STOCK TITAN

Design Therapeutics Q3 net loss widens to $20.3M

Quarter-end cash, cash equivalents and investment securities were $208.608 million; DT-216P2 updates are expected in Q4 2026 and Q1 2027.

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Sentiment and the balance of points

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Form Type
8-K

Rhea-AI Filing Summary

Design Therapeutics, Inc. reported financial results for the three and nine months ended September 30, 2026. For the quarter, research and development expenses were $16.926 million versus $14.589 million in 2025, general and administrative expenses were $5.304 million versus $4.722 million, and net loss was $20.288 million versus $16.997 million. Nine-month net loss was $58.089 million, compared with $53.795 million.

Cash, cash equivalents and investment securities were $208.608 million as of September 30, 2026. The Phase 1/2 RESTORE-FA trial of DT-216P2 is ongoing; an update on registrational plans is expected in Q4 2026, with data following 12 weeks of treatment expected in Q1 2027. The Phase 1 multiple-ascending dose trial of DT-818 and Phase 2 biomarker trial of DT-168 are ongoing, with data anticipated in 2027. Design continues preclinical characterization of candidate molecules for Huntington’s disease.

0 points · 0 major

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Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 1 point

How the balance works

Positive

  • None.

Negative

  • Moderate pointQuarterly net loss rose to $20.288 million from $16.997 million; nine-month net loss was $58.089 million, compared with $53.795 million.
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Research and development expenses $16.926 million Three months ended September 30, 2026
General and administrative expenses $5.304 million Three months ended September 30, 2026
Net loss $20.288 million Three months ended September 30, 2026
Net loss $58.089 million Nine months ended September 30, 2026
Cash, cash equivalents and investment securities $208.608 million As of September 30, 2026
Net loss per share, basic and diluted $0.32 per share loss Three months ended September 30, 2026
Weighted-average common shares outstanding, basic and diluted 63,035,529 shares Three months ended September 30, 2026
GeneTAC® technical
"GeneTAC® gene targeted chimera small molecules"
multiple ascending dose medical
"Phase 1/2 multiple ascending dose RESTORE-FA trial"
A multiple ascending dose is a method used in testing new medicines where small groups of people receive gradually larger amounts of the drug over time. This approach helps researchers find the safest and most effective dose without causing too many side effects. For investors, it signals ongoing steps in drug development that can impact a company's potential success or approval prospects.
registrational plans regulatory
"an update on its registrational plans"
corneal endothelium biomarkers medical
"safety, tolerability and corneal endothelium biomarkers"
mutant DMPK allele medical
"selectively reduce transcription of the mutant DMPK allele"
A mutant DMPK allele is a faulty copy of the DMPK gene that carries a structural change causing it to produce abnormal instructions for cells, often leading to myotonic dystrophy type 1. Investors should care because this genetic defect defines the patient population, drives the scientific rationale for diagnostic tests and therapies, and strongly influences clinical trial design, regulatory hurdles, and potential market size; think of it as a corrupted blueprint that determines who needs a fix.
Research and development expenses $16.926 million from $14.589 million in the three months ended September 30, 2025
General and administrative expenses $5.304 million from $4.722 million in the three months ended September 30, 2025
Net loss $20.288 million from $16.997 million in the three months ended September 30, 2025
Nine-month net loss $58.089 million from $53.795 million in the nine months ended September 30, 2025

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were DSGN's nine-month R&D and G&A expenses in 2026?

For the nine months ended September 30, 2026, research and development expenses were $47.693 million, versus $45.704 million in 2025, and general and administrative expenses were $16.420 million, versus $15.594 million.

What were DSGN's third-quarter loss per share and weighted-average shares?

For the three months ended September 30, 2026, basic and diluted net loss per share was $0.32, versus $0.30 in 2025. Weighted-average common shares outstanding, basic and diluted, were 63,035,529, compared with 56,950,999.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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0001807120false00018071202026-11-042026-11-04

 

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 04, 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 November 4, 2026, Design Therapeutics, Inc. issued a press release announcing its financial results for the three and nine months ended September 30, 2026. 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 4, 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:

November 4, 2026

By:

/s/ Pratik Shah, Ph.D.

