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BioSig Technologies Inc. Announces Pricing of $15 Million Public Offering

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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

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Elutia Delivers Robust Growth on the Strength of EluPro™ Market Adoption

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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.

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Adagio Medical Reports Second 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 second quarter ended June 30, 2025. Recent Business Highlights: Surpassed 85% enrollment in the FULCRUM-VT pivotal study of […]

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Cytokinetics Reports Second Quarter 2025 Financial Results and Provides Business Update

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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 

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Humacyte Announces Second Quarter 2025 Financial Results and Provides Business Update

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– Total revenues of $301,000 for quarter, and $818,000 for first six months of 2025, from sales and collaborative research agreement – – 82 civilian hospitals now have VAC approval to purchase Symvess™ – – ECAT approval makes Symvess available to 35 Military Treatment Facilities and 160 U.S. Department of Veterans Affairs hospitals – – Conference call today at 8:00 am ET – DURHAM, N.C., Aug. 11, 2025 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. “During our second quarter of 2025, we continued to execute on our U.S. commercial launch and now have 82 civilian hospitals eligible to purchase Symvess,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “This is a substantial increase from the five hospitals that were eligible to purchase at our last quarterly update in May. This tremendous increase is due to a combination of individual hospital and healthcare system Value Analysis Committee (VAC) approvals. In addition, our recent inclusion on the Electronic Catalog (ECAT) means that approximately 190 Military Treatment Facilities and U.S. Department of Veterans Affairs (VA) hospitals are also eligible to purchase Symvess. While we encountered some headwinds during the second quarter of 2025 due to unsubstantiated attacks by detractors, we have moved forward and seen an acceleration in VAC approvals in late June and July. Indeed, our July product sales exceeded the total sales recorded during the first half of the year. We were also pleased to achieve our first commercial sale to a U.S. military treatment facility in July, and this facility has since re-ordered the Symvess product. We have great interest in improving the medical options available to healthcare professionals treating military personnel and their families and look forward to advancing our discussions with additional Department of Defense (DOD) hospitals.” “We were also gratified to see that our V007 trial data was one of only three presentations selected for special mention by the Society of Vascular Surgery in June, and that the Society chose to highlight the strength of the results in their own announcement,” continued Dr. Niklason. “In our V007 trial, the ATEV was observed to have superior functional patency during the first year over the autologous fistula control group not only in the overall study population but in two important subgroups: women, and men with diabetes and obesity. These two groups make up more than half of the dialysis access market and are underserved by the current standard of care, representing a high unmet medical need. We look forward to publication of the results from the V007 Phase 3 clinical trial in a major peer-reviewed medical journal this year.” Second Quarter 2025 and Recent Corporate Highlights Symvess Market Launch VAC Approval Process and Sales: To date, a total of 13 VACs have approved the Symvess product. Since these VAC approvals include multi-hospital networks, 82 civilian hospitals are now eligible to purchase Symvess. Furthermore, an additional 40 VACs are currently conducting their review process. Humacyte has experienced an acceleration in VAC approvals in late June and July 2025, and July product sales of $0.3 million exceeded the sales recorded during the first half of the year. To date, 12 hospitals have ordered Symvess, with multiple facilities re-ordering additional product during the month of July.ECAT Approval: In July 2025, Symvess was granted ECAT listing approval from the U.S. Defense Logistics Agency. ECAT is an internet system that provides the DOD and other federal agencies with access to manufacturers’ and distributors’ products. The ECAT approval makes Symvess available to healthcare professionals treating military service members, veterans, and other patients receiving care at approximately 35 Military Treatment Facilities and approximately 160 VA hospitals.First Military Treatment Facility Sale: Following the ECAT approval, the first sale of Symvess to a U.S. Military Treatment Facility was completed in July. The facility is a state-of-the-art medical complex located on a major U.S. military base that provides healthcare to approximately 200,000 active-duty service personnel, retirees, and their family members. Subsequent to the initial shipment, the facility has re-ordered Symvess. We are in active discussions with additional DOD facilities that are expressing interest in purchasing Symvess. ATEV in Dialysis V007 Phase 3 Study Results in Dialysis Highlighted at Major Vascular Surgery Conference: Results from the V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous (AV) access were presented in a plenary session at the Society for Vascular Surgery Vascular Annual Meeting (VAM25) in June 2025. The V007 clinical trial enrolled a total of 242 patients, of which 110 were described as high-risk of fistula non-maturation – either women, or men having diabetes and obesity. Among this cohort, functional patency at six months and secondary patency at 12 months were significantly higher in ATEV recipients (85.7% and 76.8%, respectively), compared with AV fistula (51.9% and 46.3%, respectively) (global p-value, p

