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 Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the "Company"), a clinical-stage biotechnology company, reported financial results for the first quarter ended March 31, 2026, and provided a strategic corporate update.

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Junyi Dai, Indaptus Therapeutics’ Chief Executive Officer and Chairman of the Board, commented, "Following recent changes in executive management, the Company has conducted a review of its development programs, operating resources and ongoing corporate initiatives. While this transition period involves certain operational and organizational adjustments, the Company remains focused on supporting and advancing its therapeutic and research activities."

"Currently we are evaluating our Decoy platform, including its preclinical data and underlying scientific rationale, as we assess its potential relevance to the Company’s ongoing therapeutic, immunological and translational research activities. As part of this process, we believe it is prudent to reassess the Company’s development priorities, operating initiatives and resource allocation considerations," Mr. Dai commented.

Key Highlights

● Executive management transition. Recent changes in executive management have resulted in a transition period during which certain operational and organizational adjustments are underway. The Company continues to evaluate operational priorities, ongoing corporate initiatives and resource allocation matters.
● Corporate and development evaluation activities. The Company continues to evaluate corporate initiatives, research activities and potential development opportunities intended to support the Company’s long-term operational and therapeutic objectives. Any such activities will be assessed based on scientific validation, clinical and regulatory considerations, resource availability and overall development planning.
● Preferred stock conversion completed. During the first quarter of 2026, all outstanding shares of the Company’s Series AA Preferred Stock and Series AAA Preferred Stock were converted into shares of common stock.

Financial Highlights for the First Quarter Ended March 31, 2026

Research and development expenses for the three months ended March 31, 2026 were approximately $0.5 million, a decrease of approximately $2.3 million from approximately $2.8 million in the three months ended March 31, 2025. The change was primarily due to a decrease of approximately $1.9 million in clinical costs related to the Company’s Phase 1 study, as well as a decrease of approximately $0.4 million in payroll and related expenses due to reductions in headcount and base salaries.

General and administrative expenses for the three months ended March 31, 2026 were approximately $1.7 million, a decrease of approximately $0.1 million, or 5%, from approximately $1.8 million for the three months ended March 31, 2025. The decrease was primarily attributable to a decrease in certain expenses related to operating as a public company and the transition of management.

Net loss for the three months ended March 31, 2026 was approximately $2.5 million, compared with a net loss of approximately $4.5 million for the three months ended March 31, 2025. Loss per share for the three months ended March 31, 2026 was approximately $0.23, compared with approximately $9.11 for the three months ended March 31, 2025. The change in our other income (expense)was approximately $0.4 million and consists primarily of the warrant repricing as well as income earned on the Company’s cash and cash equivalent accounts. All share and per-share amounts have been retroactively adjusted to reflect the Company’s one-for-twenty-eight reverse stock split effected on June 27, 2025.

As of March 31, 2026, the Company had cash and cash equivalents of approximately $1.5 million, compared with approximately $8.5 million as of December 31, 2025. The Company will need to raise additional capital to support its business objectives, and there can be no assurance that such financing will be available on acceptable terms, or at all. The Company continues to assess financing alternatives and strategic options that would support its corporate strategy.

Net cash used in operating activities was approximately $7.0 million for the three months ended March 31, 2026, compared with net cash used in operating activities of approximately $5.0 million for the three months ended March 31, 2025. The increase in net cash used in operating activities was primarily attributable to a decrease in accounts payable and other current liabilities, partially offset by a decrease in net loss.

There was no net cash provided by financing activities during the three months ended March 31, 2026, compared with net cash provided by financing activities of approximately $3.2 million for the three months ended March 31, 2025, which was primarily provided by the issuance and sale of common stock and warrants in the January 2025 financing and the issuance and sale of common stock under the Company’s standby equity purchase agreement.

