bioAffinity Technologies Announces Pricing of Private Placement and Warrant Inducement Transaction for Approximately $1.2 Million in Gross Proceeds

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.

Pilatus Biosciences Announces Clinical Trial Collaboration with Roche to Evaluate PLT012 in First-in-Human Study in Hepatocellular Carcinoma

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.

Zai Lab Establishes Oncology Scientific Advisory Board

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.

Flatiron Health Announces Research to Be Presented at IASLC 2025 World Conference on Lung Cancer Hosted by the International Association for the Study of Lung Cancer

On August 13, 2025 Flatiron Health reported eight abstracts leveraging its high-quality multimodal data have been accepted for poster presentation and e-Poster presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain (Press release, Flatiron Health, AUG 13, 2025, View Source [SID1234655219]).

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"AI is a transformative force enabling scale, speed, and novel insights that were previously impossible. By harnessing advanced AI across our global network of more than five million people with cancer, we’re setting a new standard for real-world data at scale," said Nathan Hubbard, Chief Business Officer, Flatiron Health. "Our research at this year’s World Conference on Lung Cancer exemplifies how high-quality, multimodal real-world data combined with responsible AI practices can illuminate treatment patterns, measure effectiveness, and reveal where innovation is most urgently needed."

A highlight of Flatiron’s presence at WCLC 2025 is the first published research leveraging the Flatiron Health–Caris Life Sciences Clinical-Molecular Database (CMDB), the largest and most robust multimodal dataset of its kind, to identify a novel gene signature that predicts risk of liver metastasis in patients with advanced non-small cell lung cancer (NSCLC). By integrating high-quality clinical data with comprehensive molecular profiling, the research addresses a critical unmet need—providing clinicians with a new tool to identify high-risk patients and potentially enable more personalized surveillance and treatment strategies.

Additional highlights include:

a poster highlighting ongoing gaps in biomarker testing after assessing over 13,000 patients with NSCLC in the US and UK
a poster providing new insights into how NSCLC is managed in the UK, including details on the most commonly used treatments, patterns in biomarker testing, and overall survival outcomes
Schedule a meeting with Flatiron Health at WCLC 2025 and follow Flatiron Health on X and LinkedIn for more updates from #WCLC25.

Abstracts and Poster Presentations
A Novel Predictive Gene Signature for Liver Metastasis (LM) in NSCLC Using a Comprehensive Linked Clinical-Molecular Database
Partner: Caris Life Sciences
Poster
Session: P2.06 – Pathology and Biomarkers
Presentation Number: P2.06.45
Location: Exhibit Hall
Session Start/End: Monday, September 8, 10:30AM – 12PM

Real-world Biomarker Testing and Treatment Initiation in Patients with Resected Early-stage NSCLC (eNSCLC) in the US and UK
Poster
Session: P1.07 – Early-Stage Non-small Cell Lung Cancer
Presentation Number: P1.07.05
Location: Exhibit Hall
Session Start/End: September 7, 10:30AM – 12PM

Real-World Outcomes of Prophylactic Cranial Irradiation in Extensive-Stage Small Cell Lung Cancer Treated with First-Line Immunotherapy and Platinum-Etoposide
Poster
Session: P3.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: P3.13.10
Location: Exhibit Hall
Session Start/End: September 9, 10 – 11:30AM

Real-World Survival Outcomes in Non–Small Cell Lung Cancer: Insights from UK EHR-Derived Data
E-Poster
Session: EP.17 – Global Health, Health Services, and Health Economics
Presentation Number: EP.17.34

Disease Burden and rwPFS as a Surrogate Endpoint for rwOS in NTRK+ NSCLC and Other Advanced/Metastatic Solid Tumors
Partners: Bristol-Myers Squibb, University of Colorado Cancer Center
E-poster
Session: EP.12 – Metastatic Non-small Cell Lung Cancer – Targeted Therapy
Presentation Number: EP.12.23

Real-World Treatment Patterns in ES-SCLC Highlight Continued Unmet Medical Need in the Era of New Therapies: ESSENCE Study
Partners: Montefiore Medical Center, GSK, Rush University
E-poster
Session: EP.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: EP.13.25

Evolving Treatment Patterns in Early-Stage Non-Small Cell Lung Cancer in the United States
Partners: Lilly
E-poster
Session: EP.17 – Global Health, Health Services, and Health Economics
Presentation Number: EP.17.33

Real-World Treatment Patterns and Clinical Outcomes in Patients With Metastatic Neuroendocrine Neoplasms of the Lung (NEN-L)
Partners: Merck & Co
E-poster
Session: EP.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: EP.13.44

CIT Therapeutics Forms Strategic Partnership with the Institute for Follicular Lymphoma Innovation (IFLI), Securing Up to $2.5M to Advance Novel Cancer Therapies

On August 13, 2025 CIT Therapeutics, Inc. (CIT), a biotechnology company focused on developing next-generation small molecule therapies targeting SUMOylation for cancer treatment, reported a strategic partnership with the Institute for Follicular Lymphoma Innovation (IFLI) (Press release, Institute for Follicular Lymphoma Innovation, AUG 13, 2025, View Source [SID1234655218]). As part of this collaboration, IFLI will invest up to $2.5 million to support CIT’s clinical development efforts, particularly in follicular lymphoma.

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CIT is advancing a first-in-class, orally bioavailable small molecule that selectively inhibits the SUMO E1 enzyme through an allosteric covalent mechanism. This novel approach has demonstrated high specificity in proteome-wide analyses, offering a promising therapeutic strategy to both kill cancer cells and stimulate the immune system.

The investment from IFLI will support CIT’s upcoming Phase 1/1b clinical trial of its lead candidate, SB-4826, in patients with Non-Hodgkin Lymphoma, including those with relapsed or refractory follicular lymphoma.

This partnership underscores IFLI’s commitment to accelerating the development of transformative therapies for follicular lymphoma and related blood cancers. It also highlights CIT’s innovative platform as a potential game-changer in the oncology landscape.

"We are pleased to collaborate with CIT in their mission to improve outcomes for patients with follicular lymphoma," said Dave McCullagh, Managing Director of IFLI.

"This partnership represents a significant step forward in bringing SUMOylation-targeted therapies to the clinic. We are proud to support CIT in pioneering this new therapeutic modality. Inhibiting SUMOylation can reprogram tumor microenvironments, sensitize tumors to chemo and radiotherapy, and suppress oncogenic signaling" Michel Azoulay, MD, Chief Medical Officer of IFLI.

"Our vision is to transform cancer care by developing therapies that target novel biological mechanisms, which aligns with that of IFLI," said Yuan Chen, PhD, Founder and CEO of CIT Therapeutics and Professor and Chief in the Division of Surgical Sciences and Professor in the Division Surgical Oncology in the Department of Surgery at University of California, San Diego (UCSD) and Moores Cancer Center. "We are excited for this partnership and eager to start our clinical trial to deliver meaningful benefit to patients."