On July 15, 2025 GT Medical Technologies, Inc., a medical device company dedicated to improving the lives of patients with brain tumors, reported the company has completed the close of its oversubscribed $53 million Series D equity financing (Press release, GT Medical Technologies, JUL 15, 2025, View Source [SID1234654392]).

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The final close of the Series D comprised an additional $16 million from new investors including FemHealth Ventures, Warren Point Capital, an undisclosed strategic investor, and increased commitments from all existing institutional investors. Earlier this year, GT Medical Technologies announced the completion of a $37 million first close of the Series D equity financing led by Evidity Health Capital, alongside new investor Accelmed Partners and existing investors MVM Partners, Gilde Healthcare, and Medtech Venture Partners.

"Increasing the size of the Series D allows us to stay focused on driving results for patients into the foreseeable future," said Per Langoe, Chief Executive Officer at GT Medical Technologies. "We are thankful for our investors’ continued support as we expand our commercial footprint and clinical initiatives for GammaTile."

The company will use the funds to drive the expansion of its U.S. commercial activities for GammaTile. In addition, the financial resources will enable GT Medical Technologies to complete enrollment of its ROADS randomized controlled trial for newly diagnosed brain metastases and will fund an additional randomized control trial of GammaTile in newly diagnosed glioblastoma cases.

"FemHealth Ventures is excited to join GT Medical Technologies as an investor and support the commercial acceleration of GammaTile Therapy," stated Maneesha Ghiya, Managing Partner at FemHealth Ventures. "We are proud to back a company that is transforming the standard of care in oncology and shares our commitment to improving health outcomes, including meaningful applications in women’s health."

GammaTile is an innovative form of radiation therapy placed at the time of brain tumor removal surgery, delivering immediate, targeted radiation to the tumor site when cancer cells are at their lowest levels. Unlike conventional approaches, which often require a delay between surgery and radiation therapy to allow for wound healing, GammaTile eliminates this treatment gap. By delivering immediate, localized radiation directly at the tumor site, it is designed to maximize the treatment’s effectiveness against remaining cancer cells to reduce the risk of regrowth.1

"The completion of an oversubscribed Series D equity financing from premier medical device investors is a testament to the important work of our team and mission," added James Leech, Chief Financial & Strategy Officer of GT Medical Technologies.

Recent GT Medical Technologies Milestones

GT Medical Technologies recently celebrated important milestones, reflecting the growing adoption of GammaTile. To date, more than 1,900 patients have been treated with GammaTile Therapy, and over 800 patients have been enrolled in GammaTile clinical studies.

Looking Ahead

GT Medical Technologies anticipates completing enrollment in both the ROADS and GESTALT studies in Q3 2025.

On July 15, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS) based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), reported that it has received an additional advance of US$2.0M from Hanmi Pharmaceutical Co. Ltd. ("Hanmi"), as part of a US$8.5M loan facility agreement with Hanmi (the "Loan Agreement") announced prior on June 20, 2025 (Press release, Aptose Biosciences, JUL 15, 2025, View Source [SID1234654377]). To date, Aptose has received an aggregate of US$4.5M under the Loan Agreement.

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"Tuspetinib in combination with venetoclax and azacitidine (the TUS+VEN+AZA triplet) continues to demonstrate exciting antileukemic activity and safety across genetically diverse populations of newly diagnosed AML patients – including TP53-mutated AML and wildtype AML, representing large AML populations for which there are few treatment options," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "We are very grateful to Hanmi for its continued support to help advance tuspetinib clinical development and further extend Aptose’s ability to fund this important study."

Tuspetinib is a convenient once daily oral agent that potently inhibits targets that drive excessive proliferation and anti-apoptotic mechanisms, including SYK, mutated and wild type forms of FLT3, mutated KIT, JAK1/2, and RSK2 kinases. Yet, TUS maintains a favorable safety profile by avoiding typical toxicity concerns observed with other agents. The ongoing TUSCANY triplet Phase 1/2 study is designed to test various doses and schedules of TUS in combination with standard dosing of azacitidine and venetoclax in newly diagnosed patients with AML who are ineligible to receive induction chemotherapy. At the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June, Aptose reported early data from the first two dose cohorts that have demonstrated safety, CRs and minimal residual disease (MRD) negativity across patients with diverse mutations.

On July 15, 2025 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported it has entered into an exclusive worldwide licensing agreement with Debiopharm International S.A. ("Debiopharm"), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, for lunresertib, a first-in-class precision oncology PKMYT1 inhibitor (Press release, Repare Therapeutics, JUL 15, 2025, View Source [SID1234654393]).

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"The exclusive worldwide licensing agreement with Debiopharm allows for the continued development of lunresertib, a novel PKMYT1 inhibitor, that has demonstrated encouraging results across multiple clinical trials in difficult-to-treat solid tumors. This agreement builds upon the success of Repare and Debiopharm’s existing collaboration studying the combination of lunresertib and Debio 0123," said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. "Our recent business development efforts have continued to enable Repare to focus on the advancement of our clinical priorities and sustained value creation. We remain focused on two ongoing Phase 1 clinical trials with readouts expected in the second half of 2025: the LIONS trial evaluating our RP-1664 PLK4 inhibitor and the POLAR trial evaluating our RP-3467 Polθ ATPase inhibitor."

