CRSP

EX-99.1

2 crsp-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

CRISPR Therapeutics Provides Business Update and Reports Second Quarter 2026 Financial Results

ZUG, Switzerland and BOSTON, August 3, 2026 – CRISPR Therapeutics (Nasdaq: CRSP) today reported financial results for the second quarter ended June 30, 2026.

"The second quarter reflected strong execution across CRISPR Therapeutics' portfolio and platform," said Samarth Kulkarni, Ph.D., Chairman and Chief Executive Officer of CRISPR Therapeutics. "CASGEVY's momentum continued to build, highlighted by the FDA's approval for children as young as 2 years old, while we expanded our in vivo pipeline with the initiation of Phase 1 clinical trials for CTX340 for refractory hypertension and CTX460 for alpha-1 antitrypsin deficiency. We enter the second half of 2026 well positioned, with a number of important milestones ahead across our pipeline."

Recent Highlights and Outlook

Hemoglobinopathies and CASGEVY® (exagamglogene autotemcel)

CASGEVY is a non-viral, ex vivo, CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT that has been shown to reduce or eliminate vaso-occlusive crises (VOCs) for patients with SCD and transfusion requirements for patients with TDT. CASGEVY is approved in 39 countries across North America, Europe, and the Middle East.

• CASGEVY generated second quarter 2026 revenue of $76 million, representing 78% growth quarter-over-quarter and 151% growth year-over-year.

• The U.S. FDA recently approved CASGEVY in children 2 years of age and older with SCD or TDT, the first genetic therapy indicated for children as young as 2 years for both SCD and TDT. With this approval, achieved in just 53 days post filing, approximately 5,500 patients with SCD or TDT may be eligible for treatment with CASGEVY for the first time. Regulatory submissions have also been completed for CASGEVY in the Kingdom of Saudi Arabia (KSA) and the United Kingdom (U.K.) for the treatment of children 5 to 11 years of age.

• In May, Vertex secured reimbursement for CASGEVY for eligible patients 12 years and older with SCD or TDT in Germany. Efforts remain underway with government and reimbursement authorities globally to ensure sustainable access for eligible patients.

• CRISPR Therapeutics continues to advance its in vivo hematopoietic stem cell editing approach using lipid nanoparticle (LNP)-mediated delivery. This approach has the potential to expand the addressable patient populations for SCD and TDT.

In Vivo Liver Editing

CRISPR Therapeutics continues to advance a diversified portfolio of in vivo gene editing programs leveraging its proprietary liver-directed LNP delivery platform.

• Development of CTX310®, an investigational therapy targeting angiopoietin-related protein 3 (ANGPTL3), continues in a Phase 1b clinical trial, with the Company prioritizing indications in severe hypertriglyceridemia (sHTG) and refractory hypercholesterolemia. U.S. trials have been initiated, with ex-U.S. trials ongoing.

• CRISPR Therapeutics announced that a late-breaking abstract entitled "Durability of Effects of CTX310, a CRISPR-Cas9 Gene Editing Targeting ANGPTL3" has been accepted for presentation at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany, on August 28 at 4:30 p.m. CET to discuss a clinical update of the ongoing Phase 1a trial. The Company also expects to provide a Phase 1b clinical update in the second half of 2026.

• CTX340™, targeting angiotensinogen (AGT), has received IND clearance from the FDA. The Company has initiated a Phase 1 clinical trial for patients with refractory hypertension.

• CTX460™, targeting SERPINA1 for the treatment of alpha-1 antitrypsin deficiency (AATD), is the first investigational candidate generated from the Company's SyNTase™ editing platform. The Company has initiated a Phase 1 clinical trial for CTX460.

• CRISPR Therapeutics' pipeline of preclinical in vivo gene editing candidates includes CTX321™, the Company's next-generation LPA program, which is progressing through IND/CTA-enabling studies. The candidate incorporates an optimized guide RNA that delivered approximately two-fold greater potency in preclinical models, paired with the same LNP delivery system used previously. An Lp(a) program update is anticipated in 2026.

siRNA-based Programs

CRISPR Therapeutics' small interfering RNA (siRNA)-based portfolio includes clinical-stage programs targeting cardiovascular and thromboembolic diseases, developed in collaboration with Sirius Therapeutics.

• CTX611 (SRSD107), a long-acting siRNA therapeutic targeting Factor XI (FXI), is advancing through a Phase 2 clinical trial in patients undergoing total knee arthroplasty (TKA). The Company expects to provide an update in the second half of 2026.

• CTX611 has the potential to address a broad range of thromboembolic and clotting-related indications, including atrial fibrillation (AF), venous thromboembolism (VTE), ischemic stroke, cancer-assoc

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8-K

0001674416false00-000000000016744162026-02-122026-02-12

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 12, 2026

CRISPR THERAPEUTICS AG

(Exact name of registrant as specified in its charter)

Switzerland

001-37923

Not Applicable

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

Baarerstrasse 14

6300 Zug, Switzerland

Not Applicable

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: 41 (0)41 561 32 77

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Shares, nominal value CHF 0.03

CRSP

The NASDAQ Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On February 12, 2026, CRISPR Therapeutics AG announced its financial results for the quarter and year ended December 31, 2025 and other business highlights. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Form 8-K (including Exhibit 99.1) 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 the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibits: The following exhibits shall be deemed to be furnished, and not filed:

Exhibit No.

Description

99.1

Press Release by CRISPR Therapeutics AG, dated February 12, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

CRISPR Therapeutics AG

Date:

February 12, 2026

By:

/s/ Samarth Kulkarni

Samarth Kulkarni, Ph.D. Chief Executive Officer