On August 10, 2026 AB Science S.A. (the "Company" or "AB Science", Euronext – FR0010557264 – AB) reported the successful completion of capital increases of a total gross amount of EUR 14.2 million subscribed by a limited number of investors (the "Private Placement").

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The capital increase was subscribed for EUR 12 million by an existing long-term investor who expressed its intention to accompany the development of the Company.

Stéphane Ledermann, the Chief Executive Officer of the Company, also contributed to the round of financing, and indicated "My personal financial investment in this capital increase, alongside long-standing, long-term shareholders whom I thank, provides a lasting foundation for our new governance. This stability is necessary to pursue the transformation of the Company initiated four weeks ago.

This exceptional, non-recurring financing covers our working capital requirements for the months to come without any additional funding and secures the implementation of our new growth priorities, which are currently being finalized. The value-creation strategies for our employees and shareholders will be approved in the coming weeks and announced during September."

The Private Placement is not subject to a prospectus requiring an approval from the French Financial Market Authority (Autorité des Marchés Financiers – the "AMF"). In accordance with Article 1.5.(ba) of the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, as amended (the "Prospectus Regulation"), the Company file with the AMF a document containing the information set out in Appendix IX of the Prospectus Regulation (the "Information document"), copies of which will be available free of charge on the Company’s website at www.ab-science.com and on the AMF’s website at www.amf-france.org.

Use of proceeds

The Company intends to use the net proceeds from the Private Placement to fund its research and development programs, with primary focus on:

AB8939 development in acute myeloid leukemia;
Masitinib development in amyotrophic lateral sclerosis; and
Nearer-term value-creation projects that are expected to be finalized and disclosed in September.

This transaction strengthens the Company’s cash position and enables it to cover its financing needs beyond the next 12 months.

Terms and conditions of the Private Placement

The Private Placements, for a total amount of EUR 14.2 million (including share issue premium), was carried out through the issuance, without preferential subscription rights and without a priority subscription period, of:

(i) 3,606,560 new ordinary shares of the Company (the "New Shares"), each with one share warrant attached (a "BSA-1" and, together with the New Share to which it is attached, an "ABSA-1") – five BSA-1 entitle their holder to subscribe to three new ordinary shares of the Company at a price of EUR 1.00 per ordinary share; and

(ii) 19,672,132 New Shares, each with one share warrant attached (a "BSA-2" and, together with the New Share to which it is attached, an "ABSA-2") – four BSA-2 entitle their holder to subscribe to seven new ordinary shares of the Company at a price of EUR 1.00 per ordinary share.

The total of 23,278,692 New Shares (ABSA-1 and ABSA-2) are collectively called the "ABSA". The total of 23,278,692 warrants attached (BSA-1 and BSA-2) are collectively called the "BSA".

The issuance of the ABSA was conducted through share capital increases with cancellation of shareholders’ preferential subscription rights for the benefit of investors within the category of persons defined by the 15th resolution of the Combined General Meeting of the Company’s shareholders of June 30, 2026 (the "General Meeting"), in accordance with article L. 225-138 of the French commercial code.

The issue of the ABSA, representing approximately 29.09% of the Company’s share capital, on a non-diluted basis, before completion of the Private Placement, and 22.53% of the Company’s share capital, on a non-diluted basis, after completion of the Private Placement, was decided on August 9, 2026 by the Chief Executive Officer, pursuant to the delegation of competence granted to him by the board of directors dated August 8, 2026, pursuant to the delegation of competence granted to it under the 15th resolution of the General Meeting.

The issue price of one ABSA is EUR 0.61 (including share issue premium), representing a facial discount of 24.87% (i.e. EUR 0.2019) to the volume-weighted average price of the AB Science shares on the regulated market of Euronext Paris ("Euronext Paris") over the three trading days preceding the setting of such issue price, i.e. August 5, 6 and 7, 2026, i.e. EUR 0.8119 (the "3-day VWAP").

The issue price of:

one ABSA-1, including the theoretical value of the BSA-1 attached to it (as described below, together with the issue price of the new ordinary shares issued upon exercise of the BSA-1) represents a total 22.11% discount per AB Science share to the 3-day VWAP, consistent with the maximum discount authorized by the General Meeting pursuant to its 15th resolution; and

one ABSA-2, including the theoretical value of the BSA-2 attached to it (as described below, together with the issue price of the new ordinary shares issued upon exercise of the BSA-2) represents a total 20.19% discount per AB Science share to the 3-day VWAP, consistent with the maximum discount authorized by the General Meeting pursuant to its 15th resolution.

