Lumos Pharma Q2 2024 Financial Results and Clinical Development Update

Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company focused on rare diseases, recently announced its financial results for the quarter ending June 30, 2024, along with updates on its clinical programs. The company is making significant strides in the development of LUM-201, a potential oral treatment for moderate Pediatric Growth Hormone Deficiency (PGHD). 

Rick Hawkins, Chairman and CEO of Lumos Pharma, highlighted the positive progress following an End of Phase 2 Meeting with the FDA. The company is finalizing its proposal for a Phase 3 double-blind, placebo-controlled clinical trial involving approximately 150 subjects, with a 2:1 randomization ratio. This trial design, influenced by FDA feedback, recognizes LUM-201's mechanism as a growth hormone secretagogue and supports a placebo-controlled trial as a suitable approach. The finalization of the Phase 3 trial design is expected in the fourth quarter, with trial initiation anticipated in the second quarter of 2025. 

During the second quarter, Lumos Pharma presented new analyses from the OraGrowtH212 Trial at ENDO 2024. These analyses suggest that LUM-201 can enhance the natural pulsatile secretion of growth hormone, producing growth comparable to injectable recombinant human growth hormone (rhGH) but with significantly less circulating hormone exposure. The data also indicate that LUM-201 has a durable effect, sustaining annualized height velocity over 24 months, unlike what has been observed with injectable growth hormone in historical studies. This supports the company’s strategy for the upcoming placebo-controlled Phase 3 trial.

Lumos Pharma is also working with Piper Sandler & Co. to explore strategic opportunities to maximize shareholder value as they advance the LUM-201 platform. 

In terms of financial performance for Q2 2024, Lumos Pharma ended the quarter with cash, cash equivalents, and short-term investments totaling $16.8 million, down from $36.0 million on December 31, 2023. The company is managing its cash resources carefully and expects to support operations into the first quarter of 2025. 

Research and development expenses for the quarter were $4.6 million, a decrease of $1.4 million compared to the same period in 2023. This reduction was primarily due to lower contract manufacturing and personnel-related expenses. General and administrative expenses also decreased to $3.7 million, down by $0.5 million from the same period in 2023, mainly due to reductions in personnel-related, travel, and consulting expenses. The net loss for the quarter was $7.6 million, compared to a net loss of $8.9 million in the same quarter of the previous year. 

Lumos Pharma had 8,123,186 shares outstanding at the end of Q2 2024. 

Lumos Pharma is dedicated to transforming the ~$4.7 billion global growth hormone market from injectable to oral therapy with their lead candidate, LUM-201. Currently in multiple Phase 2 clinical studies for PGHD, LUM-201 has received Orphan Drug Designation in both the US and EU.

Lumos Pharma continues to advance its mission to develop and commercialize therapeutics for rare diseases, driven by a management team with extensive experience in drug development for rare conditions. The company remains optimistic about the potential of LUM-201 to become the first oral therapy for PGHD and continues to work towards achieving positive clinical outcomes.

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