WALTHAM, Mass., March 20, 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 it has granted inducement equity awards to its newly appointed Chief Financial Officer, Erick J. Lucera. The awards were approved by the Compensation Committee of Dyne and made as an inducement material to Mr. Lucera's acceptance of employment with Dyne under Dyne ...

Erick J. Lucera Erick J. Lucera, Chief Financial Officer (CFO) of Dyne Therapeutics - Proven financial leader brings decades of experience in capital allocation, business development and shareholder value creation - WALTHAM, Mass., March 20, 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 the appointment of Erick J. Lucera, as chi ...

Core Insights - Dyne Therapeutics is advancing DYNE-251, a therapeutic for Duchenne muscular dystrophy (DMD), showing significant functional improvements in clinical trials [2][3][4] - The DELIVER trial has fully enrolled its registrational expansion cohort, with data expected in late 2025 and a potential Biologics License Application submission for U.S. accelerated approval anticipated in early 2026 [2][13] Group 1: Clinical Trial Results - The DELIVER trial demonstrated unprecedented and sustained functional improvement at the registrational dose of 20 mg/kg Q4W, with meaningful improvements observed in multiple functional endpoints [2][4] - At the 6-month mark, patients receiving 20 mg/kg of DYNE-251 exhibited a mean absolute dystrophin expression of 8.72% of normal, indicating significant clinical efficacy [4][10] - Safety data as of February 7, 2025, continues to show a favorable profile for DYNE-251, with no new treatment-related serious adverse events reported [13] Group 2: Regulatory Pathway and Future Plans - The company is leveraging dystrophin expression as a surrogate endpoint for regulatory submissions, with the FDA's precedent for using dystrophin as a biomarker for accelerated approval still available [5][13] - Dyne Therapeutics has fully enrolled a registrational expansion cohort of 32 patients in the DELIVER trial, with plans for data release in late 2025 [13] - The potential for rapid adoption of DYNE-251 by physicians and patients is anticipated if the therapy receives approval [3][13] Group 3: Industry Context - DMD is a rare genetic disorder affecting approximately 12,000 to 15,000 individuals in the U.S. and 25,000 in Europe, characterized by progressive muscle degeneration due to lack of dystrophin [14] - Current therapies for DMD provide limited benefits, highlighting the urgent need for effective treatments like DYNE-251 [14][15] - Dyne Therapeutics is building a global DMD franchise, with ongoing preclinical programs targeting other exons beyond exon 51 [11][15]

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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 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]

- Data from DELIVER and ACHIEVE Clinicals Trial to be Presented - - Presentation on ACHIEVE Trial in DM1 and Company Symposium to Feature Data on the Use of Splicing Correction as a Prognostic Biomarker of Functional Outcomes in DM1 - - Presentations Add Insights into the FORCE™ Platform’s Ability to Deliver Targeted Therapeutics to Muscle and the CNS - WALTHAM, Mass., Feb. 14, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular disease company focused on advancin ...