Longeveron Reports Q2 2024 Financial Results and Business Update

Longeveron Inc., a clinical-stage regenerative medicine biotechnology company, reported its financial results for the quarter ending on June 30, 2024, and provided significant business updates. The company, listed on NASDAQ under the ticker LGVN, is developing cellular therapies to treat severe and chronic aging-related conditions, primarily focusing on their investigational therapy, Lomecel-B™.

Longeveron's CEO, Wa’el Hashad, highlighted the company's progress in advancing Lomecel-B™ as a potential treatment for both Alzheimer’s disease and Hypoplastic Left Heart Syndrome (HLHS). He noted that based on impressive clinical data, the U.S. FDA has granted Lomecel-B™ both the Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for treating mild Alzheimer's disease. The company presented positive data from the Phase 2a CLEAR MIND clinical trial at the Alzheimer’s Association International Conference, reinforcing the therapeutic potential of Lomecel-B™.

For the treatment of HLHS, a rare pediatric congenital heart defect, Longeveron is conducting a Phase 2b clinical trial named ELPIS II, which has reached 70% enrollment, targeting completion by the end of 2024. The trial is in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), and builds on the promising results of the ELPIS I trial where children showed a 100% transplant-free survival rate up to five years of age. Lomecel-B™ has also received Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation from the FDA for the treatment of HLHS.

In Alzheimer's disease research, the full results from the Phase 2a CLEAR MIND clinical trial were presented, showing that patients treated with Lomecel-B™ experienced a slower progression of disease compared to those given a placebo. The trial met its primary safety and secondary efficacy endpoints, demonstrating statistically significant improvements in various clinical and biomarker measures. These results bolster the case for further clinical development of Lomecel-B™ in treating mild Alzheimer’s disease.

The company has also seen corporate developments, including the election of three new board members at its annual meeting. These new members bring extensive industry experience, bolstering Longeveron's leadership team. Additionally, Longeveron has launched a contract development and manufacturing business, projected to generate $4-5 million in annual revenues once fully operational.

Financially, Longeveron reported revenues of $1.0 million for the first half of 2024, a significant increase from $0.5 million in the same period of 2023, primarily driven by greater participant demand in their Bahamas-based Frailty and Cognitive Impairment registry trial. Contract manufacturing revenue also contributed to this increase.

The company managed to reduce its total operating expenses by 22% year-over-year during the first half of 2024. General and administrative expenses decreased to approximately $4.3 million from $5.5 million in 2023, and research and development expenses also saw a reduction, mainly due to the completion of the Phase 2a Alzheimer's disease trial and reduced costs in other areas.

Longeveron raised $15.3 million in gross proceeds through a financing transaction and warrant exercises in July, which is expected to suffice for funding operations through the fourth quarter of 2025. The company’s cash and cash equivalents totaled $12.4 million as of June 30, 2024, bolstered by additional capital raises and warrant exercises.

Overall, Longeveron has made significant strides in advancing its clinical programs and strengthening its financial position, setting a solid foundation for future growth and development in the regenerative medicine space.

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