-- Achieved key clinical and regulatory milestones across clinical pipeline, including the completion of enrollment in Longeveron’s Phase 2a trial for Alzheimer’s Disease --
-- Conference call scheduled for
“This quarter, we continued to make robust progress across our 3 clinical programs,” said
Third Quarter Business Updates:
Lomecel-BTM for Alzheimer’s Disease:
Longeveron completed enrollment in a Phase 2a trial of Lomecel-BTM in patients with mild Alzheimer’s Disease (AD). Each patient is followed in the study for a duration of 12 months, and the Company expects to share topline results in 2024. The Phase 2a trial is designed as a 48-patient, 4-arm, parallel design, randomized (1:1:1:1) clinical trial of Lomecel-BTM to evaluate the safety of single and multiple infusions of two different dose levels compared to placebo in patients with mild Alzheimer’s Disease (AD). The primary endpoint is safety as measured by the occurrence of serious adverse events (SAEs) within the first 30 days after administration of Lomecel-BTM. Secondary and exploratory endpoints include brain volumetry by magnetic resonance imaging (MRI), biomarkers relevant to inflammation and endothelial/vascular systems, and measures of cognitive function. Lomecel-BTM may have the potential to impact Alzheimer’s Disease by modulating neuroinflammation and vascular dysfunction that contribute to AD, and this trial is intended to give valuable information about those potential effects.
Lomecel-BTM for Hypoplastic Left Heart Syndrome (HLHS):
- The
ELPIS II trial (Phase 2a) has fully activated all 7 clinical sites and continues to enroll infants with HLHS, a rare and life-threatening congenital heart defect affecting approximately 1,000 babies per year. Infants born with HLHS have an underdeveloped or absent left ventricle, which necessitates three reconstructive heart surgeries within the first five years of life, with many requiring a heart transplant. Without treatment, the condition is always fatal, and even with reconstructive surgical interventions, HLHS still leads to high mortality with survival rates from birth to adolescence estimated from 50% to 60%. Lomecel-BTM may have the potential to boost the function of the baby’s single ventricle once the surgeries are performed, and in so doing could potentially reduce the need for heart transplantation in these children. Longeveron intends to provide further guidance on overall timelines forELPIS II when a sufficient portion of the intended treatment population have been enrolled. EPLIS II is a 38-patient, randomized (1:1), blinded, controlled Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial injection of Lomecel-BTM in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery. Lomecel-BTM for HLHS has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from theU.S. Food and Drug Administration (FDA), and the Company plans to engage with the FDA closely on a regulatory strategy going forward for Lomecel-B.
Lomecel-BTM for Aging Frailty:
- This quarter,
Longeveron initiated screening patients for a Phase 2 study evaluating Lomecel-BTM in patients with Aging Frailty inJapan . The Phase 2 clinical trial is a 3-arm, parallel design, randomized (1:1:1), placebo-controlled, double-blind single-infusion study of two different dose levels of Lomecel-B™. The primary objective of the study is to evaluate the safety of Lomecel-B™ as a treatment for Aging Frailty. The Phase 2 trial is being conducted in partnership with theNational Center for Geriatrics & Gerontology (NCGG;Nagoya ) andJuntendo University Hospital (Tokyo ). - The goal of this study is to provide support for an eventual limited approval under Japan’s Act on the Safety of Regenerative Medicine (ASRM).
- ASRM approval (https://www.pmda.go.jp/files/000219466.pdf) allows regenerative medicine products to be administered to patients by approved hospitals or clinics under the practice of medicine. The primary bar to be achieved for approval for this commercialization pathway is to document safety in a trial in
Japan . - Lomecel-BTM may have the potential to improve patient health span and physical function at older ages by increasing physical capacity. In addition to safety, this trial will assess physical function as measured by the 6-minute walk distance test.
