UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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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 7, 2024, Design Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 2024. 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. |
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Description |
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99.1 |
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Press Release of Design Therapeutics, Inc. dated November 7, 2024 |
104 |
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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.
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Design Therapeutics, Inc. |
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Date: |
November 7, 2024 |
By: |
/s/ Pratik Shah, Ph.D. |
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Pratik Shah, Ph.D. |
Exhibit 99.1
Design Therapeutics Announces Third Quarter 2024 Financial Results and Reviews Near-term Milestones for GeneTACTM Portfolio
Fuchs Endothelial Corneal Dystrophy (FECD) Phase 1 Trial Initiated with Data Expected in the First Half of 2025
Friedreich Ataxia (FA) Program on Track to Initiate Phase 1 Single Ascending Dose, Healthy Volunteer Study in the First Half of 2025
Active Research Pipeline Advancing with Programs in Myotonic Dystrophy Type-1 (DM1) and Huntington’s Disease (HD)
Well-Capitalized with Cash and Securities of $254.1 Million to Fund Operations Through Up to Four Potential Clinical Proof-of-Concept Data Sets
Carlsbad, Calif., November 7, 2024 - Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today announced its third quarter 2024 financial results and reviewed anticipated upcoming program milestones for its portfolio of GeneTAC™ candidates.
“Thanks to our progress so far this year, the first half of 2025 will be a busy one, with data expected from our ongoing Phase 1 trial in FECD and the start of clinical activities for our FA program,” said Pratik Shah, Ph.D., chairperson and chief executive officer of Design Therapeutics. “We believe these programs lead a pipeline of GeneTAC™ small molecules capable of transforming the status quo in genomic medicines, with the potential for multiple clinical proof-of-concept data sets over the next few years.”
Corporate Highlights and Anticipated Upcoming Milestones
Third Quarter 2024 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. In addition to its lead GeneTAC™ small molecule, DT-216, in development for patients with Friedreich ataxia, the company is advancing programs in Fuchs endothelial corneal dystrophy, Huntington’s disease and myotonic dystrophy type-1. 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 projections from early-stage programs, nonclinical data and early-stage clinical data; the progression or completion of certain development activities, including the selection of development candidates; the initiation and progression of studies and clinical trials for DT-216P2 and DT-168 and the timing thereof; the expected timing for data readouts; Design’s pipeline, including the potential to have four programs with clinical proof-of-concept with Design’s current cash runway; 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,” “on track to,” “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 acceptance of INDs by the FDA or similar applications by foreign regulatory agencies for the conduct of planned clinical trials of our product candidates and our proposed design of future clinical trials; nonclinical development activities and results of nonclinical studies; conducting a clinical trial and patient enrollment, which are 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 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; whether promising early research or clinical
trials will demonstrate safety and/or efficacy in later nonclinical studies or 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 key third parties, including contract manufacturers and contract research organizations; 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; Design’s ability to recruit and retain key scientific or management personnel; 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 June 30, 2024, as filed with the SEC on August 5, 2024, and under the “Risk Factors” heading of Design’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, 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 Strategic Communications
renee@thrustsc.com
DESIGN THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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(unaudited) |
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Operating expenses: |
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Research and development |
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$ |
11,876 |
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$ |
13,257 |
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$ |
32,193 |
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$ |
46,051 |
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General and administrative |
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4,370 |
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5,565 |
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13,496 |
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17,018 |
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Total operating expenses |
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16,246 |
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18,822 |
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45,689 |
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63,069 |
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Loss from operations |
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(16,246 |
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(18,822 |
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(45,689 |
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(63,069 |
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Other income, net |
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3,207 |
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3,033 |
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9,752 |
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8,049 |
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Net loss |
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$ |
(13,039 |
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$ |
(15,789 |
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$ |
(35,937 |
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$ |
(55,020 |
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Net loss per share, basic and diluted |
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$ |
(0.23 |
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$ |
(0.28 |
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$ |
(0.64 |
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$ |
(0.98 |
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Weighted-average shares of common stock outstanding, basic and diluted |
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56,620,731 |
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55,988,691 |
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56,555,312 |
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55,948,867 |
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DESIGN THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
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September 30, |
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December 31, |
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2024 |
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2023 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash, cash equivalents and investment securities |
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$ |
254,074 |
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$ |
281,798 |
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Prepaid expenses and other current assets |
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3,168 |
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2,786 |
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Total current assets |
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257,242 |
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284,584 |
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Property and equipment, net |
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1,559 |
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1,691 |
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Right-of-use asset, related party |
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2,401 |
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2,938 |
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Other assets |
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427 |
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430 |
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Total assets |
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$ |
261,629 |
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$ |
289,643 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
1,470 |
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$ |
1,940 |
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Accrued expenses and other current liabilities |
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5,962 |
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7,682 |
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Total current liabilities |
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7,432 |
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9,622 |
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Operating lease liability, net, related party |
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1,744 |
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2,334 |
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Total liabilities |
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9,176 |
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11,956 |
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Total stockholders’ equity |
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252,453 |
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277,687 |
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Total liabilities and stockholders’ equity |
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$ |
261,629 |
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$ |
289,643 |
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