Loading... Monday, the company released topline data results from the NEST-IN1 Phase 2b randomized, double-blind, placebo-controlled trial of the efficacy, safety, and immunogenicity of HIL-214 in infants approximately five months of age at the time of initial vaccination. In the NEST-IN1 study, there were 51 primary endpoint events, with 25 in the vaccine arm (n=1,425) and 26 in the placebo arm (n=1,399), resulting in a vaccine efficacy of 5%. "We are disappointed that the NEST-IN1 study did not meet its p ...

The company is exploring the potential for continued development of HIL-214 and HIL-216 in adults In the NEST-IN1 study there were 51 primary endpoint events with 25 in the vaccine arm (n=1,425) and 26 in the placebo arm (n=1,399) resulting in vaccine efficacy of 5% (95% confidence interval; -64%, 45%). The study did not meet its primary endpoint of efficacy against moderate or severe acute gastroenteritis (AGE) events due to GI.1 or GII.4 norovirus genotypes. No clinical benefit was observed across seconda ...

"We sincerely thank the trial investigators, clinical sites and the HilleVax team for conducting a highly rigorous study, and we are deeply appreciative to the infants and families that participated in this trial," said Dr. Hershberg. The NEST-IN1 study was conducted after a Phase 2b study in adults, NOR-211, demonstrated statistically significant efficacy against moderate or severe AGE due to norovirus. The company plans to discontinue further development of HIL-214 in infants and is exploring the potentia ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-41365 HILLEVAX, INC. (Exact Name of Registrant as Specified in its Charter) | Delaware | 85-0545060 | | --- | --- | | (State or o ...

Exhibit 99.1 HilleVax Reports First Quarter 2024 Financial Results and Highlights Recent Company Progress Topline data from NEST-IN1 Phase 2B clinical study of HIL-214 in infants expected in mid-2024 $272.7 million of cash, cash equivalents and marketable securities as of March 31, 2024 BOSTON, May 9, 2024 – HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today reported financial results for the quarter ended March 31, 2024, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-41365 HILLEVAX, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 85-0545060 (State or other jurisdiction of incorp ...

Exhibit 99.1 HilleVax Reports Full Year 2023 Financial Results and Highlights Recent Company Progress Topline data from NEST-IN1 Phase 2B clinical study of HIL-214 in infants expected in mid-2024 Enrollment for NEST-IN1 study completed in Q2 2023 $303.5 million of cash, cash equivalents and marketable securities as of December 31, 2023 BOSTON, March 20, 2024 – HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today reported fi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-41365 HILLEVAX, INC. (Exact Name of Registrant as Specified in its Charter) | Delaware | 85-0545060 | | --- | --- | | (State ...

