On December 1, 2025 One-carbon Therapeutics AB, a clinical-stage biotechnology company pioneering first-in-class cancer therapies, reported the closing of an oversubscribed 153 million SEK (€13.9 million) private placement financing round supported by current and new investors and private Swedish family offices.

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One-carbon Therapeutics will use the net proceeds from the private placement to strengthen its financial position and expand its ongoing Phase 1/2 ODIN clinical study of TH9619, an MTHFD1/2 inhibitor, thereby further accelerating its momentum through a data-driven strategy. The financing follows the company’s recent important milestone of dosing the first subject in the ODIN Phase 1/2 study – marking One-carbon Therapeutics’ successful transition from preclinical to clinical-stage company.

"We are very encouraged by the strong confidence and enthusiasm shown by our existing and new investors, who recognize the potential of our lead asset. Their support is crucial for securing rapid execution and delivery of the potential new therapy to patients in need," said Ana Slipicevic, Chief Executive Officer.

One-carbon Therapeutics also extends its appreciation to clinical and academic collaborators, partners and advisors for their continued trust and partnership, and for their belief in our vision and science. Their support has been instrumental in driving the company’s scientific and clinical progress, enabling the advancement of TH9619.

Selma Legal AB has served as legal adviser to One-carbon Therapeutics AB in the transaction.

About TH9619

TH9619 is a first-in-class, potent, small-molecule, and dual inhibitor of MTHFD1/2, highly overexpressed and cancer-specific enzymes within the one-carbon metabolic pathway. TH9619 kills cancer cells via a dual mechanism of action (1) inhibition of MTHFD1 traps folate leading to thymidine depletion (2) inhibition of nuclear MTHFD2 disrupts DNA damage response and repair pathways. With its unique characteristics, TH9619 kills tumor cells while sparing healthy tissue.

About ODIN Phase 1/2 Clinical Study

This is a first-in-human, multicenter, open label, dose escalation and expansion study, aiming at evaluating safety, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of TH9619 as monotherapy in subjects with advanced refractory solid tumors, including colorectal cancer, non-small cell lung cancer, head & neck squamous cell carcinoma, gastric cancer or gastroesophageal junction cancer. The trial is currently being conducted across leading academic and clinical research centers in the United Kingdom, France, and Spain, with expansion planned across additional European sites in the coming months.

Clinicaltrials.gov NCT07151040; EudraCT No. 2024-519639-40-00

(Press release, One-carbon Therapeutics, DEC 1, 2025, View Source [SID1234661125])

On December 1, 2025 Rakovina Therapeutics Inc. ("Rakovina" or the "Company") (TSX-V: RKV) (FSE: 7JO0), a biopharmaceutical company advancing cancer therapies through AI-powered drug discovery, reported its financial results for the three months ended September 30, 2025 ("Q3 2025"), and provided an update on recent corporate developments.

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Q3 2025 Financial Highlights

Reported a net loss of $1,781,757.
Research and development (R&D) expenses were $1,102,371, reflecting continued advancement of AI-powered drug candidates.
General and administrative (G&A) expenses were $539,174 including investor & public relations and exchange-related fees.
Cash and cash equivalents as at September 30, 2025 were $822,293.
"Over the past several months, Rakovina Therapeutics has delivered a series of meaningful scientific and corporate milestones that underscore the strength of our AI-enabled DDR pipeline and the growing global interest in our programs," stated Jeffrey Bacha, Rakovina Therapeutics executive chairman. "From compelling CNS-penetrant ATR data at AACR (Free AACR Whitepaper)-NCI-EORTC to multiple presentations at the Society for Neuro-Oncology Annual Meeting, together with increased visibility at leading investor and industry conferences and the advancement of strategic collaborations such as our NanoPalm joint-venture initiative, we are entering 2026 with significant momentum. These achievements not only validate the depth of our science but also position the company for the next phase of growth as we work to bring transformative therapies to patients in need."