Terms and conditions of the BSA

One BSA is attached to each New Share.

Five BSA-1 entitle their holder to subscribe to three new ordinary shares of the Company at a price of EUR 1.00 per ordinary share.

Four BSA-2 entitle their holder to subscribe to seven new ordinary shares of the Company at a price of EUR 1.00 per ordinary share.

The BSAs may be exercised at any time within 60 months of their issuance. In the event all BSAs are exercised, a total number of 36,590,166 additional ordinary shares of the Company will be issued, representing additional total proceeds of approximately EUR 36 million.

The theoretical value of each BSA, assuming a volatility of 32.088%1, based on closing price as of August 7, 2026 and using Black & Scholes model, is equal to:

EUR 0.1982 by BSA-1; and

EUR 0.5780 by BSA-2.

The BSAs will be immediately detached (détachés) from the New Shares upon issuance and will not be listed.

Impact of the Private Placement on the Company’s shareholding

Following the issuance of the ABSAs, the Company’s total share capital will be EUR 1,033,083.57 (and EUR 1,265,870 in the event of exercise of all BSAs). It will be comprised of 96,530,683 ordinary shares (and of 133,120,849 ordinary shares in the event of exercise of all BSAs) with a par value of EUR 0.01. There will be no change on the number of preferred shares.

To the Company’s knowledge, immediately prior to completion of the Private Placement and after completion of the Private Placement, the breakdown of the Company’s share capital is as follows:

Before the capital increase After the capital increase (before exercising the warrants) After the capital increase and exercise of the warrant
Number of shares ( 1) % Diluted base ( 2) Number of shares ( 1) % Diluted base ( 2) Number of shares ( 1) % Diluted base ( 2)
Investors above 5% 25 315 344 31,63% 32,54% 44 987 476 43,55% 41,72% 79 413 707 56,77% 53,10%
Single Private Investor 6 259 910 7,82% 6,85% 25 932 042 25,10% 20,56% 60 358 273 43,14% 36,54%
Subtotal concert A. Moussy 19 055 434 23,81% 25,69% 19 055 434 18,45% 21,16% 19 055 434 13,62% 16,56%
A. Moussy 6 782 434 8,47% 14,38% 6 782 434 6,57% 11,84% 6 782 434 4,85% 9,27%
AMY SAS (3) 12 273 000 15,34% 11,31% 12 273 000 11,88% 9,31% 12 273 000 8,77% 7,29%
Other Investors 54 714 321 68,37% 67,46% 58 320 881 56,45% 58,28% 60 484 816 43,23% 46,90%
Total 80 029 665 100,00% 100,00% 103 308 357 100,00% 100,00% 139 898 523 100,00% 100,00%
(1) All classes of shares are affected. The number of ordinary shares amounts to 73,251,991 before the Private Placement, 96,530,683 after the Private Placement (but before exercise of the BSAs), and 133,120,849 after the Private Placement and exercise of the BSAs.
(2) The diluted basis takes into account the exercise of all instruments giving access to the capital, the definitive allocation of all free shares and the conversion of all preferred shares into ordinary shares (aiming for the highest theoretical dilution).
(3) AMY SAS is a company controlled by A. Moussy.

On the basis of the share capital of the Company immediately after completion of the Private Placement, the interest of a shareholder who held 1.00% of the Company’s share capital prior to the above-mentioned capital increase and who did not subscribe to it now stands at 0.7747% on a non-diluted basis and 0.6072% on a diluted basis.

Admission to trading of the New Shares

The New Shares are expected to be admitted to trading on the regulated market of Euronext Paris on August 14, 2026.

The New Shares will be subject to the provisions of the Company’s by-laws and will be assimilated to existing shares upon final completion of the Private Placement. They will bear current dividend rights and will be admitted to trading on the same listing line as the Company’s existing shares under the same ISIN code FR0010557264 – AB.

The BSAs will not be admitted to trading on any market.

The new ordinary shares issued upon exercise of the BSAs will be, when issued, subject to the provisions of the Company’s by-laws and will be assimilated to existing shares. They will bear current dividend rights and will be admitted to trading on the same listing line as the Company’s existing shares under the same ISIN code FR0010557264 – AB.

Lock-up commitments

The Company has signed a lock-up commitment (to the benefit of the investors) pursuant to which it has agreed to a lock-up period of 30 calendar days from the date of the settlement and delivery of the Private Placement, subject to certain customary exceptions.

