REGENXBIO Q3 Update: $574.8M Cash, R&D Spends Rise

TL;DR

REGENXBIO has $574.8M cash, R&D up to $54.2M in Q3. AbbVie & Novartis deals ongoing.

AI Summary

REGENXBIO Inc. filed its 10-Q for the period ending September 30, 2024. The company reported cash, cash equivalents, and marketable securities totaling $574.8 million as of September 30, 2024. Research and development expenses for the third quarter of 2024 were $54.2 million, compared to $49.6 million for the same period in 2023. The filing also references collaborations with AbbVie and Novartis Gene Therapies.

Why It Matters

This filing provides insight into REGENXBIO's financial health and operational spending, crucial for investors assessing the company's progress in developing gene therapies.

Risk Assessment

Risk Level: medium — The company operates in the highly competitive and capital-intensive biotechnology sector, with significant R&D expenses and reliance on partnerships.

Key Numbers

• $574.8M — Cash, Cash Equivalents, and Marketable Securities (As of September 30, 2024, indicating financial liquidity.)
• $54.2M — R&D Expenses (For the three months ended September 30, 2024, showing investment in pipeline development.)
• $49.6M — R&D Expenses (For the three months ended September 30, 2023, for year-over-year comparison.)

Key Players & Entities

• REGENXBIO Inc. (company) — Filer of the 10-Q
• $574.8 million (dollar_amount) — Cash, cash equivalents, and marketable securities as of September 30, 2024
• $54.2 million (dollar_amount) — Research and development expenses for Q3 2024
• $49.6 million (dollar_amount) — Research and development expenses for Q3 2023
• AbbVie (company) — Collaboration partner
• Novartis Gene Therapies (company) — Collaboration partner
• September 30, 2024 (date) — End of reporting period

FAQ

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share RGNX The Nasdaq Global Se

Filing Documents

• rgnx-20240930.htm (10-Q) — 2170KB
• rgnx-ex10_1.htm (EX-10.1) — 99KB
• rgnx-ex10_2.htm (EX-10.2) — 144KB
• rgnx-ex31_1.htm (EX-31.1) — 12KB
• rgnx-ex31_2.htm (EX-31.2) — 12KB
• rgnx-ex32_1.htm (EX-32.1) — 11KB
• img183429381_0.jpg (GRAPHIC) — 139KB
• 0000950170-24-122330.txt ( ) — 10091KB
• rgnx-20240930.xsd (EX-101.SCH) — 1355KB
• rgnx-20240930_htm.xml (XML) — 1928KB

—FINANCIAL INFORMATION

PART I—FINANCIAL INFORMATION Item 1.

Financial Statements (Unaudited)

Financial Statements (Unaudited) 3 Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023 3 Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2024 and 2023 4 Consolidated Statements of Stockholders' Equity for the Three and Nine Months Ended September 30, 2024 and 2023 5 Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023 7

Notes to Consolidated Financial Statements

Notes to Consolidated Financial Statements 8 Item 2.

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

Management's Discussion and Analysis of Financial Condition and Results of Operations 25 Item 3.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 35 Item 4.

Controls and Procedures

Controls and Procedures 35

—OTHER INFORMATION

PART II—OTHER INFORMATION Item 1.

Legal Proceedings

Legal Proceedings 36 Item 1A.

Risk Factors

Risk Factors 36 Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities 36 Item 3. Defaults Upon Senior Securities 36 Item 4. Mine Safety Disclosures 36 Item 5. Other Information 36 Item 6. Exhibits 37

Signatures

Signatures 38 Table of Contents INFORMATION REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as "anticipate," "assume," "believe," "continue," "could," "design," "estimate," "expect," "forecast," "goal," "intend," "may," "objective," "plan," "position," "potential," "predict," "project," "seek," "should," "will," "would" or variations of such words or by similar expressions. We have based these forward-looking statements on our current expectations, estimates and assumptions and analyses in light of our experience and our perception of historical trends, current conditions and expected future developments, as well as other factors we believe are appropriate under the circumstances. However, whether actual results and developments will conform with our expectations and predictions is subject to a number of risks, uncertainties, assumptions and other important factors, including, but not limited to: our ability to establish and maintain development partnerships, including our collaboration with AbbVie to develop and commercialize ABBV-RGX-314; our ability to obtain and maintain regulatory approval of our product candidates and the labeling for any approved products; the timing of enrollment, commencement, completion and the success of our AAVIATE , AFFINITY BEYOND , AFFINITY DUCHENNE , ALTITUDE , ASCENT, ATMOSPHERE and CAMPSIITE clinical trials; the timing of commencement and completion and the success of preclinical studies conducted by us and our development partners; the timely development and launch of new products; the scope, progress, expansion and cos

– FINANCI AL INFORMATION

PART I – FINANCI AL INFORMATION

Financi al Statements

Item 1. Financi al Statements. REGENXBIO INC. CONSOLIDATED BALANCE SHEETS (unaudited) (in thousands, except per share data) September 30, 2024 December 31, 2023 Assets Current assets Cash and cash equivalents $ 56,617 $ 34,522 Marketable securities 198,843 240,736 Accounts receivable, net 23,604 24,790 Prepaid expenses 11,002 14,520 Other current assets 23,330 20,403 Total current assets 313,396 334,971 Marketable securities 23,108 38,871 Accounts receivable 404 701 Property and equipment, net 120,551 132,103 Operating lease right-of-use assets 55,293 60,487 Restricted cash 2,030 2,030 Other assets 4,332 4,807 Total assets $ 519,114 $ 573,970 Liabilities and Stockholders' Equity Current liabilities Accounts payable $ 19,522 $ 22,786 Accrued expenses and other current liabilities 48,642 49,703 Deferred revenue 144 148 Operating lease liabilities 7,720 7,068 Liability related to sale of future royalties 26,697 50,567 Total current liabilities 102,725 130,272 Operating lease liabilities 76,342 82,222 Liability related to sale of future royalties 35,052 43,485 Other liabilities 3,579 6,249 Total liabilities 217,698 262,228 Stockholders' equity Preferred stock; $ 0.0001 par value; 10,000 shares authorized, no shares issued and outstanding at September 30, 2024 and December 31, 2023 — — Common stock; $ 0.0001 par value; 100,000 shares authorized at September 30, 2024 and December 31, 2023; 49,534 and 44,046 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 5 4 Additional paid-in capital 1,182,956 1,021,214 Accumulated other comprehensive loss ( 582 ) ( 4,429 ) Accumulated deficit ( 880,963 ) ( 705,047 ) Total stockholders' equity 301,416 311,742 Total liabilities and stockholders' equity $ 519,114 $ 573,970 T

View Full Filing

View this 10-Q filing on SEC EDGAR