DSGN Design Therapeutics Inc.

15.48
-0.96  -6%
Previous Close 16.44
Open 16.38
52 Week Low 14.385
52 Week High 50.5
Market Cap $860,956,145
Shares 55,617,322
Float 27,448,448
Enterprise Value $861,574,144
Volume 100,437
Av. Daily Volume 156,292
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Drug Pipeline

Drug Stage Notes
GeneTAC program
Friedreich ataxia (FA)
Phase 1
Phase 1
Phase 1 trial to commence 1H 2022.

Latest News

  1. CARLSBAD, Calif., June 07, 2021 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (NASDAQ:DSGN), a biotechnology company developing treatments for degenerative genetic disorders, today reported that João Siffert, M.D., president and chief executive officer, will participate in a fireside chat during the Goldman Sachs 42nd Annual Global Healthcare Conference on Wednesday, June 9, 2021 at 1:20 p.m. ET.

    The live webcast will be available in the investor section of the company's website at www.designtx.com. The webcast will be archived for 60 days following the presentation.

    About Design Therapeutics
    Design Therapeutics is a biotechnology company developing a new class of therapies based on a platform of gene targeted chimera (GeneTAC™) small molecules…

    CARLSBAD, Calif., June 07, 2021 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (NASDAQ:DSGN), a biotechnology company developing treatments for degenerative genetic disorders, today reported that João Siffert, M.D., president and chief executive officer, will participate in a fireside chat during the Goldman Sachs 42nd Annual Global Healthcare Conference on Wednesday, June 9, 2021 at 1:20 p.m. ET.

    The live webcast will be available in the investor section of the company's website at www.designtx.com. The webcast will be archived for 60 days following the presentation.

    About Design Therapeutics

    Design Therapeutics is a biotechnology company developing a new class of therapies based on a platform of gene targeted chimera (GeneTAC™) small molecules. Our GeneTAC molecules are designed to either turn on or turn off a specific disease-causing gene to address the underlying cause of disease. The company'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.

    Contact:

    Alicia Davis

    THRUST Strategic Communications

    (910) 620-3302



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  2. CARLSBAD, Calif., June 07, 2021 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (NASDAQ:DSGN), a biotechnology company developing treatments for degenerative genetic disorders, today announced the appointments of industry veterans, Heather Behanna, Ph.D., principal of SR One, and Deepa Prasad, managing director of WestRiver Group, to its board of directors effective June 15, 2021.

    "We are delighted to further strengthen the Design team with the appointments of both Heather and Deepa to our board of directors, who bring a wealth of experience and insights in corporate and financial strategy and biotechnology company growth," said João Siffert, M.D., president and chief executive officer of Design Therapeutics. "Over the course of 2021, we…

    CARLSBAD, Calif., June 07, 2021 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (NASDAQ:DSGN), a biotechnology company developing treatments for degenerative genetic disorders, today announced the appointments of industry veterans, Heather Behanna, Ph.D., principal of SR One, and Deepa Prasad, managing director of WestRiver Group, to its board of directors effective June 15, 2021.

    "We are delighted to further strengthen the Design team with the appointments of both Heather and Deepa to our board of directors, who bring a wealth of experience and insights in corporate and financial strategy and biotechnology company growth," said João Siffert, M.D., president and chief executive officer of Design Therapeutics. "Over the course of 2021, we have continued to progress our pipeline of novel GeneTAC™ therapeutic candidates, and their expertise will be invaluable as we look to make the important transition to a clinical-stage company with the anticipated initiation of clinical development for our Friedreich ataxia program in the first half of next year."

    Dr. Behanna currently serves as a principal at SR One Capital Management, concentrating on early-stage innovative therapeutic opportunities. Dr. Behanna is currently a board member of Second Genome and Entasis Therapeutics (ETTX) and a board observer of Dren Bio. Prior to SR One, she was with Sofinnova Investments, and prior to that, was an equity research analyst at Wedbush and JMP Securities, focused primarily on therapies for rare disease. Dr. Behanna was formerly a chemist at the Astellas Research institute and adjunct faculty at the Feinberg Northwestern School of Medicine. Dr. Behanna received her Ph.D. in chemistry at Northwestern University, MSc. in organic chemistry at the Weizmann Institute of Science and B.S. from Tufts University.

