Paltusotine

Announced Vertex Agreement to Acquire Crinetics for Total Equity Value of Approximately $10.0 Billion, or Approximately $8.8B Net of Estimated Cash Acquired PALSONIFY® (Paltusotine) Net Product Revenue of $24.0 Million for Second-Quarter 2026 SAN DIEGO, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, today reported financial results for the second quarter ended June 30, 2026. Company Announcements and Second Quarter Highlights: ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); On July 6, 2026, Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Crinetics announced that the companies have entered into a definitive agreement under which Vertex will acquire Crinetics for $85.00 per share in cash, for a total equity value of approximately $10.0 billion, or approximately $8.8 billion net of estimated cash acquired. The transaction was unanimously approved by both the Vertex and Crinetics Boards of Directors and is anticipated to close in the third quarter of 2026, subject to customary closing conditions, including receipt of regulatory approvals and approval by Crinetics stockholders. Announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation (RPDD) to atumelnant, a novel, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist investigational candidate in Phase 3 clinical development for the treatment of classic congenital adrenal hyperplasia (CAH) in both pediatric patients and adults. Reported $24.0 million in net product revenue, reflecting the growing adoption of PALSONIFY as the preferred choice for the acromegaly community. Received 245 enrollment forms 1 during the second quarter of 2026. Breadth and depth of PALSONIFY prescribers continued to expand, with 385 unique healthcare providers (HCPs) having prescribed PALSONIFY within the first three quarters of launch. Over 70% of patients treated with PALSONIFY at the end of the second quarter of 2026 were on reimbursed therapy. Second Quarter 2026 Financial Results: Revenue was $25.1 million for the quarter ended June 30, 2026, compared to $1.0 million for the same period in 2025. Revenue for the quarter ended June 30, 2026 includes $24.0 million in net product revenue from the U.S. commercial launch of PALSONIFY, up from $10.3 million in net product revenue reported in the first quarter of 2026. Cost of product revenue was $0.2 million for the quarter ended June 30, 2026, primarily related to distribution, packaging, and fulfillment of PALSONIFY. Research and development expenses were $99.9 million for the quarter ended June 30, 2026, compared to $80.3 million for the same period in 2025, and compared to $100.1 million in the quarter ended March 31, 2026. The increase compared to the prior year period was primarily attributable to increased investment in our clinical programs and an increase in personnel costs. Research and development expenses for the current quarter were generally consistent with the sequential period. Selling, general and administrative expenses were $57.6 million for the quarter ended June 30, 2026, compared to $49.8 million for the same period in 2025, and compared to $50.8 million in the quarter ended March 31, 2026. The increase compared to the prior year period is related to investments in our corporate infrastructure as we transition into a commercial-stage company. The increase compared to the prior quarter reflects timing of commercial investment and costs related to the proposed transaction with Vertex. Net loss was $120.9 million for the quarter ended June 30, 2026, compared to net loss of $115.6 million for the same period in 2025. Cash, cash equivalents, and investment securities totaled $1.2 billion as of June 30, 2026, compared to $1.0 billion as of December 31, 2025. Business Outlook and Conference Call In light of Crinetics’ July 6, 2026 announcement regarding the proposed transaction with Vertex, Crinetics will not be providing updated guidance and is withdrawing its previously issued guidance. In addition, Crinetics will not host an earnings conference call or webcast reporting on its second quarter 2026 results. About Crinetics Pharmaceuticals Crinetics Pharmaceuticals is a global pharmaceutical company committed to transforming the treatment of endocrine diseases and endocrine-related tumors through science rooted in patient needs. Crinetics is focused on discovering, developing, and