On May 17, 2026 ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic therapy (VTP) to treat a range of solid tumors, reported updated results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial carcinoma (UTUC). These data will be shared during a podium presentation and in an interactive poster at the American Urological Association (AUA) Annual Meeting taking place May 15-18, 2026, in Washington, D.C.

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"These updated efficacy and durability results from the Phase 3 ENLIGHTED trial continue to reinforce Padeliporfin VTP’s potential to become an attractive alternative, minimally invasive ureteroscopic treatment option for patients with low-grade UTUC," said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. "The promising complete response rate and encouraging durability observed to date, alongside a well-established safety profile, further support the opportunity to provide a meaningful organ-sparing treatment for patients with limited options in UTUC and additional solid tumor indications. We look forward to sharing topline data from ENLIGHTED later this year and preparing for regulatory submission in 2027, while exploring strategic opportunities to commercialize the program and maximize Padeliporfin VTP’s impact for UTUC patients facing great unmet need."

Key updated results from the ongoing Phase 3 ENLIGHTED study of Padeliporfin VTP:

As of April 20, 2026, the data cut-off for the poster presentation at AUA 2026, 82 patients had begun treatment, of which 72 had completed PRE and were evaluable for efficacy.

Efficacy Profile:

Overall response rate: 88%
50 of the 72 (70%) response-evaluable patients achieved a CR at the end of PRE.
13 of the 72 (18%) response-evaluable patients achieved a partial response (PR) at the end of PRE.

Durability Profile:

18 of the 21 (85.7%) response-evaluable patients who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months as of the data cutoff date, with additional patients ongoing the MTP that have yet to complete the 12-month evaluation period. Padeliporfin VTP treatment has demonstrated evidence of efficacy and durability.
The current median duration of response (DoR) in the treated area for evaluable patients is 23.9 months based on available follow-up, with ongoing responses still being observed.

Safety and Tolerability Profile:

Padeliporfin VTP was well-tolerated with a safety profile consistent with the previous data obtained from the Phase 1 study and previously announced preliminary Phase 3 results. Padeliporfin VTP treatment has demonstrated a consistent and acceptable safety profile.
Adverse events (AEs): the majority of treatment-emergent adverse events (TEAEs) were mild or moderate, primarily related to the ureteroscopic procedure, and resolved within a few days. Two patients had Grade 3 serious adverse events related to VTP treatment which resolved within two days. No TEAEs of special interest were reported and no TEAE led to discontinuation of the study treatment.

While the Company is pursuing strategic partnering opportunities to support the commercialization of its low-grade UTUC program, ImPact recently presented initial data supporting the advancement of Padeliporfin VTP in locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) at the Society of Interventional Radiology (SIR) 2026 Annual Meeting, which demonstrated a consistent tolerability profile alongside early signs of clinical efficacy, showing potential to convert patients with unresectable stage III LA tumors to surgically resectable candidates.

Additional updates from both programs will be presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, IL.

AUA Presentation Details:

Interactive Poster Title: The ENLIGHTED Phase 3 Trial: Advancing Treatment of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP)
Presenter: Vitaly Margulis, M.D., Professor of Urologic Oncology, University of Texas Southwestern Medical Center
Poster Number: IP30-04
Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma I
Session Date & Time: Saturday, May 16, 2026 at 7:00 AM ET

Podium Presentation Title: ENLIGHTED Phase 3 Trial of Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC)
Presenter: Jonathan Coleman, M.D., Urologic Surgeon, Memorial Sloan Kettering Cancer Center
Session Title: Clinical Trials in Progress: Bladder Cancer
Session Date & Time: Sunday, May 17, 2026 at 9:16 AM ET

About ENLIGHTED
The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of
the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an ureteroscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.

