Core Viewpoint - HilleVax, Inc. (HLVX) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system emphasizes the importance of earnings estimate revisions, which are strongly correlated with stock price movements, particularly due to institutional investors' reliance on these estimates for valuation [4][6]. - For HilleVax, the Zacks Consensus Estimate for the fiscal year ending December 2025 remains at -$0.58 per share, unchanged from the previous year, but analysts have increased their estimates by 57.4% over the past three months [8]. Zacks Rating System - The Zacks Rank stock-rating system categorizes stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - HilleVax's upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting a strong potential for near-term price appreciation due to favorable earnings estimate revisions [10].

[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported a net loss of $6.1 million for Q1 2025, a significant reduction from $46.8 million in Q1 2024, driven by lower operating expenses after program discontinuation [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $178.8 million as of March 31, 2025, from $192.7 million, primarily due to reduced cash and cash equivalents, while liabilities also decreased Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $47,485 | $154,467 | | Marketable securities | $112,054 | $16,965 | | Total current assets | $165,709 | $178,347 | | Total assets | $178,821 | $192,690 | | **Liabilities & Equity** | | | | Total current liabilities | $6,545 | $16,455 | | Total liabilities | $27,908 | $38,204 | | Total stockholders' equity | $150,913 | $154,486 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss significantly improved to $6.1 million in Q1 2025 from $46.8 million in Q1 2024, primarily due to reduced R&D expenses and no in-process R&D costs Statement of Operations Highlights (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $1,983 | $25,978 | | In-process research and development | $0 | $15,325 | | General and administrative | $5,621 | $8,494 | | **Total operating expenses** | **$7,604** | **$49,797** | | Loss from operations | ($7,604) | ($49,797) | | **Net loss** | **($6,061)** | **($46,829)** | | Net loss per share, basic and diluted | ($0.12) | ($0.97) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $12.7 million in Q1 2025, with $94.3 million used in investing activities, leading to a $107.0 million net decrease in cash Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($12,718) | ($33,002) | | Net cash used in investing activities | ($94,264) | ($57,662) | | Net cash provided by financing activities | $0 | $15,062 | | **Net decrease in cash, cash equivalents and restricted cash** | **($106,982)** | **($75,602)** | | Cash, cash equivalents and restricted cash—end of period | $49,116 | $142,707 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, the discontinuation of the HIL-214 program, the $15.0 million Kangh license agreement, debt repayment, and management's liquidity assessment - The company is a biopharmaceutical firm focused on vaccines, exploring strategic alternatives after discontinuing its HIL-214 infant program[19](index=19&type=chunk)[108](index=108&type=chunk) - Management believes current working capital is sufficient to fund operations for at least the next **twelve months** from the financial statement issuance date[21](index=21&type=chunk) - In January 2024, the company entered an exclusive license agreement with Kangh for HIL-216, making an upfront payment of **$15.0 million** expensed as in-process R&D[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) - On July 19, 2024, the company fully repaid its **$26.2 million** outstanding loan with Hercules Capital, terminating the agreement[92](index=92&type=chunk) - Following HIL-214 infant development discontinuation, the company implemented a workforce reduction completed in January 2025 and terminated related vendor contracts[108](index=108&type=chunk)[109](index=109&type=chunk)[113](index=113&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the discontinuation of HIL-214 development due to trial results, significant reduction in Q1 2025 operating expenses, and a strong liquidity position of $159.5 million - The Phase 2b NEST-IN1 trial for HIL-214 in infants did not meet its primary efficacy endpoint, leading to discontinuation