에 대한 최신 뉴스 Longeveron (NASDAQ:LGVN) 주식

Longeveron

Longeveron Inc is a clinical-stage biotechnology company developing regenerative medicines to address unmet medical needs for specific aging-related and life-threatening conditions. Its investigational product is Lomecel-B an stem cell formulation sourced from the bone marrow of young, healthy adult donors and has potential mechanisms of action that can promote tissue repair and healing. The company currently has three pipeline indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's disease (AD) and Aging-related Frailty.

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각 거래일에는 트레이더들이 전체 시장과 개별 종목들에 대한 최신 뉴스를 볼 수 있는 소스의 하나인 Benzinga Pro에 수백 개의 헤드라인과 보도 자료가 제공된다. 2024년 7월 한 달 동안 Benzinga Pro에서 가장 많이 검색된 주식을 살펴보겠다. 현재 가격과 연간 실적은 8월 1일을 기준으로 하며 배당금은 포함되지 않는다. 4월 검색결과는 추적되지 않았다.

단독: 7월 벤징가 프로에서 가장 많이 검색된 상위 20개 종목 - 테슬라, 엔비디아, CRWD 순위는?

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각 거래일에는 트레이더들이 전체 시장과 개별 종목에 대한 최신 뉴스를 볼 수 있는 소스인 Benzinga Pro에 수백 개의 헤드라인과 보도 자료가 제공된다. 6월 한 달 동안 Benzinga Pro에서 가장 많이 검색된 주식을 살펴보겠다. 현재 가격과 연간 성과는 6월 30일 기준이며 배당금은 포함되어 있지 않다. 4월 검색결과는 추적되지 않았다.

단독: 6월 벤징가 프로에서 가장 많이 검색된 상위 10종목 - 엔비디아, 애플, 테슬라는 어디에?