commercializing novel therapies, with a core expertise in targeting G-protein coupled receptors (GPCRs) with small molecules that have specifically tailored pharmacology and properties. Crinetics’ first commercial product, PALSONIFY™ (paltusotine), is the first once-daily, oral treatment approved by the U.S. FDA and EMA for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics’ deep pipeline of programs includes late-stage investigational candidate atumelnant, which is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, and CRN09682, a nonpeptide drug conjugate candidate that is being developed to treat somatostatin receptor 2 (SST2) expressing neuroendocrine tumors and other SST2 expressing solid tumors. Additional discovery programs are focused on a variety of endocrine targets such as thyroid stimulating hormone (TSH), parathyroid hormone (PTH), somatostatin receptor 3 (SST3), and growth hormone (GH), as well as GPCR-targeted oncology indications. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements related to the expected growth and commercial trajectory of PALSONIFY sales, the expected insurance coverage and reimbursement environment for PALSONIFY, the ability of PALSONIFY to become the preferred choice or the standard of care for acromegaly, statements regarding the plans and timelines for the clinical development of atumelnant and paltusotine for the treatment of carcinoid syndrome; and statements related to Crinetics, Vertex and the transactions (the “Transactions”) contemplated by the Merger Agreement by and among Crinetics, Vertex and Clark Merger Sub Inc. (the “Merger Agreement”). In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “upcoming” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, Crinetics may not be able to obtain, maintain and enforce its patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting clinical studies and preclinical studies, interruptions or additional costs or tariffs imposed on the manufacturing and supply chain, or impairing employee productivity; unexpected adverse side effects, complications and/or drug interactions or inadequate efficacy of Crinetics’ product candidates that may limit their development, regulatory approval and/or commercialization; Crinetics’ dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments or political changes, including policies related to pricing and pharmaceutical drug reimbursement, in the United States and foreign countries; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics’ drug candidates may not advance in development or be approved for marketing; Crinetics may use its capital resources sooner than expected or our cash burn rate may accelerate; any future impacts to our business resulting from geopolitical developments outside our control; the occurrence of any event or circumstance that could give rise to the right of Crinetics or Vertex to terminate the Merger Agreement, including circumstances requiring payment of a termination fee pursuant to the Merger Agreement; failure to obtain applicable regulatory or Crinetics’ stockholder approval in a timely manner or otherwise; the risk that the Transactions may not close in the anticipated timeframe or at all due to one or more of the other closing conditions not being satisfied or waived; the possibility that competing offers will be made; the risk that there may be unexpected costs, charges or expenses resulting from the Transactions; risks related to the ability of the Company and Vertex to successfully integrate the businesses and the possibility that integration may be more difficult, time consuming or costly than expected; the risk that the Transactions disrupt Crinetics’ or Vertex’s current plans and operations; the risk that certain restrictions during the pendency of the proposed transaction may impact Crinetics’ ability to pursue certain business opportunities or strategic transactions; risks related to disruption of each company’s management’s time and attention from ongoing business operations due to the Transactions; the risk that any announcements relating to the Transactions could have adverse effects on the market price of Crinetics’ and/or Vertex’s common stock, credit ratings or operating results; the risk of litigation that could be instituted against the parties or their respective directors, managers or officers