Market Newsdesk

LEHI, Utah, April 22, 2025 (GLOBE NEWSWIRE) — Nature’s Sunshine Products, Inc. (Nasdaq: NATR) (Nature’s Sunshine), a leading manufacturer of high-quality herbal and nutritional supplements, will conduct a conference call on Tuesday, May 6, 2025, at 5:00 p.m. Eastern time (3:00 p.m. Mountain time) to discuss its financial results for the first quarter ended March 31, 2025. The company will report its financial results in a press release prior to the conference call.

Nature’s Sunshine CEO Terrence Moorehead and CFO Shane Jones will host the conference call, followed by a question and answer period.

Date: Tuesday, May 6, 2025
Time: 5:00 p.m. Eastern time (3:00 p.m. Mountain time)
Toll-free dial-in number: 1-800-717-1738
International dial-in number: 1-646-307-1865
Conference ID: 16234

Please call the conference telephone number 5-10 minutes prior to the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Gateway Group at 1-949-574-3860.

The conference call will be broadcast live and available for replay here and via the Events section of the Nature’s Sunshine website here.

A replay of the conference call will be available after 8:00 p.m. Eastern time on the same day through Tuesday, May 20, 2025.

Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 1116234

About Nature’s Sunshine

Nature’s Sunshine Products (Nasdaq: NATR), a leading natural health and wellness company, markets and distributes nutritional and personal care products in more than 40 countries. Nature’s Sunshine manufactures most of its products through its own state-of-the-art facilities to ensure its products continue to set the standard for the highest quality, safety, and efficacy on the market today. Additional information about the Company can be obtained at its website, www.naturessunshine.com.

Investor Relations:

Gateway Group, Inc.
Cody Slach
1-949-574-3860
[email protected]

SUNNYVALE, Calif., April 22, 2025 (GLOBE NEWSWIRE) — Intuitive (the “Company”) (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced financial results for the quarter ended March 31, 2025.

Q
1
Highlights

• Worldwide da Vinci procedures grew approximately 17% compared with the first quarter of 2024.
• The Company placed 367 da Vinci surgical systems, compared with 313 in the first quarter of 2024. The first quarter 2025 da Vinci surgical system placements included 147 da Vinci 5 systems, compared with 8 in the first quarter of 2024.
• The Company grew its da Vinci surgical system installed base to 10,189 systems as of March 31, 2025, an increase of 15% compared with 8,887 as of March 31, 2024.
• First quarter 2025 revenue of $2.25 billion increased 19% compared with $1.89 billion in the first quarter of 2024.
• First quarter 2025 GAAP net income attributable to Intuitive was $698 million, or $1.92 per diluted share, compared with $545 million, or $1.51 per diluted share, in the first quarter of 2024.
• First quarter 2025 non-GAAP* net income attributable to Intuitive was $662 million, or $1.81 per diluted share, compared with $541 million, or $1.50 per diluted share, in the first quarter of 2024.

Q
1
Financial Summary

Gross profit, income from operations, net income attributable to Intuitive Surgical, Inc., and net income per diluted share attributable to Intuitive Surgical, Inc. are reported on a GAAP and non-GAAP* basis. The non-GAAP* measures are described below and are reconciled to the corresponding GAAP measures at the end of this release.

First quarter 2025 revenue was $2.25 billion, an increase of 19% compared with $1.89 billion in the first quarter of 2024. The higher first quarter revenue was driven by growth in da Vinci procedure volume, higher da Vinci system placements, and an increase in the installed base of systems.

First quarter 2025 instruments and accessories revenue increased by 18% to $1.37 billion, compared with $1.16 billion in the first quarter of 2024. The increase in instruments and accessories revenue was primarily driven by approximately 17% growth in da Vinci procedure volume and approximately 58% growth in Ion procedure volume.

