Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results

Why It Matters

The regulatory milestones and robust cash position position Cogent to launch bezuclastinib and capture market share in rare KIT‑mutant diseases, while its expanding pipeline diversifies future revenue streams.

Key Takeaways

• Bezuclastinib NDA submissions on track for 2026.
• Cash runway extends to 2028 with $901 million.
• PEAK trial shows 46% ORR, doubling sunitinib.
• APEX trial reports 89% mast cell reduction.
• Expanded access program supports US GIST and SM patients.

Pulse Analysis

Cogent Biosciences is leveraging bezuclastinib’s selective inhibition of KIT D816V and related exon 17 mutations to address two underserved oncology niches: systemic mastocytosis and gastrointestinal stromal tumors. The drug’s recent pivotal trial readouts—89% mast‑cell reduction in AdvSM and a 46% objective response rate in second‑line GIST—place it among the few therapies with best‑in‑class potential. By aligning NDA submissions with the FDA’s Real‑Time Oncology Review and Breakthrough Therapy pathways, Cogent aims to accelerate market entry and secure premium pricing for a high‑unmet‑need patient population.

Financially, Cogent’s balance sheet now exceeds $900 million, providing a runway to 2028 and insulating the company from near‑term cash constraints. R&D outlays rose to $269.8 million for 2025, reflecting accelerated trial activity and pipeline expansion, while G&A costs more than doubled, driven by commercial build‑out and equity‑based compensation. Although the net loss widened to $328.9 million, the cash cushion and disciplined capital allocation suggest the firm can sustain its growth trajectory without dilutive financing, a point of interest for investors monitoring biotech cash burn profiles.

Beyond bezuclastinib, Cogent’s pipeline diversification targets additional high‑value molecular segments. The KRAS(ON/OFF) inhibitor CGT1263 demonstrated picomolar potency across KRAS mutants, while CGT4255 (CNS‑penetrant ErbB2) and CGT6297 (selective PI3Kα) are advancing through dose‑escalation phases. Early‑stage IND filings for pan‑KRAS and JAK2 V617F candidates further broaden the therapeutic portfolio. This multi‑track strategy not only mitigates reliance on a single product but also positions Cogent to capitalize on emerging precision‑medicine trends across oncology and hematology.

Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results

February 17, 2026 08:00 ET · Source: Cogent Biosciences, Inc.

• Strong financial position with $901 million sufficient to fund operations into 2028

• Six abstracts from SUMMIT trial of bezuclastinib in patients with Non‑AdvSM accepted for presentation at the 2026 AAAAI annual meeting

• PEAK NDA initiated for bezuclastinib in patients with 2L GIST under Real‑Time Oncology Review (RTOR) and Breakthrough Therapy Designation (BTD); completion of NDA on track for April 2026

• SUMMIT NDA for bezuclastinib in patients with Non‑AdvSM submitted in December 2025; APEX NDA submission for bezuclastinib in patients with AdvSM on track for 1H 2026

WALTHAM, Mass. and BOULDER, Colo., Feb. 17, 2026 (GLOBE NEWSWIRE) – Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2025.

“Following three positive pivotal trials in 2025, we have entered 2026 with tremendous momentum and multiple value‑creating regulatory catalysts underway,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We have submitted our SUMMIT NDA for bezuclastinib in patients with Non‑AdvSM, initiated our PEAK NDA under the FDA’s RTOR program for bezuclastinib in patients with second‑line GIST, and remain on track to submit our APEX NDA for bezuclastinib in patients with AdvSM in the first half of this year. These recent and upcoming milestones underscore the breadth of bezuclastinib’s best‑in‑class potential across KIT‑mutant driven diseases. With a very strong balance sheet entering 2026, we will soon finish building our commercial organization and will be ready to launch bezuclastinib in the second half of 2026.”

Recent Company Highlights

SUMMIT trial (Non‑AdvSM) – December 2025

Presented full data at the American Society of Hematology (ASH) annual meeting and submitted an NDA. Key findings:

• Forty‑eight‑week data showing continued deepening of symptomatic improvement over time.

• Reduction in objective measures of disease, including serum tryptase, correlating with improvements in symptom severity – the first demonstration of this relationship in Non‑AdvSM patients.

• Clear clinical benefit across all symptom domains, including significant improvements across 11 individual symptoms and the most severe symptom at baseline.

APEX trial (AdvSM) – December 2025

Topline results from the registration‑directed, global, open‑label trial. Key findings:

• 89 % of patients achieved a ≥50 % reduction in bone‑marrow mast cells or clearance of aggregates.

• Objective response rate (CR + CRh + PR + CI) of 57 % per mIWG criteria and 80 % per PPR criteria.

PEAK trial (GIST, second‑line) – November 2025

Topline results from the Phase 3 trial of bezuclastinib + sunitinib, the first positive Phase 3 trial in second‑line GIST in over 20 years. Highlights:

• Safety profile well‑tolerated with no unique risks versus sunitinib alone.

• 46 % objective response rate (ORR) for the combination vs. 26 % for sunitinib monotherapy (p < 0.0001).

• Median progression‑free survival (mPFS) of 16.5 months for the combination vs. 9.2 months for sunitinib alone (HR = 0.50, 95 % CI 0.39‑0.65; p < 0.0001).

