Form 8-K

8-K — Design Therapeutics, Inc.

Accession: 0001193125-26-187012

Filed: 2026-04-28

Period: 2026-04-28

CIK: 0001807120

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Regulation FD Disclosure

Documents

8-K — dsgn-20260428.htm (Primary)

EX-99.1 (dsgn-ex99_1.htm)

EX-99.2 (dsgn-ex99_2.htm)

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8-K

8-K (Primary)

Filename: dsgn-20260428.htm · Sequence: 1

8-K

false000180712000018071202026-04-282026-04-28

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): April 28, 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 April 28, 2026, Design Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended March 31, 2026. A copy of the press release is attached hereto as Exhibit 99.1.

Item 7.01

Regulation FD Disclosure.

On April 28, 2026, the Company updated its corporate presentation for use in meetings with investors, analysts and others. The presentation is being published on the Company’s website in the Investors—News & Events—Events & Presentations section, and will be accompanied by a recorded narrative. A copy of the updated presentation is attached hereto as Exhibit 99.2.

The information in Items 2.02 and 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 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 April 28, 2026

99.2

Company Presentation

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:

April 28, 2026

By:

/s/ Pratik Shah, Ph.D.

Pratik Shah, Ph.D.

President, Chief Executive Officer and Chairperson

EX-99.1

Filename: dsgn-ex99_1.htm · Sequence: 2

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):

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.

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

•

Pipeline:

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.

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.

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: projections from early-stage programs, nonclinical data and early-stage clinical data; the progression or completion of certain development activities, including the selection of development candidates; the initiation and progression of studies and clinical trials for DT-216P2, DT-168 and DT-818 and the timing thereof; the anticipated timing for data readouts; the potential attributes and potential best-in-disease profile of DT-818; establishing clinical proof of concept for any product candidate; Design's ability to advance the GeneTAC® platform; Design’s estimated cash runway and the sufficiency of its resources to support its planned operations; and the capabilities and potential advantages of Design’s pipeline of GeneTAC® molecules. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “designed to,” “anticipates,” “capable of,” “plans to,” “expects,” “estimate,” “intends,” “will,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Design’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with: the data we observe from early clinical and nonclinical studies may impact our clinical development plans; pursuing a biomarker-driven clinical development strategy carries increased risks as there are currently a limited number of approved biomarker-specific therapies; nonclinical development

activities and results of nonclinical studies; conducting a clinical trial and patient enrollment and retention, which are affected by many factors, and any difficulties or delays encountered with such clinical trial or patient enrollment or retention may delay or otherwise adversely affect Design’s clinical development plans; the process of discovering and developing therapies that are safe and effective for use as human therapeutics and operating as a development stage company; undesirable side effects or other undesirable properties, which could cause Design or regulatory authorities to suspend or discontinue clinical trials and thereby delay or prevent Design’s product candidates’ development or regulatory approval; Design’s ability to develop, initiate or complete nonclinical studies and clinical trials for its product candidates on the timeframe anticipated, or at all; whether promising early research or clinical trials will result in demonstrated safety and/or efficacy in later clinical trials; changes in Design’s plans to develop its product candidates; reliance on third parties to successfully conduct clinical trials and nonclinical studies; competitive products, which may make any products we develop or seek to develop obsolete or noncompetitive; Design’s reliance on third parties, including contract manufacturers and contract research organizations; Design’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; Design’s ability to obtain and maintain intellectual property protection for its product candidates; and Design’s ability to recruit and retain key scientific or management personnel. For a more detailed discussion of these and other factors, please refer to Design’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of Design’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC on March 9, 2026, and under the “Risk Factors” heading of Design’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, being filed with the SEC later today. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Design undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

# # #

Contact:

Renee Leck, THRUST

renee@thrustsc.com

DESIGN THERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

Three Months Ended March 31,

2026

2025

(unaudited)

Operating expenses:

Research and development

14,379

15,377

General and administrative

5,327

5,041

Total operating expenses

19,706

20,418

Loss from operations

(19,706

)

(20,418

)

Other income, net

2,070

2,703

Net loss

(17,636

)

(17,715

)

Net loss per share, basic and diluted

(0.29

)

(0.31

)

Weighted-average shares of common stock outstanding, basic and diluted

61,434,457

56,757,827

DESIGN THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(in thousands)

March 31,

December 31,

2026

2025

(unaudited)

Assets

Current assets:

Cash, cash equivalents and investment securities

222,823

219,845

Prepaid expenses and other current assets

4,226

3,939

Total current assets

227,049

223,784

Property and equipment, net

824

981

Right-of-use asset

2,569

1,438

Total assets

230,442

226,203

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

2,276

2,312

Accrued expenses and other current liabilities

7,914

10,743

Total current liabilities

10,190

13,055

Operating lease liability

2,198

645

Total liabilities

12,388

13,700

Total stockholders’ equity

218,054

212,503

Total liabilities and stockholders’ equity

230,442

226,203

EX-99.2

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EX-99.2

Exhibit 99.2

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-Subsection 2

+ Details

Name:

dei_EntityExTransitionPeriod

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

Former Legal or Registered Name of an entity

+ References

No definition available.

+ Details

Name:

dei_EntityInformationFormerLegalOrRegisteredName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

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Data Type:

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Balance Type:

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