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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 14, 2023

 

 

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. ☒

 

 

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Item 2.02	Results of Operations and Financial Condition.

 

On March 14, 2023, Design Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and twelve months ended December 31, 2022. 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 14, 2023
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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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 14, 2023	By:	/s/ João Siffert, M.D.
			João Siffert, M.D. President and Chief Executive Officer

 

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Exhibit 99.1

 

 

 

Design Therapeutics Highlights Pipeline Progress and Reports Fourth Quarter and Full Year 2022 Financial Results

Phase 1 Multiple-Ascending Dose Trial of DT-216 for Friedreich Ataxia Ongoing with Data Expected Mid-Year

Continued Progress Across Pipeline of GeneTACTM Small Molecules with Three Programs Expected to be in Clinical Development in the Next Two Years

Strong Financial Position with $330 Million in Cash and Securities Expected to Support Operating Runway through 2025

 

Carlsbad, Calif., March 14, 2023 – Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today highlighted recent progress and anticipated upcoming milestones across its clinical and research-stage pipeline of novel GeneTAC™ small molecules and reported fourth quarter and full year 2022 financial results.

“We are very proud of the important progress made last year with our novel GeneTAC™ small molecules, which represent a potential new class of therapies for patients suffering from devastating genetic diseases,” said João Siffert, M.D., president and chief executive officer of Design Therapeutics. “The data from the Phase 1 single-ascending dose clinical trial of DT-216 in patients with Friedreich ataxia (FA) showed, for the first time, that our GeneTAC™ small molecule DT-216 could be dosed safely and is capable of overcoming the transcription block for frataxin in individuals with FA. This underscores the potential for DT-216 to address the root cause of the disease. We’re underway with our Phase 1 multiple-ascending dose trial and look forward to evaluating the effects of three doses of DT-216 in people with FA.”

Dr. Siffert continued, “Beyond FA, we further advanced and expanded our earlier-stage pipeline, selecting DT-168 as the development candidate for our second program in FECD and progressing our DM1 program through lead optimization and advancing our discovery portfolio, with the aim of bringing two additional programs into the clinic in the next two years. With a solid cash position to support operations through a steady cadence of milestones ahead, an expert team, and diligent execution, we are well-positioned to deliver on our near- and long-term goals.”

Pipeline Progress and Anticipated Upcoming Milestones

 

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Fourth Quarter and Full Year 2022 Financial Results

 

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. Design is currently evaluating its lead GeneTAC™ small molecule, DT-216, in an ongoing Phase 1 clinical trial in patients with Friedreich ataxia. The company is also advancing programs in Fuchs endothelial corneal dystrophy and myotonic dystrophy type-1. Discovery efforts for multiple other serious degenerative disorders caused by nucleotide repeat expansions are also underway, including for fragile X syndrome, spinocerebellar ataxias, Huntington disease, spinobulbar muscular atrophy, and C9orf72-amyotrophic lateral sclerosis/frontotemporal dementia. 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, preclinical data and early-stage clinical data; the potential benefits of restoring FXN in FA patients; expectations for reporting data for the MAD Phase 1 clinical trial and the timing thereof; the expected initiation of Design’s Phase 2 clinical trial for DT-216 in patients with FA and the timing thereof; Design’s aim to bring two additional programs into the clinic in the next two years; Design’s ability to meet its stated milestones and advance the GeneTACTM platform; Design’s estimated financial runway

 

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and the sufficiency of its resources to support its planned operations; the ability of DT-216 to overcome the transcription block for frataxin in individuals with FA; the potential of DT-216 to address the root cause of FA; Design’s anticipated timeline to submit an IND for DT-168 in the second half of 2023; Design’s anticipated timeline to select a development candidate and submit an IND for its GeneTAC™ program for the treatment of DM1 in 2024; the potential of Design’s GeneTAC™ small molecules to be a new class of therapies for patients suffering from devastating genetic diseases; 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,” “on-track to,” “anticipates,” “aims,” “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 associated with conducting a clinical trial and patient enrollment, which is affected by many factors, and any difficulties or delays encountered with such clinical trial or patient enrollment may delay or otherwise adversely affect Design’s ongoing Phase 1 clinical trials for DT-216; the process of discovering and developing therapies that are safe and effective for use as human therapeutics and operating as a development stage company; Design’s ability to develop, initiate or complete preclinical studies and clinical trials for its product candidates; the risk that promising early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials; changes in Design’s plans to develop its product candidates; uncertainties associated with performing clinical trials, regulatory filings and applications; risks associated with reliance on third parties to successfully conduct clinical trials and preclinical studies; 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 reliance on key third parties, including contract manufacturers and contract research organizations; Design’s ability to obtain and maintain intellectual property protection for its product candidates; Design’s ability to recruit and retain key scientific or management personnel; competition in the industry in which Design operates, which may result in others discovering, developing or commercializing competitive products before or more successfully than Design; and market conditions. 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 September 30, 2022, as filed with the SEC on November 3, 2022, and under the “Risk Factors” heading of Design’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, 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.

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Contact:
Investors:

Chelcie Lister

THRUST Strategic Communications

chelcie@thrustsc.com

 

Media:

Amanda Sellers

Verge Scientific Communications

asellers@vergescientific.com

 

 

 

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DESIGN THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(in thousands)

 

		December 31,				December 31,
		2022				2021
Assets
Current assets:
Cash, cash equivalents and investment securities		$	330,387			$	384,064
Prepaid expense and other current assets			4,732				1,371
Total current assets			335,119				385,435
Property and equipment, net			1,947				1,508
Right-of-use asset, related party			3,612				3,614
Other assets			459				—
Total assets		$	341,137			$	390,557
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	3,025			$	1,620
Accrued expenses and other current liabilities			7,751				3,663
Total current liabilities			10,776				5,283
Operating lease liability, net, related party			3,051				3,144
Total liabilities			13,827				8,427
Total stockholders’ equity			327,310				382,130
Total liabilities and stockholders’ equity		$	341,137			$	390,557

 

 

 

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DESIGN THERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

 

		Quarter Ended December 31,								Year Ended December 31,
		2022				2021				2022				2021
		(unaudited)
Operating expenses:
Research and development		$	14,255			$	7,336			$	48,613			$	24,778
General and administrative			5,137				3,790				18,980				11,053
Total operating expenses			19,392				11,126				67,593				35,831
Loss from operations			(19,392	)			(11,126	)			(67,593	)			(35,831	)
Other income, net			2,052				61				4,285				298
Net loss		$	(17,340	)		$	(11,065	)		$	(63,308	)		$	(35,533	)
Net loss per share, basic and diluted		$	(0.31	)		$	(0.20	)		$	(1.14	)		$	(0.77	)
Weighted-average shares of common stock outstanding, basic and diluted			55,864,872				55,362,390				55,707,517				45,936,235

 

 

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