Dyne Therapeutics Announces Key Leadership Appointments

Rhea-AI Summary

Dyne Therapeutics (Nasdaq: DYN) announced key leadership appointments to drive its next phase of growth and prepare for potential commercialization. Doug Kerr, M.D., Ph.D., MBA, has been appointed chief medical officer, succeeding Wildon Farwell, M.D., MPH. Johanna Friedl-Naderer joins as chief commercial officer, and Lucia Celona as chief human resources officer.

These appointments aim to support Dyne's transition into a fully integrated biotech company, focusing on expedited approval pathways for its myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) programs. The new leaders bring extensive experience in launching rare disease therapies globally and building teams with expertise in these areas.

Simultaneously, Susanna High, MBA, chief operating officer, and Jonathan McNeill, M.D., chief business officer, are stepping down to pursue other opportunities. The company emphasizes its solid foundation and potential for future success with its clinical programs and robust pipeline for rare muscle diseases.

Positive

• Appointment of experienced leaders in rare disease therapies and global commercialization
• Focus on expedited approval pathways for DM1 and DMD programs
• Transition towards becoming a fully integrated biotech company
• Solid foundation with two clinical programs showing potential best-in-class profiles
• Robust pipeline for rare muscle diseases

Negative

• Departure of key executives including COO and CBO

Insights

Medical Research Analyst

The appointment of Doug Kerr as CMO is a strategic move for Dyne Therapeutics. His extensive experience in neurology and rare diseases, particularly his work on spinal muscular atrophy (SMA) at Biogen, aligns well with Dyne's focus on muscle diseases. This expertise could accelerate the development of Dyne's DM1 and DMD programs.

The retention of the outgoing CMO, Wildon Farwell, through 2024 ensures continuity in clinical execution, which is important for maintaining momentum in the company's expedited approval pathways. This transition period is a positive sign for investors, indicating a smooth handover of critical responsibilities.

However, the departure of the COO and CBO might raise concerns about operational stability. Investors should monitor how these roles are filled or redistributed to ensure no disruption to ongoing programs.

Market Research Analyst

The appointment of Johanna Friedl-Naderer as CCO is a significant move towards commercialization readiness. Her track record of successful product launches in rare diseases across multiple markets is particularly relevant for Dyne's global ambitions. This hire suggests the company is preparing for potential near-term product approvals, which is a positive signal for investors.

The addition of Lucia Celona as CHRO indicates a focus on organizational scaling and talent management, important for a company transitioning from clinical-stage to commercial operations. Her experience in building global rare disease organizations aligns well with Dyne's growth trajectory.

These appointments collectively signal Dyne's transition from a purely R&D-focused entity to a fully integrated biotech company. This evolution could potentially unlock new value for shareholders, but also brings execution risks that investors should monitor closely.

- Building Team to Prepare for Commercialization as Company Pursues Expedited Approval Pathways for DM1 and DMD Clinical Programs -

WALTHAM, Mass., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced key leadership appointments to drive its next phase of growth and operational success. Doug Kerr, M.D., Ph.D., MBA, has been appointed chief medical officer (CMO) succeeding Wildon Farwell, M.D., MPH, who is stepping down from his role and will remain at Dyne full-time through the end of 2024 to assist in the continued successful execution of the company’s clinical plans, including advancing its myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) programs toward registration. In addition, Johanna Friedl-Naderer is joining Dyne as chief commercial officer and Lucia Celona has been appointed chief human resources officer.

“As Dyne enters its exciting next chapter of becoming a fully integrated biotech company, I’m pleased to welcome Doug, Johanna and Lucia to the leadership team. They bring to Dyne tremendous experience in launching rare disease therapies globally, all while building and leading teams with proven expertise in these areas. This will be invaluable as we prepare for the potential of expedited approval, registration and commercialization of our co-lead DM1 and DMD programs,” said John Cox, Dyne’s president and chief executive officer. “Together we will build on the impressive progress the team has already made as we work towards advancing our mission to deliver life-transforming therapies for patients with serious muscle diseases.”

• Doug Kerr, M.D., Ph.D., MBA, chief medical officer (CMO), brings more than 25 years of expertise in early-and late-stage clinical development, with deep experience in neurology. For the last year, Dr. Kerr was a venture partner at Atlas Venture. From 2017 to 2023, he was an integral member of Generation Bio, joining initially as the head of research and development and most recently serving as its CMO. Previously, he oversaw neurology-focused franchises at Shire, and prior to that he held senior positions at Biogen where he was the global lead for a series of programs in Alzheimer’s disease, amyotrophic lateral sclerosis (ALS) and spinal muscular atrophy (SMA). Dr. Kerr holds a B.A. in biochemistry from Princeton University and an M.D. from Jefferson Medical College, as well as his Ph.D. in molecular biology from Thomas Jefferson University. He obtained his MBA, with a specialization in entrepreneurship and finance from Northeastern University and completed his medical residency at Johns Hopkins School of Medicine and served on their faculty for 10 years.
  
