Financial

Orchestra BioMed Reports Full Year 2025 Financial Results and Provides Fourth Quarter Business Update

Financial by 0 comments

$106.5 million cash position as of December 31, 2025 to be further enhanced by $35 million expected from Medtronic and Ligand in Q2 2026 from previously announced transactions, as well as Haemonetics’ Vivasure acquisition proceeds$33.5 million in 2025 non-recurring revenue primarily driven by impact of new Virtue SAB agreement with Terumo that was announced in October 2025Strong balance sheet supports focused execution of pivotal trials for both AVIM Therapy and Virtue SAB programs NEW HOPE, Pa., March 12, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today reported its full year 2025 financial results and provided a fourth quarter business update. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed stated, “We are very proud of our significant clinical, strategic and financing accomplishments in 2025. We are now in an excellent financial and operational position to achieve upcoming value-driving milestones for both of our pivotal stage programs. In the second half of 2025, we leveraged our partnership-driven business model to substantially strengthen our financial position with nearly $150 million in new capital and capital commitments, including strategic transactions with Medtronic, Ligand and Terumo. With a strong balance sheet in place, we are fully focused on driving pivotal trial execution for both AVIM Therapy and Virtue SAB, high impact therapies designed to address major unmet needs in large, established global procedure markets.” Hochman continued, “As we enter 2026 with two pivotal trials underway, we remain focused on disciplined execution and long-term value creation for patients, clinicians and shareholders. We are encouraged by the accelerated pace of enrollment in the BACKBEAT global pivotal study following protocol amendments implemented in the fourth quarter and we plan to provide a substantive update in our next quarterly report. We are also pleased with the early progress of the Virtue Trial, which we initiated during the fourth quarter of 2025. We expect to provide additional updates on this trial, which is randomizing coronary in-stent restenosis patients to treatment with Virtue SAB versus the AGENT™ paclitaxel-coated balloon, as we gain further visibility into enrollment trends over the course of the year.” Q4 2025 and Recent Business Highlights: Accelerated patient enrollment of the BACKBEAT global pivotal study, in collaboration with Medtronic (NYSE: MDT), evaluating the efficacy and safety of Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of uncontrolled hypertension in patients indicated for a pacemaker.Initiated patient enrollments in the Virtue SAB U.S. pivotal trial, a randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT paclitaxel-coated balloon for the treatment of coronary in-stent restenosis (the “Virtue Trial”).Entered into an agreement with Terumo (“ROFR Agreement”) pursuant to which we and Terumo terminated our distribution agreement, and Orchestra BioMed granted Terumo a right of first refusal (the “ROFR”) with respect to certain strategic transactions relating to Virtue® Sirolimus AngioInfusionTM Balloon (“Virtue SAB”) for the treatment of coronary artery disease globally in exchange for a fee of $10.0 million. In connection with the ROFR Agreement, Terumo invested an additional $20.0 million in Orchestra BioMed through a new series of non-voting convertible preferred stock (the “Series A Preferred Stock”), which is convertible into common stock in the future, subject to certain conditions, at a minimum of $12 per share.Up to $21 million in total proceeds expected in connection with the acquisition of Vivasure Medical, previously a strategic holding of Orchestra BioMed, by Haemonetics. Orchestra BioMed expects to receive up to $10.7 million of these proceeds in 2026, including an initial upfront payment of $4.7 million received in January 2026 and the remainder expected later in the year as a first-milestone payment. The Company may receive additional proceeds in the future associated with potential revenue earnouts. Financial Results for the Year Ended December 31, 2025 Revenue for 2025 was $33.5 million, compared with $2.6 million for 2024, which represents an increase of 1,539%. The increase is primarily due to recognizing the remainder of the deferred revenue from our prior distribution agreement with Terumo of $15.4 million as a result of the termination of that agreement, $10.0 million in consideration for the ROFR, and $7.4 million associated with the premium paid above the fair market value of the Series A Preferred Stock.Research and development expenses for 2025 were $58.2 million, compared with $42.8 million for 2024, which represents an increase of 36%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study and to advance the Virtue SAB program, including the Virtue Trial.Selling, general and administrative expenses for 2025 were $26.9 million, compared with $23.9 million for 2024, which represents an increase of 12%. The increase was primarily due to an increase in professional fees.Net loss attributable to common stockholders for 2025 was $52.7 million, or ($1.11) per share, compared with a net loss attributable to common stockholders of $61.0 million, or ($1.66) per share, for 2024 which represents a decrease of 14%. Net loss attributable to common stockholders for the year-ended 2025 included non-cash stock-based compensation expense of $12.0 million, compared with $10.6 million for the same period in 2024, representing an increase of 13%.Net cash used in operating activities and for the purchase of fixed assets excluding the payment for the ROFR and the Series A Preferred Stock premium, which was recognized as revenue, was $66.9 million during 2025, compared with $50.8 million for 2024, with the primary driver of this increase being increased cash outflows for research and development, including clinical trial activities, during 2025.Cash and cash equivalents and Marketable securities totaled $106.5 million as of December 31, 2025. The Company has commitments from Ligand and Medtronic to receive a combined $35.0 million in additional proceeds on or before May 1, 2026, based on the terms of agreements with those parties and subject to the conditions therein. Additionally, in January 2026, Haemonetics closed on the acquisition of Vivasure in which we expect to receive up to $10.7 million of proceeds in 2026, consisting of an upfront payment of approximately $4.7 million, which has already been received, and approximately $6.0 million expected to be received in a first milestone payment. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. 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 proceeds expected to be received by the Company pursuant to the achievement of certain milestones in connection with the acquisition of Vivasure by Haemonetics; and the timing of any update on anticipated enrollment completion and potential primary endpoint results with respect to the BACKBEAT global pivotal study as well as the provision of any update on the Virtue Trial. 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, 2025, which was filed with the SEC on March 12, 2026.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 Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com ORCHESTRA BIOMED HOLDINGS, INC.Consolidated Balance Sheets(in thousands, except share and per share data)(unaudited)            December 31,     December 31,   2025  2024 ASSETS        CURRENT ASSETS:       Cash and cash equivalents $34,690  $22,261 Marketable securities  71,822   44,551 Accounts receivable, net  95   92 Inventory  310   173 Prepaid expenses and other current assets  994   2,094 Total current assets  107,911   69,171 Property and equipment, net  1,715   1,384 Right-of-use assets  1,496   2,103 Strategic investments  2,495   2,495 Deposits and other assets  1,240   1,020 TOTAL ASSETS $114,857  $76,173        LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY        CURRENT LIABILITIES:        Accounts payable $6,095  $5,134 Accrued expenses and other liabilities  9,890   6,084 Operating lease liability, current portion  751   550 Deferred revenue, current portion  —   4,439 Total current liabilities  16,736   16,207 Deferred revenue, less current portion  —   10,989 Royalty purchase agreement  16,482   — Loan payable  14,268   14,292 Derivative liability  2,749   — Operating lease liability, less current portion  936   1,687 Other long-term liabilities  308   40 TOTAL LIABILITIES  51,479   43,215        Series A Preferred Stock, $0.0001 par value per share; 200,000 issued and outstanding at December 31, 2025 and 0 issued and outstanding at December 31, 2024; aggregate liquidation preference of $20,000 at December 31, 2025  9,808   —        STOCKHOLDERS’ EQUITY        Preferred stock, $0.0001 par value, 10,000,000 shares authorized;  —   — Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 57,032,963 and 38,194,442 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively.  6   4 Additional paid-in capital  416,083   342,780 Accumulated other comprehensive income  60   52 Accumulated deficit  (362,579)  (309,878)TOTAL STOCKHOLDERS’ EQUITY  53,570   32,958 TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY $114,857  $76,173  ORCHESTRA BIOMED HOLDINGS, INC.Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(unaudited)            Year Ended December 31,   2025  2024 Revenue:        Partnership revenue $32,871  $2,005 Product revenue  611   633 Total revenue  33,482   2,638 Expenses:        Cost of product revenues  190   204 Research and development  58,185   42,804 Selling, general and administrative  26,914   23,931 Total expenses  85,289   66,939 Loss from operations  (51,807)  (64,301)Other (expense) income:        Interest (expense) income, net  (1,148)  3,356 Change in the fair value of derivative liability  254   — Loss on fair value of strategic investments  —   (68)Other expense  —   (11)Total other (expense) income  (894)  3,277 Net loss  (52,701)  (61,024)Adjustment to carrying value of Series A Preferred Stock  (254)  — Net loss attributable to common stockholders $(52,955) $(61,024)       Net loss attributable to common stockholders per share        Basic and diluted $(1.11) $(1.66)Weighted-average shares used in computing net loss attributable to common stockholders per share, basic and diluted  47,747,078   36,821,042 Comprehensive loss       Net loss $(52,701) $(61,024)Unrealized gain on marketable securities  8   62 Comprehensive loss $(52,693) $(60,962)