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BioCardia Reports Second Quarter 2025 Business Highlights and Financial Results

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SUNNYVALE, Calif., Aug. 11, 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 second quarter of 2025 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 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) Two-year results from the double-blind randomized placebo-controlled Phase 3 CardiAMP HF Trial of 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 on March 30, 2025. For study subjects, all on stable guideline directed medical therapy, the CardiAMP HF treatment group had a lower incidence of both all cause death and non-fatal MACCE than the control group during the entire 24-month period of the CardiAMP HF study (p=0.17) and the composite endpoint of all cause death, non-fatal MACCE, and quality of life was statistically significant in the subgroup of patients with elevated NTproBNP (p =0.02).CardiAMP HF Trial data has been submitted to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and we have requested a meeting to receive advice to align with PMDA on the acceptability of the clinical data and positioning of the CardiAMP system for Japanese patients with heart failure. We anticipate an in-person consultation in the fourth quarter of 2025, the outcome of which could enable us to submit for approval of the CardiAMP system for market entry in Japan.We have reported parallel ongoing efforts towards requesting a meeting with the FDA on the approvability of the FDA Designated Breakthrough CardiAMP System based on this clinical data in the fourth quarter 2025.The confirmatory CardiAMP HF II phase 3 trial is underway in the United States, with four sites actively enrolling patients and additional sites being onboarded. This trial focuses on patients with active heart stress with a primary composite endpoint of all cause death, non-fatal MACCE, and quality of life achieved in CardiAMP HF (p=0.02). CardiAMP HF II includes using the cell population analysis at screening to define treatment doses, which enables more patients to be eligible for the therapy, and improvements to the Helix system, with the use of the FDA approved Morph DNA steerable platform. Medicare reimbursement for both treated and controlled patients under C9782 is currently $17,500, which helps offset the costs of this study and reported as a reduction in R&D expense. 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 CardiAMP cell therapy procedure for chronic myocardial ischemia is also reimbursed by CMS under reimbursement code C9782, which covers both treated and controlled patients. The last roll-in cohort patient has reached this six-month primary endpoint, and we intend to prepare the primary results of this cohort for publication and presentation. CardiALLO allogeneic cell therapy in Ischemic Heart Failure (BCDA-03) The Investigational New Drug application (IND) for a Phase 1/2 trial to deliver our allogeneic MSC for the treatment of HFrEF follows our previous cosponsored TRIDENT and POSEIDON clinical trials enrolling 45 patients at dosages up to 100 million cells delivered with our Helix transendocardial catheter. The current trial includes a 3+3 roll-in dose escalation up to a dose of 200 million cells followed by a 30-patient randomized double-blind controlled study based on a recent IND amendment to right size the study for nondilutive funding opportunities which are under discussion. The low dose cohort of 20 million cells has been completed 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. Helix Biotherapeutic Delivery The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart and underlies BCDA-01, 02, and 03 programs. We recently announced our intent to submit for approval of the Helix transendocardial system as a DeNovo 510(k) in the third quarter 2025. Intellectual Property The Company’s intellectual property portfolio was strengthened with the issuance of another patent this past quarter. In June, the Company announced that the that United States Patent Office has granted US patent No. 12,311,127 titled “Radial and Trans-endocardial Delivery Catheter.” The patent describes the Company’s minimally invasive interventional biotherapeutic delivery catheter systems to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal, site-specific treatment, minimizes off-target toxicities, and avoids the need for surgical access to the heart. The allowed patent protects BioCardia’s helical needle-tipped catheter technology platform, which the scientific literature supports is the safest1 and most efficient2 approach for biotherapeutic delivery to the heart. “Heart failure remains a large, unmet need, impacting the lives of 56 million people worldwide, and we have made significant progress advancing our autologous CardiAMP cell therapy candidate intended to promote increased microvascular density and reduce fibrosis for a significant subgroup of these patients,” said BioCardia CEO Peter Altman, Ph.D. “Our active discussions on the approvability of the CardiAMP Cell