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Merit Medical Acquires Biolife Delaware, L.L.C.

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Acquired business offers the StatSeal® and WoundSeal® products, which provide hemostasis solutions that complement the wide range of procedures Merit’s portfolio supports.Acquisition projected to add approximately $18 million of revenue, on an annualized basis beginning in fiscal year 2026, with a mid-teens growth and accretive non-GAAP margin and profitability profileMerit reaffirms full-year 2025 financial guidance previously issued on April 24, 2025, and updates full-year 2025 financial guidance to include the projected impact from this acquisition SOUTH JORDAN, Utah, May 20, 2025 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced that it has acquired Biolife Delaware, L.L.C. (“Biolife”) in a merger transaction through which Biolife has become a wholly-owned subsidiary of Merit. Biolife, which is headquartered in Sarasota, Florida, manufactures unique patented hemostatic devices under the brand names StatSeal and WoundSeal. The aggregate transaction consideration, paid in cash and assumption of Biolife liabilities, was approximately $120 million. This strategic acquisition positions Merit to provide clinicians with more products designed to standardize, simplify, and minimize post-procedure care and maintenance. Many Merit products operate through small openings in the skin that require efficient solutions to stop bleeding, help patients recover, and minimize costly complications. In such cases, StatSeal specifically works with the patient’s blood to rapidly form a protective seal over the procedure site. Adding StatSeal to Merit’s hemostasis portfolio is intended to provide healthcare partners with an additional effective solution that complements a wide range of percutaneous procedures, including interventional radiology and cardiology, dialysis, electrophysiology, biopsy, and drainage. “We are excited to enhance the portfolio of hemostatic solutions offered to clinicians with the acquisition of Biolife,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “The acquisition provides effective, differentiated, hemostatic solutions for all percutaneous devices with a broad range of clinical applications including vascular closure and indwelling catheter bleeding complications. BioLife’s StatSeal and WoundSeal products address an estimated $350M global market opportunity, are clinically validated, and will enhance our ability to deliver comprehensive solutions to our customers. Moreover, with Merit’s resources and expertise, we believe we are well positioned to further develop and expand the reach of these product lines, ultimately benefiting patients and healthcare providers globally.” Mr. Lampropoulos continued, “We have updated our full-year 2025 financial guidance to include the projected impact of this acquisition from the merger effective date of May 20, 2025 to December 31, 2025 and we have reaffirmed our updated full-year 2025 financial guidance previously issued on April 24, 2025. While we anticipate the transaction will be slightly dilutive to our full-year 2025 non-GAAP profitability given the partial-year contribution, we believe the financial profile of this acquisition is very attractive and is consistent with our goal of delivering sustainable, constant currency growth, improving profitability and strong free cash flow generation. We look forward to discussing this acquisition in further detail on our second quarter earnings report on July 30, 2025.” Non-GAAP net income; non-GAAP earnings per share; non-GAAP gross margin; non-GAAP operating margin and constant currency revenue are non-GAAP financial measures. A quantitative reconciliation of such financial measures to comparable GAAP financial measures is not available without unreasonable effort. For more information about Merit Medical and the StatSeal and WoundSeal product lines, please visit www.merit.com. Financial Summary Merit believes that the acquired assets generated approximately $15 million of revenue over the twelve-month period ended December 31, 2024. The acquired assets are expected to contribute revenue, from the merger effective date of May 20, 2025 through December 31, 2025, in the range of $10 to $11 million and are projected, during the same period of time, to dilute Merit’s previously forecasted non-GAAP net income and non-GAAP earnings per share, inclusive of approximately $3.0 million of lower interest income on cash balances used for the total purchase consideration and excluding approximately $7.2 million of non-cash and non-recurring transaction-related expenses, and to be dilutive to Merit’s full-year 2025 GAAP net income and GAAP earnings per share. The acquisition is projected to be accretive to non-GAAP gross margin, non-GAAP operating margin in 2025 and slightly accretive to non-GAAP net income and non-GAAP earnings per share in 2026. The acquisition is projected to be dilutive to Merit’s GAAP net income and GAAP earnings per share in the first full-year post close and accretive thereafter. Updated Fiscal Year 2025 Financial Guidance Merit’s updated full-year 2025 financial guidance now reflects the projected impacts of the Biolife acquisition from the merger effective date of May 20, 2025 through December 31, 2025. Merit is otherwise reaffirming prior full-year 2025 financial guidance previously