Larimar Therapeutic Inc

Larimar Therapeutics, Inc. (NASDAQ: LRMR) is a clinical-stage biotechnology company. The Company is focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide (CPP) technology platform. The Company’s lead product candidate, nomlabofusp, is a subcutaneously administered, recombinant fusion protein intended to deliver tissue frataxin (FXN), an essential protein, to the mitochondria of patients with Friedreich's ataxia (FA). FA is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. Its CPP platform, which enables a therapeutic molecule to cross a cell membrane to reach intracellular targets, has the potential to enable the treatment of other rare and orphan diseases.

Recent Business and Financial Updates

• Clinical Development Updates:
  • First Patient Dosed in Open-Label Extension Study: In March 2024, Larimar Therapeutics dosed the first patient in its open-label extension (OLE) study, administering daily subcutaneous injections of 25 mg of nomlabofusp. Participants from the Phase 2 dose exploration study or previous trials of nomlabofusp are eligible for this study. The OLE study will assess safety, tolerability, pharmacokinetics, frataxin levels in peripheral tissues, and other pharmacodynamic markers. Dose escalation depends on FDA review of Phase 2 data and OLE study data. Interim results are anticipated in Q4 2024.
  • Positive Phase 2 Dose Exploration Study Results: In February 2024, Larimar reported positive top-line results from its Phase 2 dose exploration study of nomlabofusp (CTI-1601) in Friedreich’s Ataxia (FA) patients. The study demonstrated that nomlabofusp was generally well-tolerated and showed dose-dependent increases in frataxin levels in skin and buccal cells. Notably, all patients treated with 50 mg achieved frataxin levels in skin cells exceeding 33% of the average level in healthy volunteers, with three patients exceeding 50%. These results reinforce the therapeutic potential of nomlabofusp. 

• Regulatory and Commercial Progress:
  • Biologics License Application and FDA Discussions: Larimar has initiated discussions with the FDA regarding the use of tissue frataxin levels as a novel surrogate endpoint, aiming to pursue an accelerated approval pathway. The FDA acknowledged the critical role of frataxin deficiency in FA pathogenesis and the unmet need for treatments addressing the underlying disease. Larimar plans to submit a Biologics License Application (BLA) in the second half of 2025, supported by data from the OLE study and additional nonclinical pharmacology information.
  • Strengthened Financial Position: In February 2024, Larimar raised net proceeds of approximately USD 161.8 million through a public offering of common stock. This financing increased the Company’s cash, cash equivalents, and marketable securities to USD 239 million as of March 31, 2024, extending the projected cash runway into 2026.
• Recent Corporate Developments:
  • Commercial Team Expansion: In March 2024, Larimar appointed Frank Nazzario, RPh, as Vice President of Commercial. Mr. Nazzario brings nearly 30 years of experience in drug launches for rare diseases. His previous roles include Senior Vice President of Sales at BioCryst Pharmaceuticals, leading the commercialization of Luxturna® at Spark Therapeutics, and launching Cinryze® at ViroPharma, Inc.
• First Quarter 2024 Financial Results:
  • Financial Highlights: As of March 31, 2024, Larimar reported cash, cash equivalents, and marketable securities totaling USD 239 million. The Company raised USD 161.8 million in net proceeds through a public offering of common stock in February 2024.
  • Increased Net Loss: For the first quarter of 2024, Larimar reported a net loss of USD 14.7 million, or USD 0.27 per share, compared to a net loss of USD 6.5 million, or USD 0.15 per share, for the same period in 2023.
  • Research and Development Expenses: Research and development expenses for Q1 2024 were USD 12.9 million, up from USD 4.6 million in Q1 2023. This increase was driven by higher manufacturing costs for nomlabofusp, clinical costs associated with the OLE study, personnel expenses, consulting fees, and stock compensation expenses.
  • General and Administrative Expenses: General and administrative expenses rose to USD 3.8 million in Q1 2024, compared to USD 3.1 million in Q1 2023. The increase was due to higher personnel expenses, legal fees, and stock compensation expenses.

Technical Observation (on the daily chart):

The Relative Strength Index (RSI) over a 14-day period stands upward trending with value of 48.67, with expectations of a consolidation or an upward momentum. Additionally, the stock's current positioning is below both the 50-period SMA and 200-period SMA, which may serve as dynamic short to medium-term resistance levels.

As per the above-mentioned price action, recent key business and financial updates, momentum in the stock over the last month, and technical indicators analysis, a ‘WATCH’ rating has been given to Larimar Therapeutics, Inc. (NASDAQ: LRMR) at the closing market price of USD 7.38 as of May 28, 2024. 

Individuals can evaluate the stock based on the support and resistance levels provided in the report in case of keen interest taking into consideration the risk-reward scenario. 

Markets are trading in a highly volatile zone currently due to certain macro-economic issues and prevailing geopolitical tensions. Therefore, it is prudent to follow a cautious approach while investing.

Related Risk: This report may be looked at from a high-risk perspective and a recommendation is provided for a short duration. This report is solely based on technical parameters, and the fundamental performance of the stocks has not been considered in the decision-making process. Other factors which could impact the stock prices include market risks, regulatory risks, interest rates risks, currency risks, social and political instability risks etc. 

Note 1: Past performance is not a reliable indicator of future performance.

Note 2: The reference date for all price data, currency, technical indicators, support, and resistance level is May 28, 2024. The reference data in this report has been partly sourced from REFINITIV.

Note 3: Investment decisions should be made depending on an individual's appetite for upside potential, risks, holding duration, and any previous holdings. An 'Exit' from the stock can be considered if the Target Price mentioned as per the Valuation and or the technical levels provided has been achieved and is subject to the factors discussed above.

Note 4: Target Price refers to a price level that the stock is expected to reach as per the relative valuation method and or technical analysis taking into consideration both short-term and long-term scenarios.

Note 5: ‘Kalkine reports are prepared based on the stock prices captured either from the New York Stock Exchange (NYSE), NASDAQ Capital Markets (NASDAQ), and or REFINITIV. Typically, all sources (NYSE, NASDAQ, or REFINITIV) may reflect stock prices with a delay which could be a lag of 15-20 minutes. There can be no assurance that future results or events will be consistent with the information provided in the report. The information is subject to change without any prior notice.