of development and exploration of strategic alternatives[116](index=116&type=chunk) - As of March 31, 2025, the company held **$159.5 million** in cash, cash equivalents, and marketable securities, deemed sufficient for at least the next **12 months**[118](index=118&type=chunk)[139](index=139&type=chunk)[149](index=149&type=chunk) - In July 2024, the company fully repaid its term loan facility with Hercules, terminating the agreement[146](index=146&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Total operating expenses drastically decreased to $7.6 million in Q1 2025 from $49.8 million in Q1 2024, driven by reduced R&D and general and administrative costs Comparison of Operations (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $1,983 | $25,978 | $(23,995) | | In-process research and development | $0 | $15,325 | $(15,325) | | General and administrative | $5,621 | $8,494 | $(2,873) | | **Total operating expenses** | **$7,604** | **$49,797** | **$(42,193)** | | **Net loss** | **$(6,061)** | **$(46,829)** | **$40,768** | - The **$24.0 million** decrease in R&D expenses was primarily due to a **$12.9 million** reduction from HIL-214 discontinuation and **$8.0 million** in lower personnel costs[135](index=135&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) The company's capital sources include equity and debt, with **$159.5 million** in cash and equivalents as of March 31, 2025, deemed sufficient for the next 12 months Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,718) | $(33,002) | | Net cash used in investing activities | $(94,264) | $(57,662) | | Net cash provided by financing activities | $0 | $15,062 | - Net cash used in operating activities decreased to **$12.7 million** in Q1 2025 from **$33.0 million** in Q1 2024, primarily due to a smaller net loss[153](index=153&type=chunk)[154](index=154&type=chunk) - Net cash used in investing activities increased to **$94.3 million** in Q1 2025, driven by **$111.3 million** in purchases of marketable securities[155](index=155&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is omitted as the company qualifies as a smaller reporting company - The company has omitted this section as it is not applicable to a smaller reporting company[166](index=166&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the reporting period end[167](index=167&type=chunk) - No material changes occurred in internal control over financial reporting during the quarter[168](index=168&type=chunk) [PART II OTHER INFORMATION](index=32&type=section&id=PART%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - As of the filing date, the company is not a party to any material legal proceedings[170](index=170&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes have occurred to the risk factors disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[171](index=171&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or issuer repurchases during the period - There were no unregistered sales of equity securities or issuer repurchases of equity securities[174](index=174&type=chunk)[175](index=175&type=chunk) [Other Information](index=33&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted or terminated Rule 10b5-1 trading plans or non-Rule 10b5-1 trading arrangements during Q1 2025 - No officers or directors adopted or terminated any Rule 10b5-1 trading plans during the three months ended March 31, 2025[178](index=178&type=chunk) [Exhibits](index=34&type=section&id=Item%206.%20Exhibits) The report includes various exhibits, such as the Non-Employee Director Compensation Program, CEO and CFO certifications, and Inline XBRL documents - Filed exhibits include the Non-Employee Director Compensation Program (10.1), CEO and CFO certifications (31.1, 31.2, 32.1, 32.2), and XBRL data files[179](index=179&type=chunk)

