“2022 was a momentous year for HilleVax where the company achieved many important milestones including the initiation and execution of our Phase 2b clinical trial NEST-IN1 and the completion of our initial public offering,” said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax.  “We look forward to completing enrollment of our NEST-IN1 clinical trial in 2023 and announcing top line safety and clinical efficacy data in the first quarter of 2024.”

Recent Business Highlights

• In Q4 2022, HilleVax announced positive immunogenicity results for the NEST-IN1 run-in cohort.
• In Q3 2022, HilleVax announced the positive recommendation by the safety data monitoring committee to continue enrollment of the remaining 2,800 subjects in the NEST-IN1 clinical trial after the evaluation of safety data from the prespecified 200 subject run-in. 

Upcoming Expected Milestones

• Topline safety and clinical efficacy data from NEST-IN1 in the first quarter of 2024.

Full Year 2022 Financial Results

As of December 31, 2022, the company had cash and cash equivalents totaling $279.4 million.

Research and development expenses for the fourth quarter 2022 were $17.6 million and $45.9 million for the full year ended December 31, 2022, compared to $8.4 million for the fourth quarter 2021 and $10.0 million for the full year ended December 31, 2021.

General and administrative expenses for the fourth quarter 2022 were $5.5 million and $16.7 million for the full year ended December 31, 2022, compared to $2.7 million for the fourth quarter 2021 and $5.8 million for the full year ended December 31, 2021.

Other income for the fourth quarter 2022 was $1.9 million, compared to $26.3 million of other expense for the fourth quarter 2021. The other income in the fourth quarter of 2022 was primarily driven by interest income on the company’s cash and cash equivalents while the other expense in the fourth quarter of 2021 was primarily driven by changes in the fair value of convertible promissory notes and warrant liabilities and interest expense on outstanding convertible debt.

Other expense for the full year ended December 31, 2022 was $94.7 million, compared to $49.0 million for the full year ended December 31, 2021. The other expense in 2022 was primarily driven by changes in the fair value of convertible promissory notes and warrant liabilities and interest expense on our convertible promissory notes, offset by interest income on the company’s cash and cash equivalents. The other expense in 2021 was primarily driven by changes in the fair value of convertible promissory notes and warrant liabilities and interest expense on outstanding convertible debt.

Net loss for the fourth quarter 2022 was $21.2 million and $159.8 million for the full year ended December 31, 2022, compared to $37.3 million for the fourth quarter 2021 and $102.4 million for the full year ended December 31, 2021.