Financial Data and Key Metrics Changes - Total revenue for the first quarter was $26.2 million, down 10% compared to the same period in 2024, primarily due to pricing pressure in the OEM channel [9][20] - Gross margin for the first quarter was 56%, down nine percentage points year over year, driven by a $4 million drop in sales of MONOVISC and ORTHOVISC [22][23] - Operating expenses decreased by 12% year over year to $19 million, reflecting cost-saving measures [25] Business Line Data and Key Metrics Changes - Revenue in the commercial channel increased by 18% year over year to $11.3 million, with international OA pain products growing by 13% [20] - The regenerative solutions portfolio achieved 33% growth year over year, driven by the performance of the Integrity product [12][21] - OEM channel revenue decreased by 23% to $14.9 million, primarily due to lower pricing for MONOVISC and ORTHOVISC [20][22] Market Data and Key Metrics Changes - International OA pain management revenue grew by 13% year over year, indicating strong market demand [9][20] - The company is focused on expanding its global reach and strengthening distribution networks to mitigate pricing pressures in the U.S. market [10][11] Company Strategy and Development Direction - The company is advancing its strategic initiatives by focusing on proprietary hyaluronic acid technologies and optimizing its commercial channel [6][7] - Key products like the Integrity Implant System and anticipated U.S. approvals of HYALOFAST and CINGAL are seen as market drivers in tendon and cartilage repair [8][17] - The company is actively working on new product expansion programs to diversify revenue sources beyond J&J [11] Management's Comments on Operating Environment and Future Outlook - Management acknowledged ongoing pricing challenges in the domestic OA pain market and short-term supply production yield issues [5][6] - The company expects a modest pricing rebound in the second quarter, with overall revenue guidance for the OEM channel updated to reflect a 16% to 20% decline [28][29] - Management remains optimistic about the long-term trajectory, driven by investments in regenerative solutions and upcoming product launches [32] Other Important Information - The company ended the quarter with $53 million in cash and no debt, indicating a strong liquidity position [26][70] - Adjusted EBITDA guidance for 2025 has been revised to a range of negative 3% to positive 3%, reflecting lower manufacturing yields and pricing pressures [30][32] Q&A Session Summary Question: Timeline and investment for the CINGAL bioequivalence study - Management expects to begin the study by the end of the year, with further updates to be provided as progress is made [38][39] Question: OEM revenue guidance and expected improvement - The sequential growth in OEM revenue is expected to be driven primarily by pricing, with indications of a pricing rebound in the second quarter [41] Question: Commercial revenue guidance maintenance - The decision to maintain commercial revenue guidance was based on strong Q1 performance, despite tougher comparisons in Q2 [43] Question: Timing for HYALOFAST final module filing - The final module filing for HYALOFAST is expected to be completed by the end of the year, with updates to be provided in future earnings calls [48][49] Question: Distribution plans for CINGAL - Management is exploring distribution opportunities for CINGAL, with more details to come as the regulatory process progresses [67][68] Question: Cash position and sufficiency for regulatory processes - The company has sufficient cash to navigate the regulatory filings for both HYALOFAST and CINGAL, with expectations of improvements in cash flow in the second half of the year [70][71]