Longeveron Inc

Dear Fellow Shareholders,
Twenty twenty-four was a year of execution for Longeveron. We made significant progress advancing Longeveron's founding mission - developing cutting-edge cellular therapy research to impact patients' lives for the better by addressing unmet medical needs. We have come a long way pursuing that mission and now have clarity on the pathway to our first potential Biological License Application (BLA) submission.
Today, I am excited to update you on our overall strategy, progress, and key priorities and goals for 2025.
Strategic Overview and 2024 Progress: Over the past decade, stem cell therapy has seen remarkable strides, transforming from a promising field into one delivering tangible clinical outcomes. We've seen the solidification of cell therapy's role in regenerative medicine and its potential to treat a wide range of conditions, signaling an exciting future for both scientific innovation and patient care.
Longeveron has been at the forefront of this evolution in medicine. Our lead investigational product is laromestrocel (Lomecel-B&#x2122;), a stem cell therapy derived from culture-expanded mesenchymal stem cells (MSCs) that are sourced from bone marrow of young healthy adult donors. The number of functional MSCs in the body declines as we age, which has driven interest in their use for aging-related conditions. Their unique properties — including the ability to reduce inflammation, promote tissue repair and regeneration, modulate immune responses, and improve vascularization — also support their application in some rare cardiovascular diseases/conditions with high unmet medical need. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions.
A decade ago, our stem cell therapy vision was an academic idea. Today, laromestrocel represents a pipeline in a product opportunity that has delivered positive results from multiple clinical trials: Phase 1 &amp; 2 in Alzheimer's disease, Phase 1 &amp; 2 in Aging-related Frailty, Phase 1 in Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric disease. We are currently conducting a pivotal Phase 2b clinical trial for HLHS. Our development programs for these 3 initial indications address market opportunities of what we estimate to be approximately ~$5+ billion, ~$4+ billion and up to ~$1 billion, respectively. Earlier this year, the World Health Organization's International Nonproprietary Names (INN) Expert Committee approved "laromestrocel" as the non-proprietary name for Lomecel-B&#x2122; — a key milestone in the development and future commercialization of our stem cell therapy.
As we did this past year, in 2025, we will continue focusing our efforts on two of our most promising programs: HLHS and Alzheimer's disease.
Hypoplastic Left Heart Syndrome (HLHS):
HLHS is a rare pediatric disease in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. Because the left ventricle is the chamber that normally pumps blood to the body, infants born with this condition have a profound reduction in blood flow and thus cannot get the normal supply of oxygen to their organs. In order for the children to survive, they must undergo a complicated, three-stage heart reconstruction surgery over the course of the first 5 years of their lives. Despite this surgical reconstruction, only 50% of the affected children survive to age 15 without heart transplantation.
Our program is designed to boost/improve the heart function in these children with the goal of potentially enhancing their survival. In our Phase I clinical trial (ELPIS I) evaluating laromestrocel in 4-month-old infants with HLHS, we observed 100% transplant-free survival up to five years following treatment. This contrasts with an approximately 20% mortality rate observed in historical control data. Five-year post-treatment long-term survival data from the ELPIS I Phase 1 clinical trial was presented at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting in October 2024.
We are currently nearing completion of enrollment for our Phase 2b study, ELPIS II, which is evaluating laromestrocel as a potential adjunct treatment to the standard of care for HLHS. ELPIS II has achieved nearly 95% enrollment, and we expect to complete enrollment in the second quarter of this year.
In September 2024, we completed a Type C meeting with the U.S. FDA regarding our HLHS development program and the pathway toward a potential BLA submission. We reached foundational alignment on the primary endpoint and secondary endpoints for the ELPIS II trial. The FDA confirmed that, contingent on positive results, ELPIS II may be considered a pivotal trial and potentially acceptable for BLA submission seeking full traditional approval. With this regulatory clarity, we are now focused on BLA preparedness and enabling activities for the HLHS program. Notably, because this program has received Rare Pediatric Disease Designation, we may be eligible to receive a Priority Review Voucher (PRV) if our BLA is approved. We may use the PRV internally or sell to a third party. Historically, PRVs have commanded values exceeding $100 million.
Alzheimer's Disease:
The laromestrocel Alzheimer's disease (AD) program continues to garner important recognition and support. In 2024, data from the CLEAR MIND Phase 2a clinical trial evaluating laromestrocel in mild Alzheimer's disease were presented as a featured research oral presentation at the 2024 Alzheimer's Association International Conference held at the end of July and as a late breaking poster presentation at the 17th edition of the Clinical Trials on Alzheimer's Disease Conference (CTAD24) in October. We are very excited about the trial's positive results. The trial met its primary objective of demonstrating safety, with laromestrocel being well-tolerated. In addition, we observed encouraging trends suggesting a potential slowing or prevention of disease progression in patients treated with laromestrocel compared to placebo.
This program has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations, providing us with the opportunity for enhanced and frequent communication with the FDA to facilitate the development and review process. In March of this year, results from the trial were <a href="https://www.globenewswire.com/Tracker?data=q5z76BEDJ6-_BNlI7zxiW7bj7HH_JA6z2l_-sTbO61K_qKYtMQAMaF9FDMVXrEj3T_9nYmWCk-Lq0zdwrX4bx2qd5ntW3sf1N8Ytp1j1BkoTux4GUbqWzdOydRL9flts">published</a> in Nature Medicine.
Also in March of this year, we held a Type B meeting with the FDA to discuss the regulatory pathway for a potential BLA for laromestrocel in mild Alzheimer's disease. We reached foundational alignment on the overall study design for a proposed single, pivotal, seamless adaptive Phase 2/3 clinical trial. To support an accelerated path to potential approval, the FDA agreed to consider a BLA submission based on positive interim results from this planned single study.
With this regulatory clarity in hand, we are focused on seeking partnership opportunities and/or non-dilutive funding for the Alzheimer's disease program.
Our Core Business Objectives: Our strategic plan is built on the strength of the science underlying our stem cell therapy laromestrocel. For 2025, we are focused on four key objectives:
<ol>
<li>Advance HLHS Program as the Main Near-Term Value Driver:
<ul>
<li>Pivotal Phase 2 clinical trial (ELPIS II) is nearing enrollment completion.</li>
<li>Regulatory pathway clarified with U.S. FDA.</li>
<li>Potential to initiate rolling BLA submission in 2026.</li>
<li>Potential to receive a Rare Pediatric Disease priority review voucher associated with HLHS upon BLA approval which could have significant monetary value and further enhance our product's value proposition upon approval.</li>
</ul>
</li>
<li>HLHS BLA and Commercialization Readiness:
<ul>
<li>Successful meeting with FDA confirmed ELPIS II could be pivotal.</li>
<li>2025 will see significant focus on organizational readiness for potential BLA filing for HLHS in 2026. Our goal is to accomplish BLA readiness this year ahead of data readout to potentially shorten the timeline to BLA submission.</li>
<li>Emphasis on Chemistry, Manufacturing, and Controls (CMC) preparedness.</li>
<li>Hired industry veteran Chief Technology Officer to support BLA preparedness.</li>
<li>We are committed to helping HLHS patients worldwide. In 2025, we intend to take initial steps connecting with non-U.S. regulatory bodies, including EMA (European Union), MHRA (United Kingdom), PMDA (Japan) and HealthCanada.</li>
<li>Recognizing substantial revenue potential from worldwide commercialization, we anticipate capitalizing on recent rare disease pricing trends and the unique aspects of our treatment.</li>
</ul>
</li>
<li>Strategic Collaborations for Alzheimer's Disease:
<ul>
<li>We believe our Alzheimer's disease program holds immense potential. Due to the large size of the affected population, it involves larger-scale studies and commercialization requirements. This scale of development effort necessitates significant investment, prompting our focus on potential strategic partnerships with biotech/pharmaceutical companies and/or non-dilutive funding sources.</li>
<li>We believe the clarity on the pathway to potential BLA submission and the need for only a single pivotal clinical trial enhance the attractiveness and economic benefits of the program to potential partners.</li>
</ul>
</li>
<li>Efficient Resource Management and Capital Allocation:
<ul>
<li>We strive to be prudent stewards of shareholder capital and focus allocating it to the organization's top priorities to effectuate optimal resource utilization and alignment with strategic objectives.</li>
<li>We prudently manage expenses. In 2024, we reduced total operating expenses 13% while continuing to effectively advance our development programs.</li>
</ul>
</li>
</ol>
Financial Position and Capital Strategy: Longeveron is working diligently to effectively advance our development programs while managing expenses and our capital. We will need additional capital to achieve our business strategy and objectives.
We indicated in our recently filed Annual Report on Form 10K that we anticipated our existing cash and cash equivalents would fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. However, as we also indicated, as a result of our successful Type C meeting with the FDA in August 2024 with respect to the HLHS regulatory pathway, we have started to ramp up BLA enabling activities to prepare for a potential filing with the FDA in 2026 if the current ELPIS II trial is successful. We expect our operating expenses and capital expenditure requirements to accelerate this year as a result of these activities, including CMC (Chemistry, Manufacturing, and Controls) and manufacturing readiness. We intend to seek additional financing and non-dilutive funding options to support these activities, and additional non-dilutive funding and/or strategic partners to support the AD development program. We anticipate that our current cash projections may be impacted by these ramped up activities and any financing transactions we enter into.
2025 Goals and Priorities Our goals for 2025 center on efficient, effective execution of our strategic plan with an emphasis on three primary operational goals:
<ol>
<li>ELPIS II Completion: We anticipate completion of ELPIS II enrollment in the second quarter of 2025. We will then focus on supporting our investigative sites through completion of the 12-month primary endpoint follow-up period and preparation for data collection and analysis at the end of the study.</li>
<li>HLHS BLA Preparedness: We intend to accomplish the majority of BLA readiness in 2025 to support a potentially shortened time frame from clinical trial readout to BLA submission.</li>
<li>Alzheimer's Disease Program Partnering: We plan to leverage the strength of our Phase 2 data and clarity on the clinical pathway to a potential BLA for AD to engage with potential funding/commercialization partners. &nbsp;</li>
</ol>
Outlook Longeveron has made tremendous progress in two important stem cell development programs over the past 12 months, successfully delivering on our strategic plan. We are now approaching multiple potentially transformational milestones over the next 12 months including completion of enrollment in our pivotal Phase 2b clinical trial in HLHS which may establish the timeline for a potential BLA submission for HLHS, and potential partnering for the Alzheimer's disease program. Our team's expertise and industry experience enable the organization to accomplish so much with a small team and few resources. Generating several positive initial results across five clinical trials in three indications, continues to position Longeveron as a leader in stem cell therapy research and, potentially, commercialization of cellular therapeutics.
We believe Longeveron's demonstrated track record of successful clinical execution, strength of data generated to date and the potential size of addressable markets provide for a compelling investment opportunity.
We deeply appreciate the support of our stakeholders and look forward to continued collaboration and progress in the future.
Sincerely, Wa'el Hashad CEO, Longeveron