First quarter 2025 systems revenue was $523 million, compared with $418 million in the first quarter of 2024. The Company placed 367 da Vinci surgical systems, of which 147 were da Vinci 5 systems, in the first quarter of 2025, compared with 313 systems, of which 8 were da Vinci 5 systems, in the first quarter of 2024. The first quarter 2025 da Vinci surgical system placements included 198 systems placed under operating lease arrangements, of which 107 systems were placed under usage-based operating lease arrangements, compared with 159 systems placed under operating lease arrangements, of which 94 systems were placed under usage-based operating lease arrangements in the first quarter of 2024.

First quarter 2025 GAAP income from operations increased to $578 million, compared with $469 million in the first quarter of 2024. First quarter 2025 GAAP income from operations included share-based compensation expense of $190 million, compared with $156 million in the first quarter of 2024. First quarter 2025 non-GAAP* income from operations increased to $768 million, compared with $630 million in the first quarter of 2024.

First quarter 2025 GAAP net income attributable to Intuitive Surgical, Inc. was $698 million, or $1.92 per diluted share, compared with $545 million, or $1.51 per diluted share, in the first quarter of 2024. First quarter 2025 GAAP net income attributable to Intuitive Surgical, Inc. included excess tax benefits of $145 million, or $0.40 per diluted share, compared with $111 million, or $0.31 per diluted share, in the first quarter of 2024.

First quarter 2025 non-GAAP* net income attributable to Intuitive Surgical, Inc. was $662 million, or $1.81 per diluted share, compared with $541 million, or $1.50 per diluted share, in the first quarter of 2024.

The Company ended the first quarter of 2025 with $9.10 billion in cash, cash equivalents, and investments, an increase of $269 million during the quarter, primarily driven by cash generated from operations, partially offset by taxes paid related to net share settlement of equity awards and capital expenditures.

“Core measures of our business were healthy this quarter, and we are pleased by continued customer adoption of our platforms, including da Vinci 5,” said Gary Guthart, Intuitive CEO. “As we look ahead, we remain focused on enabling our customers to deliver on their goals: better patient outcomes, improved patient and care team experiences, lower total cost to treat, and increased access to care.”

2025 Financial Outlook

The Company expects the following results for the full year of 2025:

• Worldwide da Vinci procedure growth of approximately 15% to 17% in 2025, compared to 17% in 2024.
• Non-GAAP* gross profit margin to be within a range of 65% and 66.5% of revenue in 2025, compared to 69.1% in 2024. This range includes an estimated impact from tariffs of 1.7% of revenue, plus or minus 30 basis points.
• Non-GAAP* operating expense growth of 10% to 14% in 2025, compared to 10% in 2024.

The updated range for expected non-GAAP* gross profit margin reflects the Company’s estimates of the impact from tariffs that are in effect or have been announced with both a firm percentage and implementation date as of the time of this press release and assumes such tariffs remain in place. Should additional tariffs be implemented, the adverse impact on the Company’s financial results in 2025 (including the decrease in expected non-GAAP* gross profit margin) could be material. The ultimate impact from any tariffs will depend on various factors, including the volume of system sales in China, the proportion of components procured and finished goods manufactured outside of the United States, and the amount, scope, nature, and timing of the tariffs.

The 2025 financial outlook provided above includes forward-looking, non-GAAP financial measures, which management uses in measuring performance. We do not provide a reconciliation of non-GAAP outlook measures to corresponding GAAP measures on a forward-looking basis, because we are unable to predict with reasonable certainty the exact timing and ultimate outcome of certain items, including but not limited to legal proceedings, without unreasonable efforts. These items are uncertain, depend on various factors, and could be material to Intuitive’s results computed in accordance with GAAP. For additional information regarding the nature of these items, refer to the reconciliations of historical GAAP to non-GAAP measures included elsewhere in this release.

Additional supplemental financial and procedure information has been posted to the Investor Relations section of the Intuitive website at https://isrg.gcs-web.com/.

Webcast and Conference Call Information

Intuitive will hold a teleconference at 1:30 p.m. PDT today to discuss the first quarter 2025 financial results. The call will be webcast live and can be accessed on Intuitive’s website at www.intuitive.com. For those individuals planning to participate on the call, registration can be completed online at https://register-conf.media-server.com/register/BI439c259c8fa4442b8d85d70b71ffee0f to receive dial-in details and an individual pin. The webcast replay of the call will be made available on our website at www.intuitive.com within 24 hours after the end of the live teleconference and will be accessible for at least 30 days.