Continue Reading →

Milestone Pharmaceuticals to Announce Fourth Quarter and Full-Year 2025 Financial Results on March 20, 2026

Financial by 0 comments

Conference Call and Webcast Scheduled for Friday, March 20 at 8:30am ETMONTREAL and CHARLOTTE, N.C., March 12, 2026 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced that it will report fourth quarter and full-year 2025 results and provide a business update on Friday, March 20, 2026, before the market opens. The announcement will be followed by a conference call and webcast for investors at 8:30am ET. Conference Details: Conference Dial-in:1-877-407-0792International Dial-in:1-201-689-8263Conference ID:13759195Webcast link:click here Call me™: Participants can use Guest dial-in numbers above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. The Call me™ link will be made active 15 minutes prior to scheduled start time. A replay of the audio webcast of the call will be available under the “Investors and Media” section of Milestone’s corporate website, www.milestonepharma.com. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST™ (etripamil) nasal spray, a novel calcium channel blocker, which is FDA approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.  Etripamil is also in development for the control of symptomatic episodic attacks associated with AFib-RVR.  Contact: Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com Media Relations Rebecca Novak, rnovak@milestonepharma.com

Continue Reading →

Elutia Reports Fourth Quarter and Full Year 2025 Financial Results; Initiates NXT-41 Regulatory Process