    "Friedreich ataxia is devastating, with no cure or approved disease-modifying treatment option today. I am highly encouraged by the opportunity enabled by Design's approach to address the underlying cause of this disease," said Dr. Behanna. "I look forward to working alongside the entire team to help guide the business strategy and development plans, so that we may potentially deliver the first treatment to increase endogenous frataxin for patients with Friedreich ataxia."

    Ms. Prasad currently serves as a managing director at WestRiver Group (WRG), where she leverages her more than 20 years of investing and operating experience to focus on investments in healthcare innovation across biotech and digital health and artificial intelligence. Prior to WRG, Ms. Prasad served as chief of staff at Blue Shield, regional vice president and general manager for Optum, head of managed care at the California Hospital Association, and Coherus Biosciences (CHRS) where she led financial strategy and business development. She began her career in investment banking working with biotech and pharma companies on private placements and buyside and sellside mergers and acquisitions. She currently serves on the Grant Funding Committee for UC Davis and as a charter member for TiE, a non-profit global network of entrepreneurs and venture capitalists. Ms. Prasad earned her bachelor's degree in business administration at the University of California, Berkeley and her M.B.A. from the Kellogg School of Management at Northwestern University with emphasis in finance and health industry management.

    "Design's proprietary GeneTAC platform has a unique opportunity to address the root cause of genetic diseases driven by inherited nucleotide repeat expansions and make a significant impact on the lives of those affected," said Ms. Prasad. "The team has made remarkable progress since its founding in 2017, and I am pleased to partner with the Design team and board of directors, so that we may bring forward a new class of small molecule therapeutics that provide a potentially disease-modifying therapy for these patients."

    About Design Therapeutics

    Design Therapeutics is a biotechnology company developing a new class of therapies based on a platform of gene targeted chimera (GeneTAC™) small molecules. Our GeneTAC molecules are designed to either turn on or turn off a specific disease-causing gene to address the underlying cause of disease. The company'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; the effectiveness of Design's GeneTAC program in the treatment of Friedreich ataxia and myotonic dystrophy type-1; 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 forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "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 early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials; uncertainties associated with performing clinical trials, regulatory filings and applications; 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 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; the loss of key scientific or management personnel; competition in the industry in which Design operates; and general market conditions. For a more detailed discussion of these and other factors, please refer to Design's filings with the Securities and Exchange Commission. 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:

    Alicia Davis

    THRUST Strategic Communications

    (910) 620-3302



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  3. Successful $276 Million IPO Completed to Advance GeneTACTM Programs for Friedreich Ataxia and Myotonic Dystrophy Type-1 Toward Clinical Development

    Company On-track to Initiate Phase 1 Clinical Trial for the Treatment of Friedreich Ataxia in the First Half of 2022

    CARLSBAD, Calif., May 10, 2021 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (NASDAQ:DSGN), a biotechnology company developing treatments for degenerative genetic disorders, today reported business highlights and first quarter 2021 financial results.

    "2021 has been a meaningful year so far for Design, with marked progress across our proprietary gene targeted chimera (GeneTACTM) platform, our small molecule pipeline, and our business operations," said João Siffert, M.D., president…

    Successful $276 Million IPO Completed to Advance GeneTACTM Programs for Friedreich Ataxia and Myotonic Dystrophy Type-1 Toward Clinical Development

    Company On-track to Initiate Phase 1 Clinical Trial for the Treatment of Friedreich Ataxia in the First Half of 2022

    CARLSBAD, Calif., May 10, 2021 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (NASDAQ:DSGN), a biotechnology company developing treatments for degenerative genetic disorders, today reported business highlights and first quarter 2021 financial results.

    "2021 has been a meaningful year so far for Design, with marked progress across our proprietary gene targeted chimera (GeneTACTM) platform, our small molecule pipeline, and our business operations," said João Siffert, M.D., president and chief executive officer of Design Therapeutics. "We transitioned to a public company and stand well-capitalized to fuel the continued advancement of our platform, led by the development of a potentially disease-modifying treatment for people living with Friedreich ataxia, a debilitating autosomal-recessive genetic disease. Following a recent successful pre-IND meeting with the FDA, we remain on track to initiate clinical development for our FA program in the first half of 2022 and make the important transformation to a clinical-stage organization."

