Company Announces 2024 Strategic Priorities Focused on Advancement of Lomecel-B™ in Hypoplastic Left Heart Syndrome
ELPIS II Phase 2 Trial of Lomecel-B™ in HLHS Continues Enrollment; Completion of Study Enrollment Anticipated in 2024
Long-term Survival Data from ELPIS 1 Trial Presented at the 2023 Scientific Sessions of the
Announced Additional Validating Clinical Data and Imaging Biomarker Results from the CLEAR MIND Phase 2a Trial of Lomecel-B™ in the Treatment of Mild Alzheimer’s Disease
Gross Proceeds of
Company to Hold Conference Call and Webcast Today,
“In 2023 we made significant strides advancing studies of our investigational product, Lomecel-B™, in Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer’s disease, with long-term survival data from ELPIS I trial presented at the
Recent Highlights
HLHS
- Company prioritizing development of Lomecel-B™ in HLHS;
- Long-term transplant-free survival data from the ELPIS I trial of Lomecel-B™ for patients with HLHS presented as a poster at
American Heart Association 2023 Scientific Sessions; - Children in ELPIS I trial had 100% transplant-free survival up to five years of age after receiving Lomecel-B™ compared to approximate 20% mortality rate observed from historical control data;
- Data reinforce potential survival benefit of Lomecel-B™ for patients in this indication;
- Company anticipates completing enrollment in
ELPIS II trial in 2024.
Alzheimer’s disease
- Announced topline results from the Phase 2a CLEAR MIND trial of Lomecel-B™ for the treatment of mild Alzheimer’s disease:
- The study met the primary safety endpoint, and no patient experienced Alzheimer’s Related Imaging Abnormality (ARIA);
- The study also met its secondary endpoint, a prespecified composite Alzheimer’s Disease (CADS) endpoint with a prespecified p-value of p<0.1.
- Additional clinical data and biomarker data announced in December, 2023 showed statistically significant improvements in the following clinical and biomarker endpoints in specific Lomecel-B™ groups compared to placebo, as follow:
- Cognitive function improved as measured by Montreal Cognitive Assessment (MoCA) (p<0.05);
- Daily life activity increased as assessed by the caregiver and measures by Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) (p<0.05);
- Brain MR imaging demonstrated whole brain volume loss slowed accompanied by significant preservation of left hippocampal volume (both p<0.05);
- Brain neuroinflammation as measured by diffuse tensor imaging (DTI) also diminished (p<0.01).
- These results support the therapeutic potential of Lomecel-B™ in the treatment of mild Alzheimer’s disease and provided evidence-based support for further clinical development;
- Company anticipates presenting CLEAR MIND results at major medical meetings in 2024.
Aging-related Frailty
- Company has discontinued its clinical trial in
Japan to evaluate Lomecel-B™ for Aging-related Frailty in order to focus on its strategic priority in HLHS; Longeveron management continues to believe in the potential of Lomecel-B™ in this disease state and will evaluate options for continued development at a future date.