(Press release, ImPact Biotech, MAY 17, 2026, View Source [SID1234665816])

On May 17, 2026 EORTC reported final results from a landmark EORTC randomised trial with more than 20 years of follow-up show that irradiation of the internal mammary and medial supraclavicular lymph nodes reduces breast cancer mortality but does not improve overall survival. The findings highlight the importance of very long-term follow-up when evaluating cancer treatments, particularly in patients with otherwise favourable prognosis.

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The results stem from EORTC trial 22922/10925 and were presented at the ESTRO 2026 Congress in Stockholm during the plenary session: Joint Green Journal – The Lancet Oncology Top Clinical Trials. Reflecting the strength and clinical relevance of these findings, the planned 20-year analysis of the full trial population has been simultaneously published in CA: A Cancer Journal for Clinicians, while The Lancet Oncology has accepted to publish soon a complementary paper reporting an unplanned subset analysis in the patients with node-negative (pN0) breast cancer.

Between 1996 and 2004, the trial enrolled 4,004 patients with stage I–III breast cancer at 46 centres in 13 countries. Patients were randomised to receive postoperative radiation therapy with or without elective irradiation of the internal mammary and medial supraclavicular (IM-MS) lymph nodes. At final analysis, the median follow-up was 22.2 years — the longest planned, as well as median, follow-up of any randomised breast cancer radiation therapy trial.

Long‑term outcomes across the overall trial population
At 20 years, overall survival was similar in patients treated with or without IM-MS irradiation. However, breast cancer–related mortality was significantly lower among patients who received IM-MS irradiation. This benefit was counterbalanced over time by an increase in deaths from causes other than breast cancer, which emerged after approximately 15 years, resulting in no survival advantage.

Long-term cardiac and pulmonary toxicity was reported more frequently after IM-MS irradiation, although severe side effects remained very uncommon. Of note, patients were treated using radiation therapy techniques available more than two decades ago.

Outcomes in node-negative breast cancer patients
The proffered paper presented at ESTRO also included the subset analyses on the 1,778 patients with node-negative (pN0) breast cancer and centrally or medially located tumours. Despite a lower absolute risk of breast cancer death in this group, the long-term pattern closely mirrored that of the overall trial population.

Reductions in breast cancer mortality were again offset by a later increase in non–breast cancer–related deaths, resulting in no improvement in overall survival. These findings suggest that long‑term trade‑offs must be considered even in patients with a favourable prognosis and call for careful evaluation of nodal irradiation in axillary‑node‑negative disease.

"Such large, decades-long trials with rigorous quality assurance, allowing clinically meaningful subgroup analyses, are only possible thanks to the sustained support and collaboration fostered by organisations like EORTC," agreed both study coordinators.

The investigators note that advances in modern radiation therapy planning and delivery, sharply reducing radiation exposure to organs such as the heart and lungs, very likely improves the balance between benefits and risks for patients treated today.

Why this trial matters
It provides the longest planned, as well as median follow-up, of any randomised breast cancer radiation therapy trial.
It shows that treatment benefits and risks continue to evolve well beyond 15–20 years.
It demonstrates that node‑negative patients experience similar long‑term trade‑offs as the overall trial population.
It informs ongoing discussions on optimising and potentially de-escalating treatments in favourable-risk breast cancer.
Conducted by the EORTC Radiation Oncology and Breast Cancer Groups, trial 22922/10925 remains a cornerstone study for understanding the long‑term impact of locoregional treatments in breast cancer and for guiding future research aimed at improving both survival and quality of life.

ESTRO 2026 presentation number: 5580 Internal Mammary and Medial Supraclavicular irradiation in stage I-III breast cancer: 20 years results of the randomised EORTC trial 22922/10925, including in pN0 patients (Presenter: Philip Poortmans & Orit Kaidar-Person)

Funding: This study was supported by donations from the La Ligue nationale contre le cancer from France; the KWF Kanker Bestrijding from the Netherlands; and from the Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society from Belgium.

The fellowship of Lydia Champezou was financially supported by the EORTC Cancer Research Fund (ECRF).