Projected Near‑Term Milestones

Bezuclastinib

• Pending FDA approval, launch in the second half of 2026.

• Present updated SUMMIT data across six poster presentations at the AAAAI Annual meeting (Feb 2026).

• Present detailed clinical data from the PEAK and APEX pivotal trials at major medical meetings during 1H 2026.

• Submit APEX NDA in 1H 2026 for AdvSM.

• Complete submission of PEAK NDA in April 2026 for GIST patients previously treated with imatinib.

• Acceptance of the NDA for Non‑AdvSM in February 2026.

KRAS(ON/OFF) inhibitor CGT1263 – October 2025

Poster at the 2025 AACR‑NCI‑EORTC International Conference highlighted picomolar activity across KRAS mutant cell lines, selectivity over HRAS/NRAS, and pre‑clinical tumor‑growth inhibition data versus other KRAS exemplars.

Pipeline

• Complete dose escalation for CGT4255 (CNS‑penetrant mutant ErbB2 inhibitor) and CGT6297 (selective PI3Kα inhibitor).

• Share clinical data on CGT4859 (FGFR 2/3 inhibitor) from its Phase 1/2 study.

• Submit IND applications for CGT1815 (pan‑KRAS(ON) inhibitor) and CGT1145 (JAK2 V617F inhibitor).

Bezuclastinib – Expanded Access Program

Cogent has active Expanded Access Programs for U.S. patients with GIST or SM meeting disease‑specific criteria. More information: https://www.cogentbio.com/bezuclastinib-program-development/#our-expanded-access-policy

Upcoming Investor Conference

Leerink Healthcare Conference – Wednesday, March 11 at 10:40 a.m. ET. A live webcast will be available on the Investors & Media page of Cogent’s website; a replay will be posted approximately two hours after the event and archived for up to 30 days.

Fourth Quarter and Full Year 2025 Financial Results

• Cash and cash equivalents: $900.8 million as of Dec 31 2025. Q4 cash usage driven by repayment of $54.8 million of long‑term debt and $38.5 million of one‑time performance‑based equity compensation.

• R&D expenses: $75.6 million (Q4 2025) and $269.8 million (FY 2025), up from $62.0 million and $232.7 million respectively in 2024. Includes $7.5 million (Q4) and $23.1 million (FY) of non‑cash stock compensation.

• G&A expenses: $23.9 million (Q4 2025) and $63.6 million (FY 2025), up from $11.7 million and $43.3 million in 2024. Includes $8.3 million (Q4) and $23.0 million (FY) of non‑cash stock compensation.

• Net loss: $102.5 million (Q4 2025) and $328.9 million (FY 2025), compared with $67.9 million and $255.9 million respectively in 2024.

Inducement Grants (Nasdaq Listing Rule 5635(c)(4))

On Feb 11 2026, Cogent’s Compensation Committee approved inducement equity awards to twelve new employees under the 2020 Inducement Plan. The awards include non‑qualified options to purchase 59,300 shares of common stock and 47,000 restricted stock units (RSUs). Options have a 10‑year term, an exercise price equal to the closing price on the grant date, and a 4‑year vesting schedule (25 % after one year, then monthly). RSUs vest annually over four years.

About Cogent Biosciences, Inc.

Cogent Biosciences is a biotechnology company developing precision therapies for genetically defined diseases. Its most advanced clinical program, bezuclastinib, is a selective tyrosine‑kinase inhibitor targeting the KIT D816V mutation and other KIT exon 17 mutations that drive systemic mastocytosis and advanced gastrointestinal stromal tumors (GIST). The company also has a Phase 1 study of a novel FGFR2 inhibitor and a pipeline of targeted agents against ErbB2, PI3Kα, KRAS, and JAK2. Cogent is based in Waltham, MA and Boulder, CO. More information: www.cogentbio.com.

Forward‑Looking Statements

This press release contains forward‑looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding: plans to submit NDAs for bezuclastinib in AdvSM and GIST, anticipated cash runway into 2028, bezuclastinib’s best‑in‑class potential, commercial launch timelines, potential of the JAK2 V617F inhibitor, expected FDA acceptance of the Non‑AdvSM NDA, upcoming clinical data presentations, and IND submissions for pre‑clinical candidates. Such statements are subject to risks and uncertainties, including those described in Cogent’s most recent Form 10‑Q. Cogent does not undertake any obligation to update these statements, except as required by law.

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Consolidated Statements of Operations (unaudited, in thousands)

| | Three Months Ended Dec 31 | | Year Ended Dec 31 | |

|---------------------|---------------------------|----------------|-------------------|----------------|

| | 2025 | 2024 | 2025 | 2024 |

| Research & Development | $75,559 | $62,045 | $269,780 | $232,658 |

| General & Administrative | $23,934 | $11,689 | $63,583 | $43,281 |

| Total operating expenses | $99,493 | $73,734 | $333,363 | $275,939 |

| Loss from operations | $(99,493) | $(73,734) | $(333,363) | $(275,939) |

| Other income: | | | | |

| Interest income | $5,477 | $3,859 | $14,689 | $18,088 |

| Interest expense | $(1,289) | — | $(3,062) | — |

| Loss on debt extinguishment | $(7,181) | — | — | — |