Design Therapeutics, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 4 November 2026: press release. Guidance figures: 4 kept. The quarter’s numbers.

Key takeaways

R&D expense rose year on year: R&D expense was $16.9 million, against $14.6 million in the third quarter of 2025 and $16.4 million in the second quarter of 2026. Nine-month R&D was $47.7 million against $45.7 million. Source
Net loss widened from prior year: Net loss was $20.3 million, against $17.0 million a year earlier. Diluted EPS was $(0.32) against $(0.30). Nine-month net loss was $58.1 million against $53.8 million. Source
RESTORE-FA trial ongoing: The Phase 1/2 multiple ascending dose RESTORE-FA trial of DT-216P2 is ongoing. The company reports it is evaluating DT-216P2 over longer treatment durations. Source
DM1 Phase 1 trial ongoing: The DT-818 Phase 1 multiple-ascending dose trial is ongoing. The small molecule is designed to selectively reduce transcription of the mutant DMPK allele in patients with DM1. Source
FECD biomarker trial ongoing: A Phase 2 biomarker trial of DT-168 is ongoing in FECD patients scheduled for corneal transplant surgery. It evaluates safety, tolerability and corneal endothelium biomarkers. Source
Total operating expenses rose: Total operating expenses were $22.2 million, against $19.3 million in the third quarter of 2025. Loss from operations equalled total operating expenses for the period. Source
Cash position at quarter-end: Cash, cash equivalents and investment securities were $208.6 million at September 30, 2026. That compares with $207.4 million at June 30, 2026 and $219.8 million at December 31, 2025. Source
Management cites cash runway: The headline says the cash balance provides financial runway. The release gives no duration for that runway. Source

“We remain focused on evaluating DT-216P2 over longer treatment durations and preparing for the next stage of clinical development in Friedreich ataxia”
Pratik Shah, Ph.D., chairperson and chief executive officer of Design Therapeutics

Guidance

Area	Period	Figure	Against last quarter
Registrational plans, Friedreich ataxia (DT-216P2) Source	fourth quarter 2026	fourth quarter of 2026	Kept
RESTORE-FA 12-week data (DT-216P2) Source	first quarter 2027	first quarter of 2027	Kept
Phase 1 MAD data (DT-818, DM1) Source	2027	2027	Kept
Biomarker trial data (DT-168, FECD) Source	2027	2027	Kept

What changed from last quarter

Guidance kept: The timing for the registrational plan update is unchanged at the fourth quarter of 2026 from the prior release. Source
Guidance kept: The timing for RESTORE-FA 12-week data is unchanged at the first quarter of 2027. Source
Guidance kept: DT-168 data timing remains 2027. The prior release's reference to a delay in DT-168 blow-fill-seal supply does not appear in this release. Source

Quarterly results

R&D expense rose year on year: R&D expense was $16.9 million, against $14.6 million in the third quarter of 2025 and $16.4 million in the second quarter of 2026. Nine-month R&D was $47.7 million against $45.7 million. Source
Net loss widened from prior year: Net loss was $20.3 million, against $17.0 million a year earlier. Diluted EPS was $(0.32) against $(0.30). Nine-month net loss was $58.1 million against $53.8 million. Source
Other income declined year on year: Other income, net was $1.9 million, against $2.3 million in the third quarter of 2025 and $2.0 million in the second quarter of 2026. Source
Weighted share count increased: Weighted-average basic and diluted shares were 63,035,529 for the quarter, against 56,950,999 a year earlier. Source

Friedreich ataxia program

RESTORE-FA trial ongoing: The Phase 1/2 multiple ascending dose RESTORE-FA trial of DT-216P2 is ongoing. The company reports it is evaluating DT-216P2 over longer treatment durations. Source
Preparing next clinical stage: Management said the company is preparing the next stage of clinical development in Friedreich ataxia. No design details for that stage are given in the release. Source

“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.”
Pratik Shah, Ph.D., chairperson and chief executive officer of Design Therapeutics

Other GeneTAC programs

DM1 Phase 1 trial ongoing: The DT-818 Phase 1 multiple-ascending dose trial is ongoing. The small molecule is designed to selectively reduce transcription of the mutant DMPK allele in patients with DM1. Source
FECD biomarker trial ongoing: A Phase 2 biomarker trial of DT-168 is ongoing in FECD patients scheduled for corneal transplant surgery. It evaluates safety, tolerability and corneal endothelium biomarkers. Source
Huntington's preclinical work continues: Management said the company continues preclinical characterization of several candidate molecules for its Huntington's disease program. Source

Operating expenses

Total operating expenses rose: Total operating expenses were $22.2 million, against $19.3 million in the third quarter of 2025. Loss from operations equalled total operating expenses for the period. Source
G&A fell from second quarter: G&A expense was $5.3 million, down from $5.8 million in the second quarter of 2026 and up from $4.7 million in the third quarter of 2025. Source
Nine-month G&A higher: Nine-month G&A was $16.4 million against $15.6 million a year earlier. Source

“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”
Pratik Shah, Ph.D., chairperson and chief executive officer of Design Therapeutics

Cash and balance sheet

Cash position at quarter-end: Cash, cash equivalents and investment securities were $208.6 million at September 30, 2026. That compares with $207.4 million at June 30, 2026 and $219.8 million at December 31, 2025. Source
Management cites cash runway: The headline says the cash balance provides financial runway. The release gives no duration for that runway. Source
Equity declined from year-end: Total stockholders' equity was $202.2 million, against $212.5 million at December 31, 2025. Total liabilities were $14.6 million. Source
Payables and lease liability moved: Accounts payable was $2.1 million, down from $3.1 million at June 30, 2026. The operating lease liability was $1.9 million, up from $0.6 million at December 31, 2025. Source

Platform and discovery

Company describes GeneTAC platform: Design describes itself as a clinical-stage biotechnology company developing a new class of therapies based on its GeneTAC gene targeted chimera small molecule platform. Source
Molecules tune gene expression: The company says GeneTAC molecules are designed to either dial up or dial down expression of a specific disease-causing gene. Source
Discovery work underway: The release states that discovery efforts are underway for multiple genomic medicines. Source

Coming up, as management said on 4 November 2026

Registrational plan update due: Management expects to provide an update on DT-216P2 registrational plans in the fourth quarter of 2026. Source
RESTORE-FA 12-week data due: Data after 12 weeks of treatment are expected in the first quarter of 2027. Source
DM1 and FECD data due in 2027: Management anticipates reporting DT-818 data in 2027, and DT-168 biomarker data are expected in 2027. Source

Figures management reported

Figure	Reported
R&D spend Source	$16.9 million (third quarter 2026)
Pipeline milestone Source	Registrational plan update, fourth quarter 2026
Trial readout Source	RESTORE-FA 12-week data, first quarter 2027
Trial readout Source	DT-818 Phase 1 data, 2027
Trial readout Source	DT-168 Phase 2 biomarker data, 2027

Earlier plans management reported on

Not stated: Management refers to a registrational plan update planned for the fourth quarter of 2026. The release does not state progress against it. Source
Delayed: The prior release said DT-168 data timing moved to 2027 because of a delay in the supply of blow-fill-seal eye droppers.
Not stated: Management anticipates reporting DT-818 Phase 1 data in 2027. The release does not state progress against this plan. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

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

Forward-looking statements notice

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.

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

Contacts
Renee Leck, THRUST renee@thrustsc.com
DESIGN THERAPEUTICS, INC.