Spero Therapeutics Strengthens Leadership Team to Advance Immunology Pipeline

Other members of the executive leadership team will assume the chief operating officer's responsibilities following his retirement.

Rhea-AI Summary

Spero Therapeutics (Nasdaq: SPRO) appointed Amy Rock as Chief Regulatory and Quality Officer and Dae Gon Ha as Senior Vice President, Corporate Development.

Rock will lead global regulatory strategy, quality and drug safety monitoring, supporting SP001's clinical development in IgG4-related disease and potential additional indications. Ha will lead investor relations strategy and business development, including evaluating opportunities to expand the immunology pipeline.

Chief Operating Officer Timothy Keutzer will retire effective December 31, 2026, after 11 years at Spero. His work included leading development of Utebzi, the company's legacy program licensed to GSK.

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-4.05% vs previous close $1.06 last price 1.5x rel. volume Open Argus

Details

Market move: SPRO -4.05% vs previous close. executive leadership change

$1.06 – $1.11 Day Range

$62.02M Mkt Cap at Last Price

On Oct 26, the day this news came out, the latest delayed price for SPRO is 4.05% below the previous close. The latest delayed price is $1.06. Relative volume is above average at 1.5x the average.

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Key Figures

COO retirement effective date: December 31, 2026

COO retirement effective date

December 31, 2026

Timothy Keutzer's retirement from Spero

Key Terms

pharmacovigilance, fast track designation, breakthrough therapy designation, orphan drug designation

4 terms

pharmacovigilance medical

"quality, and pharmacovigilance functions"

Pharmacovigilance is the process of monitoring and assessing the safety of medicines after they are on the market, ensuring that any side effects or risks are identified and managed. For investors, it matters because it helps ensure that pharmaceutical companies maintain safe products, which can influence a company’s reputation, regulatory approval, and financial stability over time.

fast track designation regulatory

"FDA Fast Track and Breakthrough Therapy designations"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

breakthrough therapy designation regulatory

"Fast Track and Breakthrough Therapy designations"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

orphan drug designation regulatory

"EMA PRIME and Orphan Drug designations"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• Amy Rock, Ph.D., appointed Chief Regulatory and Quality Officer, bringing extensive experience in global regulatory strategy, clinical development, and with approvals of novel immunotherapies
• Dae Gon Ha, Ph.D., appointed Senior Vice President, Corporate Development, bringing expertise in biopharmaceutical capital markets strategy and business development
• Chief Operating Officer Timothy Keutzer to retire after eleven years of leadership and instrumental contributions to Utebzi (tebipenem pivoxil), Spero's legacy program out licensed to GSK
  

CAMBRIDGE, Mass., Oct. 26, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on advancing next-generation medicines for patients with serious immune-mediated diseases, today announced the appointments of Amy Rock, Ph.D., as Chief Regulatory and Quality Officer and Dae Gon Ha, Ph.D., as Senior Vice President, Corporate Development. The Company also announced that Timothy Keutzer, Chief Operating Officer, will retire from Spero effective December 31, 2026.

Dr. Rock will lead Spero's global regulatory strategy, quality, and pharmacovigilance functions, including engagement with global health authorities to support SP001's clinical development in IgG4-related disease and potential additional indications. Dr. Ha will lead investor relations strategy and business development, including engagement with the investment community and evaluating opportunities to expand the Company's immunology pipeline.

“These appointments represent another important step to bolster our leadership team, as we execute on Spero's immunology-focused strategy, advancing SP001 and evaluating opportunities to expand our pipeline of therapies for immune-mediated diseases,” said Esther Rajavelu, President and Chief Executive Officer of Spero Therapeutics. “Amy brings a strong track record of navigating complex regulatory pathways for innovative therapies, including biologics, and will be instrumental in shaping an efficient global development strategy for SP001. Dae Gon brings a distinctive combination of scientific expertise and deep knowledge of biopharma markets. Together with the recent appointment of Dr. Debra Zack as Chief Medical Officer, these appointments significantly strengthen our ability to advance SP001 and execute our long-term strategy.”