Financial by 0 comments

– Base biologic matrix NXT-41 submitted to FDA; on track for anticipated FDA clearance in second half of 2026 and full NXT-41x clearance in 1H27 – – $44.4 million in cash and escrowed proceeds at year-end – – Conference call today at 5:00 p.m. ET / 2:00 p.m. PT – GAITHERSBURG, Md., March 11, 2026 (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 fourth quarter and full year ended December 31, 2025. Business Highlights: NXT-41x Development Program On Track: Elutia continues to advance development of NXT-41x, a next-generation antibiotic-eluting biomatrix for plastic and reconstructive surgery. The Company has submitted the 510(k) application for the base biologic matrix, NXT-41, to FDA and anticipates clearance later this year. Clearance for the full NXT-41x drug-eluting biologic is anticipated in the first half of 2027. Surgeon engagement and feedback continue to support the potential of NXT-41x in the $1.5 billion U.S. breast cancer surgery market, where post-operative infection rates remain at 15–20%.Leadership and Commercial Readiness: Elutia strengthened its Board and leadership team to support commercialization of the NXT-41x platform. Guido J. Neels, Operating Partner at EW Healthcare Partners and former Chief Operating Officer of Guidant Corporation, joined the Company’s Board of Directors. Pete Ligotti joined the Company as Chief Commercial Officer following a 20-year career at Integra Life Sciences and will lead the Company’s overall commercialization strategy and launch readiness activities.BioEnvelope Sale Closed: On October 1, 2025, Elutia closed the $88 million cash sale of its EluPro™ and CanGaroo BioEnvelope business to Boston Scientific Corporation, validating the strength of the Company’s proprietary drug-eluting biologics platform and providing capital to fund development and launch of NXT-41x.Transformed Balance Sheet: During the fourth quarter, the Company repaid the full $26.9 million in outstanding principal, accrued interest, and accrued exit fees associated with its loan facility with SWK Holdings. As of December 31, 2025, cash on hand was $36.4 million with an additional $8.0 million held in escrow related to the BioEnvelope divestiture, expected to be released in the fourth quarter of 2026.SimpliDerm Strategic Process Initiated: Given the progress and growing confidence in the NXT-41x program, Elutia has initiated a process to explore strategic options for its patented SimpliDerm product line. The process aims to sharpen the company’s time and resources on the upcoming launch and commercialization of NXT-41x. “2025 was the year we proved our drug-eluting biologic platform works, and the market wants it,” said Dr. Randy Mills, Chief Executive Officer of Elutia. “With the $88 million BioEnvelope divestiture to Boston Scientific, we were able to remove debt and legacy distractions and transform Elutia into a high-velocity organization that’s about to shake up the stagnant $1.5 billion breast cancer surgery market. The current standard of care fails one in three women, and to us, that’s unacceptable. We are Ridiculously Relentless about ensuring that when a woman undergoes reconstruction, her recovery isn’t hijacked by a preventable complication, and we think NXT-41x will do just that. I want to thank the Elutia CRU for an outstanding year and welcome our new members to the team as we fight to ensure our mothers and daughters thrive without compromise.” Fourth Quarter 2025 Financial ResultsNet sales and operating results discussed below reflect continuing operations and exclude the divested BioEnvelope business. For the three-month period ended December 31, 2025, as compared to the same period of 2024: Overall net sales were $3.3 million, compared to $2.8 million in Q4 2024, an increase of 16%.Net sales of SimpliDerm were $2.1 million, compared to $2.3 million in Q4 2024.Net sales of Cardiovascular products were $1.2 million, compared to $0.5 million in Q4 2024.Gross margin on a GAAP basis was 58.5%, compared to 46.9%.Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 66.8%, compared to 56.5%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.Total operating expenses were $8.5 million, compared to $8.8 million.Loss from continuing operations was $6.6 million, compared to $7.5 million.Net loss from continuing operations was $6.5 million, compared to a loss of $7.2 million.Income from discontinued operations was $77.3 million, primarily reflecting the gain on the sale of the BioEnvelope business to Boston Scientific Corporation.Net income (which includes the gain on the sale of the BioEnvelope business) was $70.8 million, compared to a net loss of $9.1 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 $4.2 million, compared to a loss of $3.4 million. A reconciliation of net income (loss) to adjusted EBITDA is included in the accompanying financial tables.Cash balance as of December 31, 2025, was $36.4 million. An additional $8.0 million related to the BioEnvelope divestiture is held in escrow and is expected to be released in the fourth quarter of 2026.As of December 31, 2025, there were 42.8 million shares of Class A common stock outstanding with an additional 4.5 million pre-funded warrants outstanding. Full Year 2025 Financial ResultsNet sales and operating results discussed below reflect continuing operations and exclude the divested BioEnvelope business. For the year ended December 31, 2025, as compared to the same period of 2024: Overall net sales were $12.3 million, compared to $14.5 million, reflecting the changes in the SimpliDerm and cardiovascular distribution models.Net sales of SimpliDerm were $9.1 million, compared to $11.6 million.Net sales of Cardiovascular products were $3.2 million, compared to $2.9 million.Gross margin on a GAAP basis was 53.7%, compared to 46.4%.Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 62.4%, compared to 53.9%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.Total operating expenses were $33.5 million, compared to $37.4 million.Net loss from continuing operations was $15.9 million, compared to a loss of $45.3 million.Income from discontinued operations was $69.3 million, primarily reflecting the gain on the sale of the BioEnvelope business.Net income (including the gain on the sale of the BioEnvelope business) was $53.4 million, compared to a net loss of $53.9 million.Adjusted EBITDA was a loss of $12.8 million, compared to a loss of $11.2 million. A reconciliation of net income (loss) to adjusted EBITDA is included in the accompanying financial tables. Conference CallElutia will host a conference call today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its fourth quarter and full year 2025 financial results and performance. The conference call can be accessed using the following information: Webcast: Click here Dial-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 believes 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 loss from discontinued operations, stock-based compensation, FiberCel and other Viable Bone Matrix (VBM) litigation costs, loss or gain on revaluation of warrant liability, loss on early repayment of debt, 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 regarding the future success of new products in Elutia’s breast reconstruction business. 