announced on April 24, 2025. Based upon the information currently available to Merit’s management, for the year ending December 31, 2025, after giving effect to the Biolife acquisition and absent material acquisitions, non-recurring transactions or other factors beyond Merit’s current expectations, Merit now expects the following financial results: Revenue and Earnings Guidance*         Updated GuidancePrior Guidance(2)Financial Measure Year Ending% Change Year Ending% Change   December 31, 2025Y/YDecember 31, 2025Y/Y      Net Sales $1.480 – $1.501 billion9% – 11%$1.470 – $1.490 billion8% – 10%Cardiovascular Segment $1.407 – $1.426 billion8% – 10%$1.397 – $1.415 billion7% – 9%Endoscopy Segment $73.0 – $75.0 million34% – 37%$73.0 – $75.0 million34% – 37%      Non-GAAP     Earnings Per Share(1) $3.28 – $3.41(5%) – (1%)$3.29 – $3.42(5%) – (1%) *Percentage figures approximated; dollar figures may not foot due to rounding(1) Merit’s non-GAAP earnings per share reflect the dilutive impact of its 3.00% Convertible Senior Notes due 2029 (the “Convertible Notes”) calculated using the if-converted method of approximately $0.05 for the year ending December 31, 2025. Any offsetting impacts of the capped call associated with the Convertible Notes are not considered(2) “Prior Guidance” reflects Merit’s full-year 2025 financial guidance, previously updated on April 24, 2025. 2025 Net Sales Guidance – % Change from Prior Year (Constant Currency) Reconciliation*            Updated Guidance Prior Guidance(1)  Low High Low High2025 Net Sales Guidance – % Change from Prior Year (GAAP) 9.1% 10.7% 8.4% 9.8%Estimated impact of foreign currency exchange rate fluctuations 0.4% 0.4% 0.4% 0.4%2025 Net Sales Guidance – % Change from Prior Year (Constant Currency) 9.5% 11.0% 8.7% 10.2% *Percentage figures approximated and may not foot due to rounding(1)“Prior Guidance” reflects Merit’s full-year 2025 financial guidance, previously introduced on April 24, 2025. Merit does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures (other than revenue) because Merit is unable to predict with reasonable certainty the financial impact of various items which could impact Merit’s future financial results, such as expenses attributable to acquisitions or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain employee termination benefits, performance-based stock compensation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, Merit is unable to address the significance of the unavailable information, which could be material to future results. Specifically, Merit is not, without unreasonable effort, able to reliably predict the impact of these items and Merit believes inclusion of a reconciliation of these forward-looking non-GAAP measures to their GAAP counterparts could be confusing to investors or cause undue reliance. Merit’s financial guidance for the year ending December 31, 2025 is subject to risks and uncertainties identified in this release and Merit’s filings with the U.S. Securities and Exchange Commission (the “SEC”). This guidance is based on information and estimates available to Merit as of May 20, 2025. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results will likely vary, and could vary materially, from past results and those anticipated, estimated or projected. Advisors: Piper Sandler & Co. acted as a financial advisor to Merit. Parr Brown Gee & Loveless P.C. served as legal advisor to Merit. Nelson Mullins Riley & Scarborough LLP served as legal advisor to Biolife. ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,300 people worldwide. ABOUT BIOLIFE, L.L.C. Biolife Delaware, L.L.C., headquartered in Sarasota, Florida, manufactures innovative healthcare and first-aid solutions designed to improve patient quality of life. Biolife’s products consist of a powder with two main ingredients: potassium ferrate and a hydrophilic polymer. The products work independently of the clotting cascade to seal the wound or vascular access site while accelerating hemostasis. StatSeal products for the healthcare industry are available in powder and disc (compressed powder) form. WoundSeal products for the consumer and occupational health industries are available in powder form. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This 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 include, among others: statements proceeded or followed by, or that include the words, “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “intends,” “seeks,” “believes,” “estimates,” “projects,” “forecasts,” “potential,” “target,” “continue,” “upcoming,” “optimistic” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology;statements that address Merit’s future operating performance or events or developments that Merit’s management expects or anticipates will occur, including, without limitation, any statements regarding Merit’s projected revenues, earnings or other financial measures, Merit’s plans and objectives for future operations, Merit’s proposed new products or services, the integration, development or commercialization of the business or any assets acquired from other parties, future economic conditions or performance, the implementation of, and results which may be achieved through, Merit’s Continued Growth Initiatives Program or other business optimization initiatives, and any statements of assumptions underlying any of the foregoing; andstatements regarding Merit’s past performance, efforts, or results about which inferences or assumptions may be made, including statements proceeded or followed by the words “preliminary,” “initial,” “potential,” “possible,” “diligence,” “industry-leading,” “compliant,” “indications,” or “early feedback” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology. The forward-looking statements contained in this release are based on Merit management’s current expectations and assumptions regarding future events or outcomes. If underlying expectations or assumptions prove inaccurate, or risks or uncertainties materialize, actual results will likely differ, and could differ materially, from Merit’s expectations reflected in any forward-looking statements. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Investors are cautioned not to unduly rely on any such forward-looking statements. The following are some of the important risks and uncertainties that could cause Merit’s actual results to differ from Merit’s expectations in any forward-looking statements: inherent risks and uncertainties associated with Merit’s acquisition of Biolife; Merit’s integration of the Biolife business and operations and its ability to achieve projected financial results, product development and other anticipated benefits of the acquisition; uncertainties as to whether Merit will achieve sales, gross and operating margin, net income and earnings per share performance consistent with its forecasts projected for the Biolife acquisition; risks and uncertainties regarding trade policies or related actions implemented by the U.S. or other countries, including existing, proposed or prospective tariffs, duties or other measures; inherent risks and uncertainties associated with Merit’s integration of businesses or assets previously acquired from third parties, including the acquisitions of certain businesses and assets from Cook Medical Holdings LLC in November 2024 and EndoGastric Solutions, Inc. in July 2024, and Merit’s ability to achieve the anticipated operating and financial results, product development and other anticipated benefits of such acquisitions; forecasted results and consequences of regulatory approvals of Merit’s products; effects of Merit’s 3.00% Convertible Senior Notes due 2029 on Merit’s net income and earnings per share performance; disruptions in Merit’s supply chain, manufacturing or sterilization processes; U.S. and global political, economic, competitive, reimbursement and regulatory conditions; reduced availability of, and price increases associated with, components and other raw materials; increases in transportation expenses; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; fluctuations in interest or foreign currency exchange rates and inflation; risks and uncertainties associated with Merit’s information technology systems, including the potential for breaches of security and evolving regulations regarding privacy and data protection; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; difficulties relating to development, testing and regulatory approval, clearance and maintenance of Merit’s products; the safety, efficacy and patient and physician adoption of Merit’s products; uncertainties regarding enrollment and outcomes of ongoing and future clinical trials and market studies relating to Merit’s products; modification or limitation of governmental or private insurance reimbursement policies; litigation and other judicial proceedings affecting Merit; the potential of fines, penalties or other adverse consequences if Merit’s employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; consequences associated with a Corporate Integrity Agreement executed between Merit and the U.S. Department of Justice; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; product recalls and product liability claims; potential for significant adverse changes in governing regulations; changes in tax laws and regulations in the United States or other jurisdictions or exposure to additional tax liabilities which may adversely affect Merit’s effective tax rate; termination of relationships with Merit’s suppliers, or failure of such suppliers to perform; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; dependence on distributors to commercialize Merit’s products in various jurisdictions outside the U.S.; failure to comply with applicable environmental laws; changes in key personnel; labor shortages and increases in labor costs; price and product competition; extreme weather events; and geopolitical events. For a further discussion of the risks and uncertainties which may affect Merit’s business, operations and financial condition, see Part I, Item 1A, “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (the “SEC”), Part II, Item 1A, “Risk Factors” in Merit’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 filed with the SEC and Merit’s other filings with the SEC. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Those estimates and all other forward-looking statements included in this release are made only as of the date of this release, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to estimates and all other forward-looking statements. TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. CONTACTS PR/Media Inquiries Sarah Comstock Merit Medical +1-801-432-2864 | sarah.comstock@merit.com   INVESTOR INQUIRIES Mike Piccinino, CFA, IRC Westwicke – ICR +1-443-213-0509 | mike.piccinino@westwicke.com

