Private company
HilleVax, Inc.
In its 2025 annual report the company says: “We are a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year, as well as significant additional economic and social burden.”4 It is headquartered in Boston, Massachusetts.1
Last updated Oct 21, 2026.
Overview
- IndustryBiological Products, (No Diagnostic Substances)1
- HeadquartersBoston, Massachusetts1
- Incorporated inDE2
- Business address321 Harrison Ave, Suite 500, Boston, Ma 021182
- Filer category, Emerging growth company2
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We are a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year, as well as significant additional economic and social burden. To date, HIL-214 has been studied in nine clinical trials conducted by Takeda Vaccines, Inc. (Takeda) and its predecessor, LigoCyte Pharmaceuticals, Inc. (LigoCyte), which collectively generated safety data from more than 4,500 subjects and immunogenicity data from more than 2,200 subjects, including safety and immunogenicity data from more than 800 pediatric subjects. A randomized, placebo-controlled Phase 2b field ef…4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Financial statements
| Fiscal year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Operating expenses | $53.4M5 | $65.1M6 | $133.3M7 | $155.3M7 | ||
| Operating income | -$53.4M5 | -$65.1M6 | -$133.3M7 | -$155.3M7 | ||
| Interest | $2.8M5 | $3.4M6 | $2.4M6 | |||
| Net income | -$102.4M5 | -$159.8M6 | -$123.6M7 | -$147.3M7 | ||
| Earnings per share | -$18.225 | -$5.896 | -$3.047 | -$3.007 | ||
| Earnings per share (diluted) | -$18.225 | -$5.896 | -$3.047 | -$3.007 | ||
| Shares (weighted, basic) | 5.6M shares5 | 27.1M shares6 | 40.6M shares7 | 49.2M shares7 | ||
| Shares (weighted, diluted) | 5.6M shares5 | 27.1M shares6 | 40.6M shares7 | 49.2M shares7 |
| Fiscal year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Cash | $124.6M5 | $279.4M6 | $216.7M7 | $154.5M7 | ||
| Current assets | $124.7M5 | $290.6M6 | $310.7M7 | $178.3M7 | ||
| Property, plant and equipment | $42.0K5 | $5.6M6 | $14.0M7 | $5.2M7 | ||
| Total assets | $127.2M5 | $317.2M6 | $344.4M7 | $192.7M7 | ||
| Accounts payable | $1.0M5 | $4.7M6 | $7.5M7 | $3.2M7 | ||
| Current liabilities | $227.8M5 | $13.0M6 | $29.3M7 | $16.5M7 | ||
| Long-term debt | $14.8M6 | $25.2M7 | ||||
| Total liabilities | $227.9M5 | $50.0M6 | $78.9M7 | $38.2M7 | ||
| Retained earnings | -$105.2M5 | -$265.0M6 | -$388.6M7 | -$535.8M7 | ||
| Shareholders’ equity | -$2.8M5 | -$100.8M6 | $267.2M7 | $265.5M7 | $154.5M7 | |
| Shares outstanding | 6.6M shares5 | 37.7M shares6 | 47.7M shares7 | 49.7M shares7 | 50.1M shares7 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Cash from operations | -$7.3M5 | -$62.0M6 | -$86.8M7 | -$108.8M7 | ||
| Stock-based compensation | $67.0K5 | $3.0M6 | $13.6M7 | $20.8M7 | ||
| Capital spending | $45.0K5 | $4.0M6 | $10.7M7 | $522.0K7 | ||
| Free cash flow | -$7.3M | -$66.0M | -$97.5M | -$109.3M | ||
| Cash from investing | -$2.8M5 | -$6.5M6 | -$94.6M7 | $58.4M7 | ||
| Cash from financing | $134.2M5 | $225.0M6 | $118.7M7 | -$11.8M7 |
Corporate structure
HilleVax, Inc. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of HilleVax, Inc.