Recent Corporate Highlights

On November 24, 2025, the Company announced the presentation of two scientific posters at the 2025 Society for Neuro-Oncology Annual Meeting in Honolulu, Hawaii. The posters provided updates on the Company’s ATR and PARP1 programs, including compelling preclinical data from the ATR program. Rakovina’s lead ATR compounds have now been confirmed as dual ATR/mTOR inhibitors and demonstrate properties highly relevant to treatment-resistant, PTEN-deficient solid tumors, where PTEN loss is one of the most common genetic alterations across cancers and is strongly associated with a high incidence of brain metastases.
On November 18, 2025, the Company announced that its President & CSO, Prof. Mads Daugaard, has been invited to present and participate as a panelist at the 9th Annual DNA Damage Response (DDR) Inhibitors Summit in January 2026, where he will highlight the Company’s AI-enabled DDR drug discovery programs and ongoing preclinical progress.
On October 27, 2025, the Company announced the presentation of new pre-clinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) confirming that its AI-discovered ATR inhibitor program (kt-5000 series) achieved potent ATR inhibition and demonstrated confirmed CNS penetration – a milestone differentiator in the DDR inhibitor space.
On September 4, 2025, the Company announced that senior management would attend the H.C. Wainwright 27th Annual Global Investment Conference (September 8–10, New York), to engage with investors and potential pharmaceutical partners to discuss the company’s AI-enabled oncology pipeline, corporate strategy, and upcoming milestones.
On August 26, 2025, the Company announced that our president & CSO, Prof. Mads Daugaard, was invited to speak at the 13th Tuscany Retreat on Cancer Research & Apoptosis (August 23–30), highlighting Rakovina Therapeutics DDR-targeted drug discovery and development accomplishments.
On August 12, 2025, the Company announced that Rakovina Therapeutics and NanoPalm Ltd. announced a non-binding Letter of Intent to form a joint venture to co-develop AI-discovered small-molecule oncology therapies—beginning with the dual PARP-HDAC inhibitor KT-3283 delivered via NanoPalm’s proprietary patterned lipid nanoparticle (pLNP) system—combining Rakovina’s drug candidates and validation data with NanoPalm’s nanoparticle platform, manufacturing capabilities, and support infrastructure under a Saudi Arabia-based JV with global development and commercialization rights.
On July 28, 2025, the Company granted an aggregate of 540,000 stock options to certain directors, officers, employees, and consultants pursuant to its Long-Term Incentive Plan. Each option is exercisable at a price of $0.70 per share for a period of five years and vests in equal installments every six months over three years.
On July 15, 2025, the Company announced that its common shares are now eligible for electronic clearing and settlement through the Depository Trust Company (DTC).
Selected Financial Results for Q3 2025

Sept. 30, 2025 ($) Dec 31, 2024 ($)
Cash and Cash Equivalents 822,293 1,312,743
Working Capital deficit (489,279) 321,442
Intangible Assets 3,576,493 3,977,473
Total Assets 5,267,709 6,240,920
Total Liabilities 3,380,019 1,942,005
Deficit (21,785,345) (14,997,929)
Statement of Loss and Comprehensive Loss – Q3 Three months ended September 30

Sept. 30, 2025 ($) Sept. 30, 2024 ($)
Research & Development 1,102,371 676,200
General and Administrative 539,174 266,920
Net loss and comprehensive loss (1,781,757) (1,011,141)
Basic and diluted loss per share (0.08) (0.11)
Weighted average shares outstanding 21,148,038 (post) 8,966,762 (post)
Rakovina Therapeutics’ financial statements as filed with SEDAR can be accessed from the Company’s website at: View Source

(Press release, Rakovina Therapeutics, DEC 1, 2025, View Source [SID1234661054])

On December 1, 2025 Novocure (NASDAQ: NVCR) reported the appointment of Frank Leonard as Chief Executive Officer (CEO), effective immediately. Mr. Leonard previously served as President of Novocure and succeeds Ashley Cordova who has resigned from the company.

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"During his more than 15-year career at Novocure, Frank has led many of our global business operations developing deep expertise in delivering our unique, device-based cancer therapy to patients to extend their survivals. Frank has been instrumental in creating Novocure’s culture and guiding the organization at critical points, including preparing the company for its first commercial launch and establishing the business functions that continue to drive our growth," said William Doyle, Executive Chairman, Novocure. "Frank embodies Novocure’s core values and has an unwavering commitment to our patient-forward mission. He is the ideal person to lead our organization through the exciting, transformative milestones anticipated in the years ahead. We are thrilled for him to step into the CEO role.

"On behalf of the Novocure Board of Directors, I want to thank Ashley Cordova for the contributions she made to our organization during her career at Novocure. She was unquestionably dedicated to our mission and helped build Novocure into the company it is today. We wish her success in her future endeavors," continued Mr. Doyle.