 

 

 

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

 


Exhibit 99.1

img267412975_0.jpg

 

 

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

DT-216P2 Anticipated Milestones: Registrational Plan Update in Q4 2026 and 12-Week RESTORE-FA Data in Q1 2027

Cash and securities of $208.6 million at quarter-end provide strong financial runway

 

Carlsbad, Calif., November 4, 2026 - Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today reported third quarter 2026 financial results and highlighted business updates and upcoming milestones across its GeneTAC® portfolio.

 

“We remain focused on evaluating DT-216P2 over longer treatment durations and preparing for the next stage of clinical development in Friedreich ataxia,” said Pratik Shah, Ph.D., chairperson and chief executive officer of Design Therapeutics. “In DM1, our Phase 1 trial of DT-818 is evaluating an approach designed to selectively reduce transcription of the mutant DMPK allele, targeting the source of toxic RNA. Clinical readouts expected in 2027 will help guide these programs as we pursue our vision for the GeneTAC® platform: to address the underlying causes of serious genetic diseases and deliver meaningful benefits for patients.”

 

Corporate Highlights

•
Friedreich ataxia (FA): The Phase 1/2 multiple ascending dose RESTORE-FA trial of DT-216P2 is ongoing. Design expects to provide an update on its registrational plans in the fourth quarter of 2026, with data following 12 weeks of treatment expected in the first quarter of 2027.
•
Myotonic Dystrophy Type-1 (DM1): The 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 patients with DM1, is ongoing. Design anticipates reporting data from this trial in 2027.
•
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 expected in 2027.
•
Huntington’s disease (HD): Design continues to advance preclinical characterization of several candidate molecules for its Huntington’s disease program.

 

Third Quarter 2026 Financial Results

•
R&D Expenses: Research and development (R&D) expenses were $16.9 million for the quarter ended September 30, 2026.
•
G&A Expenses: General and administrative (G&A) expenses were $5.3 million for the quarter ended September 30, 2026.

 


 

•
Net Loss: Net loss was $20.3 million for the quarter ended September 30, 2026.
•
Cash Position: Cash, cash equivalents and investment securities were $208.6 million as of September 30, 2026.

 

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: the progression or completion of certain development activities; 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 and other program updates; 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; interactions with regulatory authorities; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as filed with the SEC on August 3, 2026, and under the “Risk Factors” heading of Design’s Quarterly Report on Form 10-Q for the quarter ended September 30, 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 September 30,

 

 

Nine Months Ended September 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

 

 

(unaudited)

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

16,926

 

 

$

14,589

 

 

$

47,693

 

 

$

45,704

 

General and administrative

 

 

5,304

 

 

 

4,722

 

 

 

16,420

 

 

 

15,594

 

Total operating expenses

 

 

22,230

 

 

 

19,311

 

 

 

64,113

 

 

 

61,298

 

Loss from operations

 

 

(22,230

)

 

 

(19,311

)

 

 

(64,113

)

 

 

(61,298

)

Other income, net

 

 

1,942

 

 

 

2,314

 

 

 

6,024

 

 

 

7,503

 

Net loss

 

$

(20,288

)

 

$

(16,997

)

 

$

(58,089

)

 

$

(53,795

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.32

)

 

$

(0.30

)

 

$

(0.93

)

 

$

(0.95

)

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

 

 

63,035,529

 

 

 

56,950,999

 

 

 

62,330,974

 

 

 

56,856,779

 

 

 


 

DESIGN THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(in thousands)

 

 

September 30,

 

 

December 31,

 

 

 

2026

 

 

2025

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash, cash equivalents and investment securities

 

$

208,608

 

 

$

219,845

 

Prepaid expenses and other current assets

 

 

5,355

 

 

 

3,939

 

Total current assets

 

 

213,963

 

 

 

223,784

 

Property and equipment, net

 

 

573

 

 

 

981

 

Right-of-use asset

 

 

2,272

 

 

 

1,438

 

Total assets

 

$

216,808

 

 

$

226,203

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,078

 

 

$

2,312

 

Accrued expenses and other current liabilities

 

 

10,675

 

 

 

10,743

 

Total current liabilities

 

 

12,753

 

 

 

13,055

 

Operating lease liability

 

 

1,859

 

 

 

645

 

Total liabilities

 

 

14,612

 

 

 

13,700

 

Total stockholders’ equity

 

 

202,196

 

 

 

212,503

 

Total liabilities and stockholders’ equity

 

$

216,808

 

 

$

226,203

 

 

 


Filing Exhibits & Attachments

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