[HilleVax First Quarter 2025 Financial Results and Company Progress](index=1&type=section&id=HilleVax%20First%20Quarter%202025%20Financial%20Results%20and%20Company%20Progress) [Financial Highlights](index=1&type=section&id=Financial%20Highlights) HilleVax significantly reduced its net loss to $6.1 million in Q1 2025, driven by decreased R&D and G&A expenses, with cash reserves at $159.5 million Cash Position (in millions) | Date | Cash, Cash Equivalents & Marketable Securities | | :--- | :--- | | March 31, 2025 | $159.5 | | December 31, 2024 | $171.4 | Quarterly Expense Comparison (Q1 2025 vs Q1 2024, in millions) | Expense Category | Q1 2025 | Q1 2024 | Change Driver | | :--- | :--- | :--- | :--- | | Research & Development | $2.0 | $26.0 | Lower clinical development costs | | General & Administrative | $5.6 | $8.5 | Lower personnel related costs | Quarterly Profitability (Q1 2025 vs Q1 2024, in millions) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Other Income | $1.5 | $3.0 | | Net Loss | $(6.1) | $(46.8) | [Company Overview and Strategy](index=1&type=section&id=Company%20Overview%20and%20Strategy) HilleVax, a clinical-stage biopharmaceutical company, focuses on VLP-based norovirus vaccine candidates and is exploring strategic development and business opportunities - HilleVax's core focus is on developing and commercializing novel vaccines, with initial programs **HIL-214** and **HIL-216** targeting the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus[4](index=4&type=chunk) - The company is actively exploring strategic options, which include the continued development of its norovirus vaccine candidates for adults, business development opportunities, and other strategic alternatives[1](index=1&type=chunk) - Norovirus represents a significant global health and economic burden, causing approximately **700 million cases of AGE**, **200,000 deaths**, and over **$64 billion** in combined direct and societal costs annually[4](index=4&type=chunk) [Condensed Consolidated Financial Statements](index=3&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents HilleVax's unaudited condensed consolidated financial statements, including the Statement of Operations and Balance Sheet, for Q1 2025 and 2024 [Condensed Consolidated Statement of Operations Data](index=3&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations%20Data) Condensed Consolidated Statement of Operations (in thousands, except per share data) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | **2025** | **2024** | | **Operating expenses:** | | | | Research and development | $1,983 | $25,978 | | In-process research and development | — | $15,325 | | General and administrative | $5,621 | $8,494 | | **Total operating expenses** | **$7,604** | **$49,797** | | **Loss from operations** | **$(7,604)** | **$(49,797)** | | **Total other income, net** | **$1,543** | **$2,968** | | **Net loss** | **$(6,061)** | **$(46,829)** | | **Net loss per share, basic and diluted** | **$(0.12)** | **$(0.97)** | | Weighted-average shares outstanding | 49,980,752 | 48,460,185 | [Condensed Consolidated Balance Sheet Data](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) Condensed Consolidated Balance Sheet (in thousands) | | **March 31, 2025** | **December 31, 2024** | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $159,539 | $171,432 | | **Total assets** | **$178,821** | **$192,690** | | **Total liabilities** | **$27,908** | **$38,204** | | **Total stockholders' equity** | **$150,913** | **$154,486** | | **Total liabilities and stockholders' equity** | **$178,821** | **$192,690** |

Core Viewpoint - HilleVax, Inc. reported its financial results for the first quarter of 2025, highlighting a significant reduction in net loss and ongoing development of norovirus vaccine candidates [1][3]. Financial Performance - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $159.5 million, down from $171.4 million as of December 31, 2024 [2][8]. - Research and development expenses for Q1 2025 were $2.0 million, a decrease from $26.0 million in Q1 2024, primarily due to lower clinical development costs [2][7]. - General and administrative expenses for Q1 2025 were $5.6 million, down from $8.5 million in Q1 2024, mainly due to reduced personnel-related costs [3][7]. - Other income for Q1 2025 was $1.5 million, compared to $3.0 million in Q1 2024, driven by lower accretion of marketable securities [3]. - The net loss for Q1 2025 was $6.1 million, significantly reduced from $46.8 million in Q1 2024 [3][7]. Company Overview - HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, specifically targeting norovirus with its candidates HIL-214 and HIL-216 [4]. - Norovirus is responsible for over 700 million cases of acute gastroenteritis globally and results in approximately 200,000 deaths annually, leading to over $4 billion in direct health system costs and $60 billion in societal costs [4].