Therapy System, as well the anticipated submission for approval of its dedicated Helix transendocardial biotherapeutic delivery catheter with even broader therapeutic impact have potential to be transformative for patients, physicians, and shareholders alike.” Second Quarter 2025 Financial Results: Research and development expenses increased to approximately $1.4 million for the three months ended June 2025 from approximately $0.8 million in the three months ended June 2024, and increased to approximately $2.9 million in the six months ended June 2025 from the six months ended June 2024, primarily due to closeout activities in the CardiAMP HF Trial and the beginning of enrollment in the CardiAMP HF II Trial.Selling, general and administrative expenses decreased to approximately $0.7 million in the three months ended June 2025 compared to approximately $0.9 million for the three months ended June 2024, primarily due to lower professional fees and share-based compensation expense. Selling, general and administrative expenses remained consistent at approximately $1.9 million in the six months ended June 2025, as compared to approximately $1.9 million in the six months ended June 2024.Our net loss was approximately $2.0 million for the three months ended June 2025, compared to approximately $1.6 million for the three months ended June 2024, and was approximately $4.8 million for the six months ended June 2025, compared to approximately $3.9 million for the six months ended June 2024. These increases were due primarily to the increased expenses associated with closeout activities in the CardiAMP HF Trial and the beginning of enrollment in the CardiAMP HF II Trial.Net cash used in operations for the three months ended June 2025 was approximately $1.6 million, as compared to approximately $1.3 million for the three months ended June 2024. Net cash used in operations for the six months ended June 2025 was approximately $3.3 million, as compared to approximately $2.8 million for the six months ended June 2024.Our cash balance on June 30, 2025, was approximately $980,000. During the period from July 1, 2025 to August 8, 2025, we sold an aggregate of 296,422 shares of common stock under our ATM program at an average price of $2.59 per share to total gross proceeds of $769,000. This brings our current cash balance to approximately $1.1 million and provides runway into October 2025. ANTICIPATED UPCOMING MILESTONES AND EVENTS: BCDA-01 CardiAMP Autologous Cell Therapy in Heart Failure (HF) CardiAMP HF manuscript – Q4 2025CardiAMP HF Japan PMDA Clinical Review – Q4 2025CardiAMP HF FDA meetings on approvability based on subgroup and safety – Q4 2025CardiAMP HF II Enrollment – Ongoing            BCDA-02 CardiAMP Autologous Cell Therapy in Chronic Myocardial Ischemia CardiAMP CMI Top line Data Rollin Cohort – Q4 2025 BCDA-03 CardiALLO Allogeneic MSC Cell Therapy in Heart Failure CardiALLO HF Nondilutive Funding – Q1 2026 Helix Biotherapeutic Delivery System Helix biotherapeutic delivery FDA Submission for Approval – Q3 2025 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 PMDA, product clearances, the efficacy and safety of our products and therapies, 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.”  1. Raval AN and Pepine CJ. Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting, Cardiovasc Revasc Med, 2021.2. Mitsutake Y, Pyum WB, Rouy D, et al. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart, Int Heart J. 2017.  BIOCARDIA, INC.             Consolidated Statements of Operations             (Unaudited In thousands, except share and per share amounts)                               Three Months endedJune 30,   Six Months endedJune 30,       2025  2024   2025  2024 Revenue:              Collaboration agreement revenue$— $3  $— $58 Costs and expenses:              Research and development 1,368  800   2,898  2,041  Selling, general and administrative 683  852   1,879  1,941   Total costs and expenses 2,051  1,652   4,777  3,982   Operating loss (2,051) (1,649)  (4,777) (3,924)Other income (expense):               Total other income, net  2  3   16  11 Net loss$(2,049) $(1,646)  $(4,761) $(3,913)                  Net loss per share, basic and diluted$(0.40) $(0.88)  $(0.98) $(2.20)                  Weighted-average shares used in computing             net loss per share, basic and diluted 5,059,736  1,877,069   4,848,922  1,776,305                   BioCardia, Inc.      Selected Balance Sheet Data      (amounts in thousands)               June 30,2025(1)   December 31,2024(1)            Assets:      Cash and cash equivalents$980  $2,371Other current assets 219   251Property, plant and equipment and other noncurrent assets 890   1,102Total assets$2,089  $3,724Liabilities and Stockholders’ Equity (Deficit)      Current liabilities$3,642  $2,321Operating lease liability – noncurrent 333   566Total stockholders’ equity (deficit) (1,886)  837Total liabilities and stockholders’ equity (deficit)$2,089  $3,724       (1) June 30, 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.         Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120