News

Longeveron Issues Letter To Shareholders

Offerings

Longeveron Files For Mixed Shelf Of Up To $70M

HC Wainwright &amp; Co. analyst Raghuram Selvaraju reiterates Longeveron (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGVN#NASDAQ">LGVN</a>) with a Buy and maintains $10 price target.

Price Target

Reiteration

Analyst Ratings

HC Wainwright & Co. Reiterates Buy on Longeveron, Maintains $10 Price Target

<a href="https://www.globenewswire.com/Tracker?data=CfDdIU-vUWn-uP7WHZnuaEMaCT_kqK23e2B2rnWSgQ5QTVFsFxDKp6KvoNJv4aIe5LwgelnDBkS8uQ2d1vFWv_zrjJe72SQMKwWgyt9sjno=">Longeveron Inc.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGVN#NASDAQ">LGVN</a>), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced the positive outcome of a Type B meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of <a href="https://www.globenewswire.com/Tracker?data=vYENKpHkG8Q8TKtnRxrYYFtmm_mUPJS_XTwI5jShRSwA5Dr06tUzISpzZEL9NxPouMnJI0KUgXAnhKBQomWSBWMdIFwZsURvx6s39Xd4YDgljvier2cBsVb7vvOcmB2C">laromestrocel (Lomecel-B</a><a href="https://www.globenewswire.com/Tracker?data=H-H0Ucz0WPTEb36hcT-70z9e_WbFg-Z8bsgF9UaKGYDsTdENcA3nzIgYTf8iKQEYwAVwH-nb1iksUeViM8KA1Q==">TM</a>), a proprietary, scalable, allogeneic, investigational cellular therapy, as a potential treatment for <a href="https://www.globenewswire.com/Tracker?data=wZ5v0WKJTKNsAImVqEvVI5wS4Ce0JLoAGRVmvMihw6AXPD-OIwMKUX0v-4Cqp7P6jgGfR-1NN6SepnEXcg1bxn_PeVHqlbgbL8N4JlbAV4Y=">Alzheimer's</a> disease (AD).
The Company and the FDA reached foundational alignment on the overall study design for a proposed single, pivotal, seamless adaptive Phase 2/3 clinical trial, including proposed AD patient population, proposed placebo control, laromestrocel (Lomecel-BTM) dose selection and frequency, trial duration and trial endpoints. To accelerate the pathway to potential approval, the FDA agreed to consider a BLA based on positive interim trial results from the planned single study.