Under the terms of the agreement, Repare will receive a $10 million upfront payment, and is eligible to receive up to $257 million in potential clinical, regulatory, commercial and sales milestones, including up to $5 million in potential near-term payments, and single-digit royalties on global net sales. Repare and Debiopharm entered into a clinical study and collaboration agreement in January 2024 to explore the synergy between lunresertib and Debio 0123, a potential best-in-class, brain penetrant and highly selective WEE1 inhibitor. Debiopharm will assume sponsorship of the MYTHIC study and take over existing and future development activities related to lunresertib.

"We are excited to enter into this worldwide license agreement with Repare for lunresertib. Based on very promising Phase 1/1b clinical data, we believe the combination of lunresertib and Debio 0123 is highly synergistic and could potentially drive rapid and deep tumor regressions," said Bertrand Ducrey, CEO of Debiopharm. "We believe the synthetic lethality approach of lunresertib in combination with Debio 0123 will allow us to bring this innovative precision therapy to patients with difficult to treat cancers."

Continued Prioritization of RP-3467 and RP-1664

Moving forward, Repare will remain focused on the advancement of its two ongoing Phase 1 clinical trials, POLAR and LIONS. The POLAR clinical trial is a multicenter, open-label, dose-escalation Phase 1 clinical trial designed to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3467, a small molecule inhibitor of polymerase theta (Polθ) that is a synthetic lethality target associated with BRCA mutations and other genomic alterations, alone or in combination with olaparib in adults with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma. Topline safety, tolerability and early efficacy data from the Phase 1 POLAR clinical trial of RP-3467 alone and in combination with olaparib is expected in the third quarter of 2025. The LIONS clinical trial is a first-in-human, multicenter, open-label Phase 1 clinical trial designed to investigate safety, pharmacokinetics, pharmacodynamics and the preliminary efficacy of RP-1664, a first-in-class, highly selective, oral inhibitor of Polo-like kinase 4 (PLK4) that is a synthetic lethality target associated with TRIM37 overexpression. Initial topline safety, tolerability and early efficacy data from the Phase 1 LIONS clinical trial of RP-1664 is expected in the fourth quarter of 2025.

On July 15, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath Lung, the Company’s commercially available test for early-stage lung cancer, reported it has received notification of allowance from the China National Intellectual Property Administration (CNIPA) for a patent application related to methods of predicting the likelihood of lung cancer using flow cytometry (Press release, BioAffinity Technologies, JUL 15, 2025, View Source [SID1234654378]).

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China represents a large prospective market for CyPath Lung with more than 300 million people who smoke, or nearly one-third of the world’s total smokers, according to the World Health Organization. The China cancer registry estimated 1.06 million new cases of lung cancer were diagnosed in 2022.

"This patent is another step forward in our strategy to safeguard and expand the reach of our proprietary diagnostic platform internationally," said Maria Zannes, President and CEO of bioAffinity Technologies. "With lung cancer representing a major health burden globally and particularly in China, we believe that securing this intellectual property positions us well for future opportunities in one of the world’s largest and most underserved healthcare markets. It reflects our continued execution toward building long-term shareholder value through innovation, protection of our unique assets, and a clear focus on early cancer detection that can save lives."

The newly allowed Chinese patent—titled "System and Method for Determining Lung Health"—protects the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum.

CyPath Lung is the Company’s first commercial product, with clinical study results demonstrating 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. In the study, CyPath Lung detected all forms of lung cancer and 80% of cancers that were Stage 1.

This newly allowed patent complements bioAffinity’s expanding global patent estate, which now includes multiple patents in the U.S, China, Japan, Australia, Mexico, Canada and the EU.

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 July 15, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that patient enrollment has begun in the National Cancer Institute (NCI)’s Vanguard Study to evaluate emerging multi-cancer detection (MCD) technology (Press release, Guardant Health, JUL 15, 2025, View Source [SID1234654394]). Guardant’s Shield MCD test was selected for use in the four-year study, which aims to enroll up to 24,000 patients and evaluate the use of MCD tests—blood tests that can screen for several types of cancer simultaneously—in future randomized controlled trials.

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Guardant’s Shield MCD test was chosen for the study based on the overall performance of its Shield platform in detecting 10 cancer types, including lung, breast, colorectal, prostate, bladder, ovarian, pancreatic, esophageal, liver and gastric. The data were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago. The Vanguard study was initiated following review and approval by the U.S. Food and Drug Administration (FDA) as part of the NCI’s submission for an investigational device exemption (IDE).

"New screening technology like the Shield MCD test has the potential to detect multiple cancers earlier through a simple blood draw," said Craig Eagle, MD, Guardant Health Global Chief Medical Officer. "The earlier we can screen and diagnose cancers, the more options we can bring to patients and ultimately the more lives we can save. The Vanguard Study is a critical step in research to evaluate the role of this breakthrough technology in helping reduce cancer deaths."

The Vanguard Study, conducted by the Cancer Screening Research, a new NCI-sponsored clinical trials network, is enrolling individuals ages 45-75 who do not currently have cancer and who have not received a cancer diagnosis in the past five years. All participants will be offered standard cancer screenings as part of their care. Results from the study will inform the design of a much larger randomized controlled trial to evaluate the use of MCD tests for cancer screening.

"Initiation of the Vanguard Study is an exciting milestone, as we look to evaluate a new way to screen for cancer," said Scott Ramsey, M.D., Ph.D., director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutch Cancer Center and principal investigator for the Vanguard Study. "The study will help us learn more about multi-cancer detection tests and assess whether they can help people from all backgrounds find cancer early, when it may be easier to treat."

The Shield MCD test recently received Breakthrough Device Designation from the FDA for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer. The FDA grants Breakthrough Device designation to a limited set of qualifying devices that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer, than current options. The goal of the FDA’s Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review.