About Intuitive

Intuitive (Nasdaq: ISRG), headquartered in Sunnyvale, California, is a global leader in minimally invasive care and the pioneer of robotic-assisted surgery. Our technologies include the da Vinci surgical systems and the Ion endoluminal system. By uniting advanced systems, progressive learning, and value-enhancing services, we help physicians and their teams optimize care delivery to support the best outcomes possible. At Intuitive, we envision a future of care that is less invasive and profoundly better, where diseases are identified early and treated quickly, so patients can get back to what matters most.

Product and brand names/logos are trademarks or registered trademarks of Intuitive or their respective owner. See www.intuitive.com/trademarks.

For more information, please visit the Company’s website at www.intuitive.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements relate to expectations concerning matters that are not historical facts. Statements using words such as “estimates,” “projects,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “may,” “will,” “could,” “should,” “would,” “targeted,” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements are necessarily estimates reflecting the judgment of the Company’s management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. These forward-looking statements include, but are not limited to the following: statements related to future results of operations, including expected procedure growth in 2025, expected non-GAAP gross profit margins in 2025, and expected non-GAAP operating expense growth in 2025; future financial position; the adoption by customers of the Company’s products; and the goals it shares with its customers, including improving patient outcomes. These forward-looking statements should be considered in light of various important factors, including, but not limited to, the following: the overall macroeconomic environment, which may impact customer spending and the Company’s costs, including tariffs, the levels of inflation, and interest rates; the conflict between Ukraine and Russia; conflicts in the Middle East; disruption to the Company’s supply chain, including difficulties in obtaining a sufficient supply of materials; curtailed or delayed capital spending by hospitals; the impact of global and regional economic and credit market conditions on healthcare spending; delays in obtaining new product approvals, clearances, or certifications from the United States (“U.S.”) Food and Drug Administration (“FDA”), comparable regulatory authorities, or notified bodies; the risk of the Company’s inability to comply with complex FDA and other regulations, which may result in significant enforcement actions; regulatory approvals, clearances, certifications, and restrictions or any dispute that may occur with any regulatory body; healthcare reform legislation in the U.S. and its impact on hospital spending, reimbursement, and fees levied on certain medical device revenues; changes in hospital admissions and actions by payers to limit or manage surgical procedures; the timing and success of product development and customer acceptance of developed products; the results of any collaborations, in-licensing arrangements, joint ventures, strategic alliances, or partnerships, including the joint venture with Shanghai Fosun Pharmaceutical (Group) Co., Ltd.; the Company’s completion of and ability to successfully integrate acquisitions; intellectual property positions and litigation; risks associated with the Company’s operations and any expansion outside of the U.S.; unanticipated manufacturing disruptions or the inability to meet demand for products; the Company’s reliance on sole- and single-sourced suppliers; the results of legal proceedings to which the Company is or may become a party; adverse publicity regarding the Company and the safety of the Company’s products and adequacy of training; the impact of changes to tax legislation, guidance, and interpretations; changes in tariffs, trade barriers, and regulatory requirements (including changes to tariffs imposed by the U.S. on imports from various countries, including Mexico, where we currently manufacture a significant majority of our instruments and accessories); and other risks and uncertainties. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release and which are based on current expectations and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those risk factors identified under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as updated by the Company’s other filings with the Securities and Exchange Commission. The Company’s actual results may differ materially and adversely from those expressed in any forward-looking statement, and the Company undertakes no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law.

*
About Non-GAAP Financial Measures

To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles (“GAAP”), the Company uses the following non-GAAP financial measures: non-GAAP gross profit, non-GAAP income from operations, non-GAAP net income attributable to Intuitive Surgical, Inc., and non-GAAP net income per diluted share attributable to Intuitive Surgical, Inc. (“EPS”). The presentation of this financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP.

