Dysfunction ("FSD"). Female sexual dysfunction is a prevalent problem, afflicting approximately 40% of women and there are few treatment options. FSD is more typical as women age and is a progressive and widespread condition. (Allahdadi, KJ et al. (2009) Cardiovascular & hematological agents in medicinal chemistry, 7(4), 260-269). There is no available drug for the treatment of FSD. In June 2019, the U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder ("HSDD") in premenopausal women. This is the only available drug treatment. Vyleesi has essentially replaced the only other drug for HSDD - however, it has a long list of drug-drug interactions, including commonly used antidepressants, such as fluoxetine and sertraline. In addition, it has a black box warning regarding its use with alcohol, a combination that has been associated with hypotension and syncopal episodes. Therefore, there is an urgent need for effective therapy against FSD and HSDD. Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”) that involve substantial risks and uncertainties. We generally identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “would,” “intend,” “target,” “aim,” “project,” “believe,” “estimate,” “predict,” “potential,” “seek,” “indicate,” or “continue” or the negative of these terms or other similar words, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future, such as our estimates regarding anticipated operating income or losses, future performance, future revenues and projected expense, including that to fund our clinical and other development programs; our liquidity and our expectations regarding our needs for and ability to raise additional capital; our ability to continue as a going concern; our ability to select and capitalize on commercially desirable product opportunities as a result of limited financial resources; our ability to manage our expenses effectively and raise the funds needed to continue our business; our ability to retain the services of our current or future executive officers, directors and principal consultants; the competitive nature of our industry and the possibility that our products or product candidates may become obsolete or may not generate revenues as expected or at all; our ability to obtain and maintain regulatory approval of our existing products and any future products we may develop; the development of and the process of commercializing AI/Blockchain and other technologies for supporting the development of OT- 101 and Artemisinin for COVID-19, OT-101, including development of OT-101, Artemisinin, OXi4503, CA4P and our 2021 in-licensing of apomorphine; the initiation, timing, progress and results of our preclinical and clinical trials, research and development programs; regulatory and legislative developments in the United States and foreign countries; the timing, costs and other limitations involved in obtaining regulatory approval for any product; the further preclinical or clinical development and commercialization of our product candidates; the entering into any corporate transactions to develop our products through partnerships, joint ventures or other corporate transactions; our ability to make a proposed initial public offering between us and our joint-venture partners for the joint venture, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof: building and the success of our nanoparticle platform and the related success of launching the platform; the expected valuation of the JV, and therefore a corresponding increase in the valuation of the Company, by virtue of it’s ownership in the JV; the success of the launch of Pet2DAO, a corporation with a DAO infrastructure, the success of Pet2DAO and the plans surrounding the pet and animal health, the ability for the Company to register the tokens of Pet2DAO, the actual filing of a registration statement and approval of the tokens as registrable securities with the Securities and Exchange Commission (“SEC”) through a registration statement, the ability of the tokens to be tradable or any value such tokens may have if they become tradable; our ability to obtain and maintain orphan drug exclusivity for some of our product candidates; the potential benefits of our product candidates over other therapies; our ability to enter into and maintain any collaboration with respect to product candidates; our ability to continue to develop or commercialize our products or product candidates in the event any license agreements in place with third parties expire or are terminated; the performance and conduct of third parties, including our third-party manufacturers and third party service providers used in our clinical trials; our ability to obtain and maintain intellectual property protection for our products and operate our business without infringing upon the intellectual property rights of others; the potential liability exposure related to our products and our insurance coverage for such exposure; our ability to form alliances with other third parties to develop the products in our pipeline through partnerships, joint ventures, mergers or acquisitions; the successful development of our sales and marketing capabilities; the size and growth of the potential markets for our products and our ability to serve those markets; the rate and degree of market acceptance of any future products; the volatility of the price of our common stock; the ability to achieve secondary trading of our stock in certain states; the dilutive effects of potential future equity issuances; our expectation that no dividends will be declared on our common stock in the foreseeable future; our ability to maintain an effective system of internal controls; the payment and reimbursement methods used by private or governmental third-party payers; our ability to retain adequate staffing levels; unfavorable global economic conditions; unfavorable global epidemic and pandemic conditions; a failure of our internal computer systems or those of our contractors and consultants; potential misconduct or other improper activities by our employees, contractors or consultants; the ability of our business continuity and disaster recovery plans to protect us in the event of a natural disaster; and other factors discussed elsewhere in this document or any document incorporated by reference herein or therein. Contact Information: For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com

