-Positive Phase 1 data for CTX310® presented in a late-breaking presentation at the American Heart Association (AHA) Scientific Sessions and simultaneously published in The New England Journal of Medicine- -CASGEVY® momentum accelerating; nearly 300 patients have been referred to Authorized Treatment Centers (ATCs), approximately 165 patients have completed their first cell collection and 39 have received infusions across all regions; Vertex expects clear line of sight to over $100 million in total CASGEVY revenue this year and significant growth expected in 2026- -Pediatric development of exa-cel is advancing in SCD and TDT, with enrollment in two global Phase 3 studies completed; initial data will be presented at the upcoming American Society of Hematology (ASH) annual meeting- -Clinical trials ongoing for CTX112™, targeting CD19, across multiple indications; broad updates for CTX112 in autoimmune disease and oncology expected by year-end- -Preclinical data for CTX460™, presented at the European Society of Gene and Cell Therapy (ESGCT) annual congress, demonstrated in vivo gene correction of alpha-1 antitrypsin deficiency (AATD) with a potential best-in-class profile; clinical trial initiation planned for mid-2026- -Phase 2 clinical trial ongoing for SRSD107, targeting Factor XI for the prevention of thromboembolic disorders; first patient dosed and trial expanded to additional sites in Europe- -Strong balance sheet with approximately $1.9 billion in cash, cash equivalents, and marketable securities as of September 30, 2025- ZUG, Switzerland and BOSTON, Nov. 10, 2025 (GLOBE NEWSWIRE) — CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today reported financial results for the third quarter ended September 30, 2025. “This has been another strong quarter of execution and progress across our portfolio,” said Samarth Kulkarni, Ph.D., Chairman and Chief Executive Officer of CRISPR Therapeutics. “CASGEVY® momentum continues to build globally, reflecting growing patient engagement and clinical advancement. Enrollment has been completed in two global Phase 3 pediatric studies, and dosing is on track to complete this quarter. Additionally, positive Phase 1 data for CTX310® presented in a late-breaking presentation at the American Heart Association Scientific Sessions and published in The New England Journal of Medicine, highlight the breadth and potential of our platform to address serious cardiovascular disease. We continue to advance our broader pipeline, including dosing the first patient in the Phase 2 clinical trial of SRSD107 and unveiling our novel SyNTase™ editing platform with CTX460™, highlighting continued innovation and expansion of our therapeutic toolkit. With strong execution and growing momentum across our programs, CRISPR Therapeutics is well positioned to lead the next wave of gene editing innovation and deliver potentially transformative therapies to patients.” Recent Highlights and Outlook Hemoglobinopathies and CASGEVY® (exagamglogene autotemcel [exa-cel]) CASGEVY is a non-viral, ex vivo, CRISPR/Cas9 gene-edited cell therapy for eligible patients with sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT), designed to eliminate both vaso-occlusive crises (VOCs) and transfusion requirements. CASGEVY is approved in the U.S., Great Britain, the EU, the Kingdom of Saudi Arabia (KSA), the Kingdom of Bahrain (Bahrain), Qatar, Canada, Switzerland and the United Arab Emirates (UAE) for the treatment of both SCD and TDT. Across these markets, there are more than 60,000 eligible patients in these countries, including approximately 37,000 in North America and Europe and more than 23,000 in the Middle East. With a well-established treatment pathway and a growing number of patients progressing through each stage, CASGEVY has strong momentum heading into late 2025 and beyond. In September, a reimbursement agreement was reached in Italy for patients with SCD and TDT. Italy represents the largest population of individuals with TDT in Europe, with approximately 5,000 people aged 12 years and older with TDT and approximately 2,300 with SCD.Globally, since launch through September 30th, 2025, approximately 165 patients with SCD or TDT have completed their first cell collection, including 50 people in the third quarter. 39 patients have received infusions of CASGEVY, including 10 infused in the third quarter of 2025. Nearly 300 patients have been referred by their physicians to an authorized treatment center (ATC) to begin the treatment process. This includes 110 cell collections in the first nine months of 2025, double the total for all of 2024. Enrollment of children 5 to 11 years of age with SCD or TDT in two global Phase 3 studies of CASGEVY has been completed, and dosing is expected to be completed this quarter. Initial data from these studies will be presented at the American Society of Hematology (ASH) annual meeting on December 6th, 2025.The number of ATCs initiating patients continues to increase in the U.S., Europe, and the Middle East. Through the end of September, 25 ATCs had initiated more than 5 patients, with at least one ATC in each region initiating 20 or more patients.Momentum continues to build through the final months of 2025. With continued uptake and reimbursement progress across major regions, Vertex expects a clear line of sight to over $100 million in total CASGEVY revenue this year with significant growth expected in 2026. In Vivo Liver Editing CRISPR Therapeutics is advancing a pipeline of in vivo gene editing candidates addressing major unmet needs in cardiovascular, metabolic and rare diseases using its proprietary, de-risked lipid nanoparticle (LNP) delivery platform.CTX310®, targeting ANGPTL3, is in an ongoing Phase 1 clinical trial in patients with homozygous familial hypercholesterolemia (HoFH), severe hypertriglyceridemia (SHTG), heterozygous familial hypercholesterolemia (HeFH), or mixed dyslipidemias. Phase 1 data were presented in a late-breaking session at the American Heart Association (AHA) Scientific Sessions and published simultaneously in The New England Journal of Medicine (NEJM). Results from the Phase 1 clinical trial highlight the potential of CTX310 to safely and durably lower both triglycerides (TG) and low-density lipoprotein (LDL) following a single-course IV administration. CRISPR Therapeutics is advancing CTX310 into Phase 1b clinical trials, prioritizing development in sHTG and mixed dyslipidemia.CTX320™ is in an ongoing Phase 1 clinical trial targeting the LPA gene in patients with elevated lipoprotein(a) [Lp(a)], a genetically determined risk factor associated with an increased incidence of major adverse cardiovascular events (MACE). Elevated Lp(a) levels affect up to 20% of the global population and remain unaddressed by current therapies. The Company plans to provide an update in the first half of 2026.CRISPR Therapeutics continues to advance its preclinical in vivo programs: CTX460™, targeting SERPINA1 for the treatment of alpha-1 antitrypsin deficiency (AATD); CTX340™, targeting AGT for the treatment of refractory hypertension; and CTX450™, targeting ALAS1 for the treatment of acute hepatic porphyria (AHP). CTX460 is the first investigational candidate using the Company’s novel SyNTase editing platform, unveiled in October. SyNTase is designed to enable precise, in vivo gene correction, and represents an important expansion of CRISPR Therapeutics’ toolkit. Preclinical data presented at the European Society of Gene and Cell Therapy (ESGCT) Annual Congress demonstrated >90% mRNA correction, a 5-fold increase in total AAT levels, and >99% serum M-AAT:Z-AAT ratio in AATD disease models. These findings provide preclinical proof-of-concept for precise, single-dose in vivo gene correction using the SyNTase editing platform and support the potential best-in-class profile of CTX460. CRISPR Therapeutics expects to initiate a clinical trial of CTX460 in mid-2026.Preclinical data from CTX340 were presented in a late-breaking poster presentation at the American Heart Association (AHA) Scientific Sessions. In a spontaneous hypertensive rat model, CTX340 showed >70% liver editing and mean arterial pressure reduction of 53 mmHg compared to vehicle that was durable throughout the study (~8.5 months). Furthermore, in non-human primates, CTX340 showed greater than 90% AGT reduction with a two-dose regimen showing the additive effects of repeat dosing and enabling dose titration. CTX340 was well tolerated with no hypotension or hypokalemia observed. CTX340 is currently in IND/CTA-enabling studies. Autoimmune Disease and Immuno-Oncology CTX112™, targeting CD19, is being developed for autoimmune disease and hematologic malignancies and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma. A Phase 1 clinical trial in autoimmune disease is underway in systemic lupus erythematosus (SLE), systemic sclerosis and inflammatory myositis. In parallel, a Phase 1 clinical trial of CTX112 in relapsed or refractory B-cell malignancies is ongoing. The Company plans to provide a broad update on CTX112 by year-end. CTX131™, targeting CD70, was previously in development for both solid tumors and hematologic malignancies. While the Phase 1 data are encouraging, the Company has strategically redirected resources away from this program to advance other programs with the greatest potential for long-term value creation.CRISPR Therapeutics is leveraging its expertise and proprietary lipid nanoparticle (LNP) delivery platform, mRNA, and conjugation capabilities to advance an in vivo CAR T platform with the ability to address autoimmune disease and oncology.CRISPR Therapeutics’ autoimmune disease and immuno-oncology programs are supported by a wholly-owned, GMP manufacturing facility located in Framingham, Massachusetts, which provides end-to-end production capabilities for its cell therapy portfolio and supports both clinical and future commercial supply. siRNA In September, CRISPR Therapeutics and its partner Sirius Therapeutics announced that the first patient was dosed in Europe in the Phase 2 clinical trial of SRSD107, a long-acting Factor XI (FXI) small interfering RNA (siRNA) for thromboembolic disorders. The trial is evaluating the safety and efficacy of SRSD107 in preventing venous thromboembolism (VTE) following total knee arthroplasty (TKA) and will inform dose selection for future pivotal trials. SRSD107 has the potential to be a best-in-class FXI inhibitor, showing deep reductions in FXI via semi-annual subcutaneous injection. SRSD107 is being co-developed by CRISPR Therapeutics and Sirius Therapeutics as part of a broader strategic collaboration to advance RNA-based medicines.CRISPR Therapeutics and Sirius Therapeutics have expanded the Phase 2 clinical trial with additional centers in Europe. SRSD107 is being developed for a range of thromboembolic and clotting-related indications, including arterial fibrillation (AF), cancer-associated thrombosis (CAT), chronic kidney disease (CKD), peripheral vascular disease (PVD), chronic coronary artery disease (CAD), ischemic stroke and VTE. Regenerative Medicine CRISPR Therapeutics continues to advance its regenerative medicine efforts for Type 1 diabetes (T1D). Beyond CTX211™, the Company is developing next-generation programs that leverage induced pluripotent stem cell (iPSC) derived, allogeneic, gene-edited, beta islet cell precursors. These approaches aim to achieve insulin independence in T1D patients without requiring chronic immunosuppression. The Company expects to provide an update this year. Upcoming Events The Company will participate in the following events in November: Guggenheim 2nd Annual Healthcare Innovation ConferenceDate: Wednesday, November 12, 2025Time: 11:30 a.m. ET Jefferies Global Healthcare ConferenceDate: Wednesday, November 19, 2025Time: 1:00 p.m. GMT Third Quarter 2025 Financial Results Cash Position: Cash, cash equivalents, and marketable securities were $1,944.1 million as of September 30, 2025, compared to $1,903.8 million as of December 31, 2024. The increase in cash was primarily driven by proceeds from the issuance of common shares, option exercise activity and interest income, offset by operating expenses, as well as the $25.0 million upfront cash payment made as part of the Sirius Agreement. R&D Expenses: R&D expenses were $58.9 million for the third quarter of 2025, compared to $82.2 million for the third quarter of 2024. The decrease in