Scholar Rock(US:SRRK)2025-11-14 12:15Financial Performance - The company reported a net loss of $287.0 million for the nine months ended September 30, 2025, with an accumulated deficit of $1.2 billion[96]. - The net loss for the three months ended September 30, 2025, was $102.2 million, representing a 58.5% increase from a net loss of $64.5 million in 2024[108]. - The company reported a net loss of $287.0 million for the nine months ended September 30, 2025, which is a 59.6% increase from a net loss of $179.8 million in 2024[114]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $224.5 million, compared to $151.4 million for the same period in 2024[127][129]. - Cash and cash equivalents increased to $286.8 million as of September 30, 2025, compared to $177.9 million at the end of 2024[122]. - The total cash, cash equivalents, and marketable securities decreased by $67.6 million during the nine months ended September 30, 2025, primarily due to operating expenses[122]. Research and Development - Apitegromab achieved its primary endpoint in the pivotal Phase 3 SAPPHIRE clinical trial for SMA, with positive top-line results announced in October 2024[88]. - Over 90% of patients in the Phase 2 TOPAZ trial for apitegromab remained on treatment at 48 months, showing sustained clinical benefit[89]. - The FDA granted priority review designation for the Biologics License Application (BLA) for apitegromab, indicating potential significant improvement in treatment for SMA[88]. - The company plans to initiate dosing of SRK-439 in healthy volunteers in Q4 2025, following FDA clearance of its investigational new drug application[93]. - In the Phase 2 EMBRAZE trial, patients receiving apitegromab with tirzepatide showed a 54.9% preservation of lean mass compared to tirzepatide alone (p=0.001)[93]. - Research and development expenses are expected to remain substantial as the company progresses its clinical development programs[101]. - The company expects continued substantial research and development expenses driven by employee compensation and clinical program development, particularly for apitegromab and SRK-439[111]. - The company expects substantial expenses related to the research and development of apitegromab and other product candidates[135]. Operating Expenses - For the three months ended September 30, 2025, total operating expenses increased by 59.8% to $103.6 million compared to $64.8 million in the same period of 2024[108]. - Research and development expenses for the three months ended September 30, 2025, were $50.5 million, up 3.6% from $48.7 million in 2024[109]. - General and administrative expenses surged by 230.4% to $53.1 million for the three months ended September 30, 2025, compared to $16.1 million in 2024[112]. - For the nine months ended September 30, 2025, research and development expenses totaled $161.6 million, an increase of 20.4% from $134.2 million in 2024[115]. - General and administrative expenses for the nine months ended September 30, 2025, were $131.2 million, up 170.4% from $48.5 million in 2024[118]. Future Outlook - The company continues to build its commercialization capabilities to support future product sales and marketing activities[96]. - The company expects to incur significant commercialization expenses related to the marketing approval and sales of apitegromab[132]. - The company anticipates that existing cash and marketable securities will fund operations into 2027, but additional capital will be required for clinical development and commercialization[133]. - The company will continue to rely on additional financing to achieve business objectives, with potential dilution of common stockholder ownership interests[136]. Capital and Financing - As of September 30, 2025, the company has sold 3,386,290 shares under the ATM program, generating net proceeds of $96.9 million[123]. - Net cash provided by investing activities was $179.7 million for the nine months ended September 30, 2025, up from $119.3 million in 2024[130]. - Net cash provided by financing activities was $155.1 million for the nine months ended September 30, 2025, significantly higher than $6.7 million in 2024[131]. - The company had 17,362,147 pre-funded warrants outstanding as of September 30, 2025, with none exercised during the nine months ended[125]. - The company had 8,220,620 common warrants outstanding with an exercise price of $7.35, which expire on December 31, 2025[126].