Mr. Leonard joined Novocure in 2010 to prepare the company for its first commercial launch and he has held various leadership roles including establishing Novocure’s finance, reimbursement, and business development functions, and led the company’s early innovation and product development teams. In his role as Novocure’s President, Frank led global sales, marketing, field medical affairs, patient experience, public affairs, market access, and product and portfolio strategy functions.

"The patient is at the center of what we do and why we are committed to extending survival in the most aggressive cancers," said Mr. Leonard. "I am honored to lead Novocure and partner with our incredible employees around the world as we prepare to launch products in new indications, complete multiple clinical trials, and work to deliver the full potential of our innovative therapy."

(Press release, NovoCure, DEC 1, 2025, View Source [SID1234661036])

On December 1, 2025 SAGA Diagnostics, a pioneer in blood-based cancer detection and precision medicine redefining the standard for ultra-sensitive and early molecular residual disease (MRD) detection, reported it will present five posters—three new studies and two trials in progress—at the 2025 San Antonio Breast Cancer Symposium (SABCS), December 9-12, 2025 in San Antonio, TX.

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The posters build on the TRACER clinical study findings published in Clinical Cancer Research, which demonstrated 100% sensitivity, 100% specificity, and a 13.7-month lead time to recurrence across all subtypes of stage I–III breast cancer. The data presented at SABCS further validates the best-in-class performance of Pathlight, SAGA’s structural-variant (SV)–based MRD test. This clinical validation data provided the basis for a positive coverage determination for Pathlight under the US Centers for Medicare Services MolDx program. SAGA’s collaborating investigators will also present posters introducing a prospective interventional study designed to evaluate clinical utility using Pathlight.

"Building on the very compelling TRACER data, we are advancing into prospective interventional trials to address the critical question of clinical utility," said Dr. David Cescon, Medical Oncologist and Clinician Scientist at Princess Margaret Cancer Centre, University of Toronto. "Our CLAIRE and CATER studies are now enrolling participants to evaluate whether ctDNA-based surveillance and intervention can improve outcomes in early-stage breast cancer. This is an important step toward integrating MRD-guided strategies into standard clinical care."

Updated TRACER Study Analysis

The retrospective analysis of an expanded set of 121 patients with TNBC, HER2+, or ER+/HER2– early breast cancer showed 100% sensitivity, 100% specificity, and a median 12-month lead time from ctDNA detection to clinical recurrence. Rising ctDNA ("molecular progression") preceded radiographic progression in all patients, and baseline SVs were reproducibly detected across longitudinal timepoints in both early-stage and metastatic disease.

Studies Advancing Clinical Utility

Pathlight is being used in two studies to evaluate the impact of MRD detection on clinical decision-making:

Circulating Liquid Biomarkers for Assessment and Identification in Early BREast Cancer (CLAIRE): A multicenter surveillance study using Pathlight every three months for up to five years in intermediate- to high-risk ER+/HER2– early breast cancer, to prospectively characterize the surveillance process and identify candidates for interventional MRD trials.
CApecitabine for Targeted Eradication of Rising ctDNA Molecular Residual Disease in ER+/HER2- Breast Cancer (CATER): An open-label, Phase II study testing whether secondary adjuvant metronomic capecitabine can eradicate ctDNA in patients previously diagnosed with high-risk ER+/HER2– early breast cancer who have detectable MRD despite standard curative intent therapies. Pathlight will be used to assess ctDNA clearance at 16 weeks as the primary endpoint.
Additional posters will be presented focusing on TNBC, including a poster spotlight, highlighting Pathlight’s performance in the neoadjuvant setting.

"The studies presented at SABCS 2025 continue to validate what we consistently see with Pathlight—ultra-sensitive ctDNA detection that can meaningfully improve early breast-cancer management," said Wendy Levin, MD, MS, Chief Clinical Officer of SAGA Diagnostics. "By leveraging truncal SVs, Pathlight provides a dependable signal clinicians can trust. The new prospective studies take us beyond analytical performance into demonstrating true clinical utility."

SAGA Diagnostics also celebrates the recognition of Dr. Mitchell J. Elliott, first author of the TRACER study, who has been selected to receive the prestigious Margaret Foti Foundation Scholar-in-Training Award at SABCS. This award honors outstanding young scientists conducting high-quality cancer research, and Dr. Elliott’s contributions to advancing ultra-sensitive MRD detection in breast cancer exemplify that standard.