The directors and officers of the Company have signed a lock-up commitment (to the benefit of the investors) pursuant to which they have agreed to a lock-up period of 30 calendar days from the date of the settlement and delivery of the Private Placement, subject to certain customary exceptions.

Indicative timetable

August 8, 2026 Decisions of the Board of Directors deciding the principle of the Private Placement.
August 9, 2026 Decisions of the Chief Executive Officer setting the terms and conditions of the Private Placement (including the subscription price of the ABSAs and the gross amount of the Private Placement).
August 10, 2026 Publication of this press release.
Publication of the Information Document
August 12, 2026 Settlement-delivery of the ABSAs – Detachment of the BSA
August 14, 2026 Start of trading of the New Shares on Euronext Paris.
Risk factors

AB Science draws the attention of the public to the risk factors relating to the Company and its business described in its annual management reports and press releases, which are available free of charge on the Company’s website (www.ab-science.com).

In addition, the main risks specific to securities are as follows:

The existing shareholders who do not participate in the Private Placement will see their shareholding in the share capital of AB Science diluted, and this shareholding may also be diluted in the event of exercise of the BSA, as well as in the event of new securities transactions.

The volatility and liquidity of AB Science shares could fluctuate significantly. The market price of the Company’s shares may fluctuate and fall below the subscription price of the shares issued in the context of the Private Placement. The sale of Company shares may occur on the secondary market, after the Private Placement, and have a negative impact on the Company share price.

About masitinib

Masitinib is a novel oral tyrosine kinase inhibitor that is being developed to target mast cells and macrophages, key immune cells, through inhibition of a limited number of kinases. Through its activity on mast cells and microglial cells and therefore its inhibitory effect on the activation of the inflammatory process, masitinib may have an effect on the course of central nervous system diseases.

About AB8939

AB8939 is a new synthetic microtubule-destabilizing drug candidate. Preclinical data suggests that AB8939 has broad anticancer activity, with a notable advantage over standard chemotherapies that target microtubules of being able to overcome P-glycoprotein (Pgp) and myeloperoxidase (MPO) mediated drug resistance. Development of drug resistance often restricts the clinical efficacy of microtubule-targeting chemotherapy drugs (for example, taxanes and vinca alkaloids); thus, AB8939 has the potential to be developed in numerous oncology indications.

(Press release, AB Science, AUG 10, 2026, View Source [SID1234669898])

On August 10, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, and Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported a multi-part collaboration including: a clinical collaboration to evaluate drug combinations incorporating select clinical-stage oncology assets from BeOne with any of Revolution Medicines’ four clinical RAS(ON) inhibitors, and a separate regional rights agreement granting BeOne exclusive development and commercialization rights to these Revolution Medicines assets in select Asian markets.

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Clinical collaboration will explore potential targeted combination approaches for patients with RAS-addicted cancers

Potential drug combinations for development as part of the clinical collaboration will include certain BeOne assets and Revolution Medicines’ four clinical RAS(ON) inhibitors: daraxonrasib, a RAS(ON) multi-selective inhibitor; zoldonrasib, a RAS(ON) G12D-selective inhibitor; elironrasib, a RAS(ON) G12C-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor. Planned combination studies include: BeOne’s MTA-cooperative PRMT5 inhibitor, BGB-58067, and an EGFR x MET x MET trispecific antibody, BG-T187, with either daraxonrasib or zoldonrasib.

Regional rights agreement leverages BeOne’s established R&D and commercial expertise and Revolution Medicines’ clinical stage RAS(ON) inhibitor portfolio

Under the regional rights agreement, Revolution Medicines has granted BeOne exclusive rights in select Asian markets to develop and commercialize or solely commercialize, depending on the market, these four clinical-stage RAS(ON) inhibitors. Revolution Medicines is eligible to receive development and sales milestone payments and tiered royalties on net sales in the partnered region. Revolution Medicines retains development and commercial rights to all its assets outside of the licensed territory, including Japan and South Korea. As part of this multi-part arrangement, BeOne will fund and conduct a global registrational Phase 3 study for one of Revolution Medicines RAS(ON) inhibitors using BeOne’s differentiated, fully in-house development superhighway, while Revolution Medicines continues to advance a broad range of global registrational studies across its portfolio.