(Press release, EORTC, MAY 17, 2026, View Source [SID1234665809])

On May 16, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory ("JBL"), the Tokyo-based developer and manufacturer of the Tokyo strain of BCG (Tokyo-172 BCG). The agreement provides ImmunityBio exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo-172 BCG.

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JBL’s Tokyo strain of BCG is supported by the February 2026 positive Phase III readout of SWOG S1602, a randomized Phase III study sponsored by the National Cancer Institute (NCI), which demonstrated non-inferiority of the Tokyo strain of BCG to TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer (NMIBC). The pre-specified non-inferiority margin was a hazard ratio of 1.34 (hazard ratio 0.82; 95.8% CI 0.63–1.08). The Tokyo strain of BCG is investigational in the United States and has not been approved by the FDA.

Dr. Patrick Soon-Shiong will discuss the JBL agreement and provide updates on ImmunityBio’s efforts to expand BCG access and advance research in the BCG-naïve setting during his presentation, "The Role of IL-15 in the Urological Setting," at the American Urological Association Annual Meeting on May 16, 2026 at 1:30 EDT. The presentation will also highlight the role of IL-15 in urological oncology, including mechanisms driving T cell and natural killer (NK) cell activation, current clinical evidence, and emerging combination approaches in bladder and prostate cancer. A livestream of the presentation will be available through the 2026 AUA Annual Meeting website.

"For more than 70 years, Japan BCG Laboratory has been dedicated to the development and manufacture of high-quality BCG products," said Seiichi Inoue, President of Japan BCG Laboratory. "We are pleased to partner with ImmunityBio to bring the Tokyo strain of BCG to patients in the United States, and we look forward to supporting ImmunityBio in its engagement with the FDA."

ImmunityBio plans to engage with the FDA to pursue U.S. approval of the Tokyo strain of BCG and will lead all regulatory submissions, clinical development, and commercialization in the United States as the sole BLA applicant. Upon any approval, ImmunityBio will be the sole Marketing Authorization Holder. The Tokyo strain of BCG has been used in Japan for almost 30 years for the treatment of high-risk NMIBC.

SWOG S1602 (NCT03091660) is a Phase III randomized controlled trial that enrolled 1,000 patients (984 eligible) between February 2017 and December 2020 with BCG-naïve high-grade NMIBC, randomized 1:1:1 to intravesical TICE BCG (n=330), intravesical Tokyo-172 BCG (n=327), or intradermal priming, followed by intravesical Tokyo-172 BCG (n=327). The pre-specified non-inferiority margin for the primary endpoint of high-grade recurrence-free survival (HGRFS) was a hazard ratio of 1.34.

At a median follow-up of 4.6 years, results presented at the February 2026 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (Svatek RS, et al. J Clin Oncol. 2026;44[7 suppl]:LBA629) demonstrated non-inferiority of intravesical Tokyo strain of BCG versus intravesical TICE BCG on the primary endpoint of HGRFS (HR 0.82; 95.8% CI 0.63–1.08), with the upper confidence bound well below the pre-specified non-inferiority margin of HR 1.34. Complete response (CR) in carcinoma in situ (CIS) at 6 months was 66.4% (Tokyo) versus 70.2% (TICE). Progression-free survival was similar across arms. The estimated 5-year HGRFS was 64% in the Tokyo arm, 58% in the TICE arm.

ImmunityBio is in discussions with the SWOG Cancer Research Network, the NCI, and Fred Hutchinson Cancer Research Center to establish a Data Use Agreement that would allow incorporation of the S1602 data into the company’s planned BLA submission.