The Company uses these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. The Company believes that these non-GAAP financial measures provide meaningful supplemental information regarding its performance by excluding items such as amortization of intangible assets, share-based compensation (“SBC”) and long-term incentive plan expenses, and other special items. Long-term incentive plan expense relates to phantom share awards granted in China by the Company’s Intuitive-Fosun joint venture to its employees that vest over four years and can remain outstanding for seven to ten years. These awards are valued based on certain key performance metrics. Accordingly, they are subject to significant volatility based on the performance of these metrics and are not tied to performance of the Company’s business within the period. The Company believes that both management and investors benefit from referring to these non-GAAP financial measures in assessing its performance and when planning, forecasting, and analyzing future periods. These non-GAAP financial measures also facilitate management’s internal comparisons to its historical performance. The Company believes these non-GAAP financial measures are useful to investors, because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making, and (2) they are used by institutional investors and the analyst community to help them analyze the performance of the Company’s business.

Non-GAAP gross profit. The Company defines non-GAAP gross profit as gross profit, excluding SBC and long-term incentive plan expenses and amortization of intangible assets.

Non-GAAP income from operations. The Company defines non-GAAP income from operations as income from operations, excluding SBC and long-term incentive plan expenses, amortization of intangible assets, litigation charges, and gains on the sale of a business.

Non-GAAP net income attributable to Intuitive Surgical, Inc. and EPS. The Company defines non-GAAP net income as net income attributable to Intuitive Surgical, Inc., excluding SBC and long-term incentive plan expenses, amortization of intangible assets, litigation charges, gains on the sale of a business, losses on strategic investments, tax adjustments, including the excess tax benefits or deficiencies associated with SBC arrangements and the net tax effects related to intra-entity transfers of non-inventory assets, and adjustments attributable to noncontrolling interest in joint venture, net of the related tax effects. The Company excludes the excess tax benefits or deficiencies associated with SBC arrangements as well as the tax effects associated with non-cash amortization of deferred tax assets related to intra-entity non-inventory transfers, because the Company does not believe these items correlate with the ongoing results of its core operations. The tax effects of the non-GAAP items are determined by applying a calculated non-GAAP effective tax rate, which is commonly referred to as the with-and-without method. Without excluding these tax effects, investors would only see the gross effect that these non-GAAP adjustments had on the Company’s operating results. The Company’s calculated non-GAAP effective tax rate is generally higher than its GAAP effective tax rate. The Company defines non-GAAP EPS as non-GAAP net income attributable to Intuitive Surgical, Inc. divided by diluted shares outstanding, which are calculated as GAAP weighted-average outstanding shares plus dilutive potential shares outstanding during the period.

There are a number of limitations related to the use of non-GAAP measures versus measures calculated in accordance with GAAP. Non-GAAP gross profit, non-GAAP income from operations, non-GAAP net income attributable to Intuitive Surgical, Inc., and non-GAAP EPS exclude items such as SBC and long-term incentive plan expenses, amortization of intangible assets, excess tax benefits or deficiencies associated with SBC arrangements, and non-cash amortization of deferred tax assets related to intra-entity transfer of non-inventory assets, which are primarily recurring items. SBC expense has been, and will continue to be for the foreseeable future, a significant recurring expense in the Company’s business. In addition, the components of the costs that the Company excludes in its calculation of non-GAAP net income attributable to Intuitive Surgical, Inc. and non-GAAP EPS may differ from the components that its peer companies exclude when they report their results of operations. Management addresses these limitations by providing specific information regarding the GAAP amounts excluded from non-GAAP net income attributable to Intuitive Surgical, Inc. and non-GAAP EPS and evaluating non-GAAP net income attributable to Intuitive Surgical, Inc. and non-GAAP EPS together with net income attributable to Intuitive Surgical, Inc. and net income per share attributable to Intuitive Surgical, Inc. calculated in accordance with GAAP.

Contact: Investor Relations
(408) 523-2161

MIAMI, April 22, 2025 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders.

Dear Fellow Shareholders,

Twenty twenty-four was a year of execution for Longeveron. We made significant progress advancing Longeveron’s founding mission – developing cutting-edge cellular therapy research to impact patients’ lives for the better by addressing unmet medical needs. We have come a long way pursuing that mission and now have clarity on the pathway to our first potential Biological License Application (BLA) submission.