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: risks associated with shifting focus to our drug-eluting biomatrix solutions in the breast reconstruction area and away from our BioEnvelope business; our ability to successfully execute or achieve expected benefits from the divestiture of our BioEnvelope business; 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 achieve or sustain profitability; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; 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 former FiberCel and other VBM 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 dependence on a limited number of third-party suppliers and manufacturers; 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, 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 STATEMENT OF OPERATIONS(Unaudited, in thousands, except share and per share data)     Three months ended December 31, Twelve months ended December 31,  2025   2024   2025   2024             Net sales$3,271  $2,816  $12,293  $14,467 Cost of goods sold 1,357   1,494   5,697   7,752 Gross profit 1,914   1,322   6,596   6,715 Operating expenses:              Sales and marketing 1,902   1,197   5,765   4,988    General and administrative 4,288   4,245   15,080   18,073    Research and development 1,215   727   4,163   2,998    Litigation costs, net 1,070   2,611   8,499   11,368 Total operating expenses 8,475   8,780   33,507   37,427 Loss from continuing operations (6,561)  (7,458)  (26,911)  (30,712)Interest (income) expense, net (345)  138   (387)  934 Other expense (income), net 305   (443)  (10,666)  13,692 Loss from continuing operations before provision for income taxes (6,521)  (7,153)  (15,858)  (45,338)Income tax expense (benefit) (11)  2   13   7 Net loss from continuing operations (6,510)  (7,155)  (15,871)  (45,345)Income (loss) from discontinued operations 77,301   (1,906)  69,251   (8,604)Net income (loss)$70,791  $(9,061) $53,380  $(53,949)            Net income (loss) per share – basic$1.66  $(0.26) $1.29  $(1.86)Net income (loss) per share – diluted$1.48  $(0.26) $0.87  $(1.86)            Weighted average shares outstanding – basic 42,721,201   34,845,672   41,416,850   29,071,113 Weighted average shares outstanding – diluted 47,243,564   34,845,672   45,942,787   29,071,113                  ELUTIA INC.CONSOLIDATED BALANCE SHEET DATA(Unaudited, in thousands)      Assets December 31, 2025  December 31, 2024Current assets:        Cash and cash equivalents$36,350  $13,239    Accounts receivable, net 1,734   2,276    Inventory 2,617   1,931    Insurance receivables of litigation costs 4,846   4,760    Prepaid expense and other current assets 10,271   1,986    Current assets of discontinued operations –   1,980 Total current assets 55,818   26,172       Property and equipment, net 2,511   671 Intangible assets, net 1,529   2,600 Operating lease right-of-use assets, and other 2,492   179 Noncurrent assets of discontinued operations –   6,505 Total assets$62,350  $36,127       Liabilities and Stockholders’ Deficit     Current liabilities:        Accounts payable, accrued expenses and other$9,143  $11,253    Current portion of long-term debt –   1,250    Current portion of revenue interest obligation 4,400   4,400    Contingent liability for legal proceedings 11,241   20,432    Current operating lease liabilities 355   145    Current liabilities of discontinued operations –   315 Total current liabilities 25,139   37,795       Long-term debt –   22,603 Long-term revenue interest obligation 2.828   5,490 Warrant liability 3,124   16,076 Other long-term liabilities 3,587   16 Noncurrent liabilities of discontinued operations –   407 Total liabilities 34,678   82,387       Stockholders’ equity (deficit):        Common stock 43   35    Additional paid-in capital 203,842   183,298    Accumulated deficit (176,213)  (229,593)Total stockholders’ equity (deficit) 27,672   (46,260)Total liabilities and stockholders’ equity (deficit)$62,350  $36,127  ELUTIA INC.NON-GAAP RECONCILIATIONS OF ADJUSTED GROSS PROFIT AND ADJUSTED GROSS MARGIN(Unaudited, in thousands, except share and per share data)     Three months ended December 31, Twelve months ended December 31,  2025   2024   2025   2024             Net sales$3,271  $2,816  $12,293  $14,467 Gross profit 1,914   1,322   6,596   6,715    Intangible asset amortization expense 270   270   1,077   1,077 Adjusted gross profit (Non-GAAP)$2,184  $1,592  $7,673  $7,792 Gross margin 58.5%  46.9%  53.7%  46.4%Adjusted gross margin (Non-GAAP) 66.8%  56.5%  62.4%  53.9%                 ELUTIA INC.NON-GAAP RECONCILIATIONS OF EBITDA AND ADJUSTED EBITDA(Unaudited, in thousands, except share and per share data)     Three months ended December 31, Twelve months ended December 31,  2025   2024   2025   2024             Net income (loss)$70,791  $(9,061) $53,380  $(53,949)Interest (income) expense, net(1) (345)  138   (387)  934 Provision (benefit) for income taxes (11)  2   13   7 Depreciation and amortization 297   281   1,174   1,124 EBITDA (Non-GAAP) 70,732   (8,640)  54,180   (51,884)            (Income) loss from discontinued operations (77,301)  1,906   (69,251)  8,604 Stock-based compensation 947   1,162   4,397   7,043 Litigation costs, net(2) 1,070   2,611   8,499   11,368 (Gain) loss on revaluation of warrant liability(3) (906)  (443)  (13,424)  14,878 Loss on early repayment of debt(4) 1,287   –   1,287   – Warrant issuance expenses –   –   105   257 Loss (gain) on revaluation of revenue interest obligation(5) –   –   1,443   (1,443)Adjusted EBITDA (Non-GAAP)$(4,171) $(3,404) $(12,764) $(11,177) (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 loss recognized on the full repayment of the SWK loan facility prior to maturity through the proceeds from the sale of our BioEnvelope business. (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.