Longeveron Says Co. And FDA Reached Foundational Alignment On Overall Study Design Supporting Laromestrocel In Alzheimer's Disease

<ul>
<li>Phase 2a results demonstrated laromestrocel (Lomecel-B&#x2122;) improved cognitive function, quality of life, and brain volume in the treatment of mild Alzheimer's disease</li>
<li>This encouraging clinical trial data adds to the body of evidence supporting the safety of single and multiple doses of laromestrocel (Lomecel-B&#x2122;) treatment for mild Alzheimer's disease and provides indications of efficacy in combating decline of brain volume and potentially cognitive function</li>
<li>Laromestrocel (Lomecel-B&#x2122;) is, to Company's knowledge, the first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer's disease</li>
</ul>

Biotech

General

Longeveron Publishes Results Of Phase 2a Clinical Trial Evaluating Laromestrocel In Alzheimer's Disease In Nature Medicine

WIIM

Longeveron shares are trading higher after the company provided 2024 clinical updates and financial results.

Longeveron (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGVN#NASDAQ">LGVN</a>) reported quarterly losses of $(2.62) per share which beat the analyst consensus estimate of $(3.53) by 25.78 percent. The company reported quarterly sales of $2.392 million which beat the analyst consensus estimate of $2.143 million by 11.63 percent.

Earnings

Longeveron FY 2024 GAAP EPS $(2.62) Beats $(3.53) Estimate, Sales $2.392M Beat $2.143M Estimate

<h3>Companies Reporting Before The Bell</h3>
• Frontline (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FRO#NYSE">FRO</a>) is estimated to report quarterly earnings at $0.27 per share on revenue of $282.62 million. 
• Nordic American Tankers (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NAT#NYSE">NAT</a>) is estimated to report quarterly earnings at $0.04 per share on revenue of $53.07 million. 
• Fluent (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FLNT#NASDAQ">FLNT</a>) is estimated to report quarterly loss at $0.23 per share on revenue of $68.06 million. 
• Recursion Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RXRX#NASDAQ">RXRX</a>) is expected to report quarterly loss at $0.41 per share on revenue of $18.17 million. 
• Oxford Square Cap (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OXSQ#NASDAQ">OXSQ</a>) is projected to report quarterly earnings at $0.06 per share on revenue of $9.90 million. 
• Integral Ad Science (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IAS#NASDAQ">IAS</a>) is estimated to report quarterly earnings at $0.25 per share on revenue of $148.94 million. 
• PAR Technology (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PAR#NYSE">PAR</a>) is estimated to report quarterly loss at $0.08 per share on revenue of $99.26 million. 
• ANI Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) is expected to report quarterly earnings at $0.31 per share on revenue of $175.12 million. 
• TeraWulf (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WULF#NASDAQ">WULF</a>) is estimated to report quarterly loss at $0.02 per share on revenue of $37.36 million. 
• Global Partners (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GLP#NYSE">GLP</a>) is estimated to report quarterly earnings at $0.90 per share on revenue of $5.80 billion. 
• Rapid Micro Biosystems (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RPID#NASDAQ">RPID</a>) is expected to report quarterly loss at $0.22 per share on revenue of $7.60 million. 
• FuboTV (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FUBO#NYSE">FUBO</a>) is estimated to report quarterly loss at $0.11 per share on revenue of $444.91 million. 
• Butterfly Network (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BFLY#NYSE">BFLY</a>) is expected to report quarterly loss at $0.08 per share on revenue of $21.01 million. 
• Natural Resources (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NRP#NYSE">NRP</a>) is projected to report earnings for its fourth quarter. 
• Apellis Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APLS#NASDAQ">APLS</a>) is expected to report quarterly loss at $0.37 per share on revenue of $191.93 million. 
• Calumet (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CLMT#NASDAQ">CLMT</a>) is estimated to report quarterly loss at $0.36 per share on revenue of $929.11 million. 
• 1stdibs.com (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DIBS#NASDAQ">DIBS</a>) is estimated to report quarterly earnings at $0.00 per share on revenue of $22.02 million. 
• LandBridge (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LB#NYSE">LB</a>) is projected to report quarterly earnings at $0.78 per share on revenue of $244.81 million. 
• Fulgent Genetics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FLGT#NASDAQ">FLGT</a>) is estimated to report quarterly loss at $0.37 per share on revenue of $75.39 million. 
• Owens &amp; Minor (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/OMI#NYSE">OMI</a>) is estimated to report quarterly earnings at $0.53 per share on revenue of $2.73 billion. 
• Amneal Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMRX#NASDAQ">AMRX</a>) is projected to report quarterly earnings at $0.15 per share on revenue of $700.83 million. 
• Banco Latinoamericano (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BLX#NYSE">BLX</a>) is likely to report quarterly earnings at $0.44 per share on revenue of $251.03 million. 
• Chart Industries (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GTLS#NYSE">GTLS</a>) is expected to report quarterly earnings at $3.23 per share on revenue of $1.18 billion. 
• Alpha Metallurgical (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AMR#NYSE">AMR</a>) is estimated to report quarterly earnings at $1.12 per share on revenue of $683.10 million. 
• Docebo (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DCBO#NASDAQ">DCBO</a>) is expected to report quarterly earnings at $0.27 per share on revenue of $56.24 million. 
• Northwest Natural Hldg (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NWN#NYSE">NWN</a>) is expected to report quarterly earnings at $1.49 per share on revenue of $395.05 million. 
<h3>Companies Reporting After The Bell</h3>
• BIT Mining (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BTCM#NYSE">BTCM</a>) is estimated to report earnings for its fourth quarter. 
• Monroe Cap (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRCC#NASDAQ">MRCC</a>) is expected to report quarterly earnings at $0.27 per share on revenue of $14.99 million. 
• Longeveron (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGVN#NASDAQ">LGVN</a>) is projected to report quarterly loss at $0.36 per share on revenue of $660 thousand. 
• Middlesex Water (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MSEX#NASDAQ">MSEX</a>) is likely to report quarterly earnings at $0.37 per share on revenue of $45.00 million. 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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Earnings Scheduled For February 28, 2025

