Oncotelic Therapeutics Highlights 2 Years of Clinical and Regulatory Advancements Across Late-Stage Pipeline

Rhea-AI Summary

Oncotelic Therapeutics (OTCQB: OTLC) has provided a comprehensive update on its clinical and regulatory progress over the past two years. The company's pipeline features multiple late-stage drug candidates targeting oncology and rare diseases.

Key programs include OT-101 in Phase 3 for pancreatic cancer, OXi4503 advancing to Phase 3 for AML/MDS, CA4P/Fosbretabulin for oncology, AL-101 in Phase 2 for Parkinson's and sexual dysfunctions, and AL-102 for Alzheimer's disease. The company is also developing pediatric rare disease programs and a nanomedicine pipeline utilizing the 505(b)(2) pathway for expedited approval.

Positive

• Diverse late-stage pipeline addressing multi-billion dollar markets
• Multiple drug candidates reaching significant clinical milestones
• Strategic use of 505(b)(2) pathway for faster and cost-efficient approvals
• Development of programs eligible for Priority Review Vouchers

Negative

• Early-stage status of some pipeline candidates like AL-102
• Complex development program spanning multiple therapeutic areas requiring significant resources

News Market Reaction – OTLC

+3.22%

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+3.22% News Effect

On the day this news was published, OTLC gained 3.22%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

AGOURA HILLS, Calif., Sept. 12, 2025 (GLOBE NEWSWIRE) -- via IBN -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) ("OTLC" or the "Company"),  a clinical-stage biopharmaceutical company developing transformative oncology and immunotherapy treatments, today announces a summary of its major accomplishments over the past two years. These milestones underscore meaningful clinical progress and regulatory validation across the Company’s lead drug candidates.

Oncotelic’s pipeline includes multiple late-stage programs targeting oncology and rare diseases, with several drug candidates achieving significant clinical milestones

Two-Year Clinical Progress Snapshot

• • OT-101 (TGF-β inhibitor): Phase 3 for pancreatic cancer, with additional applications in ARDS/COVID-19
  • OXi4503 (vascular disrupting agent): Phase 2 in AML/MDS; advancing toward pivotal phase 3 design
  • CA4P / Fosbretabulin: Late-stage oncology asset currently under repositioning
  • AL-101 (intranasal apomorphine): Phase 2 for Parkinson’s disease and sexual dysfunctions
  • AL-102 (oligonucleotide antisense via intrathecal injection): Discovery stage for Alzheimer’s disease
  • Pediatric Rare Disease Programs: Targeting orphan indications with the potential to generate Priority Review Vouchers (PRVs)
  • Nanomedicine Pipeline: Advancing multiple 505(b)(2) drug candidates into clinical testing, leveraging the 505(b)(2) pathway—a faster and more cost-efficient route to market approval compared to a full New Drug Application (NDA).

“OTLC has achieved steady progress across multiple programs, strengthening our position as a late-stage biotech with broad value creation potential. Our pipeline addresses multi-billion-dollar markets with high unmet medical need,” said Dr. Vuong Trieu, Chairman and CEO of Oncotelic.

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 intellectual property 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 Contact
Oncotelic Therapeutics, Inc.
Investor Relations
ir@oncotelic.com

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FAQ

What are the main drug candidates in Oncotelic Therapeutics (OTLC) pipeline?

Oncotelic's main drug candidates include OT-101 (Phase 3 for pancreatic cancer), OXi4503 (Phase 2 in AML/MDS), CA4P/Fosbretabulin (late-stage oncology), AL-101 (Phase 2 for Parkinson's), and AL-102 (discovery stage for Alzheimer's).

What is the current development stage of OTLC's OT-101 drug candidate?

OT-101, a TGF-β inhibitor, is currently in Phase 3 clinical trials for pancreatic cancer, with additional applications in ARDS/COVID-19.

How is Oncotelic Therapeutics accelerating its drug approval process?

Oncotelic is utilizing the 505(b)(2) pathway for its nanomedicine pipeline, which provides a faster and more cost-efficient route to market approval compared to traditional New Drug Applications.

What potential value drivers exist in OTLC's pediatric rare disease programs?

Oncotelic's pediatric rare disease programs target orphan indications that have the potential to generate Priority Review Vouchers (PRVs), which can provide significant value.

What therapeutic areas does Oncotelic Therapeutics (OTLC) focus on?

Oncotelic focuses on multiple therapeutic areas including oncology, rare diseases, Parkinson's disease, Alzheimer's disease, and sexual dysfunctions through various drug candidates in different development stages.