Longeveron® Announces Third Quarter 2024 Financial Results and Provides Business Update
Longeveron reported Q3 2024 financial results and business updates. The company's Phase 2b ELPIS II trial for Lomecel-B™ in HLHS has reached 80% enrollment, with FDA confirming it as pivotal for BLA submission. Total revenue increased 177% to $1.8M in the first nine months of 2024. Operating expenses decreased 14% year-over-year. The company maintains $22.8M in cash, expected to fund operations through Q4 2025. Notable developments include positive Phase 2a CLEAR MIND trial data in Alzheimer's disease and successful Type C FDA meeting confirming ELPIS II's pivotal status.
Longeveron ha riportato i risultati finanziari e aggiornamenti aziendali per il terzo trimestre del 2024. Il trial di Fase 2b ELPIS II per Lomecel-B™ nell'HLHS ha raggiunto l'80% di arruolamento, con la FDA che ne ha confermato l'importanza per la presentazione della BLA. Le entrate totali sono aumentate del 177%, raggiungendo 1,8 milioni di dollari nei primi nove mesi del 2024. Le spese operative sono diminuite del 14% rispetto all'anno precedente. L'azienda mantiene 22,8 milioni di dollari in contante, previsti per finanziare le operazioni fino al quarto trimestre del 2025. Tra gli sviluppi notevoli ci sono i dati positivi del trial di Fase 2a CLEAR MIND sull'Alzheimer e il successo nella riunione di tipo C con la FDA che conferma lo status fondamentale di ELPIS II.
Longeveron informó sobre los resultados financieros y actualizaciones comerciales del tercer trimestre de 2024. El ensayo de Fase 2b ELPIS II para Lomecel-B™ en HLHS ha alcanzado el 80% de inscripción, con la FDA confirmando su importancia para la presentación de la BLA. Los ingresos totales aumentaron un 177%, alcanzando 1,8 millones de dólares en los primeros nueve meses de 2024. Los gastos operativos disminuyeron un 14% en comparación con el año anterior. La compañía mantiene 22,8 millones de dólares en efectivo, que se espera financien las operaciones hasta el cuarto trimestre de 2025. Los desarrollos notables incluyen datos positivos del ensayo de Fase 2a CLEAR MIND en la enfermedad de Alzheimer y una reunión exitosa tipo C con la FDA que confirma el estado crucial de ELPIS II.
론지버론(Longeveron)은 2024년 3분기 재무 결과 및 비즈니스 업데이트를 발표했습니다. HLHS에서 로메셀-B™(Lomecel-B™)에 대한 2단계 ELPIS II 시험은 80% 등록을 달성했으며, FDA는 BLA 제출을 위한 중추적인 시험으로 확인했습니다. 총 수익은 2024년 첫 9개월 동안 177% 증가한 180만 달러에 달했습니다. 운영 비용은 전년 대비 14% 감소했습니다. 회사는 2,280만 달러의 현금을 보유하고 있으며, 이는 2025년 4분기까지 운영 자금을 지원할 것으로 예상됩니다. 주목할 만한 발전으로는 알츠하이머병에 대한 2단계 CLEAR MIND 시험의 긍정적인 데이터와 ELPIS II의 중추적 지위를 확인하는 성공적인 FDA의 C형 회의가 포함됩니다.
Longeveron a annoncé ses résultats financiers et ses mises à jour commerciales pour le troisième trimestre 2024. L'essai de phase 2b ELPIS II pour Lomecel-B™ dans le cas de HLHS a atteint 80 % de recrutement, avec la FDA confirmant son importance pour la soumission du BLA. Les revenus totaux ont augmenté de 177 %, atteignant 1,8 million de dollars au cours des neuf premiers mois de 2024. Les dépenses opérationnelles ont diminué de 14 % par rapport à l'année précédente. L'entreprise dispose de 22,8 millions de dollars en liquidités, prévues pour financer les opérations jusqu'au quatrième trimestre de 2025. Parmi les développements notables figurent des données positives de l'essai de phase 2a CLEAR MIND sur la maladie d'Alzheimer et une réunion réussie de type C avec la FDA confirmant le statut décisif d'ELPIS II.
Longeveron hat die finanziellen Ergebnisse und Unternehmensupdates für das dritte Quartal 2024 veröffentlicht. Die Phase-2b-Studie ELPIS II für Lomecel-B™ bei HLHS hat eine Einschreibungsrate von 80% erreicht, und die FDA hat dies als entscheidend für die BLA-Einreichung bestätigt. Der Gesamtumsatz stieg um 177% auf 1,8 Millionen US-Dollar in den ersten neun Monaten des Jahres 2024. Die Betriebskosten sanken im Jahresvergleich um 14%. Das Unternehmen hält 22,8 Millionen US-Dollar in bar, die voraussichtlich die Betriebe bis zum vierten Quartal 2025 finanzieren werden. Zu den bemerkenswerten Entwicklungen gehören positive Daten der Phase-2a-Studie CLEAR MIND zur Alzheimer-Krankheit und ein erfolgreiches Type-C-Meeting mit der FDA, das den entscheidenden Status von ELPIS II bestätigt.
- Revenue growth of 177% YoY to $1.8M for first nine months
- Operating expenses reduced by 14% YoY
- Strong cash position of $22.8M
- FDA confirmation of ELPIS II as pivotal trial for BLA submission
- 100% survival rate in ELPIS I five-year post-treatment data
- Net loss of $11.9M for first nine months of 2024
- Additional funding likely needed for BLA enabling activities in 2025
- Potential enrollment completion delay to Q1 2025 for ELPIS II trial
Insights
The Q3 results reveal mixed financial performance. While revenue growth of
The pivotal ELPIS II trial progress and FDA feedback represent significant de-risking events. The potential for BLA submission in 2026 could be a major value driver, but investors should monitor cash burn rate and potential future dilution.
The clinical development progress is encouraging, particularly in HLHS where the ELPIS II trial has reached
The Alzheimer's disease program also shows promise with positive Phase 2a CLEAR MIND trial results, though more details on efficacy endpoints would be needed to fully assess potential. The dual RMAT and Fast Track designations for both programs indicate regulatory support for accelerated development.
- Phase 2b clinical trial (ELPIS II) evaluating Lomecel-B™ in rare pediatric disease HLHS has achieved more than
80% enrollment - Positive 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 approval
- Positive 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 Trial - Focused expenditure management reduced first nine months Total Operating Expenses
14% year-over-year while maintaining investments in advancing the clinical pipeline - Current 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 forecast
- Company 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
Development Programs Update
Longeveron’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 approximate20% 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 to83% survival in the Single Ventricle Reconstruction (SVR) trial through 5 years post-Glenn surgery, and a5.2% 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.
- Five-year post-Glenn procedure Kaplan-Meier survival was
- 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 , or177% , 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 , or67% 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 , or506% , 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 , or16% , 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 , or11% , 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 , or23% , 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: | 1.877.407.0789 |
| Conference ID: | 13749428 |
| Call me™ Feature: | Click Here |
| Webcast: | 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 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
| 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, | – | – | |||||
| Class A common stock, | 13 | 1 | |||||
| Class B common stock, | 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 ended September 30, | Nine months ended September 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
FAQ
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