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TEL AVIV, Israel & MIAMI–(BUSINESS WIRE)–Biobeat Technologies Ltd, a medical device company that has developed a wearable cuff-less ambulatory blood pressure monitoring system that records and analyzes numerous physiological parameters, today announced the appointment of Raymond W. Cohen as its Chairman of the Board of Directors. Biobeat Technologies appoints seasoned […]
Former U.S. Surgeon General will help guide Eko’s mission to expand access to AI-powered cardiac screening and early detection worldwide SAN FRANCISCO, Aug. 21, 2025 /PRNewswire/ — Eko Health, a leader in AI-powered cardiac and pulmonary detection, today announced that Jerome Adams, MD,…
SOUTH SAN FRANCISCO, Calif., Aug. 20, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the appointment of James M. Daly to its Board of Directors effective August 19, 2025. Mr. Daly brings over 30 years of global biopharmaceutical leadership experience with particular expertise in commercialization to the Company’s Board of Directors. “Jim has longstanding expertise leading commercial launches of innovative therapies, coupled with extensive Board experience guiding later-stage, global biopharma companies,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We are pleased to welcome him to our Board and look forward to his contributions and oversight as our company advances toward becoming a fully integrated commercial organization.” Most recently, Mr. Daly served as the Chief Commercial Officer at Incyte Corporation where he led the launch of Jakafi® (ruxolitinib) and oversaw development of the company’s global commercial capabilities. Previously, he spent 10 years at Amgen where he held multiple senior leadership positions, including Senior Vice President of North America Commercial Operations, and launched several successful medicines including Neulasta®, Xgeva®, Nplate® and Vectibix®. He began his career at GlaxoSmithKline, serving in escalating positions of seniority over his 16-year tenure with the company. He earned a B.S. in Pharmacy and an M.B.A. from the University at Buffalo, SUNY. Mr. Daly currently serves on the Boards of Madrigal Pharmaceuticals, argenx SE, and Acadia Pharmaceuticals. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities of Cytokinetics’ product candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlines in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757
CLEVELAND–(BUSINESS WIRE)–Centerline Biomedical, Inc. (“Centerline”), an innovative leader in cardiovascular navigation and visualization systems, announced the appointment of Jim Dillon as President and Chief Executive Officer (CEO) and a member of its board of directors. He will assume his responsibilities on August 18, 2025. “It is an honor to join […]
Breakthrough Therapy designation granted for LX2006 based on interim data from Phase I/II trials demonstrating clinically meaningful improvements in cardiac and neurologic measures of Friedreich ataxia LX2006 selected for FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, created to facilitate CMC registrational readiness and support faster patient access Eight participants dosed in Phase I/II clinical trial (HEROIC-PKP2) of LX2020 for PKP2-ACM; interim clinical data update on track for second half of 2025 Strategic partnership announced with Perceptive Xontogeny Venture Funds and venBio Partners to advance non-viral, RNA-based therapeutics for genetic cardiac diseases $80 million equity financing to support development of clinical stage pipeline; cash, cash equivalents and investments in marketable securities of $152.5 million expected to provide operational runway into 2028 Louis Tamayo appointed Chief Financial Officer NEW YORK, Aug. 14, 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 second quarter 2025 financial results. “Over the last several months, Lexeo has made significant progress advancing our clinical stage programs, diversifying our pipeline through a strategic partnership that we believe enables us to stay on the cusp of leading-edge cardiovascular science, and further strengthening our balance sheet,” said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics. “FDA Breakthrough Therapy designation for LX2006 underscores the potential of this gene therapy candidate, and we are moving as quickly as possible in close partnership with patient advocates, clinicians, and the FA community to initiate a registrational study early next year. We are also continuing to advance our LX2020 program for arrhythmogenic cardiomyopathy with eight participants dosed to date and data updates expected in the second half of this year.” Business and Program Updates LX2006 in Friedreich Ataxia (FA): Regulatory Updates: In July 2025, Lexeo received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for LX2006 based on interim clinical data demonstrating clinically meaningful improvements in cardiac and neurologic measures of FA. LX2006 has also been selected to participate in the FDA Chemistry, Manufacturing, and Controls (CMC) Development Readiness Pilot (CDRP) program, created to accelerate CMC registrational readiness for therapies with expedited clinical development timelines. Lexeo expects final alignment with FDA on the LX2006 registrational study in late Q3 to early Q4 2025.Natural History: The CLARITY-FA natural history study is currently enrolling and is expected to serve as a concurrent external control arm for the planned registrational study.Safety: LX2006 continues to be generally well tolerated with no clinically significant complement activation, and no new treatment-related serious adverse events to report.Next Steps: Lexeo expects to initiate a registrational study in early 2026 with a potential efficacy readout in 2027. LX2020 in PKP2-ACM: Dosing Update: Eight participants have been dosed to date 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 two participants in dose-expansion Cohort 3 at the high dose (6×1013 vg/kg). Cohort 3 is still enrolling and up to two additional participants may be dosed in this cohort.Safety: LX2020 has been generally well tolerated with no clinically significant complement activation, and no treatment-related serious adverse events to date across all dose cohorts.Next Steps: Lexeo expects to share an interim clinical data update in the second half of 2025. Closed $80 Million Equity Financing: In May 2025, Lexeo announced the closing of an $80 million equity financing to further advance development of its clinical stage genetic medicine candidates. Lexeo anticipates that current cash, cash equivalents and marketable securities will