• Matteo Levisetti, M.D., promoted to Chief Medical Officer, effective January 17, 2023
• Acting CMO Kenneth Pienta, M.D., to transition to a clinical advisory role

Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, announced today that Matteo Levisetti, M.D., senior vice president (SVP) of clinical development at Cue Biopharma, has been promoted to Chief Medical Officer (CMO) effective January 17, 2023. Current acting CMO Kenneth Pienta, M.D., has transitioned from his current role and will serve as a clinical advisor to the company effective as of the same date.

“We are very pleased to announce the appointment of Dr. Levisetti as our new chief medical officer,” said Daniel Passeri, chief executive officer of Cue Biopharma. “Throughout his tenure as SVP of clinical development and having worked alongside Dr. Pienta for almost two years, Dr. Levisetti has contributed much to our progress in the clinical development of CUE-101 and CUE-102. Dr. Levisetti has also been responsible for building a strong team of dedicated professionals within the clinical group. We have tremendous confidence that as newly appointed CMO, Dr. Levisetti will continue to build on the foundational principles that Dr. Pienta helped to establish, positioning our company to achieve additional key clinical milestones, and supporting our continued progress forward throughout the coming year and beyond.”

Mr. Passeri, added, “I also want to take the opportunity to personally thank Dr. Pienta for providing his depth of experience and expertise in oncology since the early stages of Cue Biopharma’s corporate development in 2016. His clinical leadership and advice have been a cornerstone to the company’s evolution and progress. As acting CMO, Dr. Pienta not only helped bring two cancer drug candidates to the clinic, CUE-101 and CUE-102, but also established a network of top tier clinical sites in collaboration with leading clinicians, principal investigators and key opinion leaders. On behalf of Cue Biopharma, we thank him for his invaluable service and tremendous contributions as well as his profound commitment to patients. We are fortunate to have continuity to access Ken’s guidance and clinical expertise in his new advisory role.”

Dr. Levisetti stated, “It is with great honor that I take this new role as CMO. I am grateful to have worked with Dr. Pienta these past two years which will help to ensure a seamless and smooth transition. I look forward to leading the advancement of Cue Biopharma’s promising oncology pipeline, as I believe the company’s unique platform assets and derivatives could be a breakthrough development with great potential to change the current treatment landscape for people with cancer.”

Dr. Pienta added, “I would like to thank Dan, the leadership team and the many employees I had the privilege of working with these past years for their meaningful work and dedication. I am immensely proud to have helped advance the company’s promising Immuno-STAT™ platform into the clinic and I am excited to continue seeing great progress in potentially making Cue Biopharma’s therapies available to patients who need them most. Dr. Levisetti has been invaluable to the clinical development process, and I strongly believe that the company is in the best hands for its next phase of growth.”

Dr. Levisetti holds extensive experience leading global clinical development for mid and large-size pharmaceutical companies. Prior to joining Cue Biopharma in 2021, he held CMO positions at DNAtrix and previously at Dauntless Pharmaceuticals, where he directed and managed clinical development and operations, and regulatory strategy for a number of endocrinology and oncology assets. Previously, he directed immuno-oncology programs as executive director of clinical development at Mirati Therapeutics. Before joining Mirati, Dr. Levisetti served as global head & vice president, Translational Medicine, Immunology and Inflammation at Roche Pharma Research & Early Development. Prior to that, he held several senior clinical development positions at Pfizer, where he led multiple early clinical development programs across several therapeutic areas, including endocrinology, immunology and oncology. Dr. Levisetti received his medical degree from the University of Chicago Pritzker School of Medicine and served on the faculty at Washington University School of Medicine prior to his transition to leadership roles in industry.

About Cue Biopharma

Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and biologics are designed to harness the body’s intrinsic immune system as T cell engagers without the need for ex vivo manipulation or broad systemic modulation.

Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.

For more information please visit www.cuebiopharma.com and follow us on Twitter at https://twitter.com/CueBiopharma.

Forward-Looking Statements 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the safe harbor created by those sections. Such forward-looking statements include, but are not limited to, those regarding the company’s business strategies, plans and prospects. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s limited operating history, limited cash and a history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies, its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including COVID-19, including possible effects on the company’s trials; negative or inconclusive results from the company’s clinical trials or preclinical studies or serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future; operations and clinical the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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