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Milestone Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Regulatory and Corporate Update

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FDA Accepted the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray; New PDUFA Target Date of December 13, 2025 Milestone Strengthens Balance Sheet to Fully Commercialize CARDAMYST if Approved Public Offering Raised Total Gross Proceeds of up to $170 Million if all Warrants are Exercised $75 Million Royalty Purchase Agreement Payment from RTW Extended Through End of 2025 MONTREAL and CHARLOTTE, N.C., Aug. 12, 2025 (GLOBE NEWSWIRE) — Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the second quarter ended June 30, 2025 and provided corporate and regulatory updates. “With the FDA’s recent acceptance of our response to the CRL, our team is energized as we work toward the potential approval of CARDAMYST in its first indication, PSVT,” said Joe Oliveto, President and Chief Executive Officer of Milestone. “In parallel to our regulatory progress, we completed an equity financing in July with high-quality investors which strengthened our balance sheet and extended our operating runway. Our goal is to make CARDAMYST quickly available to PSVT patients, should the FDA grant approval this year.” Second Quarter and Recent Program Updates Etripamil for patients with PSVT FDA accepted the Company’s response to the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) Nasal Spray and set a new Prescription Drug User Fee Act (PDFUA) target date of December 13, 2025.  In June, Milestone submitted to the FDA its response to a CRL for CARDAMYST, its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). On July 11, 2025, the Company announced the FDA accepted the response to issues raised in the CRL and assigned a new PDUFA target date of December 13, 2025. Milestone has maintained its launch infrastructure that was in place prior to the CRL and has restarted targeted pre-launch activities given the new potential approval date of CARDAMYST. Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) Phase 3 protocol of etripamil in AFib-RVR finalized. Milestone has finalized the Phase 3 study protocol following FDA’s review and obtained concurrence with the Agency to proceed. The Company has paused initiation of enrollment in the study to prioritize resources for the preparation of the expected launch of etripamil in PSVT. Second Quarter and Recent Corporate Updates In July 2025, Milestone completed a public equity offering, raising total gross proceeds of up to $170 million, if all Series A and B warrants are exercised for cash, including immediate net proceeds of approximately $48.7 million. Milestone intends to use the proceeds from the underwritten public offering (the “Offering”), together with existing cash and cash equivalents, to fund the continued development and commercial launch of CARDAMYST in its lead indication of PSVT, as well as for working capital and other general corporate purposes. The Offering consisted of the sale and issuance of (i) 31,500,000 of its common shares (the “Shares”), accompanying Series A common warrants (the “Series A Common Warrants”) to purchase an aggregate of 31,500,000 common shares and accompanying Series B common warrants (the “Series B Common Warrants”) to purchase an aggregate of 31,500,000 common shares , at a combined public offering price of $1.50 per share and accompanying Series A Common Warrant and Series B Common Warrant and (ii) in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase 3,502,335 common shares, accompanying Series A Common Warrants to purchase an aggregate of 3,502,335 common shares and accompanying Series B Common Warrants to purchase an aggregate of 3,502,335 common shares, at a combined public offering price of $1.499 per pre-funded warrant and accompanying Series A Common Warrant and Series B Common Warrant, which represented the combined public offering price for the Shares and accompanying common warrants less the $0.001 per share exercise price for each such pre-funded warrant. The net proceeds to the Company received from the Offering were approximately $48.7 million after deducting underwriting commissions and estimated offering expenses payable by the Company.Amended Royalty Agreement with RTW. Milestone extended the marketing approval deadline in its $75 million purchase and sale agreement (the “Royalty Purchase Agreement”) with existing shareholder, RTW Investments, LP, and certain of its affiliates (RTW) from September 30, 2025 to December 31, 2025. The proceeds from the Royalty Purchase Agreement are expected to fund the continued development and commercial launch of CARDAMYST in its lead indication of PSVT, following potential FDA approval and satisfaction of other customary closing conditions. Second Quarter 2025 Financial Results   As of June 30, 2025, Milestone had cash, cash equivalents, and short-term investments of $43.4 million, compared to $69.7 million as of December 31, 2024. Subsequent to the end of the quarter, the company raised net proceeds of approximately $48.7 million from the Offering, as described above.There was no revenue for the second quarter ended June 30, 2025 or for the second quarter of 2024.Research and development expense for the second quarter of 2025 was $3.7 million, compared with $2.8 million for the prior year period. For the six months ended June 30, 2025, research and development expense was $8.6 million compared with $6.5 million for the same period in 2024. The increase was primarily due to higher consulting and outside service costs that were partially offset by lower personnel-related costs.General and administrative expense for the second quarter of 2025 was $3.8 million, compared with $5.0 million for the prior year period. For the six months ended June 30, 2025, general and administrative expense was $8.9 million, compared with the $9.0 million for the prior year period.  