On August 13, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (" BriaCell " or the " Company "), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported its acceptance into Memorial Sloan Kettering Cancer Center’s (MSK’s) Therapeutics Accelerator 2025 Cohort program (Press release, BriaCell Therapeutics, AUG 13, 2025, View Source [SID1234655429]). This project aims to accelerate the clinical development of Bria-OTS+, BriaCell’s next generation personalized off-the-shelf immunotherapy, for multiple cancer indications including metastatic breast cancer, prostate cancer, and other cancers.

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As one of the world’s foremost cancer research and treatment institutions, MSK has more than 135 years of leadership in patient care, education and discovery. Through the MSK Therapeutics Accelerator Cohort program, BriaCell will explore access to MSK’s expertise and institutional resources, including GMP manufacturing services, Investigational New Drug (IND) Application preparation and submission and regulatory strategy support to expedite Bria-OTS+ development.

"We are honored to work with the scientific and clinical experts at MSK Therapeutics Accelerator," stated Dr. William V. Williams, BriaCell’s President and CEO. "MSK’s deep expertise in cancer therapy development and state-of-the-art resources make it an ideal partner to accelerate our personalized off-the-shelf immunotherapy platform."

"We are excited to welcome BriaCell into the cohort program," stated Eileen Flowers, PhD, Director, Technology Development & Licensing, in the Office of Entrepreneurship and Commercialization at MSK.

"We believe Bria-OTS+ has the potential to transform cancer care, offering meaningful advances in efficacy and safety for thousands of patients," stated Dr. Miguel Lopez-Lago, BriaCell’s Chief Scientific Officer. "Our participation in this cohort program is yet another step towards achieving that vision."

On August 13, 2025, the Strategic Collaboration and License Agreement between Adaptive Biotechnologies Corporation ("Adaptive") and Genentech, Inc. ("Genentech"), dated as of December 19, 2018 (the "Agreement"), was terminated, with termination effective February 9, 2026 (Filing, 8-K, Adaptive Biotechnologies, AUG 13, 2025, View Source [SID1234655339]). Adaptive and Genentech entered into the Agreement in 2018 to collaborate on research and development of certain cancer cell therapy products.

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The parties will wind down activities under the Agreement. Upon termination, Adaptive will be released from exclusivity obligations with respect to cell therapies in oncology.

As a result of the termination, Adaptive expects to recognize $33.7 million during the second half of 2025 in non-cash revenue from the remaining amortization of the cash consideration received under the Agreement.

Adaptive’s ongoing Immune Medicine programs and financial goals continue to focus on: (i) developing and deploying digital TCR-antigen prediction models that enable novel immunology applications and partnering opportunities; (ii) developing a pre-clinical data package for the lead T-cell depletion program in autoimmunity; and (iii) achieving the fiscal year 2025 Immune Medicine cash burn target of $25–$30 million.

On August 13, 2025 LAVA Therapeutics N.V. (NASDAQ: LVTX, "LAVA," or the "Company"), a clinical-stage immuno-oncology company historically focused on its proprietary Gammabody bispecific gamma delta T cell engagers, reported financial results for the second quarter ended June 30, 2025 and provided a corporate update (Press release, Lava Therapeutics, AUG 13, 2025, View Source [SID1234655305]).

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"We are pleased to announce that LAVA has recently entered into a definitive agreement to be acquired by XOMA Royalty Corporation," said Steve Hurly, Chief Executive Officer of LAVA. "This deal is the outcome of a comprehensive and diligent strategic review process by management and our Board of Directors, conducted under the guidance of our legal and financial advisors, with the objective of maximizing value for our shareholders while supporting the sustained success of LAVA’s business. Our Board of Directors has unanimously determined that the deal is in the best interests of all of our shareholders and has approved the proposed acquisition."