PART I FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) The unaudited financial statements for H1 2023 show a **$54.8 million** net loss, with cash decreasing to **$244.1 million** due to operations and capital expenditures [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets decreased to **$286.5 million**, liabilities increased to **$67.8 million**, and equity declined to **$218.8 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $158,375 | $279,401 | | Marketable securities | $85,675 | $0 | | Total current assets | $253,039 | $290,613 | | Total assets | $286,522 | $317,211 | | **Liabilities & Equity** | | | | Total current liabilities | $18,338 | $13,046 | | Long-term debt, net | $24,835 | $14,792 | | Total liabilities | $67,759 | $49,982 | | Total stockholders' equity | $218,763 | $267,229 | | Total liabilities and stockholders' equity | $286,522 | $317,211 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net losses for Q2 and H1 2023 were **$27.9 million** and **$54.8 million**, respectively, with operating loss widening due to increased R&D expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2023 | Q2 2022 | 6 Months 2023 | 6 Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $22,953 | $8,826 | $46,117 | $15,037 | | General and administrative | $7,231 | $3,982 | $13,026 | $6,585 | | **Loss from operations** | **($30,184)** | **($12,808)** | **($59,143)** | **($24,122)** | | Total other income (expense) | $2,282 | ($41,121) | $4,352 | ($97,694) | | **Net loss** | **($27,902)** | **($53,929)** | **($54,791)** | **($121,816)** | | Net loss per share | ($0.74) | ($2.03) | ($1.45) | ($7.30) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash decreased by **$121.0 million** in H1 2023, driven by **$38.4 million** used in operations and **$92.9 million** in investing activities Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($38,371) | ($23,925) | | Net cash used in investing activities | ($92,933) | ($2,500) | | Net cash provided by financing activities | $10,278 | $218,102 | | **Net (decrease) increase in cash** | **($121,026)** | **$191,677** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the **HIL-214** vaccine, Takeda license, Hercules loan, and ATM program, confirming sufficient capital for **12 months** - The company is a biopharmaceutical firm focused on developing and commercializing novel vaccines, with its initial candidate being **HIL-214**. It has funded operations through convertible notes, debt, and its May 2022 IPO[20](index=20&type=chunk)[23](index=23&type=chunk) - Under the Takeda License, HilleVax is obligated to pay a **$7.5 million** development milestone, up to **$150.0 million** in sales milestones, and tiered royalties on net sales of **HIL-214** products[80](index=80&type=chunk) - The company entered a loan agreement with Hercules Capital for up to **$75.0 million**. As of June 30, 2023, **$25.0 million** has been borrowed. A June 2023 amendment modified the borrowing conditions and periods for the remaining tranches[90](index=90&type=chunk)[91](index=91&type=chunk) - In May 2023, the company established an At-the-Market (ATM) equity offering program to sell up to **$100.0 million** of common stock. No shares had been sold under this program as of June 30, 2023[98](index=98&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses **HIL-214** development, a **$54.8 million** net loss, increased operating expenses, and **$244.1 million** in capital for **12 months** - The company's primary focus is **HIL-214**, a vaccine candidate for norovirus-induced acute gastroenteritis. The Phase 2b trial, **NEST-IN1**, is ongoing, with top-line safety and efficacy data expected in mid-2024[114](index=114&type=chunk) - The company believes its existing cash, cash equivalents, and marketable securities of **$244.1 million** as of June 30, 2023, are sufficient to fund operations for at least the next **12 months**[118](index=118&type=chunk)[143](index=143&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Operating expenses rose in H1 2023, with R&D up **$31.1 million** and G&A up **$6.4 million**, while net loss decreased due to non-recurring adjustments Comparison of Operating Expenses (in thousands) | Expense Category | 6 Months 2023 | 6 Months 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $46,117 | $15,037 | $31,080 | | General and administrative | $13,026 | $6,585 | $6,441 | | **Total operating expenses** | **$59,143** | **$24,122** | **$35,021** | - The increase in R&D expenses for the six months ended June 30, 2023, was primarily due to **$22.6 million** in clinical development expenses for **HIL-214** and a **$6.9 million** increase in personnel-related costs[139](index=139&type=chunk) - The increase in G&A expenses for the six months ended June 30, 2023, was mainly driven by a **$4.0 million** increase in personnel-related costs and **$1.5 million** in facility and other expenses[141](index=141&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds **$244.1 million** in liquidity, funded by IPO proceeds and a Hercules loan, with a **$100 million** ATM program for future needs - The company has a term loan facility of up to **$75.0 million** with Hercules Capital. In June 2023, it borrowed an additional **$10.0 million**, bringing the total outstanding balance to **$25.3 million** (including PIK interest)[144](index=144&type=chunk)[145](index=145&type=chunk)[148](index=148&type=chunk) - On May 12, 2023, the company entered into an At-the-Market (ATM) Sales Agreement to offer and sell up to **$100.0 million** of its common stock. As of June 30, 2023, no sales have been made under this agreement[151](index=151&type=chunk) - The company expects its existing cash, cash equivalents, and marketable securities will be sufficient to complete enrollment and dosing in the Phase 2b **NEST-IN1** study and report top-line data[152](index=152&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - Not applicable to a smaller reporting company[169](index=169&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2023, with no material changes to internal controls - Management concluded that as of June 30, 2023, the company's disclosure controls and procedures were effective[170](index=170&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[171](index=171&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not currently subject to any material legal proceedings[173](index=173&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors previously disclosed in the 2022 Annual Report on Form 10-K - There have been no material changes to the risk factors disclosed in the Annual Report on Form 10-K for the year ended December 31, 2022[174](index=174&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales; **$97.1 million** of **$209.5 million** IPO proceeds used for general corporate purposes and **HIL-214** development - The company's IPO on May 3, 2022, resulted in net proceeds of approximately **$209.5 million**[177](index=177&type=chunk) - As of June 30, 2023, approximately **$97.1 million** of the IPO proceeds have been used for general corporate purposes, including the clinical development of **HIL-214**[178](index=178&type=chunk) [Other Information](index=36&type=section&id=Item%205.%20Other%20Information) No other information is required to be reported for this period - None[182](index=182&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-41365 HILLEVAX, INC. (Exact Name of Registrant as Specified in its Charter) If an emerging growth company, indicate by check mark ...