- Phase 2b clinical trial evaluating Lomecel-BTM in rare pediatric disease HLHS on track for completing enrollment by end of 2024
- Data from Phase 2a clinical trial evaluating Lomecel-BTM in Alzheimer’s Disease selected for Featured Research
Oral Presentation at 2024 Alzheimer’sAssociation International Conference - Completed two financings in April raising gross proceeds of
$11.4 million to fund continued clinical development - Focused expenditure management reduced first quarter Total Operating Expenses 8% year-over-year
- Company to host conference call and webcast today at
5:00pm ET
“In the first quarter, we continued to focus on advancing our cutting-edge cellular therapy research and its application through our investigational product candidate, Lomecel-BTM, in Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer’s disease, both of which are devastating for impacted patients and their families,” said Wa’el Hashad, Chief Executive Officer of
Development Programs Update
Longeveron’s lead investigational therapeutic candidate is Lomecel-BTM, a proprietary, scalable, allogenic 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.
- On-going Phase 2b clinical trial (
ELPIS II ) enrolling 38 pediatric patients, with enrollment completion anticipated by year end 2024 ELPIS II is being conducted in collaboration with the National Heart, Lung, andBlood Institute (NHLBI) through grants from theNational 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-BTM compared to approximate 20% mortality rate observed from historical control data- The Company intends to request a Type B meeting with the
U.S. Food and Drug Administration (FDA) to discuss development strategy for HLHS and expectations for the potential Biologics License Application (BLA) approval
Alzheimer’s Disease (AD) – a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options.
- In a completed Phase 2a clinical trial (CLEAR MIND), Lomecel-B™ treated patients showed an overall slowing/prevention of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy endpoints and showed statistically significant improvements in pre-specified clinical and biomarker endpoints in specific Lomecel-B™ groups compared to placebo
- These results support the therapeutic potential of Lomecel-BTM in the treatment of mild Alzheimer’s disease and provided evidence-based support for further clinical development
- Full results from the CLEAR MIND study have been selected for a featured research oral presentation at the 2024 Alzheimer's
Association International Conference (AAIC) - The Company anticipates meeting with the FDA to review future clinical and regulatory strategy
Recent Corporate Highlights
- In
January 2024 , the United States Patent and Trademark Office mailed a notice of allowance to the Company for itsUnited States patent application with claims directed to methods for use of allogeneic human mesenchymal stem cells as an adjuvant to benefit patients with Aging-related Frailty who are receiving vaccines for conditions such as Covid and the flu. (That application issued asU.S. Patent No. 11,975,068, onMay 7 , 2024.) - In April, the Company completed two capital raises which resulted in gross proceeds of
$11.4 million .
First Quarter 2024 Summary Financial Results
- Revenues, Cost of Revenues and Gross Profit: Revenues for the three months ended
March 31, 2024 and 2023 were$0.5 million and$0.3 million , respectively. 2024 revenues increased$0.2 million , or 96%, when compared to 2023 mainly as a result of increased participant demand for our Bahamas Registry Trial. Grant revenue for the three months endedMarch 31, 2024 and 2023 was$0 and less than$0.1 million , respectively. Clinical trial revenue, which is derived from the Bahamas Registry Trial, for the three months endedMarch 31, 2024 and 2023 was$0.5 million and$0.2 million , respectively. Clinical trial revenue for the three months endedMarch 31, 2024 increased by$0.3 million , or 116%, when compared to 2023 as a result of increased participant demand. Contract manufacturing revenue for the three months endedMarch 31, 2024 and 2023 was less than$0.1 million and$0 , respectively. - Related cost of revenues: Cost of revenues was
$0.2 million for the three-month periods endedMarch 31, 2024 and 2023. The increase of less than$0.1 million , or 8%, was primarily due to the increase in the revenues earned from the investigational Frailty and Cognitive Impairment registry trial in theBahamas and reduced direct costs associated with our grants program. This resulted in a gross profit of approximately$0.3 million for the three months endedMarch 31, 2024 , an increase of$0.2 million , or 333%, when compared with a gross profit of$0.1 million for 2023. - General and Administrative Expenses: General and administrative expenses for the three months ended
March 31, 2024 increased to approximately$2.2 million , compared to$2.0 million for the same period in 2023. The increase of approximately$0.2 million , or 9%, was primarily related to an increase in expenses related to professional fees. - Research and Development Expenses: Research and development expenses for the three months ended
March 31, 2024 decreased to approximately$2.2 million , from approximately$2.8 million for the same period in 2023. The decrease of$0.6 million , or 20%, was primarily due to a decrease of$0.6 million in research and development expenses being incurred for the Alzheimer’s disease clinical trial and reduced costs for the Aging-related Frailty clinical trial following our decision to discontinue trial activities inJapan , reduced cost of supplies of$0.3 million , and a decrease of$0.2 million in equity-based compensation expenses allocated to research and development expenses. These reductions were partially offset by$0.4 million of higher compensation and benefit costs. - Other Expense (Income), net: Other income for the three months ended
March 31, 2024 was less than$0.1 million . Other income consisted of less than$0.1 million from interest earned on money market funds and marketable securities. Other income for the three months endedMarch 31, 2023 was$0.1 million as result of gains from marketable securities. - Net Loss: Net loss decreased to approximately
$4.1 million for the three months endedMarch 31, 2024 from a net loss of$4.6 million for the same period in 2023. The decrease in the net loss of$0.5 million , or 13%, was for the reasons outlined above. - Cash and cash equivalents and marketable securities as of
March 31, 2024 were$2.3 million . InApril 2024 , the Company completed two capital raises which resulted in gross proceeds of$11.4 million . The Company believes its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2024. These estimates are based on assumptions that may prove to be imprecise, and the Company could utilize its available capital resources sooner than it expects.
