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WALTHAM, Mass., March 11, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on advancing life-transforming therapeutics for people living with genetically driven neuromuscular diseases, today announced that management is scheduled to participate in a fireside chat at the Stifel 2025 Virtual CNS Forum on Tuesday, March 18, 2025 at 4:00 p.m. ET. A live webcast will be available in the Investors & Media section of Dyne’s website at https://investors.dyne-tx.com/ne ...

Financial Outlook - The Company expects to report cash, cash equivalents, and marketable securities of approximately $642 million as of December 31, 2024[5]. Clinical Trials and Drug Development - DYNE-101 demonstrated significant splicing correction at the 6.8 mg/kg Q8W dose at 3 months, associated with improvements in multiple functional endpoints[15]. - The Registrational Expansion Cohort for DYNE-101 will include approximately 32 patients, with a primary endpoint of mean splicing correction at 3 months[19]. - The Company plans to submit for U.S. Accelerated Approval for DYNE-101 in the first half of 2026[19]. - DYNE-251 showed unprecedented dystrophin expression and functional improvement on multiple measures, including Stride Velocity 95th Centile[23]. - The DELIVER trial has administered approximately 837 doses, representing over 65 patient-years of follow-up[23]. - The Company anticipates completion of enrollment for the DELIVER trial's Registrational Expansion Cohort in the first quarter of 2025[23]. - The safety profile for DYNE-101 remains favorable, with the majority of treatment emergent adverse events being mild or moderate[18]. - The Company has completed the Multiple Ascending Dose portion of the ACHIEVE trial and selected the 6.8 mg/kg Q8W dose for further evaluation[14]. - Approximately 855 doses of DYNE-101 have been administered, with some patients followed for up to 2.1 years[18].

Core Insights - Dyne Therapeutics has received FDA Fast Track Designation for DYNE-101 for the treatment of myotonic dystrophy type 1 (DM1) [7] - The company plans to fully enroll the Registrational Expansion Cohort of the ACHIEVE Trial for DYNE-101 by mid-2025 to support a submission for U.S. Accelerated Approval [1][7] - Dyne anticipates completing enrollment for the Registrational Expansion Cohort of the DELIVER Trial for DYNE-251 in Duchenne muscular dystrophy (DMD) by Q1 2025, with data expected in late 2025 [1][7] Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $642.3 million [5] - The company incurred R&D expenses of $81.8 million for Q4 2024, up from $58.8 million in Q4 2023, and $281.4 million for the full year 2024, compared to $210.8 million in 2023 [6][14] - General and administrative expenses for Q4 2024 were $15.3 million, compared to $8.8 million in Q4 2023, and $62.5 million for the full year 2024, up from $31.4 million in 2023 [6][14] Net Loss - The net loss for Q4 2024 was $89.5 million, or $0.88 per share, compared to a net loss of $66.6 million, or $1.09 per share, in Q4 2023 [9][14] - For the full year 2024, the net loss was $317.4 million, or $3.37 per share, compared to a net loss of $235.9 million, or $3.95 per share, in 2023 [9][14] Business Strategy - The company is focused on advancing therapeutics for genetically driven neuromuscular diseases, leveraging its FORCE™ platform [10] - Dyne is pursuing expedited approval pathways globally for both DYNE-101 and DYNE-251 [7]

Financial Performance - For the year ended December 31, 2024, the company reported a net loss of $317.4 million, compared to a net loss of $235.9 million for 2023, representing an increase in loss of $81.5 million[647]. - As of December 31, 2024, the company had an accumulated deficit of $949.9 million[647]. - Net cash used in operating activities was $292.4 million in 2024, compared to $188.2 million in 2023, indicating a 55.5% increase in cash outflow[680]. - Interest income for 2024 was $26.9 million, up from $7.6 million in 2023, reflecting a significant increase due to higher cash balances[668]. - Net cash provided by financing activities reached $809.9 million in 2024, a substantial increase from $54.3 million in 2023[682]. Expenses - Research and development expenses for 2024 were $281.4 million, up from $210.8 million in 2023, reflecting an increase of $70.6 million[663]. - General and administrative expenses increased to $62.5 million in 2024 from $31.4 million in 2023, a rise of $31.1 million[663]. - The total operating expenses for 2024 were $343.9 million, compared to $242.2 million in 2023, marking an increase of $101.7 million[663]. - Research and development expenses for DYNE-101 rose to $74.1 million in 2024 from $67.1 million in 2023, a 10.5% increase, while DYNE-251 expenses increased by 41.4% to $90.5 million[664][665]. - General and administrative expenses surged to $62.5 million in 2024 from $31.4 million in 2023, marking a 99.5% increase[667]. - The company expects to incur significant expenses related to developing commercialization capabilities if any product candidates are approved[648]. - The company anticipates increased expenses related to ongoing clinical development of product candidates DYNE-101 and DYNE-251[685]. Cash and Funding - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $642.3 million[672]. - The company believes its existing cash and marketable securities will fund operations into the second half of 2026[651]. - The company expects to fund its operating expenses into the second half of 2026 based on current cash reserves and projections[686]. - The company issued 3,800,465 shares of common stock in 2024, generating net proceeds of $97.9 million at an average price of $26.86 per share[675]. Agreements and Obligations - The company has entered into a license agreement with the University of Mons, with payment obligations contingent upon achieving specified development, regulatory, and commercial milestones[690]. - A lease agreement for office and laboratory space has been established, with a base rent obligation starting at $0.4 million per month, increasing to $0.5 million per month over the lease term[691]. - A master manufacturing services agreement has been signed with a CMO, obligating the company to compensate the CMO at least $60 million for production through 2026[692]. Accounting Policies - The company emphasizes the importance of accrued research and development expenses as a critical accounting policy, which is expected to have a material impact on financial condition and results of operations[694]. - The company estimates accrued research and development expenses based on contracts and service provider communications, with no material differences reported to date between estimates and actual incurred amounts[696]. - Stock-based compensation is measured using the Black-Scholes option-pricing model, with expenses recognized over the requisite service period[697]. Risk Factors - The investment portfolio includes cash, cash equivalents, and marketable securities, with no material impact from interest rate changes reported for the years ended December 31, 2024, 2023, and 2022[703][704]. - The company is exposed to foreign currency exchange risk from contracts with vendors outside the U.S., but changes in exchange rates did not materially impact financial results for the years ended December 31, 2024, 2023, and 2022[705][706].

