MMP14

Cellular therapy Lomecel-B™ has been granted an International Non-proprietary Name (INN) of “laromestrocel” on the INN List issued by the World Health Organization (WHO) Lomecel-B™ is a proprietary, scalable, allogeneic cellular therapy being evaluated in Alzheimer’s disease and hypoplastic left heart syndrome (HLHS), a rare pediatric disease and orphan indication Lomecel-B™ first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer’s disease MIAMI, Feb. 18, 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 International Nonproprietary Names (INN) Expert Committee of the World Health Organization approved “laromestrocel” for the non-proprietary name of the Company’s cellular therapy Lomecel-B™. Commonly referred to as a generic name, each INN is a unique name used to identify pharmaceutical substances or active pharmaceutical ingredients. Lomecel-B™ is a proprietary, scalable, allogeneic cellular therapy being evaluated in Alzheimer’s disease and hypoplastic left heart syndrome (HLHS), a rare pediatric disease and orphan indication. “Approval of the name laromestrocel is an important step in the development and potential commercialization of Lomecel-BTM,” said Wael Hashad, Chief Executive Officer of Longeveron. “Following on our positive Phase 2a data in mild Alzheimer’s disease and the upcoming completion of enrollment for our on-going Phase 2b clinical trial in HLHS, receiving this INN marks yet another important milestone in the advancement of Lomecel-BTM as a potential therapeutic for patients in need of new treatment options.” The U.S. FDA has granted Lomecel-B™ Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease, and Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment of HLHS. About Lomecel-B™ (laromestrocel) Lomecel-B™ is a living cell product made from specialized cells isolated from the bone marrow of young healthy adult donors. These specialized cells, known as medicinal signaling cells (MSCs), are essential to our endogenous biological repair mechanism. MSCs have been shown to perform a number of complex functions in the body, including the formation of new tissue. They also have been shown to respond to sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative. We believe that Lomecel-B™ may have multiple potential mechanisms of action that may lead to anti-inflammatory, pro-vascular regenerative responses, and therefore may have broad application for a range of rare and aging related diseases. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. Lomecel-BTM development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking Statements Certain statements in this press release 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 risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” 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, the anticipated use of proceeds from recent offerings. 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, market and other conditions, our limited operating history and lack of products approved for commercial sale; adverse global conditions, including macroeconomic uncertainty; inability to raise additional capital necessary to continue as a going concern; our history of losses and inability to achieve profitability going forward; the absence of FDA-approved allogenic, cell-based therapies for Aging-related Frailty, Alzheimer’s disease, or other aging-related conditions, or for HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; our exposure to product liability claims arising from the use of our product candidates or future products in individuals, for which we may not be able to obtain adequate product liability insurance; the adequacy of our trade secret and patent position to protect our product candidates and their uses: others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition, and results of operations; if certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected; the inability to protect the confidentiality of our proprietary information, trade secrets, and know-how; third-party claims of intellectual property infringement may prevent or delay our product development efforts; intellectual property rights do not necessarily address all potential threats to our competitive advantage; the inability to successfully develop and commercialize our product candidates and obtain the necessary regulatory approvals; we cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals; final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect our ability to generate operating revenues; we may not be able to secure and maintain research institutions to conduct our clinical trials; ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations; if we receive regulatory approval of Lomecel-B™ or any of our other product candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense; being subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates; reliance on third parties to conduct certain aspects of our preclinical studies and clinical trials; interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data; the volatility of the price of our Class A common stock; provisions in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock; we have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; and in order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth. 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, 2023, filed with the Securities and Exchange Commission on February 27, 2024, as amended by the Annual Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The forward-looking statements contained in this press release are made as of the date of this press release, 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 derek.cole@iradvisory.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cfb4911d-2b0b-4c52-b2fa-b6982947155d

