DYN Dyne Therapeutics Inc.

14.71
-1.15  -7%
Previous Close 15.86
Open 15.56
52 Week Low 13.5001
52 Week High 32.315
Market Cap $757,983,779
Shares 51,528,469
Float 29,972,271
Enterprise Value $443,718,518
Volume 130,805
Av. Daily Volume 200,490
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Drug Pipeline

Drug Stage Notes
DYNE-101
Myotonic Dystrophy
Phase 1
Phase 1
IND planned for 1Q 2022.
DYNE-251
Duchenne muscular dystrophy (DMD)
Phase 1
Phase 1
IND planned for 4Q 2021.

Latest News

  1. - Robust In Vivo Data Presented at Scientific Meetings Support Advancement of Dyne's Co-lead Candidates into the Clinic -

    - Investigational New Drug (IND) Submissions Anticipated for DYNE-251 in DMD During the Fourth Quarter of 2021 and for DYNE-101 in DM1 During the First Quarter of 2022 -

    WALTHAM, Mass., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the third quarter of 2021 and business highlights.

    "We made tremendous progress during the third quarter and are now preparing to advance Dyne's two co-lead programs into the clinic, with the…

    - Robust In Vivo Data Presented at Scientific Meetings Support Advancement of Dyne's Co-lead Candidates into the Clinic -

    - Investigational New Drug (IND) Submissions Anticipated for DYNE-251 in DMD During the Fourth Quarter of 2021 and for DYNE-101 in DM1 During the First Quarter of 2022 -

    WALTHAM, Mass., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the third quarter of 2021 and business highlights.

    "We made tremendous progress during the third quarter and are now preparing to advance Dyne's two co-lead programs into the clinic, with the IND submission for DYNE-251 in DMD anticipated during the fourth quarter of 2021, followed by the IND submission for DYNE-101 in DM1 expected in the first quarter of 2022," said Joshua Brumm, president and chief executive officer of Dyne. "As we highlighted at our recent R&D Day and presentations at the World Muscle Society and Muscle Study Group meetings, we have generated robust in vivo data for these programs. The team has also done extensive work to engage with multiple stakeholders, including thought leaders, regulators, advocacy groups and patients to prepare to move both candidates into the clinic. The FORCE™ platform is exhibiting powerful potential to address these rare muscle diseases where patients have few or no therapeutic options, and I'm proud that the Dyne team remains fully focused on urgently delivering on our mission."

    Recent Highlights

    • Dyne presented new in vivo data during the World Muscle Society 2021 Virtual Congress in September 2021 demonstrating the ability of DYNE-101 in myotonic dystrophy type 1 (DM1) to target the nucleus and achieve knockdown of toxic DMPK RNA, foci reduction and correction of splicing in muscle tissues in the novel hTfR1/DMSXL mouse model. DYNE-101 was also well tolerated in a non-GLP toxicology dose-range finding study in non-human primates (NHPs).



    • The Company presented new in vivo data on October 1, 2021 during the 2021 Muscle Study Group Annual Scientific Meeting for its Duchenne muscular dystrophy (DMD) program, showing dystrophin restoration of 90% of wild-type levels in the diaphragm and 78% in the heart with approximately 80% dystrophin-positive fibers following a single dose of FORCE in the mdx mouse model. Its candidate, DYNE-251, also achieved exon 51 skipping of 52% in the diaphragm and 43% in the heart in NHPs and was well tolerated in a GLP toxicology study.



    • Dyne held its inaugural R&D Day on October 13, 2021, highlighting preclinical data and clinical development plans for DYNE-251 in DMD and DYNE-101 in DM1. Following the IND submissions and review with regulators, the Company plans to initiate global, placebo-controlled multiple ascending dose (MAD) clinical trials for each of these candidates, evaluating safety, key disease markers and muscle function in patients with DMD and DM1, with the intention of dosing patients in both trials by the middle of 2022. The R&D Day also featured presentations and commentary by leading neuromuscular disease experts, Valeria Sansone, M.D., Ph.D. and John Day, M.D., Ph.D. A replay is available at https://investors.dyne-tx.com/events/event-details/dyne-rd-day.

    Upcoming Events and Milestones

    • IND submission for DYNE-251 in DMD is planned during the fourth quarter of 2021.