be sufficient to fund operating and capital expenditures into 2028, through a potential efficacy readout for the registrational study of LX2006 in 2027. Research Collaboration with Perceptive Xontogeny Venture Funds and venBio Partners: In June 2025, Lexeo announced a strategic partnership to develop therapies for genetic cardiac diseases utilizing a novel non-viral RNA platform. PXV Funds and venBio will contribute up to $40 million in private equity financing to a new entity addressing cardiac genetic diseases that existing AAV platforms are unable to treat. Lexeo is contributing expertise and know-how in cardiac genetic medicines, preclinical intellectual property and technology to the partnership, with a double-digit percentage equity position in the new entity at transaction close alongside entitlement to future milestone payments, royalties, and opt-in rights to certain program(s). New Leadership Appointment: Lexeo announced today that Louis Tamayo has been appointed Chief Financial Officer. Mr. Tamayo succeeds Kyle Rasbach who remains an advisor to Lexeo. Mr. Tamayo will support Lexeo’s late-stage clinical and commercialization plans as LX2006 development accelerates and LX2020 development continues, alongside strategic planning, portfolio management, capital allocation, and other financial operations. Mr. Tamayo brings extensive commercial finance experience, having previously served as Senior Vice President at Siemens Healthineers AG, responsible for driving revenue growth and market expansion for the company’s $5 billion global diagnostics division. In this role, he built and led high-performing finance organizations that supported multiple global product launches and strategic partnerships, directed R&D capital allocation, and oversaw large-scale transformation initiatives. Prior to Siemens Healthineers, Mr. Tamayo was the Business Unit CFO for Becton, Dickinson and Company’s $1.2 billion global diabetes care business. Mr. Tamayo began his career at Pfizer where he held a series of financial, strategic, and analytical leadership roles across U.S. and international markets. Mr. Tamayo holds a BBA in Finance and Marketing from Northeastern University. Recent Data Presentations: Lexeo presented new data at the 28th American Society of Gene & Cell Therapy (ASGCT) Annual Meeting on AAV manufacturing optimization via the Company’s Sf9-baculovirus process. Data presentations reviewed the high purity and potency of Lexeo yields with improved scalability of production and reduced cost. Lexeo also presented data at the Global Cell and Gene Therapy Summit reviewing the favorable complement profile of AAVrh10 based on clinical monitoring experience across the three gene therapy studies in FA and PKP2 in which no clinically significant events related to complement activation have been observed to date. Second Quarter Financial Results Cash Position: As of June 30, 2025, cash, cash equivalents, and investments in marketable securities were $152.5 million, which Lexeo believes will be sufficient to fund operations into 2028. Research and Development Expenses: Research and Development expenses were $14.7 million for the three months ended June 30, 2025, compared to $16.6 million for the three months ended June 30, 2024. General and Administrative Expenses: General and Administrative expenses were $16.0 million for the three months ended June 30, 2025, compared to $7.0 million for the three months ended June 30, 2024. Net Loss: Net loss was $26.1 million or $0.60 per share (basic and diluted) for the three months ended June 30, 2025, compared to $21.2 million or $0.64 per share (basic and diluted) for the three months ended June 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) cardiomyopathy, 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 March 31, 2025, filed with the SEC on May 12, 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 Statements of Operations Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Operating expenses Research and development$14,721 $16,560 $31,892 $32,302 General and administrative 15,967 6,990 32,601 14,539 Total operating expenses 30,688 23,550 64,493 46,841 Operating loss (30,688) (23,550) (64,493) (46,841) Other income and expense Gain on long-term investment 3,390 – 3,390 – Other income (expense), net (14) (1) (18) (6) Interest expense (25) (35) (53) (72) Interest income 1,268 2,348 2,461 3,999 Amortization of premium on investments (34) – (46) – Total other income and expense 4,585 2,312 5,734 3,921 Loss from operations before income taxes (26,103) (21,238) (58,759) (42,920) Income taxes – – – – Net loss$(26,103) $(21,238) $(58,759) $(42,920) Net loss per common share, basic and diluted$(0.60) $(0.64) $(1.53) $(1.41) Weighted average number of shares outstanding used incomputation of net loss per common share, basic and diluted 43,573,628 33,001,946 38,372,704 30,490,892 Condensed Balance Sheet Data June 30,2025 December 31,2024 Cash, cash equivalents, and investments in marketable securities$152,506 $128,530 Total assets 176,068 146,942 Total liabilities 37,850 30,100 Total stockholders’ equity 138,218 116,842
Business highlights include: Adult NEUTRALIZE-AKI trial enrolls 31 new patients, now over 60% enrolledThree new top-rated children’s hospitals adopt QUELIMMUNE therapy for ultra-rare pediatric Acute Kidney Injury (AKI)Positive survival results reported from QUELIMMUNE SAVE Surveillance RegistryWebcast call today at 4:30 p.m. Eastern Time DENVER, Aug. 13, 2025 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today financial results for the three months ended June 30, 2025, and provided business updates on key initiatives. “Since the beginning of the second quarter, we have made great progress on several fronts,” said Eric Schlorff, CEO of SeaStar Medical. “We enrolled 31 additional patients in the NEUTRALIZE-AKI trial, reported three new QUELIMMUNE customers from top-rated U.S.