On November 10, 2026 The Board of Directors of Recordati S.p.A. reported the interim financial statements as of September 30, 2026, representing additional voluntary financial reporting(6). The report was prepared using the assessment, measurement and recognition criteria prescribed by international accounting standards (IFRS). The Group’s Interim Report as of September 30, 2026 will be available within the legal deadline at the company’s offices and on the company’s website (www.recordati.com) and can also be viewed on the authorized storage system 1Info (www.1Info.it).

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Rob Koremans, Chief Executive Officer of Recordati, commented: "The performance in the first nine months of 2026 reflects the resilience of our business and the continued successful execution of our strategy. Our Rare Diseases franchise remains a key driver of growth, supported by strong momentum across our portfolio, particularly Isturisa in the U.S., and continued progress in advancing our pipeline. At the same time, our Specialty & Primary Care business continues to demonstrate resilience, supported by the strength of our established brands and disciplined commercial execution. As we approach the end of the year, we remain focused on delivering against our commitments, investing in our future growth opportunities and ensuring that we continue to make a meaningful difference to the lives of patients around the world."

Financial highlights

Consolidated net revenue for the first nine months of 2026 was € 2,103.7 million, up 7.5% or 9.4% on a like-for-like(3) basis at CER (+8.0% excluding Türkiye) versus the first nine months of 2025. This was driven, in particular, by the strong momentum from the Rare Diseases business. The adverse FX impact for the first nine months of 2026 was € 35.6 million (-1.8%), mainly driven by the devaluation of the U.S. dollar and the Turkish lira.

Rare Diseases revenue was € 928.2 million for the first nine months of 2026, up 18.7%, or 21.3% on a like-for-like(3) basis at CER as compared to the first nine months of 2025, driven by strong volume growth across the Endocrinology and Hema-Oncology franchises. The Endocrinology franchise achieved net revenue of € 389.8 million, an increase of 37.5%, reflecting continued growth of Isturisa (€ 285.9 million, +54.8%), driven by strong new patient uptake across geographies, particularly in the U.S., and growth of Signifor (€ 103.9 million, +5.1%). The Hema-Oncology franchise achieved net revenue of € 347.5 million, growing by 15.3%, reflecting the strong momentum of Enjaymo across geographies (€ 135.2 million, +30.0%), as well as growth of Qarziba (€ 125.5 million, +7.3%) and Sylvant (€ 74.4 million, +6.8%). The Metabolic franchise achieved net revenue of € 190.9 million, a decrease of 3.3%, with positive growth in the second and third quarters of 2026, and reflecting phasing of Carbaglu across geographies and positive one-offs in 2025 in France, and slightly lower demand of Panhematin in Brazil against a strong performance in the first nine months of 2025.

Specialty & Primary Care revenue was € 1,135.5 million for the first nine months of 2026, up 0.5% or 1.7% on a like-for-like(3) basis at CER as compared to the first nine months of 2025(7), reflecting continued in-market growth of the promoted portfolio (+8.4%(8)) and some expected one-off headwinds. In particular, the Cardiovascular franchise achieved net revenue of € 311.4 million, an increase of 0.4%, mainly reflecting the loss of the Cardicor license, offset by the growing contribution of Vazkepa and Livazo. The Urology franchise achieved net revenue of € 312.5 million, an increase of 1.0%, driven by the strong performance of Eligard benefiting from a competitor stock-out in Türkiye, as well as by local products, mostly offset by the one-off Tergynan re-launch in Russia in 2025. The Gastrointestinal franchise achieved net revenue of € 196.2 million, an increase of 2.1%, mainly driven by Procto-Glyvenol. The Cough & Cold franchise achieved net revenue of € 82.1 million, a decrease of 8.6% due to a weaker season in key markets.

EBITDA(1) was € 801.1 million for the first nine months of 2026, up 7.7% compared to the first nine months of 2025, with margin of 38.1% of net revenue. Strong revenue performance and the positive mix effect at the gross profit level was partially offset by a higher level of investments to support the U.S. expansion, primarily for Isturisa, the continued development of Enjaymo, ongoing geographic expansion in Rare Diseases as well as the launch of Vazkepa in Specialty & Primary Care.

