Scholar Rock Reports Q3 Results, Faces Net Loss

Ticker: SRRK · Form: 10-Q · Filed: Nov 12, 2024 · CIK: 1727196

Sentiment: neutral

Topics: 10-Q, biotechnology, financials, offering

TL;DR

SRRK Q3 results show a net loss, but they've been active with offerings and agreements.

AI Summary

Scholar Rock Holding Corp. reported its third-quarter results for the period ending September 30, 2024. The company's financial statements indicate a net loss for the quarter. Key events include a subsequent event related to an underwriting agreement on October 8, 2024, and an at-market offering during the first nine months of 2024.

Why It Matters

This filing provides insight into Scholar Rock's financial performance and ongoing operational activities, which are crucial for investors assessing the company's future prospects in the biotechnology sector.

Risk Assessment

Risk Level: medium — The company is in the biotechnology sector, which is inherently risky due to long development cycles and high failure rates, and the filing indicates a net loss.

Key Numbers

Key Players & Entities

FAQ

What was Scholar Rock's net loss for the quarter ending September 30, 2024?

The filing indicates a net loss for the quarter, but the specific dollar amount is not provided in this excerpt.

What is the nature of the subsequent event on October 8, 2024?

The subsequent event on October 8, 2024, is related to an underwriting agreement.

What type of offering occurred during the first nine months of 2024?

An 'At-Market Offering' occurred during the period from January 1, 2024, to September 30, 2024.

What is Scholar Rock's state of incorporation?

Scholar Rock Holding Corp. is incorporated in Delaware (DE).

What is the company's primary business sector?

The company's Standard Industrial Classification is 'BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES)'.

Filing Stats: 4,466 words · 18 min read · ~15 pages · Grade level 20 · Accepted 2024-11-12 07:20:28

Key Financial Figures

Filing Documents

– FINANCIAL INFORMATION

PART I – FINANCIAL INFORMATION

Financial Statements (Unaudited)

Item 1. Financial Statements (Unaudited) 5 Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023 5 Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2024 and 2023 6 Consolidated Statements of Stockholders' Equity for the Nine Months Ended September 30, 2024 and 2023 7 Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023 9

Notes to Consolidated Financial Statements

Notes to Consolidated Financial Statements 10

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 20

Quantitative and Qualitative Disclosures About Market Risk

Item 3. Quantitative and Qualitative Disclosures About Market Risk 35

Controls and Procedures

Item 4. Controls and Procedures 35

OTHER INFORMATION

PART II. OTHER INFORMATION

Legal Proceedings

Item 1. Legal Proceedings 36

Risk Factors

Item 1A. Risk Factors 37

Unregistered Sales of Equity Securities and Use of Proceeds

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 85

Defaults Upon Senior Securities

Item 3. Defaults Upon Senior Securities 85

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 85

Other Information

Item 5. Other Information 85

Exhibits

Item 6. Exhibits 86

SIGNATURES

SIGNATURES 87 4 Table of Contents

FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION

. Financial Statements

Item 1 . Financial Statements SCHOLAR ROCK HOLDING CORPORATION CONSOLIDATED BALANCE SHEETS (Unaudited) (In thousands, except share and per share data) September 30, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $ 76,391 $ 101,855 Marketable securities 62,674 178,083 Prepaid expenses and other current assets 13,862 8,256 Total current assets 152,927 288,194 Property and equipment, net 3,156 4,600 Operating lease right-of-use asset 16,834 11,417 Restricted cash 2,407 2,407 Other long-term assets 3,809 4,417 Total assets $ 179,133 $ 311,035 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 4,071 $ 3,465 Accrued expenses 29,260 20,449 Operating lease liability 6,041 7,408 Short-term debt — 1,334 Other current liabilities — 85 Total current liabilities 39,372 32,741 Long-term portion of operating lease liability 10,466 4,392 Long-term debt 50,099 48,684 Total liabilities 99,937 85,817 Commitments and contingencies (Note 9) Stockholders' equity: Preferred stock, $ 0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2024 and December 31, 2023 — — Common stock, $ 0.001 par value; 300,000,000 shares authorized; 80,081,535 and 75,979,495 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 80 76 Additional paid-in capital 935,249 901,471 Accumulated other comprehensive income 128 92 Accumulated deficit ( 856,261 ) ( 676,421 ) Total stockholders' equity 79,196 225,218 Total liabilities and stockholders' equity $ 179,133 $ 311,035 The accompanying notes are an integral part of these consolidated financial statements. 5 Table of Contents SCHOLAR ROCK HOLDING CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (In thousands, except share and per share data)

Notes to Consolidated Financial Statements

Notes to Consolidated Financial Statements (Unaudited) 1. Nature of the Business Scholar Rock Holding Corporation (the "Company") is a late-stage biopharmaceutical company focused on the discovery, development, and delivery of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. As a global leader in transforming growth factor beta ("TGF") superfamily biology, the Company's novel understanding of the molecular mechanisms of growth factor activation enabled the development of a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target the precursor, or latent, forms of growth factors. By targeting the signaling proteins at the cellular level and acting in the disease microenvironment, the Company believes that it may avoid the historical dose-limiting safety challenges associated with inhibiting growth factors for therapeutic effect. The Company's first product candidate, apitegromab, is a highly selective, fully human, monoclonal antibody, with a unique mechanism of action that results in inhibition of the activation of the growth factor, myostatin, in skeletal muscle. Apitegromab is being developed as a potential first muscle-targeted therapy for the treatment of spinal muscular atrophy ("SMA"). The Company is conducting SAPPHIRE, a pivotal Phase 3 clinical trial to evaluate the efficacy and safety of apitegromab in patients with nonambulatory Type 2 and Type 3 SMA. The Company completed enrollment of SAPPHIRE in 2023. In October 2024, the Company announced positive top-line results that showed the study achieved its primary endpoint. Additionally, in 2024, the Company announced data from the Phase 2 TOPAZ trial extension period which showed patient outcomes at 48 months of treatment with apitegromab. The FDA granted Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation to apitegromab for the tr

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