Financial Performance - The company has incurred significant operating losses of $147.3 million and $123.6 million for the years ended December 31, 2024 and 2023, respectively, and expects to continue incurring losses for the foreseeable future [204]. - The company has no products approved for commercial sale and has not generated any revenue since its inception in 2019, relying heavily on financing through convertible promissory notes, bank debt, and public offerings [201][204]. - The company anticipates that its existing cash and cash equivalents will fund operations for at least the next 12 months, but may need to seek additional funds sooner than planned [207]. - The company may incur significant additional losses if it fails to successfully commercialize its products, either independently or through third-party collaborations [299]. Clinical Development Challenges - The company reported that the clinical trial for its norovirus vaccine candidate HIL-214 did not meet its primary endpoint, with no clinical benefit observed across secondary endpoints [213]. - The company reported that its Phase 2b study for HIL-214 did not meet its primary efficacy endpoint, resulting in plans to discontinue further development of this candidate [220]. - The company may incur additional operating expenses if negative or inconclusive results from clinical trials necessitate further studies [221]. - The company may face challenges in enrolling subjects for clinical trials, which could adversely affect clinical development activities [232]. - Delays in clinical trials can arise from various factors, including regulatory authorizations, recruitment challenges, and manufacturing issues [228]. Regulatory and Compliance Risks - Regulatory approval processes are lengthy and costly, with no guarantee of success, impacting the timeline for commercialization of vaccine candidates [237]. - The company must demonstrate substantial evidence from adequate and well-controlled clinical trials to obtain regulatory approval for its vaccine candidates [238]. - The FDA and other regulatory authorities can delay or deny approval due to disagreements on clinical trial design, negative results, or safety concerns [239]. - The company may face significant risks in obtaining regulatory approvals for its norovirus vaccine candidates in foreign markets, particularly in Europe, which may require additional clinical trials [300]. - The company is subject to various healthcare laws and regulations, which could increase compliance costs and impact its financial condition [309]. Competition and Market Landscape - The company faces significant competition in the biopharmaceutical industry, which may adversely affect its ability to develop and commercialize products [202]. - The company faces intense competition in the vaccine market, with major players like BioNTech, Moderna, and Pfizer dominating global sales [295]. - There are currently no approved vaccines for norovirus-related illness, but several companies are developing candidates, indicating a competitive landscape [296]. - Many competitors possess greater resources and experience, which could impact the company's ability to successfully commercialize its vaccine candidates [297]. Intellectual Property Risks - The company does not own any patent applications or issued patents and relies entirely on intellectual property licensed from third parties, including the Takeda License and the Kangh License [357]. - Any termination of the Takeda License or Kangh License would result in the loss of significant rights, potentially harming the ability to commercialize vaccine candidates HIL-214 and HIL-216 [357]. - The company may face challenges in maintaining, enforcing, and protecting its licensed intellectual property, which could adversely affect the commercialization of its norovirus vaccine candidates [358]. - The company may need to obtain additional licenses to advance its research or commercialize vaccine candidates, which may not be feasible on reasonable terms [357]. Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for vaccine candidates, increasing risks related to supply and cost, which could delay development and commercialization efforts [260]. - There are no long-term supply agreements with third-party manufacturers, raising the risk of failing to obtain sufficient quantities of vaccine candidates on time [262]. - Manufacturing biologics is complex, and any contamination or failure in the manufacturing process could lead to significant delays and increased costs [265]. - The company may need to find alternative manufacturing facilities if current third-party manufacturers do not comply with regulatory requirements, which could significantly impact development timelines [265]. Strategic and Operational Risks - The company may engage in strategic transactions such as acquisitions, which could increase expenses and distract management, potentially affecting financial condition and liquidity [347]. - The company is highly dependent on its management and clinical personnel, and the loss of key individuals could delay product development and commercialization efforts [304]. - The company currently lacks a marketing and sales organization, necessitating significant investment to develop these capabilities for product commercialization [298]. - The company may need to collaborate with third parties for marketing and distribution, which could result in lower product revenue and profitability [299]. Legal and Regulatory Changes - Legislative changes, including cost-containment measures, may affect the company's ability to profitably sell its vaccine candidates [311]. - The company faces significant risks related to product liability claims, which could result in substantial liabilities and limit commercialization efforts [320]. - The company may face penalties for non-compliance with regulatory requirements, which could adversely affect commercialization efforts [275]. - Changes in patent laws or their interpretation may diminish the company's ability to protect intellectual property, affecting its competitive position [350].

Exhibit 99.1 HilleVax Reports Full Year 2024 Financial Results and Highlights Recent Company Progress $171.4 million of cash, cash equivalents and marketable securities as of December 31, 2024 The company is exploring the potential for continued development of its norovirus vaccine candidates in adults as well as business development related activities and other strategic alternatives Net loss for the fourth quarter 2024 was $33.9 million and $147.3 for the year ended December 31, 2024, compared to $37.0 mi ...

