Fulcrum Therapeutics (FULC) Q2 Earnings call transcript Jul 31, 2024
AInvestWednesday, Jul 31, 2024 9:22 pm ET
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Fulcrum Therapeutics held its second quarter 2024 financial results and business update conference call, providing a comprehensive overview of its progress with losmapimod and pociredir, two of its clinical stage assets. The call, led by CEO and President Alex Sapir, was a testament to Fulcrum's commitment to addressing the unmet needs in facioscapulohumeral muscular dystrophy (FSHD) and sickle cell disease.

Losmapimod: A Promising Therapy for FSHD

Losmapimod, an oral small molecule selective T-38 alpha-beta MAP kinase inhibitor, is a potential game-changer for FSHD patients. Fulcrum's collaboration with Sanofi, announced in May 2024, has significantly bolstered the company's efforts to develop and commercialize losmapimod for all territories outside of the U.S. The partnership's strategic alignment with Fulcrum's expertise in FSHD and Sanofi's regulatory and commercial capabilities in neuromuscular markets worldwide is expected to deliver a much-needed therapy for FSHD patients.

The Phase III REACH trial, which is registration-enabling in both the U.S. and ex-U.S. geographies, is on track to report top line data by the end of October. The trial's primary endpoint, the change from baseline in the relative surface area (RSA), has shown promising results, with 98% of patients choosing to enroll in the open-label extension study. The high percentage of patients opting for the open-label phase underscores the significant unmet need for patients with FSHD and the potential of losmapimod to deliver a meaningful improvement in their quality of life.

Pociredir: A Potential Solution for Sickle Cell Disease

Pociredir, an oral HbF inducer, is another promising asset in Fulcrum's pipeline. Given the high unmet need for an oral therapeutic option that is broadly protective of sickle cell disease symptomatology, pociredir's first-in-class status makes it a potentially transformative therapy. The Phase Ib PIONEER trial is progressing, with data expected to be shared in 2025. The trial's focus on evaluating pociredir at different dosages aims to determine its impact on disease severity, paving the way for a potential commercial launch.

Financial Performance and Outlook

Fulcrum's financial performance in the second quarter of 2024 was marked by a cash position of $273.8 million, a significant increase from the previous year. This was largely due to the $80 million upfront payment received from Sanofi. Collaboration revenue for the quarter was $80 million, up from $0.9 million in the previous year. Despite anticipating a loss position for the foreseeable future, Fulcrum's cash runway is expected to be sufficient to fund its operating requirements into 2027.

Conclusion

Fulcrum Therapeutics' second quarter 2024 financial results and business update showcased its strategic progress in developing losmapimod and pociredir. The company's commitment to addressing the unmet needs in FSHD and sickle cell disease, coupled with its partnerships and financial stability, positions Fulcrum for continued growth and innovation in the years ahead. With top line data for the Phase III REACH trial expected by the end of October and the progress of the Phase Ib PIONEER trial, Fulcrum is well on its way to delivering potentially life-changing therapies for patients with FSHD and sickle cell disease.

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