- EcoR1 Capital, LLC Filed SCHEDULE 13G/A on HilleVax, Inc., latest Nov 14, 2025 (2 filings since Jul 24, 2025)
- TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13D/A on HilleVax, Inc., latest Sep 19, 2025 (2 filings since May 2, 2025)
- Takeda Pharmaceutical Company Filed SCHEDULE 13D/A on HilleVax, Inc., latest Sep 19, 2025 (2 filings since May 9, 2022)
- Frazier Life Sciences Public Fund, L.P. Filed SCHEDULE 13D/A on HilleVax, Inc., latest Sep 17, 2025 (6 filings since May 6, 2022)
- Deep Track Capital, LP Filed SC 13G/A on HilleVax, Inc., latest Nov 14, 2024 (3 filings since Sep 29, 2023)
- James E. Flynn Filed SC 13G/A on HilleVax, Inc., latest Nov 14, 2024 (4 filings since May 3, 2022)
- TANG CAPITAL PARTNERS LP Filed SC 13G on HilleVax, Inc., latest Jul 22, 2024
- Lightspeed Venture Partners Select IV, L.P. Filed SC 13G/A on HilleVax, Inc., latest Feb 14, 2024 (2 filings since May 13, 2022)
- RA CAPITAL MANAGEMENT, L.P. Filed SC 13G/A on HilleVax, Inc., latest Feb 14, 2024 (2 filings since Feb 14, 2023)
- Carlyle Group Filed SC 13G/A on HilleVax, Inc., latest Feb 12, 2024 (2 filings since Feb 10, 2023)
- Abingworth LLP Filed SC 13G on HilleVax, Inc., latest May 13, 2022
- HilleVax, Inc. Boston, Massachusetts
- HilleVax Securities Corporation Subsidiary · Massachusetts, United States
Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What HilleVax, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $8.0M7 Dec 31, 2024 | $14.9M7 Dec 31, 2023 | −46.4% |
| Accumulated depreciation | $2.8M7 Dec 31, 2024 | $880.0K7 Dec 31, 2023 | +213.2% |
| Property and equipment, net | $5.2M7 Dec 31, 2024 | $14.0M7 Dec 31, 2023 | −62.7% |
| Operating-lease assets (leased space) | $7.5M7 Dec 31, 2024 | $18.1M7 Dec 31, 2023 | −58.7% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $154.5M7 Dec 31, 2024 | $216.7M7 Dec 31, 2023 | −28.7% |
| Marketable securities, current | $17.0M7 Dec 31, 2024 | $86.8M7 Dec 31, 2023 | −80.5% |
| Debt securities available for sale | $17.0M7 Dec 31, 2024 | $86.8M7 Dec 31, 2023 | −80.5% |
Properties, in its own words
We lease space for our principal offices and laboratory in Boston, Massachusetts pursuant to a written lease for approximately 32,000 square feet. The current term of our lease expires in December 2032. We believe that our existing facilities will be sufficient for our needs for the foreseeable future.
Item 2 of the 10-K filed Mar 28, 2025.4
Leadership
Who has led HilleVax, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
- Chief executive officerRobert Hershberg Apr 28, 2022 to now10
- PresidentRobert Hershberg Apr 28, 2022 to now10
- Chief financial officerShane Maltbie Jan 10, 2023 to now11
- Chief financial officerDavid A. Socks Apr 28, 2022 to Apr 28, 202212
- Chief operating officerSean McLoughlin Jan 26, 2024 to now13
- Chief operating officerAditya Kohli Apr 28, 2022 to Feb 3, 202314
Board members and other officers (11)
- OfficerRobert Hershberg Feb 12, 2024 to now15
- Chief Medical OfficerAstrid Borkowski Apr 28, 2022 to Feb 12, 202416
- Board memberNanette Cocero May 10, 2023 to now17
- Board memberAditya Kohli Apr 28, 2022 to now14
- Board memberGary Dubin Apr 28, 2022 to now18
- Board memberJaime Sepulveda Apr 28, 2022 to now19
- Board memberJeryl L. Hilleman Apr 28, 2022 to now20
- Board memberPatrick J. Heron Apr 28, 2022 to now21
- Board memberRobert Hershberg Apr 28, 2022 to now10
- Board memberShelley Chu Apr 28, 2022 to now22
- Board memberSusan Michele Silbermann Apr 28, 2022 to Aug 23, 202223
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- HilleVax Securities Corporation Massachusetts3
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Timeline
- Sep 17, 20258-K Completed an acquisition or sale; Listing notice or transfer; Change to shareholders' rights24