Longeveron Announces WHO Approval Of Non-Proprietary Name Laromestrocel For Cellular Therapy Lomecel-B In Alzheimer's And HLHS Treatment

<a href="https://scr.zacks.com/files/News/2024/Zacks_SCR_Research_11132024_LGVN_Sorensen-pdf.pdf" title="https://scr.zacks.com/files/News/2024/Zacks_SCR_Research_11132024_LGVN_Sorensen-pdf.pdf">https://scr.zacks.com/files/News/2024/Zacks_SCR_Research_11132024_LGVN_Sorensen-pdf.pdf</a>

Watching Longeveron; Zacks Small-Cap Research Sets $9.50 Price Valuation

Longeveron (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGVN#NASDAQ">LGVN</a>) reported quarterly losses of $(0.34) per share which beat the analyst consensus estimate of $(0.44) by 22.73 percent. This is a 87.81 percent increase over losses of $(2.79) per share from the same period last year. The company reported quarterly sales of $773.000 thousand which beat the analyst consensus estimate of $397.000 thousand by 94.71 percent. This is a 415.33 percent increase over sales of $150.000 thousand the same period last year.

Earnings Beats

Longeveron Q3 2024 GAAP EPS $(0.34) Beats $(0.44) Estimate, Sales $773.000K Beat $397.000K Estimate

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Avadel Pharmaceuticals plc - American Depositary Shares each representing one Ordinary Share

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The Beachbody Company, Inc. Class A Common Stock

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Earnings Scheduled For November 12, 2024

Longeveron (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGVN#NASDAQ">LGVN</a>) will release its quarterly earnings report on Tuesday, 2024-11-12. Here's a brief overview for investors ahead of the announcement.
Analysts anticipate Longeveron to report an earnings per share (EPS) of $-0.44.
Anticipation surrounds Longeveron's announcement, with investors hoping to hear about both surpassing estimates and receiving positive guidance for the next quarter.
New investors should understand that while earnings performance is important, market reactions are often driven by guidance.
<h3>Overview of Past Earnings</h3>
During the last quarter, the company reported an EPS missed by $0.78, leading to a 5.75% drop in the share price on the subsequent day.
Here's a look at Longeveron's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
<th>Q4 2023</th>
<th>Q3 2023</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>-1.05</td>
<td>-2</td>
<td>-2.1</td>
<td>-2.2</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>-1.83</td>
<td>-1.61</td>
<td>-2.5</td>
<td>-2.8</td>
</tr>
<tr>
<td>Price Change %</td>
<td>-6.0%</td>
<td>-4.0%</td>
<td>-6.0%</td>
<td>-6.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2024/1731341085_0.png" alt="eps graph" />
<h3>Longeveron Share Price Analysis</h3>
Shares of Longeveron were trading at $2.2 as of November 08. Over the last 52-week period, shares are down 87.71%. Given that these returns are generally negative, long-term shareholders are likely unhappy going into this earnings release. 
<h3>Analyst Insights on Longeveron</h3>
For investors, staying informed about market sentiments and expectations in the industry is paramount. This analysis provides an exploration of the latest insights on Longeveron.
A total of 4 analyst ratings have been received for Longeveron, with the consensus rating being Buy. The average one-year price target stands at $9.0, suggesting a potential 309.09% upside.
<h3>Comparing Ratings with Peers</h3>
The below comparison of the analyst ratings and average 1-year price targets of and Longeveron, three prominent players in the industry, gives insights for their relative performance expectations and market positioning.
<h3>Comprehensive Peer Analysis Summary</h3>
The peer analysis summary presents essential metrics for and Longeveron, unveiling their respective standings within the industry and providing valuable insights into their market positions and comparative performance.

