UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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| Item 8.01. | Other Events. |
On September 11, 2023, Invivyd, Inc. posted an updated corporate presentation on its website at www.invivyd.com. A copy of the presentation is filed herewith as Exhibit 99.1 and is incorporated by reference in this Item 8.01.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Corporate Presentation, dated September 11, 2023 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| INVIVYD, INC. | ||||||
| Date: September 11, 2023 | By: | /s/ Jill Andersen | ||||
| Jill Andersen | ||||||
| Chief Legal Officer and Corporate Secretary | ||||||
Exhibit 99.1 CORPORATE OVERVIEW September 2023 © 2023 Invivyd, Inc. Invivyd and the Invivyd logo are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “seek,” “could,” “intend,” “target,” “aim,” “project,” “designed to,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward- looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning, among other things, our mission to rapidly deliver antibodies that protect vulnerable populations from viral threats; the future of the COVID-19 landscape; our expectations regarding the size of target patient populations and the potential market opportunity for our product candidates, as well as our market position; our beliefs regarding the clinical utility of anti-SARS-CoV-2 monoclonal antibodies (mAbs) and our product candidates; the potential of our platform-based approach to continuously discover and optimize mAb candidates that can perpetually protect the vulnerable from serious viral threats; the anticipated broad activity and prolonged utility of VYD222; our ongoing research and clinical development plans and the timing thereof, including with respect to VYD222; the possibility of a unique, rapid development pathway to potential emergency use authorization (EUA) in the U.S. for mAbs using immunobridging via serum neutralizing titers; the anticipated CANOPY clinical trial design, including our plans to use an immunobridging approach comparing data obtained in the CANOPY clinical trial to certain historical adintrevimab data; our expectation to rapidly generate clinical data in the CANOPY clinical trial for a potential VYD222 EUA submission, and the timing of anticipated initial primary endpoint data from the CANOPY clinical trial; our plans to generate a robust pipeline of product candidates which, if authorized or approved, could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications; our belief that our existing cash resources will be sufficient to support operating runway into the fourth quarter of 2024; and other statements that are not historical fact. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing and progress of our discovery, preclinical and clinical development activities; our ability to rapidly generate the clinical data needed from the CANOPY clinical trial to support a potential EUA submission for VYD222; clinical trial site activation or enrollment rates that are lower than expected; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of VYD222 or other product candidates based on neutralizing activity in preclinical studies; the risk that results of preclinical studies or clinical trials may not be predictive of future results in connection with current or future clinical trials; variability of results in models used to predict activity against SARS- CoV-2 variants of concern; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; whether our platform-based approach enables us to continuously discover and optimize mAb candidates that can perpetually protect the vulnerable from serious viral threats; whether VYD222 or any other product candidate is able to demonstrate and sustain neutralizing activity against predominant SARS-CoV-2 variants, particularly in the face of viral evolution; whether we are able to successfully submit an EUA in the future, and the outcome of any such EUA submission; whether our research and development efforts will identify and result in safe and effective therapeutic options for infectious diseases other than COVID-19; and whether we have adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this presentation are described under the heading “Risk Factors” in our most recent Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (SEC), and in our other filings with the SEC, and in our future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this presentation are made as of this date, and we undertake no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. © 2023 Invivyd, Inc. Invivyd and the Invivyd logo are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners. 2
