Author: Ken Dropiewski

NewAmsterdam Pharma Provides Corporate Update and Reports Third Quarter Financial Results

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– 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 

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Lexeo Therapeutics Reports Third Quarter 2025 Financial Results and Operational Highlights

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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 

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AVS Announces Positive Safety and Effectiveness Data in First 95 Patients Treated in Pulse IVL IDE Study

Peripheral/Endo by 0 comments

Data from the POWER PAD II Study presented at VIVA will support FDA 510(k) submission in 2026   WALTHAM, Mass.–(BUSINESS WIRE)–Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease, presented the results of the first 95 patients treated in the POWER […]

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Longeveron® Announces Third Quarter 2025 Financial Results and Provides Business Update

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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

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Dallas Cardiology Group Expands Access to Advanced Cardiac Imaging in North Texas Following High Patient Demand

Coronary/Structural Heart by 0 comments

Connected Cardiovascular Care Associates brings Arineta’s SpotLight scanner to its Rockwall location, broadening availability to the same technology they first brought to Dallas in 2023    Dallas, TX – October 29, 2025 – Connected Cardiovascular Care Associates (C3), a Dallas-based cardiology practice, is expanding its Arineta SpotLight installations that provide […]

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New Data Show Viz.ai’s AI-Enabled ECG Screening Increases Detection and Accelerates Diagnosis of Hypertrophic Cardiomyopathy

Rhythm by 0 comments

Real-world evidence from the University of Virginia and University of Texas Medical Branch to be presented at American Heart Association (AHA) Scientific Sessions 2025 SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced new clinical data demonstrating how Viz HCM enables faster, accurate detection […]

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Tulyp Medical Emerges From Sofinnova’s Medtech Accelerator and Announces FDA Submission Following Initial First-in-Human Use

Coronary/Structural Heart by 0 comments

Company unveils patented technology designed to help maintain healthy blood flow during vascular procedures Backed by Sofinnova MD Start and led by experienced medtech entrepreneurs and cardiologists PARIS–(BUSINESS WIRE)–Tulyp Medical, a Paris-based startup developing a medical device for intelligent pressure-driven perfusion, emerged from stealth and announced it has submitted its […]

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