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RenovoRx Reports First Quarter 2025 Financial Results and Business Highlights

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Q1 2025 RenovoCath® Revenues of ~$200,000, Exceeding Expectations and Anticipated to Continue Growing Sequentially with New Customer Purchase Orders and Reorders Cash on Hand of $14.6 Million Anticipated to Fully Fund both RenovoCath Commercialization Scale-up and Continued Progress Towards the Completion of the Ongoing Phase III TIGeR-PaC Clinical Trial Completion of […]

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Adagio Medical Reports First Quarter 2025 Results

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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 first quarter ended March 31, 2025. Recent Business Highlights: Received Breakthrough Device Designation from the U.S. Food and […]

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TriSalus Life Sciences Reports First Quarter 2025 Results and Provides Updated 2025 Guidance

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Company delivers 42% revenue growth year-over-year and strengthens balance sheet with $22 million gross proceeds from recent private placement Expands commercial footprint, and invests further in new applications for TriNav already in use Updates 2025 guidance to reflect strategic investment in our core liver market and new applications for PEDD […]

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Philips Future Health Index 2025: AI poised to transform global healthcare, urging leaders to act now

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May 15, 2025AI has the power to cut care delays and manage data overload, but trust gaps among clinicians and patients threaten to slow adoption and impactAmsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, has released its 10th annual Future Health Index (FHI) report, highlighting the growing strain on global healthcare systems. The FHI 2025 Report, the largest global survey of its kind analyzing key concerns of healthcare professionals and patients, indicates AI holds promise for transforming care delivery. However, gaps in trust threaten to stall progress at a time when innovation is most needed.“The need to transform healthcare delivery has never been more urgent,” said Carla Goulart Peron, M.D., Chief Medical Officer at Philips. “In more than half of the 16 countries surveyed, patients are waiting nearly two months or more for specialist appointments, with waits in Canada and Spain extending to four months or longer. As healthcare systems face mounting pressures, AI is rapidly emerging as a powerful ally, offering unprecedented opportunities to transform care and overcome today’s toughest challenges.”Long waits, worsening outcomesThe FHI 2025 report reveals 33% of patients have experienced worsening health due to delays in seeing a doctor, and more than 1 in 4 end up in the hospital due to long wait times. “Cardiac patients face especially dangerous delays, with 31% being hospitalized before even seeing a specialist. Without urgent action, a projected shortfall of 11 million health workers by 2030 could leave millions without timely care,” Dr. Peron added.Clinician burnout and data burdens call for digital reliefMore than 75% of healthcare professionals report losing clinical time due to incomplete or inaccessible patient data, with one-third losing over 45 minutes per shift, adding up to 23 full days a year lost by each professional. “These inefficiencies amplify stress on already understaffed teams and contribute to burnout,” said Gretchen Brown, RN, VP and Chief Nursing Information Officer at Stanford Health Care. “Recognizing this, as clinicians, we see AI as a solution and understand that delayed adoption can also carry major risks.”   Of the nearly 2,000 healthcare professionals surveyed, if AI is not implemented:

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SeaStar Medical Reports First Quarter 2025 Financial Results and Provides Business Updates