- Aug 6, 20258-K Results of operations25
- Aug 4, 20258-K Entered a material agreement; Ended a material agreement; Regulation FD disclosure26
- Jun 25, 20258-K Shareholder vote27
- May 8, 20258-K Results of operations28
- Mar 28, 20258-K Results of operations29
- Dec 5, 20248-K Exit or restructuring costs; Executive or director change30
- Nov 7, 20248-K Results of operations31
- Oct 16, 20248-K Exit or restructuring costs32
- Aug 9, 20248-K Results of operations33
- Jul 31, 20248-K Exit or restructuring costs34
- Jul 23, 20248-K Ended a material agreement35
- Apr 28, 2022New chief executive Robert Hershberg becomes CEO10
Calendar
When it reported results
- Aug 6, 2025Reported quarterly or annual results25
- May 8, 2025Reported quarterly or annual results28
- Mar 28, 2025Reported quarterly or annual results29
- Nov 7, 2024Reported quarterly or annual results31
- Aug 9, 2024Reported quarterly or annual results33
- May 9, 2024Reported quarterly or annual results36
- Mar 20, 2024Reported quarterly or annual results37
- Nov 9, 2023Reported quarterly or annual results38
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
221 filings to the SEC since October 2021: 3 annual reports, 11 quarterly reports, 35 major events, 82 insider forms, 27 large holders, 63 other. The latest 20:
- Nov 14, 2025SCHEDULE 13G/A EDGAR
- Sep 29, 202515-12G EDGAR
- Sep 22, 2025EFFECT EDGAR
- Sep 22, 2025EFFECT EDGAR
- Sep 19, 20254 EDGAR
- Sep 19, 2025SCHEDULE 13D/A EDGAR
- Sep 19, 2025SCHEDULE 13D/A EDGAR
- Sep 17, 2025SCHEDULE 13D/A EDGAR
- Sep 17, 20254 EDGAR
- Sep 17, 2025S-8 POS EDGAR
- Sep 17, 2025POS AM EDGAR
- Sep 17, 2025POS AM EDGAR
- Sep 17, 20254 EDGAR
- Sep 17, 20254 EDGAR
- Sep 17, 20254 EDGAR
- Sep 17, 20254 EDGAR
- Sep 17, 20254 EDGAR
- Sep 17, 20254 EDGAR
- Sep 17, 20254 EDGAR
- Sep 17, 20254 EDGAR
The 221 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
35 open-market trades by officers, directors and large owners since October 2021: 3 buys and 32 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Feb 11, 2025 | HERSHBERG ROBERTPresident and CEO | Sale | 11,901 | $1.76 | $20.9K | Form 4 |
| Feb 11, 2025 | Maltbie ShaneChief Financial Officer | Sale | 4,345 | $1.76 | $7.6K | Form 4 |
| Feb 4, 2025 | HERSHBERG ROBERTPresident and CEO | Sale | 14,634 | $1.89 | $27.7K | Form 4 |
| Feb 4, 2025 | Maltbie ShaneChief Financial Officer | Sale | 3,946 | $1.89 | $7.5K | Form 4 |
| May 22, 2024 | Kohli AdityaDirector | Sale | 6,000 | $14.73 | $88.4K | Form 4 |
| May 21, 2024 | Kohli AdityaDirector | Sale | 6,000 | $14.21 | $85.3K | Form 4 |
| May 20, 2024 | Kohli AdityaDirector | Sale | 6,000 | $15.45 | $92.7K | Form 4 |
| May 3, 2024 | Kohli AdityaDirector | Sale | 723 | $14.15 | $10.2K | Form 4 |
| May 2, 2024 | Kohli AdityaDirector | Sale | 6,000 | $14.01 | $84.1K | Form 4 |
| May 1, 2024 | Kohli AdityaDirector | Sale | 175 | $14.03 | $2.5K | Form 4 |
| Apr 5, 2024 | Kohli AdityaDirector | Sale | 6,000 | $14.44 | $86.6K | Form 4 |
| Apr 4, 2024 | FHMLS X, L.P.10% owner | Buy | 8,850 | $14.50 | $128.3K | Form 4 |
| Apr 4, 2024 | Kohli AdityaDirector | Sale | 6,000 | $14.71 | $88.3K | Form 4 |
| Apr 3, 2024 | Kohli AdityaDirector | Sale | 6,000 | $14.93 | $89.6K | Form 4 |
| Mar 28, 2024 | McLoughlin SeanChief Operating Officer | Buy | 1,250 | $16.98 | $21.2K | Form 4 |
| Mar 20, 2024 | Kohli AdityaDirector | Sale | 6,000 | $164,221.00 | $985.3M | Form 4 |
| Mar 19, 2024 | Kohli AdityaDirector | Sale | 6,000 | $17.42 | $104.5K | Form 4 |
| Mar 18, 2024 | Kohli AdityaDirector | Sale | 6,000 | $17.66 | $106.0K | Form 4 |
| Mar 8, 2024 | Kohli AdityaDirector | Sale | 6,000 | $18.66 | $112.0K | Form 4 |
| Mar 7, 2024 | Kohli AdityaDirector | Sale | 6,000 | $18.37 | $110.2K | Form 4 |
All 35 trades can be filtered by person here when JavaScript is on.