shiota/ iStock Researchers in pharma and beyond have historically glommed onto a limited number of disease targets, limiting innovation. AI could change that. Proteins that fight tumor growth, gene exons that can be modified, and receptors on immune cells that control their cancer-killing powers. These are the types of mechanisms and bodily processes that could be key to curing or treating disease, and which form the targets of modern drug development. While the number of such targets is nearly infinite, a relatively small number have emerged as the most popular among pharmaceutical companies. In a phenomenon termed “herding,” numerous pharmaceutical firms, research organizations and even academic scientists are targeting not just the same narrow band of conditions, but the same limited set of drug targets. In 2020, 68% of targets pursued by the top 10 pharmaceutical firms were the basis of five or more R&D programs. Some firms were dedicating 80% or more of their research time and dollars to those popular targets. Chief among these targets are those associated with cancer; in 2022, there were nine assets per actively investigated oncology target among the top pharma firms, up from 1.8 in 2000, with most of the research dedicated to breast, hematological and brain cancer. While there are understandable reasons for herding and even advantages in certain situations, the overall effect of this “me-too” style of innovation is to set limits in drug development. But how can we break away from the crowd and forge our own path? As vice president of business development at Evogene, which offers an AI-driven computational chemistry platform, I believe artificial intelligence is the answer. AI has the power to transform drug development by identifying novel targets and compounds that can interact with them. The Drawbacks of Herding Well-known examples of “me-too” drugs include many of the selective serotonin reuptake inhibitors (SSRIs) used in treating depression—such as Prozac, Zoloft and Paxil—and various statins—think Lipitor and Crestor. One of the most comprehensive studies of drug targets curated 1,578 FDA-approved drugs acting on 893 unique molecular targets, meaning nearly 50% of FDA-approved drugs share common targets. Similarly, about 60% of drugs on the World Health Organization’s list of essential treatments fit into this “me-too” category, and more than 50% of the 50 novel drugs approved by the FDA in 2024 relied on pre-existing targets. In many ways, herding makes sense, and it has benefitted some patients and pharma companies. Many of the targets that experience herding, especially in the oncology space, are highly efficacious, and pharma firms want to follow what works and, ideally, create best-in-class treatments in these drug classes. Of course, there is a great demand—and a large need—for these improvements. In addition, when it comes to single-gene diseases such as thalassemia, Duchenne muscular dystrophy and Huntington’s, herding has emerged alongside progress in developing gene therapies. For example, instead of focusing solely on the mutant gene, companies might look at targeting cellular pathways disrupted by the mutant protein. Such approaches make up only 10%–30% of attempts to develop new therapies, while the majority still focus on the mutant gene itself. Such concentrated research efforts, exemplified by the focus on the CFTR gene in cystic fibrosis leading to therapies like Ivacaftor, can indeed accelerate progress in understanding and treating rare genetic diseases. But the focus on the gene itself and a small set of cellular pathways leaves other pathways under explored. This over-concentration diverts critical resources, exacerbating challenges in resource allocation and clinical trial design and ultimately hindering efforts to pursue novel targets and more innovative therapies. This is especially problematic for rare diseases, where the pool of trial participants is naturally low and standards limit patients to one trial at a time. If all or most of the patients are enrolled in trials testing drugs with the same target or few targets, there is little room to open a trial with a new target, further discouraging innovation. Innovation Through AI Pursuing new targets and therapies is essential to reversing the herding trend, and one of the tools for doing this is AI. AI offers the ability to navigate the vast chemical and biological landscape, uncovering hidden patterns and relationships that traditional methods overlook. By integrating data from genomics, proteomics and cheminformatics, AI can identify novel targets that have been underexplored, evaluating their potential with remarkable speed and accuracy. Over the past three years the market for AI platforms for the entire healthcare industry has tripled . As more companies— and regulators —embrace AI-based research, companies will be better equipped to break free from the constraints of herding and the redundancy of structurally similar drugs, shifting toward more innovative and diverse therapeutic strategies. McKinsey predicts that AI could increase the number of actionable drug targets by at least 30% . There are already signs of progress in de-herding as novel biological targets and molecules for drug development emerge. For example, AstraZeneca, in collaboration with BenevolentAI, has identified novel targets in chronic kidney disease (CKD) beyond the well-known renin-angiotensin system, opening pathways to treatments focused on kidney fibrosis and inflammation. AI-based research by Verve Therapeutics, meanwhile, has shifted from traditional statin targets to gene editing therapies for inherited cardiovascular conditions. And for rare diseases, including amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy, companies like Insilico have utilized AI-driven systems to identify specific genetic targets. In addition to finding new targets, deep learning enables the de novo design of novel ligands, the active molecules that are the basis of many potential new drugs. Generative architectures such as GANs (generative adversarial networks), VAEs (variational autoencoders) and GPTs (generative pre-trained models) allow researchers to create unique molecular structures that are specifically tailored to their targets. This capability is transformative because it avoids the redundancy of relying on existing compound libraries, which are often biased toward known targets. AI-driven de novo ligand generation explores new chemical spaces, ensuring structural diversity and reducing the risk of producing yet another version of an existing drug. Companies like Atomwise , Insilico and Recursion are using AI for structure-based drug design, and have discovered unique ligands for various indications. Evogene recently began to leverage its AI-driven computational chemistry platform, first developed for agricultural applications, to break into the world of novel ligand discovery and drug development. Despite its promise, AI-driven drug discovery faces challenges such as variable data quality and the “black box” nature of some models, which can complicate validation and regulatory approval. While the promise of AI-first drugs is yet to be fully realized—none have progressed beyond Phase II clinical trials due to long development timelines—it’s important to note that the most advanced drugs in the pipeline were created using technology that has since matured rapidly. These issues are recognized as part of an evolving field, with ongoing innovation addressing concerns like data standardization and model transparency. I have strong confidence that these hurdles will be overcome in time, ultimately enabling AI to revolutionize drug development and improve patient outcomes. AI use in the pharmaceutical industry is far from universal, but by collaborating with AI-first companies, pharmas can remain at the forefront of technological advancements, ensuring their pipelines are fueled by cutting-edge breakthroughs rather than incremental advances. As AI-driven research becomes the norm, fuelled by these strategic collaborations, we can anticipate transformative progress that will benefit pharmaceutical companies and patients alike.