UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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| Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
Appointment of Chief Financial Officer
Effective January 6, 2023, the Board of Directors (the “Board”) of HilleVax, Inc. (the “Company”) appointed Shane Maltbie, the Company’s Vice of President, Finance, to serve as the Company’s Chief Financial Officer. Additionally, effective as of such date, Mr. Maltbie was designated as the Company’s principal financial officer and principal accounting officer. On January 6, 2023, in connection with Mr. Maltbie’s promotion, David Socks notified the Company of his resignation as Chief Financial Officer, including his resignation as the Company’s principal financial officer and principal accounting officer. Mr. Socks will continue his employment with the Company as its Chief Business Officer.
Mr. Maltbie, age 41, has served as the Company’s Vice President of Finance since December 2021. Prior to joining the Company, Mr. Maltbie was the Vice President of Finance at TScan Therapeutics, Inc. and prior to that the Vice President of Finance at Axcella Health Inc. Mr. Maltbie started his career in the Boston office of Deloitte & Touche LLP in the audit practice. Mr. Maltbie is a certified public accountant in the Commonwealth of Massachusetts (inactive license). He received his B.S. in Accounting and Business Management from Hartwick College and his MSA from Northeastern University.
There are no family relationships between either Mr. Maltbie and any director or executive officer of the Company, and each of them has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(k) of Regulation S-K.
In connection with Mr. Maltbie’s appointment as the Company’s Chief Financial Officer, the Company entered into an amended and restated employment letter with Mr. Maltbie. The employment letter for Mr. Maltbie provides for an annual base salary of $430,000, and an annual bonus with a target amount equal to 40% of Mr. Maltbie’s annual base salary. Additionally, under the employment letter, Mr. Maltbie is eligible to participate in all employee benefit plans and programs generally available to similarly situated employees of our company and is entitled to vacation benefits in accordance with our policies.
Regardless of the manner in which Mr. Maltbie’s employment terminates, he will be entitled to receive amounts previously earned during his term of employment, including unpaid salary and accrued but unused vacation. In addition, Mr. Maltbie will be entitled to certain severance benefits under his employment letter, subject to execution of a release of claims, return of all company property, compliance with post-termination obligations and resignation from positions with us.
Mr. Malbtie’s employment letter provides for severance benefits for certain terminations that arise during and outside a change in control period (as defined below). Upon a termination without “cause” or resignation for “good reason” (each, as defined in the employment letter) outside of a change in control period (as defined below), Mr. Maltbie will be entitled to: (1) continuation of his base salary for 9 months (such applicable period, the “severance period”), (2) a lump sum equal to his target bonus for the year during which such termination occurs, prorated for the portion of the calendar year in which his termination occurs that has elapsed prior to such termination, plus any unpaid annual bonus for the calendar year prior to the year in which his termination occurs, to the extent he is entitled to such bonus and if such bonus has not already been paid, (3) payments of the COBRA premiums for his and his eligible dependents until the earliest of (a) the end of the severance period, (b) expiration of his eligibility for continuation coverage under COBRA, or (c) the date he becomes eligible for health insurance coverage in connection with his new employment, and (4) acceleration of the vesting of all outstanding equity awards that would have vested during the severance period.
Upon a termination without cause or resignation for good reason that occurs 24 months after a change in control (the “change in control period”), Mr. Maltbie will be entitled to all of the same severance benefits described above, except (1) the severance period is increased from 9 months to 12 months, (2) he will be entitled to a lump sum payment equal to his target bonus for the year during which such termination occurs, plus any unpaid annual bonus for the calendar year prior to the year in which his termination occurs, to the extent he is entitled to such bonus and if such bonus has not already been paid, and (3) all unvested and outstanding equity awards will become fully vested on the effective date of his release.
In addition, to the extent that any payment or benefit received in connection with a change in control would be subject to an excise tax under Section 4999 of the Internal Revenue Code, such payments and/or benefits will be subject to a “best pay cap” reduction if such reduction would result in a greater net after-tax benefit to Mr. Maltbie than receiving the full amount of such payments.