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- EcoR1 Capital, LLCSCHEDULE 13G/A, 2 filings Jul 24, 2025 to Nov 14, 202539
- TANG CAPITAL MANAGEMENT LLCSCHEDULE 13D/A, 2 filings May 2, 2025 to Sep 19, 202540
- Takeda Pharmaceutical CompanySCHEDULE 13D/A, 2 filings May 9, 2022 to Sep 19, 202541
- Frazier Life Sciences Public Fund, L.P.SCHEDULE 13D/A, 6 filings May 6, 2022 to Sep 17, 202542
- Deep Track Capital, LPSC 13G/A, 3 filings Sep 29, 2023 to Nov 14, 202443
- James E. FlynnSC 13G/A, 4 filings May 3, 2022 to Nov 14, 202444
- TANG CAPITAL PARTNERS LPSC 13G, 1 filing Jul 22, 202445
- Lightspeed Venture Partners Select IV, L.P.SC 13G/A, 2 filings May 13, 2022 to Feb 14, 202446
- RA CAPITAL MANAGEMENT, L.P.SC 13G/A, 2 filings Feb 14, 2023 to Feb 14, 202447
- Carlyle GroupSC 13G/A, 2 filings Feb 10, 2023 to Feb 12, 202448
- Abingworth LLPSC 13G, 1 filing May 13, 202249
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2024 | Robert HershbergM.D., Ph.D. | $666.8K | $6.7M50 | |
| 2024 | Sean McLoughlinFormer Chief Operating Officer | $450.0K | $4.5M50 | |
| 2024 | Aditya KohliPh.D. | $500.0K | $3.0M50 | |
| 2024 | Shane Maltbie | 43 | $473.0K | $2.2M50 |
| 2023 | ChairmanPresident and Chief Executive Officer | $635.6K | $9.7M50 | |
| 2023 | Former Chief Business Officer and former Chief Operating Officer | $498.2K | $4.1M50 |
SEC filer profile
How HilleVax, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARHilleVax, Inc.1
- CIK0001888012
- Employer ID (EIN)85-05450604
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address321 Harrison Ave, Suite 500, Boston, MA 021181
- Phone(617) 213-50541
- Shares outstanding50,141,064 as of Aug 6, 20259
- Public float$344.8M as of Jun 30, 20244
- AuditorErnst & Young LLP, San Diego, California PCAOB ID 42; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceOct 19, 20211
- Filings225 in all: 4 (65), 8-K (35), 3 (15), 10-Q (11), 144 (9), SC 13G/A (9), CORRESP (6), SC 13G (6)1
All 46 form types
EFFECT (5), UPLOAD (5), DEFA14A (4), SC 13D/A (4), 10-K (3), ARS (3), DEF 14A (3), SCHEDULE 13D/A (3), 424B5 (2), DRS/A (2), DRSLTR (2), POS AM (2), S-1/A (2), S-3 (2), SC 13D (2), SC14D9C (2), SEC STAFF LETTER (2), 15-12G (1), 25-NSE (1), 3/A (1), 4/A (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), PRE 14A (1), S-1 (1), S-1MEF (1), S-8 (1), S-8 POS (1), SC 14D9 (1), SC 14D9/A (1), SC TO-C (1), SC TO-T (1), SC TO-T/A (1), SCHEDULE 13D (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Mar 28, 2025
Quarterly report (10-Q) Aug 6, 2025
Proxy statement (DEF 14A) Apr 30, 2025
Latest 8-K (8-K) Sep 17, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.0001 par value per share | HLVX | Nasdaq Global Select Market |
From the cover page of the 10-K filed Mar 28, 2025 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks HilleVax, Inc. names in Item 1A of its 10-K filed Mar 28, 2025: 73 risks under these headings, as written.4
- Risks Related to Our Limited Operating History, Financial Position and Capital Requirements
- We have a limited operating history and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability.