Financial Data and Key Metrics Changes - Total revenue for the first quarter was $26.2 million, down 10% compared to the same period in 2024, primarily due to pricing pressure in the OEM channel [9][20] - Gross margin for the first quarter was 56%, down nine percentage points year over year, driven by a $4 million drop in MONOVISC and ORTHOVISC sales [22][23] - Operating expenses decreased by 12% year over year to $19 million, reflecting cost-saving measures [26] Business Line Data and Key Metrics Changes - Revenue in the commercial channel increased by 18% year over year to $11.3 million, with international OA pain products growing by 13% [20] - The regenerative solutions portfolio achieved 33% growth year over year, driven by the performance of the Integrity product [12][20] - OEM channel revenue decreased by 23% to $14.9 million, primarily due to lower pricing for MONOVISC and ORTHOVISC [21] Market Data and Key Metrics Changes - The company experienced ongoing pricing challenges in the domestic OA pain market, impacting overall revenue [6][9] - International OA pain management growth was reported at 13% year over year, indicating strong performance in global markets [9][20] Company Strategy and Development Direction - The company is focusing on leveraging proprietary hyaluronic acid technologies and has made progress in strategic initiatives [7][8] - Plans to diversify revenue sources and grow the OEM channel outside of existing partnerships are underway, particularly through new product expansion programs [11] - The anticipated U.S. approvals of HYALOFAST and CINGAL are seen as key drivers for future growth in tendon and cartilage repair markets [8][18] Management's Comments on Operating Environment and Future Outlook - Management acknowledged ongoing pricing pressures but expressed confidence in the company's ability to return to historic production levels in the second half of the year [35] - The company expects modest pricing rebounds in the second quarter and anticipates accelerated growth in the second half of the year [29][30] - Management remains optimistic about the long-term trajectory, driven by investments in regenerative solutions and upcoming product launches [33] Other Important Information - The company ended the first quarter with $53 million in cash and no debt, indicating a strong liquidity position [27][71] - Adjusted EBITDA guidance for 2025 has been updated to a range of negative 3% to positive 3%, reflecting lower pricing and manufacturing challenges [30][31] Q&A Session Summary Question: Timeline and investment for the CINGAL bioequivalence study - Management expects to begin the study by the end of the year and will provide further updates as progress is made [38][39] Question: OEM guidance and expected improvement in revenue - Sequential growth in OEM revenue is anticipated to be driven primarily by pricing adjustments [41] Question: Commercial revenue guidance maintenance - The decision to maintain guidance was based on strong Q1 performance and expected challenges in Q2 [43] Question: Timing for HYALOFAST final module filing - The final module is expected to be filed by the end of the year, with updates to be provided in future earnings calls [48][49] Question: Distribution plans for CINGAL - Management is exploring distribution opportunities and will provide more details as they develop [68] Question: Cash flow expectations and regulatory process funding - The company has sufficient cash to navigate the regulatory processes for both HYALOFAST and CINGAL [71][72]

Financial Data and Key Metrics Changes - Total revenue for the first quarter was $26.2 million, down 10% compared to the same period in 2024, primarily due to pricing pressure in the OEM channel [8][19] - Gross margin decreased to 56%, down nine percentage points year over year, driven by a $4 million drop in MONOVISC and ORTHOVISC sales [21][22] - Operating expenses were $19 million, down 12% year over year, reflecting cost-saving measures [24] Business Line Data and Key Metrics Changes - Revenue in the commercial channel increased by 18% year over year to $11.3 million, with international OA pain products growing by 13% [19] - Regenerative solutions revenue grew by 33% year over year, driven by the performance of the Integrity product [20][11] - OEM channel revenue decreased by 23% to $14.9 million, primarily due to lower pricing for MONOVISC and ORTHOVISC [20][21] Market Data and Key Metrics Changes - The U.S. market for MONOVISC and ORTHOVISC continues to face pricing volatility, which has not been fully offset by measures implemented by J and J MedTech [9][10] - The company anticipates a modest pricing rebound in the second quarter, but overall OEM revenue is expected to decline by 16% to 20% for the full year [28][29] Company Strategy and Development Direction - The company is focusing on leveraging proprietary hyaluronic acid technologies and expanding its commercial channel, which has shown strong growth [6][11] - Strategic initiatives include diversifying revenue sources and enhancing product offerings, particularly in regenerative solutions [10][12] - The company is advancing its pipeline programs, including HYALOFAST and CINGAL, with expected U.S. launches in 2026 [15][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming short-term manufacturing challenges and returning to historic production levels in the second half of the year [34] - The company remains well-positioned to fund its product pipeline and expects to see improvements in gross margins in the second half of the year [32][70] Other Important Information - The company ended the quarter with $53 million in cash and no debt, indicating strong liquidity to support ongoing operations and regulatory processes [27][69] - Adjusted EBITDA guidance for 2025 has been revised to a range of negative 3% to positive 3%, reflecting lower manufacturing yields and pricing pressures [30][32] Q&A Session Summary Question: Could you elaborate on the timeline and investment needed for the CINGAL bioequivalence study? - Management expects to begin the study by the end of the year and will provide further updates as progress is made [38][39] Question: What drives the expected improvement in OEM revenue through the year? - The improvement is primarily driven by anticipated price stabilization in the second quarter [41] Question: What factors influenced the decision to maintain commercial revenue guidance? - The decision was based on strong Q1 performance and expectations of continued growth despite tougher comparisons in Q2 [42] Question: Can you provide insight into the distribution plans for CINGAL once approved? - The company is exploring various distribution opportunities and will provide more details in the future [65][66] Question: Is there sufficient cash to get through the regulatory process? - Management confirmed that the company has adequate cash to support regulatory filings for both HYALOFAST and CINGAL [69][70]