"SWOG and the National Cancer Institute have our deep respect for designing and completing SWOG S1602, a randomized controlled trial of approximately one thousand patients in BCG-naïve high-grade NMIBC that took nearly a decade to read out," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "S1602 is the kind of rigorous, publicly funded science that should inform FDA decision-making. Its non-inferiority finding for the Tokyo strain of BCG, alongside our rBCG partnership with Serum Institute and the FDA-approved use of ANKTIVA with BCG in BCG-unresponsive disease, points to a future where U.S. patients with bladder cancer will have the supply and the treatment options they need."

With the JBL agreement, ImmunityBio now has a second potential BCG source for the United States. The Company’s ongoing partnership with Serum Institute of India, one of the world’s largest vaccine manufacturers, supports the supply of recombinant BCG (rBCG), an investigational product. ImmunityBio will continue its FDA Expanded Access Program (EAP) for rBCG, so eligible patients can receive treatment while the regulatory path for the Tokyo strain of BCG moves forward. Taken together, the two partnerships aim to give U.S. urologists and their patients a more reliable BCG supply.

"U.S. urologists and their patients have lived with a chronic BCG shortage for more than a decade," said Richard Adcock, President and Chief Executive Officer of ImmunityBio. "This agreement with Japan BCG Laboratory for the Tokyo strain of BCG gives ImmunityBio a second potential BCG source for the United States. We plan to work with the FDA on the regulatory path for the Tokyo strain of BCG. In the meantime, through our ongoing partnership with the Serum Institute of India, rBCG remains available to eligible patients through our FDA Expanded Access Program."

ANKTIVA is approved by the FDA in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in-situ (CIS), with or without papillary tumors. ImmunityBio expects to provide further updates on the U.S. regulatory pathway for the Tokyo strain of BCG, including the timing of pre-FDA interactions and any anticipated BLA submission, in future communications.

Important Safety Information

U.S. IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

Investigational Use Notice: The Tokyo strain of BCG (manufactured by Japan BCG Laboratory) and recombinant BCG or rBCG (manufactured by Serum Institute of India under ongoing partnership with ImmunityBio) are investigational in the United States and have not been approved by the FDA. The safety and effectiveness of these investigational products have not been established. Availability of rBCG is limited to ImmunityBio’s FDA Expanded Access Program for eligible patients. To enroll in the Expanded Access Program for recombinant BCG, please visit View Source

(Press release, ImmunityBio, MAY 16, 2026, View Source [SID1234665810])

On May 15, 2026 MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company developing allogeneic invariant natural killer T (allo-iNKT) cell therapies to restore immune balance and treat immune-mediated diseases and cancer, reported financial results for the first quarter ending March 31, 2026, and provided a corporate update.

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"MiNK entered 2026 focused on converting a growing body of clinical and translational evidence into prospective validation," said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. "During the first quarter and subsequent period, we advanced agenT-797 into a randomized Phase 2 study in acute lung injury and critical illness, presented data that further support the context-dependent biology of iNKT cells, and continued to expand the platform through selective, non-dilutive collaborations. This is the next phase of MiNK’s strategy: disciplined clinical execution, rigorous translational validation, and capital-efficient expansion of a broadly deployable cell therapy platform."

Dr. Buell continued, "What continues to distinguish agenT-797 is both its biology and its practicality. As an off-the-shelf iNKT cell therapy administered without lymphodepletion or HLA matching, agenT-797 is designed for settings where immune dysfunction drives poor outcomes and where speed, tolerability and deployability matter. We believe this is particularly relevant in severe acute lung injury and critical illness, where patients often face a cascade of respiratory failure, secondary infection and organ dysfunction with limited therapeutic options."

Recent Business and Development Highlights

agenT-797 Advanced into Randomized Phase 2 Clinical Evaluation in Acute Lung Injury and Critical Illness

MiNK initiated a randomized Phase 2 clinical trial evaluating agenT-797 plus standard of care compared with placebo plus standard of care in adults with severe acute lung injury and critical illness, including moderate to severe acute hypoxemic respiratory failure due to severe pneumonia, who meet Global ARDS criteria and are admitted to the ICU. The study is being designed with a seamless Phase 2/3 operational framework intended to support efficient transition into later-stage development if findings from the randomized Phase 2 portion are prospectively confirmed.