Today, I am excited to update you on our overall strategy, progress, and key priorities and goals for 2025.

Strategic Overview and 2024 Progress:

Over the past decade, stem cell therapy has seen remarkable strides, transforming from a promising field into one delivering tangible clinical outcomes. We’ve seen the solidification of cell therapy’s role in regenerative medicine and its potential to treat a wide range of conditions, signaling an exciting future for both scientific innovation and patient care.

Longeveron has been at the forefront of this evolution in medicine. Our lead investigational product is laromestrocel (Lomecel-B™), a stem cell therapy derived from culture-expanded mesenchymal stem cells (MSCs) that are sourced from bone marrow of young healthy adult donors. The number of functional MSCs in the body declines as we age, which has driven interest in their use for aging-related conditions. Their unique properties — including the ability to reduce inflammation, promote tissue repair and regeneration, modulate immune responses, and improve vascularization — also support their application in some rare cardiovascular diseases/conditions with high unmet medical need. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions.

A decade ago, our stem cell therapy vision was an academic idea. Today, laromestrocel represents a pipeline in a product opportunity that has delivered positive results from multiple clinical trials: Phase 1 & 2 in Alzheimer’s disease, Phase 1 & 2 in Aging-related Frailty, Phase 1 in Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric disease. We are currently conducting a pivotal Phase 2b clinical trial for HLHS. Our development programs for these 3 initial indications address market opportunities of what we estimate to be approximately ~$5+ billion, ~$4+ billion and up to ~$1 billion, respectively. Earlier this year, the World Health Organization’s International Nonproprietary Names (INN) Expert Committee approved “laromestrocel” as the non-proprietary name for Lomecel-B™ — a key milestone in the development and future commercialization of our stem cell therapy.

As we did this past year, in 2025, we will continue focusing our efforts on two of our most promising programs: HLHS and Alzheimer’s disease.

Hypoplastic Left Heart Syndrome (HLHS):

HLHS is a rare pediatric disease in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. Because the left ventricle is the chamber that normally pumps blood to the body, infants born with this condition have a profound reduction in blood flow and thus cannot get the normal supply of oxygen to their organs. In order for the children to survive, they must undergo a complicated, three-stage heart reconstruction surgery over the course of the first 5 years of their lives. Despite this surgical reconstruction, only 50% of the affected children survive to age 15 without heart transplantation.

Our program is designed to boost/improve the heart function in these children with the goal of potentially enhancing their survival. In our Phase I clinical trial (ELPIS I) evaluating laromestrocel in 4-month-old infants with HLHS, we observed 100% transplant-free survival up to five years following treatment. This contrasts with an approximately 20% mortality rate observed in historical control data. Five-year post-treatment long-term survival data from the ELPIS I Phase 1 clinical trial was presented at the Congenital Heart Surgeons’ Society (CHSS) 51st Annual Meeting in October 2024.

We are currently nearing completion of enrollment for our Phase 2b study, ELPIS II, which is evaluating laromestrocel as a potential adjunct treatment to the standard of care for HLHS. ELPIS II has achieved nearly 95% enrollment, and we expect to complete enrollment in the second quarter of this year.

In September 2024, we completed a Type C meeting with the U.S. FDA regarding our HLHS development program and the pathway toward a potential BLA submission. We reached foundational alignment on the primary endpoint and secondary endpoints for the ELPIS II trial. The FDA confirmed that, contingent on positive results, ELPIS II may be considered a pivotal trial and potentially acceptable for BLA submission seeking full traditional approval. With this regulatory clarity, we are now focused on BLA preparedness and enabling activities for the HLHS program. Notably, because this program has received Rare Pediatric Disease Designation, we may be eligible to receive a Priority Review Voucher (PRV) if our BLA is approved. We may use the PRV internally or sell to a third party. Historically, PRVs have commanded values exceeding $100 million.

