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.

On August 13, 2025 bioAffinity Technologies, Inc. (NASDAQ: BIAF, BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, reported that it has entered into securities purchase agreements with several institutional and accredited investors (the "Purchasers") for the purchase and sale of 990 shares of the Company’s Series B Convertible Preferred Stock (the "Preferred Stock") and warrants (the "Private Placement Warrants") to purchase approximately 6.7 million shares of common stock (the "Private Placement") (Press release, BioAffinity Technologies, AUG 13, 2025, View Source [SID1234655222]).

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The shares of Preferred Stock have a stated value of $1,000 per share and are initially convertible into an aggregate of approximately 4.3 million shares of common stock at a conversion price of $0.23 per share. The Private Placement Warrants will be exercisable following the date on which the Company obtains stockholder approval of the exercise thereof at an initial exercise price of $0.352 per share and expire five years from the original exercise date.

The Company also announced today it has entered into a warrant exercise agreement with an existing accredited investor to exercise (i) outstanding warrants to purchase 450,000 shares of the Company’s shares of common stock that were issued in August 2024 (the "August Warrants") and (ii) outstanding warrants to purchase 650,000 shares of the Company’s common stock that were issued in October 2024 (the "October Warrants" and together with the August Warrants, the "Existing Warrants"), which reduced the exercise prices of the August Warrants from $1.50 to $0.23 per share and the October Warrants from $1.25 to $0.23 per share and provided for the issuance to such investor of new unregistered warrants (the "New Warrants") to purchase up to an aggregate of 1.43 million shares of the Company’s common stock in consideration for the immediate exercise in full of the Existing Warrants for gross cash proceeds to the Company of approximately $253,000 (the "Warrant Inducement"). The New Warrants will have an exercise price of $0.352 per share and will be initially exercisable on the date that stockholder approval of the exercise of the New Warrants is obtained and will expire five years from the date of such approval.

The closing of the Private Placement and Warrant Inducement is expected to occur on or about August 14, 2025, subject to the satisfaction of customary closing conditions.

The expected aggregate proceeds (before expenses) of the Private Placement and Warrant Inducement will be approximately $1.2 million. The Company shall use the net proceeds from the Private Placement and Warrant Inducement for working capital and general corporate purposes.

WallachBeth Capital LLC is acting as the sole placement agent for the Private Placement and financial advisor for the Warrant Inducement.

The securities described above will be offered in a private placement exempt from the registration requirements under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and in a transaction not involving a public offering and have not been registered under the Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock underlying the Preferred Stock, the Private Placement Warrants and New Warrants within 15 calendar days after the closing date.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

On August 13, 2025 Pilatus Biosciences, Inc., a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, reported a clinical trial collaboration with Roche (Press release, Pilatus Biosciences, AUG 13, 2025, View Source [SID1234655221]). Under the terms of the agreement, Roche will provide atezolizumab (Tecentriq), its anti-PD-L1 therapy, to support Pilatus’ upcoming first-in-human Phase 1 trial evaluating PLT012 in combination with atezolizumab in patients with hepatocellular carcinoma (HCC).

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PLT012 is Pilatus’ lead immunomodulatory candidate designed to reprogram the fibrotic and immunosuppressive tumor microenvironment (TME) characteristic of HCC. The investigational combination will be assessed in Pilatus-sponsored clinical trials to assess safety and tolerability.

"We are pleased to collaborate with Roche as we explore the potential synergy between PLT012 and atezolizumab in patients with HCC," said Raven Lin, Ph.D., Chief Executive Officer, Pilatus Biosciences. "Current treatments, including checkpoint inhibitors as monotherapy, often fail to generate durable responses in liver cancer. PLT012’s ability to reshape the TME may enhance immune activation and unlock deeper, more sustained responses when administered in combination with anti-PD-L1 therapies such as atezolizumab."

