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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 10, 2022

 

 

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 10, 2022, Design Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and twelve months ended December 31, 2021. 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 10, 2022
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 10, 2022	By:	/s/ João Siffert, M.D.
			João Siffert, M.D. President and Chief Executive Officer

 

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Exhibit 99.1

 

 

 

 

Design Therapeutics Reports Pipeline and Business Progress and Fourth Quarter and Full Year 2021 Financial Results

Phase 1 Trial of DT-216, a Novel FA GeneTACTM Molecule, in Patients with Friedreich Ataxia On Track to Begin Soon

Preclinical Data Supporting Development of Novel GeneTACTM Small Molecules for the Treatment of Fuchs Endothelial Corneal Dystrophy (FECD) to be Presented at ARVO 2022

Well-Capitalized with $384.1 Million in Cash and Investments at the End of 2021 to Support Upcoming Milestones

 

Carlsbad, Calif., March 10, 2022 – Design Therapeutics, Inc. (Nasdaq: DSGN), a biotechnology company developing treatments for degenerative genetic disorders, today announced pipeline and business progress and reported fourth quarter and full year 2021 financial results.

“This is an exciting time for Design as we continue to progress our pipeline of novel GeneTACTM molecules toward patients, particularly those with limited therapeutic options or no disease modifying treatments available today,” said João Siffert, M.D., president and chief executive officer of Design Therapeutics. “The recent clearance of our IND for DT-216 is a significant milestone for the company, and we're excited to begin our clinical trial in patients with Friedreich ataxia, a genetic, progressive disease that has a life-altering impact. In parallel, we continue to advance our myotonic dystrophy type-1 GeneTACTM molecules toward clinical development, and have recently generated encouraging new data showing that our GeneTACTM molecules may be able to correct the most common underlying genetic cause of Fuchs endothelial corneal dystrophy, a prevalent genetic condition affecting over 1 million people in the United States that can lead to vision loss. 2022 is set to be a meaningful year for Design, with key upcoming milestones and a pipeline comprised of potentially transformative new genomic medicines.”

“Design was founded to address the known monogenic causes of a range of inherited degenerative diseases and now, just two years from launch, is on the cusp of initiating its first clinical trial,” added Pratik Shah, Ph.D., executive chair of Design Therapeutics. “With a highly productive platform, an experienced team and a strong balance sheet in place, the company is well-positioned to advance its robust pipeline to bring forward a new class of treatments for patients living with devastating genetic diseases.”

Recent Pipeline Progress

 

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Upcoming Medical Meeting Presentations

Recent Business Progress

Fourth Quarter and Full Year 2021 Financial Results

 

About Design Therapeutics

Design Therapeutics is a 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’s lead program is focused on the treatment of Friedreich ataxia, followed by a program in myotonic dystrophy type-1 and discovery efforts for multiple other serious degenerative disorders caused by nucleotide repeat expansions. 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, statements related to: the expected initiation of Design’s Phase 1 clinical trial of DT-216 in patients with Friedreich ataxia and the timing thereof; the potential initiation of a clinical trial in patients with myotonic dystrophy type-1 and the timing thereof; the ability of Design's GeneTACTM molecules to correct the most common underlying genetic cause of Fuchs endothelial corneal dystrophy; the potential advancement of Design’s pipeline and ability to bring forward a new class of treatments for patients living with devastating genetic diseases; and the potential advantages of these GeneTAC™ programs. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such

 

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forward-looking statements. Words such as "believes," “designed to,” "anticipates," “planned,” "expects," “estimate,” "intends," "will," "goal," "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 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; 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, 2021, as filed with the SEC on November 9, 2021, and under the “Risk Factors” heading of Design’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, which is being filed with the SEC on March 10, 2022. 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:

Rachel Ford Hutman

Ford Hutman Media

rachel@fordhutmanmedia.com

 

 

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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,
		2021				2020				2021				2020
		(unaudited)
Revenue:
Grant revenue		$	—			$	33			$	—			$	226
Operating expenses:
Research and development			7,336				2,708				24,778				6,060
General and administrative			3,790				1,186				11,053				2,496
Total operating expenses			11,126				3,894				35,831				8,556
Loss from operations			(11,126	)			(3,861	)			(35,831	)			(8,330	)
Other income, net			61				6				298				50
Net loss		$	(11,065	)		$	(3,855	)		$	(35,533	)		$	(8,280	)
Net loss per share, basic and diluted		$	(0.20	)		$	(0.24	)		$	(0.77	)		$	(0.52	)
Weighted-average shares of common stock outstanding, basic and diluted			55,362,390				15,925,284				45,936,235				15,796,674

 

 

 

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DESIGN THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(in thousands)

		December 31,				December 31,
		2021				2020
Assets
Current assets:
Cash, cash equivalents and investment securities		$	384,064			$	36,091
Prepaid expense and other current assets			1,371				142
Total current assets			385,435				36,233
Property and equipment, net			1,508				71
Right-of-use asset, related party			3,614				—
Deferred offering costs			—				212
Total assets		$	390,557			$	36,516
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable		$	1,620			$	1,399
Accrued expenses and other current liabilities			3,663				931
Total current liabilities			5,283				2,330
Operating lease liability, net, related party			3,144				—
Other long-term liabilities			—				145
Total liabilities			8,427				2,475
Convertible preferred stock			—				45,356
Total stockholders’ equity (deficit)			382,130				(11,315	)
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)		$	390,557			$	36,516

 

 

 

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