Varegacestat

Highlighting multibillion-dollar drug discoveries and advancing novel oncology and immunotherapy assets AGOURA HILLS, Calif., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) (“OTLC” or the “Company”), a clinical stage biopharmaceutical company developing transformative oncology and immunotherapy treatments, today highlights the depth of its oncology and immunotherapy pipeline while recognizing the extraordinary intellectual property contributions of its Chairman and CEO, Dr. Vuong Trieu. Dr. Trieu is a prolific industry pioneer with over 500 filed patents and 75 issued patents covering biologics, small molecules, nanoparticles, diagnostics. Over his career he has invented, co-invented, and developed multiple novel therapeutics that have advanced to U.S. Food and Drug Administration (FDA) approval or late-stage development. Most notably, Dr. Trieu co-invented and developed Abraxane® (nab-paclitaxel), acquired by Celgene in 2010 as part of a $2.9 billion transaction. He later developed and sold Cynviloq™ (nanoparticle paclitaxel) to NantPharma in 2015 in a deal valued at $1.3 billion. His career contributions extend across oncology, cardiovascular, reproductive, infectious-disease, neuro-critical-care, aging, and rare diseases, with a consistent focus on delivering first-in-class therapeutics to address high unmet medical needs. OTLC Pipeline Overview OT-101 (TGF-β inhibitor): Phase 3 for pancreatic cancer, with additional applications in ARDS/COVID-19OXi4503 (vascular disrupting agent): Phase 2 in AML/MDS; advancing toward pivotal phase 3 designCA4P / Fosbretabulin: Late-stage oncology asset currently under repositioningAL-101 (intranasal apomorphine): Phase 2 for Parkinson’s disease and Sexual DysfunctionsAL-102 (oligonucleotide antisense via intrathecal injection): Discovery stage for Alzheimer’s diseasePediatric Rare Disease Programs: Targeting orphan indications with the potential to generate Priority Review Vouchers (PRVs) Dr. Trieu’s innovations form the cornerstone of OTLC’s intellectual property portfolio, reinforcing the Company’s strategy of building value through differentiated biotechnology assets with strong competitive barriers. “Our strength lies not only in OTLC’s clinical pipeline but also in the breadth of intellectual property generated over my career, converting deep tumour-microenvironment biology into globally protected, clinic-ready technologies that redefine how drugs are delivered, monitored, and personalised,” said Dr. Trieu. “We remain committed to transforming these innovations into life-saving therapies for patients and long-term value for shareholders.” About Oncotelic Therapeutics Oncotelic Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of oncology and immunotherapy products. The Company’s mission is to address high-unmet-need cancers and rare pediatric indications with innovative, late-stage therapeutic candidates. In addition to its directly owned and developed drug pipeline, Oncotelic benefits from the robust portfolio of inventions created by its CEO, Dr. Vuong Trieu, who has filed over 150 patent applications and holds 39 issued U.S. patents. Beyond its internal programs, the Company also licenses and co-develops select drug candidates through joint ventures. Currently, Oncotelic owns 45% of GMP Bio, a joint venture under Dr. Trieu’s leadership and guidance, which is advancing its own pipeline of drug candidates that further complement and strengthen Oncotelic’s strategic position in oncology and rare disease therapeutics. For more information, please visit: www.oncotelic.com Oncotelic Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this release other than statements of historical fact are forward-looking and are based on current expectations, estimates, and projections about our business and future plans. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “project,” “forecast,” “potential,” “continue,” and similar expressions (including the negative of such terms). Forward-looking statements in this release include, without limitation: our plans, timelines, and priorities for the OT-101 program in PDAC and other indications; potential biomarker-driven development strategies; the advancement, scope, timing, and results of current or future preclinical and clinical studies; regulatory interactions and potential approvals; development or commercialization of any product candidates within the Oncotelic/GMP Bio/Sapu ecosystem; the utility of our PDAOAI platform; future financings, strategic transactions, and/or public offerings involving our joint ventures or affiliates; and other statements that are not historical facts. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to: the inherent uncertainties of drug discovery and development; our ability to enroll patients and complete studies on expected timelines; whether preclinical or early clinical findings (including biomarker associations) will be replicated in larger, controlled trials; regulatory developments in the United States and other jurisdictions; competitive developments; our ability to obtain or maintain intellectualproperty protection; our liquidity and access to capital; the performance of collaborators, suppliers, and manufacturers; and other risks described in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our most recent Form 10-K and subsequent periodic reports. Forward-looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise such statements, whether as a result of new information, future events, or otherwise, except as required by law. Investor & Media ContactOncotelic Therapeutics, Inc.Investor Relationsir@oncotelic.com