    • IND submission for DYNE-101 in DM1 is anticipated in the first quarter of 2022.



    • IND submission for DYNE-301 in facioscapulohumeral muscular dystrophy (FSHD) is expected in the second half of 2022.



    • Dyne management is scheduled to participate in fireside chats during three upcoming investor conferences. The event webcasts and replays (available for 90 days) can be accessed in the Investors & Media section of Dyne's website at https://investors.dyne-tx.com/news-and-events/events-and-presentations:
      • Stifel 2021 Virtual Healthcare Conference on November 15, 2021 at 8:00 a.m. ET
      • Jefferies London Healthcare Conference, pre-recorded and available on November 18, 2021 beginning at 8:00 a.m. GMT / 3:00 a.m. ET.
      • Piper Sandler 33rd Annual Virtual Healthcare Conference, pre-recorded and available on November 22, 2021 beginning at 10:00 a.m. ET.

    Third Quarter 2021 Financial Results



    Cash position: Cash, cash equivalents and marketable securities were $407.5 million as of September 30, 2021, which is anticipated to fund operations into the second half of 2024. 



    Research and development (R&D) expenses: R&D expenses were $36.5 million for the third quarter of 2021 compared to $9.7 million for the third quarter of 2020. 



    General and administrative (G&A) expenses: G&A expenses were $6.3 million during the third quarter of 2021 compared to $3.8 million for the third quarter of 2020. 



    Net loss: Net loss was $42.6 million or $0.83 per share of common stock for the third quarter of 2021 compared to $13.9 million, or $2.01 per share of common stock for the third quarter of 2020.



    About Dyne Therapeutics

    Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne has a broad portfolio of therapeutic candidates for serious muscle diseases, including myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

    Forward-Looking Statements 



    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Dyne's strategy, future operations, prospects and plans, objectives of management, the potential of the FORCE platform, the expected timeline for submitting investigational new drug applications and dosing patients in trials, the anticipated design of the trials and the sufficiency of its cash resources, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing," "plan," "predict," "project," "potential," "should," or "would," or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Dyne may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies; the timing of and Dyne's ability to submit and obtain regulatory clearance for investigational new drug applications and initiate clinical trials; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; whether investigators and regulatory agencies will agree with the design of Dyne's planned clinical trials; whether Dyne's cash resources will be sufficient to fund the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties associated with the impact of the COVID-19 pandemic on Dyne's business and operations; as well as the risks and uncertainties identified in Dyne's filings with the Securities and Exchange Commission (SEC), including the Company's most recent Form 10-Q and in subsequent filings Dyne may make with the SEC. In addition, the forward-looking statements included in this press release represent Dyne's views as of the date of this press release. Dyne anticipates that subsequent events and developments will cause its views to change. However, while Dyne may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Dyne's views as of any date subsequent to the date of this press release.

    Dyne Therapeutics, Inc.
    Condensed Consolidated Statement of Operations (Unaudited)
    (in thousands, except share and per share data)
             
      Three Months Ended September 30, Nine Months Ended September 30,
       2021   2020   2021   2020 
    Operating expenses:        
    Research and development $36,510  $9,679  $79,007  $23,102 
    General and administrative  6,256   3,841   19,058   6,945 
         Total operating expenses   42,766     13,520     98,065     30,047  
    Loss from operations  (42,766)  (13,520)  (98,065)  (30,047)
    Other (expense) income, net  184   (400)  560   (741)
    Net loss $ (42,582) $ (13,920) $ (97,505) $ (30,788)
    Net loss per share—basic and diluted $(0.83) $(2.01) $(1.92) $(7.51)
    Weighted-average common shares outstanding used in net loss per share—basic and diluted  51,320,940   6,920,008   50,676,668   4,100,504 



    Dyne Therapeutics, Inc.
    Condensed Consolidated Balance Sheet Data (Unaudited)
    (in thousands)
         
      September 30, December 31,
      2021  2020
    Assets    
    Cash, cash equivalents and marketable securities $407,523 $345,314
    Other assets  59,355  8,020
    Total assets $ 466,878  $ 353,334
    Liabilities and Stockholders' Equity    
    Liabilities  52,762  10,967
    Stockholders' equity  414,116  342,367
    Total liabilities and stockholders' equity $ 466,878  $ 353,334
     