The decrease between the quarters is primarily due to a decrease in legal fees, professional fees, and personnel costs.Commercial expense for the second quarter of 2025 was $5.1 million, compared with $1.8 million for the prior year period. For the six months ended June 30, 2025, commercial expense was $15.5 million compared with $4.7 million for the prior year period. These increases are a result of additional personnel costs, professional costs and other operational expenses related to preparation for the launch of CARDAMYST. As a result of the CRL, Milestone temporarily paused the ramping of operational expenditures related to launch, but has maintained the capability to launch quickly, pending approval of CARDAMYST by the FDA.For the second quarter of 2025, net loss was $13.0 million, compared to $9.4 million for the prior year period. For the six months ended June 30, 2025, Milestone’s net loss was $33.7 million, compared to $19.7 million in the prior year period. For further details on the Company’s financials, refer to the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC. About EtripamilEtripamil is Milestone’s lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR. About Milestone PharmaceuticalsMilestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will”, “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: the outcomes of future interactions with the FDA, including the potential approval of the NDA for CARDAMYST for PSVT; Milestone’s ability to receive additional cash proceeds from the warrants issued in the Offering; Milestone’s ability to receive the $75.0 million royalty payment under the Royalty Purchase Agreement on the timeline provided, or at all; Milestone’s expected operating runway; CARDAMYST’s potential as a novel treatment option to help patients with PSVT; Milestone’s ability to make CARDAMYST quickly available to PSVT patients following FDA approval, if received; the success of Milestone’s launch infrastructure; the timing of patient enrollment in the Phase 3 study of etripamil for AFib-RVR; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended June 30, 2025, in each case under the caption “Risk Factors,” as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Contact:  Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com        Milestone Pharmaceuticals Inc.Condensed Consolidated Balance Sheets (Unaudited)(in thousands of US dollars, except share data)       June 30, 2025 December 31, 2024Assets           Current assets     Cash and cash equivalents$42,499  $25,314 Short-term investments918  44,381 Research and development tax credits receivable1,079  901 Prepaid expenses748  1,840 Other receivables924  1,490 Total current assets46,168  73,926 Operating lease right-of-use assets1,090  1,376 Property and equipment159  197 Total assets$47,417  $75,499       Liabilities, and Shareholders’ (Deficit) Equity           Current liabilities     Accounts payable and accrued liabilities$8,768  $7,555 Operating lease liabilities515  571 Total current liabilities9,283  8,126 Operating lease liabilities, net of current portion641  874 Senior secured convertible notes55,238  53,352 Total liabilities65,162  62,352             Shareholders’ (Deficit) Equity     Common shares, no par value, unlimited shares authorized, 53,494,261 shares issued and outstanding as of June 30, 2025, 53,353,984 shares issued and outstanding as of December 31, 2024288,263  288,048 Pre-funded warrants – 12,910,590 issued and outstanding as of June 30, 2025 and 12,910,590 as of December 31, 202453,076  53,076 Additional paid-in capital42,188  39,568 Accumulated deficit(401,272) (367,545)      Total shareholders’ (deficit) equity(17,745) 13,147       Total liabilities and shareholders’ equity$47,417  $75,499       Milestone Pharmaceuticals Inc.Condensed Consolidated Statements of Loss (Unaudited)(in thousands of US dollars, except share and per share data)                 Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024                Revenue$—  $—  $—  $—                 Operating expenses               Research and development, net of tax credits 3,669   2,815   8,647   6,454 General and administrative 3,759   5,046   8,926   8,999 Commercial 5,103   1,801   15,481   4,685                 Loss from operations (12,531)  (9,662)  (33,054)  (20,138)                Interest income 516   1,186   1,213   2,180 Interest expense (951)  (887)  (1,886)  (1,759)                Net loss and comprehensive loss$(12,966) $(9,363) $(33,727) $(19,717)                Weighted average number of shares and pre-funded warrants outstanding, basic and diluted  66,380,118   66,165,461   66,333,024   58,160,286                 Net loss per share, basic and diluted$(0.20) $(0.14) $(0.51) $(0.34)                