Financial Results for Third quarter Ended
Revenue: Revenue for the third quarters of 2022 and 2021 was
- Clinical trial revenue, which comes from the Bahamas Registry Trial, for the three months ended
September 30, 2022 , and 2021 was$210,000 and$164,000 , respectively, representing a 28% improvement in performance due to an increase in participant demand in the Bahamas Registry Trial. - Grant revenue for the three months ended
September 30, 2022 , and 2021 was$55,000 and$68,000 , respectively. Grant revenue for the three months endedSeptember 30, 2022 , was approximately$13,000 , or 19% lower when compared to the same period in 2021, primarily due to a reduction in grant funds available due in part to the completion of the grant-funded clinical trials.
R&D Expenses: Research and development expenses in the third quarter 2022 were
G&A Expenses: General and administrative expenses in the third quarter 2022 were
Net Loss: Net loss was
Per Share: Net loss per share was
Cash and short-term investments: Cash and short-term investments was
Financial Outlook
We believe, based on the current operating plan and financial resources, that our existing cash and short-term investments will be sufficient to cover expenses and capital requirements into the first half of 2024.
Conference Call and Webcast
Management will host a conference call today at
Dial-in Number
All
Access code: 982246
All
Conference ID: 329422
An audio webcast of the call may also be accessed from the ‘Investors’ page of the
About
Cautionary Note Regarding 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 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. 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, statements about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; existing regulations and regulatory developments in the
Investor Contact:
212-698-8700
elsie.yau@sternir.com
Source:
Selected Balance Sheet Data
(in thousands)
(unaudited) | |||||||
Cash | $ | 13,574 | $ | 25,658 | |||
Short-term investments | 8,742 | 9,385 | |||||
Property and equipment | 3,064 | 3,062 | |||||
Intangible assets | 2,373 | 2,334 | |||||
Other assets | 2,762 | 2,327 | |||||
Total assets | $ | 30,515 | $ | 42,766 | |||
Total liabilities | 5,890 | 5,313 | |||||
Total stockholders’ equity | 24,615 | 37,453 | |||||
Total liabilities and stockholders’ equity | $ | 30,515 | $ | 42,766 |
Condensed Statements of Operations
(In thousands, except per share data)
(Unaudited)
Three months ended | Nine months ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Revenues | |||||||||||||||
Clinical trial revenue | $ | 210 | $ | 164 | $ | 860 | $ | 543 | |||||||
Grant revenue | 55 | 68 | 241 | 554 | |||||||||||
Total revenues | 265 | 232 | 1,101 | 1,097 | |||||||||||
Cost of revenues | 173 | 68 | 549 | 576 | |||||||||||
Gross profit | 92 | 164 | 552 | 521 | |||||||||||
Operating expenses | |||||||||||||||
General and administrative | 2,074 | 2,996 | 6,481 | 8,454 | |||||||||||
Research and development | 2,960 | 2,048 | 6,107 | 5,359 | |||||||||||
Selling and marketing | 245 | 25 | 766 | 132 | |||||||||||
Total operating expenses | 5,279 | 5,069 | 13,354 | 13,945 | |||||||||||
Loss from operations | (5,187 | ) | (4,905 | ) | (12,802 | (13,424 | ) | ||||||||
Other (expense) and income | |||||||||||||||
Non-operating lawsuit expense | - | - | (1,398 | ) | - | ||||||||||
Forgiveness of Paycheck Protection Program loan | - | - | - | 300 | |||||||||||
Interest expense | - | (1 | ) | (1 | ) | (3 | ) | ||||||||
Other income, net | (57 | ) | 51 | (177 | ) | 151 | |||||||||
Total other (expenses) and income, net | (57 | ) | 50 | (1,576 | ) | 448 | |||||||||
Net loss | $ | (5,244 | ) | $ | (4,855 | ) | $ | (14,378 | ) | $ | (12,976 | ) | |||
Basic and diluted net loss per share | $ | (0.25 | ) | $ | (0.25 | ) | $ | (0.69 | $ | (0.70 | ) | ||||
Basic and diluted weighted average common shares outstanding | 21,001,613 | 19,115,152 | 20,952,569 | 18,543,024 |
Source:
Source: LGVN
Source:
2022 GlobeNewswire, Inc., source