    Contact:



    Dyne Therapeutics

    Amy Reilly



    857-341-1203

     



    Primary Logo

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  2. - Investigational New Drug (IND) Submissions Anticipated for DYNE-251 in DMD During the Fourth Quarter of 2021 and for DYNE-101 in DM1 During the First Quarter of 2022 -

    - Event also Features Presentations and Commentary by Leading Neuromuscular Disease Experts, Valeria Sansone, M.D., Ph.D. and John Day, M.D., Ph.D. -

    WALTHAM, Mass., Oct. 13, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, hosts its first Research and Development Day today focused on the Company's co-lead development programs for rare muscle diseases, Duchenne muscular dystrophy (DMD) and myotonic dystrophy…

    - Investigational New Drug (IND) Submissions Anticipated for DYNE-251 in DMD During the Fourth Quarter of 2021 and for DYNE-101 in DM1 During the First Quarter of 2022 -

    - Event also Features Presentations and Commentary by Leading Neuromuscular Disease Experts, Valeria Sansone, M.D., Ph.D. and John Day, M.D., Ph.D. -

    WALTHAM, Mass., Oct. 13, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, hosts its first Research and Development Day today focused on the Company's co-lead development programs for rare muscle diseases, Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1). "The Muscle to Move to the Clinic" live virtual event (8:00-10:30 a.m. ET) as well as the replay and slide presentation are available at https://investors.dyne-tx.com/events/event-details/dyne-rd-day.

    "We are thrilled to host our inaugural R&D Day a little more than a year after our IPO, and just two and a half years after announcing the launch of Dyne and our focus on building the world's leading muscle disease company. Today we will share that we plan to submit INDs for DYNE-251 in DMD during the fourth quarter of 2021 and for DYNE-101 in DM1 during the first quarter of 2022, with the intention of initiating global, placebo-controlled trials evaluating safety, key disease markers and muscle function in patients," said Joshua Brumm, President and Chief Executive Officer of Dyne. "Dr. Sansone and Dr. Day are recognized leaders in the field of neuromuscular disease, and we are grateful to them for sharing their expertise during the event and informing our programs. People living with DMD are underserved by current therapies and individuals with DM1 have no approved treatment options, so we feel a tremendous sense of urgency for the rare muscle disease community and are excited to advance these programs to the clinic."

    The R&D Day program includes presentations and discussion with the following speakers, along with introductory remarks from Mr. Brumm:

    • Presentations and commentary from Dr. Sansone, who is the Clinical and Scientific Director at Clinical Center NeMO and Associate Professor of Neurology at University of Milan; and Dr. Day, who serves as Professor of Neurology and Pediatrics and Director of the Neuromuscular Division at Stanford Neuroscience Health Center.

    • Oxana Beskrovnaya, Ph.D., Dyne's Chief Scientific Officer, reviews recent in vivo data presented during the World Muscle Society 2021 Virtual Congress on the DM1 program and during the 2021 Muscle Study Group Annual Scientific Meeting on the DMD program, which provide strong support for the planned IND submissions.

    • Wildon Farwell, M.D., MPH, Dyne's Chief Medical Officer, outlines preparations for advancing both programs into the clinic and initial plans for clinical trials, which will be finalized following review with investigators and regulators. For its DMD program, Dyne intends to initiate a global, placebo-controlled, multiple-ascending dose (MAD) clinical trial to evaluate DYNE-251 in patients with mutations amenable to exon 51 skipping. The Company also intends to initiate a global, placebo-controlled, MAD clinical trial evaluating DYNE-101 in adult patients with DM1.

    • While the R&D Day event is focused on Dyne's co-lead programs, the Company also noted that it expects to submit an IND for DYNE-301 in facioscapulohumeral muscular dystrophy (FSHD) in the second half of 2022.