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QUELIMMUNE adoption drives four-fold increase in sequential quarter net revenue NEUTRALIZE AKI trial exceeds 50% enrollment, triggers start of Interim AnalysisWebcast Today at 4:30 pm Eastern Time DENVER, May 14, 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 March 31, 2025, and provided business updates on key initiatives. “This is our second full quarter of the QUELIMMUNE launch and we believe our four-fold increase in revenue represents the strong commitment by our customers to improve outcomes in their pediatric patients with Acute Kidney Injury (AKI) with this potential life-saving therapy,” said Eric Schlorff, CEO of SeaStar Medical. “We also continue to attract new customers, including a nationally recognized children’s medical center that just completed Institutional Review Board (IRB) approvals and placed its first order for the QUELIMMUNE therapy.” Mr. Schlorff continued, “Importantly, we are now looking to expand access to our promising technology into the adult AKI market, where this is also a very high unmet need. Our NEUTRALIZE-AKI trial in adult AKI patients is now 50% enrolled and we look forward to completing the trial and potentially filing the Premarket Approval (PMA) application in 2026. Our team is already actively engaging with health care providers in peer-to-peer nephrology venues to provide education and awareness of our Selective Cytopheretic Device (SCD) therapy. Given the same mechanism of action as QUELIMMUNE, albeit a larger device for the adult SCD therapy, we are excited to unveil results from this trial in 2026.” Key Business Highlights in 2025 Since the beginning of 2025, SeaStar Medical’s key business updates include the following: Reported a four-fold increase in QUELIMMUNE net product revenue in the first quarter of 2025 to approximately $293 thousand compared to approximately $68 thousand in the fourth quarter of 2024.Broadened the QUELIMMUNE customer base, securing three new customers in 2025, including a nationally recognized children’s medical center that recently completed IRB approvals and placed an initial order for QUELIMMUNE therapy.Achieved 50% enrollment in the NEUTRALIZE-AKI pivotal trial, triggering the initiation of the prespecified, per protocol Interim Analysis by the trial’s independent Data Safety Monitoring Review Board (DSMB). SeaStar Medical anticipates the DSMB will report its findings to the company in the third quarter of 2025.Awarded two new Breakthrough Device Designations for use of the SCD therapy to treat systemic inflammatory response in 1) adult patients undergoing cardiac surgery and 2) pediatric patients undergoing cardiac surgery towards prevention of post-operative adverse complications and outcomes. This brings SeaStar Medical’s total Breakthrough Device Designations to six therapeutic indications, enabling a potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch.Successfully completed an FDA site inspection of SeaStar Medical’s facility for QUELIMMUNE kitting operations, eliminating its contract manufacturer and enabling internal controls over the entire kitting process.Received from the FDA an Investigational Device Exemption (IDE) for a clinical trial to evaluate the SCD therapy as a bridging strategy to left ventricular assist device (LVAD) implantation in patients with chronic heart failure who have progressed to acute decompensated heart failure. This indication has been granted Breakthrough Device Designation by the FDA.  It represents a market where there is serious unmet need for effective treatments.  Awarded the NKF 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. Financial Results for the First Quarter 2025 Net revenue for the three months ended March 31, 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 March 31, 2025, and 2024, were $2.4 million and $1.7 million, respectively. The increase in research and development expenses was primarily driven by an increase in clinical trial costs related to the NEUTRALIZE-AKI pivotal trial, as well as medical affairs and personnel costs, partially offset by a decline in costs for external services. General and administrative expenses for the three months ended March 31, 2025, and 2024, were approximately $1.7 million and $2.3 million, respectively. The decrease in general and administrative expenses was the result of a decline in accounting-related costs, as well as legal-related and consulting expenses, partially offset by an increase in SEC-related expenses. Other expenses (net) decreased approximately $8.8 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease was primarily related to the retirement of outstanding debt obligations and the elimination of convertible notes and related warrants since March 31, 2024. Net loss for the three months ended March 31, 2025, SeaStar Medical was approximately $3.8 million, or $0.44 per share on approximately 8.6 million weighted-average shares outstanding. This compared with a net loss of approximately $12.7 million, or $4.73 per share, on approximately 2.7 million weighted-average shares outstanding for the three months