BALA CYNWYD, PA — Larimar Therapeutics, Inc. (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its fourth quarter and full year 2022 operating and financial results.
“Our recent progress provides a strong foundation for growth as we work to develop CTI-1601 as the first FA therapy designed to potentially address frataxin deficiency, which is the underlying cause of the disease,” said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. “The first cohort of our Phase 2 trial is fully enrolled, with an update that will outline the next steps for the trial anticipated in the second quarter. We also recently strengthened our balance sheet and leadership team with a financing and the appointment of long-time Johnson & Johnson veteran Dr. Gopi Shankar as our Chief Development Officer. Looking forward, we believe these accomplishments, together with our Phase 1 proof-of-concept data, leave us well positioned to build on our positive momentum as we seek to improve the therapeutic paradigm for patients with FA, who remain in need of a therapy that may address the root cause of the disease by increasing frataxin levels.”<
2022 and Subsequent Highlights
- Larimar recently completed enrollment in the 25 mg cohort of a Phase 2, four-week, placebo-controlled, dose exploration trial of CTI-1601 in participants with FA. The trial was cleared to begin enrollment in this first cohort in September 2022, when the U.S. Food and Drug Administration (FDA) lifted the full clinical hold previously placed on the CTI-1601 program and imposed a partial hold. The initiation of additional cohorts in the Phase 2 trial and/or the initiation of other clinical trials of CTI-1601 are contingent on a review of the Phase 2 trial’s 25 mg cohort data by its independent data monitoring committee (IDMC) and the FDA. Larimar expects to provide an update on the next steps for the Phase 2 trial in Q2 2023, after it receives feedback from the FDA and IDMC on their review of data from the trial’s 25 mg cohort. Top-line safety, pharmacokinetic, and pharmacodynamic (e.g., frataxin level) data from both cohorts of the Phase 2 trial are expected in 2H 2023.
- In September 2022, Larimar raised net proceeds of approximately $75.2 million through an underwritten offering of common stock, with Deerfield Management and other notable life science investors participating in the offering.
- In October 2022, Larimar announced the issuance of U.S. Patent No. 11,459,363, which provides composition of matter protection for CTI-1601 into at least July 2040.
- In February 2023, Larimar strengthened its leadership team with the appointment of Gopi Shankar, PhD, MBA, FAAPS, to the newly created position of Chief Development Officer. In this role, Dr. Shankar is responsible for the strategic development of Larimar’s clinical and R&D programs. Dr. Shankar joined Larimar with more than 20 years of experience leading the development of novel biologics, most recently serving as Vice President and Global Head, Biologics Development Sciences at Janssen Research & Development (a pharmaceutical company of Johnson & Johnson, Inc.).
Fourth Quarter and Full Year 2022 Financial Results
As of December 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $118.4 million.
The Company reported a net loss for the fourth quarter of 2022 of $9.4 million, or $0.21 per share, compared to a net loss of $9.1 million, or $0.50 per share, for the fourth quarter of 2021.
Research and development expenses for the fourth quarter of 2022 were $7.2 million compared to $6.3 million for the fourth quarter of 2021. The increase in research and development expenses compared to the prior year period was primarily driven by an increase of $1.8 million in clinical costs associated with the ongoing Phase 2 trial, an increase of $0.4 million in personnel expense, an increase of $0.3 million associated with the license milestone achievement in Q4 2022 and an increase of $0.1 million in non-cash, stock-based compensation expense associated with stock option grants made in 2022, partially offset by a decrease of $0.5 million in drug manufacturing costs, a decrease of $0.4 million in consulting expenditures, a decrease of $0.4 million in nonclinical development costs and a decrease of $0.3 million in internal lab costs.
General and administrative expenses for the fourth quarter of 2022 were $3.2 million compared to $2.8 million for the fourth quarter of 2021. The increase in general and administrative expense was primarily driven by an increase of $0.2 million in legal fees associated with the new ATM agreement and patent work performed during Q4 2022, an increase of $0.2 million in personnel expense primarily associated with an employee severance agreement, partially offset by a decrease of $0.2 million in operational costs primarily related to technology and recruiting services.
For the full year 2022, the Company reported a net loss of $35.4 million, or $1.37 per share, compared to a net loss of $50.6 million, or $2.95 per share for the same period in 2021.
Research and development expenses for the full year 2022 were $24.3 million compared to $38.4 million for the same period in 2021. The decrease in research and development expenses was primarily driven by a decrease of $9.5 million in drug manufacturing costs, a decrease of $3.7 million in nonclinical development costs, a decrease of $1.6 million in clinical expense, a decrease of $0.9 million in consulting expenditures, and a decrease of $0.7 million in internal lab costs. These decreases were partially offset by an increase of $1.2 million in personnel expense, an increase of $0.7 million in non-cash, stock-based compensation expense associated with stock option grants made in 2021 and 2022 and an increase of $0.3 million in royalty fees associated with the milestone achieved in 2022.
General and administrative expenses for the full year 2022 were $12.2 million compared to $12.1 million for the same period in 2021. The increase in general and administrative expense was primarily driven by an increase of $0.5 million in stock-based compensation expense associated with stock option grants made in 2021 and 2022 and an increase of $0.5 million in personnel expense, partially offset by a decrease of $0.6 million in operational costs primarily related to technology and recruiting services and a decrease of $0.2 million in professional fees primarily associated with legal and consulting expense.
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