DSGN

EX-99.1

2 dsgn-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Design Therapeutics Announces First Quarter 2026 Financial Results and Recent Business Updates

Additional Detail Provided for RESTORE-FA (DT-216P2) Trial Design, Dosing and Endpoints

David Shapiro, M.D., Appointed to Board of Directors, Strengthening Clinical and Regulatory Expertise

Cash and Securities of $222.8 Million at Quarter-End Provide Runway to Support Ongoing Clinical Execution

Carlsbad, Calif., April 28, 2026 - Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today reported first quarter 2026 financial results and highlighted business updates and upcoming milestones across its GeneTAC® portfolio.

“The first quarter was marked by continued operational execution across our portfolio as we progress our clinical programs, including our ongoing RESTORE-FA multiple ascending dose trial evaluating DT-216P2,” said Pratik Shah, Ph.D., chairperson and chief executive officer of Design Therapeutics. “DT-216P2 is designed to restore endogenous frataxin, with the potential to address the underlying cause of Friedreich ataxia and deliver a differentiated therapeutic approach. We believe our GeneTAC® platform represents a novel way to modulate gene expression, with the potential to unlock new therapeutic opportunities across a broad range of rare genetic diseases. We are also pleased to welcome David Shapiro, M.D., to our Board, where his experience will support the continued advancement of our clinical programs.”

Corporate Highlights

• Friedreich Ataxia (FA):

o Design continues to dose FA patients in its RESTORE-FA trial, a Phase 1/2 multiple ascending dose study of DT-216P2 over four- or 12-week treatment periods to evaluate safety, pharmacokinetics and biomarker endpoints assessing changes in endogenous frataxin (FXN) mRNA and protein levels in whole blood and muscle biopsy samples. Exploratory clinical endpoints include the modified Friedreich Ataxia Rating Scale (mFARS), Upright Stability Score, and PROMIS Fatigue Scale.

o Design anticipates providing an update on the effect of DT-216P2 on endogenous frataxin levels in the second half of 2026.

• Pipeline:

o Fuchs Endothelial Corneal Dystrophy (FECD): A Phase 2 biomarker trial of DT-168 is ongoing to evaluate safety, tolerability and corneal endothelium biomarkers in FECD patients who are scheduled for corneal transplant surgery, with data anticipated in the second half of 2026.

o Myotonic Dystrophy Type-1 (DM1): Design expects to begin dosing DM1 patients in its Phase 1 multiple-ascending dose (MAD) trial of DT-818, a GeneTAC® small molecule designed to selectively reduce transcription of the mutant DMPK allele, in the first half of 2026. The study, with results anticipated in 2027, is expected to assess safety and correction of mis-splicing.

o Huntington’s disease (HD): Design continues to advance preclinical characterization of several candidate molecules for its Huntington’s disease program.

• Board of Directors: In March 2026, Design appointed David Shapiro, M.D., to its board of directors. Dr. Shapiro has extensive biopharmaceutical experience, including serving as Chief Medical Officer and Head of R&D at Intercept Pharmaceuticals, where he advanced therapies through clinical development and regulatory approval, and as a member of multiple boards of directors.

First Quarter 2026 Financial Results

• R&D Expenses: Research and development (R&D) expenses were $14.4 million for the quarter ended March 31, 2026.

• G&A Expenses: General and administrative (G&A) expenses were $5.3 million for the quarter ended March 31, 2026.

• Net Loss: Net loss was $17.6 million for the quarter ended March 31, 2026.

• Cash Position and Operating Runway: Cash, cash equivalents and investment securities were $222.8 million as of March 31, 2026, which the company expects to fund its planned operations into 2029.

About Design Therapeutics

Design Therapeutics is a clinical-stage biotechnology company developing a new class of therapies based on its platform of GeneTAC® gene targeted chimera small molecules. The company’s GeneTAC® molecules are designed to either dial up or dial down the expression of a specific disease-causing gene to address the underlying cause of disease. In addition to its clinical-stage GeneTAC® programs, DT-216P2, in development for patients with Friedreich ataxia, DT-168, for Fuchs endothelial corneal dystrophy, and DT-818, for myotonic dystrophy type-1, the company is advancing a program in Huntington’s disease. Discovery efforts are underway for multiple genomic medicines. For more information, please visit designtx.com.

Forward-Looking Statements

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: p

8-K

false000180712000018071202026-03-092026-03-09

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): March 09, 2026

Design Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-40288

82-3929248

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

6005 Hidden Valley Road Suite 110

Carlsbad, California

92011

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (858) 293-4900

N/A

(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 Stock, $0.0001 par value per share

DSGN

Nasdaq Global Select 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 March 9, 2026, Design Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and twelve months ended December 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1.

The information in this Item and the exhibit attached hereto are being furnished and 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 they be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, whether filed before or after the date hereof and regardless of any general incorporation language in such filing.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release of Design Therapeutics, Inc. dated March 9, 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.

Design Therapeutics, Inc.

Date:

March 9, 2026

By:

/s/ Pratik Shah, Ph.D.

Pratik Shah, Ph.D. President, Chief Executive Officer and Chairperson

8-K

0001807120false00018071202025-11-052025-11-05

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): November 05, 2025

Design Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-40288

82-3929248

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

6005 Hidden Valley Road Suite 110

Carlsbad, California

92011

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (858) 293-4900

N/A

(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 Stock, $0.0001 par value per share

DSGN

Nasdaq Global Select 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 November 5, 2025, Design Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 2025. A copy of the press release is attached hereto as Exhibit 99.1.

The information in this Item and the exhibit attached hereto are being furnished and 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 they be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, whether filed before or after the date hereof and regardless of any general incorporation language in such filing.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release of Design Therapeutics, Inc. dated November 5, 2025

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.

Design Therapeutics, Inc.

Date:

November 5, 2025

By:

/s/ Pratik Shah, Ph.D.

Pratik Shah, Ph.D. President, Chief Executive Officer and Chairperson