    About Dyne Therapeutics

    Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne's broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Dyne's strategy, future operations, prospects and plans, objectives of management, the expected timeline for submitting investigational new drug applications and anticipated design of the trials, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing," "plan," "predict," "project," "potential," "should," or "would," or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Dyne may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies; the timing of and Dyne's ability to submit and obtain regulatory clearance for investigational new drug applications; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; whether investigators and regulatory agencies will agree with the design of Dyne's planned clinical trials; whether Dyne's cash resources will be sufficient to fund the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties associated with the impact of the COVID-19 pandemic on Dyne's business and operations; as well as the risks and uncertainties identified in Dyne's filings with the Securities and Exchange Commission (SEC), including the Company's most recent Form 10-Q and in subsequent filings Dyne may make with the SEC. In addition, the forward-looking statements included in this press release represent Dyne's views as of the date of this press release. Dyne anticipates that subsequent events and developments will cause its views to change. However, while Dyne may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Dyne's views as of any date subsequent to the date of this press release.

    Contact:



    Dyne Therapeutics

    Amy Reilly

      

    857-341-1203



    Primary Logo

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  3. - Dystrophin Restoration of 90% of Wild-Type Levels Observed in the Diaphragm and 78% in the Heart with ~80% Dystrophin-Positive Fibers After a Single Dose in mdx Mouse Model -

    - DYNE-251 Achieves Exon 51 Skipping of 52% in the Diaphragm and 43% in the Heart in Non-Human Primates and is Well Tolerated in GLP Toxicology Study -

    - DYNE-251 in DMD and DYNE-101 in DM1, Co-Lead Programs Advancing to the Clinic and Focus of R&D Day on October 13 -

    WALTHAM, Mass., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, announced new data being presented today during the 2021 Muscle Study Group

    - Dystrophin Restoration of 90% of Wild-Type Levels Observed in the Diaphragm and 78% in the Heart with ~80% Dystrophin-Positive Fibers After a Single Dose in mdx Mouse Model -

    - DYNE-251 Achieves Exon 51 Skipping of 52% in the Diaphragm and 43% in the Heart in Non-Human Primates and is Well Tolerated in GLP Toxicology Study -

    - DYNE-251 in DMD and DYNE-101 in DM1, Co-Lead Programs Advancing to the Clinic and Focus of R&D Day on October 13 -

    WALTHAM, Mass., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, announced new data being presented today during the 2021 Muscle Study Group Annual Scientific Meeting for its Duchenne muscular dystrophy (DMD) program that demonstrate robust and durable exon skipping and dystrophin expression in both cardiac and skeletal muscles in in vivo models.

    "We are excited about the data from these latest studies in an established DMD in vivo model as well as in non-human primates as we prepare to advance our program into the clinic," said Oxana Beskrovnaya, Ph.D., Dyne's chief scientific officer. "The level of dystrophin expression achieved with FORCE™ after a single dose in the mdx mouse model is substantial and the protein is widely expressed, with at least 80% dystrophin-positive fibers in both skeletal and cardiac muscle. We also observed duration of dystrophin expression for over 8 weeks post dose, suggesting the potential for less frequent dosing than approved therapies that require weekly dosing. Our candidate, DYNE-251, was well tolerated and demonstrated impressive exon 51 skipping in non-human primates, especially in the heart and diaphragm muscles that weaken over time leading to mortality in people with DMD. These data, combined with our recent preclinical splicing data of DYNE-101 presented during World Muscle Society, demonstrate the power of the FORCE platform in the development of potentially life transforming therapies for people living with serious muscle diseases."

    "The magnitude of dystrophin expression and percent dystrophin-positive fibers achieved in these mdx mice studies, a widely accepted preclinical model for Duchenne muscular dystrophy, are very compelling. Dystrophin restoration is an important step in improving outcomes for patients with DMD. These data, combined with the robust exon skipping observed in the heart, diaphragm and quadriceps of non-human primates suggest the potential of DYNE-251 in individuals with Duchenne muscular dystrophy, and I look forward to seeing this program progress into clinical studies," said Francesco Muntoni, FRCPCH, FMedSci, who chairs the pediatric neurology department at University College London and directs the Dubowitz Neuromuscular Centre. Dr. Muntoni is a leader in the DMD field and also serves on Dyne's Scientific Advisory Board.

    DMD is a rare disease caused by mutations in the gene that encodes for dystrophin, a protein critical for the normal function of muscle cells. Dyne's FORCE platform targets the transferrin 1 (TfR1) receptor, which is highly expressed on the surface of muscle cells. In DMD, FORCE delivers phosphorodiamidate morpholino oligomers (PMO) to muscle tissue to promote the skipping of specific DMD exons in the nucleus, allowing muscle cells to create a truncated, functional dystrophin protein and potentially stop or reverse disease progression. DYNE-251, the lead program in Dyne's DMD franchise, is being developed for patients with mutations amenable to skipping exon 51.