Adjusted operating income(9) was € 642.2 million in the nine months of 2026, an increase of 8.6% versus the first nine months of 2025. This represents 30.5% of net revenue, compared with 30.2% in the prior year, supported by strong operating performance. Operating income was € 621.2 million in the first nine months of 2026, up 25.1% over the first nine months of 2025, when non-cash charges of € 62.5 million were posted, mainly due to the fair value revaluation of the inventory acquired as part of the acquisition of the Enjaymo rights. Non-recurring costs were € 21.0 million, compared with € 32.0 million in the first nine months of 2025, mainly reflecting the acceleration of the LTI Performance Share Plan triggered by the potential delisting of Recordati.

Financial expenses were € 83.2 million in the first nine months of 2026, up by € 15.9 million compared to the same period of the previous year, mainly due to net exchange rate losses of € 5.3 million as compared to exchange rate gains of € 10.9 million in the first nine months of 2025, with the variance mainly driven by the performance of the U.S. dollar. Lower interest expenses contributed a positive impact of € 2.4 million compared to the same period of the previous year, mainly due to lower net debt, while impact of hyperinflation was negative € 4.3 million compared to € 4.5 million in the first nine months of 2025.

Adjusted net income(2) was € 524.9 million, 25.0% of net revenue, up by 6.4% compared to the same period of 2025, benefitting from higher adjusted operating income, partly offset by higher financial expenses and tax rate. Net income was € 407.1 million, 19.4% of net revenue, an increase of 24.8% versus the prior year, reflecting higher operating income, despite the higher financial expenses and income tax rate versus the first nine months of 2025.

Free cash flow(4) was € 459.8 million for the first nine months of 2026, an increase of € 63.0 million versus the first nine months of 2025, driven primarily by higher EBITDA, while higher income tax paid were offset by a favorable impact of changes in other assets and liabilities.

Net debt(5) as of September 30, 2026 was € 1,697.8 million, or leverage around 1.6x EBITDA, compared to net debt of € 2,037.3 million on December 31, 2025.

Shareholders’ equity was € 2,339.9 million.

Pipeline Development

The osilodrostat (Isturisa) Phase IV study in patients with hypertension caused by hypercortisolemia due to Cushing’s syndrome was initiated in August 2026.

The Phase 2 trial evaluating pasireotide for the treatment of post-bariatric hypoglycemia met its primary endpoint with a dose-dependent and significant increase in glucose levels during a standardized meal test (p<0.02)(10). The Phase 3 development plan is expected to be finalized by the end of 2026.

On the basis of encouraging FDA feedback as well as early clinical evidence showing that sutimlimab, by targeting the classical complement pathway, can lead to a rapid and sustained platelet response in patients with immune thrombocytopenia (ITP) refractory to multiple lines of treatment, Recordati expects to advance sutimlimab into a pivotal registrational Phase 3 trial for the treatment of chronic ITP at the beginning of 2027.

The other lifecycle management programs are progressing in line with plans.

Corporate Development

On January 29, 2026, Recordati announced a collaboration and license agreement with Moderna to develop and commercialize worldwide mRNA-3927, an investigational product for the treatment of propionic acidemia (PA). Under the terms of the agreement, Moderna will continue to lead the development of mRNA-3927, in collaboration with Recordati, and if approved, Recordati will lead global commercialization. mRNA-3927 is a post proof-of-concept, investigational product aimed to restore propionyl-CoA carboxylase (PCC) enzyme activity in patients with propionic acidemia. If approved, this could be the first disease-modifying treatment option on the market for this severe disease. mRNA-3927 is currently being evaluated in a potential registrational clinical study. The target patient enrollment has been reached, with a data readout expected by the end of 2026.

On June 25, 2026, Recordati announced a license agreement with Ionis Pharmaceuticals, Inc. for exclusive development and commercialization rights to zilganersen, an investigational RNA-targeted medicine for the treatment of Alexander disease (AxD), in all countries outside the U.S. Recordati will be responsible for regulatory filings and commercialization outside the U.S., including country-specific support for early access pathways based on local regulations and access dynamics. Ionis will maintain sole commercial responsibility for zilganersen in the U.S. and will continue to lead development globally. Alexander disease is a rare, progressive and often fatal neurological disorder caused by mutations in the GFAP gene. The disease affects astrocytes, critical support cells in the brain, leading to progressive loss of neurological function, including mobility, independence, swallowing and breathing. There are currently no approved disease-modifying therapies for AxD.