Continue Reading →

Trinity Capital Inc. Provides $20 Million in Growth Capital to Emboline, Inc. to Advance Interventional Heart Procedure Technology

Financial by 0 comments

PHOENIX, March 11, 2026 /PRNewswire/ — Trinity Capital Inc. (Nasdaq: TRIN) (“Trinity”), a leading international alternative asset manager, today announced the commitment of $20 million in growth capital to Emboline, Inc. (“Emboline”), a MedTech company focused on reducing strokes and…

Continue Reading →

SS Innovations Reports Fourth Quarter and Full Year 2025 Financial Results

Financial by 0 comments

Strong growth in SSi Mantra installations, procedures and revenuesFORT LAUDERDALE, Fla., March 10, 2026 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced unaudited financial results for the three and twelve months ended December 31, 2025. The Company also filed its Annual Report on Form 10-K for the year ended December 31, 2025, with the Securities and Exchange Commission on March 10, 2026. Fourth Quarter 2025 Overview Revenue increased 79.1% to $14.5 million from $8.1 million in the fourth quarter of 2024.Gross margin of 43.9% compared to 48.9% in the fourth quarter of 2024.Gross profit rose 60.7% to $6.4 million from $4.0 million in the fourth quarter of 2024.Net loss of $2.5 million, or $(0.01) per diluted share, compared to a net loss of $1.9 million, or $(0.01) per diluted share, in the fourth quarter of 2024.SSi Mantra surgical robotic system installations totaled 40, up 81.8% from 22 installations in the fourth quarter of 2024 and up 48.1% from 27 installations in the third quarter of 2025. Full Year 2025 Overview Revenue increased 105.7% to $42.5 million from $20.6 million in 2024.Gross margin expanded to 46.0% from 40.9% in 2024.Gross profit rose 131.2% to $19.5 million from $8.5 million in 2024.Net loss of $12.1 million, or $(0.06) per diluted share, compared to net loss of $19.2 million, or $(0.11) per diluted share, in 2024.SSi Mantra surgical robotic system installations totaled 103, up 119.1% from 47 installations in 2024. As of December 31, 2025 Long-term debt of $0.Cash and cash equivalents totaled $3.2 million, excluding restricted cash.SSi Mantra cumulative installed base totaled 168 across ten countries and cumulative surgeries reached 7,885, including 120 telesurgeries, 390 cardiac procedures and 121 pediatric surgeries. CEO Commentary Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “In the fourth quarter of 2025, we achieved strong growth in SSi Mantra installations, procedures and revenues, capping off a successful year for SS Innovations. Among our accomplishments in 2025, we gained significant share of the surgical robotics market in India, expanded into new global geographies, and progressed along the regulatory pathways required for entering the United States and European Union markets. We also continued to pioneer robotic telesurgery, attaining multiple new procedure milestones and unveiling cutting-edge innovations such as the Tele Surgeon Console and MantraM mobile robotic telesurgery unit. Finally, the uplisting of our shares to Nasdaq has enhanced market awareness of our growth story and expanded our audience of potential investors.” Dr. Srivastava continued, “After quarter-end we completed a private placement of common stock, which brings us new long-term oriented institutional investors and approximately $18.6 million of gross proceeds aimed to fuel SS Innovations’ growth in 2026 and beyond. Significant insider participation in this financing reflects our strong confidence in SS Innovations’ future. We will continue to invest in enhancements to our advanced, cost-effective SSi Mantra surgical robotic system and expand our capacity to lead the vast Indian market, penetrate underserved global geographies, and prepare for our entry into the United States and European Union. We anticipate that the U.S. Food and Drug Administration will complete its review of our 510(k) premarket notification for the SSi Mantra by mid-2026. We also continue along the pathway towards a European Union CE marking certification for the SSi Mantra, which we believe we can also obtain this year. In conclusion, we expect continuing strong growth in 2026 as we deploy the SSi Mantra in existing and new markets, increasing access to world-class surgical robotic care.” Select Business Highlights in Fourth Quarter 2025 On November 6, 2025, the Company announced the successful completion of the first telesurgery performed with the SSi Mantra Tele Surgeon Console.On December 5, 2025, the Company submitted a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) for the SSi Mantra surgical robotic system, covering multiple indications including general, urological, colorectal, gynecological and cardiac surgeries. Subsequent Events On January 6, 2026, the Company announced the development of five new 5-millimeter surgical instruments for clinical use across multiple specialties, including pediatric, cardiac, and head and neck surgery, among other procedures involving smaller anatomical structures.On March 9, 2026, the Company announced the completion of a private placement of its