Conference Call and Webcast
The Company will host a conference call and webcast today at
Conference Call Number: | 1.877.407.0789 | ||||
Conference ID: | 13745868 | ||||
Call meTM 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
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 the private placement. 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, AD, 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
Investor Contact:
Investor Relations Advisory Solutions
derek.cole@iradvisory.com
Condensed Balance Sheets
(In thousands, except share and per share data)
2024 | 2023 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 1,940 | $ | 4,949 | ||||
Marketable securities | 351 | 412 | ||||||
Prepaid expenses and other current assets | 1,288 | 376 | ||||||
Accounts and grants receivable | 178 | 111 | ||||||
Total current assets | 3,757 | 5,848 | ||||||
Property and equipment, net | 2,348 | 2,529 | ||||||
Intangible assets, net | 2,263 | 2,287 | ||||||
Operating lease asset | 1,139 | 1,221 | ||||||
Other assets | 190 | 193 | ||||||
Total assets | $ | 9,697 | $ | 12,078 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,467 | $ | 638 | ||||
Accrued expenses | 2,401 | 2,152 | ||||||
Current portion of lease liability | 601 | 593 | ||||||
Deferred revenue | 826 | 506 | ||||||
Total current liabilities | 5,295 | 3,889 | ||||||
Long-term liabilities: | ||||||||
Lease liability | 1,295 | 1,448 | ||||||
Other liabilities | 66 | - | ||||||
Total long-term liabilities | 1,361 | 1,448 | ||||||
Total liabilities | 6,656 | 5,337 | ||||||
Commitments and contingencies (Note 9) | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, | - | - | ||||||
Class A Common Stock, | 1 | 1 | ||||||
Class B Common Stock, | 1 | 1 | ||||||
Additional paid-in capital | 92,080 | 91,823 | ||||||
Stock subscription receivable | - | (100 | ) | |||||
Accumulated deficit | (89,042 | ) | (84,984 | ) | ||||
Accumulated other comprehensive loss | 1 | - | ||||||
Total stockholders’ equity | 3,041 | 6,741 | ||||||
Total liabilities and stockholders’ equity | $ | 9,697 | $ | 12,078 |
Condensed Statements of Operations
(In thousands, except per share data)
(Unaudited)
Three months ended | ||||||||
2024 | 2023 | |||||||
Revenues | ||||||||
Clinical trial revenue | $ | 515 | $ | 238 | ||||
Contract manufacturing revenue | 33 | - | ||||||
Grant revenue | - | 41 | ||||||
Total revenues | 548 | 279 | ||||||
Cost of revenues | 219 | 203 | ||||||
Gross profit | 329 | 76 | ||||||
Operating expenses | ||||||||
General and administrative | 2,200 | 2,012 | ||||||
Research and development | 2,219 | 2,780 | ||||||
Total operating expenses | 4,419 | 4,792 | ||||||
Loss from operations | (4,090 | ) | (4,716 | ) | ||||
Other income and (expenses) | ||||||||
Other income, net | 32 | 69 | ||||||
Total other income, net | 32 | 69 | ||||||
Net loss | $ | (4,058 | ) | $ | (4,647 | ) | ||
Basic and diluted net loss per share | $ | (1.61 | ) | $ | (2.21 | ) | ||
Basic and diluted weighted average common shares outstanding | 2,513,587 | 2,103,362 |
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/455da66f-07a0-49fe-9b5d-6b82b97f6e89
Wa'el Hashad
Wa'el Hashad, Chief Executive Officer, Longeveron Inc.
2024 GlobeNewswire, Inc., source