Amended and Restated Employment Letter with Robert Hershberg
Effective January 6, 2023, the Company and our Chief Executive Officer, Robert Hershberg, entered into an amended and restated employment letter. The terms and conditions of Dr. Hershberg’s employment letter are the same as in the original employment letter, as amended and restated, except as noted below.
Under his amended employment letter, Dr. Hershberg is entitled to receive an annual base salary of $635,000, increased from $600,000;
Upon a termination without “cause” or resignation for “good reason” (each, as defined in the employment letter) outside of a change in control period (as defined below), Mr. Hershberg will be entitled to all of the same severance benefits in the original employment letter, except that he will be entitled to: (1) continuation of his base salary for 12 months (such applicable period, the “severance period”), which was increased from 9 months, (2) payments of the COBRA premiums for his and his eligible dependents until the earliest of (a) the end of the new 12-month severance period (increased from 9 months), (b) expiration of his eligibility for continuation coverage under COBRA, or (c) the date he becomes eligible for health insurance coverage in connection with his new employment, and (3) acceleration of the vesting of all outstanding equity awards that would have vested during the severance period (provided that Dr. Hershberg’s founders’ shares will be governed by the terms of his stock restriction agreement);
Upon a termination without cause or resignation for good reason that occurs during the change in control period, Dr. Hershberg will be entitled to all of the same severance benefits in the original employment letter, except (1) the severance period is 18 months (increased from 12 months), (2) Dr. Hershberg will be entitled to a lump sum payment equal to his target bonus for the year during which such termination occurs (rather than a pro-rated portion of his target bonus as provided in the original employment letter), and (3) payments of the COBRA premiums for his and his eligible dependents until the earliest of (a) the end of the new 18-month severance period (increased from 12 months), (b) expiration of his eligibility for continuation coverage under COBRA, or (c) the date he becomes eligible for health insurance coverage in connection with his new employment; and
To the extent that any payment or benefit received in connection with a change in control would be subject to an excise tax under Section 4999 of the Internal Revenue Code, such payments and/or benefits will be subject to a “best pay cap” reduction if such reduction would result in a greater net after-tax benefit to Dr. Hershberg than receiving the full amount of such payments.
Amended and Restated Employment Letter with David Socks
Effective January 6, 2023, the Company and our Chief Business Officer, David Socks, entered into an amended and restated employment letter. The terms and conditions of Mr. Sock’s employment letter are the same as in the original employment letter, as amended and restated, except as noted below.
Under his amended employment letter, Mr. Socks’ position with the Company will be Chief Business Officer, and he is entitled to receive an annualized base salary of $477,000, increased from $450,000;
Upon a termination without cause or resignation for good reason that occurs within the change in control period, Mr. Socks will be entitled to all of the same severance benefits in the original employment letter, except he will be entitled to a lump sum payment equal to his target bonus for the year during which such termination occurs (rather than a pro-rated portion of his target bonus as provided in the original employment letter); and
To the extent that any payment or benefit received in connection with a change in control would be subject to an excise tax under Section 4999 of the Internal Revenue Code, such payments and/or benefits will be subject to a “best pay cap” reduction if such reduction would result in a greater net after-tax benefit to Mr. Socks than receiving the full amount of such payments.
Amended and Restated Employment Letter with Aditya Kohli
Effective January 6, 2023, the Company and our Chief Operating Officer, Aditya Kohli, entered into an amended and restated employment letter. The terms and conditions of Dr. Kohli’s employment letter are the same as in the original employment letter, as amended and restated, except as noted below.
Under his amended employment letter, Dr. Kohli is entitled to receive an annual base salary of $500,000, increased from $490,000;
Upon a termination without cause or resignation for good reason that occurs during the change in control period, Dr. Kohli will be entitled to all of the same severance benefits in the original employment letter, except he will be entitled to a lump sum payment equal to his target bonus for the year during which such termination occurs (rather than a pro-rated portion of his target bonus as provided in the original employment letter); and
To the extent that any payment or benefit received in connection with a change in control would be subject to an excise tax under Section 4999 of the Internal Revenue Code, such payments and/or benefits will be subject to a “best pay cap” reduction if such reduction would result in a greater net after-tax benefit to Dr. Kohli than receiving the full amount of such payments.