    Business Highlights

    • On-track with Clinical Development Plans for Friedreich Ataxia Program Following Pre-IND Meeting with FDA: Design Therapeutics successfully completed a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the preclinical and clinical development plans for its lead GeneTAC program for the treatment of Friedreich ataxia (FA). As part of the meeting, Design gained alignment with the FDA on its development plans and, pending regulatory approval, is preparing to initiate a Phase 1 clinical trial in patients with FA in the first half of 2022. FA is a devastating disease for which more than 95% of cases are caused by homozygous guanine-adenine-adenine (GAA) triplet repeat expansions in the first intron of the FXN gene.
    • Myotonic Dystrophy Type-1 Program Advancing as Planned: Design's second GeneTAC program is focused on the development of a potentially disease-modifying treatment for myotonic dystrophy type-1 (DM1). The company is advancing its DM1 GeneTAC program, with plans to seek regulatory clearance for a first-in-human trial in 2023.
    • $276 Million Initial Public Offering (IPO) Successfully Completed: In March 2021, Design sold 13,800,000 shares of its common stock, which included 1,800,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a public offering price of $20.00 per share. Including the option exercise, the aggregate gross proceeds to Design from the offering were $276.0 million, before deducting the underwriting discounts and commissions and offering expenses.

    First Quarter 2021 Financial Results

    For the first quarter ended March 31, 2021, Design reported a net loss of $5.5 million, compared to a net loss of $0.7 million for the comparable period in 2020.

    Research and development expenses for the first quarter of 2021 were $3.9 million, compared to $0.4 million for the comparable period in 2020. The increase in the company's research and development expenses in 2021 was primarily attributable to the advancement of its FA program and related activities, including chemistry and manufacturing development costs, and costs incurred on its DM1 program in 2021 that were not incurred in 2020. Further the company incurred higher personnel costs to support its development programs, including an additional $0.2 million of non-cash stock-based compensation costs.

    General and administrative expenses for the first quarter of 2021, were $1.8 million, compared to $0.4 million for the comparable period in 2020. The increase in general and administrative expenses in 2021 was primarily attributable to increased personnel and related costs as the company expanded its general and administrative team to support its operations, including an additional $0.5 million of non-cash stock-based compensation costs. Further, the company incurred increased professional fees for legal and accounting services during the first quarter of 2021 as compared to same period in 2020.

    As of March 31, 2021, Design reported cash, cash equivalents and investment securities of $411.3 million, an increase of $375.2 million from the $36.1 million reported as of December 31, 2020. The increase during the first quarter of 2021 was attributed to the net proceeds from the company's IPO in March 2021 and its Series B convertible preferred stock financing in January 2021.

    About Design Therapeutics

    Design Therapeutics is a biotechnology company developing a new class of therapies based on a platform of gene targeted chimera (GeneTAC™) small molecules. Our GeneTAC molecules are designed to either turn on or turn off a specific disease-causing gene to address the underlying cause of disease. The company'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; the effectiveness of Design's GeneTAC program in the treatment of Friedreich ataxia and myotonic dystrophy type-1; the potential advantages of these GeneTAC programs; 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," "anticipates," "plans," "expects," "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; 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; 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 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; the loss of 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. 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:

    Alicia Davis

    THRUST Strategic Communications

    (910) 620-3302

     
    DESIGN THERAPEUTICS, INC.

    STATEMENTS OF OPERATIONS
    (in thousands, except share and per share data)

    (unaudited)
        
      Three Months Ended March 31, 
      2021  2020 
    Revenue:        
    Grant revenue $  $142 
    Operating expenses:        
    Research and development  3,875   377 
    General and administrative  1,805   388 
    Total operating expenses  5,680   765 
    Loss from operations  (5,680)  (623)
    Other income (expense), net  166   (40)
    Net loss $(5,514) $(663)
             
    Net loss per share, basic and diluted $(0.31) $(0.04)
    Weighted-average shares of common stock outstanding, basic and diluted  17,630,178   15,667,115 
             



     
    DESIGN THERAPEUTICS, INC.