<table>
<thead>
<tr>
<th>Company</th>
<th>Consensus</th>
<th>Revenue Growth</th>
<th>Gross Profit</th>
<th>Return on Equity</th>
</tr>
</thead>
<tbody>
<tr>
<td>Longeveron</td>
<td>Buy</td>
<td>115.67%</td>
<td>$344K</td>
<td>-132.73%</td>
</tr>
</tbody>
</table>

Key Takeaway:
Longeveron ranks at the bottom for Revenue Growth with a negative percentage. It also ranks at the bottom for Gross Profit with the lowest value. Additionally, it ranks at the bottom for Return on Equity with a negative percentage. Overall, Longeveron is positioned at the bottom compared to its peers across all metrics provided.
<h3>Discovering Longeveron: A Closer Look</h3>
Longeveron Inc is a clinical-stage biotechnology company developing regenerative medicines to address unmet medical needs for specific aging-related and life-threatening conditions. Its investigational product is Lomecel-B an stem cell formulation sourced from the bone marrow of young, healthy adult donors and has potential mechanisms of action that can promote tissue repair and healing. The company currently has three pipeline indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's disease (AD) and Aging-related Frailty.
<h3>Financial Insights: Longeveron</h3>
Market Capitalization Analysis: Positioned below industry benchmarks, the company's market capitalization faces constraints in size. This could be influenced by factors such as growth expectations or operational capacity.
Revenue Growth: Longeveron's remarkable performance in 3 months is evident. As of 30 June, 2024, the company achieved an impressive revenue growth rate of 115.67%. This signifies a substantial increase in the company's top-line earnings. As compared to competitors, the company surpassed expectations with a growth rate higher than the average among peers in the Health Care sector.
Net Margin: Longeveron's net margin lags behind industry averages, suggesting challenges in maintaining strong profitability. With a net margin of -2545.73%, the company may face hurdles in effective cost management.
Return on Equity (ROE): Longeveron's ROE is below industry standards, pointing towards difficulties in efficiently utilizing equity capital. With an ROE of -132.73%, the company may encounter challenges in delivering satisfactory returns for shareholders.
Return on Assets (ROA): Longeveron's ROA falls below industry averages, indicating challenges in efficiently utilizing assets. With an ROA of -81.91%, the company may face hurdles in generating optimal returns from its assets.
Debt Management: Longeveron's debt-to-equity ratio is below industry norms, indicating a sound financial structure with a ratio of 0.12.
<a href="https://www.benzinga.com/quote/LGVN/earnings">To track all earnings releases for Longeveron visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

A Look Ahead: Longeveron's Earnings Forecast

In the last three months, 4 analysts have published ratings on Longeveron (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGVN#NASDAQ">LGVN</a>), offering a diverse range of perspectives from bullish to bearish.
The following table provides a quick overview of their recent ratings, highlighting the changing sentiments over the past 30 days and comparing them to the preceding months.
<table>
<thead>
<tr>
<th></th>
<th style="text-align: right;">Bullish</th>
<th style="text-align: right;">Somewhat Bullish</th>
<th style="text-align: right;">Indifferent</th>
<th style="text-align: right;">Somewhat Bearish</th>
<th style="text-align: right;">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td style="text-align: right;">4</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td style="text-align: right;">3</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
</tbody>
</table>
Analysts have recently evaluated Longeveron and provided 12-month price targets. The average target is $9.0, accompanied by a high estimate of $10.00 and a low estimate of $6.00. A negative shift in sentiment is evident as analysts have decreased the average price target by 20.0%. 
<img src="https://www.benzinga.com/files/images/story/2024/1730750458_0.png" alt="price target chart" />
<h2>Understanding Analyst Ratings: A Comprehensive Breakdown</h2>
The perception of Longeveron by financial experts is analyzed through recent analyst actions. The following summary presents key analysts, their recent evaluations, and adjustments to ratings and price targets.
<table>
<thead>
<tr>
<th>Analyst</th>
<th>Analyst Firm</th>
<th>Action Taken</th>
<th>Rating</th>
<th>Current Price Target</th>
<th>Prior Price Target</th>
</tr>
</thead>
<tbody>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$10.00</td>
<td>$10.00</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$10.00</td>
<td>$10.00</td>
</tr>
<tr>
<td>Michael Okunewitch</td>
<td>Maxim Group</td>
<td>Lowers</td>
<td>Buy</td>
<td>$6.00</td>
<td>$15.00</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$10.00</td>
<td>$10.00</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: In response to dynamic market conditions and company performance, analysts update their recommendations. Whether they 'Maintain', 'Raise', or 'Lower' their stance, it signifies their reaction to recent developments related to Longeveron. This insight gives a snapshot of analysts' perspectives on the current state of the company.</li>
<li>Rating: Delving into assessments, analysts assign qualitative values, from 'Outperform' to 'Underperform'. These ratings communicate expectations for the relative performance of Longeveron compared to the broader market.</li>
<li>Price Targets: Analysts predict movements in price targets, offering estimates for Longeveron's future value. Examining the current and prior targets offers insights into analysts' evolving expectations.</li>
</ul>
Navigating through these analyst evaluations alongside other financial indicators can contribute to a holistic understanding of Longeveron's market standing. Stay informed and make data-driven decisions with our Ratings Table.
<a href="https://www.benzinga.com/quote/LGVN/analyst-ratings?utm_source=Benzinga Insights">Stay up to date on Longeveron analyst ratings.</a>
If you are interested in following small-cap stock news and performance <a href="https://www.benzinga.com/news/small-cap">you can start by tracking it here</a>.
<h2>All You Need to Know About Longeveron</h2>
Longeveron Inc is a clinical-stage biotechnology company developing regenerative medicines to address unmet medical needs for specific aging-related and life-threatening conditions. Its investigational product is Lomecel-B an stem cell formulation sourced from the bone marrow of young, healthy adult donors and has potential mechanisms of action that can promote tissue repair and healing. The company currently has three pipeline indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's disease (AD) and Aging-related Frailty.
<h3>Longeveron's Economic Impact: An Analysis</h3>
Market Capitalization Analysis: The company exhibits a lower market capitalization profile, positioning itself below industry averages. This suggests a smaller scale relative to peers.
Revenue Growth: Over the 3 months period, Longeveron showcased positive performance, achieving a revenue growth rate of 115.67% as of 30 June, 2024. This reflects a substantial increase in the company's top-line earnings. In comparison to its industry peers, the company stands out with a growth rate higher than the average among peers in the Health Care sector.
Net Margin: The company's net margin is below industry benchmarks, signaling potential difficulties in achieving strong profitability. With a net margin of -2545.73%, the company may need to address challenges in effective cost control.
Return on Equity (ROE): Longeveron's ROE falls below industry averages, indicating challenges in efficiently using equity capital. With an ROE of -132.73%, the company may face hurdles in generating optimal returns for shareholders.
Return on Assets (ROA): Longeveron's ROA lags behind industry averages, suggesting challenges in maximizing returns from its assets. With an ROA of -81.91%, the company may face hurdles in achieving optimal financial performance.
Debt Management: Longeveron's debt-to-equity ratio is below the industry average. With a ratio of 0.12, the company relies less on debt financing, maintaining a healthier balance between debt and equity, which can be viewed positively by investors.
<h2>Analyst Ratings: What Are They?</h2>
Ratings come from analysts, or specialists within banking and financial systems that report for specific stocks or defined sectors (typically once per quarter for each stock). Analysts usually derive their information from company conference calls and meetings, financial statements, and conversations with important insiders to reach their decisions.
Some analysts will also offer forecasts for metrics like growth estimates, earnings, and revenue to provide further guidance on stocks. Investors who use analyst ratings should note that this specialized advice comes from humans and may be subject to error.
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This article was generated by Benzinga's automated content engine and reviewed by an editor.