Core Insights - Dyne Therapeutics will present data from its ongoing DELIVER and ACHIEVE clinical trials at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, highlighting advancements in targeted therapeutics for neuromuscular diseases [1][5] Group 1: Presentations - The company will conduct two oral presentations on March 19, 2025, focusing on the DELIVER trial for Duchenne muscular dystrophy (DMD) and the ACHIEVE trial for myotonic dystrophy type 1 (DM1) [2] - The DELIVER trial presentation will cover safety and efficacy data for DYNE-251 in males with DMD mutations amenable to exon 51 skipping [2] - The ACHIEVE trial presentation will discuss safety and efficacy data for DYNE-101 in adults with DM1 [2] Group 2: Symposium and Platform - A symposium titled "Harnessing the FORCE™ Platform to Advance Targeted Therapies for Neuromuscular Diseases" will take place on March 18, 2025, detailing the platform's capabilities and data from the lead clinical programs in DM1 and DMD [5] - The FORCE™ platform is designed to deliver targeted therapeutics to muscle and the central nervous system (CNS), showcasing its potential in treating genetically driven neuromuscular diseases [6] Group 3: Conference Details - The MDA conference will feature poster presentations from March 16 to March 18, 2025, providing additional insights into Dyne's research and clinical programs [3][4]

Core Insights - Dyne Therapeutics will present data from two clinical trials at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference, focusing on Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) [1][5] Group 1: Presentations - The company will have two oral presentations: one on the DELIVER trial for DYNE-251 in DMD and another on the ACHIEVE trial for DYNE-101 in DM1 [2][5] - The DELIVER trial presentation will cover safety and efficacy data for males with DMD mutations amenable to exon 51 skipping [2] - The ACHIEVE trial presentation will focus on safety and efficacy data in adults with DM1 [2] Group 2: Poster Sessions - Poster presentations will occur from March 16 to March 18, featuring various studies related to neuromuscular diseases [3][8] - Topics include real-world data on myotonic dystrophy type 1 and the FORCE™ platform's impact on muscle function in facioscapulohumeral muscular dystrophy [8] Group 3: Symposium - A symposium titled "Harnessing the FORCE™ Platform to Advance Targeted Therapies for Neuromuscular Diseases" will take place on March 18, detailing the platform's capabilities and data from the lead clinical programs [5][7] Group 4: Company Overview - Dyne Therapeutics is dedicated to developing innovative therapeutics for genetically driven neuromuscular diseases, utilizing its FORCE™ platform to target muscle and the central nervous system [6]

Group 1 - Dyne Therapeutics, Inc. (DYN) has experienced significant selling pressure, resulting in a 10.4% decline in stock price over the past four weeks, but it is now considered to be in oversold territory, indicating a potential for recovery [1] - The Relative Strength Index (RSI) for DYN is currently at 29.98, suggesting that the stock is nearing a point of reversal due to the exhaustion of heavy selling [5] - Analysts have raised earnings estimates for DYN, with a 0.4% increase in the consensus EPS estimate over the last 30 days, which typically correlates with price appreciation [6] Group 2 - DYN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a turnaround [7]

Core Insights - Dyne Therapeutics, Inc. is a clinical-stage company focused on developing innovative therapeutics for genetically driven neuromuscular diseases [3] Group 1: Company Overview - Dyne Therapeutics is dedicated to discovering and advancing life-transforming therapeutics for individuals with genetically driven neuromuscular diseases [3] - The company utilizes its FORCE™ platform to create targeted therapeutics aimed at improving delivery to muscle tissue and the central nervous system (CNS) [3] - Dyne has a diverse pipeline addressing various neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease [3] Group 2: Upcoming Events - Management is scheduled to present during a virtual fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025, at 4:00 p.m. ET [1] - A live webcast of the presentation will be available on Dyne's website, with a replay accessible for 90 days following the event [2]

Core Viewpoint - Dyne Therapeutics, Inc. (DYN) has experienced a significant decline of 42.2% over the past four weeks, but it is now positioned for a potential trend reversal as it enters oversold territory, with analysts predicting better earnings than previously expected [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to determine if a stock is oversold, with a reading below 30 typically indicating oversold conditions [2] - DYN's current RSI reading is 18.47, suggesting that the heavy selling pressure may be exhausting, indicating a potential bounce back towards equilibrium [5] Group 2: Fundamental Analysis - There is strong consensus among sell-side analysts that earnings estimates for DYN have increased by 0.4% over the last 30 days, which often correlates with price appreciation [6] - DYN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [7]