Core Insights - HilleVax, Inc. reported a net loss of $147.3 million for the year ended December 31, 2024, compared to a net loss of $123.6 million for the previous year, indicating a worsening financial position [6][11] - The company had cash, cash equivalents, and marketable securities totaling $171.4 million as of December 31, 2024, down from $303.5 million a year earlier, reflecting a significant decrease in liquidity [2][13] - Research and development expenses decreased to $78.2 million for the full year 2024 from $106.7 million in 2023, primarily due to lower clinical development costs [3][11] - General and administrative expenses increased to $28.8 million for the full year 2024 from $26.7 million in 2023, driven by higher personnel-related costs [4][11] - The company is exploring continued development of its norovirus vaccine candidates and other strategic alternatives [1][7] Financial Performance - Total operating expenses for the year ended December 31, 2024, were $155.3 million, up from $133.3 million in 2023 [11] - Other income for the full year 2024 was $8.0 million, a decrease from $9.8 million in 2023, primarily due to interest expenses related to a term loan repayment [5][11] - The net loss per share for the year was $3.00, compared to $3.04 in the previous year [11] Company Overview - HilleVax is focused on developing and commercializing novel vaccines, with its initial programs targeting norovirus, which causes significant health burdens globally [7] - Norovirus is estimated to result in over 700 million cases of acute gastroenteritis and 200,000 deaths annually, leading to substantial healthcare costs [7]

Financial Performance - The net loss for the nine months ended September 30, 2024, was $113,320,000, compared to a net loss of $86,606,000 for the same period in 2023, representing a 30.8% increase in losses[7]. - The total comprehensive loss for the three months ended September 30, 2024, was $25,707,000, compared to $31,836,000 for the same period in 2023, a decrease of 19.3%[7]. - The net loss for Q3 2024 was $25.8 million, an improvement from a net loss of $31.8 million in Q3 2023, a reduction of $5.99 million[96]. - For the nine months ended September 30, 2024, the company reported a net loss of $113.32 million, compared to a net loss of $86.61 million for the same period in 2023, representing a 30.7% increase in losses[14]. - The company has an accumulated deficit of $501.9 million as of September 30, 2024[83]. Cash and Liquidity - Cash and cash equivalents decreased from $216,678,000 on December 31, 2023, to $103,764,000 on September 30, 2024, a reduction of 52.1%[6]. - As of September 30, 2024, the company had cash, cash equivalents, and restricted cash totaling $105.40 million, down from $210.13 million at the end of the previous period[14]. - The net cash used in operating activities for the nine months ended September 30, 2024, was $90.60 million, an increase from $65.18 million in the prior year, indicating a 38.9% rise in cash outflows[14]. - The total net cash decrease for the nine months ended September 30, 2024, was $112.9 million, compared to a decrease of $70.9 million for the same period in 2023[107]. - The company anticipates that existing cash, cash equivalents, and marketable securities will meet anticipated cash requirements for at least the next 12 months, although this forecast involves risks and uncertainties[105]. Operating Expenses - The company reported total operating expenses of $119,140,000 for the nine months ended September 30, 2024, compared to $93,054,000 for the same period in 2023, an increase of 28.0%[7]. - Research and development expenses for the three months ended September 30, 2024, were $20,165,000, down 26.0% from $27,308,000 for the same period in 2023[7]. - General and administrative expenses for the nine months ended September 30, 2024, were $22,836,000, up 16.5% from $19,629,000 for the same period in 2023[7]. - Total operating expenses for Q3 2024 were $26.4 million, compared to $33.9 million in Q3 2023, reflecting a decrease of $7.5 million[96]. - The company incurred operating lease expenses of $827,000 for the three months ended September 30, 2024, compared to $780,000 for the same period in 2023, indicating an increase of 6.0%[53]. Equity and Shares - The weighted-average shares of common stock outstanding increased from 39,039,553 for the three months ended September 30, 2023, to 49,382,277 for the same period in 2024, an increase of 26.5%[7]. - As of September 30, 2024, 9,640,604 shares were reserved for issuance under the 2022 Incentive Award Plan, with 3,945,845 shares remaining available for future issuance[70]. - The Company’s stock options activity shows a balance of 5,021,708 options outstanding as of September 30, 2024, with a weighted average exercise price of $14.25[72]. Funding and Capital Structure - The company raised approximately $209.5 million from the sale of 13,529,750 shares of common stock in its IPO in May 2022 and $107.8 million from the sale of 9,200,000 shares in its underwritten public offering in September 2023[16]. - The company completed its IPO on May 3, 2022, selling 13,529,750 shares at $17.00 per share, resulting in net proceeds of approximately $209.5 million[67]. - The company completed an underwritten public offering on September 22, 2023, raising total net proceeds of $107.8 million from the sale of 9,200,000 shares at $12.50 per share[104]. - The company raised aggregate gross proceeds of $137.2 million from convertible promissory notes since inception[83]. - The company may need to finance cash needs through equity offerings, debt financings, or collaborations, which could dilute existing stockholder interests[106]. Impairment and Liabilities - The Company recorded an impairment charge of $8.2 million on long-lived assets for the nine months ended September 30, 2024, due to a significant decline in stock price and market capitalization[29]. - The company recorded a $5.1 million impairment charge related to its operating lease right-of-use asset during the nine months ended September 30, 2024[52]. - Total liabilities decreased from $78,909,000 on December 31, 2023, to $36,349,000 on September 30, 2024, a decline of approximately 53.8%[6]. - The company has an obligation to pay Takeda $7.5 million upon achieving a specified development milestone and up to $150 million in sales milestones for HIL-214 products[58]. Research and Development - The company has not generated any revenue since its inception and expects to continue incurring net losses as it develops its norovirus vaccine candidates[16]. - Research and development expenses for the nine months ended September 30, 2024, were $72.7 million, a decrease of $0.7 million from $73.4 million in 2023[98]. - In-process research and development expenses amounted to $15.3 million for the nine months ended September 30, 2024, related to the Kangh License, with no such expenses in 2023[98]. - Research and development expenses primarily consist of salaries, payroll taxes, employee benefits, and external costs related to clinical trials of HIL-214[30]. - The company plans to discontinue further development of its HIL-214 vaccine candidate after it did not meet its primary efficacy endpoint in a recent trial[83]. Legal and Compliance - The company is not currently subject to any material legal proceedings, although it may face claims in the ordinary course of business[118]. - The Company accounts for income taxes under the asset and liability method, recognizing deferred tax assets and liabilities based on expected future tax consequences[36]. - The Company has not recognized any interest or penalties related to unrecognized tax benefits during the periods presented[36].

Financial Performance - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $189.3 million, down from $303.5 million as of December 31, 2023[2] - Research and development expenses for Q3 2024 were $20.2 million, a decrease of 26.5% compared to $27.3 million in Q3 2023[2] - General and administrative expenses for Q3 2024 were $6.2 million, down from $6.6 million in Q3 2023, reflecting a decrease of 6.1%[2] - The net loss for Q3 2024 was $25.8 million, compared to a net loss of $31.8 million in Q3 2023, representing a reduction of 18.5%[2] - The company reported total operating expenses of $26.4 million for Q3 2024, down from $33.9 million in Q3 2023, a decrease of 22.1%[6] - Total assets as of September 30, 2024, were $220.6 million, significantly lower than $344.4 million as of December 31, 2023[7] - Total liabilities decreased to $36.3 million as of September 30, 2024, from $78.9 million at the end of 2023[7] Strategic Development - The company is exploring continued development of its norovirus vaccine candidates and other strategic alternatives[1] - HilleVax's vaccine candidates aim to address the global burden of norovirus, which causes approximately 700 million cases of acute gastroenteritis annually[3] - The company has indicated potential workforce reductions and related strategic activities as part of its future plans[4]

Core Viewpoint - HilleVax, Inc. (HLVX) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling actions that affect stock prices [4]. Recent Performance of HilleVax - For the fiscal year ending December 2024, HilleVax is expected to earn -$2.47 per share, reflecting an 18.8% change from the previous year's reported number [8]. - Over the past three months, the Zacks Consensus Estimate for HilleVax has increased by 4.4%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - HilleVax's upgrade to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].