CAMBRIDGE, England & BOSTON--( BUSINESS WIRE )--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle ® ) technology, today announced updated topline Phase 1 combination data for zelenectide pevedotin plus pembrolizumab in previously untreated (first-line) cisplatin-ineligible patients with metastatic urothelial cancer (mUC). The company also announced recent accomplishments and outlined strategic priorities and anticipated milestones for 2025. “Bicycle Therapeutics made significant advances across all aspects of our business in 2024. Notably, we drove important clinical progress of our targeted therapeutics in solid tumors, including greatly expanding the number of patients who could potentially benefit from our lead therapy zelenectide pevedotin, advanced our emerging pipeline of novel radiopharmaceuticals and strengthened our financial position and operational capabilities to advance our strategic priorities,” said CEO Kevin Lee, Ph.D. “We are encouraged by our updated topline Phase 1 combination data for zelenectide pevedotin plus pembrolizumab in first-line cisplatin-ineligible patients, which we believe continue to demonstrate a differentiated safety profile and encouraging response rates in patients with poor prognosis and limited treatment options. We believe we are well-positioned to continue our strong momentum of execution over the course of 2025, which will be another year of important data milestones across our pipeline as we work to develop potentially transformative treatments that will help patients live longer and live well.” Updated Topline Zelenectide Pevedotin Plus Pembrolizumab Combination Data in First-Line mUC Highlights Zelenectide pevedotin, a Bicycle ® Toxin Conjugate (BTC ® ), has significant potential to treat Nectin-4 cancers. As of Jan. 3, 2025, updated topline results from the ongoing Phase 1 Duravelo-1 trial evaluating zelenectide pevedotin 5 mg/m 2 weekly plus pembrolizumab 200 mg once every three weeks in 22 first-line cisplatin-ineligible patients with mUC showed: 65% overall response rate (ORR) (13/20) among all efficacy-evaluable patients, and a 50% ORR (10/20) among patients with confirmed responses. Of the 3 unconfirmed responses, 1 patient remained on treatment at the time of the data cut. Median duration of response (mDOR) is not yet mature, with 12 patients still on treatment at the time of the data cut. Safety and tolerability profile continues to be broadly consistent with other Phase 1 zelenectide pevedotin monotherapy and combination cohorts. Adverse events of clinical interest such as peripheral neuropathy, skin reactions and eye disorders were primarily low grade. All cases of Grade 3 treatment-related adverse events (TRAEs) of clinical interest were reversible, and there were no Grade 4 or Grade 5 TRAEs of clinical interest. Notably, no patients withdrew from the study due to zelenectide TRAEs. Altogether, these updated data continue to position zelenectide pevedotin as a potentially promising best-in-class therapy for mUC. Bicycle Therapeutics is currently conducting the Phase 2/3 Duravelo-2 registrational trial evaluating zelenectide pevedotin plus pembrolizumab versus chemotherapy in first-line mUC (Cohort 1), and zelenectide pevedotin monotherapy and in combination with pembrolizumab in late-line mUC (Cohort 2). In each cohort, two doses of zelenectide pevedotin – 5 mg/m 2 weekly and 6 mg/m 2 two weeks on, one week off – are initially being assessed before a final dose is selected. 2024 Key Accomplishments Initiated the global Phase 2/3 Duravelo-2 trial for zelenectide pevedotin in mUC, providing multiple opportunities for potential accelerated approval. Presented updated monotherapy data for zelenectide pevedotin showing a promising 45% ORR in patients with late-line mUC who had not previously been treated with enfortumab vedotin. The data continue to support zelenectide pevedotin’s emerging differentiated profile as a potential treatment for mUC. Presented updated monotherapy data for BT5528, a BTC ® targeting EphA2, and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist ® (Bicycle TICA ® ), in advanced solid tumors. The data support each molecule’s emerging differentiated safety and tolerability profile and provide important information for continued dose selection exploration. Presented first human imaging data validating the potential of MT1-MMP as a novel target in the treatment of cancer and highlighting the potential of Bicycle ® molecules for targeted radionuclide therapy. The company also selected EphA2 as its second radiopharmaceutical target. Reported monotherapy data for zelenectide pevedotin showing an enhanced response in late-line breast cancer and non-small cell lung cancer (NSCLC) patients with NECTIN4 gene amplification and/or polysomy. Based on these data, the U.S. Food and Drug Administration granted Fast Track designation to zelenectide pevedotin for the treatment of adult patients with previously treated, NECTIN4-amplified, advanced or metastatic triple-negative breast cancer and NSCLC. Raised $555 million to help advance research and development and strategic priorities. As of Sept. 30, 2024, the company had $890.9 million in cash and cash equivalents, with expected financial runway into 2H 2027. 