(Press release, Indaptus Therapeutics, MAY 15, 2026, View Source [SID1234665806])

On May 15, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that it has entered into letters of intent to pursue collaborations with EDAP TMS S.A. (NASDAQ: EDAP, "EDAP") and Profound Medical Corp. (NASDAQ: PROF, TSX: PRN, "Profound"), leading companies developing advanced minimally invasive and image-guided treatment ablative technologies for prostate cancer, including focal, subtotal, and whole-gland treatment approaches. These initiatives reflect Telix’s commitment to advancing the integration of molecular imaging into the evolving prostate cancer treatment landscape to help inform clinical decision-making.

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The collaborations will explore the investigational use of Telix’s PSMA-PET1 imaging agents Gozellix (kit for the preparation of gallium Ga 68 gozetotide) and Illuccix (kit for the preparation of gallium Ga 68 gozetotide) with robotic high-intensity focused ultrasound (HIFU), and other image-guided therapies designed to treat localized prostate cancer, such as transurethral ultrasound ablation (TULSA).

Telix’s intention is to work with select partners to explore how PSMA-PET imaging may support emerging therapy workflows, which aim to preserve healthy tissue and minimize the risk of side effects such as incontinence and impotence. Collaborative activities will focus on non-promotional scientific, educational, and research engagement2.

"We are uniquely designed to enable the integration of PSMA-PET imaging with Focal One’s real-time ultrasound and fully robotic energy delivery to optimize treatment efficacy while minimizing side effects," said Ryan Rhodes, EDAP Chief Executive Officer. "As the market leader in robotic focal therapy, with a growing global installed base, this collaboration will accelerate the development and standardization of treatment strategies to further personalize focal therapy treatments using Telix’s PSMA-PET imaging agents and Focal One Robotic HIFU."

"Emerging clinical evidence suggests PSMA imaging may support prostate whole-gland, partial-gland, and focal ablation workflows, from treatment planning through post-treatment monitoring," said Arun Menawat, Profound’s Chief Executive Officer and Chairman. "In collaboration with Telix, we look forward to exploring optimized workflows and generating clinical evidence that may help establish best practices and accelerate adoption of PSMA-PET imaging and the MRI-guided TULSA Procedure."

"Precision medicine requires precision treatment strategies," said Kevin Richardson, CEO, Telix Precision Medicine. "As disruptive technologies continue to transform prostate cancer care, we believe PSMA-PET imaging has the potential to play an important role in helping inform clinical decision-making across a range of minimally invasive and image-guided treatment approaches. We are excited to explore collaborations with market leaders in EDAP and Profound that may further advance personalized care for patients."

(Press release, Telix Pharmaceuticals, MAY 15, 2026, View Source [SID1234665805])

On May 15, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported progress in developing Bria-OVA+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for ovarian cancer.

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"Following the encouraging efficacy and tolerability data from BriaCell’s Phase 2 study in metastatic breast cancer, we are expanding our pipeline to include cell-based immunotherapy candidates for gynecologic cancers beginning with ovarian," stated Dr. William V. Williams, BriaCell’s President & CEO. "Bria-OVA+ reflects our broader strategy to build on the Bria-OTS+ platform and advance next-generation personalized immunotherapies for difficult-to-treat cancers and become a leader in women’s health."

"Ovarian cancer remains the deadliest gynecologic cancer, and patients who do not respond to available therapies continue to face serious unmet medical need," stated Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer, and a Key Opinion Leader in ovarian cancer. "We believe Bria-OVA+ has the potential to provide a differentiated immunotherapeutic approach for ovarian cancer patients with limited treatment options."

BriaCell recently reported preclinical data for Bria-BRES+, its next-generation breast cancer immunotherapy candidate derived from the same Bria-OTS+ platform. In a recent AACR (Free AACR Whitepaper) poster presentation, Bria-BRES+ demonstrated activation of both adaptive and innate immunity, including naïve/resting T cells, dendritic cells, and natural killer (NK) cells. BriaCell believes this multipronged immune activation supports the potential of the Bria-OTS+ platform to generate anti-tumor immune responses and may help inform the development of Bria-OVA+ for ovarian cancer.

BriaCell has licensed ovarian cancer cell-lines from American Type Culture Collection (ATCC) and has commenced development activities to support production of Bria-OVA+ for potential clinical use.

