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Heart Failure Society of America’s (HFSA) Annual Scientific Meeting (ASM) 2026 will convene the entire heart failure care team to explore late-breaking science, emerging technologies, device innovation, and practical strategies that can improve care for millions of patients living with…
— IND clearance for ATR 1072 and launch of Corventis Phase 1/2 trial in PRKAG2 syndrome — — Achieved second milestone payment under global cardiovascular collaboration with Bristol Myers Squibb — SAN DIEGO, Aug. 13, 2026 /PRNewswire/ — Atrium Therapeutics, Inc. (Nasdaq: RNA)…
Independent Blinded Survey of 50 Plastic Surgeons Validates Demand; NXT-41 and NXT-41x Remain On-TrackFunded through launch: secured up to $26 million of capital without an equity offeringThe unmet need is real: 86% of surgeons surveyed say the matrices they use today increase infection riskThe demand is strong: 96% of surgeons surveyed are interested in adopting NXT-41x; 92% responded they would champion it at their hospital value analysis committeeOn track: NXT-41 FDA clearance decision expected in 4Q 2026; NXT-41x FDA clearance decision expected in 1H 2027 GAITHERSBURG, Md., Aug. 13, 2026 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today provided a business update and announced financial results for the second quarter ended June 30, 2026. “We have intentionally focused Elutia where our strengths create the greatest value for patients and shareholders,” said Dr. Randy Mills, Chief Executive Officer of Elutia. “We believe we are now funded through the anticipated clearance and full commercial launch of NXT-41x, our antibiotic-eluting biomatrix for use in plastic and reconstructive surgical procedures. And we did it without an equity offering.“As we approach anticipated FDA clearance decisions and launch, surgeon interest in NXT-41x has exceeded our expectations. In an independent study of 50 board-certified plastic and reconstructive surgeons, 86% said matrices used today increase infection risk, 96% believed our antibiotic combination would be effective at preventing infection, and 92% said they would help get NXT-41x approved at their hospital’s value analysis committee.“Having successfully created value with this technology in the pacemaker market, we are now applying it to a larger market with a substantially greater unmet need. And we believe we have the team and capital to execute.” Capital Secured to Support NXT-41x Through Clearance and Commercial LaunchElutia has secured up to $26 million of additional capital to support the Company through the anticipated clearance of NXT-41x and its first full year of commercial launch in 2028, without an equity offering: $15 million credit facility, including $10 million funded at closing and an additional $5 million available following NXT-41x FDA clearanceUp to $11 million from the SimpliDerm divestiture, including $8 million in cash at closing and up to $3 million in contingent technology transfer and commercial milestone payments In addition, the Company anticipates receiving the full $8 million held in escrow from the 2025 divestiture of the BioEnvelope business, with release expected in the fourth quarter of this year. Independent Blinded Survey Validates Surgeon Demand for NXT-41xAn independent market research firm conducted a blinded survey of 50 board-certified plastic and reconstructive surgeons across 28 states. The surgeons average 11.6 years in practice and perform about 140 complex reconstructive procedures annually. Surgeons Say the Problem Is Real Surgeons estimate a 17% surgical-site infection rate in the published literature for these procedures.86% (95% confidence interval (CI): 74–93%) report that matrices used today increase infection risk. Surgeons View NXT-41x as Differentiated and Mechanistically Sound 98% (CI: 90–99.6%) rated NXT-41x new and different from products available today.96% (CI: 87–99%) rated the combination of rifampin and minocycline effective, with 64% (CI: 50–76%) describing it as extremely effective at reducing surgical site infections. No respondents rated the combination ineffective. Surgeon Intent to Adopt NXT-41x Is Strong 100% (CI: 93–100%) indicated they would use NXT-41x in diabetic patients and in patients with high BMI, who together represent approximately one third of all reconstruction patients.96% (CI: 87–99%) expressed interest in incorporating NXT-41x into their general practice.92% (CI: 81–97%) indicated willingness to approach their hospital value analysis committee in support of NXT-41x. Interest measures are based on ratings of 4 or 5 on a five-point scale. All results are reported with 95% Wilson confidence intervals; where responses were unanimous, the lower bound of the interval is 93%. Regulatory Review and Manufacturing Progressing on ScheduleRegulatory and development activities for both NXT-41 (biologic surgical matrix without drug) and NXT-41x continue to advance according to plan. Elutia recently held a productive meeting with the FDA regarding the NXT-41 submission, which remains on track. The Company continues to expect FDA clearance for NXT-41 in the fourth quarter of 2026 and for NXT-41x in the first half of 2027. Elutia also completed the installation and operational qualification of its automated drug-coating system for commercial manufacturing. The system is designed to support target gross margins in excess of 80% at scale. Product Divestitures Further Sharpen the Company’s FocusOn July 16, 2026, Elutia signed a definitive agreement to sell its SimpliDerm business for up to $11 million in total consideration, including up to $3 million in contingent technology transfer and commercial milestone payments over the 18 months following closing, with closing expected in the third quarter of 2026. The Company’s previously announced strategic process for its Cardiovascular business also continues to advance. Together with the 2025 divestiture of the BioEnvelope business, these transactions extend Elutia’s runway and focus the organization on the launch of NXT-41x in the second half of 2027. Funded Catalysts Ahead MilestoneExpected TimingSimpliDerm business divestiture closing3Q 2026Potential cardiovascular business transaction2H 2026$8 million BioEnvelope escrow release4Q 2026NXT-41 FDA clearance decision4Q 2026NXT-41x FDA clearance decision1H 2027NXT-41x commercial soft launch2H 2027NXT-41x full commercial launch2028 Second Quarter 2026 Financial ResultsNet sales and operating results discussed below reflect continuing operations. For the three-month period ended June 30, 2026, as compared to the same period of 2025: Overall net sales were $2.4 million, compared to $2.7 million. The decrease was the result of $0.7 million reduction in SimpliDerm revenue due to a production disruption with the product’s contract manufacturer, offset by a $0.4 million increase in Cardiovascular revenue due to the transition back to direct sales.Gross margin on a GAAP basis was 59.6%, compared to 52.9%.Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 70.7%, compared to 62.7%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.Total operating expenses were $9.4 million, compared to $9.8 million. The decrease was driven by a $1.9 million reduction in net litigation costs, partially offset by a $1.5 million increase in research and development expense supporting the NXT-41 and NXT-41x programs.Loss from operations was $8.0 million, compared to $8.4 million.Net loss from continuing operations was $7.6 million, compared to $7.1 million.There was no loss from discontinued operations in the second quarter of 2026, compared to a loss of $2.5 million in the second quarter of 2025.Net loss was $7.6 million, compared to $9.6 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 $4.6 million, compared to a loss of $3.0 million. A reconciliation of net loss to adjusted EBITDA is included in the accompanying financial tables.Cash and cash equivalents at June 30, 2026 were $19.9 million. This cash position is expected to be augmented by up to an additional $34 million from signed transactions, including $10 million already received from Avenue Capital Group pursuant to a new loan agreement, $8 million held in escrow in connection with the 2025 divestiture of the BioEnvelope business, up to $11 million from the sale of the SimpliDerm business and an additional $5 million available from the Avenue Capital loan facility following FDA clearance of NXT-41x. Conference CallElutia will host a conference call on August 13, 2026 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its second quarter 2026 financial results and business performance. The conference call can be accessed using the following information: Webcast: Click hereDial-In: Click here To receive the dial-in number, as well as your personalized PIN, you must register at the above link. Once registered, you will also have the option to have the system dial out to you once the conference call begins. If you forget your PIN prior to the conference call, you can simply re-register. Please log in approximately 10 minutes prior to the scheduled start time. A live and archived webcast of the event will be available on the “Investors” section of the Elutia website at http://investors.elutia.com/. About ElutiaElutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Non-GAAP DisclosureIn 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 income or loss from discontinued operations, stock-based compensation, FiberCel and VBM litigation costs, loss or gain on revaluation of warrant liability, warrant issuance expenses and loss or gain on revaluation of revenue interest obligation. The Company defines adjusted gross profit and adjusted gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For a reconciliation of these non-GAAP measures to GAAP, see below “Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA” and “Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin.” Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning our future interactions with the U.S. Food and Drug Administration (“FDA”) regarding NXT-41 and NXT-41x; expectations for FDA clearance of NXT-41 and NXT-41x, including the timing and anticipated success thereof; preparations for the commercial launch of NXT-41x, including the timing, scale and anticipated success thereof; the sufficiency of our capital resources to fund the Company through anticipated FDA clearance and the first full year of commercial launch of NXT-41x without an equity offering; the availability of the additional $5 million tranche under our Avenue Capital financing; the expected closing of the sale of our SimpliDerm business and our receipt of the associated contingent technology transfer and commercial milestone payments; the outcome and timing of the previously announced strategic process for our Cardiovascular business; the anticipated release of the $8 million held in escrow in connection with the divestiture of the BioEnvelope business; the results, interpretation and predictive value of the independent blinded surgeon survey described in this press release, including surgeons’ stated intent to adopt NXT-41x and to support it before hospital value analysis committees; the size of the plastic and reconstructive surgery market and the potential of the Company’s next-generation drug-eluting biomatrix pipeline to compete in that market; expectations regarding manufacturing capacity, scale and target gross margins; and any statements regarding future liability with respect to the FiberCel and VBM litigation. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings, including NXT-41 and NXT-41x; our ability to obtain regulatory approval or other marketing authorizations by the U.S. Food and Drug Administration and comparable foreign authorities for our products and product candidates, including NXT-41 and NXT-41x; our ability to comply with the covenants under, and to draw the remaining availability under, our credit facility; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to achieve or sustain profitability; our ability to regain compliance with Nasdaq’s minimum bid price requirement and otherwise maintain compliance with any other listing requirement of Nasdaq Capital Market, and our ability to maintain a listing of our Class A common stock on the Nasdaq Capital Market; our ability to raise funds in the future in the amounts and at the times needed; our ability to service our indebtedness; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; risks relating to the pending sale of the SimpliDerm business, including the occurrence of any event, change or circumstance that could delay the sale of the SimpliDerm business or give rise to termination of the related asset purchase agreement, the risk that the technology transfer and commercial milestone payments from the sale of the SimpliDerm business are reduced, delayed, or not earned or received, the outcome of any legal proceedings instituted against us following announcement of the sale of the SimpliDerm business, the inability to consummate the sale of the SimpliDerm business due to failure to satisfy closing conditions; the risk that the sale of the SimpliDerm business disrupts our current plans and operations, including distraction of management and employees, and costs related to the sale of the SimpliDerm business; our ability to complete any strategic transaction involving our Cardiovascular business, on the anticipated timeline and terms, or at all, and to realize the anticipated benefits of that transaction; our ability to defend against the various lawsuits and claims related to our former FiberCel and other bone viable matrix (“VBM”) products and avoid a material adverse financial consequence; the continued and future acceptance of our products by the medical community; our dependence on independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2025, 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:Elutia Investor Relationsir@elutia.com ELUTIA INC. CONSOLIDATED BALANCE SHEET DATA(Unaudited, in thousands) AssetsJune 30, 2026 December 31, 2025Current assets: Cash and cash equivalents$19,896 $36,350 Accounts receivable, net 1,438 1,734 Inventory 2,649 2,617 Insurance receivables of litigation costs 3,854 4,846 Prepaid expense and other current assets 9,378 10,271 Total current assets 37,215 55,818 Property and equipment, net 2,922 2,511 Intangible assets, net 990 1,529 Operating lease right-of-use assets, and other 2,522 2,492 Total assets$ 43,649 $ 62,350 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable and accrued expenses$8,329 $9,143 Current portion of revenue interest obligation 6,412 4,400 Contingent liability for legal proceedings 5,619 11,241 Current operating lease liabilities 685 355 Total current liabilities 21,045 25,139 Long-term revenue interest obligation — 2,828 Warrant liability 3,163 3,124 Long-term operating lease liabilities 3,695 3,587 Total liabilities 27,903 34,678 Stockholders’ equity: Common stock 44 43 Additional paid-in capital 207,030 203,842 Accumulated deficit (191,328) (176,213)Total stockholders’ equity 15,746 27,672 Total liabilities and stockholders’ equity$ 43,649 $ 62,350 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, 2026 2025 2026 2025 Net sales$2,427 $2,747 $5,541 $5,698 Cost of goods sold 980 1,294 2,292 2,863 Gross profit 1,447 1,453 3,249 2,835 Operating expenses: Sales and marketing 1,366 1,273 2,846 2,268 General and administrative 3,454 3,552 7,545 7,273 Research and development 2,527 989 4,500 1,860 Litigation costs, net 2,057 4,004 2,663 6,576 Total operating expenses 9,404 9,818 17,554 17,977 Loss from operations (7,957) (8,365) (14,305) (15,142)Interest income, net (35) (491) (143) (307)Other (income) expense, net (284) (791) 1,300 (5,873)Loss before provision for income taxes (7,638) (7,083) (15,462) (8,962)Provision for income taxes 8 8 78 16 Net loss from continuing operations (7,646) (7,091) (15,540) (8,978)Loss income from discontinued operations — (2,519) 425 (4,565)Net loss$ (7,646) $ (9,610) $ (15,115) $ (13,543) Net loss per share — basic$(0.17) $(0.23) $(0.35) $(0.34)Net loss per share — diluted$(0.17) $(0.26) $(0.35) $(0.47) Weighted average common shares outstanding — basic 44,223,722 41,782,556 43,622,360 40,239,372 Weighted average common shares outstanding — diluted 44,223,722 46,308,642 43,622,360 44,765,897 ELUTIA INC.NON-GAAP GROSS PROFIT AND NON-GAAP GROSS MARGIN RECONCILIATIONS(Unaudited, in thousands) Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Net sales$2,427 $2,747 $5,541 $5,698 Gross profit 1,447 1,453 3,249 2,835 Intangible asset amortization expense 270 270 540 542 Adjusted gross profit (Non-GAAP)$ 1,717 $ 1,723 $ 3,789 $ 3,377 Gross margin 59.6% 52.9% 58.6% 49.8%Adjusted gross margin percentage (Non-GAAP) 70.7% 62.7% 68.4% 59.3% ELUTIA INC.EBITDA AND ADJUSTED EBITDA RECONCILIATIONS(Unaudited, in thousands) Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Net loss$(7,646) $(9,610) $(15,115) $(13,543)Interest income expense, net(1) (35) (491) (143) (307)Provision for income taxes 8 8 78 16 Depreciation and amortization 348 312 679 598 Earnings before interest, taxes, depreciation and amortization (“EBITDA”) (Non-GAAP) (7,325) (9,781) (14,501) (13,236)Loss (income) from discontinued operations(2) — 2,519 (425) 4,565 Stock-based compensation 905 1,028 1,836 2,116 Litigation costs, net(3) 2,057 4,004 2,663 6,576 (Gain) loss on revaluation of warrant liability(4) (226) (2,233) 1,429 (7,420)Warrant issuance expenses — — — 105 Loss on revaluation of revenue interest obligation(5) — 1,442 — 1,442 Adjusted EBITDA (Non-GAAP)$ (4,589) $ (3,021) $ (8,998) $ (5,852) (1) Represents interest expense recorded on all outstanding long-term debt as well as the revenue interest obligation. (2) Represents the financial results of the BioEnvelope business sold to Boston Scientific Corporation on October 1, 2025. (3) Represents litigation costs consisting primarily of legal fees and the estimated and actual costs to resolve the outstanding FiberCel and VBM litigation cases offset by the amounts recovered and recoverable under insurance, indemnity and contribution agreements for such costs. (4) Represents the non-cash revaluation of Common Warrants and Prefunded Warrants issued in connection with a private offering in September 2023 and registered direct offerings in June 2024 and February 2025. (5) Represents the non-cash revaluation of the revenue interest obligation. At each reporting period, the value of the revenue interest obligation is re-measured based on current estimates of future payments, with changes to be recorded in the consolidated statements of operations using the catch-up method.