Peeling Back The Layers: Exploring Longeveron Through Analyst Insights

Longeveron Presents Lomecel-B Data For Mild Alzheimer's At CTAD24, Showing Potential Clinical And Biomarker Improvements Through MMP14 Inhibition

Shares of LENZ Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LENZ#NASDAQ">LENZ</a>) rose sharply in <a href="https://www.benzinga.com/quote/LENZ">today's pre-market trading</a>.
CORXEL and LENZ Therapeutics revealed topline data from China Phase 3 Presbyopia trial of LNZ100.
LENZ Therapeutics shares jumped 18% to $31.88 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>Healthcare Triangle, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HCTI#NASDAQ">HCTI</a>) rose 121% to $1.28 in pre-market trading. The Healthcare Triangle announced it acquired substantially all of the business, assets, and operations relating to cloud and technology domain of Securekloud Technologies on Oct. 21.</li>
<li>Pixie Dust Technologies, Inc.  (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PXDT#NASDAQ">PXDT</a>) gained 109% to $1.40 in pre-market trading. Pixie Dust Technologies shares dipped 36% on Friday after the company recently announced it will delist its ADR units from the Nasdaq Capital Market and submit a deregistration application with the SEC.</li>
<li>Jet.AI Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JTAI#NASDAQ">JTAI</a>) shares rose 24.6% to $0.0847 in pre-market trading after falling 16% on Friday. Jet.AI announced the pricing of $1.5 million registered direct offering of 15.6 million shares of common stock at a price of $0.096 per share.</li>
<li>Top Wealth Group Holding Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TWG#NASDAQ">TWG</a>) shares surged 24.5% to $0.6720 in pre-market trading after dipping 96% on Friday.</li>
<li>TC Biopharm (Holdings) Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TCBP#NASDAQ">TCBP</a>) shares jumped 19.4% to $1.91 in pre-market trading after dipping 19% on Friday.</li>
<li>Longeveron Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGVN#NASDAQ">LGVN</a>) climbed 19% to $2.63 in pre-market trading. Longeveron shared long-term data on transplant-free survival with Lomecel-B in Hypoplastic Left Heart Syndrome (HLHS) at the 51st Annual Meeting CHSS.</li>
<li>Tarsus Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TARS#NASDAQ">TARS</a>) gained 15.5% to $45.50 in pre-market trading.</li>
<li>ImmunityBio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IBRX#NASDAQ">IBRX</a>) shares rose 11.8% to $5.95 in pre-market trading after jumping 26% on Friday.</li>
<li>ADS-TEC Energy PLC (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADSE#NASDAQ">ADSE</a>) shares gained 10.3% to $15.99 in pre-market trading.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>SMX (Security Matters) Public Limited Company (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SMX#NASDAQ">SMX</a>) shares dipped 30% to $0.9739 in pre-market trading after dipping 33% on Friday.</li>
<li>Upexi, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UPXI#NASDAQ">UPXI</a>) shares fell 21.8% to $6.33 in pre-market trading. Upexi shares jumped 170% on Friday after the company said it is currently reviewing trading activity to determine if recent activity involved possible stock manipulation.</li>
<li>Monopar Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNPR#NASDAQ">MNPR</a>) shares fell 19% to $13.72 in pre-market trading after dipping 48% on Friday. The company recently entered into an agreement with Alexion, AstraZeneca Rare Disease, for an exclusive worldwide license to ALXN-1840 for Wilson disease.</li>
<li>EON Resources Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EONR#NYSE">EONR</a>) fell 16.8% to $1.04 in today's pre-market trading.</li>
<li>ARB IOT Group Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARBB#NASDAQ">ARBB</a>) fell 16.6% to $0.57 in pre-market trading after jumping 107% on Friday.</li>
<li>Jeffs&#8217; Brands Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JFBR#NASDAQ">JFBR</a>) fell 16.5% to $0.2821 in pre-market trading after jumping 23% on Friday.</li>
<li>Koninklijke Philips N.V. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PHG#NYSE">PHG</a>) declined 16.1% to $26.58 in pre-market trading after posting downbeat quarterly results.</li>
<li>NWTN Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NWTN#NASDAQ">NWTN</a>) shares declined 13.8% to $0.8090 in pre-market trading after jumping 62% on Friday.</li>
<li>Indonesia Energy Corporation Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INDO#NASDAQ">INDO</a>) shares fell 13% to $4.03 after gaining 7% on Friday.</li>
<li>Tevogen Bio Holdings Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TVGN#NASDAQ">TVGN</a>) fell 9.5% to $2.76 in pre-market trading. Tevogen Bio issued additional guidance on introduction of T Cell therapy for oncology and specialty care therapeutic areas.</li>
</ul>
Now Read This: 
<ul>
<li><a href="https://www.benzinga.com/news/24/10/41545103/wall-streets-most-accurate-analysts-give-their-take-on-3-real-estate-stocks-delivering-high-dividend">Wall Street&#8217;s Most Accurate Analysts Give Their Take On 3 Real Estate Stocks Delivering High-Dividend Yields</a></li>
</ul>