Entry into Share Purchase Agreement; Tender Offer

On August 4, 2025, the Company announced that it has entered a definitive share purchase agreement (the "Purchase Agreement" and the transactions set forth in the Purchase Agreement, the "Transactions") with XOMA Royalty Corporation ("XOMA"), whereby XOMA will acquire all of the issued and outstanding common shares of the Company through a cash tender offer for (i) between $1.16 and $1.24 per share in cash, consisting of (A) $1.16 per share, plus (B) an additional amount of up to $0.08 per share, plus (ii) a non-transferable contingent value right per share representing the right to receive potential contingent cash payments following the closing related to the Company’s two partnered assets as well as its unpartnered programs. Pursuant and subject to the terms of the Purchase Agreement, XOMA will commence a tender offer by August 15, 2025 to acquire all of the Company’s outstanding common shares. The closing of the Transactions is subject to customary closing conditions and is expected to close in the fourth quarter of 2025.

Discontinued LAVA-1266 Program

On August 4, 2025, the Company announced its plans to discontinue its Phase 1 clinical trial of LAVA-1266 for acute myeloid leukemia and myelodysplastic syndrome, and initiate the wind-down of the LAVA-1266 program.

Updates Regarding Partnered Programs

Johnson & Johnson (J&J) Partnered Program (JNJ-89853413) – Phase 1 Trial (NCT06618001)

Designed to target CD33 and gamma delta T cells with a bispecific gamma delta T cell engager

· Key Indications: relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R higher-risk type of myelodysplastic neoplasms (MDS)

· Current Status: J&J is enrolling patients in a Phase 1, open label, multi-center trial, currently underway in Canada and Spain. The trial includes a dose escalation and dose expansion segment to evaluate JNJ-89853413 in approximately 100 adults with R/R AML or R/R higher risk type of MDS

Pfizer Partnered Program (PF08046052) – Phase 1 Trial (NCT05983133)

Potential first-in-class epidermal growth factor receptor (EGFR) and bispecific gamma delta T cell receptor-targeted therapy

· Key Indications: advanced solid tumors

· Current Status: Pfizer is enrolling patients in a Phase 1 open label, multi-center trial, currently underway in the US and UK. The trial is intended to evaluate PF08046052 in approximately 290 subjects

Second Quarter 2025 Financial Results

· As of June 30, 2025, LAVA had cash, cash equivalents, and short-term investments of $56.2 million, compared to cash, cash equivalents, and short-term investments of $76.6 million as of December 31, 2024.

· Revenue from contracts with customers was zero for the quarters ended June 30, 2025 and 2024, respectively, and zero and $7.0 million for the six months ended June 30, 2025 and 2024, respectively. Revenue of $7.0 million received in the six months ended June 30, 2024 was comprised of a $7.0 million payment from Pfizer related to the achievement of a clinical milestone.

· Research and development expenses were $4.7 million and $6.0 million for the quarters ended June 30, 2025 and 2024, respectively, and $8.9 million and $11.6 million for the six months ended June 30, 2025 and 2024, respectively. The decrease in both periods was primarily due to a reduction in headcount related to restructuring activities and resulting decrease in research and development activity, with lower preclinical and clinical expenses due to the discontinuation of the LAVA-1207 program and a reduction in the estimated remaining clinical trial activities, partially offset by activities for LAVA-1266 occurring in the quarter ended June 30, 2025.

· General and administrative expenses were $2.6 million and $3.4 million for each of the quarters ended June 30, 2025 and 2024, respectively and $6.0 million and $6.8 million for the six months ended June 30, 2025 and 2024, respectively. The decrease reflected in both periods was due to lower headcount and an overall streamlining of administrative and operating costs related to the Company’s restructuring activities, partially offset by increased professional and consultant fees related to the Company’s transition to US GAAP reporting as well as increased severance payments related to the Company’s restructuring action in February 2025.

· Other income (expense), net was a $1.3 million other expense, net and $1.2 million other income, net for the quarters ended June 30, 2025 and 2024, respectively, with other income, net of $3.1 million and $2.7 million for the six months ended June 30, 2025 and 2024, respectively. For the three months ended June 30, 2025 and 2024, the decrease is primarily due to foreign exchange loss, due to fluctuations in the US dollar currency rate compared to the Euro, as well as lower interest rates for cash held in money market accounts, partially offset by lower interest expense incurred as the Company’s outstanding innovation credit from Rijksdienst voor Ondernemend Nederland (RVO) was forgiven in March 2025. Forgiveness of the RVO credit balance also increased other income, net for the six months ended June 30, 2025.