R&D expense was primarily driven by a decrease in variable external research and manufacturing costs, as well as a decrease in employee-related expenses, including stock-based compensation expenses.G&A Expenses: General and administrative expenses were $16.9 million for the third quarter of 2025, compared to $17.4 million for the third quarter of 2024.Collaboration Expense: Collaboration expense, net, was $57.1 million for the third quarter of 2025, compared to $11.2 million for the third quarter of 2024. In the third quarter of 2024, we exercised our option to defer specified costs under the CASGEVY program in excess of the deferral limit of $110.3 million under the A&R Vertex JDCA, as amended. The increase in collaboration expense, net, was primarily attributable to the timing of when we reached the deferral limit in 2024, as no such limit was applicable in 2025.Net Loss: Net loss was $106.4 million for the third quarter of 2025, compared to a net loss of $85.9 million for the third quarter of 2024. About CASGEVY® (exagamglogene autotemcel [exa-cel])CASGEVY® is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT, in which a patient’s own hematopoietic stem and progenitor cells are edited at the erythroid specific enhancer region of the BCL11A gene. This edit results in the production of high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygen-carrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. CASGEVY has been shown to reduce or eliminate VOCs for patients with SCD and transfusion requirements for patients with TDT. CASGEVY is approved for eligible SCD and TDT patients 12 years and older by multiple regulatory bodies around the world. About the CRISPR Therapeutics – Vertex Collaboration for CASGEVY CRISPR Therapeutics and Vertex established a strategic research collaboration in 2015 to discover and develop therapies using CRISPR/Cas9 technology to address the underlying genetic causes of human disease. CASGEVY is the first approved therapy to emerge from this collaboration. Under an amended collaboration agreement, Vertex leads global development, manufacturing, and commercialization of CASGEVY and shares program costs and profits worldwide 60/40 with CRISPR Therapeutics. Vertex is the manufacturer and exclusive license holder of CASGEVY. About CTX112 CTX112 is a wholly-owned, allogeneic chimeric antigen receptor (CAR) T cell therapy product candidate targeting Cluster of Differentiation 19 (CD19), in development for both autoimmune and immuno-oncology indications. CTX112 is being investigated in ongoing clinical trials in adult patients with systemic lupus erythematosus, systemic sclerosis, and inflammatory myositis and in adult patients with relapsed or refractory B-cell malignancies. About In Vivo ProgramsCRISPR Therapeutics has established a proprietary lipid nanoparticle (LNP) delivery platform to enable gene editing in the liver using both CRISPR/Cas9 and its novel, proprietary SyNTase™ editing technologies. The Company’s in vivo portfolio includes its lead investigational programs, CTX310 (directed towards angiopoietin-related protein 3 (ANGPTL3)) and CTX320 (directed towards LPA, the gene encoding apolipoprotein(a) (apo(a)), a major component of lipoprotein(a) [Lp(a)]). Both are validated therapeutic targets for cardiovascular disease. CTX310 and CTX320 are in ongoing clinical trials in patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, mixed dyslipidemias, or severe hypertriglyceridemia, and in patients with elevated lipoprotein(a), respectively. In addition, the Company’s research and preclinical development candidates include: CTX460™, targeting SERPINA1 for the treatment of alpha-1 antitrypsin deficiency (AATD); CTX340™, targeting AGT for the treatment of refractory hypertension; and CTX450™, targeting ALAS1 for the treatment of acute hepatic porphyria (AHP). About SRSD107SRSD107 is a novel double-stranded small interfering ribonucleic acid (siRNA). SRSD107 specifically targets the human coagulation factor XI (FXI) mRNA and inhibits FXI protein expression, thereby blocking the intrinsic coagulation pathway and promoting anticoagulant/anti-thrombotic effects. SRSD107 is being co-developed by CRISPR Therapeutics and Sirius Therapeutics as part of a strategic collaboration to advance innovative treatments for cardiovascular and clotting-related diseases. About the CRISPR Therapeutics and Sirius Therapeutics CollaborationCRISPR Therapeutics and Sirius Therapeutics entered into a strategic collaboration in 2025 to develop and commercialize novel small interfering RNA (siRNA) therapies for thromboembolic disorders and other serious diseases. The lead program, SRSD107, is a long-acting siRNA targeting Factor XI (FXI) with the potential to offer best-in-class efficacy and safety. Under the agreement, the companies will co-develop SRSD107 and share costs and profits equally. CRISPR Therapeutics will lead commercialization in the U.S., while Sirius will lead in Greater China. The collaboration also provides CRISPR Therapeutics with the option to license up to two additional siRNA programs. This partnership expands CRISPR Therapeutics’ therapeutic portfolio into RNA-based medicines, complementing its ongoing efforts in gene editing and broadening its impact across serious and chronic diseases. For Sirius, the collaboration marks a major milestone in its mission to deliver innovative RNA-based therapies globally, leveraging deep expertise in siRNA design and delivery. About CTX211 CTX211 is an allogeneic, gene-edited, stem cell-derived investigational therapy for the treatment of type 1 diabetes (T1D), which incorporates gene edits that aim to make cells hypoimmune and enhance cell fitness. This immune-evasive cell replacement therapy is designed to enable patients to produce their own insulin in response to glucose. About CRISPR Therapeutics Founded over a decade ago, CRISPR Therapeutics is a leading gene editing company focused on developing transformative medicines for serious diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, oncology, regenerative medicine, cardiovascular and autoimmune, and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. To learn more, visit www.crisprtx.com.CRISPR THERAPEUTICS® standard character mark and design logo, SyNTase™, CTX112™, CTX131™, CTX211™, CTX310®, CTX320™, CTX340™, CTX450™ and CTX460™ are trademarks and registered trademarks of CRISPR Therapeutics AG. CASGEVY® and the CASGEVY logo are registered trademarks of Vertex Pharmaceuticals Incorporated. All other trademarks and registered trademarks are the property of their respective owners. CRISPR Special Note Regarding Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements made by Dr. Kulkarni in this press release, as well as regarding any or all of the following: (i) CRISPR Therapeutics preclinical studies, clinical trials and pipeline products and programs, including, without limitation, manufacturing capabilities, status of such studies and trials, potential expansion into new indications and expectations regarding data, safety and efficacy generally; (ii) data included in this press release, as well as the ability to use data from ongoing and planned clinical trials for the design and initiation of further clinical trials; (iii) CRISPR Therapeutics strategy, goals, anticipated financial performance and the sufficiency of its cash resources; (iv) plans and expectations for the commercialization of, and anticipated benefits of, CASGEVY, including anticipated patient access to CASGEVY; (v) regulatory submissions and authorizations, including timelines for and expectations regarding additional regulatory agency decisions; (vi) the expected benefits of its collaborations; and (vii) the therapeutic value, development, and commercial potential of gene editing technologies and therapies, including CRISPR/Cas9 and SyNTase, as well as other technologies. Risks that contribute to the uncertain nature of the forward-looking statements include, without limitation, the risks and uncertainties discussed under the heading “Risk Factors” in its most recent annual report on Form 10-K and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. We disclaim any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law. This press release also contains information regarding our industry, our business and the markets for certain of our product candidates, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Unless otherwise expressly stated, we obtained this industry, business, market and other data from market research firms and other third parties, including medical publications, government data and similar sources. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. This press release discusses investigational therapies and is not intended to convey conclusions about efficacy or safety as to those investigational therapies or uses of such investigational therapies. There is no guarantee that any investigational therapy will successfully complete clinical development or gain approval from applicable regulatory authorities. Investor Contact: +1-617-307-7503 ir@crisprtx.com Media Contact: +1-617-315-4493 media@crisprtx.com CRISPR Therapeutics AG Condensed Consolidated Statements of Operations (Unaudited, In thousands except share data and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Revenue: Collaboration revenue $— $— $— $— Grant revenue 889 602 2,646 1,623 Total revenue $889 602 $2,646 $1,623 Operating expenses: Research and development 58,902 82,160 201,280 238,498 Acquired in-process research and development — — 96,253 — General and administrative 16,931 17,419 55,143 54,853 Collaboration expense, net 57,115 11,153 159,777 110,250 Total operating expenses 132,948 110,732 512,453 403,601 Loss from operations (132,059) (110,130) (509,807) (401,978)Total other income, net 26,237 25,064 61,841 75,924 Net loss before income taxes (105,822) (85,066) (447,966) (326,054)Provision for income taxes (619) (876) (3,020) (2,887)Net loss (106,441) (85,942) (450,986) (328,941)Foreign currency translation adjustment (28) 76 94 66 Unrealized gain on marketable securities 973 13,368 3,052 8,586 Comprehensive loss $(105,496) $(72,498) $(447,840) $(320,289)Net loss per common share — basic $(1.17) $(1.01) $(5.12) $(3.92)Basic weighted-average common shares outstanding 91,305,337 85,234,926 88,124,241 83,988,063 Net loss per common share — diluted $(1.17) $(1.01) $(5.12) $(3.92)Diluted weighted-average common shares outstanding 91,305,337 85,234,926 88,124,241 83,988,063 CRISPR Therapeutics AGCondensed Consolidated Balance Sheets Data(Unaudited, in thousands) As of September 30, 2025 December 31, 2024 Cash and cash equivalents $286,497 $298,257 Marketable securities 1,629,213 1,605,569 Marketable securities, non-current 28,412 — Working capital 1,810,135 1,849,350 Total assets 2,245,308 2,242,034 Total shareholders’ equity 1,915,982 1,932,080
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Edgewise Therapeutics Announces Appointment of Michael Nofi as Chief Financial Officer, and the Retirement of Current CFO, R. Michael Carruthers
BOULDER, Colo., Nov. 10, 2025 /PRNewswire/ — Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions, today announced the appointment of Michael Nofi, as Chief…
Elutia Reports Third Quarter 2025 Financial Results; Closes $88 Million Sale of BioEnvelope Business to Boston Scientific Corporation; Funds NXT-41x Development
