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Entry into a Material Definitive Agreement

On July 8, 2025, Personalis, Inc. (the "Company") and Tempus AI, Inc. ("Tempus") reported to have entered into Amendment No. 4 (the "Amendment") to the Commercialization and Reference Laboratory Agreement, dated November 25, 2023, by and between the Company (as amended by Amendment No. 1, dated August 16, 2024, Amendment No. 2, dated September 20, 2024, and Amendment No. 3, dated December 13, 2024, the "Tempus Agreement") pursuant to which the Company authorizes Tempus to market NeXT Personal, the Company’s ultra-sensitive tumor-informed minimal residual disease test, in a fourth indication, colorectal cancer, on the same terms as Tempus’ marketing of the other indications subject to the Tempus Agreement (breast cancer, lung cancer and immuno-oncology monitoring, together with colorectal cancer, the "Indications") and the parties extended the term of the Tempus Agreement through November 25, 2029 (Filing, 8-K, Personalis, JUL 8, 2025, View Source [SID1234654311]).

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In addition, the Amendment includes colorectal cancer as an indication subject to exclusivity in the Tempus Agreement and extends the time period during which the Company will not allow any third party (other than an acquiror of the Company or any affiliates of such acquiror) to market the NeXT Personal in any of the Indications and Tempus will not market another tumor-informed molecular residual disease assay indicated for use in such indications (whether its own or that of a third party) to December 31, 2028, in each case subject to certain exceptions and to the extent they do not expire earlier (the "Exclusivity Period").

The Amendment modified the term of certain customary standstill restrictions agreed to by Tempus in the Tempus Agreement such that they will automatically expire on the earlier of (i) June 4, 2027 and (ii) the expiration or termination of the Exclusivity Period.

Cogent Biosciences Announces Pricing of Upsized Public Offering of Shares of Common Stock

On July 8, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the pricing of its previously announced underwritten public offering of 22,222,223 shares of its common stock, offered at a public offering price of $9.00 per share (Press release, Cogent Biosciences, JUL 8, 2025, View Source [SID1234654305]). The aggregate gross proceeds to Cogent from this offering are expected to be approximately $200 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Cogent has granted the underwriters a 30-day option to purchase up to an additional 3,333,333 shares of its common stock on the same terms and conditions. All of the securities in the offering are being sold by Cogent. The offering is expected to close on or about July 10, 2025, subject to the satisfaction of customary closing conditions.

Cogent intends to use the net proceeds from the offering for continued development, regulatory and commercial preparation activities relating to bezuclastinib and other product candidates, activities to support the planned commercial launch of bezuclastinib as well as for working capital and general corporate purposes.

J.P. Morgan, Leerink Partners and Guggenheim Securities are acting as joint book-running managers for the offering. LifeSci Capital is also acting as lead manager for the offering.

The securities described above are being offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-269707), which was filed with the Securities and Exchange Commission (SEC) on February 10, 2023 and automatically became effective upon filing.

A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering were filed with the SEC on July 8, 2025. A final prospectus supplement and the accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or 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 jurisdiction. The offering can be made only by means of a prospectus supplement and accompanying base prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Ave., New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected].

BostonGene Announces Collaboration with SWOG Cancer Research Network to Drive Personalized Approaches

On July 8, 2025 BostonGene, a leader in AI-powered solutions for drug discovery and development, reported a collaboration with the SWOG Cancer Research Network, a global cancer research community that designs and conducts publicly funded clinical trials, on a new multicohort study titled "S2409, PRISM: PRecIsion in SCLC via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab with or without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC) (Press release, BostonGene, JUL 8, 2025, View Source [SID1234654296])." This study, which is supported by the National Cancer Institute (NCI), part of the National Institutes of Health, aims to redefine the standard of care for patients with ES-SCLC by employing biomarker-driven personalized treatment strategies.

Currently, the standard treatment for ES-SCLC involves combination chemotherapy and anti-PD-L1 immunotherapy, followed by maintenance immunotherapy. While this broad approach extends overall survival by 2-3 months, it still results in disease progression in most patients.

The PRISM study is designed to utilize novel biomarkers to identify and treat patients who may benefit from the addition of targeted agents, such as PARP inhibitors, to standard therapy. The study will be led by SWOG, conducted within the NCI’s National Clinical Trials Network, and chaired by Drs. Anne Chiang, of the Yale Cancer Center, and Alberto Chiappori, of the Moffitt Cancer Center, in conjunction with Translational Medicine chairs Drs. Lauren Byers and Carl Gay, of The University of Texas MD Anderson Cancer Center.