Voluntary Tender Offer

On November 9, 2026, the offering period of the voluntary cash tender offer launched on Recordati by CVC Fund IX (through CVC Capital Partners IX Aggregator SCA SICAV-RAIF Sub-Fund 2) and GBL (through its controlled investment vehicle Black Mountain S.à r.l.), through Respighi BidCo S.p.A. (the "Offeror"), ended.

Based on the provisional results, the Offeror holds an aggregate shareholding representing approximately 91.451% of the Company’s share capital (approximately 92% of the Company’s share capital, taking also in account the treasury shares).

Upon confirmation of the provisional results, the Offeror will proceed to the squeeze-out of the remaining 16,881,530 shares, representing approximately 8% of the Company’s share capital, through the joint procedure pursuant to Articles 108, paragraph 2, and 111 of the Legislative Decree no. 58 of 24 February 1998, as subsequently amended and supplemented (the "CFA"), which will result in the delisting of Recordati shares from Euronext Milan. It is reasonable to expect that this procedure will be completed by the end of the month of November.

The final results of the reopening period will be announced by 7:29 a.m. on 16 November 2026, and the consideration for the shares tendered during the reopening period will be paid on 17 November 2026.

For additional information on the provisional results of the Offer following the reopening of the terms please refer to Press Release issued by Respighi BidCo S.p.A. on 9 November 2026 available on Recordati’s website at View Source where further information on the voluntary tender offer is also available.

Management and coordination

The Board of Directors also acknowledged that, following the settlement of the Offer, Recordati S.p.A. has become subject to the management and coordination of Respighi TopCo S.à r.l. pursuant to Articles 2497 et seq. of the Italian Civil Code, replacing Rossini Luxembourg S.à r.l. in such capacity.

Business outlook

The Group confirms its financial targets for full year 2026 as follows and expects to land in the upper end of the guidance ranges:

Net revenue between € 2,730 and € 2,800 million with FX headwind of ~-3.5%
EBITDA(1) between € 995 and € 1,030 million; margin of +/- 36.5% with FX headwind of ~-4.0%
Adjusted net income(2) between € 655 and € 685 million; margin of +/- 24.0%

The full year 2027 targets(11) remain unchanged, with strong organic growth complemented by bolt-on business development and M&A.

Interim dividend 2026
No interim dividend in view of the imminent squeeze-out and delisting

In light of the results of the Offer, the imminent squeeze-out of the minority shareholders and the resulting delisting of the Company’s shares from Euronext Milan, and considering that the Offer price of €53 per share is "cum dividend" (such that any interim dividend paid would be deducted from the Offer price and would therefore have no economic impact on the minority shareholders), the Board of Directors resolved not to approve the distribution of an interim dividend in respect of the 2026 financial year. Accordingly, the payment of the interim dividend indicated in the 2026 corporate events calendar (ex-dividend date 23 November 2026, payment date 25 November 2026) will not occur.

Conference Call

In light of the ongoing voluntary tender offer (VTO) process and Respighi’s current shareholding in Recordati, the Company will not hold a conference call in connection with its first nine months 2026 financial results. The presentation on the first nine months 2026 financial results will be made available at www.recordati.com under Investors/Company Presentations. The Investor Relations team remains available to address any questions through the usual communication channels.

(Press release, Recordati, NOV 10, 2026, View Source [SID1234674570])

On November 10, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO0) (OTCMKTS: RKVTF), a biopharmaceutical company advancing innovative cancer therapies through AI-powered drug discovery, reported that it has entered into a software licence agreement (the "Licence Agreement") with privately held Artemis Therapeutics Inc. ("Artemis") granting Rakovina an exclusive, worldwide and perpetual licence (the "Licence") to use Artemis.AI, Artemis’s artificial intelligence (AI), computational chemistry and machine-learning platform, including its Deep Docking technology, for DNA-damage response (DDR) oncology drug discovery and development.