ended March 31, 2024. The Company reported cash, cash equivalents and long-term investments of $5.3 million as of March 31, 2025, compared to $1.8 million as of December 31, 2024. In January 2025 the Company announced an approximately $6.0 million registered direct offering priced at-the-market. SeaStar Medical First Quarter Financial Results Conference Call Date/Time:Wednesday, May 14, 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 pm 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 May 20, 2025. About QUELIMMUNE The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with Renal Replacement Therapy (RRT). The QUELIMMUNE therapy was approved in February 2024 under a Humanitarian Device Exemption application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who have few treatment options. SeaStar Medical commenced its commercial launch of the QUELIMMUNE therapy in July 2025. 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 Therapy The Selective Cytopheretic Device (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 has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing nearly a million 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 RRT, 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. SeaStar’s first commercial product, QUELIMMUNE (SCD-PED), 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, 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)     March 31,2025 December 31,2024 (unaudited)  ASSETSCurrent assets   Cash$5,296  $1,819 Accounts receivable, net 110   112 Inventory 44   — Prepaid expenses 1,334   1,835 Total current assets 6,784   3,766 Other assets 813   892 Total assets$7,597  $4,658     LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT)Current liabilities   Accounts payable$3,397  $3,046 Accrued expenses 3,255   3,188 Notes payable, net of deferred financing costs 363   574 Liability classified warrants 17   33 Total current liabilities 7,032   6,841 Total liabilities 7,032   6,841     Commitments and contingencies (Note 10)           Stockholders’ equity/(deficit)   Preferred stock – $0.0001 par value, 10,000,000 shares authorized at March 31, 2025 and December 31, 2024; no shares issued and outstanding at March 31, 2025 and December 31, 2024 —   — Common stock – $0.0001 par value per share; 450,000,000 and 500,000,000 shares authorized at March 31, 2025 and December 31, 2024, respectively; 9,257,763 and 5,977,246 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 2   2 Additional paid-in capital 143,899   137,379 Accumulated deficit (143,336)  (139,564)Total stockholders’ equity/(deficit) 565   (2,183)Total liabilities and stockholders’ equity/(deficit)$7,597  $4,658          SeaStar Medical Holding CorporationCondensed Consolidated Statements of Operations(unaudited)(in thousands, except for share and per-share amounts)   Three Months Ended March 31, 2025 2024    Net revenue$293  $— Cost of goods sold —   — Gross profit 293   — Operating expenses   Research and development 2,431   1,697 General and administrative 1,684   2,253 Total operating expenses 4,115   3,950 Loss from operations (3,822)  (3,950)Other income (expense)   Interest expense (11)  (143)Interest income 48   — Change in fair value of convertible notes —   (5,758)Change in fair value of liability classified warrants 16   (2,846)Total other income (expense), net 53   (8,747)Loss before provision for income taxes (3,769)  (12,697)Provision for income taxes 3   — Net loss$(3,772) $(12,697)Net loss per share of common stock, basic and diluted$(0.44) $(4.73)Weighted-average shares outstanding, basic and diluted 8,617,932   2,684,243          SeaStar Medical Holding CorporationCondensed Consolidated Statements of Cash Flows(unaudited)   Three Months Ended March 31, 2025 2024    Cash flows from operating activities   Net loss$(3,772) $(12,697)Adjustments to reconcile net loss to net cash used in operating activities   Amortization of deferred financing costs 11   27 Change in fair value of convertible notes (issued, converted and outstanding) —   5,758 Change in fair value of liability classified warrants (exercised and outstanding) (16)  2,846 Stock-based compensation 167   434 Change in operating assets and liabilities   Accounts receivables, net 2   — Inventory (44)  — Prepaid expenses 501   614 Other assets 79   2 Accounts payable 351   (493)Accrued expenses 67   21 Net cash used in operating activities (2,654)  (3,488)    Cash flows from financing activities   Proceeds from issuance of convertible notes —   979 Proceeds from issuance of shares, net of issuance costs 1,566   4,543 Proceeds from sale of pre-funded warrants 4,785   3,769 Proceeds from exercise of warrants 2   853 Payment of notes payable (222)  (1,813)Net cash provided by financing activities 6,131   8,331 Net increase in cash 3,477   4,843 Cash, beginning of period 1,819   176 Cash, end of period$5,296  $5,019  Supplemental disclosure of cash flow informationThree Months Ended March 31, 2025 2024Cash paid for interest$—  $— Exercise of pre-funded warrants$—  $3,106 Shares issued as payment of convertible notes$—  $9,387 Issuance of convertible note warrants$—  $586 