The trial will enroll up to 900 patients and use BostonGene’s AI-powered multiomic platform to identify molecular subtypes, assigning patients to therapy based on their subtype. The platform enables deep characterization of each patient’s tumor and immune profile, supporting the selection of more effective therapies and helping to accelerate translational insights that inform future drug development.

The trial builds on the ongoing collaborative work between MD Anderson’s lung cancer group, including Drs. Byers and Gay, and BostonGene to identify and validate four molecular subtypes of SCLC that exhibit distinct biological and therapeutic profiles. Initial findings from the SWOG S1929 trial demonstrated promising improvements in progression-free survival using this targeted approach. The goal of the upcoming study is to optimize outcomes for each subtype, offering patients more effective and individualized treatments.

"S2409 PRISM will test the hypothesis that we can be more effective in treating extensive-stage small-cell lung cancer by targeting the vulnerabilities of specific molecular subtypes," said study chair Dr. Chiang, who also serves as SWOG’s executive officer overseeing lung cancer and breast cancer research.

"We hope to demonstrate that it’s feasible to identify the SCLC subtype in the clinical setting and to use that information to select the best therapy for each patient."

"Collaborating with SWOG on this landmark study aligns with our mission to deliver innovative, data-driven insights that are transforming cancer care," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "By combining advanced molecular profiling with AI, we’re not only able to classify patients more precisely but also to advance therapy selection and accelerate the development of next-generation treatments. This study is poised to reshape the treatment landscape in lung cancer and provide a roadmap of how to build and validate biomarker-driven treatment approaches across cancers."

Abdera Therapeutics Appoints Rachael Brake, Ph.D., as Chief Scientific Officer

On July 8, 2025 Abdera Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging its advanced antibody engineering ROVEr platform to design and develop tunable precision radiopharmaceuticals for cancer, reported the appointment of Rachael Brake, Ph.D., as chief scientific officer (Press release, Abdera Therapeutics, JUL 8, 2025, View Source [SID1234654295]). Dr. Brake brings more than 20 years of experience in the biopharmaceutical industry building and leading cross functional teams across basic and applied research, clinical and business development.

"We are thrilled to welcome Dr. Rachael Brake as our new chief scientific officer," said Lori Lyons-Williams, president and chief executive officer. "Rachael brings a distinguished career in oncology research and clinical development, with a proven ability to drive innovative scientific discoveries into impactful therapies for patients. Her deep expertise and leadership will be instrumental in maximizing the potential of our proprietary precision radiopharmaceutical platform."

"Abdera’s ROVEr platform stands at the forefront of radiopharmaceutical innovation in cancer treatment, empowering us to engineer targeted medicines with tunable PK properties, optimizing tumor uptake, circulation half-life and clearance rates. Collectively, the features of ROVEr will maximize the therapeutic index for this class of drugs and has the potential to transform how we consider delivering precision medicine," said Dr. Brake. "This is a truly transformative time for Abdera with clinical validation of ABD-147 emerging and ABD-320 expected to begin human clinical trials soon. I am energized to join this exceptional team and eager to shape the future of precision medicine with this new class of cancer therapy."

Dr. Brake joins Abdera from Zephyr AI where she served as chief scientific officer. Previously, Dr. Brake was the chief scientific officer at Corbus Pharmaceuticals where she built and led a research and development team and advanced multiple oncology programs into clinical development. Prior to her work at Corbus, Dr. Brake spent 11 years at Takeda Oncology, most recently as head of U.S. medical affairs, oncology business unit and as vice president, global program leader, oncology therapeutic area. In these roles, Dr. Brake managed a portfolio of programs and cross-functional teams responsible for the preclinical and clinical exploration of various solid tumor drug candidates spanning diverse mechanisms of action. Prior to joining Takeda, Dr. Brake was a research scientist at Amgen where she held increasing levels of responsibility culminating in the site lead in Cambridge, MA for the therapeutic innovation unit.

Dr. Brake began her career as a research scientist at the Western Australian Institute for Medical Research and Woden Valley Hospital. She holds a Ph.D. in molecular biology and biochemistry from the University of Western Australia.