INVIVYD IS ON A MISSION TO RAPIDLY DELIVER ANTIBODIES THAT PROTECT VULNERABLE POPULATIONS FROM VIRAL THREATS, STARTING WITH COVID-19 Near-Term Opportunity 8-18M Zero immunocompromised people authorized or approved EUA pathway provides the in the U.S. alone who may not monoclonal antibodies opportunity to rapidly bring a adequately respond to (mAbs) in the U.S. to much needed therapeutic to 1-4 COVID-19 vaccination prevent symptomatic immunocompromised people COVID-19 References: 1. Harpaz JAMA 2016; 2. Patel Emerg Infect Dis 2020; 3. U.S. 2020 Census Bureau Data; 4. Lee BMJ 2022 3
MANY IMMUNOCOMPROMISED PEOPLE HAVE AN IMPAIRED RESPONSE TO VACCINES AND LESS PROTECTION AGAINST SEVERE COVID-19 OUTCOMES Immunocompromised people are less likely to have detectable SARS- Immunocompromised people generate less protection against severe CoV-2 antibodies following vaccination than immunocompetent people outcomes than immunocompetent people after bivalent boosters Seroconversion rates (detectable Abs) in immunocompromised people vs. Vaccine effectiveness against COVID-19-associated hospitalizations after 1 2 immunocompetent controls after two COVID-19 vaccine doses [pre-Omicron] bivalent booster compared with no vaccination Immunocompetent Immunocompromised Immunocompetent Immunocompromised 98% 98% 98% 100% 100% 90% 90% 80% 80% 74% 70% 70% 62% 62% 60% 60% 50% 50% 43% 40% 40% 28% 30% 24% 30% 20% 20% 13% 10% 10% 0% 0% Haematological Organ Immune-Mediated 7-59 days 120-179 days cancers Transplant Inflammatory post bivalent booster post bivalent booster (Weighted average (Weighted average Disorders of 19 studies) of 24 studies) (Weighted average of 17 studies) References: 1. Lee BMJ 2022 ; 2. Centers for Disease Control and Prevention, Estimates of Bivalent mRNA Vaccine Durability in Preventing COVID-19–Associated Hospitalization and Critical Illness Among Adults with and Without Immunocompromising Conditions — VISION Network, September 2022–April 2023; Abs, antibodies 4 Seroconversion rates (%) Vaccine effectiveness (%)
EVEN IN PRIMARILY IMMUNOCOMPETENT POPULATIONS, COVID-19 VACCINE EFFECTIVENESS (VE) HAS WANED Monovalent boosters provided 90% VE against symptomatic Bivalent boosters have shown 4-29% VE against infection with more recent Omicron variants Delta infection vs. 46% VE against symptomatic Omicron infection 1 2 VE against symptomatic COVID-19 in primarily immunocompetent VE against SARS-CoV-2 infection in primarily immunocompetent ≥10 wks from monovalent booster Up to 26 wks from Monovalent (BNT162b2) Bivalent Booster (following two doses of monovalent vaccine) bivalent booster Omicron BA.4/5 dominant phase 29% Delta B.1.617.2 90% Omicron BQ dominant phase 20% Omicron B.1.1.529 46% Omicron XBB dominant phase 4% A mAb therapeutic that offers more robust protection against current variants would be an important addition to the COVID-19 medicine cabinet, especially for vulnerable populations References: 1. Andrews N Engl J Med 2022; 2. Shrestha Open Forum Infectious Diseases 2023 5
IN ADDITION TO PREVENTION, MONOCLONAL ANTIBODIES ALSO HAVE COMPELLING POTENTIAL IN THE TREATMENT OF COVID-19 PREVENTION TREATMENT Vaccines mAbs Antivirals Anti-SARS-CoV-2 mAbs are expected to provide: • Rapid, passive immunity Limitations for the Limitations for the immunocompromised: • Utility for prevention or immunocompromised: outpatient treatment People with impaired Significant drug-drug • Favorable tolerability without immune systems may not interactions can limit the significant drug-drug 2 generate protective levels utility of some oral interactions of antibodies following antivirals as a treatment 1 vaccination option for this 3 population References: 1. Lee BMJ 2022; 2. McCreary JAMA Netw Open 2023; 3. Marzolini Clin Pharmacol Ther 2022 6