  
• Johanna Friedl-Naderer, chief commercial officer (CCO), brings more than two decades of biopharmaceutical industry experience in global commercialization including product launches in rare disease. Most recently Ms. Friedl-Naderer served as executive vice president and chief operating officer of Vir Biotechnology in the field of infectious disease. As president Europe, Canada & Partner Markets for Biogen, she led her team to successfully launch multiple specialty and rare disease products across 35 markets, impacting the lives of hundreds of thousands of patients. Ms. Friedl-Naderer was a member of Biogen’s global leadership team where she was accountable for the entire portfolio across therapeutic areas in her respective geographic region and managed a multibillion-dollar financial portfolio which doubled under her leadership. During her more than 20-year tenure at Biogen, she held positions of increasing responsibility across a wide range of functions, building and leading teams in advancing access to groundbreaking medicines for the treatment of devastating neurological conditions, including multiple sclerosis, SMA, ALS and Alzheimer’s disease. Ms. Friedl-Naderer has also served on several boards including the European Federation of Pharmaceutical Industries & Associations (EFPIA).
  
  
• Lucia Celona, chief human resources officer (CHRO), brings more than 30 years of experience in organizational design and effectiveness, talent management and developing programs that enhance employee engagement and drive operational excellence. At Biogen, she served as the vice president of HR for pharmaceutical operations & technology, where she was the lead HR business partner responsible for the strategic partnership with senior leaders and driving HR strategies that enabled commercial success. Following her tenure at Biogen, she became the chief HR and communications officer at Bioverativ playing an integral role in building a global rare disease organization to support multiple product launches. Additionally, she oversaw the HR and corporate communications functions at Apellis, supporting the organizational build to commercial launch. From 2020-2022, she served as CHRO for Repertoire Immune Medicines, where she collaborated with leadership to build the organization, develop talent, and design effective people programs. Most recently, she operated her own consulting practice focused on providing fractional CHRO services to small to mid-size life sciences companies. Ms. Celona earned her B.S. in accounting from Bentley University.
  

In addition, the company announced that Susanna High, MBA, chief operating officer, and Jonathan McNeill, M.D., chief business officer, have decided to step down from their roles to pursue other opportunities.

“I want to thank Wildon, Susanna and Jonathan for their many contributions to Dyne. Their leadership has been instrumental in guiding the company to where it is today – two clinical programs with potential best-in-class profiles, a robust pipeline for rare muscle diseases and a solid foundation that has positioned us well for future success,” said Mr. Cox.

About Dyne Therapeutics

Dyne Therapeutics is a clinical-stage muscle disease company focused on 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. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn 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 anticipated timelines for reporting additional data from the ACHIEVE and DELIVER clinical trials and initiating registrational cohorts, expectations regarding the timing and outcome of interactions with global regulatory authorities and the availability of accelerated approval pathways for DYNE-101 and DYNE-251, 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 initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; the timing of and Dyne’s ability to enroll patients in clinical trials; whether results from preclinical studies and initial data from early clinical trials will be predictive of the final results of the clinical trials or future trials; uncertainties as to the FDA’s and other regulatory authorities’ interpretation of the data from Dyne's clinical trials and acceptance of Dyne's clinical programs and the regulatory approval process; whether Dyne’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; 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.

Contacts:

Investors
Amy Reilly
areilly@dyne-tx.com
857-341-1203

Media
Stacy Nartker
snartker@dyne-tx.com
781-317-1938

Photos accompanying this announcement are available at: 
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FAQ

What key leadership appointments did Dyne Therapeutics (DYN) announce?

Dyne Therapeutics announced the appointment of Doug Kerr as chief medical officer, Johanna Friedl-Naderer as chief commercial officer, and Lucia Celona as chief human resources officer.

What are the main clinical programs Dyne Therapeutics (DYN) is focusing on?

Dyne Therapeutics is focusing on myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) programs, pursuing expedited approval pathways for both.

Why is Dyne Therapeutics (DYN) making these leadership changes?

Dyne is making these changes to prepare for its next phase of growth, potential commercialization, and transition into a fully integrated biotech company, leveraging the new leaders' experience in launching rare disease therapies globally.

Which executives are leaving Dyne Therapeutics (DYN)?

Susanna High, chief operating officer, and Jonathan McNeill, chief business officer, are stepping down from their roles at Dyne Therapeutics to pursue other opportunities.