– Rapidly advancing NXT-41x to address significant unmet medical need for plastic and reconstructive surgery, which represents an estimated $1.5 billion U.S. market opportunity Conference call today at 5:00 p.m. ET / 2:00 p.m. PT GAITHERSBURG, Md., Nov. 06, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today provided a business update and financial results for the third quarter of 2025. Business Highlights: BioEnvelope Business Sold to Boston Scientific Corporation for $88 Million: Transaction closed October 1, 2025, with proceeds used to eliminate debt and fund NXT-41x development program.Advancing Next-Generation Antibiotic-Eluting Biomatrix for Plastic and Reconstructive Surgery: Leveraging its proven drug-eluting biologics platform, Elutia is progressing NXT-41x, a biomatrix that addresses infections and associated complications following mastectomy in the 1.5 billion U.S. market. FDA clearance of the base matrix anticipated in 2H26 and drug-eluting version anticipated in 1H27.Addressing Significant Problem with Serious Unmet Need: With one in three patients facing serious complications from breast reconstruction, combined with the high cost of treatment, Elutia is harnessing its drug-eluting platform solution to attack the most prevalent cause of implant failure.Strengthened Balance Sheet: Completed sale of the BioEnvelope business provides capital to fully fund development and launch of NXT-41x platform without the need for shareholder dilution.Medtech Leader Joins Board: Guido J. Neels, Operating Partner at EW Healthcare Partners and former Chief Operating Officer of Guidant Corporation, appointed to the Company’s Board of Directors.Scientific Evidence: Data published in Frontiers in Cardiovascular Medicine show that drug-eluting biologic materials support healthy, vascularized tissue regeneration while providing local drug delivery, demonstrating the platform’s potential for surgical applications.Legacy Litigation Substantially Resolved: Settled an additional seven FiberCel cases, leaving only six cases unresolved and significantly reducing expected litigation expenses going forward. “Behind every breast reconstruction is a woman overcoming cancer,” said Dr. Randy Mills, Chief Executive Officer of Elutia. “Incredibly, infection remains one of the biggest barriers to recovery, impacting 15–20% of reconstruction cases. Our antibiotic-eluting technology is designed to prevent infection from occurring in the first place. The Elutia CRU is laser-focused on this goal, fully resourced, and moving fast to deliver a game-changing solution that helps women everywhere thrive without compromise.” Third Quarter 2025 Financial Results For the three-month period ended September 30, 2025, as compared to the same period of 2024: Overall net sales were $3.3 million, compared to $3.7 million in Q3 2024. Net sales in both periods exclude contributions from the BioEnvelope business.Net sales of SimpliDerm were $2.4 million, compared to $3.1 million in Q3 2024.Net sales of Cardiovascular products were $0.9 million, compared to $0.6 million in Q3 2024.Gross margin on a GAAP basis was 55.8%, compared to 48.9%Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 63.9%, compared to 56.3%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.Total operating expenses were $7.1 million, compared to $11.0 million.Loss from operations was $5.2 million, compared to $9.2 million.Net loss from continuing operations was $0.4 million, compared to net income of $3.3 million.Net loss from discontinued operations was $3.5 million, compared to net loss of $2.1 million.Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain non-operating, non-cash and non-recurring items) was a loss of $2.7 million, approximately the same compared to the year ago period. A reconciliation of net loss to adjusted EBITDA is included in the accompanying financial tables.Cash balance as of September 30, 2025, was $4.7 million. On October 1, 2025, Elutia received $80.3 million in connection with the closing of the BioEnvelope business divestiture to Boston Scientific Corporation. Approximately $27.8 million of the proceeds were used at closing to pay in full and terminate Elutia’s loan facility with SWK Funding, LLC. Additionally, $8 million is held in escrow for a period of twelve months as a customary indemnity holdback. Conference Call Elutia will host a conference call today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its third quarter 2025 financial results and performance. The conference call can be accessed using the following information: Webcast: Click hereDial-In: Click here To receive the dial-in number, as well as your personalized PIN, you must register at the above link. Once registered, you will also have the option to have the system dial-out to you once the conference call begins. If you forget your PIN prior to the conference call, you can simply re-register. Please log in approximately 10 minutes prior to the scheduled start time. A live and archived webcast of the event will be available on the “Investors” section of the Elutia website at http://investors.elutia.com/. About ElutiaElutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Non-GAAP Disclosure In addition to the Company’s financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it determines to be useful in evaluating its operating performance and liquidity. The Company presents in this press release the following non-GAAP financial measures: earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted earnings before interest, taxes, depreciation and amortization (“adjusted EBITDA”), adjusted gross margin and adjusted gross profit. The Company defines EBITDA as GAAP net loss excluding interest expense, income tax expense, depreciation and amortization, and the Company defines adjusted EBITDA as EBITDA excluding loss from discontinued operations, stock-based compensation, FiberCel and VBM litigation costs, loss or gain on revaluation of warrant liability, warrant issuance expenses and loss or gain on revaluation of revenue interest obligation. The Company defines adjusted gross profit and adjusted gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For a reconciliation of these non-GAAP measures to GAAP, see below “Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA” and “Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin.” 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. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning our future interactions with the U.S. Food and Drug Administration (“FDA”) regarding NXT-41x; expectations for FDA clearance of NXT-41x, including the timing and anticipated success thereof; preparations for the launch of NXT-41x, including the timing and anticipated success thereof; , the size of the breast reduction market and the potential of the Company’s next-generation drug-eluting biomatrix pipeline to compete in that market, expectations for future sales growth and cash flow gains for ProxiCor, Tyke, and VasCure, and any statements regarding future liability with respect to the FiberCel litigation. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings, including NXT-41 and NXT-41x; our ability to obtain regulatory approval or other marketing authorizations by the U.S. Food and Drug Administration and comparable foreign authorities for our products and product candidates, including NXT-41 and NXT-41x; our ability to achieve or sustain profitability; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits related to FiberCel and other bone viable matrix products and avoid a material adverse financial consequence; our ability to raise funds in the future in the amounts and at the times needed; the continued and future acceptance of our products by the medical community; our dependence on independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the October 2025 sale of our CIED business and the November 2024 sale of Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; our ability to obtain, maintain and adequately protect our intellectual property rights.; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com ELUTIA INC.CONSOLIDATED BALANCE SHEET DATA(Unaudited, in thousands) AssetsSeptember 30, 2025 December 31, 2024 Current assets: Cash and cash equivalents$4,721 $13,239 Accounts receivable, net 3,553 2,276 Inventory 2,011 1,931 Insurance receivables of litigation costs 4,561 4,760 Prepaid expense and other current assets 539 1,986 Current assets of discontinued operations 2,993 1,980 Total current assets 18,378 26,172 Property and equipment, net 2,054 671 Intangible assets, net 1,800 2,600 Operating lease right-of-use assets, and other 2,565 179 Noncurrent assets of discontinued operations 4,610 6,505 Total assets$29,407 $36,127 Liabilities and Stockholders’ Deficit Current liabilities: Accounts payable and accrued expenses and other current liabilities$13,872 $11,253 Current portion of long-term debt 5,000 1,250 Current portion of revenue interest obligation 5,500 4,400 Contingent liability for legal proceedings 16,383 20,432 Current operating lease liabilities 222 144 Current liabilities of discontinued operations 357 316 Total current liabilities 41,334 37,795 Long-term debt 21,103 22,603 Long-term revenue interest obligation 3,910 5,490 Warrant liability 4,030 16,076 Other long-term liabilities 2,814 16 Noncurrent liabilities of discontinued operations 134 407 Total liabilities 73,325 82,387 Stockholders’ equity (deficit): Common stock 42 35 Additional paid-in capital 203,044 183,298 Accumulated deficit (247,004) (229,593)Total stockholders’ deficit (43,918) (46,260)Total liabilities and stockholders’ deficit$29,407 $36,127 ELUTIA INC.CONSOLIDATED STATEMENT OF OPERATIONS(Unaudited, in thousands, except share and per share data) Three months ended September 30, Nine months ended September 30, 2025 2024 2025 2024 Net sales$3,323 $3,662 $9,022 $11,651 Cost of goods sold 1,470 1,871 4,340 6,258 Gross profit 1,853 1,791 4,682 5,393 Operating expenses: Sales and marketing 1,601 1,241 3,863 3,791 General and administrative 3,519 4,340 10,792 13,828 Research and development 1,088 702 2,948 2,271 Litigation costs, net 853 4,683 7,429 8,757 Total operating expenses 7,061 10,966 25,032 28,647 Loss from operations (5,208) (9,175) (20,350) (23,254)Interest expense 265 131 (42) 796 Other (income) expense, net (5,098) (12,653) (10,971) 14,135 Income (loss) before provision of income taxes (375) 3,347 (9,337) (38,185)Provision for income taxes 8 8 24 5 Net loss from continuing operations (383) 3,339 (9,361) (38,190)Loss from discontinued operations (3,485) (2,053) (8,050) (6,698)Net (loss) income$(3,868) $1,286 $(17,411) $(44,888)Net (loss) income per share – basic$(0.09) $0.03 $(0.43) $(1.65)Net (loss) income per share – diluted$(0.19) $(0.33) $(0.66) $(1.65)Weighted average common shares outstanding – basic 42,431,314 32,520,134 40,965,925 27,132,216 Weighted average common shares outstanding – diluted 46,957,199 35,520,938 45,492,271 27,132,216 ELUTIA INC.NON-GAAP GROSS PROFIT AND NON-GAAP GROSS MARGIN RECONCILIATIONS(Unaudited, in thousands, except share and per share data) Three months ended September 30, Nine months ended September 30, 2025 2024 2025 2024 Net sales$3,323 $3,662 $9,022 $11,651 Gross profit 1,853 1,791 4,682 5,393 Intangible asset amortization expense 269 270 807 808 Adjusted gross profit (Non-GAAP)$2,122 $2,061 $5,489 $6,201 Gross margin 55.8% 48.9% 51.9% 46.3%Adjusted gross margin percentage (Non-GAAP) 63.9% 56.3% 60.8% 53.2% ELUTIA INC.EBITDA AND ADJUSTED EBITDA RECONCILIATIONS(Unaudited, in thousands, except share and per share data) Three months ended September 30, Nine months ended September 30, 2025 2024 2025 2024 Net income (loss)$(3,868) $1,286 $(17,411) $(44,888)Interest expense(1) 265 131 (42) 796 Provision (benefit) for income taxes 8 8 24 5 Depreciation and amortization 279 280 877 843 Earnings before interest, taxes, depreciation and amortization (“EBITDA”) (Non-GAAP) (3,316) 1,705 (16,552) (43,244)Loss from discontinued operations(2) 3,485 2,053 8,050 6,698 Stock-based compensation 1,334 1,530 3,450 5,880 Litigation costs, net(3) 853 4,683 7,429 8,757 (Gain) loss on revaluation of warrant liability(4) (5,098) (12,653) (12,518) 15,321 Warrant issuance expenses – – 105 257 Loss (gain) on revaluation of revenue interest obligation(5) – – 1,442 (1,442)Adjusted EBITDA (Non-GAAP)$(2,742) $(2,682) $(8,594) $(7,773) (1) Represents interest expense recorded on the revenue interest obligation and financed insurance premiums.(2) Represents the financial results of the BioEnvelope business sold to Boston Scientific on October 1, 2025.(3) Represents litigation costs consisting primarily of legal fees and the estimated and actual costs to resolve the outstanding FiberCel and VBM litigation cases offset by the amounts recovered and recoverable under insurance.(4) Represents the non-cash revaluation of Common Warrants and Prefunded Warrants issued in connection with a private offering in September 2023 and registered direct offerings in June 2024 and February 2025.(5) Represents the non-cash revaluation of the revenue interest obligation. At each reporting period, the value of the revenue interest obligation is re-measured based on current estimates of future payments, with changes to be recorded in the consolidated statements of operations using the catch-up method. This press release was published by a CLEAR® Verified individual.