About ABD-147

ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is a protein in the Notch pathway that is critical for the development and regulation of neuroendocrine versus epithelial cell differentiation in the lungs. In certain high grade neuroendocrine carcinomas including small cell lung cancer (SCLC), DLL3 is upregulated and specifically expressed on the cell surface in more than 80% of cases. In contrast, DLL3 is absent or very rarely expressed on the surface of nonmalignant cells. Given the high specificity of DLL3 expression on cancer cells and the distinct mechanism of action, DLL3 represents a compelling target for treating SCLC and other DLL3+ solid tumors with targeted radiotherapy.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy and Orphan Drug Designation to ABD-147 for the treatment of neuroendocrine carcinoma. ABD-147 is currently being evaluated in a first-in-human Phase 1 clinical trial in patients with SCLC or large cell neuroendocrine carcinoma of the lung who have previously received platinum-based therapy.

About ABD-320

ABD-320 is a targeted radiopharmaceutical biologic therapy engineered to deliver Actinium-225 (225Ac) to solid tumors expressing 5T4. This oncofetal protein is rarely expressed in normal adult tissues but has been shown to be up-regulated in multiple cancer types, including colorectal, head and neck, non-small cell lung, pancreatic, gastric, mesothelioma, bladder, renal, cervical, ovarian, and breast cancers. By driving tumor cell migration and survival, 5T4 plays a key role in cancer progression and is associated with advanced disease, increased invasiveness, and poor clinical outcomes in solid tumors. ABD-320 was developed leveraging Abdera’s ROVEr platform and is custom-engineered to achieve an ideal balance of tumor uptake and retention while avoiding systemic radiotoxicities. Preclinical data with ABD-320 demonstrates potent anticancer activity. ABD-320 represents the first radiopharmaceutical therapy in development to address 5T4.

Quanterix Completes Acquisition of Akoya Biosciences, Creating the First Integrated Platform Capable of Measuring Biomarkers Across the Blood and Tissue Continuum

On July 8, 2025 Quanterix Corporation ("Quanterix" or the "Company") (NASDAQ: QTRX), a company fueling scientific discovery through ultra-sensitive biomarker detection, reported that it has completed its previously announced acquisition of Akoya Biosciences, Inc., establishing a scaled leader in the early detection of disease for the neurology, oncology and immunology markets (Press release, Quanterix, JUL 8, 2025, View Source [SID1234654294]).

Under the terms of the amended merger agreement announced on April 29th, Quanterix issued approximately 7.8 million shares of its common stock and paid approximately $20 million in cash, in the aggregate, to holders of Akoya shares and other Akoya equity awards.

Masoud Toloue, PhD, Chief Executive Officer of Quanterix, said, "The acquisition of Akoya positions us to deliver comprehensive protein biomarker solutions that leverage signatures in blood and tissue, together providing a more holistic and predictive view of a patient’s disease. This transaction extends our portfolio into new markets and is expected to expand our served addressable market from $1 billion to $5 billion. We believe the combined business will benefit from significant scale, a strong balance sheet and an accelerated path to profitability by 2026."

Board and Management Appointments

As previously announced, Masoud Toloue and Vandana Sriram will continue to serve as Chief Executive Officer and Chief Financial Officer of the combined company.

Pursuant to the terms of the merger agreement, Akoya designated two of its directors, Scott Mendel and Myla Lai-Goldman, MD, to join the Quanterix Board of Directors, and Quanterix appointed Mr. Mendel and Dr. Lai-Goldman to its Board of Directors, effective at the closing of the transaction. Mr. Mendel brings over 30 years of financial and operational experience, most recently having served as CEO and President of GenMark Diagnostics. Dr. Lai-Goldman is a pioneer and leader in the diagnostics industry and has held various leadership roles at Labcorp and its predecessor company, Roche Biomedical Laboratories.

Mr. Mendel and Dr. Lai-Goldman will replace Martin D. Madaus, PhD, and Sarah Hlavinka, who have resigned from the Quanterix Board of Directors as of immediately prior to the closing of the transaction. Quanterix thanks Dr. Madaus and Ms. Hlavinka for their numerous contributions and dedication to the Company.

Balance Sheet

At the time of closing the Akoya transaction, Quanterix had approximately $163 million in cash after repayment of Akoya’s debt and transaction-related costs.