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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): November 09, 2021

 

 

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 November 9, 2021, Design Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 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 November 9, 2021
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:	November 9, 2021	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 Progress and Third Quarter 2021 Results

Clinical Initiation of Lead GeneTACTM Program for Friedreich Ataxia On-track for the First Half of 2022

 

Carlsbad, CA, Nov. 9, 2021 – Design Therapeutics, Inc. (Nasdaq: DSGN), a biotechnology company developing treatments for degenerative genetic disorders, today reported recent pipeline progress and third quarter 2021 financial results.

 

“At Design, our mission is to bring a new class of small-molecule genomic medicines to patients with inherited degenerative diseases. We’ve taken major strides toward achieving our goals, with advancements across our pipeline and GeneTACTM platform, and expansion of our leadership team to support our expected near-term transition to a clinical-stage organization,” said João Siffert, M.D., president and chief executive officer of Design Therapeutics. “We expect 2022 will be a milestone-rich and transformational year for the company, including initiation of the clinical program in Friedreich ataxia, progress with our myotonic dystrophy type-1 GeneTACTM program, and expansion of our pipeline with several earlier stage programs that represent exciting opportunities to treat additional diseases caused by nucleotide repeat expansions.”

 

Recent Pipeline Highlights

 

 

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Upcoming Investor Conference Presentations

Third Quarter 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 GeneTACTM molecules are designed to either turn on or turn off 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 progress and expected timing of Design’s development programs and any clinical trials; expected timing for initial topline data; the effectiveness of Design’s GeneTACTM program in the treatment of Friedreich ataxia and myotonic dystrophy type-1; the potential advantages of these GeneTACTM programs; Design’s continued growth, including the expected expansion of our pipeline and the timing thereof; and the strength of Design’s balance sheet and the adequacy of cash on hand. 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," “on track,” "plans," "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, developing and commercializing 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, obtain approvals for and commercialize any of 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; preliminary or expected results; changes in Design’s plans to develop and commercialize its product candidates; the risk that Design may not obtain approval to market 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; changes in Design’s plans to develop and commercialize its product candidates; 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

 

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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. 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:
Chelcie Lister

THRUST Strategic Communications

(910) 777-3049

chelcie@thrustsc.com

 

 

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DESIGN THERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(unaudited)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2021				2020				2021				2020
Revenue:
Grant revenue		$	—			$	20			$	—			$	193
Operating expenses:
Research and development			8,539				1,914				17,441				3,352
General and administrative			2,798				489				7,263				1,310
Total operating expenses			11,337				2,403				24,704				4,662
Loss from operations			(11,337	)			(2,383	)			(24,704	)			(4,469	)
Other income, net			19				63				236				44
Net loss		$	(11,318	)		$	(2,320	)		$	(24,468	)		$	(4,425	)
Net loss per share, basic and diluted		$	(0.21	)		$	(0.09	)		$	(0.57	)		$	(0.17	)
Weighted-average shares of common stock outstanding, basic and diluted			55,155,030				25,701,737				42,759,656				25,606,779

 

 

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DESIGN THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(in thousands)

(unaudited)

		September 30,				December 31,
		2021				2020
		(unaudited)
Assets
Current assets:
Cash, cash equivalents and investment securities		$	393,718			$	36,091
Prepaid expense and other current assets			1,572				142
Total current assets			395,290				36,233
Property and equipment, net			1,320				71
Right-of-use asset			3,743				—
Deferred offering costs			—				212
Total assets		$	400,353			$	36,516
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable		$	2,216			$	1,399
Accrued expenses and other current liabilities			3,289				931
Total current liabilities			5,505				2,330
Operating lease liability, net			3,273				—
Other long-term liabilities			11				145
Total liabilities			8,789				2,475
Convertible preferred stock			—				45,356
Total stockholders’ equity (deficit)			391,564				(11,315	)
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)		$	400,353			$	36,516

 

 

 

 

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