Alzheimer’s Disease:

The laromestrocel Alzheimer’s disease (AD) program continues to garner important recognition and support. In 2024, data from the CLEAR MIND Phase 2a clinical trial evaluating laromestrocel in mild Alzheimer’s disease were presented as a featured research oral presentation at the 2024 Alzheimer’s Association International Conference held at the end of July and as a late breaking poster presentation at the 17th edition of the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in October. We are very excited about the trial’s positive results. The trial met its primary objective of demonstrating safety, with laromestrocel being well-tolerated. In addition, we observed encouraging trends suggesting a potential slowing or prevention of disease progression in patients treated with laromestrocel compared to placebo.

This program has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations, providing us with the opportunity for enhanced and frequent communication with the FDA to facilitate the development and review process.
In March of this year, results from the trial were published in Nature Medicine.

Also in March of this year, we held a Type B meeting with the FDA to discuss the regulatory pathway for a potential BLA for laromestrocel in mild Alzheimer’s disease. We reached foundational alignment on the overall study design for a proposed single, pivotal, seamless adaptive Phase 2/3 clinical trial. To support an accelerated path to potential approval, the FDA agreed to consider a BLA submission based on positive interim results from this planned single study.

With this regulatory clarity in hand, we are focused on seeking partnership opportunities and/or non-dilutive funding for the Alzheimer’s disease program.

Our Core Business Objectives:

Our strategic plan is built on the strength of the science underlying our stem cell therapy laromestrocel. For 2025, we are focused on four key objectives:

1. Advance HLHS Program as the Main Near-Term Value Driver:
   • Pivotal Phase 2 clinical trial (ELPIS II) is nearing enrollment completion.
   • Regulatory pathway clarified with U.S. FDA.
   • Potential to initiate rolling BLA submission in 2026.
   • Potential to receive a Rare Pediatric Disease priority review voucher associated with HLHS upon BLA approval which could have significant monetary value and further enhance our product’s value proposition upon approval.
2. HLHS BLA and Commercialization Readiness:
   • Successful meeting with FDA confirmed ELPIS II could be pivotal.
   • 2025 will see significant focus on organizational readiness for potential BLA filing for HLHS in 2026. Our goal is to accomplish BLA readiness this year ahead of data readout to potentially shorten the timeline to BLA submission.
   • Emphasis on Chemistry, Manufacturing, and Controls (CMC) preparedness.
   • Hired industry veteran Chief Technology Officer to support BLA preparedness.
   • We are committed to helping HLHS patients worldwide. In 2025, we intend to take initial steps connecting with non-U.S. regulatory bodies, including EMA (European Union), MHRA (United Kingdom), PMDA (Japan) and HealthCanada.
   • Recognizing substantial revenue potential from worldwide commercialization, we anticipate capitalizing on recent rare disease pricing trends and the unique aspects of our treatment.
3. Strategic Collaborations for Alzheimer’s Disease:
   • We believe our Alzheimer’s disease program holds immense potential. Due to the large size of the affected population, it involves larger-scale studies and commercialization requirements. This scale of development effort necessitates significant investment, prompting our focus on potential strategic partnerships with biotech/pharmaceutical companies and/or non-dilutive funding sources.
   • We believe the clarity on the pathway to potential BLA submission and the need for only a single pivotal clinical trial enhance the attractiveness and economic benefits of the program to potential partners.
4. Efficient Resource Management and Capital Allocation:
   • We strive to be prudent stewards of shareholder capital and focus allocating it to the organization’s top priorities to effectuate optimal resource utilization and alignment with strategic objectives.
   • We prudently manage expenses. In 2024, we reduced total operating expenses 13% while continuing to effectively advance our development programs.

Financial Position and Capital Strategy:

Longeveron is working diligently to effectively advance our development programs while managing expenses and our capital. We will need additional capital to achieve our business strategy and objectives.