The foregoing description of the terms of the amended and restated employment letters for Drs. Hershberg and Kohli and Messrs. Maltbie and Socks is a summary which does not purport to be complete and is subject to and qualified in its entirety by reference to each executive’s amended and restated employment letter, copies of which will be filed as exhibits to the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
| Item 7.01 | Regulation FD Disclosure. |
On January 9, 2023 representatives of the Company will be attending meetings with investors and analysts and making a presentation in connection with the J.P. Morgan Healthcare Conference. During these meetings and the presentation, the Company will reference the corporate slide presentation attached as Exhibit 99.1 to this Current Report on Form 8-K, which is incorporated herein by reference.
The Company’s updated corporate presentation has been posted to the Company’s website, www.hillevax.com. The Company plans to use its website to disseminate future updates to its corporate presentation and does not intend to file or furnish a Form 8-K alerting investors each time the presentation is updated.
The information set forth in this Item 7.01 is being furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly provided by specific reference in such a filing.
By filing this Current Report on Form 8-K and furnishing the information in this Item 7.01, the Company makes no admission as to the materiality of Item 7.01 in this report or the presentation available on the Company’s website. The information contained in the presentation is summary information that is intended to be considered in the context of the Company’s filings with the Securities and Exchange Commission (the “SEC”) and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Current Report on Form 8-K, although it may do so from time to time as its management believes is appropriate or as required by applicable law. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases, by updating the Company’s website or through other public disclosure.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description | |
| 99.1 | Slide Presentation | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| HilleVax, Inc. | ||||||
| Date: January 8, 2023 | By: | /s/ Paul S. Bavier | ||||
| Name: | Paul S. Bavier | |||||
| Title: | General Counsel and Chief Administrative Officer | |||||
Corporate presentation January 2023 Exhibit 99.1
We caution you that this presentation contains forward-looking statements of HilleVax, Inc. (“HilleVax,” “we,” “us” or similar terms). All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design and conduct of our planned and potential clinical trials and preclinical studies for HIL-214 and any future vaccine candidates, the timing and likelihood of regulatory filings and approvals for HIL-214 and any future vaccine candidates, our ability to commercialize our vaccine candidates, if approved, the impact of COVID-19 on our business, the pricing and reimbursement of our vaccine candidates, if approved, the potential to develop future vaccine candidates, the potential benefits of strategic collaborations and our intent to enter into any strategic arrangements, the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. Actual results may differ from those set forth in this presentation due to the risks and uncertainties inherent in our business, including, without limitation: we currently depend entirely on the success of HIL-214, our only vaccine candidate, 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; 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 filings with the SEC, including under the heading “Risk Factors” in the prospectus we filed with the SEC on April 29, 2022 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 of this presentation, and except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. 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. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions, and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us. Disclaimer