    BALANCE SHEETS
    (in thousands)

    (unaudited)
           
      March 31,  December 31, 
      2021  2020 
      (unaudited)     
    Assets        
    Current assets:        
    Cash, cash equivalents and investment securities $411,339  $36,091 
    Prepaid expense and other current assets  415   142 
    Total current assets  411,754   36,233 
    Property and equipment, net  100   71 
    Deferred offering costs     212 
    Total assets $411,854  $36,516 
    Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)        
    Current liabilities:        
    Accounts payable $2,033  $1,399 
    Accrued expenses  1,673   931 
    Total current liabilities  3,706   2,330 
    Other long-term liabilities  142   145 
    Total liabilities  3,848   2,475 
    Convertible preferred stock     45,356 
    Total stockholders' equity (deficit)  408,006   (11,315)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit) $411,854  $36,516 
             


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  4. CARLSBAD, Calif., March 30, 2021 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (NASDAQ:DSGN) ("Design"), a biotechnology company developing a platform of gene targeted chimera (GeneTAC™) small molecules for the treatment of serious degenerative disorders caused by inherited nucleotide repeat expansions, today announced the closing of its previously announced initial public offering of 13,800,000 shares of its common stock, which includes 1,800,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $20.00 per share. Including the option exercise, the aggregate gross proceeds to Design from the offering were approximately $276.0 million, before deducting…

    CARLSBAD, Calif., March 30, 2021 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (NASDAQ:DSGN) ("Design"), a biotechnology company developing a platform of gene targeted chimera (GeneTAC™) small molecules for the treatment of serious degenerative disorders caused by inherited nucleotide repeat expansions, today announced the closing of its previously announced initial public offering of 13,800,000 shares of its common stock, which includes 1,800,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $20.00 per share. Including the option exercise, the aggregate gross proceeds to Design from the offering were approximately $276.0 million, before deducting the underwriting discounts and commissions and offering expenses. The shares began trading on the Nasdaq Global Select Market on March 26, 2021, under the ticker symbol "DSGN."

    Goldman Sachs & Co. LLC, SVB Leerink LLC and Piper Sandler acted as joint book-running managers for the offering.

    A registration statement relating to the offering of these securities has been filed with the Securities and Exchange Commission (SEC) and became effective on March 25, 2021. Copies of the registration statement can be accessed through the SEC's website at www.sec.gov. This offering was made only by means of a written prospectus, forming a part of the effective registration statement. Copies of the final prospectus relating to the initial public offering may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at ; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6105, or by email at ; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at (800) 747-3924, or by email at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    Contact:

    Alicia Davis                                        

    THRUST Strategic Communications                                                

    (910) 620-3302                                                        



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  5. CARLSBAD, Calif., March 25, 2021 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc., a biotechnology company developing a platform of gene targeted chimera (GeneTAC™) small molecules for the treatment of serious degenerative disorders caused by inherited nucleotide repeat expansions, today announced the pricing of its initial public offering of 12,000,000 shares of its common stock at a price to the public of $20.00 per share. The gross proceeds to Design from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $240.0 million. All of the shares are being offered by Design. In addition, Design has granted the underwriters a 30-day option to purchase up to an additional 1,800,000 shares…

    CARLSBAD, Calif., March 25, 2021 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc., a biotechnology company developing a platform of gene targeted chimera (GeneTAC™) small molecules for the treatment of serious degenerative disorders caused by inherited nucleotide repeat expansions, today announced the pricing of its initial public offering of 12,000,000 shares of its common stock at a price to the public of $20.00 per share. The gross proceeds to Design from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $240.0 million. All of the shares are being offered by Design. In addition, Design has granted the underwriters a 30-day option to purchase up to an additional 1,800,000 shares of its common stock at the initial public offering price less the underwriting discounts and commissions.

    The shares are expected to begin trading on the Nasdaq Global Select Market on March 26, 2021, under the ticker symbol "DSGN." The offering is expected to close on March 30, 2021, subject to the satisfaction of customary closing conditions.

    Goldman Sachs & Co. LLC, SVB Leerink LLC and Piper Sandler are acting as joint book-running managers for the offering.

    A registration statement relating to the offering of these securities has been filed with the Securities and Exchange Commission (SEC) and became effective on March 25, 2021. Copies of the registration statement can be accessed through the SEC's website at www.sec.gov. This offering is being made only by means of a written prospectus, forming a part of the effective registration statement. Copies of the final prospectus relating to the initial public offering may be obtained, when available, from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at ; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6105, or by email at ; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at (800) 747-3924, or by email at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    Contact:

    Alicia Davis

    THRUST Strategic Communications

    (910) 620-3302





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