Financial Results for Year Ended
- Revenues, Cost of Revenues and Gross Profit: Revenues for the years ended
December 31, 2023 and 2022 were$0.7 million and$1.2 million , respectively. 2023 revenues decreased$0.5 million , or 42%, when compared to 2022 as a result of decreased grant and lower participant demand for our Bahamas Registry Trial. Grant revenue for the years endedDecember 31, 2023 and 2022 was less than$0.1 million and$0.3 million , respectively. The decrease of$0.2 million , or 85%, when compared to 2022, was primarily due to a reduction in grant funds available due in part to the completion of the grant-funded clinical trials. Clinical trial revenue, which is derived from the Bahamas Registry Trial, for the years endedDecember 31, 2023 and 2022 was$0.7 million and$0.9 million , respectively. Clinical trial revenue for the year endedDecember 31, 2023 decreased by$0.2 million , or 29%, when compared to 2022 as a result of decreased participant demand. - Related cost of revenues: Cost of revenues was
$0.5 million and$0.7 million for the years endedDecember 31, 2023 and 2022, respectively. The decrease of$0.2 million , or 33%, was primarily due to the decrease in the revenues earned from the Bahamas Registry Trials and reduced direct costs associated with our grants program. This resulted in a gross profit of approximately$0.2 million for the year endedDecember 31, 2023 , a decrease of$0.3 million , or 56%, when compared with a gross profit of$0.5 million for 2022. - General and Administrative Expense: General and administrative expenses for the year ended
December 31, 2023 increased to approximately$11.4 million , compared to$8.1 million for the same period in 2022. The increase of approximately$3.3 million , or 40%, was primarily related to an increase of$1.6 million for compensation and benefit expenses (including$0.4 million of separation costs),$1.0 million in legal, professional and consulting fees,$0.4 million of public company expenses,$0.2 million in equity-based compensation costs allocated to general and administrative expenses, and$0.1 million for higher board fees. - Research and Development Expenses: Research and development expenses for the year ended
December 31, 2023 decreased to approximately$9.1 million , from approximately$9.4 million for the same period in 2022. The decrease of$0.3 million , or 3%, was primarily due to decreases of$0.5 million in equity-based compensation allocated to research and development expenses and$0.3 million in compensation and benefits, offset by increases of$0.4 million in supplies and costs to manufacture Lomecel-B™ and$0.2 million in research and development expenses that were not reimbursable by grants. - Selling and Marketing Expenses: Selling and marketing expenses for the years ended
December 31, 2023 and 2022 were$0.8 million and$1.0 million , respectively. The decrease of$0.2 million , or 24%, was primarily due to decreases in investor relations and international development expenses. - Non-operating Lawsuit expense: Non-operating Lawsuit expense for the years ended
December 31, 2023 and 2022 was less than$0.1 million and approximately$1.4 million , respectively. Additional detail can be found in Part I, Item 3 “Legal Proceedings” of this Form 10-K. Legal expenses incurred in ordinary business activities are reported within general and administrative expenses. - Other tax credits: Other tax credits for each of the years ended
December 31, 2023 and 2022 was less than$0.1 million and$0.3 million , respectively. Other tax credit was greater in 2022 due to receiving the Employee Retention Credit under the CARES Act which encourages businesses to keep employees on their payroll. Eligible businesses receive a refundable tax credit of up to 50% of up to$10,000 in wages paid. - Other Expense (Income), net: Other expense for the years ended
December 31, 2023 and 2023 was$0.4 million and$0.8 million , respectively. Other expense for 2023 decreased mainly as a result of non-operating lawsuit expenses of$1.4 million in 2022, compared to less than$0.1 million in 2023. This decrease was partially offset by realized losses on sales of marketable securities of$0.3 million , write-offs of intangible assets of$0.3 million and reduced benefit of tax credits of$0.3 million . Also recorded in other (expense) income in 2022 was approximately$27,000 for a gain resulting from foreign currency changes and$27,000 of sublease rental income. - Net Loss: Net loss increased to approximately
$21.4 million for the year endedDecember 31, 2023 , from a net loss of$18.8 million for the same period in 2022. The increase in the net loss of$2.6 million , or 14%, was for reasons outlined above. - Subsequent events:
- In line with the Company’s 2024 strategic direction to focus its resources on HLHS and AD and to manage its cash spend, the Company decided to discontinue its previously disclosed clinical trial in
Japan to evaluate Lomecel-B™ for Aging-related Frailty. - On
February 21, 2024 , the Company’s stockholders approved an amendment to the Company’s certificate of incorporation to effect a reverse stock split of its outstanding shares of Class A common stock and Class B common stock at a ratio ranging from one-for-five (1:5) to one-for-fifteen (1:15), with the exact ratio to be set within that range at the discretion of its Board of Directors without further approval or authorization of its stockholders. The date of the reverse stock split and the ratio has not yet been determined.