Ovarian Cancer Facts

According to National Cancer Institute, an estimated 21,010 women in the U.S. will be diagnosed with ovarian cancer, and approximately 12,450 will die from the disease in 2026. Ovarian cancer remains the deadliest gynecologic cancer. It is inherited or acquired abnormal BRCA gene. Treatments include surgery to remove the tumor/s, platinum-based chemotherapy, ELAHERE, a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate, and LYNPARZA, a poly (ADP-ribose) polymerase inhibitor, also referred to as a PARP inhibitor. However, many patients do not respond to these treatments and are often associated with harsh side effects.

(Press release, BriaCell Therapeutics, MAY 15, 2026, View Source [SID1234665804])

On May 15, 2026 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager TriKE platform, reported first quarter 2026 financial results for the period ended March 31, 2026.

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"With the initiation of our GTB-5550 Phase 1 trial, we have now advanced three TriKE candidates into the clinic, a significant milestone that underscores the continued momentum of our pipeline," said Michael Breen, Executive Chairman and Chief Executive Officer. "GTB-3650 has demonstrated an excellent safety profile thus far, and we look forward to continuing enrollment progress. With sufficient cash runway through Q4 2026, we look forward to providing updates on both programs in the second half of 2026."

GTB-3650 TriKE for CD33 positive leukemias

The ongoing Phase 1 dose escalation study is evaluating GTB-3650 for relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. Enrollment is ongoing, with Cohort 4 enrollment now complete and a total of 8 patients treated across the first four cohorts; the Company expects to provide continued progress updates throughout 2026. Dose escalation may continue up to Cohort 7 as necessary with the potential to evaluate GTB-3650 in a total of 14 patients (two patients per cohort). GTB-3650 is dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity.

GTB-5550 TriKE for B7H3 positive solid tumor cancers

The ongoing Phase 1 trial with GTB-5550 is the first nanobody TriKE tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial is focused primarily on enrolling prostate cancer patients and will evaluate up to 6 dose levels to identify the maximum tolerated dose (MTD). After the dose escalation phase, the Phase 1b expansion component will enroll patients with up to 7 different tumor types (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its safety, tolerability and preliminary anti-tumor activity.

GTB-5550 will be administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days during Week 1 and Week 2 followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration. Subsequent cycles receive treatment three times weekly for 2 weeks followed by 2 weeks of no treatment. A minimum of 2 cycles is planned, and patient-appropriate disease reassessment is performed after 2 cycles and every 8-12 weeks thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months to determine progression free survival (PFS) and overall survival (OS). More details can be found on clinicaltrials.gov with the identifier: NCT07541573.

First Quarter Ended March 31, 2026 Financial Summary

Cash Position: The Company had cash and cash equivalents of approximately $9 million as of March 31, 2026, which is anticipated to be sufficient to fund the Company’s operations through the fourth quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were approximately $400,000 compared to $1.1 million for the same comparable quarter of 2025. The $700,000 decrease was primarily due to a reduction in production costs. R&D expenses primarily relate to the Company’s continued licensing, development, production, and clinical trials of its most advanced TriKE product candidates GTB-3650 and GTB-5550 along with the progression on other promising product candidates.

Selling, General and Administrative (SG&A) Expenses (Excluding Stock Compensation): SG&A expenses for the second quarter of 2026 were approximately $2.4 million compared to $800,000 for the same comparable quarter of 2025. The $1.6 million increase was primarily due to an increase in marketing expenses, and to a lesser extent, legal fees.

Loss from Operations: The Company reported a loss from operations for the second quarter of 2026 of approximately $2.8 million compared to $1.9 million for the same comparable quarter of 2025. The 900,000 increase was primarily due to $1.6 million increase in SG&A (as described above).

Net Loss: The Company reported a net loss of approximately $2.8 million for the second quarter of 2026, compared to $800,000 for same comparable quarter of 2025. The $2 million increase consisted primarily of a $1.6 million increase in SG&A (as described above), and a decrease in non-recurring other income of approximately $1.1 million.

(Press release, GT Biopharma, MAY 15, 2026, View Source [SID1234665803])