common stock, generating approximately $18.6 million in gross proceeds before deducting offering expenses, to support growth initiatives. In the offering, the Company offered and sold a total of 5,774,839 shares of common stock consisting of: an aggregate of 1,300,006 shares of common stock at an average price of $4.00 per share to certain of the Company’s directors and executive officers, or a total of approximately $5.2 million; and an aggregate of 4,474,833 shares of common stock at $3.00 per share, or approximately $13.4 million cumulatively, to non-affiliate investors. Revenue Breakdown and Summary of Installations / Surgeries CategoryQ4 2024Q4 2025VariancePercentageSystem sales$7,735,005$13,364,153$5,629,14872.8%Instrument sales282,332844,279561,947199.0%Warranty sales80,769316,771236,002292.2%Lease income18,0879,280(8,807)(48.7)%Total revenue$8,116,193$14,534,483$6,418,29079.1%     SSi Mantra installations22401881.8%Cumulative installed base165168103158.5%     SSi Mantra surgeries6101,8281,218199.7%Cumulative surgeries12,7597,8855,126185.8%           1 at period end Category20242025VariancePercentageSystem sales$19,457,767$38,353,048$18,895,28197.1%Instrument sales942,5483,183,7572,241,209237.8%Warranty sales177,518877,033699,515394.1%Lease income71,69570,909(786)(1.1)%Total revenue$20,649,528$42,484,747$21,835,219105.7%     SSi Mantra installations4710356119.1%SSi Mantra surgeries2,1395,0872,948137.8%      About SS Innovations SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of robotic surgical procedures including cardiac surgery. An American company headquartered in India, SS Innovations plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates. About the SSi Mantra The SSi Mantra surgical robotic system is a user-friendly, modular, multi-arm system with many advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery. The SSi Mantra has been clinically validated in India in more than 100 different types of surgical procedures. Forward Looking StatementsThis press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations’ future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Investor Contact:The Equity GroupKalle Ahl, CFAT: (303) 953-9878kahl@theequitygroup.com Devin Sullivan, Managing Director T: (212) 836-9608dsullivan@theequitygroup.com Media Contact:RooneyPartners LLCKate BarretteT: (212) 223-0561kbarrette@rooneypartners.com SS INNOVATIONS INTERNATIONAL, INC.CONSOLIDATED BALANCE SHEETS(Audited)  As of   December 31, 2025  December 31, 2024        ASSETS      Current Assets:      Cash and cash equivalents $3,206,406  $466,500 Restricted cash  5,937,650   5,838,508 Accounts receivable, net  12,398,542   4,466,047 Inventory, net  17,064,002   10,206,898 Prepaids and other current assets  10,194,059   6,438,338 Total Current Assets  48,800,659   27,416,291          Property, plant, and equipment, net  9,100,546   5,385,955 Right of use asset  2,754,020   2,623,880 Deferred tax assets, net  533,727   – Accounts receivable, net  8,566,654   3,299,032 Restricted cash  458,964   318,527 Prepaids and other non current assets  4,011,647   3,341,528 Total Assets $74,226,217  $42,385,213          LIABILITIES AND STOCKHOLDERS’ EQUITY        Current Liabilities        Bank overdraft facility $11,442,948  $7,994,906 Notes payable  –   7,450,000 Current portion of operating lease liabilities  579,169   409,518 Accounts payable  5,127,193   2,312,382 Deferred revenue  3,266,686   1,278,602 Accrued expenses & other current liabilities  5,825,702   1,884,814 Total Current Liabilities  26,241,698   21,330,222          Operating lease liabilities, less current portion  2,337,697   2,349,118 Deferred Revenue  7,139,807   5,173,953 Other non current liabilities  288,764   74,817 Total Liabilities $36,007,966  $28,928,110 Commitments and contingencies        Stockholders’ equity:                 Preferred stock, authorized 5,000,000 shares of Series A, Non-Convertible Preferred Stock, $0.0001 par value per share; 1,000 shares issued and outstanding as of December 31, 2025 and December 31, 2024  1   1 Common stock, 250,000,000 shares authorized, $0.0001 par value, 194,165,141 shares and 171,579,284 shares issued and outstanding as of December 31, 2025 and December 31, 2024 respectively  19,416   17,157 Accumulated other comprehensive income (loss)  (2,022,660)  (749,625)Additional paid in capital  95,111,511   56,952,200 Capital reserve  899,917   899,917 Accumulated deficit  (55,789,934)  (43,662,547)Total stockholders’ equity  38,218,251   13,457,103 Total liabilities and stockholders’ equity $74,226,217  $42,385,213  SS INNOVATIONS INTERNATIONAL, INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Audited)  For the three months endedDecember 31,2025  For the threemonths endedDecember 31,2024      REVENUES     System sales  13,364,153   7,735,005 Instruments sale  844,279   282,332 Warranty sale  316,771   80,769 Lease income  9,280   18,087 Total revenue $14,534,483  $8,116,193 Cost of revenue  (8,157,430)  (4,147,202)        GROSS PROFIT  6,377,053   3,968,991         OPERATING EXPENSES:       Research & development expense  1,390,826   761,937 Stock