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Tempest Announces Closing of Strategic Acquisition of Dual-Targeting CAR-T Assets

On February 4, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company with a pipeline of advanced strategic therapeutic assets, reported the closing of a previously announced transaction pursuant to which Tempest acquired certain dual-targeting chimeric antigen receptor (CAR)-T programs and obtained financing support from Factor Bioscience Inc. and its affiliates (collectively, "Factor") in an all-stock transaction resulting in a diverse portfolio including clinical-stage product candidates and an extended runway with multiple potential near-term milestones (the "Transaction").

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"I am excited to join the Tempest team and to have the opportunity to develop this innovative pipeline of potential therapies to treat a range of solid tumors and hematologic malignancies," said Dr. Matt Angel, President and Chief Executive Officer of Tempest. "I look forward to advancing the company’s vision of bringing important therapies to patients."

"The Board is pleased to announce the closing of this transaction, which not only provides increased financial stability for Tempest, but also the opportunity for potentially significant milestones over the next 12-18 months from both the legacy small molecule programs and the new cell therapy assets," said Stephen Brady, Chair of the Board.

"As Tempest moves into this next phase, we would like to thank Geoff Nichol and Mike Raab." Mr. Brady continued. "We are grateful for Geoff’s support, engagement and inquisitive mind since he joined the Board in 2021, and wish him continued success in his endeavors. Mike Raab has been our Chair since 2018, during which time he provided clear leadership, thoughtful perspectives, and significant contributions to Tempest throughout his tenure. We are thrilled that Mike will continue to serve on the Board, bringing the ongoing benefit of his experience and guidance to the company."

Key Takeaways:

Amezalpat (TPST-1120) remains Phase 3 ready in first-line liver cancer ("HCC"), supported by global regulatory agreement and positive randomized Phase 2 data. Tempest plans to pursue business development discussions to advance pivotal development.
TPST-2003: new dual-targeting CD19/BCMA CAR-T asset
Phase 1 complete in patients with relapsed/refractory multiple myeloma ("rrMM"), with data expected in 2026 and a biologics license application ("BLA") in China planned for 2027
Phase 1 currently enrolling patients with POEMS syndrome, with data expected in 2027 and a BLA in China planned for 2028
Tempest has global rights to TPST-2003 outside of China, India, Turkey and Russia, and plans to pursue a potential registrational study in rrMM in the U.S. starting in 2027
Pivotal data from the Chinese study expected to validate probability of success for the program, and rights include the right to reference data generated in support of the planned China BLA
All development activities in China to be funded by strategic partner
Tempest expects a Phase 2 study of TPST-1495 in familial adenomatous polyposis ("FAP") to enroll the first patient in Q1’26 and to be funded by the National Cancer Institute and operationalized by the Cancer Prevention Clinical Trials Network.
Plan to continue the development of additional new preclinical and research-stage pipeline programs:
TPST-2206: dual-targeting CD70/CD70 CAR-T for renal cell carcinoma
TPST-3003: allogeneic dual-targeting CD19/BCMA
TPST-3206: allogeneic dual-targeting CD70/CD70
Existing cash and an investment commitment from Factor is expected to provide a runway to mid-2027 and potentially through key data milestones.
Combined Pipeline

Tempest Therapeutics Combined Pipeline
Advisors

MTS Health Partners, L.P. served as financial advisor to Tempest, and Cooley LLP served as legal advisor. In addition, MTS Securities, LLC (an affiliate of MTS Health Partners, L.P.) provided an opinion to the board of directors of Tempest regarding the fairness of the purchase price to be paid by Tempest to Factor in connection with the Transaction, subject to the qualifications and limitations set forth therein. Morse, Barnes-Brown & Pendleton, P.C. served as legal advisor to Factor.

(Press release, Tempest Therapeutics, FEB 4, 2026, View Source [SID1234662478])

Revolution Medicines to Participate in Guggenheim Securities Emerging Outlook: Biotech Summit 2026

On February 4, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that Mark A. Goldsmith, M.D., Ph.D., the company’s chief executive officer and chairman, will participate in a fireside chat as part of the Guggenheim Securities Emerging Outlook: Biotech Summit 2026 on Wednesday, February 11 at 9:30 a.m. ET.