SAN FRANCISCO, Aug. 13, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing coronary artery disease (CAD), today reported financial results for the second quarter ended June 30, 2026. Second Quarter 2026 Highlights Total revenue of $64.1 million, a 48% increase year-over-yearGross margin of 83.0%, non-GAAP gross margin of 83.3%Net operating loss of $17.9 million; non-GAAP net operating loss of $7.9 million 2026 Annual Guidance Total revenue of $246 million to $250 million (approximately 40% to 42% growth year-over-year), compared to previous guidance of $228 million to $232 million (approximately 29% to 32% growth year-over-year)Non-GAAP gross margin of approximately 82%, compared to previous guidance of approximately 81% “The second quarter reflects the growing strength of Heartflow’s category leadership and unique AI technology platform for identifying, diagnosing, managing and treating coronary artery disease,” said John Farquhar, President and CEO of Heartflow. “The CCTA market for detecting CAD continues to grow rapidly and remains significantly under-penetrated, providing a strong backdrop for continued growth. Our FFRCT business remains strong and durable, while Plaque is rapidly emerging as a meaningful second growth engine — helping us win new accounts, deepen physician utilization and expand the value of the Heartflow platform for our customers. At the same time, record gross margin and improving operating leverage demonstrate the increasing scalability of our model, giving us greater confidence in long-term, profitable growth.” Second Quarter 2026 Financial ResultsTotal revenue was $64.1 million, a 48% increase year-over-year. U.S. revenue was $59.6 million, a 51% increase year-over-year. International and other revenue was $4.5 million, a 12% increase year-over-year. The year-over-year increase in total global revenue was primarily attributable to an increase in total U.S. FFRCT revenue case volume and an increase in total U.S. Plaque revenue case volume. Gross profit was $53.2 million, compared to $32.8 million in the prior year period. Non-GAAP gross profit was $53.4 million, compared to $32.8 million in the prior year period. Gross margin was 83.0%, compared to 75.5% in the prior year period. Non-GAAP gross margin was 83.3%, compared to 75.6% in the prior year period. The year-over-year gross margin expansion was primarily attributable to an increase in total revenue case volume, an increase in total U.S. Plaque revenue case volume, and improved production team productivity driven by AI efficiency initiatives, partially offset by the hiring and training of production team personnel. Total operating expenses were $71.1 million, or 111% of total revenue, compared to $46.5 million, or 107% of total revenue, in the prior year period. Non-GAAP total operating expenses were $61.3 million, or 96% of total revenue, compared to $44.3 million, or 102% of total revenue, in the prior year period. The year-over-year operating expense increase was primarily attributable to increased investment in sales personnel and related expenses, as well as increased investments in technology and clinical research. Net operating loss was $17.9 million, compared to $13.7 million in the prior year period. Non-GAAP net operating loss was $7.9 million, compared to $11.5 million in the prior year period. Net loss was $15.7 million, or ($0.18) net loss per share, compared to $9.2 million, or ($1.46) net loss per share, in the prior year period. Non-GAAP net loss was $5.8 million, or ($0.07) non-GAAP net loss per share, compared to $17.6 million, or ($2.79) non-GAAP net loss per share, in the prior year period. Adjusted EBITDA was ($6.7) million, compared to ($10.1) million in the prior year period. Cash, cash equivalents and investments totaled $246.8 million as of June 30, 2026. For additional information regarding non-GAAP financial measures, see “Use of Non-GAAP Measures,” “Heartflow GAAP to Non-GAAP Reconciliations” and “Reconciliation of GAAP Net Loss to Adjusted EBITDA” below. Webcast and Conference Call DetailsHeartflow will host a conference call today, August 13, 2026, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its second quarter 2026 financial results. Those interested in listening to the conference call should register online using this link. Once registered, participants will receive dial-in numbers and a unique PIN to join the call. Participants are encouraged to register more than 15 minutes prior to the start of the call. A live and archived webcast of the event will also be available on the “Investor Relations” section of the Heartflow website at https://ir.heartflow.com. The archived version will be available for 12 months following completion of the live call. About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for more than 750,000 patients worldwide.1 Key benefits include: Unmatched Proprietary data pipeline: Built from the world’s largest database of more than 200 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world evidence to improve patient outcomes.2,3,4,5 Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Use of Non-GAAP MeasuresTo supplement its consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company discloses non-GAAP gross profit and non-GAAP gross margin, non-GAAP total operating expenses, non-GAAP research and development expense, non-GAAP selling, general and administrative expense, non-GAAP net operating loss, non-GAAP net loss, non-GAAP net loss per share, basic and diluted, and Adjusted EBITDA (collectively, the “Non-GAAP Measures”) in this press release. As used by the Company, these measures are adjusted to exclude stock-based compensation expense from the comparable GAAP financial measure. Non-GAAP net loss and non-GAAP net loss per share, basic and diluted, are also adjusted for change in fair value of common stock warrant liability, change in fair value of derivative liability, certain litigation expenses and asset impairment charge. In addition, Adjusted EBITDA is calculated by adding back to net loss or excluding, as appropriate, interest income and expense, provision for income taxes, certain litigation expenses, and charges for depreciation and amortization and is further adjusted by adding back in or excluding, stock-based compensation and, as appropriate, other income and expense items that are not reflective of the Company’s underlying continuing operating performance. Reconciliations of the Non-GAAP Measures to their most directly comparable GAAP financial measures are provided in the financial statement tables included at the end of this press release, and investors are encouraged to review the reconciliations. The Company believes the presentation of the Non-GAAP Measures, when shown in conjunction with the corresponding GAAP measures, provides useful information to investors as it provides visibility to the Company’s underlying continuing operating performance from period to period by excluding the impact of stock-based compensation and certain other items that are not reflective of the Company’s ongoing operations. Because of the variety of equity awards used by companies, the varying methodologies for determining stock-based compensation expense, the subjective assumptions used in those determinations, and the volatility in valuations that can be driven by market conditions outside the Company’s control, we believe excluding stock-based compensation expense enhances the ability of management and investors to understand and assess the underlying performance of our business over time and compare it against our peers, a majority of whom also exclude stock-based compensation expense from their non-GAAP results. With respect to the presentation of Adjusted EBITDA, the Company believes it is a useful measure to evaluate the Company’s operating performance and it is used by the Company to evaluate ongoing operations and for planning and forecasting purposes. Adjusted EBITDA is also a measure frequently used by analysts, investors and other interested parties to evaluate companies in our same industry. The Company’s definition of the Non-GAAP Measures may differ from similarly titled measures used by others. The Non-GAAP Measures should be considered only as a supplement to, and not as a substitute for, or superior to, their most directly comparable GAAP financial measures. Because the Non-GAAP Measures exclude the effect of items that increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the reconciliations to the most comparable GAAP financial measures at the end of this press release and, when they become available, the Company’s consolidated financial statements and publicly filed Securities and Exchange Commission (“SEC”) reports in their entirety. The Company is not able to provide a reconciliation without unreasonable efforts of its forward-looking guidance related to non-GAAP gross margin to the most directly comparable GAAP financial measure due to the unknown effect of stock-based compensation that is material to the comparable GAAP financial measure. Forward-Looking StatementsThis press