Company Performance - Organogenesis reported a quarterly loss of $0.13 per share, missing the Zacks Consensus Estimate of $0.04, and compared to a loss of $0.02 per share a year ago, representing an earnings surprise of -425% [1] - The company posted revenues of $86.69 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 4.06%, and down from $109.98 million year-over-year [2] - Over the last four quarters, Organogenesis has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Performance - Organogenesis shares have increased approximately 61.9% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] - The current consensus EPS estimate for the upcoming quarter is $0.04 on revenues of $143.96 million, and for the current fiscal year, it is $0.16 on revenues of $508.6 million [7] Industry Outlook - The Medical - Drugs industry, to which Organogenesis belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that industry performance can significantly impact stock performance [5][8]

Core Viewpoint - Longeveron Inc. is making significant progress in the development of its stem cell therapy, laromestrocel, with a focus on advancing clinical trials for Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer's disease, while preparing for potential regulatory submissions in the coming years [2][8]. Financial Results Summary - Revenues for Q1 2025 were $0.4 million, a decrease of 30% from $0.5 million in Q1 2024, primarily due to reduced participant demand for the Bahamas Registry Trial [9]. - Clinical trial revenue from the Bahamas Registry Trial decreased by 50% to $0.3 million in Q1 2025 from $0.5 million in Q1 2024 [9]. - Contract manufacturing revenue increased by approximately 270% to $0.1 million in Q1 2025 from $33,000 in Q1 2024 [9]. - General and administrative expenses rose by 34% to approximately $2.9 million in Q1 2025 compared to $2.2 million in Q1 2024 [9]. - Research and development expenses increased by 13% to approximately $2.5 million in Q1 2025 from $2.2 million in Q1 2024 [9]. - Net loss for Q1 2025 was approximately $5.0 million, an increase of 23% from $4.0 million in Q1 2024 [16]. Development Programs Update - The pivotal Phase 2b clinical trial (ELPIS II) for laromestrocel in HLHS has reached approximately 95% enrollment and is expected to complete enrollment in Q2 2025 [8][9]. - A potential Biologics License Application (BLA) submission for HLHS is anticipated in 2026, contingent on the success of ELPIS II [9]. - Results from the Phase 2a clinical trial (CLEAR MIND) for Alzheimer's disease were published in Nature Medicine, supporting further clinical development [9]. - The FDA has granted laromestrocel multiple designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease for HLHS, and RMAT and Fast Track for Alzheimer's disease [11]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines, with laromestrocel (Lomecel-B™) as its lead investigational product [11]. - The company is pursuing treatments for HLHS, Alzheimer's disease, and aging-related frailty, leveraging the therapeutic potential of its allogeneic mesenchymal stem cell therapy [11].