-based children’s hospitals, announced positive survival results for the first 20 pediatric patients treated in a commercial setting with QUELIMMUNE from the SAVE Surveillance Registry, and raised additional capital to shore up our balance sheet.” Mr. Schlorff continued, “We are now focused on several important upcoming, value-creating milestones. These include the interim results for the first 100 patients in the NEUTRALIZE-AKI trial, presentation of additional data from the SAVE Surveillance Registry, and the onboarding of other notable children’s hospitals to our customer list. Also, assuming a successful outcome from our NEUTRALIZE-AKI trial, in 2026 we plan to file our Pre-Marketing Approval (PMA) application for our Selective Cytopheretic Device (SCD) therapy as an organ-sparing and life-saving treatment for adult patients with Acute Kidney Injury (AKI) requiring continuous renal replacement therapy (CRRT).” Key Business Highlights Since the beginning of the second quarter, SeaStar Medical’s key business updates include the following: Achieved the 50% patient enrollment milestone (100 patients) in the NEUTRALIZE-AKI pivotal clinical trial, triggering the interim analysis, and subsequently increased total enrollment to 125 of 200 total anticipated patients. Recommendations from the per protocol prespecified interim analysis by the trial’s independent Data Safety Monitoring Review Board (DSMB) are expected to be provided to the Company in the third quarter of 2025.Broadened the QUELIMMUNE customer base, securing three new customers from top-rated children’s hospitals.Reported positive survival data from the SAVE Surveillance Registry, evaluating the QUELIMMUNE therapy in the first 20 critically ill pediatric patients with life-threatening AKI and sepsis or a septic condition in the commercial setting. The preliminary results showed no device related safety events with the QUELIMMUNE therapy and 75% of patients survived through 28 days. These new data are on track to validate or potentially exceed a 50% reduction in loss of life compared to historical data, as reported previously in Kidney Medicine.Received agreement from the U.S. Centers for Medicare & Medicaid Services (CMS) to pay for certain expenses incurred by medical centers treating patients covered by Medicare or Medicaid who are enrolled in the NEUTRALIZE-CRS investigational clinical trial – a rare award with less than 100 clinical trials covered annually.Announced that a $2 million United States Department of Defense (DoD) grant was awarded to The Autonomous Reanimation and Evacuation (AREVA) Research Institute to support a three-year research study that will explore the application of SeaStar Medical’s SCD therapy to reduce hyperinflammation in warfighters after severe burns, inhalation injury, and infection. The grant is one of four selected out of 160 total submissions by the 2024 Military Burn Research Program and represents cutting-edge research for extracorporeal immunomodulation to reduce inflammation after severe burns, inhalation injury, and septicemia.Implemented additional cost-saving measures to increase the company’s financial runway and focus its cash resources on the development of its SCD therapy for adult patients with AKI requiring CRRT, an annual U.S. market opportunity that is 50 times larger than the U.S. pediatric AKI market.Raised $12.4 million in gross proceeds, before deducting offering-related expenses, through a public offering in June 2025 and two registered direct offerings in July and August 2025. These offerings were priced at-the-market and proceeds will support the company’s ongoing operations into 2026. Financial Results for the Second Quarter 2025 Net revenue for the three months ended June 30, 2025, was approximately $0.3 million, reflecting sales of the QUELIMMUNE pediatric SCD therapy that was approved under a Humanitarian Device Exemption in February 2024 and launched as a commercial product by SeaStar Medical in July 2024. Research and development expenses for the three months ended June 30, 2025, and 2024, were $1.0 million and $2.3 million, respectively. The decrease in research and development expenses was primarily driven by a decline in preclinical and clinical trial expenses, consulting expenses, and personnel costs. General and administrative expenses for the three months ended June 30, 2025, and 2024, were approximately $1.0 million and $2.3 million, respectively. The decrease in general and administrative expenses was the result of a decline in audit and accounting related fees, Directors’ compensation, certain Securities and Exchange Commission (SEC) fees, personnel costs, and consultant expenditures. Other expenses (net) increased approximately $1.7 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. The increase was primarily related the decline in favorable gains from the change in fair value of liability classified warrants, a one-time financing fee, offset by the retirement of outstanding debt obligations since March 31, 2024. Net loss for the three months ended June 30, 2025, was approximately $2.0 million, or $0.18 per share on approximately 11.3 million weighted-average shares outstanding. This compares with a net loss of approximately $3.2 million, or $1.03 per share, on approximately 3.2 million weighted-average shares outstanding for the three months ended June 30, 2024. Cash at June 30, 2025 was $6.3 million, compared to $1.8 million at December 31, 2024. In July and August 2025 the Company raised an additional $8.4 million in two registered direct offerings. SeaStar Medical Second Quarter Financial Results Conference Call Date/Time:Wednesday, August 13, 2025, at 4:30 p.m. ET / 2:30 p.m. MT Webcast:The live webcast and replay can be found here. Conference ID:2078693 Dial-in numbers:1 (800) 715-9871 within the U.S. 1 (646) 307-1963 from outside the U.S. A replay of the call will be available after 7:30 p.m. ET and can be accessed as follows: The webcast replay is available here.The call replay number is 1 (609) 800-9909 and will be available through August 20, 2025. About QUELIMMUNE The QUELIMMUNE (SCD-PED) therapy is SeaStar Medical’s first commercial product based on its patented Selective Cytopheretic Device (SCD) technology. The QUELIMMUNE™ therapy is being commercialized for children (age 22 or younger) with AKI and sepsis or a septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with Renal Replacement Therapy (RRT). It was approved in February 2024 under a Humanitarian Device Exemption application that requires medical institutions to also participate in the SAVE Surveillance Registry and complete Institutional Review Board approvals prior to adoption and use of the QUELIMMUNE therapy. This prolongs the adoption timeline by medical institutions, but provides important data on the use of QUELIMMUNE in the “real-world” setting. Data from two clinical studies of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy. About NEUTRALIZE-AKI Pivotal Trial The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. About Acute Kidney Injury (AKI) and Hyperinflammation AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as sepsis, severe trauma, surgery and COVID-19. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous renal replacement therapy (CRRT) hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future CRRT, including dialysis, and prevent loss of life. About SeaStar Medical SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. The QUELIMMUNE (SCD-PED) therapy is SeaStar Medical’s first commercial product based on its patented Selective Cytopheretic Device (SCD) technology. The QUELIMMUNE (SCD-PED) therapy was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually. For more information visit www.seastarmedical.com or visit us on LinkedIn or X. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect to anticipated patient enrollment and the expansion of the clinical trial sites; the total addressable market for adult SCD applications; the ability of SeaStar Medical to gain market share and generate sales with respect to the total addressable market for adult SCD applications; the ability of SCD to treat patients with AKI and other diseases; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Contact: IR@SEASTARMED.COM — Financial Tables to Follow — SeaStar Medical Holding CorporationCondensed Consolidated Balance Sheets(in thousands, except for share and per-share amounts) June 30,2025 December 31,2024 (unaudited) ASSETS Current assets Cash $6,302 $1,819 Accounts receivable, net of allowance for credit losses of $8 and $0, respectively 217 112 Inventory 77 — Prepaid expenses 1,051 1,835 Total current assets 7,647 3,766 Other assets 736 892 Total assets $8,383 $4,658 LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT) Current liabilities Accounts payable $3,158 $3,046 Accrued expenses 1,883 3,188 Notes payable, net of deferred financing costs — 574 Liability classified warrants 1 33 Total current liabilities 5,042 6,841 Total liabilities 5,042 6,841 Commitments and contingencies (Note 10) Stockholders’ equity/(deficit) Preferred stock – $0.0001 par value, 10,000,000 shares authorized at June 30, 2025 and December 31, 2024; no shares issued and outstanding at June 30, 2025 and December 31, 2024 — — Common stock – $0.0001 par value per share; 450,000,000 and 500,000,000 shares authorized at June 30, 2025 and December 31, 2024, respectively; 17,343,269 and 5,977,246 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively 2 2 Additional paid-in capital 148,677 137,379 Accumulated deficit (145,338) (139,564)Total stockholders’ equity/(deficit) 3,341 (2,183)Total liabilities and stockholders’ equity/(deficit) $8,383 $4,658 SeaStar Medical Holding CorporationCondensed Consolidated Statements of Operations(unaudited)(in thousands, except for share and per-share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Net revenue $338 $— $631 $— Cost of goods sold 27 — 27 — Gross profit 311 — 604 — Operating expenses Research and development 1,037 2,334 3,468 4,031 General and administrative 1,030 2,335 2,716 4,588 Total operating expenses 2,067 4,669 6,184 8,619 Loss from operations (1,756) (4,669) (5,580) (8,619)Other income (expense) Interest income 45 25 93 25 Interest expense (9) (82) (18) (225)Other financing costs (298) — (298) — Change in fair value of convertible notes — (387) — (6,145)Change in fair value of warrants liability 16 1,880 32 (966)Total other income (expense), net (246) 1,436 (191) (7,311)Loss before provision for income taxes (2,002) (3,233) (5,771) (15,930)Provision for income taxes — 3 3 3 Net loss $(2,002) $(3,236) $(5,774) $(15,933)Net loss per share of common stock, basic and diluted $(0.18) $(1.03) $(0.58) $(5.36)Weighted-average shares outstanding, basic and diluted 11,329,517 3,154,782 9,981,215 2,975,248 SeaStar Medical Holding CorporationCondensed Consolidated Statements of Cash Flows(unaudited) Six Months Ended June 30, 2025 2024 Cash flows from operating activities Net loss $(5,774) $(15,933)Adjustments to reconcile net loss to net cash used in operating activities Amortization of deferred financing costs 18 57 Change in fair value of convertible notes (issued, converted and outstanding) — 6,145 Change in fair value of liability classified warrants (exercised and outstanding) (32) 966 Shares issued for the standby equity purchase agreement commitment fee 298 — Stock-based compensation 264 475 Change in operating assets and liabilities Accounts receivables, net (105) — Inventory (77) — Prepaid expenses 784 897 Other assets 156 152 Accounts payable 112 (255)Accrued expenses (1,305) 689 Other liabilities — 495 Net cash used in operating activities (5,661) (6,312) Cash flows from financing activities Proceeds from issuance of convertible notes — 979 Payment of convertible notes — (700)Proceeds from issuance of shares 5,154 4,492 Proceeds of pre-funded warrants 5,580 3,766 Proceeds from exercise of warrants 2 853 Payment of notes payable (592) (2,075)Net cash provided by financing activities 10,144 7,315 Net increase in cash 4,483 1,003 Cash, beginning of period 1,819 176 Cash, end of period $6,302 $1,179 Supplemental disclosure of cash flow information Cash paid for interest $— $439 Exercise of liability classified warrants $— $3,106 Shares issued from conversion of convertible notes $— $10,210 Issuance of convertible note warrants $— $586
Los Angeles, CA, Aug. 13, 2025 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (“BioSig” or the “Company”), which recently merged with Streamex Exchange Corporation (“Streamex”) (NASDAQ: BSGM), today announced the pricing of its previously announced underwritten public offering of 3,852,149 shares of common stock at a public offering price of $3.90 per share. The offering is expected to close on or around August 15, 2025 subject to customary closing conditions. The gross proceeds from the offering, before deducting underwriter discounts and commissions and other estimated offering expenses are expected to be approximately $15,023,381.10. BioSig intends to use the net proceeds from the offering to purchase gold bullion in accordance with its investment policy, for working capital and for general corporate purposes. Clear Street and Needham & Company are acting as joint book-running managers of the offering. The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-276298) declared effective by the Securities and Exchange Commission (the “SEC”) on December 17, 2024. A final prospectus supplement relating to the offering will be filed with the Securities and Exchange Commission, together with an accompanying base prospectus. The securities may be offered only by means of a written prospectus forming a part of the effective registration statement. Copies of the final prospectus supplement relating to the offering, together with the accompanying base prospectus, may be obtained, when available from the SEC’s website at http://www.sec.gov, from Clear Street, Attention: Syndicate, 4 World Trade Center, 150 Greenwich St, Floor 46, New York, NY 10007, or by email at syndicate@clearstreet.io and Needham & Company, 250 Park Avenue, 10th Floor, New York, NY 10177, Attn: Prospectus Department, prospectus@needhamco.com or by telephone at (800) 903-3268. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. BioSig will not, and has been advised by the joint book-running managers that they and their affiliates will not, sell any of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. About Streamex Streamex is a RWA and gold tokenization company building Institutional grade infrastructure to bring the gold market on chain, enabled by a gold denominated treasury and an institutional grade tokenization platform. Streamex is a wholly owned subsidiary of BioSig Technologies, Inc. About BioSig Technologies BioSig Technologies, Inc. is a medical device technology company with an advanced digital signal processing technology platform, the PURE EP™ Platform that delivers insights to electrophysiologists for ablation treatments of cardiovascular arrhythmias. The PURE EP™ Platform enables electrophysiologists to acquire raw signal data in real-time—absent of unnecessary noise or interference—to maximize procedural success and minimize unnecessary inefficiencies. As physician advocates, we believe that the ability to maintain the integrity of intracardiac signals with precision and clarity without driving up procedural costs has never been more pertinent. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond our control. It is possible that our actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether we will be able to realize the benefits of the acquisition of Streamex, whether shareholder approval of the acquisition and recently announced convertible debenture financing and standby equity purchase agreement will be obtained, and whether we will be able to maintain compliance with Nasdaq’s listing criteria in connection with the acquisition and otherwise. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in forward-looking statements, see our filings with the Securities and Exchange Commission, including the section titled “Risk Factors” in our Annual Report on Form 10-K, filed with the SEC on April 15, 2025. We assume no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law. CONTACT: Press & Investor Relations:
Ele Kauderer
PR@PhoenixMGMTconsulting.com
+1 888-228-0122
Henry McPhie
CEO of BioSig, Co-Founder of Streamex
contact@Streamex.com
https://x.com/streamex
EluPro™ Q2 revenue up 49% sequentially; Elutia advances next-generation drug-eluting biomatrix for breast reconstruction Conference call today at 5:00 p.m. ET / 2:00 p.m. PT GAITHERSBURG, Md., Aug. 14, 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 second quarter of 2025. Since full launch in January 2025, EluPro has rapidly established itself as the preferred antibiotic bioenvelope choice in cardiac implantable electronic device procedures, delivering robust revenue growth and expanding access through national group purchasing organization (GPO) contracts, value analysis committee (VAC) approvals, and a strategic distribution partnership with Boston Scientific. The Company also advanced its next-generation drug-eluting biomatrix pipeline, featuring the NXT-41 platform for breast reconstruction with initial product launch planned for the second half of 2026. Business Highlights: EluPro Momentum: Second quarter 2025 revenue up 49% sequentially. Total BioEnvelope revenue reached $3.5 million, up 33% year-over-year, with EluPro now contributing about two-thirds of total BioEnvelope sales.Robust Market Access of EluPro: VAC approvals now more than 160 centers, averaging about 12 new approvals monthly; customer base has grown more than 15x since launch.Strong Clinical Demand: EluPro customers are delivering meaningfully higher value than our legacy BioEnvelope platform, CanGaroo. In the second quarter, average sales per EluPro customer were 130% higher than for CanGaroo customers, reflecting stronger procedure penetration.Efficient Selling Model: Strong demand across both direct and distributor channels, fueling rapid market adoption and efficient entry into new geographies. Distributor-led growth now accounts for approximately 33% of EluPro sales.Innovation Recognition and Scientific Evidence: EluPro honored with two prestigious awards for Innovation and Product Launches at the 2025 Medical Device Network Excellence Awards; scientific leadership demonstrated by five peer-reviewed publications on EluPro.Legacy Litigation Substantially Resolved: Settled an additional 27 cases, bringing total FiberCel settlements to 97 of 110 and significantly reducing expected litigation expenses going forward.Cardiovascular Portfolio Update: Regained direct control of our sales of ProxiCor™, Tyke™, and VasCure™ in May 2025 with a seamless transition. Generated $736K in revenue in the first partial quarter of direct sales and expect continued sales growth and cash flow gains through an expanding distributor network.Pipeline Advancing: Progressing NXT-41x, a next-gen antibiotic biomatrix for breast reconstruction. Targeting FDA clearance of the base matrix in 2H26 and drug-eluting version in 1H27. Leveraging proven drug-delivery technology to address a $1.5 billion market with high complication rates. “EluPro’s performance continues to exceed expectations, and we now believe BioEnvelope sales will be approaching a $20 million annualized run rate by year-end,” said Dr. Randy Mills, CEO of Elutia. “Since its launch earlier this year, EluPro has expanded into more than 160 VAC-approved hospitals, with our commercial team rapidly growing its nationwide footprint. On the business development front, we are evaluating multiple transactions and expect to share more soon. With our first drug-eluting biologic proving to be a commercial success, we are rapidly advancing our NXT-41 platform, our next-generation antibiotic biomatrix for breast reconstruction. With FDA clearance of the base matrix expected in 2H26 and the drug-eluting version in 1H27, we are targeting a $1.5 billion market where one in three patients faces serious complications, and where NXT-41x can set a new standard of care so patients can thrive without compromise.” Second Quarter 2025 Financial Results For the three-month period ended June 30, 2025, as compared to the same period of 2024: Net sales for BioEnvelope products, including both EluPro and CanGaroo, increased by 33%, totaling $3.5 million compared to $2.6 million in Q2 2024, reflecting strong and accelerating sales of EluPro.Net sales of SimpliDerm were $2.0 million, compared to $2.6 million in Q2 2024.Net sales of Cardiovascular products were $0.7 million, compared to $1.1 million in Q2 2024.Overall net sales were $6.3 million, about the same compared to Q2 2024.Gross margin on a GAAP basis was 48.8%, compared to 44.5%Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 62.4%, compared to 58.0%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.Total operating expenses were $12.9 million, compared to $11.3 million.Loss from operations was $9.9 million, compared to $8.5 million.Net loss was $9.6 million, compared to $28.2 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 $3.8 million, compared to a loss of $2.6 million. A reconciliation of net loss to adjusted EBITDA is included in the accompanying financial tables.Cash balance as of June 30, 2025, was $8.5 million. 