John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:
"We are pleased to enter this collaboration with Revolution Medicines, which gives BeOne the opportunity to evaluate combinations between assets from our oncology pipeline and four promising RAS(ON) inhibitors from Revolution Medicines. In parallel, the regional rights transaction allows us to use our global development superhighway capabilities and established commercial presence, with the goal of bringing more medicines to patients with difficult-to-treat cancers."

Mark A. Goldsmith, M.D., Ph.D., CEO and Chairman of Revolution Medicines, said:
"This arrangement with BeOne reflects our commitment to advancing RAS(ON) inhibitors for patients with RAS-addicted cancers around the world, including in regions where we have not previously had a presence, while exploring novel combination strategies that may further expand their potential impact. BeOne brings additional established global oncology development capabilities and a strong regional commercial footprint that can help us broaden the reach of our innovative RAS(ON) inhibitors as part of our ambitious global strategy."

(Press release, BeOne Medicines, AUG 10, 2026, View Source [SID1234669916])

On August 10, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported financial results for the second quarter ended June 30, 2026, and provided a business update highlighting continued operational execution across its lead pancreatic cancer program.

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"AIM continues to execute a clear and disciplined strategy centered on advancing Ampligen in pancreatic cancer," said AIM Chief Executive Officer Thomas K. Equels. "Over the past year, we have strengthened our financial position while completing enrollment and Ampligen dosing in the metastatic pancreatic cancer Phase 2 clinical trial – critical steps as we move toward an anticipated Phase 3 study in metastatic pancreatic cancer. We anticipate DURIPANC data on clinical benefit in Q1 2027 and on Overall Survival – the gold standard data point in oncology – in Q3 2027. AIM expects that this data will amplify median Overall Survival findings from Ampligen’s Dutch-government approved Named Patient Program in late-stage pancreatic cancer, where Ampligen achieved a median Overall Survival of 34.8 months compared to 12.5 months for historical controls – with favorable safety profile and high quality of life – in a large, easily identifiable and key patient immune biomarker subset. This median improvement of 22.3 months will be a critical component of the foundation for our pivotal Phase 3 clinical trial design in metastatic pancreatic cancer."

Second Quarter and Recent Operational Highlights

Completed patient enrollment and Ampligen dosing in the ongoing Phase 2 DURIPANC study evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in metastatic pancreatic cancer.
Engaged Thermo Fisher Scientific’s PPD clinical research business to support study design of a planned pivotal Phase 3 clinical trial in metastatic pancreatic cancer.
Maintained encouraging observations from Erasmus MC Cancer Institute, including favorable safety findings, progression-free and overall survival trends, and consistently reported high quality of life among treated patients.
Strengthened the Company’s balance sheet through multiple financing transactions, providing additional resources to support continued clinical execution.
Successfully regained full compliance with NYSE American’s continued listing standards.
Planning government-focused initiatives to evaluate Ampligen’s antiviral potential against Ebola virus disease, consistent with the Company’s strategy of pursuing non-dilutive funding opportunities for select infectious disease programs while maintaining pancreatic cancer as its primary strategic focus.
For more information, please visit the Company’s website at aimimmuno.com.

Summary of Financial Highlights for Second Quarter 2026

As of June 30, 2026, AIM reported $9.9 million in cash and cash equivalents, as compared to approximately $3.0 million as of December 31, 2025.
Research and development expenses for the three months ended June 30, 2026 were approximately $589,000, compared to $1.2 million during the same period in 2025.
General and administrative expenses were approximately $2.9 million for the second quarter of 2026, compared to $1.5 million during the same period in 2025.
Net loss for the three months ended June 30, 2026 was approximately $(3.8 million), or $(0.43) per share, compared to $(2.8 million), or $(3.68) per share, for the second quarter of 2025.
The Company believes its strengthened financial position supports continued execution of its clinical development strategy and key upcoming milestones. Please refer to the Company’s Form 10-Q for the quarter ended June 30, 2026, for complete financial results and additional disclosures.

(Press release, AIM ImmunoTech, AUG 10, 2026, View Source [SID1234669899])

On August 10, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported a business update and announced results for the quarter ended June 30, 2026.

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"The team at Perspective is highly energized as we continue to build on the significant clinical progress we’re making across our pipeline, prepare for our first Phase 3 study, and advance our flagship Chicago manufacturing facility toward completion," said Thijs Spoor, Perspective’s CEO. "As precision oncology continues to evolve, long-term leadership will require differentiated science, integrated manufacturing, and the ability to reliably deliver these therapies at commercial scale. We are continuing to bring the platform that delivers."

Recent Program Updates

We advanced our four-program 212Pb pipeline, expanded our manufacturing network and attracted strong leadership.