Dr. Rock brings more than 25 years of biopharmaceutical experience spanning regulatory affairs, clinical development and quality-related functions. Most recently, she served as Senior Vice President, Regulatory Sciences at Vir Biotechnology, where she led global regulatory activities for multiple development programs, including GSK-partnered sotrovimab, a monoclonal antibody that received regulatory authorizations and approvals across multiple markets. She also supported programs that received FDA Fast Track and Breakthrough Therapy designations, as well as EMA PRIME and Orphan Drug designations. Previously, Dr. Rock held senior regulatory and clinical development leadership roles at ImmunityBio, Altor BioScience and Cumberland Pharmaceuticals, where she contributed to the development and regulatory advancement of novel immunotherapies and other pharmaceutical products. Dr. Rock holds a Ph.D. in immunology from the University of Kentucky, an MBA from Vanderbilt University and a B.A. in economics from Washington University in St. Louis.

Dr. Ha brings more than nine years of experience in biopharmaceutical equities research and subsequent business development experience. Most recently, he served as Senior Vice President, Head of Strategy and Business Development at Fulcrum Therapeutics, where he was a member of the executive team and led strategic planning, in-licensing and out-licensing initiatives across rare disease programs. Previously, Dr. Ha held biotechnology equity research positions at Stifel, BTIG, and Leerink Partners, advising institutional investors through his coverage of small- and mid-cap biotechnology companies.

Chief Operating Officer Retirement

Spero also announced that Timothy Keutzer will retire as Chief Operating Officer after 11 years of service to the Company, effective December 31, 2026. During his tenure, Mr. Keutzer was instrumental in building Spero’s operational capabilities and played a pivotal role in Spero's growth and development, including leading the Utebzi (tebipenem pivoxil) development program through important clinical and regulatory milestones.

“On behalf of the Board and the entire Spero team, I want to express my deepest appreciation to Tim for his extraordinary dedication and contributions over the past 11 years," said Ms. Rajavelu. "Tim has been an invaluable partner and trusted colleague throughout some of the most consequential chapters in Spero's history. His leadership was central to the advancement of Utebzi, its successful FDA approval and our partnership with GSK, achievements that have helped establish the foundation for Spero's growth. We are deeply grateful for his lasting contributions to Spero and wish him every happiness in his well-deserved retirement."

Following Mr. Keutzer's retirement, his responsibilities will be assumed by other members of Spero's executive leadership team.

About Spero Therapeutics
Spero Therapeutics is a clinical-stage biopharmaceutical company focused on advancing next-generation medicines for patients with serious immune-mediated diseases. The company’s lead program, SP001, is a third-generation, Fc-silent anti-CD40L monoclonal antibody being advanced first in IgG4-related disease, with potential for development in additional immunological & inflammatory diseases. For more information, visit www.sperotx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, but are not limited to, statements relating to Spero's plans to advance SP001 and execute its long-term strategy; and Spero's plans to evaluate opportunities to expand its pipeline of therapies for immune-mediated diseases. Forward-looking statements are based on Spero's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to the completion and integration of the Innovent transaction; Spero's ability to successfully develop SP001; the timing and outcome of clinical trials and regulatory interactions; the ability to obtain and maintain regulatory approvals; potential safety, efficacy, manufacturing, supply, intellectual property, financing, competitive, and market risks; and other risks described in Spero's filings with the Securities and Exchange Commission. Spero undertakes no obligation to update any forward-looking statements, except as required by law.

Investor Relations Contact:
Shai Biran, Ph.D.
Spero Therapeutics
IR@Sperotx.com

Media Inquiries:
media@sperotx.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Who is joining Spero Therapeutics' leadership team?

Amy Rock was appointed Chief Regulatory and Quality Officer, and Dae Gon Ha was appointed Senior Vice President, Corporate Development. Rock will oversee regulatory strategy, quality and drug safety monitoring. Ha will lead investor relations strategy and business development.

When will Spero COO Timothy Keutzer retire, and who will take over his responsibilities?

Timothy Keutzer will retire effective December 31, 2026, and other members of Spero's executive leadership team will assume his responsibilities. He will leave after 11 years of service.