The trial has received authorization from the Ukraine Ministry of Health, is supported by an active U.S. IND, and remains subject to FDA clearance for planned U.S. site activation. Preliminary data are expected in the second half of 2026.

Acute lung injury and ARDS remain among the most serious unresolved conditions in critical care. ARDS affects an estimated 3 million patients globally and approximately 200,000 patients annually in the United States, accounting for nearly 25% of mechanically ventilated ICU patients.i Mortality remains high, approximately 40% to 50%, and there are currently no approved pharmacologic therapies shown to reduce mortality in ARDS.ii The trial is designed to prospectively evaluate agenT-797 in a clearly defined, critical care population where ventilator-free days, secondary infection, respiratory recovery and survival can be assessed within clinically meaningful and regulatory-aligned endpoints.

Recent Data at AACR (Free AACR Whitepaper) and ASGCT (Free ASGCT Whitepaper) Strengthen the Biologic Rationale for Context-Dependent iNKT Activity

Recent clinical and translational presentations at the American Association for Clinical Research (AACR) (Free AACR Whitepaper) Annual Meeting and the American Society of Gene and Cell Therapy Meeting (ASGCT) (Free ASGCT Whitepaper) reinforced the potential of MiNK’s iNKT platform to generate disease-relevant immune activity across distinct clinical settings.

In PD-1 refractory gastroesophageal cancer, investigator-sponsored Phase 2 data showed disease control and longer-term survival in a subset of heavily pretreated patients, supported by evidence of immune activation and tumor microenvironment remodeling. The study achieved a 77% disease control rate, with long-term survival beyond 20 months observed in a subset of patients with immune-induction prior to chemotherapy. These patients also had longer progression-free survival compared with those treated without induction, with median PFS of 6.9 months versus 3.5 months.

At ASGCT (Free ASGCT Whitepaper), translational analyses showed that the same off-the-shelf agenT-797 product generated distinct immune outputs in solid tumor and ARDS patients. In solid tumor patients, agenT-797 was associated with a TH1 pro-inflammatory signature consistent with anti-tumor immune activation. In ARDS patients, the same product was associated with a TH2 anti-inflammatory signature consistent with immune restoration and lung injury recovery.

Together, these findings support MiNK’s broader development strategy: advancing agenT-797 in settings where immune dysfunction contributes to poor outcomes, while using translational data to define patient populations, biologic mechanisms and future development pathways.

Non-Dilutive Collaborations Support Capital-Efficient Platform Expansion

MiNK continued to advance its strategy of expanding the iNKT platform through selective collaborations that provide external support and potential downstream economics while preserving focus on lead clinical programs.

In the first quarter, MiNK announced a collaboration with C-Further, an international pediatric oncology therapeutics consortium enabled by Cancer Research Horizons, LifeArc and Great Ormond Street Hospital Charity, to advance a PRAME-targeted TCR-engineered iNKT cell therapy for pediatric cancers. The collaboration provides up to approximately $1.1 million in non-dilutive aggregate funding to support IND-enabling development, with potential meaningful double-digit downstream commercial revenue participation.

The C-Further program applies MiNK’s off-the-shelf iNKT platform to a validated tumor antigen strategy in pediatric oncology and reflects the company’s broader approach to platform expansion through externally supported, capital-efficient development.

MiNK is also advancing additional externally supported programs, including its graft-versus-host disease program supported by NIH STTR funding and the Mary Gooze philanthropic award. These collaborations and funding sources are intended to support pipeline progress while reducing the capital burden typically associated with multi-program cell therapy development.