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Orchestra BioMed Reports Second Quarter 2025 Financial Results and Highlights Recent Business Updates

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Secured over $111 million in proceeds and committed capital following completion of strategic transactions and concurrent public and private equity offerings, led by over $71 million in committed capital from Medtronic and LigandAchieved multiple FDA regulatory milestones: Breakthrough Device Designation for AVIM therapy; approval for expanded BACKBEAT study enrollment criteria, and IDE approval for a U.S. pivotal Virtue SAB trial versus commercially available paclitaxel-coated balloon NEW HOPE, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the second quarter ended June 30, 2025, and provided a business update highlighting recent financial and regulatory milestones. Q2 2025 and Recent Business Highlights: Completed multiple strategic transactions and concurrent public and private equity offerings totaling an expected $111.2 million in gross proceeds to support continued advancement of the Company’s late-stage atrioventricular interval modulation (“AVIM”) therapy and Virtue Sirolimus AngioInfusion Balloon (“SAB”) clinical programs. Gross proceeds are comprised of: $55 million received or to be received by May 1, 2026, subject to certain conditions, from royalty-based, non-dilutive investments from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND, “Ligand”) and Medtronic, plc (NYSE: MDT, “Medtronic”) Ligand committed $35 million in exchange for a tiered revenue interest in Orchestra BioMed’s future royalties from AVIM therapy and Virtue SABMedtronic committed $20 million in exchange for a secured subordinated promissory note convertible to capped prepaid revenue share $56.2 million received from a $40 million underwritten public offering of common stock and prefunded warrants and $11.2 million and $5 million received from private placements of common stock to Medtronic and Ligand, respectivelyProceeds expected to extend cash runway into the second half of 2027, supporting potentially significant value-creating catalysts, including: BACKBEAT study enrollment completion in mid-2026BACKBEAT study primary endpoint dataSubstantial enrollment of the Virtue Trial Medtronic and Orchestra BioMed expanded strategic collaboration to provide pathway for future development of AVIM therapy-enabled leadless pacemakers.U.S. Food and Drug Administration (“FDA”) Breakthrough Device Designation (“BDD”) granted for atrioventricular interval modulation (“AVIM”) therapy in patients with uncontrolled hypertension and increased cardiovascular risk, marking a major regulatory validation of the therapy’s potential to improve hypertensive heart disease outcomes.FDA-approved updated BACKBEAT study protocol now being implemented, broadening patient enrollment criteria for a more than 24-fold increase in the potentially eligible patient pool; full implementation to be completed in Q4 2025.FDA Investigational Device Exemption (“IDE”) Approval received for the Virtue SAB U.S. pivotal trial, a randomized head-to-head study comparing Virtue SAB with the commercially available AGENT™ DCB paclitaxel-coated balloon (the “Virtue Trial”). Trial initiation is currently targeted for the second half of 2025. Orchestra BioMed is sponsoring and in full operational control of the Virtue Trial; mediation with Terumo of certain other contractual terms is progressing, with conclusion of formal mediation process expected in Q3 2025. Intellectual Property Expansion continued with AVIM therapy patent estate reaching 137 issued patents worldwide, with recent additions bolstering coverage for both hypertension and heart failure indications. Chairman and Chief Executive Officer (“CEO”) Commentary from David Hochman: Mr. Hochman stated: “The successful completion of strategic financing transactions