Pre-Market Outlook

Movers

ADSE

ARBB

EONR

HCTI

IBRX

INDO

JFBR

JTAI

LENZ

MNPR

NWTN

PXDT

TARS

TCBP

TVGN

UPXI

Why LENZ Therapeutics Shares Are Trading Higher By Around 18%; Here Are 20 Stocks Moving Premarket

<ul>
<li>Oral presentation highlights findings that patients treated with Lomecel-BTM&nbsp;in ELPIS I, in an open-label follow-on study, experienced 5-year survival after stage 2 Glenn surgery of&nbsp;100%&nbsp;with none requiring heart transplant; this compared to the largest data set from the Single Ventricle Reconstruction Trial which showed&nbsp;83%&nbsp;survival, with a&nbsp;5.2%&nbsp;heart transplantation rate</li>
<li>ELPIS I met its primary endpoint of safety through 1-year post-treatment, with&nbsp;100%&nbsp;survival rate,&nbsp;100%&nbsp;transplant-free and patients maintained expected rate of growth one year after treatment</li>
<li>Findings support cell based therapy as a potential adjunct to HLHS reconstruction surgery to improve clinical benefits and reduce the need for subsequent heart transplantation</li>
<li>ELPIS II Phase 2b clinical trial is currently ongoing, further evaluating Lomecel-BTM&nbsp;as a potential adjunct therapy for HLHS versus standard of care alone</li>
</ul>

Reported Earlier, Longeveron Shares Long-term Data On Transplant-free Survival with Lomecel-B In Hypoplastic Left Heart Syndrome (HLHS) At the 51st Annual Meeting CHSS

Press Releases

Longeveron to Present at the Emerging Growth Virtual Conference on February 19, 2025

Presenting on the Emerging Growth Conference 79 Day 1 on February 18 Register Now

Health Care

Longeveron® Announces World Health Organization Approval of "laromestrocel" as International Non-proprietary Name for Stem Cell Therapy Lomecel-B™

Presenting on the Emerging Growth Conference 79 Day 2 on February 19 Register Now

Longeveron® to Report Full Year 2024 Financial Results and Host Conference Call on February 28, 2025

Longeveron® Announces Full-Year 2024 Financial Results and Provides Business Update

Longeveron® to Present at the 37th Annual Roth Conference

Longeveron® Announces Nature Medicine Publication of Results of Phase 2a Clinical Trial Evaluating Laromestrocel (Lomecel-B™) in Alzheimer's Disease

Longeveron® Announces Positive Type B Meeting with U.S. FDA Regarding Pathway to BLA for Laromestrocel (Lomecel-BTM) in Alzheimer's Disease

Comments

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금요일, 8월 02, 2024

화요일, 7월 02, 2024

사람들이 또한 지켜본다

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