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The Licence covers the entire DDR oncology field including the targets of Rakovina’s current programs. Rakovina pays for the Licence in two share tranches, with no cash licence fees, royalties or milestone payments, and owns the compounds it discovers.

"This exclusive license for Artemis.AI together with all future platform improvements in the field, creates a durable competitive advantage for Rakovina in the DDR oncology field," said Kim Oishi, Chief Executive Officer of Rakovina Therapeutics. "Just as important are the people behind the platform. Dr. Cherkasov and the Artemis team, led by Frank Holler, have one of the strongest track records in AI-enabled drug discovery, and they will be working alongside Rakovina’s scientists led by Dr. Mads Daugaard. Our team has been further strengthened by the recent appointments of Dr. Ranjit Bindra, Scientific Director of the Yale Brain Tumor Center, to our Scientific Advisory Board and Professor Petra Hamerlik, Chair of Translational Neuro-Oncology at the University of Manchester and former CNS Cancer Bioscience Lead at AstraZeneca, to our Board of Directors. Combining world-class AI with deep DDR biology and rigorous experimental validation is how we intend to turn computational designs into drug candidates ready for pharmaceutical partnership."

"The technology behind Artemis.AI has a proven record. Drug candidates identified with it have been licensed to pharmaceutical companies and advanced into clinical trials, and Dr. Cherkasov’s team has won two international CACHE drug-discovery challenges and this year completed what we believe is the first trillion-molecule virtual screen," said Frank Holler, Executive Chairman and Chief Executive Officer of Artemis. "Our goal in every collaboration is to pair the platform with partners who bring deep knowledge of their targets and the laboratory capability to validate what the AI designs, and to share in the success of the candidates that emerge. Rakovina brings exactly that to DNA-damage response, and our option to co-develop selected candidates gives both companies a path to build value together."

Key Terms of the Licence

Scope. Exclusive, worldwide and perpetual use of the Artemis.AI platform within DDR oncology drug discovery and development, including all updates and platform improvements and any platforms Artemis later licenses or acquires. The platform is hosted on Artemis’s servers, and up to ten hours of expert support per month are included.

Ownership and economics. Rakovina retains its existing compounds and programs, owns the compounds and data it generates with the platform, and may seek patent protection for them. No royalties or milestone payments are payable on drugs Rakovina discovers unless they are subject to a separate co-development agreement. Artemis retains ownership of the platform.

Co-development option. Artemis has a 60-day option to co-develop any platform-derived compound that Rakovina designates for development, on terms that share costs, risks and upside in proportion to each party’s contributions. Compounds Artemis declines, and programs developed without the platform, remain entirely Rakovina’s.

Exclusivity. The Licence may convert to non-exclusive if Rakovina has no active program in the field using the platform for 18 consecutive months and does not start one within 90 days after notice from Artemis.

Consideration. Rakovina will issue to Artemis common shares ("Shares") with an aggregate deemed value of C$1,000,000 in two tranches: (i) 2,500,000 Shares at a deemed price of C$0.20 per Share, within 10 days after TSX Venture Exchange ("TSXV") acceptance; and (ii) C$500,000 of Shares at a deemed price equal to the greater of C$0.265 and the Market Price at issuance (a maximum of 1,886,792 Shares), on the later of the first anniversary of the effective date and TSXV acceptance. The maximum of 4,386,792 Shares represents approximately 9.9% of Rakovina’s currently issued and outstanding shares. No Shares will be issued that would make Artemis a Control Person (as defined in TSXV policies) without prior shareholder approval. The Shares will be subject to a hold period of four months and one day from issuance. No finder’s fees are payable.

The Licence Agreement is effective November 9, 2026. The issuance of Shares is subject to TSXV acceptance; if acceptance is refused and cannot be obtained within 90 days, either party may terminate the Licence Agreement. The Licence does not by itself establish a co-development arrangement for any compound or ensure that drug candidates will be identified, validated or approved.

