Rocket Pharmaceuticals Files 8-K

TL;DR

Rocket Pharma filed an 8-K, likely routine docs, no major news.

AI Summary

Rocket Pharmaceuticals, Inc. filed an 8-K on November 18, 2024, to report on other events and financial statements. The filing does not disclose specific new material events or financial figures but serves as a general update and filing of exhibits.

Why It Matters

This 8-K filing indicates Rocket Pharmaceuticals is providing updates and submitting required financial documents to the SEC.

Risk Assessment

Risk Level: low — The filing is a standard 8-K for reporting other events and exhibits, with no immediately apparent negative or positive material information.

Key Players & Entities

• Rocket Pharmaceuticals, Inc. (company) — Registrant
• November 18, 2024 (date) — Date of Report
• Delaware (jurisdiction) — State of Incorporation
• 001-36829 (file_number) — SEC File Number
• 646-440-9100 (phone_number) — Registrant's telephone number

FAQ

Key Financial Figures

• $0.01 — nge on which registered Common stock, $0.01 par value RCKT The Nasdaq Global Ma

Filing Documents

• ef20038805_8k.htm (8-K) — 40KB
• ef20038805_ex99-1.htm (EX-99.1) — 7KB
• image00006.jpg (GRAPHIC) — 111KB
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• image00008.jpg (GRAPHIC) — 77KB
• image00009.jpg (GRAPHIC) — 67KB
• image00010.jpg (GRAPHIC) — 70KB
• image00011.jpg (GRAPHIC) — 68KB
• image00012.jpg (GRAPHIC) — 75KB
• image00013.jpg (GRAPHIC) — 94KB
• image00014.jpg (GRAPHIC) — 105KB
• image00015.jpg (GRAPHIC) — 83KB
• image00016.jpg (GRAPHIC) — 106KB
• image00017.jpg (GRAPHIC) — 72KB
• image00018.jpg (GRAPHIC) — 55KB
• image00019.jpg (GRAPHIC) — 68KB
• image00021.jpg (GRAPHIC) — 15KB
• 0001140361-24-047166.txt ( ) — 1821KB
• rckt-20241118.xsd (EX-101.SCH) — 4KB
• rckt-20241118_lab.xml (EX-101.LAB) — 21KB
• rckt-20241118_pre.xml (EX-101.PRE) — 16KB
• ef20038805_8k_htm.xml (XML) — 4KB

01

Item 7.01 Regulation FD Disclosure. Attached as Exhibit 99.l to this Current Report on Form 8-K, and incorporated into this Item 7.01 by reference, is an investor presentation (the "Investor Presentation") prepared by Rocket Pharmaceuticals, Inc. (the "Company") providing certain updates on the Company's Danon Disease Program, including certain long-term safety and efficacy results from the Phase 1 RP-A501 study for Danon Disease. The information in this Item 7.01, including Exhibit 99.1 is furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to liabilities under that section, and shall not be deemed to be incorporated by reference into the filings of the Company under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filings. This Current Report on Form 8-K will not be deemed an admission as to the materiality of any information contained in this Item 7.01, including Exhibit 99.1.

01

Item 8.01. Other Events. Danon Disease Phase 1 RP-A501 Update On November 18, 2024, the Company presented long-term safety and efficacy results from the Phase 1 RP-A501 study which showed that RP-A501 was generally well tolerated and all evaluable Danon disease patients demonstrated LAMP2 protein expression at 12 months (sustained up to 60 months) and reduction of left ventricular (LV) mass index by 10% at 12 months (sustained up to 54 months) after treatment. These data were presented today at a Late-Breaking Scientific session at the American Heart Association (AHA) Scientific Sessions 2024 , published in The New England Journal of Medicine (NEJM) and discussed on a company webinar today at 12:00 p.m. ET . The safety and preliminary efficacy of RP-A501 was evaluated in a single-arm, open-label, multi-center Phase 1 study in male patients with Danon disease. Five patients [pediatric (n=2) and adult/adolescent (n=3)] were treated with the low dose (6.7 x 10 13 GC/kg), and 2 adult/adolescent patients were treated with the high dose (1.1 x 10 14 GC/kg). Data from the Phase 1 study (cut-off April 19, 2024) showed that RP-A501 in conjunction with a transient immunomodulatory regimen was generally well tolerated. Most adverse events (AEs) were mild or moderate in severity, assessed as not related to RP-A501, and non-serious. All RP-A501 or immunomodulatory regimen-related AEs were manageable or reversible. One patient had worsening heart failure at baseline (LVEF <40%) attributed to Danon disease and required heart transplantation for cardiomyopathy progression five months after receiving RP-A501. Evidence of sustained clinically meaningful improvement was observed in pediatric patients followed up to 24 months and adult/adolescent patients followed up to 60 months. All evaluable patients in the Phase 1 trial demonstrated: Cardiac LAMP2 protein expression at 12 months and thereafter; Reduction or stabilization of LV mass index – the median reduction from baseline

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Investor Presentation dated November 18, 2024. Exhibit 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: November 18, 2024 Rocket Pharmaceuticals, Inc. By: /s/ Gaurav Shah, MD Name: Gaurav Shah, MD Title: Chief Executive Officer and Director

View Full Filing

View this 8-K filing on SEC EDGAR