and/or regulatory actions related to the Transactions, including the effects of any outcomes related thereto; the effects of the Transactions on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the impact of competitive products and pricing; that Vertex may not realize the potential benefits of the Transactions; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; and actual or contingent liabilities related to the Transactions. Forward-looking statements in this communication should be evaluated together with the many uncertainties that affect Vertex’s and Crinetics’ businesses, particularly those risks listed under the heading “Risk Factors” and the other cautionary factors discussed in the parties’ periodic reports filed with the SEC, including Vertex’s and Crinetics’ annual reports on Form 10-K for the year ended December 31, 2025, and quarterly reports on Form 10-Q and current reports on Form 8-K, all of which are available on the SEC’s website at ). The events and circumstances reflected in Crinetics’ forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. CRINETICS PHARMACEUTICALS, INC. Condensed Consolidated Statements of Operations (In thousands, except per share data) (Unaudited) Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Revenue: Product revenue, net $ 24,038 $ — $ 34,344 $ — Collaboration and license revenue 1,080 1,031 1,508 1,392 Total revenue 25,118 1,031 35,852 1,392 Operating expenses: Cost of product revenue 154 — 354 — Research and development 99,850 80,301 199,931 156,541 Selling, general and administrative 57,573 49,842 108,404 85,368 Total operating expenses 157,577 130,143 308,689 241,909 Loss from operations (132,459 ) (129,112 ) (272,837 ) (240,517 ) Total other income, net 11,604 13,475 24,137 28,106 Net loss $ (120,855 ) $ (115,637 ) $ (248,700 ) $ (212,411 ) Net loss per share — basic and diluted $ (1.14 ) $ (1.23 ) $ (2.37 ) $ (2.27 ) Weighted average shares — basic and diluted 105,560 93,791 104,834 93,448 CRINETICS PHARMACEUTICALS, INC. Condensed Consolidated Balance Sheets (In thousands, except per share data) (Unaudited) June 30, 2026 December 31, 2025 ASSETS CURRENT ASSETS Cash and cash equivalents $ 55,498 $ 101,536 Investment securities, amortized cost of $1,153,283 at June 30, 2026 and $924,317 at December 31, 2025 1,150,275 926,353 Trade accounts receivable, net 11,957 592 Inventory 3,488 2,022 Prepaid expenses and other current assets 23,144 17,839 Total current assets 1,244,362 1,048,342 Property and equipment, net 13,073 14,296 Operating lease right-of-use assets 39,107 40,492 Restricted cash, net of current portion 800 800 Prepaid expenses and other assets, net of current portion 24,541 22,327 TOTAL ASSETS $ 1,321,883 $ 1,126,257 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES Accounts payable and accrued expenses $ 42,439 $ 41,770 Accrued compensation and related expenses 29,222 35,578 Deferred revenue 1,669 1,235 Operating lease liabilities 6,585 6,489 Total current liabilities 79,915 85,072 Operating lease liabilities, non-current 40,606 42,052 Deferred revenue, non-current 3,465 3,810 Other non-current liabilities 5,935 3,240 TOTAL LIABILITIES 129,921 134,174 Commitments and contingencies STOCKHOLDERS’ EQUITY Preferred stock, $0.001 par; 10,000 shares authorized; no shares issued or outstanding at June 30, 2026 or December 31, 2025 — — Common stock and paid-in capital, $0.001 par; 200,000 shares authorized; 105,808 shares issued and outstanding at June 30, 2026; 95,575 shares issued and outstanding at December 31, 2025 2,862,360 2,407,757 Accumulated other comprehensive (loss) income (3,008 ) 1,865 Accumulated deficit (1,666,127 ) (1,417,427 ) Stock held in trust (1,263 ) (112 ) TOTAL STOCKHOLDERS’ EQUITY 1,191,962 992,083 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 1,321,883 $ 1,126,257 Investors: Gayathri Diwakar Head of Investor Relations gdiwakar@crinetics.com (858) 345-6340 Media: Natalie Badillo Head of Corporate Communications nbadillo@crinetics.com (858) 345-6075 ____________________________ 1 An enrollment form is an official document containing both HCP and patient consent, submitted to CrinetiCARE or specialty pharmacies (Orsini or Biologics) to initiate a patient on PALSONIFY. Enrollment forms metric also includes direct dispenses from pituitary treatment centers (PTCs) or community practices to patients.