    Data presented today were generated using the mdx mouse model, a validated DMD disease model which has a mutation in exon 23. In this model, Dyne's FORCE platform achieved:

    • Robust, durable exon skipping in cardiac and skeletal muscles after a single dose
    • Substantial dystrophin expression after a single dose of 30 mg/kg at 4 weeks:
      • 90% of wild-type dystrophin restoration by Western Blot with approximately 80% dystrophin-positive fibers in the diaphragm
      • 78% of wild-type dystrophin restoration by Western Blot with approximately 80% dystrophin-positive fibers in the heart
      • 46% of wild-type dystrophin restoration by Western Blot with approximately 68% dystrophin-positive fibers in the quadriceps
    • Durable expression and dystrophin-positive fibers detected out to 12 weeks after single dose

    These new data build on previous results in the mdx model showing treatment with FORCE resulted in enhanced functional benefit in multiple standardized assessments and a reduction in serum creatinine kinase, a biomarker of muscle damage.

    In non-human primate studies, DYNE-251 demonstrated:

    • Robust exon 51 skipping in cardiac and skeletal muscles after 5 weekly 30 mg/kg doses measured 8 weeks post-initial dose:
      • 52% exon skipping in the diaphragm
      • 43% exon skipping in the heart
      • 18% exon skipping in the quadriceps
    • A favorable safety profile in a GLP toxicology study with no dose-limiting toxicity observed after 5 weekly doses up to a maximally feasible dose, thus supporting advancement into the clinic.

    The presentation, "FORCE™ platform delivers exon skipping PMO, leads to durable increases in dystrophin protein in mdx mice and is well tolerated in NHPs" will be available in the Scientific Publications & Presentations section of Dyne's website.

    About Duchenne Muscular Dystrophy (DMD)

    DMD is a rare disease caused by mutations in the gene that encodes for dystrophin, a protein critical for the normal function of muscle cells. These mutations, the majority of which are deletions, result in the lack of dystrophin protein and progressive loss of muscle function. DMD occurs primarily in males and affects an estimated 12,000 to 15,000 individuals in the U.S. and 25,000 in Europe. Loss of strength and function typically first appears in pre-school age boys and worsens as they age. As the disease progresses, the severity of damage to skeletal and cardiac muscles often results in patients experiencing total loss of ambulation by their early teenage years and includes worsening cardiac and respiratory symptoms and loss of upper body function by the later teens. There is no cure for DMD and currently approved therapies provide limited benefit.

    About the FORCE™ Platform

    The proprietary FORCE™ platform drives Dyne's efforts to develop targeted, modern oligonucleotide therapeutics with the potential to be life-transforming for patients with serious muscle diseases. Dyne designed the FORCE platform using its deep knowledge of muscle biology and oligonucleotide therapeutics to overcome the current limitations in delivery to muscle tissue with the goal of stopping or reversing disease progression. The FORCE platform leverages the importance of transferrin 1 receptor, TfR1, in muscle biology as the foundation for its novel approach. TfR1, which is highly expressed on the surface of muscle cells, is required for iron transport into muscle cells. Dyne links therapeutic payloads to its TfR1-binding fragment antibody (Fab) to develop targeted therapeutics for muscle diseases.

    About Dyne Therapeutics

    Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne's broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Dyne's strategy, future operations, prospects and plans, the potential advantages of Dyne's FORCE platform and programs and expectations regarding the translation of preclinical findings to human disease constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing," "plan," "predict," "project," "potential," "should," or "would," or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Dyne may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies; the timing of and Dyne's ability to submit and obtain regulatory clearance for investigational new drug applications; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; whether Dyne's cash resources will be sufficient to fund the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties associated with the impact of the COVID-19 pandemic on Dyne's business and operations; as well as the risks and uncertainties identified in Dyne's filings with the Securities and Exchange Commission (SEC), including the Company's most recent Form 10-Q and in subsequent filings Dyne may make with the SEC. In addition, the forward-looking statements included in this press release represent Dyne's views as of the date of this press release. Dyne anticipates that subsequent events and developments will cause its views to change. However, while Dyne may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Dyne's views as of any date subsequent to the date of this press release.