release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding our strategy, market conditions, expected market growth and financial guidance, are forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements, including, but not limited to: we may not be able to achieve or sustain profitability; our dependence on the success of our two products, Heartflow FFRCT Analysis and Heartflow Plaque Analysis, healthcare providers may be unwilling to change their standard practice regarding the evaluation of coronary artery disease; adoption of the Heartflow Platform by healthcare providers may be negatively impacted if third-party payors, including government payors, do not cover or provide adequate reimbursement; the concentration of our customer base; the significant competition we face in an environment of rapid technological change; the commercialization of Heartflow Plaque Analysis is nascent; risks associated with our use and development of AI models; risks related to failing to properly manage our future growth; disruption by catastrophic events; risks associated with our dependence on our information technology systems; security breaches that we cannot anticipate or successfully defend; extensive regulatory requirements we face to bring our products to market; and third parties could develop and commercialize technology and products similar or identical to ours. For a more extensive description of these and other risks and uncertainties that could materially affect our results, you should read our filings with the SEC, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as such filings may be amended, supplemented or superseded from time to time by other reports Heartflow files with the SEC. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and we undertake no obligation to update the forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law. Investor ContactNick Laudiconlaudico@heartflow.com Media ContactElliot Levyelevy@heartflow.com ____________________1Gulati, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation & Diagnosis of Chest Pain. J Am Coll Cardiol2 Narula, et al. EHJ CVI 20243 Danad, et al. JAMA Cardiol 20174 Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI)5 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024 (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years) HEARTFLOW, INC.Consolidated Statements of Operations Data(unaudited, in thousands, except share and per share data) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 Revenue$64,082 $43,424 $116,669 $80,629 Cost of revenue 10,892 10,646 21,315 19,910 Gross profit 53,190 32,778 95,354 60,719 Operating Expenses: Research and development 26,261 15,032 47,881 28,956 Selling, general and administrative 44,829 31,461 87,395 62,980 Asset impairment charge – – 7,482 – Total operating expenses 71,090 46,493 142,758 91,936 Loss from operations (17,900) (13,715) (47,404) (31,217)Interest income 2,305 635 4,769 1,178 Interest expense – (6,621) (3) (11,714)Change in fair value of common stock warrant liability – (863) – (2,469)Change in fair value of derivative liability – 11,538 – 2,493 Other income (expense), net (126) (111) (440) 247 Loss before provision for income taxes (15,721) (9,137) (43,078) (41,482)Provision for income taxes (22) (59) (45) (59)Net loss$(15,743) $(9,196) $(43,123) $(41,541)Comprehensive loss: Net loss$(15,743) $(9,196) $(43,123) $(41,541)Other comprehensive loss: Foreign currency translation gain (loss) (9) 291 253 55 Unrealized loss on investments, net (204) – (726) – Total other comprehensive loss (213) 291 (473) 55 Total comprehensive loss$(15,956) $(8,905) $(43,596) $(41,486) Net loss per share, basic and diluted$(0.18) $(1.46) $(0.50) $(6.66)Weighted-average shares used to compute net loss per share, basic and diluted 86,398,778 6,316,315 86,021,323 6,240,885 HEARTFLOW, INC.Consolidated Balance Sheets Data(unaudited, in thousands, except par value) June 30, December 31, 2026 2025Assets Current assets Cash and cash equivalents$34,362 $44,776 Short-term investments 128,189 132,010 Accounts receivable, net 42,761 29,343 Prepaid expenses and other current assets 18,657 14,075 Total current assets 223,969 220,204 Long-term investments 84,289 103,365 Property and equipment, net 9,646 8,587 Operating lease right-of-use assets 15,236 17,488 Restricted cash, non-current 4,702 4,709 Other non-current assets 6,621 5,099 Total assets$344,463 $359,452 Liabilities and stockholders’ equity Current liabilities Accounts payable$4,937 $3,169 Accrued expenses and other current liabilities 32,367 33,279 Operating lease liabilities, current portion 6,784 5,922 Total current liabilities 44,088 42,370 Operating lease liabilities, non-current portion 20,343 16,132 Other non-current liabilities 305 303 Total liabilities 64,736 58,805 Stockholders’ equity Preferred stock, $0.001 par value – – Common stock, $0.001 par value 87 85 Additional paid-in capital 1,411,411 1,388,737 Accumulated other comprehensive loss (898) (425)Accumulated deficit (1,130,873) (1,087,750)Total stockholders’ equity 279,727 300,647 Total liabilities and stockholders’ equity$344,463 $359,452 HEARTFLOW, INC. GAAP to Non-GAAP Reconciliations (unaudited, in thousands except for per share amounts and percentage data) Three Months Ended June 30, 2026 Three Months Ended June 30, 2025 GAAP Adjustments Non-GAAP GAAP Adjustments Non-GAAP Gross profit $53,190 $173 (a)$53,363 $32,778 $45 (a)$32,823 Gross margin 83.0% 0.3% 83.3% 75.5% 0.1% 75.6% Operating Expenses: Research and development $26,261 $(2,732)(a)$23,529 $15,032 $(381)(a)$14,651 Selling, general and administrative $44,829 $(7,071)(b)$37,758 $31,461 $(1,827)(a)$29,634 Total operating expenses $71,090 $(9,803) $61,287 $46,493 $(2,208) $44,285 Loss from operations $(17,900) $9,976 $(7,924) $(13,715) $2,253 $(11,462) Net loss $(15,743) $9,976 (c)$(5,767) $(9,196) $(8,422)(d)$(17,618) Net loss per share, basic and diluted $(0.18) $0.11 $(0.07) $(1.46) $(1.33) $(2.79) (a) Represents adjustments related to stock-based compensation expense (b) Represents adjustments for: (i) stock-based compensation expense of $5.0 million; and (ii) certain litigation expenses of $2.1 million (c) Represents adjustments for: (i) stock-based compensation expense of $7.9 million; and (ii) certain litigation expenses of $2.1 million (d) Represents adjustments for: (i) stock-based compensation expense of $2.3 million; (ii) change in fair value of common stock warrant liability of $0.9 million; and (iii) change in fair value of derivative liability of $11.5 million Six Months Ended June 30, 2026 Six Months Ended June 30, 2025 GAAP Adjustments Non-GAAP GAAP Adjustments Non-GAAP Gross profit $95,354 $340 (a)$95,694 $60,719 $102 (a)$60,821 Gross margin 81.7% 0.3% 82.0% 75.3% 0.1% 75.4% Operating Expenses: Research and development $47,881 $(4,871)(a)$43,010 $28,956 $(928)(a)$28,028 Selling, general and administrative $87,395 $(11,736)(b)$75,659 $62,980 $(3,715)(a)$59,265 Asset impairment charge $7,482 $(7,482) $- $- $- $- Total operating expenses $142,758 $(24,089) $118,669 $91,936 $(4,643) $87,293 Loss from operations $(47,404) $24,429 $(22,975) $(31,217) $4,745 $(26,472) Net loss $(43,123) $24,429 (c)$(18,694) $(41,541) $4,721 (d)$(36,820) Net loss per share, basic and diluted $(0.50) $0.28 $(0.22) $(6.66) $0.76 $(5.90) (a) Represents adjustments related to stock-based compensation expense (b) Represents adjustments for: (i) stock-based compensation expense of $9.3 million; (ii) certain litigation expenses of $2.5 million; and (iii) asset impairment charge of $7.5 million (c) Represents adjustments for: (i) stock-based compensation expense of $14.5 million; (ii) certain litigation expenses of $2.5 million; and (iii) asset impairment charge of $7.5 million (c) Represents adjustments for: (i) stock-based compensation expense of $4.7 million; (ii) change in fair value of common stock warrant liability of $2.5 million; and (iii) change in fair value of derivative liability of $2.5 million HEARTFLOW, INC.Reconciliation of GAAP Net Loss to Adjusted EBITDA(unaudited, in thousands) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 GAAP net loss$(15,743) $(9,196) $(43,123) $(41,541)Non-GAAP adjustments: Interest (income) expense, net (2,305) 5,986 (4,766) 10,536 Asset impairment charge – – 7,482 – Change in fair value of common stock warrant liability – 863 – 2,469 Change in fair value of derivative liability – (11,538) – (2,493)Other (income) expense, net 126 111 440 (247)Provision for income taxes 22 59 45 59 Certain litigation expenses 2,064 – 2,481 – Depreciation and amortization 1,220 1,395 2,643 2,767 Stock-based compensation expense 7,912 2,253 14,466 4,745 Adjusted EBITDA$(6,704) $(10,067) $(20,332) $(23,705)
New Cartago facility will expand CathX Medical’s manufacturing footprint and create local jobs, advancing its integrated development-to-production model ORANGEBURG, S.C., August 13, 2026 — Zeus, the global leader in advanced polymer solutions and a provider of contract manufacturing for catheter sub-assemblies, today announced that its CathX Medical business has […]