LeMaitre Q3 2025 Financial Results
BURLINGTON, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) — LeMaitre Vascular, Inc. (Nasdaq: LMAT), a provider of vascular devices, implants, and services, today reported Q3 2025 results, announced a quarterly dividend of $0.20/share, and provided guidance.
CVRx Reports Third Quarter 2025 Financial and Operating Results
MINNEAPOLIS, Nov. 05, 2025 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the third quarter of 2025. Recent Highlights Total revenue for the third quarter 2025 was $14.7 million, an increase of 10% over the prior year quarterU.S. revenue for the third quarter of 2025 was $13.5 million, an increase of 10% over the prior year quarterActive implanting centers in the U.S. grew to 250, an increase of 20% since September 30, 2024CMS published the final rule to assign favorable physician fee payment levels in connection with the Category I CPT codes set to take effect in 2026 “We’re pleased with the solid progress we made in the third quarter as we continue to execute and build momentum across the organization,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “Our revised commercial strategy continues to show positive results. The development of our territories is progressing nicely as our newest reps are becoming increasingly more productive, resulting in both higher Barostim implant volumes and the expansion of our customer base. We’re also pleased that CMS finalized our transition to Category I CPT codes, both improving patient access and removing key adoption barriers. Our focus remains on positively impacting the lives of patients who suffer from heart failure, and we are well positioned to drive deeper adoption going forward.” Third Quarter 2025 Financial and Operating ResultsRevenue was $14.7 million for the three months ended September 30, 2025, an increase of $1.3 million, or 10%, over the three months ended September 30, 2024. Revenue generated in the U.S. was $13.5 million for the three months ended September 30, 2025, an increase of $1.2 million, or 10%, over the three months ended September 30, 2024. Revenue units in the U.S. totaled 420 and 394 for the three months ended September 30, 2025 and 2024, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim. As of September 30, 2025, the Company had a total of 250 active implanting centers in the U.S., compared to 240 as of June 30, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. The number of sales territories in the U.S. increased by three to a total of 50 during the three months ended September 30, 2025. Revenue generated in Europe was $1.2 million for the three months ended September 30, 2025, an increase of $0.1 million, or 12%, over the three months ended September 30, 2024. Total revenue units in Europe decreased to 50 for the three months ended September 30, 2025, compared to 56 in the prior year period. The number of sales territories in Europe remained consistent at five for the three months ended September 30, 2025. Gross profit was $12.8 million for the three months ended September 30, 2025, an increase of $1.6 million, or 15%, over the three months ended September 30, 2024. Gross margin increased to 87% for the three months ended September 30, 2025, compared to 83% for the three months ended September 30, 2024. Gross margin for the three months ended September 30, 2025 was higher due to an increase in the average selling price and a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies. R&D expenses increased $0.6 million, or 26%, to $3.1 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. This change was driven by a $0.5 million increase in compensation expenses and a $0.2 million increase in consulting expenses, partially offset by a $0.2 million decrease in clinical trial expenses. SG&A expenses increased $0.2 million, or 1%, to $21.9 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. This change was primarily driven by a $0.2 million increase in consulting expenses, a $0.2 million increase in travel expenses, and a $0.2 million increase in non-cash stock-based compensation expense, partially offset by a $0.2 million decrease in advertising expenses and a $0.2 million decrease in compensation expenses. Interest expense increased $0.5 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024. This increase was driven by the interest expense on higher levels of borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net was $0.9 million for each of the three months ended September 30, 2025 and 2024. These balances consisted of interest income on our interest-bearing accounts. Net loss was $12.9 million, or $0.49 per share, for the three months ended September 30, 2025, compared to a net loss of $13.1 million, or $0.57 per share, for the three months ended September 30, 2024. Net loss per share was based on 26.2 million weighted average shares outstanding for three months ended September 30, 2025 and 22.8 million weighted average shares outstanding for the three months ended September 30, 2024. As of September 30, 2025, cash and cash equivalents were $85.1 million. Net cash used in operating and investing activities was $10.0 million for the three months ended September 30, 2025 compared to $10.4 million for the three months ended September 30, 2024. Business OutlookFor the full year of 2025, the Company updated its guidance ranges and now expects: Total revenue between $55.6 million and $56.6 million, compared to prior guidance of $55.0 million to $57.0 million;Gross margin between 85% and 86%, compared to prior guidance of 83% to 84%;Operating expenses between $98.0 million and $99.0 million, compared to prior guidance of $96.0 million to $98.0 million. For the fourth quarter of 2025, the Company expects to report total revenue between $15.0 million and $16.0 million. Webcast and Conference Call InformationThe Company will host a conference call to review its results at 4:30 p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time. About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance regarding full year and fourth quarter 2025 results), our anticipated growth strategies, anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and “Part II, Item 1A. Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do 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. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily Meyers CVRx, Inc. 763-416-2853emeyers@cvrx.com CVRx, INC.Condensed Consolidated Balance Sheets(In thousands, except share and per share data)(Unaudited) September 30, December 31, 2025 2024 Assets Current assets: Cash and cash equivalents$85,124 $105,933 Accounts receivable, net of allowances of $871 and $780, respectively 8,209 9,268 Inventory 11,394 12,107 Prepaid expenses and other current assets 3,163 2,505 Total current assets 107,890 129,813 Property and equipment, net 2,446 2,505 Operating lease right-of-use asset 963 1,069 Other non-current assets 26 27 Total assets$111,325 $133,414 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$3,628 $2,582 Accrued expenses 7,590 8,180 Total current liabilities 11,218 10,762 Long-term debt 49,453 49,273 Operating lease liability, non-current portion 730 877 Other long-term liabilities 1,870 1,447 Total liabilities 63,271 62,359 Commitments and contingencies Stockholders’ equity: Common stock, $0.01 par value, 200,000,000 authorized as of September 30, 2025 and December 31, 2024; 26,193,733 and 25,324,684 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively 262 253 Additional paid-in capital 626,714 608,354 Accumulated deficit (578,718) (537,346)Accumulated other comprehensive loss (204) (206)Total stockholders’ equity 48,054 71,055 Total liabilities and stockholders’ equity$111,325 $133,414 CVRx, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data)(Unaudited) Three months ended Nine months ended September 30, September 30, 2025 2024 2025 2024 Revenue$14,690 $13,373 $40,627 $35,950 Cost of goods sold 1,937 2,248 6,112 5,763 Gross profit 12,753 11,125 34,515 30,187 Operating expenses: Research and development 3,146 2,504 8,132 8,326 Selling, general and administrative 21,875 21,632 66,464 71,077 Total operating expenses 25,021 24,136 74,596 79,403 Loss from operations (12,268) (13,011) (40,081) (49,216)Interest expense (1,480) (958) (4,410) (2,877)Other income, net 875 917 3,108 2,905 Loss before income taxes (12,873) (13,052) (41,383) (49,188)Benefit (provision) for income taxes 3 (47) 11 (126)Net loss (12,870) (13,099) (41,372) (49,314)Cumulative translation adjustment (1) 2 2 (1)Comprehensive loss$(12,871) $(13,097) $(41,370) $(49,315)Net loss per share, basic and diluted$(0.49) $(0.57) $(1.59) $(2.25)Weighted-average common shares used to compute net loss per share, basic and diluted 26,168,562 22,783,337 26,039,718 21,884,588
Arch Biopartners Expands Phase II Cardiac Surgery-Associated AKI Trial to Include Royal Columbian Hospital in British Columbia
TORONTO, Nov. 05, 2025 (GLOBE NEWSWIRE) — Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the Fraser Health Research Ethics Board (“REB”) has granted approval for the Royal Columbian Hospital (RCH) to participate in Arch’s ongoing Phase II trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
NewAmsterdam Pharma Provides Corporate Update and Reports Third Quarter Financial Results
– Marketing Authorization Applications for obicetrapib and FDC of obicetrapib plus ezetimibe accepted for review by European Medicines Agency – – BROOKLYN and BROADWAY pooled MACE analysis published in the Journal of the American College of Cardiology, while the BROADWAY pre-specified Alzheimer’s substudy was published in the Journal of Prevention of Alzheimer’s Disease – – $756.0 million in cash, cash equivalents and marketable securities at September 30, 2025 – NAARDEN, the Netherlands and MIAMI, Nov. 05, 2025 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced financial results for the quarter ended September 30, 2025 and provided a corporate update. “We remain acutely focused on our mission to deliver obicetrapib, as a novel, well-tolerated, and conveniently administered therapy for millions of patients with cardiometabolic disease who continue to struggle to reach their LDL-C goals,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “In the third quarter, we achieved a significant regulatory milestone with the European Medicines Agency’s (“EMA”) acceptance for review of the marketing authorization applications (“MAAs”), by our partner Menarini, for both obicetrapib monotherapy and the fixed-dose combination (“FDC”) with ezetimibe. These submissions, supported by data from our pivotal BROADWAY, BROOKLYN and TANDEM trials, represent an important step toward bringing obicetrapib to patients across Europe.” “In parallel, we continue to advance our broader clinical development strategy, including PREVAIL, our ongoing cardiovascular outcomes trial (“CVOT”), and REMBRANDT, our Phase 3 imaging trial,” continued Dr. Davidson. “We are also making meaningful progress building our global infrastructure to support the potential launch of obicetrapib, if approved. As we engage with the investment and medical communities through upcoming conference and medical meetings, we look forward to sharing new pooled