Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today reported its financial results for the quarter and full year ended December 31, 2020 and provided a business update.
Primary Accomplishments in 2020:
Received approval from U.S. Food and Drug Administration (FDA) to proceed with Phase 1 clinical trial for Acute Respiratory Distress Syndrome (ARDS) related to either COVID-19 or Influenza infection. This trial initiated in mid-2020 and continues to enroll subjects.
Received a $650,000, two-year Maryland Stem Cell Research Fund TEDCO Grant Award for ARDS COVID-19/Influenza Phase 1 trial.
Treated two COVID-19-related ARDS subjects with Lomecel-B infusion under FDA-approved expanded access (“compassionate use”) protocol.
Lomecel-B approved for Phase 2 Aging Frailty clinical trial by Japanese Pharmaceutical and Medical Devices Agency (PMDA) through a Clinical Trial Notification (CTN) application filed by Japan’s National Center for Geriatrics & Gerontology.
Successfully completed Phase 1 trial in subjects with Alzheimer’s Disease. Preliminary top-line results were included in the Company’s S-1 Registration Statement filed with the SEC in February 2021. Final results will be announced in the second quarter of 2021, and a Phase 2 trial is expected to commence in the second half of 2021.
Lomecel-B Phase 2 HLHS program awarded a $4.5M multiyear grant award from the National Heart, Lung and Blood Institute (NHLBI).
Revenue increased in 2020 from both grants and clinical trial (Bahamas Registry Trial) revenue sources, compared to 2019.
Highlights from Q1 2021:
Completed $29.1 million Initial Public Offering, including partial exercise of over-allotment, and concurrent listing on Nasdaq.
Successfully completed 150 subject Phase 2b clinical study of Lomecel-B infusion for Aging Frailty, with top-line trial results anticipated in the third quarter of 2021.
Successfully completed Phase 1 clinical study of Lomecel-B intramyocardial injection in Hypoplastic Left Heart Syndrome (HLHS) subjects, with full results expected in the second quarter of 2021, and Phase 2 trial expected to commence in second half of 2021.
Granted expanded access (“compassionate use”) approval by the U.S. FDA for the administration of Lomecel-B to a child with HLHS. Lomecel-B was administered peri-operatively via intramyocardial injection, and the child was discharged from the hospital and is currently being followed per protocol.
Expanded enrollment criteria for the Phase 1 ARDS “RECOVER” trial to include mild ARDS, in addition to moderate and severe ARDS.
Expanded and amended the exclusive license agreement (ELA) related to Lomecel-B technology rights with the University of Miami (UM) and entered into a Cooperative Research and Development Agreement (CRADA) with UM.
Fourth Quarter Ended December 31, 2020 and 2019
Revenue: Total revenue, consisting of revenue from grants and clinical trials (from our Bahamas Registry Trial) was $1.2 million for the fourth quarter of 2020, compared to revenue of $1.8 million for the fourth quarter of 2019. This decrease was a result of a decrease in grant revenue of $0.8 million for 2020 as compared to the same period in 2019, which was expected and is a function of the pre-planned timing of release of funds according to the terms of the various grants. Revenue from our Bahamas Registry Trial increased by $0.3 million or 119% for 2020 as compared to the same period in 2019; despite international travel being severely negatively impacted by COVID-19.
R&D Expenses: Research and development expenses were $1.2 million for the fourth quarter of 2020, compared to $0.3 million for the fourth quarter of 2019. The increase was primarily due to an increase in research and development expenses that were not reimbursable by grants.
G&A Expenses: General and administrative expenses were $0.7 million for the fourth quarter of 2020 and 2019, respectively.
Net Loss: Net loss was $1.4 million for the fourth quarter of 2020, compared to $0.5 million for the fourth quarter of 2019.
Years Ended December 31, 2020 and 2019
Revenue: Total revenue, consisting of revenue from grants, clinical trials (from our Bahamas Registry Trial), and contract manufacturing, was $5.6 million for the years ended December 31, 2020, and 2019. Grant revenue was $4.3 million for the year ended December 31, 2020, compared to $4.1 million for the year ended December 31, 2019. Revenue from the Bahamas Registry Trial was $1.3 million for the year ended December 31, 2020, compared to $1.2 million for the year ended December 31, 2019. Contract manufacturing revenue was $0.1 million for the year ended December 31, 2020, compared to $0.3 million for the year ended December 31, 2019. This decrease was primarily due to COVID-19 related decrease in travel, which restricted the business development and marketing of these services.
R&D Expenses: Research and development expenses were $2.7 million for the year ended December 31, 2020, compared to $1.8 million for the year ended December 31, 2019. The increase was primarily due to an increase in research and development expenses that were not reimbursable by grants. We expect that our research and development expenses will increase in the future as we increase our headcount to support increased research and development activities relating to our clinical programs, as well as incur additional expenses related to our clinical trials.
G&A Expenses: General and administrative expenses were $2.7 million for the year ended December 31, 2020, compared to $2.8 million for the year ended December 31, 2019. Expenses remained relatively consistent for 2020 compared to 2019; general and administrative expenses consisted primarily of rent, professional fees, insurance, and paid and accrued compensation costs. We expect that our general and administrative expenses will increase in the future as we increase our headcount to support increased administrative activities relating to our becoming a public company. We also expect to incur additional expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with Nasdaq and SEC requirements; director and officer insurance costs; and investor and public relations costs.
Net Loss: Net loss was $3.7 million for the year ended December 31, 2020, compared to $3.0 million for the year ended December 31, 2019.
Cash: Cash as of December 31, 2020 was $0.8 million, compared to $1.9 million as of December 31, 2019.
Financial Outlook
Our cash in the first quarter of 2021 was increased by the $29.1 million (gross) in funds received from our IPO. As of March 30, 2021, our cash position was $24.5 million. We believe, based on the current operating plan and financial resources, that our existing cash on hand will be sufficient to cover expenses and capital requirements through at least the fourth quarter of 2022.
Conference Call and Webcast
Management will host a conference call today at 8:30 a.m. Eastern Time to discuss its fiscal 2020 financial results and provide a business update.
The conference call will be available via telephone by dialing toll free 1-855-979-6654 for U.S. callers or +44 20-3936-2999 for international callers and using entry code 094408. You may also pre-register for the event. A webcast of the call may be accessed here or on the Company’s website at https://www.longeveron.com/.
An audio replay of the of the call will be available through April 6, 2021 and can be accessed here and by entering the access code: 40245, and will remain online for one year through March 30, 2022.
https://finance.yahoo.com/news/longeveron-provides-corporate-reports-fourth-110000659.html
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