Bamzireotide navoxetan (VMT-α-NET) in SSTR2-positive neuroendocrine tumors (NETs) and meningioma: 76 NETs patients across four cohorts and one meningioma patient treated as of July 31. ASCO (Free ASCO Whitepaper) 2026 interim data were consistent with prior findings and showed continued deepening of response. Updated data on NETs patients will be presented at ESMO (Free ESMO Whitepaper) on October 23. By late 2026, all 46 Cohort 2 patients will have had the opportunity for at least 60 weeks of follow-up, which is expected to inform the Phase 3 study design.

Preparing for a Phase 3 study evaluating a proposed cumulative 20 mCi (740 MBq) dose administered in up to four treatments every eight weeks. Additional dose cohorts could provide optionality and opportunity to further define VMT-α-NET’s therapeutic window. Phase 3 site activation targeted around year-end 2026, subject to regulatory feedback and protocol finalization.

Lapemelanotide zapixetar (VMT01) in MC1R-positive melanoma: 27 patients enrolled across multiple dose cohorts either as monotherapy or in combination with the immune checkpoint inhibitor nivolumab as of July 31. We are focused on a cumulative 9 mCi (333 MBq) dose administered in up to three treatments every eight weeks. Seven patients received this treatment regimen as a monotherapy, and six patients received this dose in combination with nivolumab.

Data presented at ASCO (Free ASCO Whitepaper) 2026 showed two partial responses among seven patients treated with 3.0 mCi monotherapy; safety data from 27 patients showed treatment was generally well tolerated. Six nivolumab combination patients are expected to reach at least 24 weeks of follow-up by late 2026.

PSV359 in FAP-α-positive solid tumors: 17 patients treated across three dose cohorts as of July 31. Cohort 3 opened and closed during 2Q 2026. The next clinical update is planned in 2027.

PSV594 in CCK2R-positive solid tumors: Preclinical data and first-in-human biodistribution observations support continued pre-IND development of PSV594.

Manufacturing: We expect the Chicago metro site to complete construction in early 2027, followed by the Los Angeles metro site in 2H 2027, expanding the network to four regional sites by the end of 2027. We believe we have sufficient capacity and isotope access to support ongoing studies and the planned VMT-α-NET Phase 3 study.

Corporate update: In July 2026, we announced that Paul Lyne, Ph.D. was appointed as Chief Science Officer.

Second Quarter 2026 Financial Summary

Cash, cash equivalents, and short-term investments as of June 30, 2026, were approximately $237 million as compared to approximately $145 million as of December 31, 2025. We believe our cash, cash equivalents, and short-term investments are sufficient to fund our current planned clinical milestones and operational investments into late 2027.

Research and development expenses were $21.5 million for the three months ended June 30, 2026, compared to $16.6 million for the three months ended June 30, 2025.

General and administrative expenses were $7.8 million for the three months ended June 30, 2026, compared to $7.7 million for the three months ended June 30, 2025.

Net loss for the three months ended June 30, 2026, was $26.8 million, or $0.22 per basic and diluted share, compared to a net loss of $21.5 million, or $0.29 per basic and diluted share, for the same period in 2025.

(Press release, Perspective Therapeutics, AUG 10, 2026, View Source [SID1234669917])

On August 10, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the second quarter ended June 30, 2026.

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"The first half of 2026 has been marked by transformative milestones toward our vision of creating best-in-class therapies for patients fighting rare, mutationally driven diseases as we submitted three New Drug Applications following positive results from each of the bezuclastinib pivotal trials," said Andrew Robbins, the Company’s President and Chief Executive Officer. "We are excited to welcome the new Cogent customer facing team to the company, and supported by our strong balance sheet, we are well prepared to launch bezuclastinib and advance the standard of care for patients with GIST and Systemic Mastocytosis while continuing to invest in our broader pipeline of precision therapies for genetically defined diseases."

Recent Business Highlights

Cogent Biosciences Integrated Business Team

•
Successfully hired and onboarded all Integrated Business Team members, spanning clinical account managers, patient access navigators and patient educators. Selected for their expertise in commercializing Oncology and Rare Disease products, Cogent now has an exceptional commercial field team in place across the country. Together with our existing medical affairs team, Cogent is well prepared for potential launch with a broad, expert, cross-functional customer-facing organization.