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BioCardia Reports First Quarter 2025 Business Highlights and Financial Results

Financial by Comments are Disabled

SUNNYVALE, Calif., May 14, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the first quarter of 2025 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2025 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session. Recent Business Highlights CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01) On March 30, 2025, two-year results from the double-blind randomized placebo-controlled Phase 3 CardiAMP HF Trial of its CardiAMP autologous minimally invasive cell therapy for the treatment of ischemic heart failure in patients with reduced ejection fraction (HFrEF) were presented as a late-breaking clinical trial at the American College of Cardiology’s Annual Scientific Sessions, demonstrating increased survival, decreased cardiovascular events such as stroke, heart attacks, and hospitalizations and improved quality of life for treated patients at two years. Statistically significant and clinically meaningful improvements were seen in the subset of patients suffering from active heart stress (50% of enrolled patients), as demonstrated by elevated NTproBNP and BNP biomarkers. The Company is on track to share the two-year data with both the FDA and Japan Pharmaceuticals and Medical Devices Agency in the coming weeks and align on pathways to make CardiAMP available for physicians and their patients.The CardiAMP HF II Trial is underway in the United States, with three sites actively enrolling patients. This confirmatory trial focuses on patients with active heart stress with a primary endpoint based on a three-tiered Finkelstein-Schoenfeld hierarchical analysis. The tiers, starting with the most serious events, are (1) all-cause death, including cardiac death equivalents, (2) non-fatal Major Adverse Coronary and Cerebrovascular Events (MACCE), (3) change from baseline in quality of life at a minimum of 12 months and a maximum of 24 months. In the CardiAMP HF Trial, this composite efficacy endpoint was achieved with statistical significance in the subset of patients with elevated NTproBNP that are the focus of the CardiAMP HF II study (p=0.02). CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02) Results from the open-label roll-in cohort of patients having chronic myocardial ischemia with refractory angina to date have shown an average 107 second increase in exercise tolerance and an 82% average reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment. The last roll-in cohort patient has recently reached this six-month primary endpoint, and we intend to prepare the primary results of this cohort for publication and presentation. CardiALLO Cell Therapy in Ischemic Heart Failure (BCDA-03) The low dose cohort of 20 million cells in the phase 1/2 clinical trial was completed in the first quarter 2025 and there have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic responses. The independent Data Safety Monitoring Board recommended that the study proceed as designed in April 2025 based on the 30-day data safety assessment from this cohort. The Company plans to progress the trial to enrollment of 39 participants in the United States and fund development through nondilutive grant applications and partnering. Helix Biotherapeutic Delivery The Company’s Helix transendocardial biotherapeutic delivery system performed well in the recent CardiAMP HF Trial as presented on March 30, with no procedure-related deaths, embolism, or need for surgical cardiac or endovascular repair occurring. This contributes to the growing body of experience using this delivery platform and supports the independent FDA submission for approval that we are currently pursuing. Helix procedures are also now using the advanced Morph DNA bidirectional steerable platform to navigate, and physician feedback has been positive. Intellectual Property The Company’s intellectual property portfolio is robust, with more than 60 patents and patent applications worldwide. In March, the Company announced that the Japan Patent Office granted Japanese Patent No: 7641330 titled “Radial and Transendocardial Delivery Catheter,” with a patent term that will expire on or after September 30, 2034. The patent describes minimally invasive interventional biotherapeutic delivery catheters to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal treatment at the sites where needed, minimizes off-target toxicities, and avoids the need for surgical access to the heart. Two additional patents have also been allowed this year and are expected to issue in the near future. “This has been a great quarter for all of our therapeutic programs in development,” said BioCardia CEO Peter Altman, Ph.D. “Most importantly, the CardiAMP HF Trial has provided significant rigorous evidence supporting both safety and meaningful benefits of CardiAMP cell therapy for heart failure patients who still have elevated biomarkers of heart stress, despite being on maximal guideline directed medical therapy. Our top priorities are the regulatory submissions for the CardiAMP Cell Therapy System clinical consultation with Japan PMDA and for the Helix transendocardial delivery system application for approval in the United States. Both are anticipated this quarter.” First Quarter 2025 Financial Results: Research and development expenses were approximately $1.5 million for the three months ended March 2025 compared to approximately $1.2 million for the three months ended March 2024, primarily due to closeout activities in the CardiAMP HF Trial and the inception of enrollment in the CardiAMP HF II Trial.Selling, general and administrative expenses were approximately $1.2 million for the three months ended March 2025 compared to approximately $1.1 million for the three months ended March 2024.Our net loss was approximately $2.7 million for the three months ended March 2025, compared to approximately $2.3 million for the three months ended March 2024.Net cash used in operations for the three months ended March 2025 was approximately $1.6 million, as compared to approximately $1.5 million for the three months ended March 2024. ANTICIPATED UPCOMING MILESTONES AND EVENTS: BCDA-01: CardiAMP Autologous Cell Therapy for Ischemic Heart Failure CardiAMP HF ManuscriptJapan PMDA Clinical Consultation request / submissionFDA Meeting request / submissionCardiAMP Heart Failure II Trial – additional sites and enrollment BCDA-02: CardiAMP Autologous Cell Therapy in Chronic Myocardial ischemia Completed roll-in cohort data submitted for presentation / publication BCDA-03: CardiALLO Allogeneic Cell Therapy in Inflammatory Ischemic Heart Failure Dose cohort 2 completed enrollment Helix Biotherapeutic Delivery Business FDA approval milestonesPartnering Morph Access Innovations Business Revenues and case reportsIndication specific deals About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLOTM allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its HelixTM biotherapeutic delivery and Morph® vascular navigation platforms. The CardiAMP Cell Therapy Trial for Heart Failure has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services. For more information visit: www.BioCardia.com. Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment in our clinical trials, the availability of data from our clinical trials, filings and communications with the FDA and Japan’s Pharmaceutical and Medical Device Agency, product clearances, the efficacy and safety of our products and therapies, preliminary conclusions about new data, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for our products and therapies, the expected benefits of our intellectual property, future prospects, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter into licensing and partnering arrangements and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent the development of our therapeutic candidates. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.  BioCardia, Inc.Condensed Consolidated Statements of Operations (Unaudited in thousands, except share and per share amounts)            Three Months endedMarch 31,    2025 2024Revenue:     Collaboration agreement revenue$—$55Costs and expenses:     Research and development 1,530 1,241 Selling, general and administrative 1,196 1,089  Total costs and expenses 2,726 2,330  Operating loss (2,726) (2,275)Other income (expense):      Total other income, net 14 8Net loss$(2,712) $(2,267)       Net loss per share, basic and diluted$(0.59)$(1.35)       Weighted-average shares used in computing   net loss per share, basic and diluted 4,635,764 1,675,539        BioCardia, Inc.     Selected Balance Sheet Data     (amounts in thousands)                   March 31,  December 31,  2025(1)  2024(1)      Assets:     Cash and cash equivalents$949 $2,371Other current assets 224  251Property, plant and equipment and other noncurrent assets 993  1,102Total assets$2,166 $3,724Liabilities and Stockholders’ Equity (Deficit)     Current liabilities$3,234 $2,321Operating lease liability – noncurrent 452  566Total stockholders’ equity (deficit) (1,520)  837Total liabilities and stockholders’ equity (deficit)$2,166 $3,724      (1) March 31, 2025 amounts are unaudited. December 31, 2024 amounts were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission on March 26, 2025.CONTACT: Media Contact:
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120

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Artivion Announces Agreements to Exchange $95 Million in Principal Amount of its 4.250% Convertible Notes Due 2025 for Common Stock

Financial by Comments are Disabled

ATLANTA, May 14, 2025 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that it entered into separate, privately negotiated exchange agreements with certain holders of its 4.250% Convertible Senior Notes…