2025 Strategic Priorities and Anticipated Milestones Seek to transform treatment across multiple Nectin-4 associated cancers with zelenectide pevedotin Report additional Phase 1 Duravelo-1 combination data with pembrolizumab in first-line cisplatin-ineligible mUC in 2H 2025. Report longer-term follow-up Phase 1 Duravelo-1 monotherapy data in late-line mUC in 2H 2025. Report Phase 2/3 Duravelo-2 Cohort 1 and Cohort 2 dose selection data in 2H 2025. Initiate Phase 1 trials in NECTIN4 gene-amplified breast cancer (Duravelo-3) in 1H 2025 and NECTIN4 gene-amplified lung cancer (Duravelo-4) and multi-tumor (Duravelo-5) in 2H 2025. Advance emerging Bicycle ® Radionuclide Conjugates (BRC ® ) pipeline and progress strategy for leadership in next-generation radiopharmaceuticals Report additional MT1-MMP human imaging data in mid-2025. Report initial EphA2 human imaging data in 2H 2025. Advance targeted therapeutics pipeline addressing novel targets that have historically been challenging to treat Report Phase 1 combination data for BT5528 plus nivolumab in 4Q 2025. Report Phase 1 combination data for BT7480 plus nivolumab in 4Q 2025. J.P. Morgan Healthcare Conference Presentation and Webcast Bicycle Therapeutics will highlight these updates and strategic priorities in a corporate presentation at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 14, 2025, at 5:15 p.m. PT, followed by a question-and-answer breakout session at 5:35 p.m. PT. A live webcast of the presentation will be accessible from the Investor section of the company’s website at www.bicycletherapeutics.com . A replay of the webcast will be archived and available following the event. About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle ® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle ® Toxin Conjugate (BTC ® ) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist ® (Bicycle TICA ® ) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle ® Radionuclide Conjugates (BRC ® ) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle ® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit www.bicycletherapeutics.com . Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Bicycle’s ability to continue its momentum, including with respect to the development of zelenectide pevedotin, BT5528 and BT7480 as well as potential radiopharmaceutical product candidates; the company’s plans to utilize a NECTIN4 gene amplification strategy in the clinical development of zelenectide pevedotin; Bicycle’s strategic goals to transform treatment across multiple Nectin-4 associated cancers, to become a leader in next-generation radiopharmaceuticals, and to advance a targeted therapeutics pipeline addressing novel targets that have historically been challenging to treat; the planned initiation of clinical trials of zelenectide pevedotin in breast cancer, lung cancer, and other cancers; achievement of multiple data milestones during the course of 2025, and the timing of announcement of data from clinical trials for zelenectide pevedotin, BT5528, BT7480, and human imaging data for MT1-MMP and EphA2 targeting Bicycle ® Radionuclide Conjugates; expectations with respect to Bicycle’s financial runway; and the use of Bicycle’s technology through various partnerships to develop potential therapies in diseases beyond oncology. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle’s product candidates; the risk that Bicycle may not realize the intended benefits of its technology, partnerships or NECTIN4 gene amplification strategy; the risk that Bicycle may not achieve any of its clinical development strategies; timing of results from clinical trials; whether the outcomes of preclinical studies and prior clinical trials will be predictive of future clinical trial results; the risk that trials may have unsatisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle’s product candidates; the risk that Bicycle’s projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle’s actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in Bicycle’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on October 31, 2024, as well as in other filings Bicycle may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Phase 2b clinical trial (ELPIS II) evaluating Lomecel-B™ in rare pediatric disease HLHS has achieved more than 80% enrollmentPositive Type C meeting with U.S. FDA confirmed ELPIS II is pivotal and, if positive, acceptable for Biological License Application (BLA) submission for full traditional approvalPositive data from the Phase 2a clinical trial (CLEAR MIND) evaluating Lomecel-B™ in Alzheimer’s disease presented in Featured Research Oral Presentation at Alzheimer’s Association International Conference® (AAIC)Total Revenue for the first nine months of 2024 increased 177% year-over-year to $1.8 million, primarily due to the successful initiation of contract manufacturing services and increased participant demand for the