Potential breakthrough for the prevention of norovirus-related illness Significant unmet medical need Potential to be first vaccine approved for norovirus-related illness 9 Phase I & II studies completed in >4,500 subjects Clinical PoC demonstrated in adult Phase IIb study Phase IIb clinical trial ongoing in 3,000 infants Multi-billion dollar commercial potential HIL-214
Senior Leadership Astrid Borkowski, MD, PhD CMO VP, Head of Clinical Development, Takeda Vaccines CMO, Europe, Novartis Vaccines Paul Bavier, JD GC & CAO GC, Velos Bio GC, Avedro GC, Biodel Rob Hershberg, MD, PhD CEO & Chair EVP BD & CSO, Celgene CEO, VentiRx CMO, Dendreon Anju Chatterji, PhD CTO SVP, Biologics Dev & Mfg, Catalyst Bio VP, Biologics Mfg, Exelixis Shane Maltbie, CPA CFO VP Finance, TScan Therapeutics VP Finance, Axcella Ozzie Berger SVP Regulatory VP, Head of Regulatory, Vaccines, GSK VP, RA Head, Global Vaccines R&D, GSK Lynn Ferrucci VP HR EVP HR, Ziopharm Oncology SVP HR, Clinical Data Aditya Kohli, PhD COO CBO, Phathom Pharma VP BD, Scout Bio Engagement Manager, McKinsey David Socks CBO CEO & CFO, Phathom Pharma COO, Incline Therapeutics SVP, Cadence Pharmaceuticals
Board of Directors Shelley Chu, MD, PhD Partner, Lightspeed Gary Dubin, MD President, Global Vaccine Business Unit, Takeda Julie Gerberding, MD, MPH President, Merck Vaccines Director, CDC Patrick Heron Managing General Partner, Frazier Rob Hershberg, MD, PhD, Chair Co-founder & CEO, HilleVax EVP BD & CSO, Celgene Jeri Hilleman Audit chair/CFO of multiple public life sciences companies Aditya Kohli, PhD Co-founder & COO, HilleVax Jaime Sepulveda, MD, PhD, MPH Exec Dir, UCSF Institute for Global Health Sciences Director, NIH Mexico Susan Silbermann President, Pfizer Vaccines President, Pfizer Emerging Markets
Norovirus is the most common cause of acute gastroenteritis in US and worldwide1 1. Centers for Disease Control and Prevention website, 2021 2. Saito et al., 2014; Cannon et al., 2019 Key vulnerable populations Young children Endemic, incidence of norovirus highest among young children2 Adults Outbreaks among HCPs, military, food handlers, travelers, other groups Older adults Outbreaks in nursing homes and hospitals, higher likelihood of hospitalization / death Highly contagious virus causing diarrhea, vomiting, stomach pain, fever, and headache Complications from dehydration can be severe, including death Easily transmitted via person-to-person contact, contaminated foods or surfaces
1. Bartsch et al., 2016 2. Bartsch et al., 2020 Norovirus global annual burden is high… Direct Medical Clinical management, hospitalizations, infection control measures and cleaning, surveillance Indirect Health Productivity losses: sick staff work days, resources not used while managing outbreak Costs … resulting in direct and indirect costs of ~$10b in US and ~$60b globally1,2 ~4M Hospitalizations ~570M Seek Care ~700M Norovirus-related illnesses ~200k Deaths
1. Inaida S et al., PLoS One 2013 2. Yu Y Biomed Res Int. 2014; 2014 (ID 196169): 1-13 3. Public Health England. PHE National norovirus and rotavirus report. 10 Jul 2014 4. Bernard H, et al. Epi infect 2014; 142(1): 63-74 Norovirus incidence by strain % total incidence GI and GII.4 genotypes comprise the majority of norovirus infections worldwide GII.4 GI Other GII Mix Other US 5 2012-2015 Brazil 6 2005-2008 Japan 1 2008 Germany 4 2001-2009 England & Wales 3 2011-2014 China 2 1999-2011 Australia 7 2013-14 5. Shah et al. CDC MMWR 2017 6. Ferreira MS, et al. J Med Virol 2010 7. Lim KL, et al. PLoS One 2016