- We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future. We may never generate any revenue or become profitable or, if we achieve profitability, we may not be able to sustain it.
- We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or vaccine candidates.
- Risks Related to the Development and Regulatory Approval of Our Vaccine Candidates
- We cannot provide any assurance we will be successful in identifying a viable development path for our vaccine candidates, or otherwise in securing business-development-related arrangements or other strategic alternatives.
- If we are unable to advance a vaccine candidate through clinical development, obtain regulatory approval and ultimately commercialize a vaccine candidate, or experience significant delays in doing so, our business will be materially harmed.
- Clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome, and the results of prior clinical trials are not necessarily predictive of our future results. We may not have favorable results in our clinical trials, or receive regulatory approval on a timely basis, if at all.
- Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects.
- We may find it difficult to enroll subjects in our clinical trials. If we encounter difficulties enrolling subjects in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- Vaccine candidates are subject to extensive regulation and compliance, which is costly and time consuming, and such regulation and compliance may cause unanticipated delays or prevent the receipt of the required approvals and licenses to commercialize our norovirus vaccine candidates.
The other 62 risks
- We may not be successful in our efforts to investigate our vaccine candidates in multiple age groups or potential indications. We may expend our limited resources to pursue a particular indication or formulation for our vaccine candidates and fail to capitalize on vaccine candidates, indications or formulations that may be more profitable or for which there is a greater likelihood of success.
- If the incidence rates of infection for the specific pathogens we are targeting are smaller than we believe they are, our clinical development may be adversely affected, and our business may suffer.
- Interim, topline and preliminary data from our preclinical studies and clinical trials that we announce or publish from time to time may change as more subject data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- Changes in methods of vaccine candidate manufacturing or formulation may result in additional costs or delay.
- Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
- Risks Related to Our Reliance on Third Parties
- We heavily rely on the Takeda License to provide us with intellectual property rights to develop and commercialize HIL-214. If the Takeda License is terminated, we would lose our rights to develop and commercialize HIL-214.
- We rely on third parties to conduct preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, our development programs and our ability to seek or obtain regulatory approval for or commercialize our norovirus vaccine candidates may be delayed.
- We currently rely on third parties for the manufacture of our vaccine candidates for clinical development and expect to continue to rely on third parties for the foreseeable future. This reliance on third parties increases the risk that we will not have sufficient quantities of our vaccine candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or potential commercialization efforts.
- If materials manufactured by our third-party manufacturers do not conform to our specifications or the regulatory requirements necessary for use in clinical trials, we may experience delays in our development efforts or may need to find alternative manufacturing facilities, which would significantly impact our ability to obtain regulatory approval for or commercialize our vaccine candidates, if approved.
- Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor or other third party will discover them or that our trade secrets will be misappropriated or disclosed.
- We may seek to enter into collaborations, license agreements and other similar arrangements and may not be successful in doing so, and even if we are, we may relinquish valuable rights and may not realize the benefits of such relationships.
- Risks Related to Commercialization of our Norovirus Vaccine Candidates
- Even if we receive regulatory approval for our norovirus vaccine candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our norovirus vaccine candidates, if approved, could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our vaccine candidates, when and if any of them are approved.
- Our norovirus vaccine candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
- The commercial success of our norovirus vaccine candidates will depend upon the degree of market acceptance of such vaccine candidates by healthcare providers, vaccine recipients, healthcare payors and others in the
- medical community, which is reliant on a number of factors, including the receipt of a preferred recommendation from the ACIP or other foreign national immunization technical advisory groups.
- The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found or alleged to have improperly promoted off-label uses, we may become subject to significant liability.
- The successful commercialization of our norovirus vaccine candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our products could limit our ability to market those products and decrease our ability to generate revenue.
- We face significant competition, and if our competitors develop technologies or vaccine candidates more rapidly than we do or their technologies are more effective, our business and our ability to develop and successfully commercialize products may be adversely affected.
- We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may need to invest significant resources to develop these capabilities. If we
- are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenue.
- Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
- Risks Related to Our Business Operations and Industry
- Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
- We are dependent on the services of our management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer.