compensation expense  2,023,433   2,338,887 Depreciation and amortization expense  309,491   145,926 Selling, general and administrative expense  3,388,300   2,560,927 TOTAL OPERATING EXPENSES  7,112,050   5,807,677         Loss from operations  (734,997)  (1,838,686)        OTHER INCOME (EXPENSE):       Interest Expense  (335,296)  (292,954)Interest and other income, net  364,566   208,249 TOTAL INCOME / (EXPENSE), NET  29,270   (84,705)        LOSS BEFORE INCOME TAXES  (705,727)  (1,923,391)Income tax expense  1,765,653   – NET LOSS $(2,471,380) $(1,923,391)        CONSOLIDATED STATEMENTS OF OTHER COMPREHENSIVE LOSS               NET LOSS $(2,471,380) $(1,923,391)        OTHER COMPREHENSIVE INCOME (LOSS)       Foreign currency translation loss  (685,735)  (385,368)Retirement Benefit (net of tax)  (48,444)  (24,086)RECLASSIFICATION ADJUSTMENTS:       Retirement Benefit (net of tax)  1,433   – Income tax effects relating to retirement benefit  14,912   – TOTAL OTHER COMPREHENSIVE LOSS  (717,834)  (409,454)TOTAL COMPREHENSIVE LOSS $(3,189,214) $(2,332,845) SS INNOVATIONS INTERNATIONAL, INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Audited)  For The Year Ended   December 31, 2025  December 31, 2024        REVENUES      System sales 38,353,048  19,457,767 Instruments sale  3,183,757   942,548 Warranty sale  877,033   177,518 Lease income  70,909   71,695 Total revenue $42,484,747  $20,649,528 Cost of revenue  (22,940,492)  (12,197,162)         GROSS PROFIT  19,544,255   8,452,366          OPERATING EXPENSES:        Research & development expense  3,685,840   2,491,771 Stock compensation expense  8,128,103   14,342,784 Depreciation and amortization expense  1,075,907   436,005 Selling, general and administrative expense  14,848,439   10,157,768 TOTAL OPERATING EXPENSES  27,738,289   27,428,328          Loss from operations  (8,194,034)  (18,975,962)         OTHER INCOME (EXPENSE):        Interest Expense  (1,108,637)  (973,235)Interest and other income, net  1,141,724   798,000 TOTAL INCOME / (EXPENSE), NET  33,087   (175,235)         LOSS BEFORE INCOME TAXES  (8,160,947)  (19,151,197)Income tax expense  3,966,440   – NET LOSS $(12,127,387) $(19,151,197)         Net loss per share – basic and diluted $(0.06) $(0.11)Weighted average – basic shares  190,009,159   170,847,444 Weighted average – diluted shares  198,699,461   181,203,673          CONSOLIDATED STATEMENTS OF OTHER COMPREHENSIVE LOSS                 NET LOSS $(12,127,387) $(19,151,197)         OTHER COMPREHENSIVE INCOME (LOSS):        Foreign currency translation loss  (1,225,696)  (539,900)Retirement Benefit  (68,809)  (14,226)RECLASSIFICATION ADJUSTMENTS:        Retirement Benefit  1,433   – Income tax effects relating to retirement benefit  20,037   – TOTAL OTHER COMPREHENSIVE LOSS  (1,273,035)  (554,126)TOTAL COMPREHENSIVE LOSS $(13,400,422) $(19,705,323) SS INNOVATIONS INTERNATIONAL, INC.CONSOLIDATED STATEMENTS OF CASH FLOWS(Audited)  For the Year Ended   December 31, 2025  December 31, 2024 Cash flows from operating activities:             Net loss $(12,127,387) $(19,151,197)Adjustments to reconcile net loss to net cash used in operating activities:        Depreciation and amortization  1,075,907   436,005 Operating lease expense  827,521   753,449 Interest Expense  271,633   317,234 Interest and other income, net  (625,883)  (418,426)Property, plant and equipment written off  –   48,456 Provision for credit loss reserve, net  324,345   955,762 Deferred income tax benefit  (512,865)  – Stock compensation expense  8,128,103   14,342,784 Provision for slow moving inventory  (110,332)  –          Changes in operating assets and liabilities:        Accounts receivable, net  (13,037,284)  (4,890,032)Inventory, net  (8,070,786)  (7,691,518)Deferred revenue  3,953,938   5,357,075 Prepaids and other assets  (5,101,794)  (1,411,621)Accounts payable  2,877,810   1,410,830 Income taxes payable, net  4,214,339   – Accrued expenses & other liabilities  161,914   1,144,037 Operating lease payment  (792,166)  (705,868)Net cash used in operating activities  (18,542,987)  (9,503,030)         Cash flows from investing activities:        Purchase of property, plant and equipment  (3,659,058)  (661,479)Net cash used in investing activities  (3,659,058)  (661,479)         Cash flows from financing activities:        Proceeds from bank overdraft facility (net)  3,448,042   1,975,980 Proceeds from issuance of promissory notes to principal shareholder  –   3,000,000 Proceeds from issuance of convertible notes to principal shareholder  28,000,000   3,000,000 Proceeds from issuance of convertible notes to other investors  –   1,450,000 Repayment of convertible notes to principal shareholder, including interest  (4,212,637)  – Repayment of convertible notes to other investors, including interest  (1,068,849)  – Net cash provided by financing activities  26,166,556   9,425,980          Net change in cash  3,964,511   (738,529)Effect of exchange rate on cash  (985,026)  274,219 Cash and cash equivalents at the beginning of the year  6,623,535   7,087,845 Cash and cash equivalents at end of the year $9,603,020  $6,623,535 