HIL-214 comprises VLPs for major genotypes GI.1 and GII.4 GI.1 selected based on its potential to promote a broad immune response to GI strains GII.4 selected because it is estimated to be responsible for nearly two-thirds of norovirus illness1 1 Virus-Like Particles (VLPs) Conformationally correct representation of the virus capsid Consensus GII.4 VLP GI.1 VLP (Norwalk) 2 Adjuvant Aluminum hydroxide Designed to enhance immunogenicity and stability of VLPs in solution Consensus Strategy Presents epitopes from three different norovirus GII.4 strains on one VLP 3 Norovirus Vaccine Prefilled Syringe (intramuscular) 1. Kumthip et al., 2019
1. Intranasal formulation of vaccine, not included in HIL-214 safety and immunogenicity subject numbers R: randomized. DB: double-blind. OL: open label. Pbo: placebo-controlled Trial No. Phase Design Study Population HIL-214 safety, n HIL-214 immuno, n LV01-103 I/II R, DB, Pbo, NoV challenge for safety, immunogenicity, and efficacy 18 - 50 years N/A1 N/A1 LV03-104 I R, DB, Pbo, dose/age-escalation for safety and immunogenicity 18 - 85 years 66 66 LV03-105 I/II R, DB, Pbo, NoV challenge for safety, immunogenicity, and efficacy 18 - 50 years 67 67 NOR-210 II Study to generate serum controls for validation of serology assay 18 - 49 years 50 50 NOR-107 II R, DB, for safety, immunogenicity, dose finding, and adjuvant justification 18 - 64 years 418 418 NOR-201 II RD, DB for safety and immunogenicity 18 - 49 years 425 425 NOR-204 II R, DB for safety, immunogenicity, dose finding and formulation selection 18 - >85 years 311 311 NOR-211 IIb R, DB, Pbo for efficacy, safety, and immunogenicity 18 - 49 years; military recruits 2,355 97 NOR-202 II R, DB for safety, immunogenicity, dose finding and adjuvant justification 6wks - 9 years 839 839 TOTAL 4,531 2,273 Large clinical program demonstrates immunogenicity, efficacy, and safety/tolerability
We believe that HIL-214 clinical data have substantially de-risked the program Dose selection Adjuvant selection Immunogenicity in infants/children Immunogenicity in adults/older adults Efficacy proof-of-concept in adults Safety/tolerability profile 5-year safety and immunogenicity HIL-214 Key Clinical Accomplishments
SAFETY >4,500 subjects (839 pediatric subjects) received vaccine in clinical studies In adults, local AEs all mild/moderate with systemic AEs similar to placebo Infant AEs largely mild to moderate with short duration (<3-4 days) HIL-214 clinical AE profile comparable to commercial vaccines Adult safety Pediatric safety NOR-202, NOR-211, NOR-204 studies, WHO, FDA prescribing information These data are presented for informational purposes only, as the comparisons in the tables to the right are not based on head-to-head clinical studies and may not be comparable due to differences in vaccine design, disease under evaluation, trial designs and populations studied.
HIL-214 immunogenicity HBGA is an attachment factor on the surface of intestinal epithelia known to promote norovirus entry into host cells Measurement of HBGA-blocking antibodies is the primary method to assess vaccine immunogenicity against norovirus Data from long-term immunogenicity study in adults (NOR-213) has shown titers to date above baseline at year 5 HBGA blocking response following vaccination with HIL-214 GII.4 HBGA blocking titers Older adults (>60 years) 15/50µg x 1 dose (NOR-204) (6 – 12 months) 50/150µg x 2 doses (NOR-202) 1 (18 – 64 years) 15/50µg x 1 dose (NOR-107) Days post vaccination GII.4 HBGA blocking titers over time Note: cross study comparisons NOR-202, NOR-107, and NOR-204 studies 1. Day 0 titers were collected 28 days prior to vaccination for adult study (NOR-107)
Cases of moderate-to-severe AGE Viral efficacy Pathogen Placebo n = 2,357 HIL-214 n = 2,355 % p value 1° HIL-214 vaccine strain only1 5 (0.2) 1 (<0.1) 80.0 p = 0.142 2° Any NoV strain 26 (1.1) 10 (0.4) 61.8 p = 0.0097 Post-hoc GII.2 strain 21 9 57.4 p = 0.0321 Phase 2b demonstrated reduction in moderate-to-severe AGE CLINICAL POC demonstrated in US Navy recruits 4,712 subjects 2 season, single site study had very few cases of HIL-214 vaccine strains of norovirus Clinical PoC demonstrated across any observed norovirus strains due to heterotypic protection provided by HIL-214 Sherwood et al, Vaccine 2020 1. GI.1 or GII.4