with Medtronic and Ligand, along with closing our first underwritten public offering are expected to give us up to $111 million in new capital to support execution of both AVIM therapy and Virtue SAB pivotal clinical studies. Our entire organization is focused on our mission to bring these high-impact, innovative, device-based therapies to market.” Mr. Hochman continued: “We were also proud to have achieved multiple key regulatory milestones for both AVIM therapy and Virtue SAB in the second quarter. The FDA Breakthrough Device Designation awarded to AVIM therapy for the treatment of uncontrolled hypertension in patients with increased cardiovascular risk has potentially significant implications to future regulatory submissions and opens up potential pathways for enhanced reimbursement for AVIM therapy-enabled devices. The FDA also approved an important update to the BACKBEAT study protocol that we are now rolling out to study centers that significantly expands eligibility criteria for enrollment and supports our enrollment completion objectives for next year. Finally, FDA approval of the updated IDE for our head-to-head pivotal trial comparing Virtue SAB to commercially available AGENT paclitaxel-coated balloon marks another significant regulatory milestone. These achievements will help us in our continued efforts to reshape clinical standards of care in both hypertensive heart disease and atherosclerotic artery disease.” Financial Results for the Second Quarter Ended June 30, 2025 Cash and cash equivalents and Marketable securities totaled $33.9 million as of June 30, 2025. Combined with net proceeds received from recent financing transactions, estimated Cash and cash equivalents and Marketable securities position was $101 million as of August 12, 2025. The Company has commitments from Ligand and Medtronic to receive a combined $35 million in additional proceeds on or before May 1, 2026, based on the terms of agreements with those parties.Net cash used in operating activities and for the purchase of fixed assets was $15.6 million during the second quarter of 2025, compared with $10.3 million for the second quarter in 2024, with the primary driver being increased research and development costs during the second quarter of 2025.Revenue for the second quarter of 2025 was $0.8 million, compared with $0.8 million for the second quarter in 2024.Research and development expenses for the second quarter of 2025 were $13.9 million, compared with $11.1 million for the second quarter in 2024. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study.Selling, general and administrative expenses for the second quarter of 2025 were $6.3 million, compared with $6.5 million for the second quarter of 2024. The decrease was primarily due to a decrease in professional fees.Net loss for the second quarter of 2025 was $19.4 million, or $0.50 per share, compared with a net loss of $16.0 million, or $0.45 per share, for the second quarter of 2024. Net loss for the second quarter of 2025 included $3.2 million in non-cash stock-based compensation expense as compared to $2.8 million for the same period in 2024. About Orchestra BioMed Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is AVIM therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About AVIM Therapy AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SAB Virtue SAB is an investigational therapeutic combination drug-device designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon, protecting the drug in transit through the arteries and consistently delivering a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary in-stent restenosis (“ISR”) in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. The FDA granted IDE approval for Orchestra BioMed to evaluate the efficacy and safety of Virtue SAB in the Virtue Trial, a pivotal trial that will randomize Virtue SAB against commercially available AGENT™ DCB, a paclitaxel-coated balloon. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s planned and ongoing pivotal trials, including the timing of completion of enrollment in the BACKBEAT study and the timing of initiation of the Virtue Trial, the receipt of committed capital, the Company’s expected cash runway, the date of completion of the formal mediation with Terumo, the potential benefits of BDD, realizing the clinical and commercial value of AVIM therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor ContactSilas NewcombOrchestra BioMed Snewcomb@orchestrabiomed.com Media ContactKelsey Kirk-EllisOrchestra BioMedKkirkellis@orchestrabiomed.com ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Balance Sheets(in thousands, except share and per share data)(Unaudited)   June 30, December 31,  2025 2024ASSETS      CURRENT ASSETS:      Cash and cash equivalents $18,749  $22,261 Marketable securities  15,175   44,551 Accounts receivable, net  83   92 Inventory  185   173 Prepaid expenses and other current assets  1,690   2,094 Total current assets  35,882   69,171 Property and equipment, net  1,366   1,384 Right-of-use assets  1,806   2,103 Strategic investments  2,495   2,495 Deposits and other assets  1,276   1,020 TOTAL ASSETS $42,825  $76,173        LIABILITIES AND STOCKHOLDERS’ EQUITY      CURRENT LIABILITIES:      Accounts payable $5,308  $5,134 Accrued expenses and other liabilities  6,650   6,084 Operating lease liability, current portion  642   550 Deferred revenue, current portion  4,461   4,439 Total current liabilities  17,061   16,207 Deferred revenue, less current portion  9,568   10,989 Loan payable  14,384   14,292 Operating lease liability, less current portion  1,328   1,687 Other long-term liabilities  189   40 TOTAL LIABILITIES  42,530   43,215        STOCKHOLDERS’ EQUITY      Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; noneissued or outstanding at June 30, 2025 and December 31, 2024.  —   — Common stock, $0.0001 par value per share; 340,000,000 shares authorized;38,643,553 and 38,194,442 shares issued and outstanding as of June 30, 2025 andDecember 31, 2024, respectively.  4   4 Additional paid-in capital  348,271   342,780 Accumulated other comprehensive income  16   52 Accumulated deficit  (347,996)  (309,878)TOTAL STOCKHOLDERS’ EQUITY  295   32,958 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $42,825  $76,173   ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(Unaudited)   Three Months Ended June 30,  2025 2024Revenue:      Partnership revenue $667  $628 Product revenue  169   150 Total revenue  836   778 Expenses:      Cost of product revenues  46   44 Research and development  13,853   11,126 Selling, general and administrative  6,264   6,467 Total expenses  20,163   17,637 Loss from operations  (19,327)  (16,859)Other (expense) income:      Interest (expense) income, net  (36)  902 Loss on fair value of strategic investments  –   (23)Total other (expense) income  (36)  879 Net loss $(19,363) $(15,980)Net loss per share      Basic and diluted $(0.50) $(0.45)Weighted-average shares used in computing net loss per share, basicand diluted  38,392,716   35,800,273 Comprehensive loss      Net loss $(19,363) $(15,980)Unrealized loss on marketable securities  (21)  (15)Comprehensive loss $(19,384) $(15,995)

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Reprieve Cardiovascular Secures $61 Million Financing and Enrolls First Patient in Pivotal Study

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— Series B fundraise led by Deerfield Management enables scaling of pivotal clinical trial and commercial readiness activities for Reprieve® System – First patient enrolled in FASTR II study by Washington University School of Medicine in St. Louis MILFORD, Mass., August 13, 2025 – Reprieve Cardiovascular, Inc., a clinical-stage company pioneering […]

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