Upcoming ATS Presentation Extends Platform Discussion into Persistent Pulmonary Infection and Immune Dysfunction

MiNK will present clinical data featuring agenT-797 at the American Thoracic Society (ATS) International Conference 2026. The presentation, titled "Novel Interleukin-15 Superagonist (N-803) and Invariant Natural Killer T Cell (agenT-797) Combination Immunotherapy for Unresolving Coccidioides immitis Infection," will be presented by Terese Hammond, M.D., and in collaboration with ImmunityBio (NASDAQ: IBRX) on May 20, 2026.

In accordance with ATS guidelines, no data or results have been disclosed prior to the conference. The presentation is expected to expand the platform discussion beyond oncology and acute inflammatory lung injury into persistent infection, immune dysfunction and pathogen control, areas where MiNK believes immune restoration may have broader therapeutic relevance.

Financial Results

MiNK ended the first quarter of 2026 with approximately $9.5 million in cash and cash equivalents, compared with approximately $13.4 million as of December 31, 2025. During the quarter, the company completed repayment of approximately $5.2 million associated with the Agenus convertible note, further simplifying its balance sheet. Following this repayment, MiNK raised approximately $3.0 million through its at-the-market sales agreement during the three months ended March 31, 2026.

Net loss for the first quarter of 2026 was approximately $2.7 million, or $0.57 per share, compared with approximately $2.8 million, or $0.70 per share, for the same period in 2025.

(Press release, MiNK Therapeutics, MAY 15, 2026, View Source [SID1234665772])

On May 15, 2026 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) ("Oncotelic" or the "Company"), a clinical-stage biotechnology company focused on oncology, AI-enabled drug development, and advanced drug delivery platforms, reported financial results for the quarter ended March 31, 2026 through its Quarterly Report on Form 10-Q, and is providing a corporate update highlighting progress across its therapeutic and platform initiatives.

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"We believe the first quarter of 2026 continues to provide validation for the strategic value of our diversified biotechnology platform," said Dr. Vuong Trieu, CEO of Oncotelic. "During the quarter, we continued advancing our oncology and AI-enabled development initiatives while maintaining the previously established fair value assessment of our GMP Bio joint venture interest as disclosed in our U.S. Securities and Exchange Commission ("SEC") filing."

Recent Operational Highlights

Continued advancement of the Company’s deciparticle-based oncology programs through its Sapu Nano joint venture, including ongoing development activities related to Sapu003 (IV everolimus) and Sapu006 (IV docetaxel).
Continued expansion of the Company’s AI-enabled biomedical development initiatives, including integration of large language model and semantic analysis capabilities designed to support biomarker identification, translational analysis, and regulatory workflow enhancement.
Completion of additional strategic development activities related to the Company’s nose-to-brain delivery platform and associated CNS-focused programs.
Ongoing development of the GMP Bio manufacturing and development infrastructure intended to support clinical-stage and commercial-scale pharmaceutical manufacturing capabilities.

Financial Highlights

As disclosed in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2026 and 2025, filed with the SEC on May 14, 2026, the Company maintained the fair value of its 45% ownership interest in GMP Biotechnology Limited, our joint venture with Dragon Overseas Limited at approximately $388 million as of March 31, 2026.

The fair value of the Company’s ownership was supported by an independent third-party valuation analysis performed in accordance with ASC 820 fair value accounting guidance utilizing a combination of discounted cash flow and market-based methodologies for the year ended December 31, 2026. Management concluded that no material events occurred during the quarter requiring adjustment to the previously established fair value or valuation framework.

Management Commentary

Mr. Amit Shah, CFO of Oncotelic said, "We believe our integrated strategy combining oncology therapeutics, advanced drug delivery technologies, AI-enabled development tools, and manufacturing infrastructure creates multiple potential value drivers, directly and through GMP Bio, across the organization. We remain focused on advancing our programs in a capital-efficient manner while pursuing strategic opportunities that may enhance long-term shareholder value."

(Press release, Oncotelic, MAY 15, 2026, View Source [SID1234665792])