HilleVax Announces Executive Management Appointments and Promotions

Rhea-AI Summary

HilleVax, a clinical-stage biopharmaceutical company, announced key leadership changes including Ozzie Berger as Senior VP of Regulatory Affairs, Anju Chatterji as Chief Technical Officer, and Shane Maltbie as Chief Financial Officer. These promotions are part of a strategic transition aimed at enhancing their Phase 2b trial of HIL-214, a vaccine for norovirus. Berger brings nearly 30 years of experience, while Chatterji and Maltbie have significant backgrounds in technical operations and financial management, respectively. The company emphasizes the ongoing enrollment and expected data readouts from its clinical trials.

Positive

• Appointment of experienced leaders to enhance regulatory and technical operations.
• Focus on advancing the Phase 2b trial of HIL-214 for norovirus.

Negative

• Dependence on the success of HIL-214, which has not completed clinical trials.
• Potential delays in clinical trials due to various uncertainties.

BOSTON, Jan. 09, 2023 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the appointment of Ozzie Berger as Senior Vice President of Regulatory Affairs, the promotion of Anju Chatterji to Chief Technical Officer, and the promotion of Shane Maltbie to Chief Financial Officer. As part of a planned transition in connection with Mr. Maltbie’s promotion, David Socks will focus on business development activities as the company’s Chief Business Officer.

“We are excited to welcome Ozzie to HilleVax and announce the promotions of Anju and Shane as we continue to progress NEST-IN1 our Phase 2b trial of HIL-214 for the prevention of moderate-to-severe norovirus-related acute gastroenteritis,” said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax. “Each of these individuals is an important leader of our organization and will be critical as we work to develop HIL-214.”

Mr. Berger brings to HilleVax nearly three decades of expertise in creating and implementing innovative regulatory strategies across all phases of product development and commercialization. Prior to joining HilleVax, Mr. Berger was Vice President and Global Regulatory Head for GSK’s Vaccine Therapeutic Group, where he led a team whose portfolio included over 40 vaccines worldwide. Mr. Berger was at GSK for over 21 years holding various leadership positions of increasing responsibility within the organization. Prior to GSK, Mr. Berger worked in the regulatory affairs group at Merck.

Dr. Chatterji has more than 20 years of experience implementing CMC development and manufacturing strategies to drive successful global regulatory filings and approvals. She served as Senior Vice President of Technical Operations for HilleVax since joining the company in January 2022. Prior to joining HilleVax, Dr. Chatterji served as SVP of Biologics Development and Manufacturing at Catalyst Biosciences. Prior to Catalyst Biosciences, Dr. Chatterji served as VP of Biologics Manufacturing at Exelixis. Previously, Dr. Chatterji held various leadership positions at Grifols, Novartis Vaccines and Diagnostics, and at Bayer HealthCare.

Mr. Maltbie was previously Vice President of Finance at HilleVax and has two decades of experience in finance operations, including building and leading multiple finance organizations. Mr. Maltbie has been influential in raising over $700 million in capital for various life sciences companies through debt and equity financing and was an important contributor in the HilleVax initial public offering. Prior to joining HilleVax, Mr. Maltbie was the Vice President of Finance at TScan Therapeutics, and prior to that the Vice President of Finance at Axcella where he was instrumental at both companies in building the finance and accounting organizations and executing their initial public offerings. Mr. Maltbie started his career at Deloitte in the audit practice.

Forward-Looking Statements

HilleVax cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, the expected continuation of enrollment in the NEST-IN1 trial and the expected timing of data readouts from this trial. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: we currently depend entirely on the success of HIL-214, and we have not yet completed any clinical trials of HIL-214; potential delays in the commencement, enrollment, and completion of clinical trials and preclinical studies; our dependence on third parties in connection with manufacturing, research and clinical and preclinical testing; unexpected adverse side effects or inadequate immunogenicity or efficacy of HIL-214 or any future vaccine candidates that may limit their development, regulatory approval, and/or commercialization; unfavorable results from clinical trials; results from prior clinical trials and studies not necessarily being predictive of future results; our ability to maintain undisrupted business operations due to the COVID-19 pandemic, including delaying or disrupting our clinical trials, manufacturing and supply chain; regulatory developments in the United States and foreign countries; any future impacts to our business resulting from the conflict between Russia and Ukraine or other geopolitical developments outside our control; our reliance on intellectual property rights under our license agreement with Takeda Vaccines, Inc.; our ability to obtain, maintain and enforce intellectual property protection for our vaccine candidates; we may use our capital resources sooner than we expect; and other risks described in our prior press releases and our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our quarterly report on Form 10-Q and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

About HilleVax

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Its initial program, HIL-214, is a VLP based vaccine candidate in development for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. Globally, norovirus is estimated to result in over approximately 700 million cases of AGE and 200,000 deaths per year, resulting in over $4 billion in direct health system costs and $60 billion in societal costs per year. The burden of norovirus falls disproportionately on young children and older adults. For more information about HilleVax, visit the company’s website at http://www.HilleVax.com.

Contact:

Shane Maltbie
IR@hillevax.com
+1-617-213-5054

FAQ

What new appointments were announced by HilleVax on January 9, 2023?

HilleVax announced the appointments of Ozzie Berger as Senior VP of Regulatory Affairs, Anju Chatterji as Chief Technical Officer, and Shane Maltbie as Chief Financial Officer.

What is the focus of HilleVax's ongoing Phase 2b trial?

The Phase 2b trial focuses on HIL-214, a vaccine candidate for preventing moderate-to-severe norovirus-related acute gastroenteritis.

What expertise does Ozzie Berger bring to HilleVax?

Ozzie Berger brings nearly three decades of expertise in regulatory strategies and product development from his previous role at GSK.

What are the risks mentioned regarding HilleVax's HIL-214 vaccine?

Risks include dependence on HIL-214's success, potential delays in trials, and challenges related to regulatory approvals.

When was the press release announcing these leadership changes published?

The press release was published on January 9, 2023.