Longeveron(US:LGVN)2024-11-12 21:05FINANCIAL INFORMATION Condensed Financial Statements The unaudited statements show significant asset growth from financing, increased revenue, and a narrowed net loss for the period Condensed Balance Sheet Highlights (in thousands) | Account | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $22,778 | $4,949 | | Total current assets | $23,767 | $5,848 | | Total assets | $29,909 | $12,078 | | Total current liabilities | $3,100 | $3,889 | | Total liabilities | $4,282 | $5,337 | | Total stockholders' equity | $25,627 | $6,741 | Condensed Statement of Operations Highlights (in thousands) | Metric | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $773 | $150 | $1,789 | $646 | | Gross profit | $682 | $54 | $1,354 | $223 | | Loss from operations | $(4,649) | $(5,161) | $(12,241) | $(15,589) | | Net loss | $(4,419) | $(5,106) | $(11,892) | $(15,385) | | Net loss per share | $(0.34) | $(2.79) | $(2.71) | $(7.29) | Condensed Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,495) | $(15,005) | | Net cash (used in) provided by investing activities | $(517) | $6,622 | | Net cash provided by (used in) financing activities | $28,841 | $(153) | | Change in cash and cash equivalents | $17,829 | $(8,536) | - The company has a history of recurring losses, with a net loss of $11.9 million for the first nine months of 2024 and an accumulated deficit of $105.5 million3132 - A 1-for-10 reverse stock split was effected on March 26, 2024, with all share and per-share data adjusted accordingly34 - A new manufacturing agreement with Secretome Therapeutics generated $0.8 million in revenue in the first nine months of 2024119123 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial results, liquidity, and strategic focus on advancing Lomecel-B™ for HLHS and Alzheimer's disease Introduction and Overview The company is a clinical-stage biotech developing Lomecel-B™ for HLHS and AD, with an accumulated deficit of $105.5 million - The company's lead investigational product is Lomecel-B™, an allogeneic Medicinal Signaling Cell (MSC) formulation for HLHS, AD, and Aging-related Frailty144145 - As of September 30, 2024, the company had an accumulated deficit of $105.5 million and expects to continue generating operating losses147 - Existing cash is expected to fund operations through Q4 2025, but accelerated HLHS program activities will require additional financing148 Clinical Development Strategy and Pipeline The core strategy is advancing Lomecel-B™ for HLHS and AD, supported by positive clinical data and FDA designations - The ELPIS II (Phase 2b) trial for HLHS is ongoing and considered pivotal by the FDA, potentially supporting a BLA submission for full approval if positive151158 - The CLEAR MIND (Phase 2a) trial for Alzheimer's disease met its primary safety endpoint, earning FDA RMAT and Fast Track designations155158163 - The clinical trial in Japan for Aging-related Frailty has been discontinued to conserve resources for the HLHS and AD programs158 Results of Operations Revenue grew significantly and net loss narrowed due to a new manufacturing contract and reduced R&D spending Q3 2024 vs. Q3 2023 Financial Comparison (in thousands) | Metric | Q3 2024 | Q3 2023 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Revenues | $773 | $150 | $623 | 415% | | Net Loss | $(4,419) | $(5,106) | $687 | -13% | Nine Months 2024 vs. 2023 Financial Comparison (in thousands) | Metric | Nine Months 2024 | Nine Months 2023 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Revenues | $1,789 | $646 | $1,143 | 177% | | Net Loss | $(11,892) | $(15,385) | $3,493 | -23% | - The increase in revenue was primarily driven by a new manufacturing services contract ($0.6M in Q3) and increased demand in the Bahamas Registry Trial180181 - Research and development expenses for the nine months ended Sep 30, 2024 decreased by 11% to $6.1 million, mainly due to lower costs for the completed Alzheimer's trial191192 Liquidity and Capital Resources Recent financing extended the cash runway through Q4 2025, but additional funds are needed for accelerated HLHS program activities - As of September 30, 2024, the company had cash and cash equivalents of $22.8 million and working capital of $20.7 million199 - In July and September 2024, the company raised gross proceeds of approximately $15.4 million through warrant exercises and a registered direct offering200204207208 - The company is actively seeking financing and has implemented cost-saving measures, including discontinuing its Aging-related Frailty trial in Japan200214 Quantitative and Qualitative Disclosures About Market Risk There have been no material changes in market risk exposure from those disclosed in the 2023 Annual Report on Form 10-K - No material changes in market risk exposure were reported compared to the disclosures in the 2023 Form 10-K226 Controls and Procedures Management concluded that disclosure controls and procedures were effective, with no material changes to internal controls - Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2024226 - There were no material changes in the company's internal control over financial reporting during the third fiscal quarter of 2024227 OTHER INFORMATION Legal Proceedings The company is not aware of any legal proceedings or material developments that would require disclosure as of the reporting date - As of September 30, 2024, the Company is not aware of any legal proceedings or material developments requiring disclosure227 Risk Factors There have been no material changes to the risk factors from those disclosed in the 2023 Annual Report on Form 10-K - There have been no material changes to the risk factors affecting the Company from those disclosed in the 2023 10-K228 Unregistered Sales of Equity Securities and Use of Proceeds The company repurchased 110,261 shares during the quarter to satisfy tax withholding obligations for vested employee stock units - The company repurchased 110,261 shares at an average price of $2.45 per share during the quarter to satisfy tax withholding obligations for vested employee stock units228 Defaults Upon Senior Securities The company reported no defaults upon senior securities - None229 Mine Safety Disclosures This item is not applicable to the company - Not applicable229 Other Information A board member terminated a Rule 10b5-1 trading plan, under which no shares were sold - On July 10, 2024, board member Rock Soffer terminated his Rule 10b5-1 trading arrangement, under which no shares had been sold230 Exhibits This section lists exhibits filed with the Form 10-Q, including warrants, agreements, and required officer certifications - Exhibits filed include forms of warrants, a securities purchase agreement, the Second Amended and Restated 2021 Incentive Award Plan, and officer certifications234