SANTA CLARA, Calif.–(BUSINESS WIRE)–PercAssist, Inc., a medical device company developing innovative technology for extravascular Biventricular Mechanical Circulatory Support to provide hemodynamic improvements for patients in cardiogenic shock (CS), today announced the first patient enrollment for the AVANXA Feasibility Study was successfully conducted in São Paulo, Brazil. “I am thrilled to share the successful clinical use of the PercAssist eVAD System in a patient with SCAI Stage D CS,” s
IRVINE, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) — WallabyPhenox today announced that the first patient has been enrolled in PROMISE (PROspective study on Management of Ischemic Stroke secondary to mEvo), an investigator initiated prospective study examining how medium vessel occlusion (MeVO) acute ischemic strokes are managed within the first 24 hours. The first subject was enrolled at Indiana University, Methodist Hospital. Dr. Devi Patra and Dr. Ann Jones are co-leads at Indiana University. Medium vessel occlusions account for a meaningful share of acute ischemic strokes, yet the field has not reached consensus on how best to treat them — mechanical thrombectomy versus medical management. PROMISE is designed to capture real-world practice across participating U.S. sites and to help characterize the current “equipoise” among treating physicians, enrolling patients managed with mechanical thrombectomy as well as those treated medically and following their outcomes over six months. “Management for MeVO related stroke is one of the next frontiers in advancing care for stroke patients. We planned this study to better understand the practice and challenges involved in management of these patients in a prospective, unbiased way. To achieve a higher level of nuanced understanding we planned the imaging to be core lab adjudicated. I thank WallabyPhenox for their support to this investigator-initiated project.” — Kaustubh Limaye, MD, Global Principal Investigator, Associate Professor at Indiana University Medical Center “This important study is expected to help answer a critical clinical question: whether revascularization attempt benefits patients with medium-vessel occlusion (MeVO). Current evidence remains largely equivocal, underscoring the need for clearer data to guide treatment decisions,” said Dr. Devi Patra, MD, a neuroendovascular surgeon at Indiana University Medical Center. Dr. Froehler, Director of Cerebrovascular Program at Vanderbilt University Medical Center said, “This study is important because it includes all MVO patients; not just those treated endovascularly. The results will help us to understand real-world MVO outcomes.” WallabyPhenox is supporting PROMISE as part of its commitment to advancing the evidence base behind stroke care. “Reaching first enrollment in PROMISE reflects WallabyPhenox’s commitment to advancing the science behind stroke care, not just the tools that support it. We’re proud to stand behind Dr. Limaye and the investigators as they generate the evidence the neurovascular community needs to make the best possible decisions for MeVO patients.” — Ruilin Zhao, Chief Executive Officer, WallabyPhenox The registry plans to enroll patients across 30 participating U.S. sites. The study is registered with Clinical Trials.gov https://clinicaltrials.gov/study/NCT07746947 CONTACT: CONTACT Ruilin Zhao
Chief Executive Officer
COMPANY WallabyPhenox
PHONE 1-844-674-3669
EMAIL cs@phenox.com
WEB https://www.phenox.com/
MENLO PARK, Calif.–(BUSINESS WIRE)– #TFX–Jupiter Endovascular appoints renowned interventional cardiologist Dr. Catalin Toma as Chief Medical Officer
Increases 2026 Annual Revenue Guidance to a Range of $3.75M to $4.25M First Treatment Delivered with RenovoCath® in Patient with Sarcoma in Clinical Setting, Marking Expansion of Device to Other Solid Tumors Phase III TIGeR-PaC Trial Reaches Full Enrollment; Completion of Trial Expected in First Half 2027 with Topline Data Readout Expected in Second Half 2027 Management to Host Conference Call Today at 4:30 p.m. ET MOUNTAIN VIEW, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) — RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device, today announced its financial results for the second quarter ended June 30, 2026, and provided shareholders with a business update highlighting continued commercial momentum and clinical progress. “In the second quarter of 2026, we delivered record revenue and executed on all three of the milestones we set for the business: revenue growth with another record revenue quarter, commercial momentum evidenced by several cancer center activations, and expansion of the application of our technology beyond locally advanced pancreatic cancer (LAPC),” said Shaun Bagai, Chief Executive Officer of RenovoRx. “We generated quarterly revenue of $909,000, an increase of approximately 61% compared to the first quarter of 2026, and approximately 115% compared to the second quarter of 2025. Our strong first half performance gives us confidence that our second half revenue will exceed our original full year forecast. This outlook is driven by more active commercial cancer center customers, more patients treated via procedures with RenovoCath, and repeat ordering across our existing customer base.” Mr. Bagai continued, “We ended the second quarter with 21 active commercial cancer center customers, an increase of more than 30% from the 16 centers reported at the time of our first quarter earnings call, and expanded our total commercial pipeline to 63 centers, including 42 additional centers progressing through evaluation, approval, and activation. We continue to see meaningful repeat utilization across our existing customer base, and for the first time, a treating physician chose RenovoCath to deliver therapy to a patient with a solid tumor beyond pancreatic cancer, marking an important, physician-driven expansion of the clinical application of our TAMP platform.” “Looking ahead, we remain focused on executing against both our near-term commercial priorities and our long-term clinical objectives,” added Mr. Bagai. “Based on current trends, we expect third quarter revenue to surpass second-quarter revenue and set another record. We remain on track to meet or exceed our target of 36 active commercial cancer center customers by year end 2026.” “The recently announced enrollment completion of our Phase III TIGeR-PaC trial positions the majority of our trial sites to also transition to commercial use in the second half of the year. Reflecting our strong first half performance, we are raising and tightening the range for our full year revenue guidance. In short, we believe RenovoRx is building a durable, capital-efficient commercial business,” said Mr. Bagai. “Management believe that reaching a quarterly revenue run-rate of approximately $5 million would position RenovoRx at cash-flow break-even, and based on our current trajectory, our internal plan anticipates achieving break-even operations in the fourth quarter of 2027.” RenovoCath Commercialization UpdateRenovoRx delivered its strongest quarterly revenue performance to date. Revenue totaled $909,000 for the second quarter, an increase of approximately 61% compared to the first quarter of 2026 and approximately 115% compared to the second quarter of 2025. Second quarter revenue alone represented approximately 83% of the Company’s total revenue generated in all of 2025. For the six months ended June 30, 2026, revenue totaled approximately $1.5 million. This growth reflects continued expansion of active commercial cancer center customers and increasing procedural utilization of RenovoCath across the Company’s growing base of commercial sites. The Company’s commercial model is currently focused on activating new cancer center customers, which have been a source of recurring demand. RenovoRx ended the second quarter of 2026 with 21 active commercial cancer center customers, an increase of more than 30% from the 16 active customers reported at the time of the Company’s first quarter 2026 earnings call. RenovoRx is also advancing a customer pipeline of 42 additional centers in various stages of evaluation, approval, or activation. Combined with its 21 active customers, this represents a total of 63 centers in the Company’s commercial funnel, a 31% increase compared to the 48 total centers reported on its first quarter call. The Company remains on pace to meet or exceed its target of 36 active commercial cancer center customers by year end 2026. In addition, 15 Phase III TIGeR-PaC clinical trial sites are positioned to transition to commercial RenovoCath use, several of which have already begun doing so. These sites represent an anticipated and meaningful contributor to revenue in the second half of 2026. RenovoRx continues to observe strong repeat ordering from existing customers, which the Company views as one of the clearest indicators of physician satisfaction and clinical utility in interventional oncology. As physicians incorporate RenovoCath into routine clinical practice, repeat utilization is expected to drive sustained revenue growth. Based on its current customer