BOTHELL, Wash.--(BUSINESS WIRE)--Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the quarter ended March 31, 2025 and provided a business update. “Immunome continued to build momentum in the first quarter of 2025,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer. “We remain on track to share topline data for the RINGSIDE trial of varegacestat in the second half of 2025, and we are optimistic that varegacestat will demonstrate differentiated efficacy across multiple endpoints. “Varegacestat is complemented by a robust pipeline of differentiated programs with first-in-class or best-in-class potential. The dose escalation portion of the Phase 1 clinical trial of IM-1021, our ROR1 ADC, is ongoing in solid tumors and lymphoma. Following the recent clearance of the IND for IM-3050, our FAP radiotherapy, we expect to start a clinical trial for that program in the second half of this year. We are making progress on IND-enabling manufacturing for IM-1617, IM-1335 and IM-1340, each of which incorporate our differentiated TOP1 inhibitor, HC74.” Pipeline Highlights Varegacestat: Full enrollment for the Phase 3 RINGSIDE Part B study of varegacestat for the treatment of desmoid tumors was completed in February 2024, and Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing the manufacturing and pharmacology work required to support a new drug application filing for varegacestat. IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with the first patient dosed in February 2025. The trial is an open-label, multicenter dose-escalation and expansion study that is expected to include participants with advanced B-cell lymphomas and advanced solid tumors. IM-3050: Immunome received IND clearance for IM-3050 in April 2025 and expects to initiate a Phase 1 clinical trial in the second half of 2025. Preclinical Pipeline: Immunome’s three preclinical ADCs against solid tumor targets, IM-1617, IM-1340 and IM-1335, each of which incorporates HC74, are currently undergoing IND-enabling work. Additional undisclosed ADCs are in discovery and lead optimization. First Quarter 2025 Financial Results As of March 31, 2025, cash, cash equivalents and marketable securities totaled $317.3 million. This total includes net proceeds of $161.7 million from the January 2025 financing and reflects approximately $11 million in payments during the quarter related to non-recurring IM-1021 milestones and 2024 annual performance bonuses. Immunome expects its current cash position to fund operations into 2027. Research and development expenses for the quarter ended March 31, 2025 were $36.9 million, including stock-based compensation costs of $2.4 million. General and administrative expenses for the quarter ended March 31, 2025 were $10.7 million, including stock-based compensation expense of $3.3 million. Immunome reported a net loss of $41.6 million for the quarter ended March 31, 2025. About Immunome, Inc. Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors. For more information, visit www.immunome.com. Cautionary Statement Regarding Forward-Looking Statements Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “focused,” “on track,” “optimistic,” “will,” “potential,” “expect,” and similar expressions to identify these forward-looking statements. These forward-looking statements include Immunome’s expected timing for providing topline data for the Phase 3 RINGSIDE Part B trial; Immunome’s expected cash runway and ability to achieve clinical milestones; Immunome’s expectation that it will enroll patients in its Phase 1 clinical trial for IM-1021 and will report resulting clinical trial data, and that it will initiate a Phase 1 clinical trial for IM-3050; Immunome’s expectations regarding regulatory filings; the ability of Immunome to advance its pipeline; the potential of Immunome’s ADC programs to provide first-in-class or best-in-class status; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including the risk that Immunome will not be able to realize the benefits of its strategic transactions; the risk that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that pre-clinical data may not be predictive of clinical data; the risk that Immunome’s programs and product candidates fail to achieve their intended endpoints; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; Immunome’s ability to grow and advance its pipeline and successfully execute on its business plan; and other risks and uncertainties included under the caption “Risk Factors” in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 19, 2025 and in Immunome’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, to be filed with the SEC later today. These documents can also be accessed on Immunome’s website at www.immunome.com by clicking on the link “Financials” under the “Investors” tab. The forward-looking statements included in this press release are made only as of the date hereof. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release. 257,613 143,351 59,710 73,952 5,807 4,036 323,130 221,339 10,953 10,113 4,163 4,278 100 100 4,347 4,411 342,693 240,241 9,126 14,189 17,656 33,177 4,015 6,941 30,797 54,307 4,770 4,769 35,567 59,076 — — 9 6 864,530 696,872 (3 ) 57 (557,410 ) (515,770 ) 307,126 181,165 342,693 240,241 Three Months Ended March 31, 2025 2024 ) ) ) ) ) ) ) ) ) ) ) )