efficacy and safety data and to further highlighting our strategic vision for obicetrapib as a differentiated therapy in a large and growing market.” Clinical Development Updates NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily investigational cholesteryl ester transfer protein (“CETP”) inhibitor, as the preferred LDL-C lowering therapy to be used in patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated. In July 2025, NewAmsterdam announced additional results from the prespecified Alzheimer’s disease (“AD”) biomarker analysis in the Phase 3 BROADWAY trial, presented at the 2025 Alzheimer’s Association International Conference (“AAIC”), which NewAmsterdam believes further support the potential of obicetrapib to modify key biomarkers of AD pathology over a 12-month period in patients with atherosclerotic cardiovascular disease (“ASCVD”). In ApoE4/E4 carriers, the highest risk category for Alzheimer’s disease, obicetrapib was observed to reduce p-tau217 levels by 20.5%, over 12 months, compared to placebo (p=0.010, n=29).In October 2025, the data was published in the Journal of Prevention of Alzheimer’s Disease. In August 2025, NewAmsterdam presented pooled efficacy and safety data from its pivotal Phase 3 BROADWAY and BROOKLYN trials at the European Society of Cardiology Congress (“ESC”) 2025, along with the simultaneous publication in the Journal of the American College of Cardiology, highlighting obicetrapib’s performance across diverse lipid-lowering backgrounds observed in these trials. The presentation and publication underscore the Company’s continued momentum in advancing obicetrapib as a differentiated oral therapy for patients with elevated LDL-C.In November 2025, NewAmsterdam expects to present additional data at the American Heart Association’s Scientific Sessions 2025, highlighting obicetrapib’s impact on LDL particles observed in BROADWAY and BROOKLYN. Upcoming Milestones and Ongoing Trials: Following the successful completion and positive topline results of the Phase 3 BROADWAY, TANDEM, and BROOKLYN trials, NewAmsterdam plans to announce additional data from these trials relating to obicetrapib and the FDC of obicetrapib plus ezetimibe. The following Phase 3 trials are currently ongoing: PREVAIL Phase 3 trial: PREVAIL is a CVOT evaluating obicetrapib in patients with a history of ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam completed enrollment of over 9,500 patients in April 2024.REMBRANDT Phase 3 trial: The trial will utilize coronary computed tomography angiography imaging to evaluate the effect of obicetrapib plus ezetimibe FDC on coronary plaque. The placebo-controlled, double-blind, randomized, Phase 3 trial is being conducted in adult participants with high-risk ASCVD with evidence of coronary plaque who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg plus ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics. The trial is expected to enroll 300 patients. NewAmsterdam also plans to initiate the RUBENS Phase 3 clinical trial to evaluate obicetrapib in combination with ezetimibe in patients with type 2 diabetes or metabolic syndrome that require additional lowering of LDL-C despite treatment with available therapy. The RUBENS trial is expected to initiate in the fourth quarter of 2025. Corporate Updates In August 2025, the EMA accepted for review the MAAs for obicetrapib 10 mg monotherapy and the FDC of 10 mg obicetrapib plus 10 mg ezetimibe for the treatment of primary hypercholesterolemia, including heterozygous familial and non-familial or mixed dyslipidemia. The EMA’s validation of the submissions, made by NewAmsterdam’s partner, A. Menarini International Licensing S.A. (“Menarini”), represents a key regulatory milestone. The submissions are supported by data from the BROADWAY, BROOKLYN, and TANDEM pivotal Phase 3 trials. Third Quarter Financial Results Cash Position: As of September 30, 2025, NewAmsterdam recorded cash, cash equivalents and marketable securities of $756.0 million, compared to $834.2 million as of December 31, 2024. The decrease was primarily driven by ongoing operating expenditures.Revenue: NewAmsterdam recognized $0.3 million in revenue for the quarter ended September 30, 2025, compared to $29.1 million in the same period in 2024. The decrease was primarily attributable to the recognition of $27.3 million of revenue from a license agreement with Menarini related to a clinical development milestone which was earned in the quarter ended September 30, 2024 while there were no clinical milestones earned in the quarter ended September 30, 2025.Research and Development (“R&D”) Expenses: R&D expenses were $31.0 million in the quarter ended September 30, 2025, compared to $35.7 million for the same period in 2024. This decrease was primarily due to a decrease in clinical expenses and manufacturing expenses, partially offset by an increase in personnel expenses, including share-based compensation and non-clinical expenses related to pipeline expansion and product lifecycle management. Share-based compensation expenses included with R&D expenses totaled $5.0 million in the quarter ended September 30, 2025, compared to $3.0 million for the same period in 2024.Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses were $24.5 million in the quarter ended September 30, 2025, compared to $18.4 million for the same period in 2024. This increase was primarily due to an increase in personnel expenses, including share-based compensation. Share-based compensation expenses included with SG&A expenses totaled $10.0 million in the quarter ended September 30, 2025, compared to $5.0 million for the same period in 2024.Net loss: Net loss for the quarter ended September 30, 2025, was $72.0 million, compared to net loss of $16.6 million for the same period in 2024. The individual components of the change are described above in addition to non-cash losses related to changes in the fair value of our derivative liabilities. About Obicetrapib Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company. About Cardiovascular Disease Cardiovascular disease remains the leading cause of death globally, despite the availability of lipid-lowering therapies (“LLTs”). By 2050 more than 184 million U.S. adults are expected to be affected by CVD and hypertension, including 27 million with coronary heart disease and 19 million with stroke. In the United States from 2019 through 2022, CVD age-adjusted mortality rates increased by 9%, reversing the trend observed since 2010 and undoing nearly a decade of progress. Despite the availability of high-intensity statins and non-statin LLTs, LDL-C target level attainment remains low, contributing to residual cardiovascular risk, and underscoring a significant clinical need for improved therapeutic regimens. Even with 269 million LLT prescriptions written over the last 12 months, 30 million under-treated US adults are not at their risk-based LDL-C goal, of which 13 million have ASCVD. Less than 1 in 4 patients with ASCVD achieve an LDL-C goal of less than 70 mg/dL and only 10% of very high risk ASCVD patients achieve the goal below 55 mg/dL. In addition to the 30 million under-treated U.S. adults, there are 10 million patients diagnosed with elevated LDL-C who are not taking any LLTs including statins. Beyond LDL-C, additional factors are at play, such as lifestyle choices, tobacco use, and obesity, as well as inflammation, thrombosis, triglyceride levels, elevated Lp(a) levels, and type 2 diabetes. Alzheimer’s Analysis In BROADWAY, a pre-specified analysis was designed to assess plasma biomarkers of Alzheimer’s disease (“AD”) in patients enrolled in the BROADWAY trial and evaluated the effects of longer duration of therapy (12 months) with a prespecified ApoE population, based on phenotypic analysis. The analysis included 1,535 patients, including 367 ApoE4 carriers (ApoE3/E4 or ApoE4/E4), whose ApoE status was able to be determined. Because this analysis was based on a subset of patients from BROADWAY (which was designed to evaluate LDL-C reductions in an ASCVD and/or HeFH population), the AD analysis was not controlled for baseline differences between the treatment and placebo populations, but statistical analyses were adjusted for baseline biomarker values and age. The absolute and percent change over 12 months in p-tau217, a key biomarker of AD pathology, was measured among patients with baseline and end of study datapoints above the lower limit of quantitation. Additional outcome measures included NFL, GFAP, p-tau181, and Aβ42/40 ratio absolute and percent change over 12 months. NewAmsterdam observed statistically significant lower absolute changes in p-tau217 compared to placebo over 12 months in both the full analysis set (p=0.025; n= 1,535) and in ApoE4 carriers (p=0.022; n=367) as well as favorable trends in the other AD biomarkers. Although a safety analysis was not performed in the AD analysis population, in BROADWAY obicetrapib was observed to be well-tolerated, with safety results comparable to placebo. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage clinical biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Company’s business and strategic plans; the Company’s commercial opportunity; the therapeutic and curative potential of the Company’s product candidates; the Company’s clinical trials and the timing for commencing trials, enrolling patients and completing trials; the timing and forums for announcing data; the achievement and timing of regulatory filings and approvals; and plans for commercialization. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Company’s product candidates and the timing of expected regulatory and business milestones, including potential commercialization; whether topline, initial or preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, or whether projections regarding clinical outcomes will reflect actual results in future clinical trials or clinical use of our product candidates, if approved; the potential for varying interpretation of the results of clinical trials and analyses; the impact of competitive product candidates; and those risks, uncertainties and other factors discussed under the caption “Item 1A. Risk Factors” and elsewhere in the Company’s most recent Form 10-K, Form 10-Q and other public filings with the Securities and Exchange Commission, which are available at www.sec.gov. Additional risks related to the Company’s business include, but are not limited to: uncertainty regarding outcomes of the Company’s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidates; risks associated with the Company’s efforts to commercialize its product candidates; the Company’s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company’s business; risks and uncertainties relating to intellectual property and regulatory exclusivities; the Company’s ability to attract and retain qualified personnel; and the Company’s ability to continue to source the raw materials for its product candidates. If any of these risks materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans, or forecasts of future events and views as of the date of this press release and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law. Company ContactMatthew