- We may encounter difficulties in managing our growth and expanding our operations successfully.
- We are subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our results of operations and financial condition.
- Recently enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize our norovirus vaccine candidates and may affect the prices we may set.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.
- Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities.
- We and any of our potential future collaborators will be required to report to regulatory authorities if any of our approved products cause or contribute to adverse medical events, and any failure to do so would result in sanctions that would materially harm our business.
- We and our service providers may be subject to a variety of data privacy and security laws, regulations, standards, and contractual obligations, which could increase compliance costs, and our actual or perceived failure to comply could subject us to potentially significant liability, fines or penalties and otherwise harm our business.
- Our information technology systems, or those of any of our service providers, may fail or suffer security breaches, loss or leakage of data and other disruptions, which could result in a material disruption of our product development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
- Our business could be affected by litigation, government investigations and enforcement actions.
- Our employees and independent contractors, including principal investigators, CROs, consultants and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
- Risks Related to Our Intellectual Property
- If we are unable to obtain, maintain and enforce patent protection for our norovirus vaccine candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our norovirus vaccine candidates may be adversely affected.
- We do not own any patent applications or issued patents and we completely depend on intellectual property licensed from third parties, including under the Takeda License and the Kangh License, and our licensors may not always act in our best interest. If we fail to comply with our obligations under our intellectual property licenses, if the licenses are terminated or if disputes regarding these licenses arise, we could lose significant rights that are important to our business.
- We may not be able to protect our intellectual property and proprietary rights throughout the world.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
- Issued patents covering our vaccine candidates could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
- Patent terms may be inadequate to protect the competitive position of our vaccine candidates for an adequate amount of time.
- If we do not obtain patent term extension and equivalent extensions outside of the United States for our vaccine candidates, our business may be materially harmed.
- We may be subject to claims challenging the inventorship of our patents and other intellectual property.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products and vaccine candidates.
- We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
- Third-party claims of intellectual property infringement, misappropriation or other violations against us or our potential future collaborators could be expensive and time consuming and may prevent or delay the development and commercialization of our vaccine candidates.
- We may become involved in lawsuits to protect or enforce our patent and other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
- Intellectual property rights do not necessarily address all potential threats.
- We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
- Intellectual property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
- Risks Related to Our Common Stock
- An active, liquid and orderly market for our common stock may not be maintained.
- The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses.
- Nasdaq may delist our securities from trading on its exchange, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.
- Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to significantly influence all matters submitted to stockholders for approval.
- If we were to “reprice” any stock option or stock appreciation right without the approval of our stockholders, proxy advisory firms may issue a negative recommendation on certain of our compensation-related proposals at future annual meetings of our stockholders.
- We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common stock.
- Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
- We are an emerging growth company and a smaller reporting company, and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.
- Provisions in our governing documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- General risk factors
Legal proceedings
We are not currently subject to any material legal proceedings. From time to time, we may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1SEC EDGARHilleVax, Inc. filings on SEC EDGAR
- 2SEC EDGARHilleVax, Inc. filings on SEC EDGAR
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- 5SEC EDGARHilleVax, Inc. 10-K for fiscal 2021
- 6SEC EDGARHilleVax, Inc. 10-K for fiscal 2022
- 7SEC EDGARHilleVax, Inc. 10-K for fiscal 2023
- 8SEC EDGARHilleVax, Inc. 10-Q for fiscal 2025
- 9SEC EDGARHilleVax, Inc. 10-Q for fiscal 2025
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- 15SEC EDGARRobert Hershberg, Officer
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- 17SEC EDGARNanette Cocero, Board member
- 18SEC EDGARGary Dubin, Board member
- 19SEC EDGARJaime Sepulveda, Board member
- 20SEC EDGARJeryl L. Hilleman, Board member
- 21SEC EDGARPatrick J. Heron, Board member
- 22SEC EDGARShelley Chu, Board member
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- 25SEC EDGARResults of operations
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- 27SEC EDGARShareholder vote
- 28SEC EDGARResults of operations
- 29SEC EDGARResults of operations
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- 31SEC EDGARResults of operations
- 32SEC EDGARExit or restructuring costs
- 33SEC EDGARResults of operations
- 34SEC EDGARExit or restructuring costs
- 35SEC EDGAREnded a material agreement
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