Item 1.01. Entry Into a Material Definitive Agreement.
Amendment No. 4 to Loan and Security Agreement
On May 17, 2024 (the “Effective Date”), Scholar Rock Holding Corporation (the “Company” or “we”) and Scholar Rock, Inc., a wholly-owned subsidiary of the Company (“Scholar Rock” and collectively with the Company, the “Borrower”), entered into the Fourth Amendment (“Loan Amendment No. 4”) to the Loan and Security Agreement, dated October 16, 2020, by and with Oxford Finance LLC and Silicon Valley Bank (each, a “Lender” and collectively, the “Lenders”).
Pursuant to the Loan Agreement, we previously received $50 million in loan proceeds under the Loan Agreement. Pursuant to Loan Amendment No. 4, we and the Lenders agreed to amend the milestones required to access an additional tranche of $25.0 million that is available to us under the Loan Agreement. The fourth tranche is available at our discretion through December 2024, upon achievement of certain clinical and business milestones. Loan Amendment No. 4 also extended the interest-only payment period for an additional six months through May 2025, with principal payments to commence in June 2025, or for an additional six months through November 2025 upon achievement of certain business performance milestones, with principal payments to commence in December 2025.
The foregoing description of Loan Amendment No. 4 does not purport to be complete and is qualified in its entirety by reference to Loan Amendment No. 4, which we intend to file as an exhibit to our Form 10-Q for the fiscal quarter ending June 30, 2024.
Item 7.01. Regulation FD Disclosure.
On May 22, 2024, the Company will hold its previously announced “Investor Day” event beginning at 8:30 a.m. ET. During the event, representatives of the Company will, among other things, provide a business update, including the initiation of the Phase 2 EMBRAZE trial of apitegromab in obesity and provide new preclinical data for SRK-439 in obesity. A copy of the press release relating to the Investor Day event is attached hereto as Exhibit 99.1 and a copy of the presentation slides to be used by the Company during the Investor Day event and webcast is attached hereto as Exhibit 99.2. A live webcast of the Investor Day event may be accessed by visiting the Investors & Media section of the Company’s website at http://investors.scholarrock.com. A recording of the webcast will also be available on the Company’s website after the event.
The information in this report furnished pursuant to Item 7.01 and Exhibits 99.1 and 99.2 shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 7.01 and Exhibits 99.1 and 99.2 of this report.
Item 8.01. Other Events.
Phase 2 EMBRAZE Proof-of-Concept Trial
On May 22, 2024, the Company announced the initiation of the Phase 2 EMBRAZE proof-of-concept trial, designed to assess the safety and efficacy of apitegromab, a highly selective myostatin inhibitor, to preserve lean muscle mass in individuals living with obesity and on background therapy of a GLP-1 receptor agonist (GLP-1 RA). The results from this trial will inform the development of SRK-439, a novel investigational selective myostatin inhibitor optimized for the treatment of cardiometabolic disorders, including obesity.
EMBRAZE is a randomized, double-blind, placebo-controlled, Phase 2 proof-of-concept trial evaluating the efficacy, safety and pharmacokinetics of apitegromab in adults with a body mass index (BMI) of >27 (overweight) or a BMI of >30 (obese) and taking a GLP-1 RA (tirzepatide or semaglutide). The target enrollment of EMBRAZE is 100 subjects aged 18-65 who are overweight or obese without diabetes. As part of the study design, the treatment period is 24 weeks, and all subjects will receive a GLP-1 RA. In addition, all subjects will be randomized 1:1 to receive either apitegromab or placebo by intravenous (IV) infusion every four weeks during the 24-week treatment period. The primary endpoint is change from baseline at Week 24 in lean mass assessed by dual-energy X-ray absorptiometry. Secondary endpoints