· Net loss was $8.6 million and $8.3 million for the quarters ended June 30, 2025 and 2024, respectively, or $0.32 and $0.31 net loss per share, respectively, and $12.1 million and $8.9 million, or $0.45 or $0.33 net loss per share, for the six months ended June 30, 2025 and 2024, respectively.

On August 13, 2025 Guided Therapeutics, Inc. (OTC:QB GTHP), the maker of the LuViva Advanced Cervical Scan, a rapid and painless testing platform for cervical cancer detection based on its patented biophotonic technology, reported that it had enrolled enough patients to begin closing out the study and starting data analysis (Press release, Guided Therapeutics, AUG 13, 2025, View Source [SID1234655224]). Data analysis will consist of completing the ongoing external review of all biopsy samples, reviewing and entering data from the study case report forms and performing the statistical analysis pursuant to the study protocol. All four participating clinics have reached their minimum specified quotas resulting in a total of approximately 430 patients enrolled. Part of the pathology analysis is intended to determine the number of patients with and without disease to ensure a representative mix of disease types. Once this part of the analysis has been completed, all clinical sites will be closed out from enrolling additional patients and the clinical report will be filed with the FDA, expected later this year. Additionally, there have been no adverse events linked to the use of the LuViva device, further supporting FDA’s designation of LuViva as a non-significant risk device.

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"We want to thank all of physicians and staff at the clinical sites who made this study possible," said Mark Faupel, CEO of Guided Therapeutics. "As we move from the testing phase to the analysis phase of the study, we have met the Company’s primary 2025 objective. We are optimistic that we have conducted a successful study and look forward to the results of the statistical analyses."

On August 13, 2025 CEL-SCI Corporation (NYSE American: CVM) reported that a Breakthrough Medicine Designation application has been filed with the Saudi Food and Drug Authority (SFDA) for Multikine* (Leukocyte Interleukin, Injection) in the Kingdom of Saudi Arabia by one of the Kingdom’s premier pharmaceutical and healthcare companies (Press release, Cel-Sci, AUG 13, 2025, View Source [SID1234655223]). CEL-SCI has signed a Memorandum of Understanding (MOU) with this Saudi pharma company for the commercialization of Multikine in Saudi Arabia. A final partnership agreement is expected during the 3rd quarter of 2025.

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Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.

According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia.

The Saudi pharma company is well positioned to procure reimbursement and to accelerate Multikine’s sale and commercial launch.

Several leading Saudi funds have expressed interest in investing in Multikine, CEL-SCI, and a potential joint venture to serve the wider Middle East and North Africa (MENA) market. CEL-SCI is working closely with First Berlin of Germany and its Saudi representatives to advance its commercialization program for Multikine.

Martin Bailey, Managing Director and Founder of First Berlin, the lead advisor, commented, "CEL-SCI’s prospective new partner is a prominent and innovative leader that has rendered many valuable healthcare services to the Kingdom. The Saudi pharma company’s keen interest in Multikine to make patients’ first cancer treatment more curative is very much in line with their forward-thinking approach and fits well with Saudi Arabia’s Vision 2030 and the National Biotechnology Strategy. We look forward to facilitating the signing of a final partnership agreement and making Multikine available to patients as quickly as possible."

"This MOU and the filing for Breakthrough Medicine Designation mark a significant advancement for Multikine’s global regulatory, patient access/sale and commercial roll out," stated CEL-SCI CEO, Geert Kersten. "We’ve had a highly productive working relationship with this prestigious Saudi pharma company, First Berlin, and the SFDA and hope to see Multikine improve longevity and well-being for head and neck cancer patients in Saudi Arabia."

About the SFDA’s Breakthrough Medicine Program

The SFDA Breakthrough Medicine Program aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia’s Vision 2030 initiative. The program is voluntary and based on early dialogue with drug developers to optimize development plans and speed up evaluation. The goal is to ensure that promising medicines are available as soon as it can be concluded that the medicines’ benefits justify their risks.

Eligibility includes having to fulfill all of the following four criteria in order to gain a Breakthrough Medicine Designation:

Target serious debilitating or life-threatening conditions with unmet medical need.
The medicinal product is likely to offer major advantages over methods currently used.
The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance.
The product is not registered at any regulatory authority at the time of submission of the designation request.