pipeline and trends to date, the Company expects third quarter 2026 revenue to exceed second quarter revenue which would represent another consecutive record revenue quarter. Since receiving FDA 510(k) clearance, RenovoCath has been used in more than 900 successful procedures. RenovoRx continues to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device could translate into an approximately $400 million peak annual U.S. sales opportunity for RenovoRx. Over time, as the Company expands the platform into additional solid tumor indications, the Company believes it could unlock more than $1 billion in peak annual sales potential. Expansion of RenovoCath Beyond Locally Advanced Pancreatic CancerIn early August 2026, RenovoRx announced the first commercial clinical use of RenovoCath by an existing cancer center customer in the treatment of sarcoma, marking the expansion of its targeted drug-delivery device to solid tumors beyond pancreatic cancer. The case involved a physician who had previously treated LAPC patients using RenovoCath and returned to RenovoRx with a plan to use the catheter to treat sarcoma. The Company views this physician-driven adoption as a meaningful endorsement of RenovoCath’s potential as a standalone device across additional difficult-to-treat solid tumors within its FDA-cleared fields of use. Ongoing Phase III TIGeR-PaC Trial UpdateRecently, RenovoRx announced that it achieved full enrollment in its Phase III TIGeR-PaC trial evaluating intra-arterial delivery of intra-arterial gemcitabine (IAG) via the RenovoCath device for the treatment of LAPC. This significant milestone reflects successful patient recruitment, clinical execution, and collaboration among investigators and study teams evaluating IAG for LAPC, a difficult-to-treat cancer. The primary endpoint of the study is overall survival. TIGeR-PaC is designed to evaluate whether RenovoRx’s patented method of targeted delivery of the chemotherapy gemcitabine improves patient survival, safety, and tolerability compared to the standard of care (systemic (intravenous) chemotherapy gemcitabine + Abraxane). As of August 7, 2026, TIGeR-PaC trial investigators have been notified by RenovoRx that patient enrollment is closing. Completion of the trial is expected during the first half of 2027, after 86 events (i.e., patient deaths) have been observed. As of August 11, 2026, 78 events have occurred. Following completion of the trial, initial topline trial data is expected to be available during the second half of 2027. With enrollment complete, RenovoRx is now focused on advancing toward final data analysis. These efforts build on the successful completion of the second interim analysis in 2025, after which the independent Data Monitoring Committee recommended continuation of the trial without modification. To preserve trial integrity, the Company elected to defer publication of interim data until study completion. RenovoRx continues to view TIGeR-PaC as a critical long-term value driver, while emphasizing that its current commercial strategy is independent of the trial’s ultimate outcome and timeline. Second Quarter 2026 and Subsequent Key HighlightsRenovoRx continued to execute on its dual commercial and clinical strategy during the second quarter of 2026 and the subsequent period, building real-world evidence base for its TAMP platform. During the second quarter of 2026, several scientific data updates supported the use of intra-arterial gemcitabine delivery via TAMP in LAPC. A peer-reviewed case study by researchers at Moffitt Cancer Center, published in Radiology Case Reports, found that PET-CT imaging, rather than CT alone, showed a meaningful reduction in tumor metabolic activity after treatment. These findings suggest that PET imaging may help optimize monitoring of therapeutic response following TAMP-delivered treatment. In addition, the PK sub-study of the TIGeR-PaC trial has been accepted and will be published in the near future in the Journal of Cancer Chemotherapy and Pharmacology. The findings support TAMP as a targeted delivery method for gemcitabine, demonstrating its potential to increase local drug potency while reducing systemic exposure and common side effects. Finally, a peer-reviewed case series in Case Reports in Oncology from researchers at Hackensack Meridian Health’s Jersey Shore University’s Medical Center was accepted and will be published in the near future. The case series highlights their experience with the TAMP procedure in LAPC. The ramping up of publication of the TAMP procedure by physicians, the Company believes is another sign of adoption as TAMP traverses from an experimental procedure to becoming a potential standard of care. Cash Resources, History of Losses and Planned ActivitiesRenovoRx continued to build the evidence base for its TAMP platform through a multi-center post-marketing registry study generating real-world safety and efficacy data, as well as investigator-initiated trials (IITs) in borderline resectable and metastatic pancreatic cancer designed to achieve cost neutrality while broadening the platform’s evidence base. In the second quarter of 2026, the Company began supporting a new IIT in cholangiocarcinoma (bile duct cancer). RenovoRx received FDA Orphan Drug Designation for oxaliplatin in the treatment of pancreatic cancer in the second quarter of 2026, further expanding the potential applications of its targeted drug-delivery platform. Financial Highlights for the Second Quarter Ended June 30, 2026 Revenue for the three months ended June 30, 2026 was $909,000, compared to $422,000 for the three months ended June 30, 2025. The increase was driven by the continued commercialization of RenovoCath and expanding adoption across U.S. cancer centers.Gross profit for the three months ended June 30, 2026 was $766,000, representing a gross margin of approximately 84%, consistent with the approximately 85% gross margin in the first quarter of 2026 and reflecting the underlying economics of RenovoCath.Research and development expenses were approximately $1.2 million for the three months ended June 30, 2026, compared to approximately $1.4 million for the three months ended June 30, 2025.Selling, general, and administrative expenses were approximately $2.9 million for the three months ended June 30, 2026, compared to approximately $1.5 million for the three months ended June 30, 2025, a reflection of the Company’s continued execution on its commercial infrastructure strategy.Net loss for the three months ended June 30, 2026, was approximately $2.9 million, compared to approximately $2.9 million for the three months ended June 30, 2025. Net loss per share was $0.06 for the three months ended June 30, 2026, compared to a net loss of $0.08 for the three months ended June 30, 2025.Cash and cash equivalents were approximately $9.5 million as of June 30, 2026, compared to approximately $12.4 million as of March 31, 2026. This evidences the disciplined deployment of capital raised in the Company’s March 2026 private placement. The Company believes its current cash resources are sufficient to fund operations into the second half of 2027.Shares Outstanding: As of June 30, 2026, common shares outstanding totaled 45,121,982.Guidance: RenovoRx is raising and tightening the range of its full-year 2026 revenue guidance to a range of $3.75 million to $4.25 million, from its prior range of $3.0 million to $4.0 million. The updated guidance implies year-over-year revenue growth of approximately 241% to 286% compared to full-year 2025 revenue of $1.1 million. Conference Call DetailsEvent:RenovoRx Second Quarter 2026 Financial Results and Business Highlights Conference CallDate:Wednesday, August 12, 2026Time:4:30 p.m. ETLive Call:1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)Webcast:https://ir.renovorx.com/news-events/ir-calendar-events For interested individuals unable to join the conference call, a link to the recording will be available on RenovoRx’s Investor Relations website, and a dial-in replay will be available until August 26, 2026, and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13761368. A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event. RENOVORX, INC.CONDENSED STATEMENTS OF OPERATIONS(Unaudited)(Dollar in thousands, except per share amounts) Three Months EndedJune 30,Six Months EndedJune 30, 2026 2025 2026 2025 Revenues$909 $422 $1,472 $619 Cost of revenues 143 152 227 246 Gross profit$766 $270 $1,245 $373 84.3% 64.0% 84.6% 60.3%Operating expenses: Research and development 1,200 1,426 2,428 3,068 Selling, general and administrative 2,915 1,522 5,635 3,093 Total operating expenses 4,115 2,948 8,063 6,161 Income/(loss) from operations (3,349) (2,678) (6,818) (5,788) Other income (expense), net: Interest income, net 90 133 134 239 Loss on disposition of asset (2) — (2) — Change in fair value of common warrant liability 350 (350) 254 234 Total other income (expense), net 438 (217) 386 473 Net loss$(2,911)$(2,895)$(6,432)$(5,315)Net loss per share Basic and diluted$(0.06)$(0.08)$(0.15)$(0.16)Weighted-average shares used in computing net loss per share: Basic and diluted 47,298,148 36,576,567 42,690,881 34,000,539 RENOVORX, INC.RECONCILIATION OF GAAP NET INCOME/(LOSS)TO NON-GAAP NET INCOME(Unaudited)(Dollar in thousands, except per share amounts) Three Months EndedJune 30,Six Months EndedJune 30, 2026 2025 2026 2025 GAAP net income$(2,911)$(2,895)$(6,432)$(5,315) Share-based compensation expense: Research and development 216 106 327 243 Selling, general and administrative 354 239 560 390 Total share-based compensation expense 570 345 887 633 Non-GAAP net income$(2,341)$(2,550)$(5,545)$(4,682) GAAP basic earnings per share$(0.06)$(0.08)$(0.15)$(0.16)Effect of non-GAAP adjustments on basic earnings per share 0.01 0.01 0.02 0.02 Non-GAAP basic earnings per share$(0.05)$(0.07)$(0.13)$(0.14) Weighted-average shares used in computing net loss per share: Basic and diluted 47,298,148 36,576,567 42,690,881 34,000,539 RENOVORX, INC.CONDENSED BALANCE SHEETS(Unaudited)(Dollar in thousands) June 30, December 31, 2026 2025 Assets Current assets: Cash and cash equivalents$9,479 $7,024 Accounts receivable, net 480 139 Inventory 383 189 Prepaid expenses 315 324 Other current assets 153 217 Total current assets 10,810 7,893 Operating lease right-of-use asset 368 190 Property and equipment, net 94 12 Other non-current assets 200 — Total assets$11,472 $8,095 Liabilities and stockholders’ equity Current liabilities: Accounts payable$866 $799 Accrued expenses and other current liabilities 1,018 1,163 Total current liabilities 1,884 1,962 Common stock warrant liability 350 604 Operating lease liability, net of current portion 259 107 Total liabilities$2,493 $2,673 Stockholders’ equity: Common stock 5 4 Additional paid-in capital 76,793 66,805 Accumulated deficit (67,819) (61,387)Total stockholders’ equity 8,979 5,422 Total liabilities and stockholders’ equity$11,472 $8,095 About RenovoCathBased on its FDA clearance, RenovoCath® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: https://renovorx.com/wp-content/uploads/2026/06/IFU-10004-Rev.-H-Universal-IFU.pdf. About RenovoRx, Inc.RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents. RenovoRx is actively commercializing its TAMP technology and FDA-cleared RenovoCath as a standalone device. For its first full year of commercial efforts in 2025, RenovoRx generated approximately $1.1 million in RenovoCath sales and a record $563,000 of sales in the first quarter of 2026. RenovoRx is actively working to expand the number of medical institutions initiating new RenovoCath orders, including esteemed, high-volume National Cancer Institute-designated centers. RenovoRx is also evaluating its novel drug-device combination oncology product candidate intra-arterial gemcitabine delivered via RenovoCath, (known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, which is FDA-cleared for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. RenovoRx achieved full enrollment in the TIGeR-PaC trial in August 2026, with completion of trial expected in first half 2027 and with topline data readout expected in second half 2027. The IAG combination product candidate, enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA. For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X. Non-GAAP Financial MeasuresIn addition to reporting financial results in accordance with U.S. generally accepted accounting principles (“GAAP”), the operating results presented in the accompanying tables include certain non-GAAP financial measures that exclude the non-cash expense associated with share-based compensation. We are providing such non-GAAP financial information in this press release, including non-GAAP operating expenses, net income (loss), and earnings (loss) per share, as a supplement to our consolidated financial statements prepared in accordance with GAAP which appear in this press release and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 as filed with the U.S. Securities and Exchange Commission. Our management uses these non-GAAP measures internally to analyze financial results, evaluate operational performance, and assess liquidity. We believe that both management and investors benefit from referring to these non-GAAP measures when assessing performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP measures also enhance investors’ understanding of key financial metrics used in operational decision-making and are useful for comparing our performance to that of other companies. However, readers are cautioned that non-GAAP results are presented for supplemental information purposes only and should not be considered a substitute for GAAP financial information. These measures may differ from similarly titled non-GAAP measures presented by other companies. Moreover, non-GAAP financial measures are not required to be uniformly applied and are not audited. Cautionary Note Regarding Forward-Looking StatementsThis press release and statements of the Company’s management and third parties made in connection therewith contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our clinical trials and studies (including expectations for full enrollment and data read out), (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and (iii) our efforts to commercialize our RenovoCath and TAMP technology for use in treating pancreatic and other solid tumor cancers, and our expected financial results from such efforts, including our estimates for 2026 annual revenue. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control, and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections, and statements relating to our research and development plans, commercial and other business plans, intellectual property development, clinical trials, our therapy platform, financing plans, objectives, and expected operating results, all of which are based on current expectations and assumptions that are subject to significant known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “aim,” “goal,” “estimates,” “intends,” and “potential,” or derivatives of these terms or other comparable terminology regarding RenovoRx’s statements about the future, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our commercial efforts our TAMP technology (enabled by RenovoCath) may not lead to the achievement of our revenue forecasts or to viable, revenue generating operations in general; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding; (iii) the timing of the initiation, progress, completion and potential results (including the results of interim analyses) of our preclinical studies, clinical trials, and our research programs (notably with respect to our TIGeR-PaC trial); (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate; (v) that applicable regulatory authorities may disagree with our interpretation of the data, research, and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements, needs for additional financing, our ability to obtain additional capital and our ability to maintain the listing of our common stock on Nasdaq; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates, and research programs; (xviii) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xix) the pricing, coverage, and reimbursement of our product candidates, if approved; and (xx) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission, which can be accessed at https://ir.renovorx.com/sec-filings. Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law. Investor Contact:KCSA Strategic CommunicationsValter Pinto or Jack PerkinsT: 212-896-1254RenovoRx@KCSA.com Media Contact:STiR CommunicationsHannah WilliamsT: 803-521-1214hannah@stir-communications.com
SUNNYVALE, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter 2026 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2026 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. “This second quarter, BioCardia had three important positive meetings with regulatory agencies in Japan and the United States,” said Peter Altman, PhD, Chief Executive Officer of BioCardia. “Japan’s Pharmaceutical and Medical Device Agency (PMDA) has said it supports regulatory submission for approval of our CardiAMP Cell Therapy for Ischemic Heart Failure, the U.S. Food and Drug Administration (FDA) has said the CardiAMP HF II trial may be sufficient for approval in the United States, and the FDA has said DeNovo approval of Helix is possible.” Dr. Altman continued, “We are preparing the CardiAMP cell therapy PMDA submission for the fourth quarter, actively enrolling in the CardiAMP HF II trial, and awaiting FDA minutes on the DeNovo Pre-Submission for approval of the Helix transendocardial delivery catheter held with FDA in May. We are engaged in business development around our cell therapies and separately our experience and technologies for delivery of cardiac biologics which our therapies utilize. We are proud of our demonstrated efficient use of capital while executing on significant goals and expect success in these activities to deliver meaningful benefits for patients and stockholders.” Recent Business Highlights CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01) In May, we announced the Japan’s Pharmaceutical and