"This collaboration represents an opportunity to investigate how modulation of the TME can enhance immune checkpoint blockade in liver cancer," said Dr. Ann-Lii Cheng, NTU Chair professor and President Emeritus of the NTU Cancer Center of National Taiwan University, and scientific collaborator at Pilatus Biosciences. "Combining PLT012 with atezolizumab has the potential to overcome key mechanisms of resistance in HCC and potentially drive more durable patient response and potentially improve patient outcomes for this aggressive disease." Dr. Cheng also served as the global principal investigator of the landmark IMbrave150 trial (atezolizumab plus bevacizumab for HCC, published in NEJM 2020).

Atezolizumab, a standard of care treatment for first-line HCC in combination with bevacizumab (Avastin), will be provided by Genentech, a member of the Roche Group, for use in Pilatus’ clinical research. HCC is the most common type of primary liver cancer and remains one of the leading causes of cancer-related death worldwide.

Tecentriq (atezolizumab) and Avastin (bevacizumab) are registered trademarks of Genentech, a member of the Roche Group.

About PLT012

PLT012 is a humanized monoclonal antibody designed to selectively block CD36-mediated lipid uptake, a key mechanism driving immunosuppression and immune exclusion within the tumor microenvironment. By targeting lipid metabolism, PLT012 exerts a unique mechanism of action: it depletes immunosuppressive cell populations, including Tregs and pro-tumor macrophages, while simultaneously enhancing anti-tumor activities of intratumoral NK cell and cytotoxic CD8+ T cell that are otherwise susceptible to lipid-induced exhaustion. In preclinical studies, PLT012 has demonstrated potent monotherapy efficacy in models of liver malignancies, with a favorable safety profile across species. Leveraging its distinct mechanism of action, PLT012 further acts as a potent sensitizer in combination with anti–PD-L1 therapies, effectively overcoming drug resistance in immune "cold" tumors and liver metastases.

On August 13, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the creation of its Oncology Scientific Advisory Board (SAB) (Press release, Zai Laboratory, AUG 13, 2025, View Source [SID1234655220]). The newly formed Oncology SAB is comprised of distinguished oncology leaders and will support the advancement of the Company’s robust oncology products and pipeline, including multiple internally developed investigational therapies.

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"We are honored to bring together this esteemed group of oncology leaders who will support our continued development and advancement of innovative treatment options for patients globally," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "The formation of this Board is an important step for Zai; we know our clinical programs will benefit tremendously from the guidance and perspective of this highly regarded and experienced group of individuals."

Zai Lab’s Oncology SAB comprises the following:

Lieping Chen, M.D., Ph.D., is a United Technologies Corporation chair in cancer research, professor of immunobiology, dermatology and medicine at the Yale University School of Medicine.

Richard S. Finn, M.D., is director of the Signal Transduction Program in the Jonsson Comprehensive Cancer Center at University of California, Los Angeles (UCLA).

Thomas F. Gajewski, M.D., Ph.D., directs the Melanoma Oncology Clinic and leads the Immunology and Cancer Program at the University of Chicago Comprehensive Cancer Center.

Melissa L. Johnson, M.D., directs lung cancer research at the Sarah Cannon Research Institute.

Matthew Krebs, M.D., Ph.D., is a clinical senior lecturer in experimental cancer medicine at the University of Manchester and leads early phase clinical trials at The Christie NHS Foundation Trust, Manchester, U.K.

Patricia LoRusso, M.D., D.O., is director of the Early Phase Clinical Trials Program and Associate Center Director of Experimental Therapeutics at Yale Cancer Center.

Michael T. Lotze, M.D., FACS, is professor of surgery, immunology and bioengineering, and director of the DAMP Laboratories at the University of Pittsburgh Medical Center Hillman Cancer Center.

Timothy Yap, M.B.B.S., Ph.D., FRCP, is a medical oncologist, physician-scientist and professor at the University of Texas MD Anderson Cancer Center.