Bahamas Registry TrialFocused expenditure management reduced first nine months Total Operating Expenses 14% year-over-year while maintaining investments in advancing the clinical pipelineCurrent cash and cash equivalents are expected to be sufficient to fund Company through the fourth quarter of 2025 based on the current operating budget and cash flow forecastCompany to host conference call and webcast today at 4:30 p.m. ET MIAMI, Nov. 12, 2024 (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 reported financial results for the quarter ended September 30, 2024 and provided a business update. “In the third quarter, we continued to advance the development of our investigational cellular therapy candidate, Lomecel-B™, as a potential treatment for both Hypoplastic Left Heart Syndrome (HLHS) and mild Alzheimer’s disease,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “The ELPIS II clinical trial in HLHS is a key priority and we are delighted to have achieved more than 80% enrollment. Our recent positive Type C meeting with the FDA confirmed ELPIS II is pivotal and, if positive, acceptable for Biological License Application (BLA) submission for full traditional approval. Similarly, we are excited by the strength of the CLEAR MIND Phase 2a clinical data in mild Alzheimer’s disease and the interest it is garnering with the data selected as a featured research oral presentation at the 2024 Alzheimer's Association International Conference (AAIC) in July, and additional data selected for Late Breaking poster presentation at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24). We believe stem cell therapy has the potential to become a mainstream treatment for many conditions with significant unmet medical needs and that Longeveron is well positioned to be a leader in stem cell research and potential commercialization.” Development Programs UpdateLongeveron’s investigational therapeutic candidate is Lomecel-B™, a proprietary, scalable, allogeneic cellular therapy being evaluated in multiple indications. Hypoplastic Left Heart Syndrome (HLHS) – a rare pediatric congenital heart birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. Phase 2b clinical trial (ELPIS II) evaluating Lomecel-B™ as a potential adjunct therapy for HLHS currently enrolling 38 pediatric patients at twelve premiere infant and children’s treatment institutions across the country. Enrollment completion currently targeted for end of year, however, given their smaller populations, clinical trial timing for rare diseases is difficult to predict and enrollment completion may occur in the first quarter of 2025.Recent positive Type C meeting with the U.S. Food and Drug Administration (FDA) confirmed ELPIS II is pivotal and, if positive, acceptable for Biological License Application (BLA) submission for full traditional approval, and alignment on ELPIS II primary and secondary endpoints.ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH).ELPIS II builds on the positive clinical results of ELPIS I, in which children in the trial experienced 100% transplant-free survival up to five years of age after receiving Lomecel-B™ compared to approximate 20% mortality rate observed from historical control data.ELPIS I five-year post-treatment long-term survival data presented at the Congenital Heart Surgeons’ Society (CHSS) 51st Annual Meeting: Five-year post-Glenn procedure Kaplan-Meier survival was 100% in patients treated with Lomecel-B™ in ELPIS I with none requiring heart transplant. This compared to 83% survival in the Single Ventricle Reconstruction (SVR) trial through 5 years post-Glenn surgery, and a 5.2% heart transplantation rate.No Major Adverse Cardiovascular Events (MACE) were reported during the study.No Lomecel-B™ related safety issues were reported.These findings support the use of Lomecel-B™ as a potential adjunct to HLHS reconstruction surgery to improve transplant-free survival. The FDA has granted Lomecel-B™ Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment of HLHS. Alzheimer’s disease (AD) – a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options. Full results from the Phase 2a clinical trial (CLEAR MIND), which support the therapeutic potential of Lomecel-B™ in the treatment of mild Alzheimer’s disease and provided evidence-based support for further clinical development, were presented in a featured research oral presentation at the 2024 Alzheimer's Association International Conference (AAIC).The FDA has granted Lomecel-B™ both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease.Lomecel-BTM data in Alzheimer’s disease presented in Late Breaking poster presentation at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24). Lomecel-B™ capacity to inhibit MMP14 correlates with improved clinical and biomarker outcomes in mild Alzheimer’s disease.Findings offer potential mechanistic and clinical insights in the development of cellular-based therapy for Alzheimer’s disease. The Company anticipates meeting with the FDA in the first quarter of 2025 to review future clinical and regulatory strategy. Year to Date 2024 Summary Financial Results Revenues: Revenues for the nine months ended September 30, 2024 and 2023 were $1.8 million and $0.6 million, respectively. This represents an increase of $1.1 million, or 177%, in 2024 compared to 2023, primarily driven by