"*" indicates required fields The third quarter of 2026 has kicked off with 12 major merger and acquisition (M&A) deals and eight licensing agreements in global drug discovery and development in July. Safe to say, interest in small molecules hasn’t waned, and cell and gene therapies and artificial intelligence (AI) continue to pull in investments. Several multibillion-dollar acquisitions took place in July. American biopharma Vertex Pharmaceuticals’ first buyout this year was of Crinetics Pharmaceuticals. It bought the California-based company for $10 billion. Crinetics developed paltusotine, a small molecule for acromegaly, which was approved by the U.S. Food and Drug Administration (FDA) last year. Acromegaly is a rare hormonal disorder caused by excess growth hormone where people have enlarged tissues and organs. Belgian company Argenx has picked up autoimmune therapeutics company Forte Biosciences for $2.2 billion. This gives Argenx control over the Texas based startup’s monoclonal antibody FB102, which is undergoing clinical trials for celiac disease, vitiligo, and alopecia areata, all of which are caused by an overactive immune system. Data from the clinic are expected this year. This broadens Argenx’s own autoimmune therapies pipeline, with Vyvgart having been approved in the U.S. and the European Union for myasthenia gravis. Pharma giant Lilly bought New York-headquartered AtaiBeckley for $3.8 billion last month. AtaiBeckley is developing therapies for mental health conditions like treatment-resistant depression and anxiety disorder. It’s lead candidate mebufotenin benzoate is in phase 2 studies and it works by binding to serotonin in the brain to reset neural circuits and elevate mood to treat depression. Lilly has been on a roll these past few months signing licensing and acquisition deals with biotechs in oncology, neurology, and infectious disease research. Meanwhile, Maryland-based biopharma NextCure has merged with Avere Therapeutics. The latter is developing a small molecule that inhibits the pro-inflammatory protein IL-23 to address inflammatory conditions. This went hand-in-hand with the latter’s $320 million private investment following a licensing deal with Chinese company Hansoh Pharma for up to $2.3 billion. The financial terms of the merger were not disclosed. Moreover, Novartis is acquiring Myricx Bio, an antibody-drug conjugate (ADC) developer situated in London, for up to $1.5 billion. Novartis has expressed that this deal would strengthen its oncology pipeline. Myricx’s two ADCs target B7-H3 and HER2 for solid tumors. This is following the Swiss giant’s purchase of allergy therapies developer Excellergy, announced in March. French company Ipsen has plans to acquire Zurich-based Memo Therapeutics for €200 million ($228 million) upfront, with the opportunity for the latter to score more than €700 million ($798 million) in milestone payments. The Swiss company is holding clinical trials for the antibody potravitug to treat infections caused by BK polyomavirus. United Therapeutics has acquired Massachusetts-based stem cell company Thymmune Therapeutics. Maryland-based United is paying $140 million in cash to Thymmune and up to $160 million in milestone payments by 2031. Thymmune’s lead candidate is a cell therapy for congenital athymia, an ultra-rare condition where children are born without a thymus – an organ that makes immune cells that help fight disease. The candidate is currently in the preclinical stage. California-based Tarsus Pharmaceuticals has shelled out $75 million to eye therapies company iRenix Medical. The latter’s lead candidate is IRX-101, an antiseptic for the eyes. It is designed to reduce post-procedural pain and corneal toxicity in patients who receive intravitreal injections into their eyeballs. The antimicrobial is made of aqueous chlorine dioxide and in phase 2b/3 study. In the clinic, the therapy has helped decrease pain and corneal fluorescein staining – a measure of corneal damage – compared to the antiseptic Betadine. As Tarsus takes over the reins, it could pay up to $490 million in milestone payments. British biotech Scancell and Massachusetts-based Neuphoria Therapeutics have merged and will now operate under the name Scancell. This comes after Neuphoria Therapeutics fended off a hostile takeover and proxy contest from activist investor Lynx1 Master Fund LP after a phase 3 trial fail in treating social anxiety disorder with its lead small molecule soclenicant. On the other hand, Scancell’s focus is on oncology, with its lead antibody drug in phase 2 trials for melanoma. Australian company Dimerix, specializing in inflammatory conditions, has acquired Mission Therapeutics’ phase 2-ready kidney disease asset. MTX652 is a USP30 inhibitor for acute kidney injury, a condition where the kidneys suddenly can’t filter waste products