To listen to a live webcast of this event, or access an archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

(Press release, Revolution Medicines, FEB 4, 2026, View Source [SID1234662477])

Rakovina Therapeutics Reports Strong Industry Validation and Emerging Collaborations Following 9th Annual DDR Inhibitors Summit

On February 4, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO0)("Rakovina" or the "Company"), a biopharmaceutical company advancing cancer therapies through AI-enabled drug discovery, reported a corporate update following the participation of its President and Chief Scientific Officer, Prof. Mads Daugaard, at the 9th Annual DNA Damage Response (DDR) Inhibitors Summit in Boston, MA.

The summit, which gathered global academic and industry leaders from institutions including Dana-Farber, MD Anderson, Merck, and Roche, served as a critical forum for discussing the future of DDR therapeutics. Prof. Daugaard presented Rakovina’s AI-driven strategy to develop brain-penetrant inhibitors and participated in expert panels on translational strategy and investment alignment.

Validating the Strategy: Solving the "Brain Penetration" Gap

A focal point of the summit was the clinical landscape of ATR inhibitors, specifically considering recent Phase 3 data in non-small cell lung cancer (NSCLC)

Rakovina’s presentation highlighted a distinct competitive advantage: unlike current clinical-stage candidates, Rakovina’s lead kt-5000 series is designed to be dual-targeting (ATR + mTOR) and brain-penetrant.

"The consensus from the summit is that the field is hungry for a brain-penetrant ATR inhibitor," said Prof. Mads Daugaard, Chief Scientific Officer of Rakovina Therapeutics. "While other programs face challenges with patient stratification and blood-brain barrier penetration, our data supports a different path: positioning ATR inhibition in a PTEN-deficient context with added mTOR blockade to shut down resistance pathways. The feedback we received from clinical thought leaders was clear, we are addressing the exact limitations that have held this drug class back."

Interest in Novel ADC Payloads

In addition to its small-molecule pipeline, the Company received inbound interest regarding its kt-3000 series as potential payloads for Antibody-Drug Conjugates (ADCs). With major pharmaceutical companies actively seeking novel payloads to overcome resistance to current ADC therapies, Rakovina intends to prioritize proof-of-concept studies to further unlock this partnership value.

"Our participation in Boston transformed our standing from a quiet innovator to a recognized problem-solver in the DDR space," added Prof. Daugaard. "We have confirmed that our scientific rationale is sound, our targets are high-value, and our AI-designed molecules are doing what the competition cannot: reach the brain."

(Press release, Rakovina Therapeutics, FEB 4, 2026, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-reports-strong-industry-validation-and-emerging-collaborations-following-9th-annual-ddr-inhibitors-summit [SID1234662476])

QIAGEN Exceeds Q4 2025 Outlook Driven by Growth Pillars

On February 4, 2026 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results for the fourth quarter and full-year 2025.

Net sales for Q4 2025 rose 4% to $540 million, with sales at constant exchange rates (CER) up 1% and exceeding the outlook for steady CER results compared to the year-ago period while overcoming macroeconomic challenges and the impact of the 2025 U.S. government shutdown. Solid ongoing trends among the growth pillars, which rose 7% CER, led the performance. Net sales results included headwinds of approximately $10 million from discontinued products (NeuMoDx and Dialunox) and the first-time contributions from the Parse acquisition that was completed in December 2025. Adjusted diluted EPS CER of $0.62 CER was above the outlook for about $0.60 CER.

For full-year 2025, QIAGEN achieved its increased sales outlook for 5% CER growth, which was at the high end of the outlook for about +4-5% CER growth. Net sales included headwinds of about $20 million from discontinued products (NeuMoDx and Dialunox) as well as contributions from the Parse acquisition. Adjusted diluted EPS was $2.38, with adjusted diluted EPS of $2.40 CER ahead of the outlook for about $2.38 CER and $0.12 ahead of the initial outlook for 2025. Diluted EPS was $1.94.

For 2026, QIAGEN expects net sales growth of at least 5% CER from 2025 driven by the growth pillars contributing about 9% CER growth and combined sales of about $1.64 billion CER. Adjusted diluted EPS is expected to be at least $2.50 CER compared with $2.38 in 2025.

"QIAGEN finished 2025 with disciplined execution, exceeding our outlook for sales and adjusted EPS in Q4 2025," said Thierry Bernard, CEO of QIAGEN. "Our performance underscores the strength of our portfolio and positions us well to demonstrate our commitment to delivering solid profitable growth in a challenging environment. Our growth pillars delivered 8% growth to reach $1.49 billion CER in combined sales in 2025 and keeping us on track toward our 2028 targets. We continue to drive efficiency and digitization across the organization to fund growth investments and expand profitability."