Bezuclastinib in GIST

•
Presented detailed clinical data from the Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib monotherapy in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

o
As of the cutoff date, September 30, 2025, the bezuclastinib combination demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of PFS, reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented ORR in imatinib-resistant/intolerant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. Data for overall survival remains immature.

o
Based on the ongoing patients receiving treatment on the bezuclastinib arm as of March 31, 2026, the mean duration of treatment for the bezuclastinib combination is estimated to be 21.4 months.

•
Announced the initiation of a single-arm, 40 patient extension cohort of the PEAK trial investigating the safety and efficacy of the bezuclastinib combination in first-line GIST patients with KIT exon 9 primary mutations who have received limited or no imatinib treatment. This cohort is designed to prospectively measure ORR and PFS in this patient population, building upon the 25.1 month mPFS reported in a subgroup of 32 patients with detectable exon 9 mutations treated with the bezuclastinib combination in the Phase 3 PEAK trial.

•
Announced FDA acceptance of the New Drug Application (NDA) with priority review for bezuclastinib in combination with sunitinib in patients with GIST who have received prior treatment with imatinib.

Bezuclastinib in Systemic Mastocytosis

•
Announced submission of the NDA for bezuclastinib in Advanced Systemic Mastocytosis (AdvSM).

•
Presented detailed data from the pivotal APEX trial at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress.
o
As of the March 31, 2026 data cutoff, 81 AdvSM patients were treated with 150 mg of bezuclastinib, including 57 patients with SM-AHN, 11 patients with ASM and 13 patients with MCL. The primary endpoint of response per mIWG-MRT-ECNM was assessed on 68 evaluable patients and showed 65% ORR (CR+CRh+PR+CI), including 57% of patients who achieved CR, CRh or PR as best response.

•
Announced completion of enrollment in the "avapritinib switch" SUMMIT extension trial with preliminary results expected by end of 2026.

•
Presented preclinical data from the novel JAK2 V617F program at EHA (Free EHA Whitepaper).
o
The poster highlighted CGT1145, a potent inhibitor of the JAK2 V617F mutation with >100x selectivity over JAK2 WT and the JAK1/3 isoforms, along with high oral bioavailability and low clearance across species. CGT1145 has the potential to eradicate JAK2 V617F myeloproliferative neoplasm propagating cells and induce molecular remission with improved hematologic tolerability.

Anticipated Upcoming Milestones

•
Potential FDA approval of bezuclastinib in GIST – PDUFA date of November 30, 2026
•
Potential FDA approval of bezuclastinib in NonAdvSM – PDUFA date of December 30, 2026
•
Submit Investigational New Drug (IND) applications for CGT1815, Cogent’s novel, selective pan-KRAS(ON) inhibitor, and CGT1145, Cogent’s novel, selective JAK2 V617F inhibitor
•
Complete dose escalation for CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor

Second Quarter 2026 Financial Results

Cash Position: As of June 30, 2026, Cogent had cash, cash equivalents and marketable securities of $792.3 million. The company expects its existing cash, cash equivalents and marketable securities, with the $73.6 million gross proceeds from shares sold through the Company’s at-the-market (ATM) facility after the end of the quarter, will be sufficient to fund its operating expenses and capital expenditure requirements into late 2028, including through potential FDA approvals of bezuclastinib for GIST, NonAdvSM and AdvSM and early commercial launch activities.

R&D Expenses: Research and development expenses were $70.8 million for the second quarter of 2026 as compared to $62.2 million for the second quarter of 2025. The increase was primarily driven by costs to support the SUMMIT, PEAK and APEX clinical programs, regulatory activities associated with potential approvals of bezuclastinib, continued investment in the company’s early-stage research pipeline, and pre-approval manufacturing costs that will be capitalized following anticipated FDA approval.

R&D expenses include non-cash stock compensation expense of $8.6 million for the second quarter of 2026 as compared to $5.0 million for the second quarter of 2025.

G&A Expenses: General and administrative expenses were $31.8 million for the second quarter of 2026 as compared to $13.4 million for the second quarter of 2025. The increase was primarily driven by continued investments in commercial readiness, including personnel and infrastructure to support the anticipated launch of bezuclastinib, as well as overall organizational growth.

G&A expenses include non-cash stock compensation expense of $8.5 million for the second quarter of 2026 as compared to $4.8 million for the second quarter of 2025.

Net Loss: Net loss was $96.4 million for the second quarter of 2026 as compared to a net loss of $73.5 million for the same period of 2025.

(Press release, Cogent Biosciences, AUG 10, 2026, View Source [SID1234669900])