PhilippeP: 1-917-882-7512matthew.philippe@newamsterdampharma.com Media ContactReal Chemistry on behalf of NewAmsterdamChristian EdgingtonP: 1-513-310-6410cedgington@realchemistry.com Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: 1-212-698-8696austin.murtagh@precisionaq.com NewAmsterdam Pharma Company N.V.Condensed Consolidated Balance Sheet(Unaudited) September 30,2025 December 31,2024 (In thousands of USD) Assets Current assets: Cash and cash equivalents 538,407 771,743 Prepayments and other receivables 28,074 24,272 Employee receivables — 4,951 Marketable securities, current 164,539 62,447 Restricted cash 1,308 — Total current assets 732,328 863,413 Marketable securities, net of current portion 53,091 — Property, plant and equipment, net 323 242 Operating right of use asset 246 431 Intangible assets 439 534 Total assets 786,427 864,620 Liabilities and Shareholders’ Equity Current liabilities: Accounts payable 3,632 4,744 Accrued expenses and other current liabilities 10,098 13,608 Deferred revenue, current — 6,008 Lease liability, current 181 246 Derivative earnout liability, current — 44,798 Derivative warrant liabilities 44,361 37,514 Total current liabilities 58,272 106,918 Lease liability, net of current portion 85 202 Total liabilities 58,357 107,120 Commitments and contingencies (Note 12) Shareholders’ Equity (deficit): Ordinary shares, €0.12 par value; 400,000,000 shares authorized; 113,172,684 and 108,064,340 shares issued and outstanding as at September 30, 2025 and December 31, 2024, respectively 14,107 13,444 Additional paid-in capital 1,396,790 1,298,160 Accumulated loss (687,467) (558,571)Accumulated other comprehensive income 4,640 4,467 Total shareholders’ equity 728,070 757,500 Total liabilities and shareholders’ equity 786,427 864,620 NewAmsterdam Pharma Company N.V.Condensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited) For the three months ended September 30, For the nine months ended September 30, 2025 2024 2025 2024 (In thousands of USD, except per share amounts) Revenue 348 29,111 22,471 32,791 Operating expenses: Research and development expenses 30,971 35,702 103,238 116,511 Selling, general and administrative expenses 24,520 18,412 78,936 49,340 Total operating expenses 55,491 54,114 182,174 165,851 Operating loss (55,143) (25,003) (159,703) (133,060)Other income (expense): Interest income 6,713 4,443 21,119 12,396 Fair value change – earnout — (5,414) 3,992 (11,020)Fair value change – warrants (23,792) 4,644 (7,440) (19,008)Loss on disposal of property, plant and equipment (1) — (1) — Foreign exchange gains/(losses) 218 4,682 13,137 1,270 Loss before tax (72,005) (16,648) (128,896) (149,422)Income tax expense (benefit) — (1) — (1)Loss for the period (72,005) (16,647) (128,896) (149,421)Other comprehensive income/(loss) Unrealized gain/(loss) on available-for-sale securities, net of tax 313 — 173 — Total comprehensive loss for the period, net of tax (71,692) (16,647) (128,723) (149,421) NewAmsterdam Pharma Company N.V.Condensed Consolidated Statements of Mezzanine Equity and Shareholders’ Equity(Unaudited) (In thousands of USD, except share amounts)Shares Amount Additional Paid-In Capital Accumulated Loss Accumulated Other Comprehensive Income Total Shareholders’ Equity Balance at December 31, 2023 82,469,768 10,173 590,771 (316,973) 4,422 288,393 Issuance of Ordinary Shares and Pre-Funded Warrants, net of issuance costs 5,871,909 759 189,207 — — 189,966 Exercise of warrants 926,698 121 19,674 — — 19,795 Exercise of stock options 452,461 60 (609) — — (549)Share-based compensation — — 7,965 — — 7,965 Total loss and comprehensive loss for the period — — — (93,767) — (93,767)As at March 31, 2024 89,720,836 11,113 807,008 (410,740) 4,422 411,803 Exercise of warrants 294,521 38 6,268 — — 6,306 Share-based compensation — — 8,337 — — 8,337 Total loss and comprehensive loss for the period — — — (39,007) — (39,007)As at June 30, 2024 90,015,357 11,151 821,613 (449,747) 4,422 387,439 Exercise of Pre-Funded Warrants 2,105,248 279 (279) — — — Exercise of stock options 45,000 5 53 — — 58 Share-based compensation — — 8,012 — — 8,012 Total loss and comprehensive loss for the period — — — (16,647) — (16,647)As at September 30, 2024 92,165,605 11,435 829,399 (466,394) 4,422 378,862 Balance at December 31, 2024 108,064,340 13,444 1,298,160 (558,571) 4,467 757,500 Issuance of Earnout Shares 1,743,136 226 40,581 — — 40,807 Exercise of Pre-Funded Warrants 1,293,938 162 (162) — — — Exercise of warrants 15,942 2 410 — — 412 Exercise of stock options 909,140 116 2,875 — — 2,991 Vesting of RSUs 142,795 18 (18) — — — Share-based compensation — — 15,213 — — 15,213 Total loss and comprehensive loss for the period — — — (39,527) (33) (39,560)As at March 31, 2025 112,169,291 13,968 1,357,059 (598,098) 4,434 777,363 Exercise of warrants 100 — 2 — — 2 Exercise of stock options 340,317 46 3,378 — — 3,424 Vesting of RSUs 206 — — — — — Share-based compensation — — 15,179 — — 15,179 Total loss and comprehensive loss for the period — — — (17,364) (107) (17,471)As at June 30, 2025 112,509,914 14,014 1,375,618 (615,462) 4,327 778,497 Exercise of warrants 23,826 4 633 — — 637 Exercise of stock options 638,944 89 5,529 — — 5,618 Share-based compensation — — 15,010 — — 15,010 Total loss and comprehensive loss for the period — — — (72,005) 313 (71,692)As at September 30, 2025 113,172,684 14,107 1,396,790 (687,467) 4,640 728,070 NewAmsterdam Pharma Company N.V.Condensed Consolidated Statements of Cash Flows(Unaudited) For the nine months ended September 30, 2025 2024 (In thousands of USD) Operating activities: Loss for the period (128,896) (149,421)Non-cash adjustments to reconcile loss before tax to net cash flows: Depreciation and amortization 161 62 Non-cash rent expense 3 8 Fair value change – derivative earnout and warrants 3,448 30,028 Loss on disposal of property, plant and equipment 1 — Foreign exchange (gains)/losses (13,137) (1,270)Amortization of premium/discount on available-for-sale debt securities (1,381) — Share-based compensation 45,402 24,204 Changes in working capital: Changes in prepayments and other receivables (3,216) (8,769)Changes in accounts payable (409) (9,751)Changes in accrued expenses and other current liabilities (2,876) (708)Changes in deferred revenue (6,008) (5,466)Net cash used in operating activities (106,908) (121,083)Investing activities: Purchase of property, plant and equipment, including internal use software (146) (669)Maturities of marketable securities 71,563 — Purchases of marketable securities (225,192) — Net cash used in investing activities (153,775) (669)Financing activities: Proceeds from February 2024 offering of Ordinary Shares and Pre-Funded Warrants — 190,481 Transaction costs on February 2024 issue of Ordinary Shares and Pre-Funded Warrants — (515)Transaction costs on December 2024 issue of Ordinary Shares and Pre-Funded Warrants (1,586) — Proceeds from exercise of warrants 458 13,421 Proceeds from exercise of options 16,964 498 Payment of withholding taxes related to net share settlement of exercised options — (989)Net cash provided by financing activities 15,836 202,896 Net change in cash, cash equivalents and restricted cash (244,847) 81,144 Foreign exchange differences 12,819 1,135 Cash, cash equivalents and restricted cash at the beginning of the period 771,743 340,450 Cash, cash equivalents and restricted cash at the end of the period 539,715 422,729 Noncash financing and investing activities Right-of-use assets obtained in exchange for new operating lease liabilities — 562 Issuance of earnout shares 40,807 — Reconciliation of cash, cash equivalents and restricted cash to the Condensed Consolidated Balance Sheets Cash and cash equivalents 538,407 422,729 Restricted cash 1,308 — 539,715 422,729
Lexeo Therapeutics Reports Third Quarter 2025 Financial Results and Operational Highlights
FDA open to pooling data from ongoing Phase I/II studies of LX2006 with data from pivotal trial, and to earlier co-primary endpoint assessment, to support a Biologics License Application FDA approved comparability report between LX2006 HEK and Sf9 manufacturing processes in November 2025, endorsing use of Sf9 final commercial manufacturing process to begin dosing patients in upcoming pivotal study LX2006 interim clinical data show clinically meaningful improvements across cardiac and neurologic measures of Friedreich ataxia, including left ventricular mass index and the modified Friedreich Ataxia Rating Scale Completed enrollment of LX2020 HEROIC-PKP2 Phase I/II trial with ten participants dosed; interim data from low-dose cohort reported and additional clinical data from high-dose cohorts on track for January 2026 $154 million equity financing to support LX2006 registrational activities and further development of cardiac pipeline; in addition to Q3-25 end cash, cash equivalents and investments, expected to fund operations into 2028 NEW YORK, Nov. 05, 2025 (GLOBE NEWSWIRE) — Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today provided business updates across its portfolio and reported third quarter 2025 financial results. “We continue to build significant momentum across our cardiac pipeline, and the recent financing strengthens our ability to execute on essential manufacturing and commercial activities for LX2006 as we look towards registrational readiness,” said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics. “Interim clinical data for LX2006 demonstrate meaningful benefit across measures of cardiac health and neurologic function, including improvements in the modified Friedreich Ataxia Rating Scale (mFARS), and we believe this therapy could represent a transformational step forward in the standard of care for FA. Furthermore, with enrollment complete in the HEROIC-PKP2 Phase I/II trial, we look forward to sharing new clinical data for LX2020 in January.” Business and Program Updates LX2006 in Friedreich Ataxia (FA): Regulatory Progress: In response to questions regarding the possibility of a faster path to a Biologics License Application (BLA), the FDA has indicated openness to a BLA submission for accelerated approval that includes clinical data from the ongoing Phase I/II studies of LX2006 pooled with new clinical data to be generated in the planned pivotal study. To enable pooling of these data to support licensure, Lexeo plans to submit enhanced manufacturing comparability data and additional nonclinical data. The FDA also previously agreed to evaluate the co-primary endpoint of left ventricular mass index (LVMI) at a time point earlier than 12 months. Lexeo continues to engage with the FDA on the pivotal trial protocol and enhanced comparability. There have been no changes to the previously disclosed alignment with FDA on key parameters related to the LX2006 planned registrational study to date.Interim Clinical Data: In October 2025, Lexeo shared interim clinical data from both ongoing Phase I/II studies of LX2006, which continue to show encouraging safety and efficacy: 18% mean improvement in LVMI at 6 months and 23% mean improvement at 12 months in participants with abnormal baseline LVMI (n=6), exceeding the 10% FDA-aligned efficacy threshold for the planned pivotal study Improvement or stabilization in