Financial Data and Key Metrics Changes - Cryoport reported $41 million in revenue from continuing operations for Q1 2025, representing a 10% year-over-year growth and contributing to significant adjusted EBITDA improvement [10] - The company confirmed its revenue guidance for fiscal year 2025 in the range of $165 million to $172 million, indicating a 7.5% growth compared to fiscal year 2024 [13] Business Line Data and Key Metrics Changes - Life sciences services revenue increased by 17% year-over-year, driven by a 33% growth in support for commercial cell and gene therapies [10] - Life sciences services now account for 56% of total revenue, reflecting the increasing development and commercialization of cell and gene therapies [10] - The life sciences products business showed a 2% year-over-year growth, indicating demand stabilization [12] Market Data and Key Metrics Changes - Cryoport supported 19 commercial therapies and 711 clinical trials as of March 31, representing approximately 70% of cell and gene therapy trials [11] - The company anticipates up to 17 additional application filings and four therapy approvals for the remainder of 2025, indicating a robust pipeline [11] Company Strategy and Development Direction - The strategic partnership with DHL, involving the sale of Cryo PDP for an enterprise value of $195 million, is expected to enhance Cryoport's positioning in Asia Pacific and EMEA [12][13] - The partnership aims to leverage DHL's global scale and capabilities, allowing Cryoport to sharpen its focus on core life sciences service offerings in the regenerative medicine space [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth forecast despite potential tariff impacts, stating that they have taken steps to diversify the supply chain [14][15] - The company does not expect tariffs to significantly impact core support for clinical trials or commercial therapies [15] - Management remains optimistic about the commercial revenue ramp-up and the maturation of commercial therapies [44] Other Important Information - The company reported a significant increase in service gross margins year-over-year, with expectations for continued margin improvements [34] - The onboarding process for EntegraCell is progressing smoothly, with multiple commercial contracts already in place [65] Q&A Session Summary Question: Update on the launch of Entegrisel and client adoption - Management sees the market positively, with commercial revenue continuing to ramp and growth in clinical trials [20] Question: Contingent consideration impact on adjusted EBITDA - Management clarified that contingent consideration was backed out, and adjusted EBITDA improved significantly compared to Q1 of the previous year [29] Question: Response to potential tariffs and macro environment - Management indicated no significant tariff impact on cell and gene therapy, with continued commercial revenue growth [41][42] Question: Supply chain initiatives and margin improvements - Management stated that while they cannot quantify the impact of supply chain initiatives on margins, they expect strong gross margins to continue [54] Question: Impact of the new FDA director on therapy modalities - Management expressed optimism about the new FDA director's qualifications and the continued interest in cell and gene therapy [56] Question: Demand for new product launches - Management reported positive reception and ongoing adoption for new products, with expectations for substantial contributions in the future [62]

Financial Data and Key Metrics Changes - Cryoport reported $41 million in revenue from continuing operations for Q1 2025, representing a 10% year-over-year growth, contributing to significant adjusted EBITDA improvement [8] - The company confirmed its revenue guidance for fiscal year 2025 in the range of $165 million to $172 million, indicating a 7.5% growth relative to fiscal year 2024 [12][14] Business Line Data and Key Metrics Changes - Life sciences services revenue increased by 17% year-over-year, driven by a 33% growth in support for commercial cell and gene therapies [9][87] - Life sciences services now account for 56% of total revenue, reflecting the increasing development and commercialization of cell and gene therapies [9] Market Data and Key Metrics Changes - Cryoport supported 19 commercial therapies and 711 clinical trials as of March 31, representing approximately 70% of cell and gene therapy trials [10] - The company anticipates up to 17 additional application filings and four therapy approvals for the remainder of 2025, indicating a robust pipeline [11] Company Strategy and Development Direction - The strategic partnership with DHL, involving the sale of Cryo PDP for an enterprise value of $195 million, is expected to enhance Cryoport's positioning in Asia Pacific and EMEA [12] - The partnership aims to leverage DHL's global scale and capabilities, allowing Cryoport to sharpen its focus on core life sciences service offerings in the regenerative medicine space [12][84] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth forecast despite potential tariff impacts, stating that they have taken steps to diversify the supply chain [13] - The overall market for cell and gene therapies is viewed positively, with expectations of continued commercial revenue growth and a robust pipeline of therapies [19][20] Other Important Information - The company reported a significant increase in service gross margins, with expectations for continued expansion throughout 2025 [33] - Management noted that the new FDA director's conservative views are not expected to negatively impact the cell and gene therapy sector, emphasizing the importance of data in regulatory decisions [57][60] Q&A Session Summary Question: Update on Entegrisel launch and CGP trial growth - Management sees a positive market outlook with continued growth in commercial therapies and clinical trials, indicating a robust pipeline [19][20] Question: Contingent consideration impact on adjusted EBITDA - Management clarified that contingent consideration was backed out, and adjusted EBITDA improved significantly compared to Q1 of the previous year [28] Question: Steps to bolster shareholder value post-divestiture - Management plans to be prudent and opportunistic with cash allocation, considering stock buybacks due to undervaluation [29][30] Question: Service gross margins expansion - Management confirmed a significant increase in service gross margins and expects continued leverage from core services [33] Question: Performance of small vs. large pharma - Management reported balanced contributions from both biotech and large pharma, with a robust pipeline and continued interest in promising therapies [37] Question: Response to macroeconomic pressures and tariffs - Management indicated minimal impact from tariffs on cell and gene therapy, with ongoing commercial revenue growth [41][42] Question: Supply chain initiatives and margin improvement - Management emphasized that supply chain initiatives aim to protect margins rather than quantify specific improvements [55] Question: Impact of new FDA director on therapy approvals - Management expressed optimism regarding the new FDA director's qualifications and the continued progress of cell and gene therapies [57][60] Question: Demand for new product launches - Management reported positive reception and ongoing adoption of new products, with expectations for meaningful revenue contributions in the future [67]