We indicated in our recently filed Annual Report on Form 10K that we anticipated our existing cash and cash equivalents would fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. However, as we also indicated, as a result of our successful Type C meeting with the FDA in August 2024 with respect to the HLHS regulatory pathway, we have started to ramp up BLA enabling activities to prepare for a potential filing with the FDA in 2026 if the current ELPIS II trial is successful. We expect our operating expenses and capital expenditure requirements to accelerate this year as a result of these activities, including CMC (Chemistry, Manufacturing, and Controls) and manufacturing readiness. We intend to seek additional financing and non-dilutive funding options to support these activities, and additional non-dilutive funding and/or strategic partners to support the AD development program. We anticipate that our current cash projections may be impacted by these ramped up activities and any financing transactions we enter into.

2025 Goals and Priorities

Our goals for 2025 center on efficient, effective execution of our strategic plan with an emphasis on three primary operational goals:

1. ELPIS II Completion: We anticipate completion of ELPIS II enrollment in the second quarter of 2025. We will then focus on supporting our investigative sites through completion of the 12-month primary endpoint follow-up period and preparation for data collection and analysis at the end of the study.
2. HLHS BLA Preparedness: We intend to accomplish the majority of BLA readiness in 2025 to support a potentially shortened time frame from clinical trial readout to BLA submission.
3. Alzheimer’s Disease Program Partnering: We plan to leverage the strength of our Phase 2 data and clarity on the clinical pathway to a potential BLA for AD to engage with potential funding/commercialization partners.

Outlook

Longeveron has made tremendous progress in two important stem cell development programs over the past 12 months, successfully delivering on our strategic plan. We are now approaching multiple potentially transformational milestones over the next 12 months including completion of enrollment in our pivotal Phase 2b clinical trial in HLHS which may establish the timeline for a potential BLA submission for HLHS, and potential partnering for the Alzheimer’s disease program. Our team’s expertise and industry experience enable the organization to accomplish so much with a small team and few resources. Generating several positive initial results across five clinical trials in three indications, continues to position Longeveron as a leader in stem cell therapy research and, potentially, commercialization of cellular therapeutics.

We believe Longeveron’s demonstrated track record of successful clinical execution, strength of data generated to date and the potential size of addressable markets provide for a compelling investment opportunity.

We deeply appreciate the support of our stakeholders and look forward to continued collaboration and progress in the future.

Sincerely,
Wa’el Hashad
CEO, Longeveron

Forward-Looking Statements

Certain statements in this letter that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, statements about the various below-listed factors. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor and Media Contact:

Derek Cole
Investor Relations Advisory Solutions
[email protected]

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MENLO PARK, Calif., April 22, 2025 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT) (Sight Sciences, or the Company), an eyecare technology company focused on developing and commercializing innovative, interventional technologies that elevate the standard of care, announced today that Gerhard (Gary) F. Burbach was appointed to the Company’s Board of Directors on April 21, 2025. Mr. Burbach will serve as a Class II director with a term expiring at the 2026 Annual Meeting of Stockholders.

“We are very excited to add Gary to our Board of Directors,” stated Paul Badawi, Co-founder and Chief Executive Officer of Sight Sciences. “He brings a strong medtech industry background with a proven track record of success in commercial and operational leadership at multiple private and public medical device companies. Gary’s prior experience as CEO leading the growth of Thoratec Corporation, a company that pioneered the development of mechanical circulatory assist devices for the heart and created a new standard of care in the treatment of advanced heart failure, is particularly relevant to Sight Sciences. As we focus on maintaining our leadership position in the surgical glaucoma segment and executing on our strategy to achieve equitable market access in our dry eye segment, Gary’s substantial market development and growth expertise will be invaluable to our executive team and our Board of Directors. We look forward to his strategic insights and guidance as we continue our mission to build a leading interventional eye care business.”

Mr. Burbach added, “I am thrilled to join the Board of Directors of Sight Sciences at this pivotal time as both glaucoma and dry eye, two of the largest markets in eye care, are poised for a transformation towards interventional care and represent significant growth and market development opportunities. I look forward to collaborating with this top-tier executive team and Board to help the Company achieve its full potential.”