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 second quarter 2025 financial results and performance. The conference call can be accessed using the following information: Webcast: Click hereU.S. Investors: 877-407-8029International Investors: 201-689-8029Conference ID: 13754773 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 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 the market reception of EluPro, including the timing and anticipated success thereof, expectations regarding the Company’s next-generation drug-eluting biomatrix pipeline, including anticipated FDA clearance and 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, 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 continue as a going concern; our ability to successfully commercialize, market and sell our EluPro product; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates, including our next-generation drug-eluting biomatrix pipeline; our ability to raise capital in the amounts and at the times needed, and on acceptable terms; our ability to manage our substantial indebtedness and other obligations, such as our revenue interest obligation to Ligand Pharmaceuticals, including our ability to negotiate waivers or similar accommodations as needed; our ability to achieve or sustain profitability; 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 and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and 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 November 2023 sale of our 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 that 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) AssetsJune 30, 2025 December 31, 2024Current assets: Cash$8,500 $13,239 Accounts receivable, net 3,150 2,276 Inventory 5,243 3,911 Receivables of litigation costs 4,297 4,760 Prepaid expense and other current assets 1,090 1,986 Total current assets 22,280 26,172 Property and equipment, net 2,071 773 Intangible assets, net 6,575 8,273 Operating lease right-of-use assets, and other 2,923 909 Total assets$33,849 $36,127 Liabilities and Stockholders’ Deficit Current liabilities: Accounts payable and accrued expenses and other current liabilities$12,378 $11,253 Current portion of long-term debt 3,750 1,250 Current portion of revenue interest obligation 4,400 4,400 Contingent liability for legal proceedings 17,015 20,432 Current operating lease liabilities 405 460 Total current liabilities 37,948 37,795 Long-term debt 21,370 22,603 Long-term revenue interest obligation 4,692 5,490 Warrant liability 8,966 16,076 Other long-term liabilities 2,716 423 Total liabilities 75,692 82,387 Stockholders’ equity (deficit): Common stock 42 35 Additional paid-in capital 201,251 183,298 Accumulated deficit (243,136) (229,593)Total stockholders’ deficit (41,843) (46,260) Total liabilities and stockholders’ deficit$33,849 $36,127 ELUTIA INC.CONSOLIDATED STATEMENT OF OPERATIONS(Unaudited, in thousands, except share and per share data) Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Net sales$6,263 $6,291 $12,293 $12,985 Cost of goods sold 3,205 3,492 6,778 7,343 Gross profit 3,058 2,799 5,515 5,642 Operating expenses: Sales and marketing 3,778 3,330 6,809 6,639 General and administrative 3,695 4,689 7,566 9,745 Research and development 1,456 1,001 2,361 2,173 Litigation costs, net 4,004 2,289 6,576 4,074 Total operating expenses 12,933 11,309 23,312 22,631 Loss from operations (9,875) (8,510) (17,797) (16,989)Interest expense 518 1,267 1,603 2,580 Other (income) expense, net (791) 18,594 (5,873) 26,788 Income (loss) before provision of income taxes (9,602) (28,371) (13,527) (46,357)Income tax expense 8 (11) 16 (3)Net loss from continuing operations (9,610) (28,360) (13,543) (46,354)Income from discontinued operations – 180 – 180 Net loss (9,610) (28,180) (13,543) (46,174)Net loss per share – basic$(0.23) $(1.13) $(0.34) $(1.89)Net loss per share – diluted$(0.26) $(1.13) $(0.47) $(1.89)Weighted average common shares outstanding – basic 41,782,556 24,900,167 40,239,372 24,408,651 Weighted average common shares outstanding – diluted 46,308,642 24,900,167 44,765,897 24,408,651 ELUTIA INC.NON-GAAP GROSS PROFIT AND NON-GAAP GROSS MARGIN RECONCILIATIONS(Unaudited, in thousands, except share and per share data) Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Net sales$6,263 $6,291 $12,293 $12,985 Gross profit 3,058 2,799 5,515 5,642 Intangible asset amortization expense 849 849 1,699 1,699 Adjusted gross profit (Non-GAAP)$3,907 $3,648 $7,214 $7,341 Gross margin 48.8% 44.5% 44.9% 43.5%Adjusted gross margin percentage (Non-GAAP) 62.4% 58.0% 58.7% 56.5% ELUTIA INC.EBITDA AND ADJUSTED EBITDA RECONCILIATIONS(Unaudited, in thousands, except share and per share data) Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Net loss$(9,610) $(28,180) $(13,543) $(46,174)Interest expense(1) 518 1,267 1,603 2,580 Provision (benefit) for income taxes 8 (11) 16 (3)Depreciation and amortization 893 862 1,760 1,726 Earnings before interest, taxes, depreciation and amortization (“EBITDA”) (Non-GAAP) (8,191) (26,062) (10,164) (41,871)Income from discontinued operations – (180) – (180)Stock-based compensation 1,149 2,711 2,360 4,908 Litigation costs, net(2) 4,004 2,289 6,576 4,074 (Gain) loss on revaluation of warrant liability(3) (2,233) 18,337 (7,420) 27,974 Warrant issuance expenses – 257 105 257 (Gain) loss on revaluation of revenue interest obligation(4) 1,442 – 1,442 (1,442)Adjusted EBITDA (Non-GAAP)$(3,829) $(2,648) $(7,101) $(6,280) (1) Represents interest expense recorded on all outstanding long-term debt as well as the revenue interest obligation.(2) 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, indemnity and contribution agreements for such costs. (3) 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.(4) 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.
LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the second quarter ended June 30, 2025. Recent Business Highlights: Surpassed 85% enrollment in the FULCRUM-VT pivotal study of […]
Regulatory Reviews of Aficamten for Obstructive HCM Progressing in U.S., E.U. and China; Late-Cycle Meeting with U.S. FDA Scheduled for September Ahead of December 26, 2025 PDUFA Date Primary Results from MAPLE-HCM to be Presented in a Hot Line Session at the European Society of Cardiology Congress 2025 ~$1.0 Billion in Cash, Cash Equivalents and Investments as of June 30, 2025 SOUTH SAN FRANCISCO, Calif., Aug. 07, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the second quarter of 2025. “Following solid progress in the first half of the year, we are looking forward to several key corporate milestones. Our primary focus remains on preparations for the potential FDA approval of aficamten in late December and subsequent commercial launch in early 2026,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Additionally, we are pleased to be sharing results from MAPLE-HCM later this month, which we believe will provide important information related to the standard-of-care in obstructive HCM. With our current balance sheet and additional access to capital, we are well-positioned to execute on both the commercialization and potential label expansion opportunities of aficamten while also advancing our later-stage specialty cardiovascular pipeline.” Q2 and Recent Highlights Cardiac Muscle Programs aficamten (cardiac myosin inhibitor) Continued to support the review of the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) by the U.S. Food and Drug Administration (FDA). With the three-month extension of the Prescription Drug User Fee Act (PDUFA) target action date to December 26, 2025, the late cycle meeting is now scheduled to occur in September.Prepared responses to the Day 120 List of Questions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the Marketing Authorization Application (MAA) for aficamten for the treatment of obstructive HCM; submission on track to meet the clock stop timeline agreed with EMA. We expect a potential EMA decision regarding the MAA in 1H 2026.Completed all Good Clinical Practice (GCP) inspections for applications under review.Continued to support the review of the NDA for aficamten for obstructive HCM by the Center for Drug Evaluation (CDE) in China. Advanced the ongoing clinical trials program for aficamten: Announced positive topline results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM). The primary results will be presented in a Hot Line Session in August at the European Society of Cardiology Congress 2025.Continued conduct of ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), a pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM. We expect to share topline results of the primary cohort (excluding Japan) in 1H 2026. Dosed the first patient in the Japan cohort of ACACIA-HCM. Dosed the first patient in CAMELLIA-HCM, a Phase 3 clinical trial of aficamten in Japanese patients with obstructive HCM. CAMELLIA-HCM is being conducted by Bayer in collaboration with Cytokinetics to support potential marketing authorization in Japan.Continued enrolling patients in CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive HCM. We expect to complete patient enrollment of the adolescent cohort in 2H 2025. Presented new analyses at the European Society of Cardiology Heart Failure 2025 Congress from SEQUOIA-HCM on the effect of aficamten between patients with mild and moderate-to-severe symptoms, and across geographic regions. Expanded U.S. commercial readiness activities for aficamten including sales force recruitment, final stages of implementing patient support programs and finalization of our promotional launch campaign. Continued payer engagement to educate on the clinical data supportive of aficamten and the clinical and economic burden of HCM.Advanced European commercial readiness activities including hiring key leadership positions in our European headquarters and other EU and UK geographies, preparing Health Technology Assessment (HTA) dossiers and ensuring launch readiness for potential approval in Germany in 1H 2025. Published the following manuscripts: “A Plain Language Summary of the SEQUOIA-HCM Study: Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy” in Future Cardiology“Efficacy of Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy and Mild Symptoms: Results from the SEQUOIA-HCM Trial” in the European Heart Journal“Associations of Sex on Economic Burden in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy: Results from Medical and Pharmacy Claims Data in Frontiers in Cardiovascular Medicine“Aficamten Treatment for Symptomatic Obstructive Hypertrophic Cardiomyopathy: 48-weeks Results From FOREST-HCM” in the Journal of the American College of Cardiology – Heart Failure“Concomitant Aficamten and Disopyramide in Symptomatic Obstructive Hypertrophic Cardiomyopathy” in the Journal of the American College of Cardiology – Heart Failure“Clinical Evaluation of the Effect of Aficamten on QT/QTc Interval in Healthy Participants” in Clinical and Translational Science omecamtiv mecarbil (cardiac myosin activator) Continued conduct of COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction. We expect to continue enrollment through 2025 to enable completion of enrollment in late 2026. ulacamten (CK-4021586, cardiac myosin inhibitor) Received approval from the International Nonproprietary Names (INN) Program of the World Health Organization for ulacamten to be used as the nonproprietary name for CK-4021586.Continued conduct of AMBER-HFpEF (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF), a Phase 2 clinical trial of ulacamten in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction (LVEF) ≥ 60%. We expect to complete patient enrollment of the first two cohorts in 2H 2025. Pre-Clinical Development and Ongoing Research Continued pre-clinical development and research activities directed to additional muscle biology focused programs. Second Quarter 2025 Financial Results Cash, Cash Equivalents and Investments As of June 30, 2025, the company had approximately $1.0 billion in cash, cash equivalents and investments compared to $1.1 billion at March 31, 2025. Cash, cash equivalents and investments declined by $52.6 million during the second quarter of 2025. The Company received $75 million in proceeds from the drawing on Tranche 4 of the Royalty Pharma Multi Tranche Term Loan in the second quarter of 2025. Revenues Total revenues for the second quarter of 2025 were $66.8 million compared to $0.2 million for the same period in 2024. Revenues in the second quarter of 2025 included the recognition of $52.4 million related to the Company’s license and collaboration agreement for aficamten in Japan with Bayer, and $11.7 million for the achievement of clinical milestones in the non-obstructive HCM and obstructive HCM trials in Japan. Research and Development (R&D) Expenses R&D expenses for the second quarter of 2025 were $112.6 million, which included $13.5 million of non-cash stock-based compensation expense, compared to $79.6 million for the same period in 2024, which included $11.5 million of non-cash stock-based compensation expense. The increase was primarily due to advancing our clinical trials, higher personnel-related costs, and medical affairs-related activities. General and Administrative (G&A) Expenses G&A expenses for the second quarter of 2025 were $65.7 million, which included $14.0 million of non-cash stock-based compensation expense, compared to $50.8 million for the same period in 2024, which included $13.1 million of non-cash stock-based compensation expense. The increase was primarily due to investments toward commercial readiness and higher personnel-related costs. Net Income (Loss) Net loss for the second quarter of 2025 was $134.4 million, or $(1.12) per share, basic and diluted, compared to a net loss of $143.3 million, or $(1.31) per share, basic and diluted, for the same period in 2024. 