Aldesleukin biosimilar(AMEGA Biotech)

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

ImCheck to Present New Positive Data on ICT01 Monotherapy in Hematological Cancers at ESMO 2023 Interim data from Phase I dose escalation portion of EVICTION Phase I/IIa trial show strong safety profile and encouraging clinical activity for ICT01 monotherapy in relapsed/refractory hematological malignancies ImCheck Therapeutics announced today that updated data from its ongoing Phase I/IIa clinical trial EVICTION will be presented at the European Society for Medical Oncology (ESMO) Congress in an oral session on October 22nd in Madrid. The presentation (822O) entitled: “Activation of γ9δ2 T Cells by ICT01 as a Novel Immunotherapeutic Approach for Relapsed/Refractory Hematologic Cancers (EVICTION Study)” will provide safety and patient response results from the Phase I dose escalation portion of the EVICTION trial of ImCheck’s lead antibody, ICT01, administered as a monotherapy to relapsed/refractory patients with hematological cancers, primarily Acute Myeloid Leukemia (AML). “The positive safety profile, consistent with previous data in solid tumor patients, together with the promising clinical activity underscores the potential of ICT01 in hematological malignancies. These results in last-line patients further support the initiation of the ongoing Phase IIa cohort expansion study of ICT01 in combination with standard of care in first-line AML patients,” commented Sylvain Garciaz, M.D., Ph.D., member of the Department of Hematology, Institut Paoli-Calmettes, investigator in the EVICTION study, and presenter of the data at ESMO 2023. “We continue to generate highly encouraging clinical signals in both solid and hematological tumors. We remain focused on rapidly advancing ICT01 into late-stage clinical evaluation in combination settings as a unique clinical approach to boost the anti-tumor immune response in cancer patients,” commented Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics. EVICTION is an open-label Phase I/IIa trial assessing ICT01, a humanized anti-BTN3A monoclonal antibody that selectively activates γ9δ2 T cells, as a monotherapy in solid and hematological tumors, and as a combination therapy with pembrolizumab in solid tumors. The Phase 1 dose escalation study in relapsed/refractory hematological cancers included 26 patients who failed all available standard of care, 24 of which had acute myeloid leukemia, 1 with diffuse large B-cell lymphoma and 1 with follicular lymphoma. ICT01 was administered at doses ranging from 200 g to 75 mg every 21 days and primary endpoints consisted of the incidence of treatment-adverse events (AE) and the disease control rate (DCR) defined as the sum of complete response (CR), CR with incomplete recovery (CRi), partial response (PR) and stable disease (SD). Secondary endpoints included circulating γ9δ2 T cell measurements as well as pharmacokinetic and pharmacodynamic analyses. The reported data did not reveal any dose-limiting toxicities and demonstrated a DCR of 30% among the 10 evaluable patients at week 8. Notably, ICT01 treatment safely induced the activation and migration of γ9δ2 T cells from the blood within hours of dosing, suggesting effective target engagement. Based on these results, the company has started evaluating ICT01 in combination with Venetoclax/azacitidine in a Phase IIa expansion cohort in first-line AML patients. Details of the presentation are: Abstract title: “Activation of γ9δ2 T Cells by ICT01 as a Novel Immunotherapeutic Approach for Relapsed/Refractory Hematologic Cancers (EVICTION Study)” Session title: Proffered paper sessions – Haematological malignancies Abstract number: 822O Authors: Sylvain Garciaz (presenter), Stéphane Champiat, Pierre Peterlin, Katrien Lemmens, Aude De Gassart, Patrick Brune, Emmanuel Valentin, Céline Leparquier, Marina Iché, Daniel Olive, Norbert Vey, Paul Frohna Date/Time: Sunday October 22nd, 2023, 4:30 PM - 6:00 PM CET Location: Toledo Auditorium - Hall 3 The ESMO presentation will be available starting October 22, 2023, at 4:30 pm CET on ImCheck’s corporate website. About the EVICTION Trial EVICTION is a first-in-human, dose escalation (Part 1) and cohort expansion (Part 2) clinical trial of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard of care treatment options. Part 1 is a basket trial designed to characterize the preliminary safety, tolerability, and pharmacodynamic activity of ICT01 as monotherapy (Group A: solid tumors; Group B: hematologic tumors) and in combination with pembrolizumab (Group C: solid tumors). Group A includes bladder, breast, colorectal, gastric, melanoma, ovarian, prostate, and pancreatic cancer patients, Group B includes acute myeloid leukemia, acute lymphocytic leukemia, follicular lymphoma, and diffuse large B cell lymphoma patients, and Group C includes bladder, head and neck squamous cell carcinoma, melanoma, and non-small cell lung cancer patients. Basket trials are a clinical trial design that allows new drugs to be tested rapidly in a range of indications, providing initial data on multiple parameters that can contribute to an accelerated development timeline. Part 2 of the trial is a Phase II cohort expansion study in selected indications as both monotherapy and in combination. First indications selected for the Phase II monotherapy expansion cohorts are relapsed/refractory ovarian cancer and metastatic castrate-resistant prostate cancer. More information on the EVICTION trial can be found at clinicaltrials.gov (NCT04243499). A second clinical trial, EVICTION-2, evaluating the combination of ICT01 plus low dose subcutaneous IL-2 to selectively expand the number of γ9δ2 T cells in patients with solid tumors (prostate, pancreatic, ovarian, or colorectal cancer) is also ongoing (NCT05307874). About ICT01 ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that selectively activates γ9δ2 T cells, which are part of the innate immune system that is responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by ICT01 are overexpressed on a number of solid tumors (e.g., bladder, colorectal, melanoma, ovarian, pancreatic, lung) and hematologic cancers (e.g., leukemia & lymphoma) and also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. As demonstrated in EVICTION data presented at past AACR, EMSO and SITC conferences, ICT01 selectively activates circulating γ9δ2 T cells that leads to migration of γ9δ2 T cells out of the circulation and into target tissue (e.g., tumors), while also activating the tumor-resident γ9δ2 T cells to directly kill malignant cells, which is accompanied by secretion of two key inflammatory cytokines, IFNγ and TNFα, that contribute to the expansion of the anti-tumor immune response. ICT01 has been shown to have anti-tumor activity against a range of cancers in in vitro and in vivo tumor models. About IMCHECK THERAPEUTICS ImCheck Therapeutics is designing and developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel super-family of immunomodulators. As demonstrated by its lead clinical-stage program ICT01, which has a mechanism of action to simultaneously modulate innate and adaptive immunity, ImCheck's “first-in-class” activating antibodies may be able to produce superior clinical results as compared to the first-generation of immune checkpoint inhibitors and, when used in combination, to overcome resistance to this group of agents. In addition, ImCheck’s antagonist antibodies are being evaluated as potential treatments for a range of autoimmune and infectious diseases. Co-founder of the Marseille Immunopole cluster, ImCheck benefits from support from Prof. Daniel Olive (INSERM, CNRS, Institut Paoli Calmettes, Aix-Marseille University), a worldwide leader in γ9δ2 T cells and butyrophilins research, as well as from the experience of an expert management team and from the commitment of leading US and European investors. The content above comes from the network. if any infringement, please contact us to modify.