Related-Party Disclosure

The Licence is a Non-Arm’s Length Party transaction under TSXV policies because Rakovina insiders have interests in Artemis. Frank Holler, a director of Rakovina, is Executive Chairman, Chief Executive Officer and a director of Artemis. Dr. Mads Daugaard, President and Chief Scientific Officer of Rakovina, is a co-founder, director and Chief Scientific Officer of Artemis. Kim Oishi, Chief Executive Officer and a director of Rakovina, is a director of Artemis. In addition, Dr. Artem Cherkasov, co-founder, director and Chief Technology Officer of Artemis, is a member of Rakovina’s Scientific Advisory Board. Yevgeniy Meshcherekov, a director of Rakovina, is a director of Downstream Holdings Ltd., a shareholder of Artemis. Each of Mr. Holler, Dr. Daugaard, Mr. Oishi and Dr. Cherkasov is, directly or indirectly, a significant shareholder of Artemis.

Mr. Holler, Mr. Meshcherekov and Mr. Oishi declared their interests and abstained from voting on the Licence. The Licence was reviewed and approved by the Rakovina directors who are not related parties. In its review, the non-related party directors considered, among other things, a management analysis of the fair value of the Licence prepared using cost, income and market approaches, the terms of the Share consideration, the scope of the field, the co-development option and the exclusivity provisions, and concluded that the terms of the Licence are reasonable and in the best interests of Rakovina. The analysis is a management estimate and not an independent valuation or fairness opinion.

The Licence may constitute a "related party transaction" under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101"). Rakovina is relying on the exemptions from the formal valuation and minority shareholder approval requirements in sections 5.5(a) and 5.7(1)(a) of MI 61-101, as neither the fair market value of the subject matter of, nor the fair market value of the consideration for, the transaction, exceeds 25% of Rakovina’s market capitalization. Rakovina did not file a material change report more than 21 days before entering into the Licence Agreement because the terms were not finalized until shortly before signing. The Licence remains subject to TSXV acceptance.

(Press release, Rakovina Therapeutics, NOV 10, 2026, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-secures-exclusive-worldwide-licence-to-artemis-ai-platform [SID1234674569])

On November 10, 2026 PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, reported financial results for the third quarter ended September 30, 2026, and provided a corporate update.

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"We achieved significant milestones during the third quarter across the organization," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "The updated monotherapy interim data demonstrate the potential for rezatapopt to address a significant unmet medical need. The completed $50 million public offering also positions us well to submit an NDA in the first quarter of 2027 seeking accelerated approval for treatment of platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation."

Corporate Highlights

•
Announced closing of oversubscribed $50 million public offering of securities (the "August 2026 Public Offering"), extending expected cash runway into first quarter of 2028.
•
Provided PYNNACLE Phase 2 Monotherapy Update:
o
Announced enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE clinical trial has been completed.
o
The Company plans to provide an update on all PYNNACLE Phase 2 pivotal trial cohorts, including the primary analysis population data from the ovarian cancer cohort, in a late-breaking oral presentation at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026).
o
Announced updated rezatapopt monotherapy interim ovarian cancer data from PYNNACLE Phase 2 pivotal trial (May 14, 2026 cutoff date).
▪
The efficacy population consisted of 76 patients enrolled as of the data cutoff date who either had ≥1 post-baseline tumor assessment or discontinued early.
▪
Overall response rate (ORR) of 46% (35/76 patients, including four confirmed complete responses, 29 confirmed partial responses [PRs], and two unconfirmed PRs) per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
▪
The median time to response was 1.3 months and median duration of response was 10.0 months, based on confirmed responses only.
▪
Favorable and consistent safety and tolerability profile observed across all cohorts, with mostly Grade 1 and 2 treatment-related adverse events (AEs) observed as well as a low rate (5%) of discontinuation due to treatment-related AEs. The safety and tolerability profile of rezatapopt in the ovarian cancer cohort was similar to the overall population.

•
Appointed Matt Eckler, Ph.D., of Samsara BioCapital to Board of Directors.
•
Appointed Philip Herman as Chief Commercial Officer.

Third Quarter 2026 Financial Results

PMV Pharma ended the third quarter with $108.5 million in cash, cash equivalents, and marketable securities, compared to $112.9 million as of December 31, 2025. Net cash used in operations was $52.4 million for the nine months ended September 30, 2026, compared to $56.4 million for the nine months ended September 30, 2025.