from the blood. The Cambridge-based biotech will rake in up to $292 million in upfront and milestone payments. This gives Mission the financial capacity to develop its phase 1 small molecule MTX325 for Parkinson’s disease. American cancer therapeutics startup Processa Pharmaceuticals has bought Vidya Therapeutics, which is developing a Bruton’s tyrosine kinase (BTK) inhibitor therapy for immune-mediated diseases. Vidya has programs in food allergy, chronic spontaneous urticaria, and multiple sclerosis, all moving to phase 2 soon. The financial terms of the deal were not disclosed. Finally, Massachusetts-based synthetic biology company Synlogic and Caldera Therapeutics have merged after Caldera was launched with $112.5 million in January. The new company will go by Caldera Therapeutics. Its lead asset is a bispecific antibody for inflammatory bowel disease in phase 1 studies. British big pharma AstraZeneca inked two licensing deals in the small molecules sector last month. It has partnered with Chinese company Dizal Pharmaceutical to gain the worldwide rights to develop and commercialise Zegfrovy. The oral tyrosine kinase inhibitor was approved by the FDA to treat non-small cell lung cancer (NSCLC) last year and in China in 2023. The drug targets EGFR mutations. Now, AstraZeneca will market the medicine. It will pay Dizal $600 million upfront and up to $900 million in milestone payments. Its second collaboration in the small molecules field is with Hong Kong-headquartered Sino Biopharmaceutical. The deal is over the PDE3/4 inhibitor, TQC3721, which AstraZeneca will develop and commercialize. Sino Biopharmaceutical will secure $200 million upfront and is eligible to earn up to $1.9 billion in milestone payments. Further, Roche-owned Genentech has called on Cambridge-headquartered Astex Pharmaceuticals to identify small molecules for breast cancer. Once the British pharmaceutical has picked out the potential candidates, Genentech can then take them through preclinical and clinical studies. Astex will obtain $25 million upfront and more than $490 million in preclinical, clinical, regulatory, and sales milestones. Massachusetts-based Sail Biomedicines, which develops in vivo CAR-T treatments, has united with pharma giant Johnson & Johnson to advance cell therapies to address immune-mediated diseases. Sail will grab $785 million and up to $140 million in milestone payments. Sail’s eRNA and nanoparticle platform will be employed to create these new therapies. The pharma giant has also secured the option to acquire Sail for another $2.58 billion. This is after the American giant tapped Firefly Bio to develop degrader antibody conjugates for solid tumors back in June. AstraZeneca’s third alliance in drug development was with CSPC Pharmaceutical to co-develop small interfering RNA (siRNA) drugs for kidney diseases from two undisclosed targets. The latter’s drug discovery platform and extrahepatic targeted delivery platform will be put to use, and AstraZeneca has procured the options to license the preclinical candidates globally except in China. AstraZeneca has been teaming up with biotechs located in China this year, having signed another pact with CSPC Pharmaceutical earlier this year in weight loss. Meanwhile, Massachusetts-based Spero Therapeutics is allying with Jiangsu-based Innovent Biologics to develop, research, manufacture, and commercialize the latter’s monoclonal antibody IBI355 globally excluding in China. Spero will take IBI355 to phase 2 trials in the U.S., and Innovent will do the same in China for Sjögren’s disease next year. Sjögren’s disease is an autoimmune disorder that attacks the glands that make tears and saliva. Innovent can gather up to $1.1 billion in development, regulatory, and commercial milestone payments, aside from an undisclosed upfront amount. German pharmaceutical Boehringer Ingelheim is joining forces with German biotech Prime Vector Technologies to bring cancer vaccines to the market. The Tübingen-based startup’s Orf virus (ORFV) platform will be employed to design these vaccines. The financial terms of the deal were not revealed. Boehringer has been penning licensing deals in various therapeutics areas this year, including oncology, immunology, and metabolic disease. Finally, Japanese pharma giant has knocked on Massachusetts-based Insilico Medicine’s door to use the latter’s Pharma.AI platform to advance drug candidates across therapeutic areas. This is part of Takeda’s move towards integrating automation, robotics, and AI in its drug discovery and development process. Insilico will shovel in $60 million in project initiation fees, near-term payments, and milestones, as part of a total of up to $600 million in preclinical, clinical, commercial, and sales milestone payments. How Chiesi partners with early-stage science, and how to get on their radar