increased participant demand for our investigational Frailty and Cognitive Impairment registry trial in the Bahamas (the “Bahamas Registry Trial”) and increased contract manufacturing revenue. Clinical trial revenue, derived from the Bahamas Registry Trial, for the nine months ended September 30, 2024 and 2023 was $1.0 million and $0.6 million, respectively. This increase of $0.4 million, or 67% for the nine months ended September 30, 2024 was due to higher participant demand. Contract manufacturing revenue for the nine months ended September 30, 2024 was $0.8 million, generated from our manufacturing services contract.Cost of Revenues and Gross Profit: Cost of revenues was $0.4 million for the nine months ended September 30, 2024 and 2023. This resulted in a Gross Profit of approximately $1.3 million for the nine months ended September 30, 2024, an increase of $1.1 million, or 506%, compared to a gross profit of $0.2 million in 2023.General and Administrative Expenses: General and administrative expenses for the nine months ended September 30, 2024 decreased to approximately $7.4 million, compared to $8.9 million for the same period in 2023. This decrease of approximately $1.5 million, or 16%, was primarily due to lower personnel expenses as a result of reduced severance, legal and other administrative expenses, partially offset by higher stock compensation costs in 2024.Research and Development Expenses: Research and development expenses for the nine months ended September 30, 2024 decreased to approximately $6.1 million, from approximately $6.9 million for the same period in 2023. This decrease of $0.8 million, or 11%, was primarily driven by a reduction of $1.8 million in expenses related to the completed CLEAR MIND Alzheimer’s disease clinical trial, reduced costs for the Aging-related Frailty clinical trial following our decision to discontinue trial activities in Japan, and a $0.4 million decrease in supply costs. These reductions were partially offset by $1.1 million in higher compensation and benefit costs and a $0.2 million increase in equity-based compensation expenses allocated to research and development.Other Income, net: Other income for the nine months ended September 30, 2024 was $0.3 million, primarily consisting of interest earned on money market funds and marketable securities. Other income for the same period in 2023 was $0.2 million, primarily due to gains from marketable securities.Net Loss: Net loss decreased to approximately $11.9 million for the nine months ended September 30, 2024, from $15.3 million for the same period in 2023. This decrease of $3.5 million, or 23%, was due to the factors outlined above.Cash and cash equivalents as of September 30, 2024 were $22.8 million. Capital raises from a registered direct offering and warrant exercises in July 2024 as well as an inducement transaction in September 2024, resulted in gross proceeds of $15.4 million. The Company currently believes its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements through the fourth quarter of 2025 based on our current operating budget and cash flow forecast. However, as a result of its positive Type C meeting with the FDA in August 2024 with respect to the HLHS regulatory pathway, the Company has started to ramp up BLA enabling activities as it currently anticipates a potential filing with the FDA in 2026 if the current ELPIS II trial is successful. To the extent that our operating expenses and capital expenditure requirements accelerate in calendar 2025 as a result of these activities, including CMC (Chemistry, Manufacturing, and Controls) and manufacturing readiness, there will be a need to increase our current proposed spend and further increase our capital investments. The Company intends to seek additional financing/capital raises/non-dilutive funding options to support these activities, and current cash projections may be impacted by these ramped up activities and any financing transactions entered into. Conference Call and Webcast The Company will host a conference call and webcast today at 4:30 p.m. ET. Conference Call Number:1.877.407.0789Conference ID:13749428Call me™ Feature:Click HereWebcast:Click Here An archived replay of the webcast will be available on the “Events & Presentations” section of the Company’s website following the conference. About Longeveron Inc.Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. Lomecel-B™ development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking StatementsCertain statements in this press release 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 risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” 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, the anticipated use of proceeds from recent offerings. 