•
Net loss for the quarter ended September 30, 2026, was $34.4 million compared to $21.1 million for the quarter ended September 30, 2025. The net loss increase was primarily due to a $12.8 million non-cash loss from the change in fair value of the common stock warrant liability and $2.3 million of offering costs allocated to the warrant liability, both related to the August 2026 Public Offering, partially offset by decreased contract research organization costs.
•
R&D expenses were $16.1 million for the quarter ended September 30, 2026, compared to $18.2 million for the quarter ended September 30, 2025. The decrease in R&D expenses was primarily due to decreased contract research organization costs for the advancement of the rezatapopt program.
•
General and administrative (G&A) expenses were $4.0 million for the quarter ended September 30, 2026, compared to $4.3 million for the quarter ended September 30, 2025. The decrease in G&A expenses was primarily due to a decrease in finance and legal support costs, partially offset by increased personnel expenses.

About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track Designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C advanced solid tumors, conducted across approximately 70 sites.

For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

(Press release, PMV Pharma, NOV 10, 2026, View Source [SID1234674568])

On November 10, 2026 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported financial and operating results for the third quarter ended September 30, 2026.

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"As we approach top-line data from our pivotal Phase 3 OPERA-01 trial in the first quarter of 2027, we remain confident in palazestrant’s potential to emerge as a differentiated endocrine therapy in second- and third-line metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Turning to our pivotal Phase 3 OPERA-02 trial in first-line metastatic breast cancer, momentum continues to build. Enrollment is accelerating, investigator interest is strong, and patients with frontline disease continue to require better therapeutic options. We believe that palazestrant, in combination with ribociclib, is well positioned to become the new standard of care in this setting. With its dual mechanism of action as a complete estrogen receptor antagonist and selective estrogen receptor degrader, optimal pharmacokinetic properties, encouraging clinical profile demonstrated to date, and potential for use both as a monotherapy and in combination with other agents, we believe palazestrant is uniquely positioned to transform the metastatic breast cancer treatment paradigm."

Bohen continued, "Beyond preparing for the potential approval and commercialization of palazestrant, we remain encouraged by the potential of OP-3136, our novel KAT6 inhibitor, as it advances through clinical development across multiple indications and treatment combinations. We were also pleased to welcome Jason O’Byrne as Chief Financial Officer this quarter. His extensive experience in corporate strategy, capital markets, and financial management and operations will be invaluable as we prepare for key catalysts in 2027 and continue our transformation into a fully integrated oncology company."

Anticipated Upcoming Events

•
Present preclinical data on selective degradation of KAT6A in estrogen receptor-positive breast cancer at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium 2026 on Molecular Targets and Cancer Therapeutics (ENA) in November.
•
Present data from the Phase 1b/2 study of OP-3136 in combination with fulvestrant, the Phase 1b/2 study of palazestrant in combination with everolimus, and the Phase 1b study of palazestrant in combination with atirmociclib, all in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer, at the 2026 San Antonio Breast Cancer Symposium (SABCS) in December.

•
Initiate enrollment in the Phase 1b/2 study evaluating OP-3136 in combination with darolutamide in mCRPC in collaboration with Bayer in the fourth quarter of 2026.
•
Report top-line data from the pivotal Phase 3 OPERA-01 trial in the first quarter of 2027.

Third Quarter 2026 Financial Results

Cash, cash equivalents, and marketable securities as of September 30, 2026, were $413.8 million.

Net loss for the quarter ended September 30, 2026 was $73.6 million, as compared to $42.2 million for the quarter ended September 30, 2025. The increase in net loss for the third quarter was primarily related to increased patient enrollment in our OPERA-01 Phase 3 clinical trial, strong patient enrollment in our OPERA-02 Phase 3 clinical trial, continued advancement of our Phase 1b/2 OP-3136 clinical program, research activities, increased manufacturing and clinical supply activities in support of advancing clinical programs and early preparations for the potential commercialization of palazestrant and higher personnel related costs.