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Maze Therapeutics Reports First Quarter 2025 Financial Results and Reiterates Upcoming Milestones

Financial by Comments are Disabled

MZE829 Phase 2 HORIZON Trial Enrolling Patients with APOL1 Kidney Disease; Initial Data Expected in Q1 2026 MZE782 Phase 1 Healthy Volunteer Trial Ongoing; Initial Data Expected in Q3 2025 Strong Balance Sheet with $294.4 Million in Cash and Cash Equivalents, Expected to Provide Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., May 14, 2025 (GLOBE NEWSWIRE) — Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, metabolic and cardiovascular diseases, today reported financial results for the first quarter ended March 31, 2025, and reiterated upcoming milestones. “With two clinical programs underway – an important milestone that underscores the strength of our Compass platform and drug development expertise – Maze is entering a new phase of growth,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We’re particularly excited about MZE782, a genetically informed therapy that we believe could be best-in-class for PKU and first-in-class for CKD. We expect to report Phase 1 healthy volunteer data, including biomarker results, later this year to support Phase 2 trials in both indications. In addition, our Phase 2 HORIZON trial of MZE829 continues to actively enroll, on track for a readout in Q1 2026. With a strong balance sheet following our IPO, we’re well-positioned to deliver on our pipeline and mission.” Key Anticipated Milestones MZE829 for APOL1 Kidney Disease (AKD) MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AKD, a subset of chronic kidney disease (CKD) estimated to affect over one million people in the United States (U.S.) alone. Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes a broad population of patients with AKD, including those with diabetes, those with non-diabetic kidney disease, and patients with severe focal segmental glomerulosclerosis (FSGS).Maze expects to announce initial proof-of-concept data from the Phase 2 HORIZON trial in the first quarter of 2026. MZE782 in CKD and Phenylketonuria (PKU) MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential to be a first-in-class treatment for the approximately five million U.S. patients with CKD who inadequately respond to currently available CKD therapies, as well as potential to be a best-in-class therapy for patients with PKU, an inherited metabolic disorder. MZE782 is currently being evaluated in a Phase 1 clinical trial in healthy volunteers.Maze expects to report initial data, including proof-of-mechanism biomarker results, in the third quarter of 2025.Based on Phase 1 results, Maze plans to initiate two separate Phase 2 clinical trials of MZE782 in CKD and PKU. First Quarter 2025 Financial Results Cash Position: Cash and cash equivalents were $294.4 million as of March 31, 2025, compared to $196.8 million as of December 31, 2024. Maze expects that its current cash and cash equivalents will fund operations into the second half of 2027. Research & Development (R&D) Expenses: R&D expenses were $27.6 million and $21.9 million for the first quarter of 2025 and 2024, respectively. This increase primarily reflects higher clinical trial expenses for MZE829 and MZE782 and personnel-related expenses, including non-cash stock-based compensation expense. General & Administrative (G&A) Expenses: G&A expenses were $7.8 million and $6.1 million for the first quarter of 2025 and 2024, respectively. This increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense, and professional services fees. Net Loss: Net loss was $32.8 million and $32.5 million for the first quarter of 2025 and 2024, respectively. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which provides insights into the genetic variants in disease and links them with the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for patients. For more information, please visit mazetx.com, or follow us on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AKD or other indications, the ability of MZE782 to treat CKD, PKU or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, and the sufficiency of the company’s cash and cash equivalents to fund its operating expenses and capital expenditure requirements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. IR/Corporate Contact:Amy Bachrodt, Maze Therapeuticsabachrodt@mazetx.com Media Contact:Dan Budwick, 1ABdan@1abmedia.com   Maze Therapeutics, Inc.Select Condensed Financial Information(in thousands, except share and per share amounts)(unaudited)  Condensed Statements of Operations        Three Months Ended  March 31,  2025  2024 Operating expenses:     Research and development$27,580  $21,877 General and administrative 7,821   6,137 Total operating expenses 35,401   28,014 Loss from operations (35,401)  (28,014)Interest and other income, net 2,615   281 Change in fair value of convertible promissory notes —   (4,761)Net loss$(32,786) $(32,494)Net loss per share, basic and diluted$(1.15) $(13.91)Weighted-average shares of common stock outstanding used to compute net loss per share, basic and diluted 28,628,430   2,336,613            Condensed Balance Sheet Data        March 31,  December 31,  2025  2024 Cash and cash equivalents$294,374  $196,812 Total assets$332,840  $240,542 Total liabilities$40,772  $43,638 Total redeemable convertible preferred stock$—  $508,087 Total stockholders’ equity (deficit)$292,068  $(311,183)        

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