Continue Reading →

SS Innovations Announces Completion of an $18.6 Million Private Placement to Support Growth Initiatives

Financial by 0 comments

Financing led by Certain of the Company’s Directors and Executive OfficersFORT LAUDERDALE, Fla., March 09, 2026 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that on March 6, 2026, the Company completed a private placement of its common stock (the “Private Placement”) which generated approximately $18.6 million in gross proceeds, before deducting offering expenses. In the offering, the Company offered and sold a total of 5,774,839 shares of common stock consisting of: an aggregate of 1,300,006 shares of common stock at an average price of $4.00 per share, or a total of approximately $5.2 million, to Dr. Sudhir Srivastava, our Chairman and Chief Executive Officer ($2.0 million), Dr. Frederic H. Moll, our Vice-Chairman ($2.0 million), and Tim Adams, a director ($1.197 million); andan aggregate of 4,474,833 shares of common stock at $3.00 per share, or a total of approximately $13.4 million, to existing and new investors, led by Manipal Global Health Services, an existing shareholder.   SS Innovations intends to use the net proceeds from this financing for working capital and other general corporate purposes, including advancing the Company’s global expansion efforts. In connection with a $2.5 million investment by one of the non-affiliate investors in the Private Placement, SS Innovations will pay a FINRA member firm a cash commission of $175,000 (7% of the investment) and issue to such firm five-year warrants to purchase 41,667 shares of our common stock at an exercise price of $3.45 per share. Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “The net proceeds from this financing will advance our growth initiatives in India and other existing global markets, while supporting our preparation for entry into the United States and European Union markets. We anticipate that the U.S. Food and Drug Administration will complete its review of our 510(k) premarket notification for our SSi Mantra surgical robotic system by mid-2026. We also continue along the pathway towards a European Union CE marking certification for the SSi Mantra, which we believe we can also obtain in 2026.” Dr. Srivastava continued, “Insider participation in this financing reflects our strong confidence in SS Innovations’ future and our commitment to democratizing access to world-class surgical robotic care. We appreciate the continuing support of Manipal Global Health Services, a large existing shareholder, and welcome a respected group of new shareholders in the Company.” The securities being sold in the Private Placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws and accordingly may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About SS Innovations SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of robotic surgical procedures including cardiac surgery. An American company headquartered in India, SS Innovations plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates. About the SSi Mantra The SSi Mantra surgical robotic system is a user-friendly, modular, multi-arm system with many advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery. The SSi Mantra has been clinically validated in India in more than 100 different types of surgical procedures. Forward Looking StatementsThis press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations’ future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we do not assume any obligation to update any forward-looking statement. Investor Contact:The Equity Group        Kalle Ahl, CFA                T: (303) 953-9878        kahl@theequitygroup.com Devin Sullivan, Managing Director T: (212) 836-9608dsullivan@theequitygroup.com Media Contact:RooneyPartners LLCKate BarretteT: (212) 223-0561kbarrette@rooneypartners.com

Continue Reading →

Solid Biosciences Announces Oversubscribed $240 Million Private Placement

Financial by 0 comments

CHARLESTOWN, Mass., March 06, 2026 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it has entered into a securities purchase agreement with a select group of institutional accredited investors for an approximately $240 million private placement, before deducting placement agent fees and offering expenses, which is expected to close on or about March 9, 2026, subject to the satisfaction of customary closing conditions. The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the “Minimum Price” requirement (as defined in the Nasdaq rules). In the private placement, the Company is selling 14,973,257 shares of common stock at a price of $5.61 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase up to 27,807,482 shares of common stock at a price of $5.609 per pre-funded warrant. Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately, and will be exercisable until exercised in full. The private placement was anchored by existing and new investors, including Perceptive Advisors, Bain Capital Life Sciences, RA Capital Management, Invus, Vestal Point Capital, Janus Henderson Investors, and Deep Track Capital, among others. The Company expects to use net proceeds from the private placement to fund ongoing pipeline development programs, business development activities, and for working capital and other general corporate purposes. Leerink Partners and Citigroup are acting as joint lead placement agents for the financing. Cantor is acting as co-lead placement agent for the financing. Truist and H.C. Wainwright & Co. are acting as co-placement agents for the financing. The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) registering the resale of the shares of common stock issued in the private placement and the shares of common stock issuable upon the exercise of the pre-funded warrants issued in the private placement no later than the 30th day after the closing of the private placement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. About Solid Biosciences Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including SGT-003 for Duchenne muscular dystrophy (Duchenne), SGT-212 for Friedreich’s ataxia (FA), SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT), SGT-601 for TNNT2-mediated dilated cardiomyopathy and additional fatal, genetic cardiac diseases. The Company is also focused on developing innovative libraries of genetic regulators and other enabling technologies with promising potential to significantly impact gene therapy delivery cross-industry. Solid is advancing its diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases. Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the anticipated closing of the private placement; the anticipated use of proceeds from the private placement; the filing of a registration statement to register the resale of the shares and pre-funded warrant shares to be issued and sold in the private placement; future expectations, plans and prospects for the Company; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to: market and other financial conditions and the impact of general economic, industry or political conditions in the United States or internationally; whether the conditions for the closing of the private placement will be satisfied; the Company’s ability to advance SGT-003 and other clinical and preclinical programs, capsid libraries and other enabling technologies on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies of the Company’s product candidates; obtain, maintain or protect intellectual property rights related to its product candidates; enroll patients in ongoing trials; activate clinical trial sites; replicate preliminary or interim data from clinicals trials in the final data of such trials; compete successfully with other companies that are seeking to develop Duchenne, FA, CPVT and other neuromuscular and cardiac treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-003 and its other candidates, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 and other filings that the Company may make with the SEC in the future. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. Solid Biosciences Investor Contact:Nicole AndersonSenior Director, Investor Relations and Corporate CommunicationsSolid Biosciences Inc.investors@solidbio.com Media Contact:Glenn SilverFINN Partnersglenn.silver@finnpartners.com

Continue Reading →
1 … 10 11 12 13 14 … 487