- In line with the Company’s 2024 strategic direction to focus its resources on HLHS and AD and to manage its cash spend, the Company decided to discontinue its previously disclosed clinical trial in
As of
Conference Call and Webcast
Management will host a conference call today at
Title | Longeveron Full Year 2023 Results Conference Call |
Date | |
Time | |
Conference Call Details | 1-877-407-0789 |
Conference ID | 13744350 |
Call me™ Feature | Click Here |
Webcast | Click Here |
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. 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, 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; a history of losses and may not be able to achieve profitability going forward; no FDA-approved allogenic, cell-based therapies for Aging-related Frailty, AD, or other aging-related conditions, nor HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; the use of our product candidates or future products in individuals may expose us to product liability claims, and we may not be able to obtain adequate product liability insurance; if our trade secret and patent position does not adequately 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; 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; 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
Tel: 617-308-4306
Email: mmoyer@lifesciadvisors.com
---tables to follow---
Statements of Operations (In thousands, except per share data) | ||||||||
Years ended | ||||||||
2023 | 2022 | |||||||
Revenues | ||||||||
Grant revenue | $ | 41 | $ | 282 | ||||
Clinical trial revenue | 668 | 940 | ||||||
Total revenues | 709 | 1,222 | ||||||
Cost of revenues | 488 | 725 | ||||||
Gross profit | 221 | 497 | ||||||
Operating expenses | ||||||||
General and administrative | 11,401 | 8,119 | ||||||
Research and development | 9,066 | 9,370 | ||||||
Selling and marketing | 783 | 1,051 | ||||||
Total operating expenses | 21,250 | 18,540 | ||||||
Loss from operations | (21,029 | ) | (18,043 | ) | ||||
Other (expenses) and income | ||||||||
Lawsuit expense | (30 | ) | (1,398 | ) | ||||
Other refundable tax credits | 23 | 306 | ||||||
Other expense (income), net | (377 | ) | 300 | |||||
Total other (expense)s and income, net | (384 | ) | (792 | ) | ||||
Net loss | $ | (21,413 | ) | $ | (18,835 | ) | ||
Deemed dividend attributable to warrant down round feature | (798 | ) | - | |||||
Net loss attributable to common stockholders | $ | (22,211 | ) | $ | (18,835 | ) | ||
Basic and diluted net loss per share | $ | (1.02 | ) | $ | (0.90 | ) | ||
Basic and diluted weighted average common shares outstanding | 21,734,901 | 20,969,032 | ||||||
See accompanying notes to unaudited condensed financial statements.
Condensed Balance Sheets (In thousands, except share and per share data) | ||||||||
2023 | 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 4,949 | $ | 10,503 | ||||
Marketable securities | 412 | 9,155 | ||||||
Prepaid expenses and other current assets | 376 | 404 | ||||||
Accounts and grants receivable | 111 | 218 | ||||||
Total current assets | 5,848 | 20,280 | ||||||
Property and equipment, net | 2,529 | 2,949 | ||||||
Intangible assets, net | 2,287 | 2,409 | ||||||
Operating lease asset | 1,221 | 1,531 | ||||||
Other assets | 193 | 244 | ||||||
Total assets | $ | 12,078 | $ | 27,413 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 638 | $ | 1,751 | ||||
Accrued expenses | 2,152 | 650 | ||||||
Current portion of lease liability | 593 | 564 | ||||||
Estimated lawsuit liability | - | 1,398 | ||||||
Deferred revenue | 506 | 506 | ||||||
Total current liabilities | 3,889 | 4,869 | ||||||
Long-term liabilities: | ||||||||
Lease liability | 1,448 | 2,041 | ||||||
Total long-term liabilities | 1,448 | 2,041 | ||||||
Total liabilities | 5,337 | 6,910 | ||||||
Commitments and contingencies (Note 9) | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, | - | - | ||||||
Class A Common Stock, | 10 | 6 | ||||||
Class B Common Stock, | 15 | 15 | ||||||
Additional paid-in capital | 91,800 | 83,712 | ||||||
Stock subscription receivable | (100 | ) | (100 | ) | ||||
Accumulated deficit | (84,984 | ) | (62,773 | ) | ||||
Accumulated other comprehensive loss | - | (357 | ) | |||||
Total stockholders’ equity | 6,741 | 20,503 | ||||||
Total liabilities and stockholders’ equity | $ | 12,078 | $ | 27,413 | ||||
See accompanying notes to unaudited condensed financial statements.
Source:
2024 GlobeNewswire, Inc., source