Key SAGA Diagnostics presentations during SABCS 2025:

Abstract title

Presentation details

Prevalence and Dynamics of Circulating Tumor DNA Among Patients with Triple-negative Breast Cancer Undergoing Preoperative Systemic Therapy With or Without Immunotherapy

Poster presentation PS2-07-06

Date: December 10, 2025

Time: 5:00-6:30 PM CST

Presenter: Tae-Kyung Robyn Yoo, Asan Medical Center, Seoul, Republic of Korea

Longitudinal ctDNA Tracking in Early and Recurrent Breast Cancer Using an Ultra-Sensitive Structural Variant-Based Assay: An Updated Analysis from the TRACER Study

Poster Presentation PS2-07-08

Date: December 10, 2025

Time: 5:00-6:30 PM CST

Presenter: Mitchell J Elliott, Princess Margaret Cancer Centre, Toronto, ON, Canada

Neo-N (neon) – Three-year Event-free Survival and Ultra-Sensitive ctDNA Dynamics in Early Triple-negative Breast Cancer Treated with Neoadjuvant Carboplatin/Paclitaxel and Nivolumab

Poster Spotlight 7 (PD7-10): Early Triple Negative Breast Cancer—Biomarkers and Novel Approaches

Date: December 11, 2025

Time: 7:00-8:30 AM CST

Presenter: Sherene Loi, Peter MacCallum Cancer Centre, Melbourne, Australia

CLAIRE – a multicenter, prospective single-arm phase II trial, evaluating liquid biopsy guided intensified follow-up surveillance in women with intermediate to high-risk ER+/HER2-negative early-stage breast cancer

Poster Presentation: PS2-07-08

Date: December 12, 2025

Time: 12:30-2:00 PM CST

Presenter: Mitchell J Elliott, Princess Margaret Cancer Centre, Toronto, ON, Canada

CATER-MRD: Capecitabine for Targeted Eradication of ctDNA Molecular Residual Disease in ER-positive/HER2-negative Early-stage Breast Cancer

Poster Presentation: PS5-09-28

Date: December 12, 2025

Time: 12:30-2:00 PM CST

Presenter: Mitchell J Elliott, Princess Margaret Cancer Centre, Toronto, ON, Canada

The full posters will be available on SAGA Diagnostics’ website after they are presented.

(Press release, SAGA Diagnostics, DEC 1, 2025, View Source [SID1234661035])

On December 1, 2025 Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved the company’s IsoPSA in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) process. IsoPSA is a blood-based test indicated as an aid in the decision for prostate biopsy for men ≥ 50 years of age with elevated PSA levels.

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"FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics’ mission to help physicians and patients detect cancer early when it is most treatable and survivable," shared Arnon Chait, PhD, company president and CEO. "We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide."

FDA approval of the IsoPSA test was based on clinical evidence from a large-scale, prospective study conducted at 14 sites across the U.S. and data from supporting analytical validation studies.

Prostate cancer is the second most common cancer in American men, with 1 in 8 diagnosed during their lifetime. In the U.S., greater than 1 million men undergo prostate biopsies each year, yet up to 75% of those follow-up tests are negative for high-grade disease. This diagnostic gap subjects millions to invasive, costly procedures that can produce physical risks, emotional stress, and significant healthcare costs. IsoPSA helps close this gap, giving clinicians and patients a more accurate risk assessment and greater confidence in biopsy decision-making.

"As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients and appreciate the critical need for early and accurate risk assessment and testing," added Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Associated Urological Specialists in Chicago. "IsoPSA represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence."

"FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer," said Dr. Eric Klein, Emeritus Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and Distinguished Scientist at GRAIL, Inc.* "I’m very pleased to see this milestone achieved; it represents the culmination of extensive study and test development over the past decade."

The IsoPSA IVD kit leverages Cleveland Diagnostics’ IsoClear platform. This proprietary technology investigates protein biomarkers at a structural level in the blood to provide clinically relevant insights into disease state.

Cleveland Diagnostics has offered IsoPSA as a Laboratory-Developed Test (LDT) since 2020, and Medicare and a growing number of commercial payors now cover the test. IsoPSA is included in leading clinical practice guidelines, including the National Comprehensive Cancer Network (NCCN) Prostate Cancer Early Detection Guideline (2025) and the Early Detection of Prostate Cancer: American Urology Association/Society of Urologic Oncology Guideline (2023).

(Press release, Cleveland Diagnostics, DEC 1, 2025, View Source;-Cleveland-Diagnostics-Novel-Blood-Based-Prostate-Cancer-Test [SID1234661034])