We intend to focus our initial development primarily on the infant population Endemic pattern of infection Higher prevalence of GII.4 Comparison to subjects without pre-existing immunity Regulatory and operational precedent of rotavirus vaccines Advantages of studying HIL-214 in infants
NEST-IN1 Phase 2b pediatric study ongoing 1 Vaccinations at Day 1 and Day 29 - 57 2 Key secondary endpoints may include evaluation of efficacy against any GI or GII norovirus strain HIL-2141 (n = 1,500) Placebo1 (n = 1,500) Primary Endpoint Efficacy against moderate/ severe AGE due to HIL-214 vaccine strain (GI.1 or GII.4)2 Healthy 5 mo. infants (n = ~3,000) Sites in the US and Latin America
NEST-IN1 has achieved significant milestones since 2Q22 initiation DMC completed Cohort 1 (203 subjects) safety review and recommended study continuation without modification Cohort 1 immune responses1 were consistent with prior infant studies of HIL-214 Enrollment continues for remaining subjects Topline data expected 1Q24 NEST-IN1 updates 1. Pan-Ig antibody responses 28 days post second dose
Development and regulatory strategy Initial clinical program focused on infant population Followed by immunobridging and/or efficacy studies in older adults Clinical program and concurrent epidemiology and pharmacoeconomic studies to support potential ACIP recommendations Phase 2b PoC study in infants n ~ 3,000 Phase 3 pivotal study in infants n ~ 5,000 – 6,000 Infant registration 1 Establish initial indication in infants 2 Broaden label of vaccine to adults and older adults Immunobridging and/or efficacy studies Adult/older adult registration
Disease Age US cases US hospitalizations US deaths US economic burden (in 2020 dollars) Norovirus < 4 years 2.8 million 12,000 20 $1.2 billion 5 – 64 years 15.7 million 34,000 70 $6.4 billion > 65 years 3.7 million 50,000 1,250 $3.2 billion All ages 22 million 96,000 1,350 $10.6 billion Rotavirus (pre-vaccine) < 5 years 2.7 million 70,000 60 $1.5 billion Shingles (pre-vaccine) > 50 years 1.0 million 46,000 80 $2.4 billion CDC and Bartsch et al., 2020 ACIP recommendation will be sought for both the infant and older adult populations Norovirus burden of disease compares favorably to other viruses which have vaccines that carry ACIP recommendations Norovirus burden (today) is comparable to rotavirus and shingles burden (pre-vaccines) in the United States
Potential multi-billion dollar commercial opportunity Similar burden of disease between norovirus and rotavirus Two rotavirus vaccines were launched in 2006 and 2008 (RotaTeq and Rotarix) ACIP recommendation for routine infant use $1.5B global net sales in 2021 $210-360 per rotavirus vaccine course (US) CDC recommended vaccine for older adults Zostavax approved in 2006; rapidly replaced by Shingrix approved Oct 2017 ACIP recommendation for adults over 50 $2.3B global net sales of Shingrix in 2021 $200-300 per shingles vaccine course (US) 1 INFANTS/TODDLERS 2 OLDER ADULTS ROTAVIRUS VACCINES AS A CASE STUDY SHINGLES VACCINES AS A CASE STUDY + OTHER ADULTS including HCPs, military, travelers, food handlers +
3Q22 1Q24 Phase 2b interim safety results first 200 subjects Anticipated milestones 4Q22 Phase 2b interim immunogenicity results first 200 subjects Phase 2b topline data Strong Capital position As of September 30, 2022: $292.1M cash $75M term loan: $5M drawn + up to $70M available prior to P2b topline results1 1 Subject to certain milestones and conditions Positive safety DMC recommendation Aug 2022 Positive immunogenicity results Dec 2022
Most advanced norovirus vaccine candidate Clinical PoC demonstrated in adults Phase IIb study ongoing in 3,000 infants Blockbuster potential commercial opportunity Highly experienced leadership team NASDAQ: HLVX*