Medical Device Agency (PMDA) Consultation Record of Advice supports Shonin pre-market regulatory submission for approval based on the three completed clinical trials. PMDA’s Consultation Record confirms alignment on remaining questions to address before, and as part of the submission, for regulatory approval for ischemic HFrEF patients. PMDA noted that the positive outcomes seen in the trial were credible.PMDA requested BioCardia demonstrate that enrolled patients were on guideline-directed medical therapy (GDMT) and not eligible for revascularization procedures, required per CardiAMP HF protocol, and provide additional details for each incidence of all-cause death, heart transplantation or left ventricular assist device implantation. PMDA also provided guidelines for developing the post marketing study. BioCardia believes these requests will be addressed to PMDA’s satisfaction and the post marketing study to be developed together with PMDA and Japanese medical societies will be straightforward.In June, we announced receipt of FDA minutes from our Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER). The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance.BioCardia is preparing for regulatory submission in Japan in Q4 2026. We are working to complete the electronic trial master file, conduct 3rd party Japanese good clinical practice audits to PMDA standards, and structure clinical research data in accordance with CDISC Standards, which support data consistency, traceability, and regulatory compliance. We are reviewing extensive product documentation. We expect to soon engage a Designated Marketing Authorization Holder, or DMAH, as the local regulatory representative to enable BioCardia sales of CardiAMP Cell Therapy in Japan.BioCardia continues to actively enroll in the CardiAMP HF II trial. Four clinical sites have enrolled in the study and are actively recruiting patients. Three additional patients are expected to qualify for the study this month, and two are scheduled for their procedures this month. CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02) In May, primary results of this cohort were presented at Euro PCR, a world-leading course in interventional cardiovascular medicine. Results presented showed that the minimally invasive CardiAMP Cell Therapy procedure was well-tolerated with no treatment emergent major adverse cardiac events. Patients demonstrated positive clinical outcomes including increased exercise tolerance and reduced frequency of angina episodes with the autologous cell therapy up through 2 years follow-up. Prior to treatment, all patients were on GDMT and had received all available percutaneous and/or surgical options as appropriate for their medical condition. Patients experienced increased exercise tolerance, improving by an average of 179 seconds, which persisted for the two-year study follow-up. Angina episodes were reduced by an average of 82% by six-months after treatment. Helix™ Biotherapeutic Delivery System In May, BioCardia had a De Novo Pre-Submission meeting with FDA on approvability of the Helix transendocardial delivery catheter. As is customary, BioCardia provided draft minutes to FDA on May 12th with expectation that formal revised minutes from FDA or notification that the minutes are accepted and final would be provided on or before June 12th. FDA has advised us that we would receive these minutes soon and we anticipate submitting the follow-on pre-submission incorporating agency advice which could enable Helix approval via the DeNovo pathway. Heart3D™ Fusion Imaging In April, the Company announced the allowance of Japanese Patent, “Target Site Selection, Entry, and Update with Automatic Remote Image Annotation.” This patent adds further protection to BioCardia’s proprietary Heart3D™ Fusion Imaging (Heart3D) software intended for treatment planning and real-time navigation during CardiAMP Cell Therapy procedures. Heart3D is being advanced towards regulatory approval via the software as a medical device 510(k) submission route. It has been in discussions with many developers of gene and cell-based therapies on its potential to enhance others development efforts. Second Quarter 2026 Financial Results: Net cash used in operations for the three months ended June 2026 increased to $1.7 million, as compared to $1.6 million for the three months ended June 2025, and increased to $3.4 million for the six months ended June 2026, as compared to $3.3 million for the six months ended June 2025, primarily due to the timing of supplier payments.During the second quarter, BioCardia raised net proceeds of approximately $4.9 million under our “At the Market” facility.The Company ended the quarter with cash and cash equivalents totaling $4.1 million, providing anticipated runway into 2027.Research and development expenses decreased to $0.9 million for the three months ended June 2026 from $1.4 million for the three months ended June 2025 and decreased to $2.1 million for the six months ended June 2026 from $2.9 million for the six months ended June 2025, primarily due to close out of the CardiAMP HF Trial, partially offset by early enrollment in the CardiAMP HF II Trial and regulatory activities to advance CardiAMP in Japan.Selling, general and administrative expenses remained consistent at $0.7 million for both the three months ended June 2026 and June 2025, and decreased to $1.8 million for the six months ended June 2026 compared to $1.9 million in the six months ended June 2025.Our net loss decreased to $1.6 million for the three months ended June 2026 compared to $2.0 million for the three months ended June 2025, and to $3.9 million for the six months ended June 2026 compared to $4.8 million for the six months ended June 2025, primarily due to lower research and development expenses. ANTICIPATED UPCOMING MILESTONES AND EVENTS: Shonin Submission of CardiAMP Cell Therapy to Japan PMDA (Q4 2026)Continued CardiAMP Cell Therapy development in the USA with FDA engagementStrategic partnership / licensing progress in Helix/Heart3D for cell, gene, and protein delivery to the heart Strategic partnerships / licensing around our clinical allogeneic MSC platform Conference call access: Participants can register for the conference by navigating to https://dpregister.com/sreg/10211154/104a4f51d2e. Please note that registered participants will receive their dial-in number upon registration. For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730 and ask to be connected to the BioCardia call. All callers should dial-in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=ufQzaenK. A webcast replay of the call will be available approximately one hour after the end of the call at the following link: https://services.choruscall.com/ccforms/replay.html. A telephonic replay of the call will be available and may be accessed by calling 1-855-669-9658 (toll free domestic/Canada) and 1-412-317-0088 (international toll) by using access code 3063624. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. 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 sufficiency of data from our clinical trials, filings and communications with the FDA and Japan’s Pharmaceutical and Medical Device Agency, product clearances, the efficacy and safety of our products and therapies, preliminary conclusions about new data, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for our products and therapies, the expected benefits of our intellectual property, future prospects, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter 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 24, 2026, under the caption titled “Risk Factors BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. BIOCARDIA, INC.Consolidated Statements of Operations(Unaudited In thousands, except share and per share amounts) Three Months ended June 30, Six Months ended June 30, 2026 2025 2026 2025Costs and expenses: Research and development$893 $1,368 $2,128 $2,898 Selling, general and administrative 730 683 1,761 1,879 Total costs and expenses 1,623 2,051 3,889 4,777 Operating loss (1,623) (2,051) (3,889) (4,777)Other income (expense): Total other income, net 10 2 17 16 Net loss$(1,613)$(2,049)$(3,872)$(4,761) Net loss per share, basic and diluted$(0.13)$(0.40)$(0.34)$(0.98) Weighted-average shares used in computing net loss per share, basic and diluted 12,093,268 5,059,736 11,456,382 4,848,922 BioCardia, Inc. Selected Balance Sheet Data (amounts in thousands) June 30, December 31, 2026(1) 2025(1) Assets: Cash and cash equivalents$4,117 $2,496 Other current assets 181 236 Property, plant and equipment and other noncurrent assets 457 681 Total assets$4,755 $3,413 Liabilities and Stockholders’ Equity Current liabilities$2,055 $2,432 Operating lease liability – noncurrent 86 Total stockholders’ equity 2,700 895 Total liabilities and stockholders’ equity$4,755 $3,413 (1) June 30, 2026 amounts are unaudited. December 31, 2025 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, 2025, filed with the U.S. Securities and Exchange Commission on March 24, 2026. 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