Mr. Burbach is a member of the Board of Directors and Chair of the Compensation Committee of BWX Technologies (NYSE: BWXT), a publicly-traded company that provides innovative nuclear technology solutions including medical isotopes and radiopharmaceuticals, and Chairman of the Board of Directors of Procyrion Inc., a private medical device company focused on the treatment of chronic heart failure. He previously served as a member of the Board of Directors of Fluidigm Corporation (now Standard Bio Tools (NAS: LAB)), a public company manufacturing and marketing innovative technologies for life sciences research, from 2013 to 2023, as Chairman of the Board of Directors of Artelon, Inc., a private company specializing in biomaterial development for tendon and ligament reconstruction, from 2020 until its acquisition by Stryker Corporation in 2024, and as a member of the Board of Directors of Vascular Dynamics, Inc., a private medical device company that developed innovative solutions for heart failure and hypertension, from 2017 to 2024. From 2006 to 2014, Mr. Burbach was President, Chief Executive Officer and a member of the Board of Directors of Thoratec Corporation, manufacturer of proprietary medical devices for circulatory support that was acquired by St. Jude Medical, Inc. (now Abbott Laboratories). Prior to that, he held executive leadership positions at Digirad Corporation, Philips Medical Systems, and ADAC Laboratories. Mr. Burbach also spent six years at McKinsey & Company, Inc., focused primarily on the firm’s healthcare practice. Mr. Burbach holds a Bachelor of Science in Industrial Engineering from Stanford University and a Master of Business Administration from Harvard Business School.

About Sight Sciences

Sight Sciences is an eyecare technology company focused on developing and commercializing innovative and interventional solutions intended to transform care and improve patients’ lives. Using minimally invasive or non-invasive approaches to target the underlying causes of the world’s most prevalent eye diseases, Sight Sciences seeks to create more effective treatment paradigms that enhance patient care and supplant conventional outdated approaches. The Company’s OMNI® Surgical System is an implant-free glaucoma surgery technology (i) indicated in the United States to reduce intraocular pressure in adult patients with primary open-angle glaucoma; and (ii) CE Marked for the catheterization and transluminal viscodilation of Schlemm’s canal and cutting of the trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma. Glaucoma is the world’s leading cause of irreversible blindness. The SION® Surgical Instrument is a bladeless, manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork. The Company’s TearCare® System is 510(k) cleared in the United States for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland disease (MGD), enabling clearance of gland obstructions by physicians to address the leading cause of dry eye disease. Visit www.sightsciences.com for more information.

Sight Sciences, the Sight Sciences logo, TearCare, SmartHub and SmartLids are trademarks of Sight Sciences registered in the United States. OMNI and SION are trademarks of Sight Sciences registered in the United States, European Union and other territories.

© 2025 Sight Sciences. All rights reserved.

Forward-Looking Statements

This press release, together with other statements and information publicly disseminated by the Company, contains certain 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, which statements are subject to considerable risks and uncertainties. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and includes this statement for purposes of complying with these safe harbor provisions. Any statements made in this press release that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements and should be evaluated as such. Forward-looking statements include all statements other than statements of historical fact, including statements concerning the Company’s focus on maintaining its leadership position in the surgical glaucoma segment and executing on its strategy to achieve equitable market access in the dry eye segment, the Company’s ability to build a leading interventional eye care business, the Company’s growth and market development opportunities, and the expectations and perceived benefits of the appointment of Gerhard F. Burbach to the Company’s Board of Directors. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “will,” “forecast” and other similar expressions. We base these forward-looking statements on our current expectations, plans and assumptions that we have made in light of our experience in the industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances at such time. Although management believes these forward-looking statements are based upon reasonable assumptions at the time they are made, management cannot guarantee their accuracy or completeness. Forward-looking statements are subject to and involve risks, uncertainties and assumptions that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance, or achievements predicted, assumed or implied by such forward-looking statements. Some of the risks and uncertainties that may cause actual results to materially differ from those expressed or implied by these forward-looking statements are discussed under the caption “Risk Factors” in the Company’s filings with the SEC, as may be updated from time to time in subsequent filings. These cautionary statements should not be construed by you to be exhaustive and are made only as of the date of this press release. Sight Sciences undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Media contact:

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Investor contact:

Philip Taylor
Gilmartin Group
415.937.5406
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