    Contact:

    Dyne Therapeutics

    Amy Reilly



    857-341-1203



    Primary Logo

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  4. - "The Muscle to Move to the Clinic" Event Will Highlight Preclinical Data Supporting Advancement of Dyne's DM1 and DMD Programs Toward Clinical Trials and Anticipated Timelines, and Feature Leading Experts in Both Disease Areas -

    WALTHAM, Mass., Sept. 28, 2021 (GLOBE NEWSWIRE) --  Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, will host a virtual Research and Development Day on Wednesday, October 13, 2021 from 8:00 – 10:30 a.m. ET. "The Muscle to Move to the Clinic" event will focus on Dyne's co-lead development programs for rare muscle diseases, myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy…

    - "The Muscle to Move to the Clinic" Event Will Highlight Preclinical Data Supporting Advancement of Dyne's DM1 and DMD Programs Toward Clinical Trials and Anticipated Timelines, and Feature Leading Experts in Both Disease Areas -

    WALTHAM, Mass., Sept. 28, 2021 (GLOBE NEWSWIRE) --  Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, will host a virtual Research and Development Day on Wednesday, October 13, 2021 from 8:00 – 10:30 a.m. ET. "The Muscle to Move to the Clinic" event will focus on Dyne's co-lead development programs for rare muscle diseases, myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD).

    The program will feature presentations, discussion and Q&A with the following speakers:

    • Valeria Sansone, M.D., Ph.D., Clinical and Scientific Director, Clinical Center NeMO, Milan; Associate Professor of Neurology, University of Milan
    • John Day, M.D., Ph.D., Professor of Neurology and Pediatrics, and Director of the Neuromuscular Division, Stanford Neuroscience Health Center
    • Joshua Brumm, President and Chief Executive Officer: Dyne's mission, key program updates and milestones
    • Oxana Beskrovnaya, Ph.D., Chief Scientific Officer: FORCE™ platform and review of preclinical data for Dyne's DM1 and DMD programs, including new in vivo data presented during the World Muscle Society 2021 Virtual Congress and the 2021 Muscle Study Group Annual Scientific Meeting
    • Wildon Farwell, M.D., MPH, Chief Medical Officer: preparations for advancing both programs into the clinic and initial plans for clinical trials

    A live webcast of the event will be available in the Events & Presentations page of the Investors & Media section of Dyne's website and a replay will be accessible for 90 days following the presentation. An accompanying slide presentation will also be available. To register for the live webcast and replay, please visit: https://investors.dyne-tx.com/events/event-details/dyne-rd-day.

    About Dyne Therapeutics



    Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne's broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

    Contact:



    Dyne Therapeutics

    Amy Reilly

     

    857-341-1203



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  5. WALTHAM, Mass., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that management is scheduled to present during Chardan's Virtual 5th Annual Genetic Medicines Conference.

    Joshua Brumm, Dyne's president and chief executive officer, and Oxana Beskrovnaya, Ph.D., chief scientific officer, will participate in a fireside chat on October 5, 2021 at 9:00 a.m. ET. A live webcast of the chat will be available in the Investors & Media section of Dyne's website at https://investors.dyne-tx.com/news-and-events/events-and-presentations and a replay will be accessible for 90…

    WALTHAM, Mass., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that management is scheduled to present during Chardan's Virtual 5th Annual Genetic Medicines Conference.

    Joshua Brumm, Dyne's president and chief executive officer, and Oxana Beskrovnaya, Ph.D., chief scientific officer, will participate in a fireside chat on October 5, 2021 at 9:00 a.m. ET. A live webcast of the chat will be available in the Investors & Media section of Dyne's website at https://investors.dyne-tx.com/news-and-events/events-and-presentations and a replay will be accessible for 90 days following the presentation.

    Dr. Beskrovnaya is also an invited speaker on a panel, "RNA-based Targeted Delivery Approaches," which will be available to conference participants.  

    About Dyne Therapeutics

    Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne's broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

    Contact:

    Dyne Therapeutics

    Amy Reilly

      

    857-341-1203

     



    Primary Logo

    View Full Article Hide Full Article
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