2025 Financial Guidance The company is maintaining its full year 2025 financial guidance: GAAP operating expense*$670 million to $710 millionNon-cash stock-based compensation expense included in GAAP operating expense$120 million to $110 million *GAAP operating expense comprised of R&D and SG&A expenses. Anticipated year-over-year increase in GAAP operating expense includes investments toward commercial readiness for the potential approval and launch of aficamten for patients with obstructive HCM. The financial guidance does not include the effect of GAAP adjustments as may be caused by events that occur subsequent to publication of this guidance, including but not limited to Business Development activities. Conference Call and Webcast Information Members of Cytokinetics’ senior management team will review the company’s second quarter 2025 results on a conference call today at 4:30 PM Eastern Time. The conference call will be simultaneously webcast and can be accessed from the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com or directly at the following link: Cytokinetics Q2 2025 Earnings Conference Call. An archived replay of the webcast will be available via Cytokinetics’ website for six months. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our or our partners’ research and development and commercial readiness activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of any of our clinical trials, or more specifically, our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by the target PDUFA date or any other date, if ever, our ability to complete enrollment of CEDAR-HCM and AMBER-HFpEF in the second half of 2025, our ability to complete patient enrollment of COMET-HF in 2026, our ability to announce the results of ACACIA-HCM in the first half of 2026, our ability to announce the results of any of our clinical trials by any particular date, the timing of interactions with FDA or any other regulatory authorities in connection to any of our drug candidates and the outcomes of such interactions; statements relating to the potential patient population who could benefit from aficamten, omecamtiv mecarbil, CK-586, CK-089 or any of our other drug candidates; statements relating to our ability to receive additional capital or other funding, including, but not limited to, our ability to meet any of the conditions relating to or to otherwise secure additional loan disbursements under any of our agreements with entities affiliated with Royalty Pharma or additional milestone payments from Sanofi or Bayer in connection with our collaborations for aficamten in China or Japan respectively; statements relating to our operating expenses or cash utilization for the remainder of 2025 or any other period, and statements relating to our cash balance at any particular date or the amount of cash runway such cash balances represent at any particular time. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Cytokinetics’ need for additional funding and such additional funding may not be available on acceptable terms, if at all; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may incur unanticipated research and development and other costs; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Quarterly Report on Form 10-A for the quarter ended March 31, 2025. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757 Cytokinetics, IncorporatedCondensed Consolidated Balance Sheets(in thousands) June 30, 2025 December 31, 2024 (unaudited) ASSETS Current assets: Cash and short term investments $858,135 $1,076,014 Other current assets 28,407 31,926 Total current assets 886,542 1,107,940 Long-term investments 178,201 145,055 Property and equipment, net 70,219 65,815 Operating lease right-of-use assets 76,120 75,158 Other assets 14,553 7,705 Total assets $1,225,635 $1,401,673 LIABILITIES AND STOCKHOLDERS’ DEFICIT Current liabilities: Accounts payable and accrued liabilities $68,543 $75,692 Short-term operating lease liabilities 19,585 18,978 Current portion of long-term debt 14,400 11,520 Derivative liabilities measured at fair value 17,600 11,300 Deferred revenue 1,344 52,370 Other current liabilities 9,592 9,814 Total current liabilities 131,064 179,674 Term loan, net 159,058 93,227 Convertible notes, net 553,987 552,370 Liabilities related to revenue participation right purchase agreements, net 489,503 462,192 Long-term operating lease liabilities 111,028 112,582 Liabilities related to RPI Transactions measured at fair value 147,700 137,000 Other non-current liabilities 2,015 — Total liabilities 1,594,355 1,537,045 Commitments and contingencies Stockholders’ deficit Common stock 119 118 Additional paid-in capital 2,628,829 2,563,876 Accumulated other comprehensive (loss) income (158) 2,398 Accumulated deficit (2,997,510) (2,701,764)Total stockholders’ deficit (368,720) (135,372)Total liabilities and stockholders’ deficit $1,225,635 $1,401,673 Cytokinetics, IncorporatedCondensed Consolidated Statements of Operations(in thousands except per share data)(unaudited) Three Months Ended Six Months Ended June 30, 2025 June 30, 2024 June 30, 2025 June 30, 2024Revenues: Collaboration revenues $2,416 $249 $3,995 $1,084 License and milestone revenues 64,353 — 64,353 — Total revenues 66,769 249 68,348 1,084 Operating expenses: Research and development 112,554 79,597 212,395 161,167 General and administrative 65,721 50,824 123,090 96,324 Total operating expenses 178,275 130,421 335,485 257,491 Operating loss (111,506) (130,172) (267,137) (256,407)Interest expense (11,084) (12,732) (19,952) (19,835)Non-cash interest expense on liabilities related to revenue participation right purchase agreements (13,181) (11,567) (27,259) (21,785)Interest and other income, net 13,001 11,553 26,702 19,466 Change in fair value of derivative liabilities 3,000 (600) 2,600 (600)Change in fair value of liabilities related to RPI Transactions (14,600) 200 (10,700) 200 Net loss $(134,370) $(143,318) $(295,746) $(278,961)Net loss per share — basic and diluted $(1.12) $(1.31) $(2.49) $(2.63)Weighted-average number of shares used in computing net loss per share — basic and diluted 119,457 109,240 118,979 106,013