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, market and other conditions, our limited operating history and lack of products approved for commercial sale; adverse global conditions, including macroeconomic uncertainty; inability to raise additional capital necessary to continue as a going concern; our history of losses and inability to achieve profitability going forward; the absence of FDA-approved allogenic, cell-based therapies for Aging-related Frailty, Alzheimer’s disease, or other aging-related conditions, or for HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; our exposure to product liability claims arising from the use of our product candidates or future products in individuals, for which we may not be able to obtain adequate product liability insurance; the adequacy of our trade secret and patent position to protect our product candidates and their uses: others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition, and results of operations; if certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected; the inability to protect the confidentiality of our proprietary information, trade secrets, and know-how; third-party claims of intellectual property infringement may prevent or delay our product development efforts; intellectual property rights do not necessarily address all potential threats to our competitive advantage; the inability to successfully develop and commercialize our product candidates and obtain the necessary regulatory approvals; we cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals; final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect our ability to generate operating revenues; we may not be able to secure and maintain research institutions to conduct our clinical trials; ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations; if we receive regulatory approval of Lomecel-B™ or any of our other product candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense; being subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates; reliance on third parties to conduct certain aspects of our preclinical studies and clinical trials; interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data; the volatility of the price of our Class A common stock; provisions in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock; we have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; and in order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth. 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, 2023, filed with the Securities and Exchange Commission on February 27, 2024, as amended by the Annual Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The forward-looking statements contained in this press release are made as of the date of this press release, 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 ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com Longeveron Inc.Condensed Balance Sheets(In thousands, except share and per share data) September 30,2024 December 31,2023 (Unaudited) Assets Current assets: Cash and cash equivalents$22,778 $4,949 Marketable securities – 412 Prepaid expenses and other current assets 609 376 Accounts and grants receivable 380 111 Total current assets 23,767 5,848 Property and equipment, net 2,622 2,529 Intangible assets, net 2,347 2,287 Operating lease asset 970 1,221 Other assets 203 193 Total assets$29,909 $12,078 Liabilities and stockholders’ equity Current liabilities: Accounts payable$887 $638 Accrued expenses 1,479 2,152 Current portion of lease liability 616 593 Deferred revenue 118 506 Total current liabilities 3,100 3,889 Long-term liabilities: Lease liability 983 1,448 Other liabilities 199 – Total long-term liabilities 1,182 1,448 Total liabilities 4,282 5,337 Commitments and contingencies (Note 9) Stockholders’ equity: Preferred stock, $0.001 par value per share, 5,000,000 shares authorized, no shares issued and outstanding at September 30, 2024, and December 31, 2023 – – Class A common stock, $0.001 par value per share, 84,295,000 shares authorized, 13,352,770 shares issued and outstanding at September 30, 2024; 1,025,183 issued and outstanding at December 31, 2023 13 1 Class B common stock, $0.001 par value per share, 15,705,000 shares authorized, 1,484,005 shares issued and outstanding at September 30, 2024; 1,485,560 issued and outstanding at December 31, 2023 1 1 Additional paid-in capital 131,139 91,823 Stock subscription receivable – (100)Accumulated deficit (105,525) (84,984)Accumulated other comprehensive loss (1) – Total stockholders’ equity 25,627 6,741 Total liabilities and stockholders’ equity$29,909 $12,078 See accompanying notes to unaudited condensed financial statements. Longeveron Inc.Condensed Statements of Operations(In thousands, except per share data)(Unaudited) Three months endedSeptember 30, Nine months endedSeptember 30, 2024 2023 2024 2023 Revenues Clinical trial revenue $210 $150 $1,012 $605 Contract manufacturing revenue 563 - 777 - Grant revenue - - - 41 Total revenues 773 150 1,789 646 Cost of revenues 91 96 435 423 Gross profit 682 54 1,354 223 Operating expenses General and administrative 3,125 3,372 7,447 8,902 Research and development 2,206 1,843 6,148 6,910 Total operating expenses 5,331 5,215 13,595 15,812 Loss from operations (4,649) (5,161) (12,241) (15,589)Other income Other income, net 230 55 349 204 Total other income, net 230 55 349 204 Net loss $(4,419) $(5,106) $(11,892) $(15,385)Deemed dividend – warrant inducement offers (149) (798) (8,650) (798)Net loss attributable to common stockholders $(4,568) $(5,904) $(20,542) $(16,183)Basic and diluted net loss per share $(0.34) $(2.79) $(2.71) $(7.29)Basic and diluted weighted average common shares outstanding 13,627,793 2,117,877 7,572,601 2,110,646 See accompanying notes to unaudited condensed financial statements. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cfb4911d-2b0b-4c52-b2fa-b6982947155d