GAAP research and development (R&D) expenses were $67.6 million for the quarter ended September 30, 2026, as compared to $40.0 million for the quarter ended September 30, 2025. The increase in R&D expenses was primarily related to increased spending on the continued enrollment of our pivotal Phase 3 OPERA-01 and OPERA-02 clinical trials for palazestrant, increased manufacturing and clinical supply activities supporting these programs, continued advancement of our Phase 1 OP-3136 clinical program, and higher personnel-related costs to support expanding development activities, including an increase in non-cash stock-based compensation expense of $5.1 million, mainly due to higher grant prices in 2026 and higher headcount.

Non-GAAP R&D expenses were $59.9 million for the quarter ended September 30, 2026, excluding $7.7 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $37.4 million for the quarter ended September 30, 2025, excluding $2.6 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $9.9 million for the quarter ended September 30, 2026, as compared to $5.9 million for the quarter ended September 30, 2025. The increase in G&A expenses primarily reflects continued investment in personnel and corporate infrastructure to support our expanding late-stage clinical development activities, and early preparations for the potential commercialization of palazestrant, including an increase in non-cash stock-based compensation expense of $2.7 million, mainly due to higher grant prices in 2026, and an increase in professional fees of $1.0 million.

Non-GAAP G&A expenses were $5.5 million for the quarter ended September 30, 2026, excluding $4.4 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $4.3 million for the quarter ended September 30, 2025, excluding $1.7 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

(Press release, Olema Oncology, NOV 10, 2026, View Source [SID1234674566])

On November 10, 2026 NextCure, Inc. (Nasdaq: NXTC), reported a business update and announced financial results for the third quarter ended September 30, 2026.

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The Company continues to advance its proposed merger (the "Merger") with Avere Therapeutics, Inc., a privately held biotechnology company focused on oral therapies for IL-23-driven inflammatory diseases ("Avere"), which is now supported by approximately $820 million of committed financing from a syndicate of leading healthcare-focused and institutional investors. The financing is expected to provide substantial capital to support development of Avere’s lead program, AVR-001, other corporate purposes and the future operations of the combined company following completion of the proposed transaction.

"During the third quarter, we continued to execute on the strategic initiatives associated with our proposed merger with Avere Therapeutics," said Michael Richman, President and CEO of NextCure. "Importantly, total financing commitments supporting the proposed transaction increased to approximately $820 million from a syndicate of leading healthcare-focused and institutional investors. We believe this significant financing commitment reflects strong confidence in Avere’s clinical development strategy and the potential of AVR-001, while enhancing the opportunity to create long-term value for NextCure stockholders."

Recent Business Highlights

Proposed Merger with Avere

● Financing commitments supporting the Merger increased to approximately $820 million, consisting of the previously announced $320 million concurrent private placement and an additional $500 million private placement, of which approximately $266 million will be satisfied through the contribution and cancellation of Avere’s outstanding convertible notes.

● The financing is supported by a syndicate of leading healthcare-focused and institutional investors and is expected to provide substantial capital to advance development of AVR-001 and support future operations of the combined company.
● Subject to stockholder approval and other customary closing conditions, the combined company is expected to operate as Avere and trade on the Nasdaq Global Select Market (Nasdaq) under the ticker symbol "AVRX."
● On November 2, 2026, the Delaware Court of Chancery entered a final order validating the Company’s July 2025 reverse stock split amendment and all shares issued in reliance thereon.
● On November 6, 2026, the Registration Statement on Form S-4 relating to the proposed merger was declared effective by the Securities and Exchange Commission ("SEC"). The Company established November 3, 2026 as the record date and scheduled a special meeting of stockholders for December 9, 2026 at 9:00 a.m. Eastern Time to consider and vote upon the proposals necessary to complete the merger.
● Existing NextCure stockholders are expected to retain an ownership interest in the combined company and receive contingent value rights ("CVRs") tied to specified legacy NextCure assets.