secondary cardiac biomarkers high-sensitivity troponin I and lateral wall thickness in 14 of 16 participants (n=16)2.0-point mean improvement in mFARS from baseline at latest visit across all participants with >6-months of follow-up (n=16)Previously reported cardiac biopsy data from the SUNRISE-FA trial (n=8) showed that all study participants achieved increases in frataxin protein expression from baseline at 3 months, exceeding FDA-aligned efficacy threshold for frataxin expressionTreatment with LX2006 has been generally well tolerated with no Grade 3+ SAEs to date, no clinically significant complement activation, and minimal, transient liver function test (LFT) elevations Analytical Comparability: In November 2025, FDA approved the analytical comparability report establishing comparability between LX2006 HEK293 and Sf9 manufacturing processes. This approval endorses use of the optimized, Sf9 final commercial manufacturing process for LX2006 in the planned pivotal study and clears comparability requirements to begin dosing patients. In October 2025, Lexeo shared manufacturing data from this report demonstrating similar frataxin expression in vitro between the two processes, as well as the high quality of the Sf9 material with minimal residual DNA.Next Steps: Lexeo plans to initiate a registrational study in the first half of 2026, pending finalization of the trial protocol in early 2026. LX2020 in PKP2-ACM: Dosing Update: Enrollment is complete with ten participants dosed in the HEROIC-PKP2 Phase I/II clinical trial, including three participants in Cohort 1 at the low dose (2×1013 vg/kg), three participants in Cohort 2 at the high dose (6×1013 vg/kg), and four participants in dose-expansion Cohort 3 at the high dose (6×1013 vg/kg).Low-dose (Cohort 1) Interim Update: In October 2025, Lexeo shared interim clinical data for the three participants dosed in Cohort 1 (n=2 at 12 months; n=1 at 9 months), assessing multiple cardiac parameters at latest visit relative to baseline: Arrythmia burden: premature ventricular contractions (PVCs) were reduced in one of three participants and non-sustained ventricular tachycardia (NSVT) was reduced or stable in two of three participantsElectrical activity: QRS duration was normalized or stable in two of three participants and T-wave inversions were reduced in two of three participantsCardiac function: left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) were stable in three of three participants Safety: LX2020 continues to be generally well tolerated across participants with no clinically significant complement activation. One Grade 3 serious adverse event of sustained ventricular tachycardia (VT) was observed three months after dosing in a single participant in the high dose cohort and assessed as possibly treatment related. The participant was successfully treated with anti-arrhythmic medication and was discharged with no additional intervention required.Next Steps: Lexeo expects to provide a substantive LX2020 data update in January. This data update is expected to include safety data for all ten participants dosed, clinical efficacy data for five high-dose participants at >6 months of follow up and three low-dose participants at >12 months of follow up, and cardiac biopsy data from five participants in high-dose Cohorts 2 and 3. Closed $154 Million Equity Financing: In October 2025, Lexeo announced the closing of an oversubscribed $154 million equity financing to further advance development of its cardiac pipeline and to support registrational readiness activities for LX2006. Third Quarter Financial Results Cash Position: As of September 30, 2025, cash, cash equivalents, and investments in marketable securities were $122.8 million, excluding the $153.8 million of proceeds from the October 2025 public offering and concurrent PIPE which Lexeo believes will be sufficient to fund operations into 2028.Research and Development Expenses: Research and Development expenses were $15.7 million for the three months ended September 30, 2025, compared to $23.4 million for the three months ended September 30, 2024.General and Administrative Expenses: General and Administrative expenses were $6.0 million for the three months ended September 30, 2025, compared to $8.1 million for the three months ended September 30, 2024.Net Loss: Net loss was $20.3 million or $0.33 per share (basic and diluted) for the three months ended September 30, 2025, compared to $29.5 million or $0.89 per share (basic and diluted) for the three months ended September 30, 2024. About Lexeo TherapeuticsLexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to reshaping heart health by applying pioneering science to fundamentally change how cardiovascular diseases are treated. The Company is advancing a portfolio of therapeutic candidates that take aim at the underlying genetic causes of conditions, including LX2006 in Friedreich ataxia (FA), LX2020 in plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy, and others in devastating diseases with high unmet need. Cautionary Note Regarding Forward-Looking StatementsCertain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, Lexeo’s expectations and plans regarding its current product candidates and programs and the timing for receipt and announcement of data from its clinical trials, the timing and likelihood of potential regulatory developments and approval, expectations regarding the time period over which Lexeo’s capital resources will be sufficient to fund its anticipated operations and estimates regarding Lexeo’s financial condition. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Lexeo believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements. These forward-looking statements are based upon current information available to the company as well as certain estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Lexeo’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different from those indicated by such forward-looking statements as a result of many factors, including but not limited to: risks and uncertainties related to global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Lexeo’s preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; delays in submission of regulatory filings or failure to receive regulatory approval; liquidity and capital resources; and other risks and uncertainties identified in Lexeo’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, filed with the SEC on August 14, 2025, and subsequent future filings Lexeo may make with the SEC. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Lexeo claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Lexeo expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Media Response:Media@lexeotx.com Investor Response:Carlo Tanzi, Ph.D.ctanzi@kendallir.com Lexeo Therapeutics, Inc.Selected Financial Information(Unaudited, in thousands, except share and per share amounts) Condensed Statement of Operations Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2025 2024 2025 2024 Operating expenses Research and development$15,695 $23,423 $47,587 $55,725 General and administrative 5,953 8,120 38,554 22,659 Total operating expenses 21,648 31,543 86,141 78,384 Operating loss (21,648) (31,543) (86,141) (78,384)Other income and expense Gain on long-term investment – – 3,390 – Other income (expense), net (9) (3) (27) (9)Interest income 1,456 2,092 3,917 6,091 Amortization of premium on investments in U.S. Treasury securities (60) – (106) – Total other income and expense 1,365 2,054 7,099 5,975 Loss from operations before income taxes (20,283) (29,489) (79,042) (72,409)Income taxes – – – – Net loss$(20,283) $(29,489) $(79,042) $(72,409)Net loss per common share, basic and diluted$(0.33) $(0.89) $(1.72) $(2.31)Weighted average number of shares outstanding used in computation of net loss per common share, basic and diluted 60,980,867 33,063,153 45,991,572 31,354,821 Condensed Balance Sheet Data September 30, December 31, 2025 2024 Cash, cash equivalents, and investments in U.S. Treasury securities $122,764 $128,530 Total assets 143,844 146,942 Total liabilities 23,013 30,100 Total stockholders’ equity 120,831 116,842
Braveheart Bio Launches with $185M Series A Aiming to Transform Care of Hypertrophic Cardiomyopathy
Leadership brings experience in company building, advancing late-stage clinical programs, and deep understanding of cardiovascular drug development Company intends to rapidly advance BHB-1893 into late-stage clinical development Board to include Chris Viehbacher as Chair, with investor…
Longeveron® Announces Third Quarter 2025 Financial Results and Provides Business Update
Than Powell
Than Powell, CBO, Longeveron
On track for top-line trial results in the third quarter of 2026 from pivotal Phase 2b clinical trial ELPIS II. ELPIS II is evaluating laromestrocel as a potential adjunct treatment for HLHS, a rare pediatric disease and orphan-designated indication and is fully enrolled.ELPIS II may serve as foundation for a Biologics License Application (BLA) submission for full approval for HLHS, if results demonstrate sufficient evidence of efficacyCompany to host conference call and webcast today at 4:30 p.m. ET MIAMI, Nov. 04, 2025 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today reported financial results for the quarter ended September 30, 2025 and provided a business update. “I am excited to step in to lead Longeveron at this transformational period in both the Company’s history, and our advancement of laromestrocel,” said Than Powell, Interim Chief Executive Officer of Longeveron. “Longeveron has made significant progress advancing three stem cell therapy programs, with each step getting us closer to treating patients with life altering diseases. Our pivotal Phase 2b clinical trial evaluating laromestrocel as a potential treatment for HLHS, a rare pediatric congenital heart defect, is on track to deliver top-line trial results in the third quarter of 2026. If positive, this trial may be the foundation of the Company’s first BLA filing with the U.S. FDA. We believe our research is driving the next wave of medical innovation and Longeveron is well positioned to be an industry leader in stem cell clinical development and commercialization for the benefit of patients and their families.” Development Programs UpdateLongeveron’s investigational therapeutic candidate is laromestrocel (Lomecel-BTM), a proprietary, scalable, allogeneic cellular therapy being evaluated in multiple indications. Hypoplastic Left Heart Syndrome (HLHS) – a rare pediatric congenital heart birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. Pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct therapy for HLHS achieved full enrollment of 40 pediatric patients in June 2025.Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-months.Laromestrocel Biological License Application (BLA) submission for full approval for HLHS, if ELPIS II results demonstrate sufficient evidence of efficacy, now anticipated in 2027 rather than late 2026 based on operational decisions to extend the cash runway for delivery of ELPIS II study results and to optimize manufacturing spend.ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH).ELPIS II builds on the positive clinical results of ELPIS I, in which children in the trial experienced 100% transplant-free survival up to five years of age after receiving laromestrocel compared to approximate 20% mortality rate observed from historical control data.The FDA has granted laromestrocel Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment of HLHS. Alzheimer’s disease (AD) – a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options. Results from the Phase 2a clinical trial (CLEAR MIND), which support the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease and provided evidence-based support for further clinical development, were published in the peer reviewed journal Nature Medicine in March 2025.Positive Type B meeting with FDA regarding pathway to BLA submission for laromestrocel in Alzheimer’s disease held in March 2025 with alignment reached on proposed trial study design, population and endpoints for a single, pivotal Phase 2/3 clinical trial that, if positive, would be acceptable for BLA submission for Alzheimer’s disease.The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease.The Company is seeking to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in addressing AD. Pediatric Dilated Cardiomyopathy (DCM) – a rare pediatric cardiovascular disease in which the muscles in one or more of the heart chambers become enlarged or stretched (dilated), with nearly 40% of children with DCM requiring a heart transplant or dying within two years of diagnosis. In July 2025, the FDA approved Longeveron’s Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for pediatric dilated cardiomyopathy (DCM). The accepted IND application provides for moving directly to a single Phase 2 pivotal registration clinical trial.The Company currently anticipates initiation of the pivotal Phase 2 clinical trial in 2026, subject to obtaining necessary financing. Corporate Updates In July, the Company announced the licensing of a new, composition of matter patent protected, stem cell technology from the University of Miami for unique induced pluripotent derived cardiomyogenic cells that have widespread therapeutic indications for heart diseases.In August, the Company completed a public offering, raising approximately $5.0 million, with up to an additional $12.5 million of potential aggregate gross proceeds upon the exercise in full of short-term warrants.In September, the Company announced key leadership updates with Than Powell being appointed Interim Chief Executive Officer, and Dr. Joshua Hare being appointed Executive Chairman of the Board of Directors.In October, the Company announced that George Paletta, Jr., MD, MBA, has been elected to the Longeveron Board of Directors. Dr. Paletta is a nationally and internationally recognized orthopedic surgeon and the head team doctor for the St. Louis Cardinals. Dr. Paletta is a developer of ambulatory surgical centers (ASCs), and has participated in the selling of two ASCs with deal values totaling almost $1 billion. Third Quarter 2025 Summary Financial Results Revenues: Revenues for the nine months ended September 30, 2025 and 2024 were $0.8 million and $1.8 million, respectively. This represents a decrease of $1.0 million, or 53% in 2025 compared to 2024, driven primarily by a decreased participant demand for our Bahamas Registry Trial and reduced demand for contract manufacturing services from our third-party client. Clinical trial revenue, which is derived from the Bahamas Registry Trial, for the nine months ended September 30, 2025 and 2024 was $0.7 million and $1.0 million, respectively. Clinical trial revenue for the nine months ended September 30, 2025 decreased by $0.3 million, or 36%, when compared to 2024 as a result of decreased participant demand. Contract manufacturing revenue for the nine months ended September 30, 2025 was $0.2 million from our manufacturing services contract, which is a decrease of $0.6 million, or 76% when compared to the $0.8 million in contract manufacturing revenue for the nine months ended September 30, 2024. This decrease was driven by a substantial reduction in activities under the Secretome Agreement; no additional manufacturing or development activities are planned, and the Company is now limited to performing stability testing and other contract testing services.Cost of Revenues and Gross Profit: Cost of revenues was $0.3 million and $0.4 million for the nine months ended September 30, 2025 and 2024, respectively. This resulted in a gross profit of approximately $0.5 million for the nine months ended September 30, 2025, a decrease of $0.9 million, or 60%, when compared with a gross profit of $1.4 million for 2024.General and Administrative Expenses: General and administrative expenses for the nine months ended September 30, 2025 increased to approximately $9.1 million, compared to $7.4 million for the same period in 2024. The increase of approximately $1.7 million, or 22%, was primarily related to an increase in personnel and related costs in 2025, including increased severance and equity-based compensation.Research and Development Expenses: Research and development expenses for the nine months ended September 30, 2025 increased to approximately $9.3 million, from approximately $6.1 million for the same period in 2024. The increase of $3.2 million, or 52%, was primarily driven by a $1.8 million increase in personnel and related costs, including equity-based compensation, $1.2 million increase in supplies and costs associated with technology transfer, including non-clinical manufacturing batches that advance our readiness for future commercial production as part of our BLA-enabling efforts and a $0.2 million increase in amortization expense related to patent costs.Other Income (Expense): Other income for the nine months ended September 30, 2025 was $0.6 million, primarily consisting of $0.3 million received as a recipient of a Milestone 1 Award in the XPRIZE Healthspan competition and $ 0.3 million interest earned on money market funds. Other income for the nine months ended September 30, 2024 was $0.3 million as result of interest earned on money market funds and marketable securities.Net Loss: Net loss increased to approximately $17.3 million for the nine months ended September 30, 2025 from a net loss of $11.9 million for the same period in 2024. The increase in the net loss of $5.4 million, or 45%, was for the reasons outlined above.Cash and cash equivalents as of September 30, 2025 were $9.2 million. As a result of the recently completed financing in August of 2025, and continued focus on disciplined and efficient capital allocation focused on first to market indications, the Company currently anticipates its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements late into the first quarter of 2026, based on its current operating budget and cash flow forecast. The Company also has access to an At-The-Market (ATM) equity financing vehicle for the sale of up to $10.7 million aggregate market value of shares of the Company’s Class A common stock. The Company intends to seek additional financing through capital raises, non-dilutive funding options, including grants and strategic partnerships across all indications. There can be no assurance the Company will be able to attain future financing at terms favorable to the Company or at all. In the event the Company is unable to attain the financing needed, it will need to materially revise its current operational plan. Conference Call and Webcast Details: Conference Call Number:1.877.407.0789Conference ID:13755997 Call me™ Feature:Click HereWebcast:Click Here An archived replay of the webcast will be available on the “Events & Presentations” section of the Company’s website following the conference. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric Dilated Cardiomyopathy (DCM) and Aging-related Frailty. Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program – Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program – Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking StatementsCertain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, statements about the various below-listed factors. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor and Media Contact:Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com —tables follow— Longeveron Inc.Condensed Balance Sheets(In thousands, except share and per share data) September 30,2025 December 31,2024 (Unaudited) Assets Current assets: Cash and cash equivalents $9,244 $19,232 Prepaid expenses and other current assets 1,044 308 Accounts and grants receivable 52 84 Total current assets 10,340 19,624 Property and equipment, net 2,122 2,449 Intangible assets, net 2,309 2,401 Operating lease asset, net 608 882 Other assets 178 202 Total assets $15,557 $25,558 Liabilities and stockholders’ equity Current liabilities: Accounts payable $1,080 $99 Accrued expenses 3,173 1,820 Current portion of lease liability 647 623 Deferred revenue 40 40 Total current liabilities 4,940 2,582 Long-term liabilities: Lease liability 336 824 Other liabilities 315 265 Total long-term liabilities 651 1,089 Total liabilities 5,591 3,671 Commitments and contingencies (Note 9) Stockholders’ equity: Preferred stock, $0.001 par value per share, 5,000,000 shares authorized, no shares issued and outstanding at September 30, 2025, and December 31, 2024 — — Class A common stock, $0.001 par value per share, 84,295,000 shares authorized, 19,576,924 shares issued and outstanding at September 30, 2025; 13,407,441 issued and outstanding at December 31, 2024 19 13 Class B common stock, $0.001 par value per share, 15,705,000 shares authorized, 1,484,005 shares issued and outstanding at September 30, 2025, and December 31, 2024 1 1 Additional paid-in capital 136,813 131,480 Accumulated deficit (126,867) (109,607)Total stockholders’ equity 9,966 21,887 Total liabilities and stockholders’ equity $15,557 $25,558 See accompanying notes to unaudited condensed financial statements. Longeveron Inc.Condensed Statements of Operations(In thousands, except per share data)(Unaudited) Three months endedSeptember 30, Nine months endedSeptember 30, 2025 2024 2025 2024 Revenues Clinical trial revenue $94 $210 $651 $1,012 Contract manufacturing lease revenue 6 186 18 377 Contract manufacturing revenue 37 377 165 400 Total revenues 137 773 834 1,789 Cost of revenues 12 91 288 435 Gross profit 125 682 546 1,354 Operating expenses General and administrative 3,583 3,125 9,113 7,447 Research and development 3,852 2,206 9,321 6,148 Total operating expenses 7,435 5,331 18,434 13,595 Loss from operations (7,310) (4,649) (17,888) (12,241)Other income and (expenses) Other income, net 89 230 628 349 Total other income, net 89 230 628 349 Net loss $(7,221) $(4,419) $(17,260) $(11,892)Deemed dividend – warrant inducement offers — (149) — (8,650)Net loss attributable to common stockholders $(7,221) $(4,568) $(17,260) $(20,542)Basic and diluted net loss per share $(0.39) $(0.34) $(1.07) $(2.71)Basic and diluted weighted average common shares outstanding 18,373,198 13,627,793 16,124,871 7,572,601 See accompanying notes to unaudited condensed financial statements. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/59470556-6cdc-4e00-86da-f80b4621b8da