"We also made good progress in capital allocation," said Roland Sackers, CFO of QIAGEN. "We returned more than $1.1 billion to shareholders to date ahead of schedule and closed two bolt-on acquisitions with Genoox strengthening our QDI business and Parse expanding our Sample technologies portfolio with our entry into single-cell analysis. At the same time, we maintain significant flexibility to continue investing in growth and shareholder returns."

Please find the full press release incl. tables as a PDF for download at the top of this page.

Investor presentation and conference call

A conference call is scheduled for Thursday, February 5, 2026, at 15:30 Frankfurt Time / 14:30 London Time / 9:30 New York Time. A live audio webcast will be available in the Investor Relations section of the QIAGEN website (www.qiagen.com), with a recording accessible after the event. The accompanying presentation will be published in advance under "Events and Presentations" in the same section.

Use of adjusted results

QIAGEN reports adjusted results and constant exchange rate (CER) measures, along with other non-GAAP financial metrics, to provide deeper insight into business performance. These include adjusted gross margin and profit, adjusted operating income and expenses, adjusted operating income margin, adjusted net income, adjusted income before taxes, adjusted diluted EPS, adjusted EBITDA, adjusted tax rate and free cash flow. Free cash flow is calculated as cash flow from operating activities less capital expenditures for property, plant and equipment. Adjusted results are non-GAAP measures that QIAGEN views as complementary to GAAP-reported results. They exclude items considered outside of ongoing core operations, subject to significant period-to-period fluctuation, or that reduce comparability with competitors and historical performance. QIAGEN also uses these non-GAAP and constant currency measures internally for planning, forecasting, reporting and employee compensation purposes. These metrics enable consistent comparison of current and past performance, which QIAGEN has historically presented on an adjusted basis.

(Press release, Qiagen, FEB 4, 2026, View Source [SID1234662475])

Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer

On February 4, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to pelareorep in combination with bevacizumab (Avastin) and leucovorin, fluorouracil, irinotecan ("FOLFIRI") for the treatment of patients with KRAS ("Kirsten rat sarcoma")-mutant, microsatellite-stable ("MSS") metastatic colorectal cancer ("mCRC") in the second-line ("2L") setting. As part of the Company’s increased focus on gastrointestinal cancer and analysis of the existing colorectal data set in the fall, the Company applied for and has now received Fast Track Designation.

The Fast Track Designation is supported by clinical data demonstrating a 33% objective response rate ("ORR") for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care ("SOC") in this patient population.1-2 In addition, pelareorep combination therapy was associated with a median progression-free survival ("PFS") of 16.6 months, compared to 5.7 months with SOC, and a median overall survival ("OS") of 27 months, compared to 11.2 months with SOC.1

KRAS-mutant MSS metastatic colorectal cancer represents one of the most challenging diseases in gastrointestinal oncology, as few effective treatment options exist following first-line progression, and available immune-based therapies provide little benefit. There are an estimated 2 million new colorectal cancer cases each year globally, with an annual total addressable market of approximately $3-5 billion for the 2L KRAS-mutant MSS mCRC subgroup.3-7

"This designation is an important validation of our focus on pelareorep’s potential as a platform immunotherapy for gastrointestinal cancers like colorectal cancer," said Jared Kelly, Chief Executive Officer of Oncolytics. "Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate in a market that is estimated to be worth several billion dollars. Pelareorep offers the potential to help a meaningful number of patients, and I look forward to continuing to collaborate with the FDA to address this treatment gap as expeditiously as possible."

Oncolytics expects to initiate a controlled clinical study in second-line KRAS-mutant MSS mCRC comparing standard-of-care therapy alone versus standard-of-care plus pelareorep. The first clinical site is expected to be activated in March, with up to 10 additional sites anticipated to open shortly thereafter. Interim data from the study are expected by year-end. Further details regarding the study design and milestones are forthcoming.

The Fast Track Designation enables more frequent meetings and communication with the FDA to ensure alignment on development plans and the collection of clinical data needed to support approval. Furthermore, clinical programs with Fast Track Designation may be eligible for Accelerated Approval and Priority Review if relevant criteria are met. For conditions where an available treatment exists, a candidate therapy regimen must show some advantage over the available treatment, such as superior effectiveness, to be granted Fast Track Designation.

(Press release, Oncolytics Biotech, FEB 4, 2026, View Source [SID1234662474])