Core Viewpoint - Cryoport, Inc. reported a strong start to 2025 with a revenue of $41.0 million for Q1, reflecting a 10% year-over-year growth, and expressed optimism for the full year due to stabilizing order patterns and increased engagement in its Life Sciences Services segment [2][6][19]. Financial Performance - Total revenue from continuing operations for Q1 2025 was $41.0 million, up from $37.3 million in Q1 2024, marking a 10.1% increase [14]. - Life Sciences Services revenue, which constituted 56% of total revenue, reached $22.9 million, a 17.3% increase year-over-year [14]. - Life Sciences Products revenue, representing 44% of total revenue, was $18.2 million, showing a 2.1% increase compared to the previous year [14]. - Adjusted EBITDA for Q1 2025 was a negative $2.8 million, an improvement from a negative $6.7 million in Q1 2024 [16][38]. - The net loss for Q1 2025 was $12.0 million, compared to a net loss of $18.9 million in Q1 2024 [24]. Business Segments - Revenue from commercial Cell & Gene therapies increased by 33% year-over-year, totaling $7.2 million [8][9]. - Life Sciences Services revenue increased by 17% year-over-year, driven by the development and commercialization of Cell & Gene-based therapies [3][9]. - BioStorage/BioServices revenue grew by 23% year-over-year, indicating strong demand for these services [7]. Strategic Developments - Cryoport announced a strategic partnership with DHL Group, which includes the anticipated acquisition of CRYOPDP, expected to close in Q2 or Q3 2025 [5][11]. - The partnership is expected to enhance operational reach in the APAC and EMEA regions and provide a strong infusion of capital [5][11]. Market Position and Outlook - The company supports 711 global clinical trials as of March 31, 2025, an increase of 36 trials from the previous year [9]. - The company anticipates continued growth in the regenerative medicine space and aims to return to positive adjusted EBITDA during 2025 [6][19].

As filed with the Securities and Exchange Commission on May 5, 2025. Registration No. 333-285692 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 AMENDMENT NO. 1 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 REGENTIS BIOMATERIALS LTD. (Exact name of registrant as specified in its charter) | State of Israel | 2834 | Not Applicable | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organizati ...

Core Viewpoint - Longeveron Inc. is set to report its first quarter 2025 financial results and provide a business update on May 8, 2025, after U.S. market close, followed by a conference call and webcast [1] Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to meet unmet medical needs [3] - The company's lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [3] - Laromestrocel has multiple potential mechanisms of action, including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects, with applications across various disease areas [3] Pipeline and FDA Designations - Longeveron is pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease (AD), and aging-related frailty [3] - The HLHS program has received three FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation [3] - The AD program has received two important FDA designations: Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [3]