LNCB74 Transition and Corporate Restructuring

● In August 2026, NextCure and LigaChem Biosciences, Inc. ("LigaChem") entered into a Transition and Continuation Agreement pursuant to which LigaChem elected to become the sole developing party for the LNCB74 program ("LNCB74") and assumed responsibility for all program costs incurred on or after July 1, 2026, with NextCure providing transition support reimbursed by LigaChem.
● On October 6, 2026, the parties completed the transfer of the LNCB74 investigational new drug application (IND) and related regulatory responsibilities to LigaChem.
● NextCure remains eligible to receive future development, regulatory and commercial milestone payments, as well as royalties on potential future net sales of LNCB74. Subject to the terms of the proposed contingent value rights arrangement, these economic interests are expected to be included in the legacy assets supporting the CVRs to be issued to pre-Merger NextCure stockholders.
● During the third quarter, the Company completed significant restructuring initiatives, including workforce reductions, termination of facility leases and disposition of all laboratory, manufacturing and facility-related assets, resulting in substantial reduction to the Company’s future operating cash requirements.

Strategic Alternatives for Legacy Assets

● The Company completed treatment and transition activities for patients enrolled in the SIM0505 clinical study by August 31, 2026 and continues to evaluate opportunities to partner, license or otherwise monetize rights associated with the program.
● The Company continues to evaluate strategic alternatives to derive value from its legacy asset portfolio for stockholders, including potential licensing, partnering and other opportunities.
Financial Results for the Quarter Ended September 30, 2026

● Cash, cash equivalents, and marketable securities as of September 30, 2026 were $8.7 million, compared to $41.8 million as of December 31, 2025. The decrease of $33.1 million was primarily attributable to cash used to fund operations of $35.2 million, partially offset by $1.2 million of net proceeds from equity sales under the Company’s existing at-the-market (ATM) program and $0.7 million from the sale of fixed assets.
● Research and development expenses were $4.5 million for the three months ended September 30, 2026, compared to $6.1 million for the three months ended September 30, 2025. The decrease of $1.6 million was primarily attributable to lower personnel costs resulting from the Company’s restructuring initiatives, lower laboratory services and supplies costs and lower depreciation expense following the disposition of all the Company’s fixed assets.
● General and administrative expenses were $4.4 million for the three months ended September 30, 2026, compared to $2.8 million for the three months ended September 30, 2025. The increase of $1.6 million was primarily attributable to $1.8 million of higher legal and professional fees incurred in connection with the Merger.
● Restructuring and asset impairment charges, net were ($2.0) million for the three months ended September 30, 2026 and included a gain of $3.4 million on the termination of our leases and a gain of $0.4 million on the sale of fixed assets, partially offset by severance charges of $1.8 million associated with our restructuring initiatives.
● Net loss was $6.8 million for the three months ended September 30, 2026, compared to a net loss of $8.6 million for the three months ended September 30, 2025. The improvement was primarily driven by the lower research and development expenses mentioned above and $2.0 million of gains, net associated with the Company’s restructuring activities, partially offset by the higher general and administrative expenses mentioned above.
About the Merger

On July 14, 2026, NextCure announced a definitive merger agreement with Avere.

On November 2, 2026, the Delaware Court of Chancery entered a final order validating the Company’s July 2025 reverse stock split amendment and all shares issued in reliance thereon.

On November 6, 2026, the Registration Statement on Form S-4 relating to the proposed merger was declared effective by the SEC. NextCure commenced distribution of definitive proxy materials and established November 3, 2026 as the record date for the special meeting of stockholders scheduled for December 9, 2026 at 9:00 a.m. Eastern Time.

Since announcement of the transaction, total financing commitments supporting the Merger have increased to approximately $820 million, consisting of the previously announced $320 million concurrent private placement and an additional $500 million private placement, of which approximately $266 million will be satisfied through the contribution and cancellation of Avere’s outstanding convertible notes. The financing is expected to provide substantial capital to support development of AVR-001 and the future operations of the combined company.

Assuming the Merger is completed, the combined company is expected to operate as Avere and trade on the Nasdaq under the ticker symbol "AVRX." Existing NextCure stockholders are expected to receive contingent value rights related to specified legacy NextCure assets and retain a minority ownership interest in the combined company.

Completion of the Merger remains subject to stockholder approval and other customary closing conditions. NextCure has set a special stockholder meeting date of December 9, 2026 to vote on approval of the various Merger-related items.

(Press release, NextCure, NOV 10, 2026, View Source [SID1234674565])