PREVENTION OF COVID-19 IN VULNERABLE POPULATIONS PRESENTS A COMPELLING, POTENTIAL LONG-TERM VALUE PROPOSITION $2.2B in total revenue of Evusheld® in 2022, a mAb previously 1 authorized to protect vulnerable populations from COVID-19 $1,400 $1,270M $1,200 In a 2023 survey of U.S. physicians $1,000 $914M who treat immunocompromised people, 76% said they would be $800 ‘extremely likely’ or ‘somewhat likely’ to use Evusheld® if it were $600 still available and relevant to 2 circulating SARS-CoV-2 strains $400 $200 $135M $0 H2 2021 H1 2022 H2 2022 References: 1. Results publicly reported by AstraZeneca; 2. Invivyd-sponsored survey of HCPs in the U.S. (N=197) (2023) 7 TOTAL REVENUE (MILLIONS)
SUMMER UPTICK FORESHADOWS POTENTIAL FALL AND WINTER WAVES AND HIGHLIGHTS ONGOING NEED FOR COVID-19 THERAPEUTICS More older adults have been hospitalized for Covid-19 over the past several weeks, according to data reviewed by health insurer Humana. August 28, 2023 September 6, 2023 August 17, 2023 July 27, 2023 8
HCPs CONTINUE TO REPORT THAT A SIGNIFICANT SUBSET OF IMMUNOCOMPROMISED PEOPLE ARE AT HIGH-RISK OF SEVERE COVID-19 Risk of severe COVID -19 for select immunocompromised populations 1 according to July 2023 survey of specialty HCPs in the U.S. 1 = No greater risk compared to the general population; 10 = Extremely high risk Lung transplant 9 “We know that if a lung transplant patient gets COVID-19, their 9 Liver transplant mortality is very high. Many patients have no way to mount a vaccine response, and those who will be transplanted in the Kidney transplant 9 future need something to protect them.” — Transplant Pulmonologist Primary immunodeficiency diseases 8 8 Hematologic / lymphatic cancer 8 Stem cell transplant “[Stem cell transplant patients] are much higher risk from not having an immune system.” — Hematologist 7 Rheumatoid arthritis 7 Non-virally suppressed HIV 6 Non-hematologic cancer “I was using Evusheld® very frequently. It was a real life-saver 6 Inflammatory bowel diseases for many patients. I stopped after it was no longer considered 5 effective.” — Neurologist Multiple sclerosis 5 Psoriasis ” 5 Early-stage chronic kidney disease 1. Participants were asked: On a scale from 1 to 10, how much greater risk for contracting severe COVID-19 does a patient with the following conditions have, compared to the general population? Reference: Invivyd-sponsored survey of specialty HCPs in the U.S. (N=141) (Jul 2023) 9 Risk of severe COVID-19
Our Platform & VYD222 © 2023 Invivyd, Inc. Invivyd and the Invivyd logo are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners.
INVIVYD IS TAKING A PLATFORM-BASED APPROACH DESIGNED TO KEEP PACE WITH VIRAL EVOLUTION By leveraging state-of-the-art viral surveillance, antibody discovery and engineering, we aim to continuously discover and optimize mAb candidates that can perpetually protect the vulnerable from serious viral threats VIRAL SURVEILLANCE & ANTIBODY DISCOVERY ANTIBODY ENGINEERING PREDICTIVE MODELING Continuous monitoring of viral evolution Deep B-cell mining to isolate Industry-leading antibody engineering to and mapping of common mutational broadly neutralizing mAbs that target rare viral improve potency, breadth, biophysical escape routes with the aim to predict epitopes that are not under strong immune pressure, properties, and developability of candidates potential future variants of concern increasing the probability of sustained utility discovered through B-cell mining STREAM OF mAb CANDIDATES 11
VYD222: ENGINEERED FOR BROAD ACTIVITY AND PROLONGED UTILITY Ph 2/3 clinical trial of ADG20 for COVID-19 prevention RBD Spike ACE2 Ph 2/3 clinical trial of ADG20 for COVID-19 treatment VYD222 Broadly neutralizing, half-life extended Binds to the spike protein receptor Engineered from adintrevimab mAb candidate in development for the binding domain (RBD) of SARS-CoV-2, (ADG20), a mAb candidate that Invivyd prevention of symptomatic COVID-19 in interfering with the virus’s ability to infect previously studied in 2 clinical trials with vulnerable populations, such as human cells clinical endpoints; data from the EVADE immunocompromised people trial expected to accelerate VYD222 development Reference: Saxena SK VirusDis 2020 (SARS-CoV-2 figure) 12
VYD222 HAS DEMONSTRATED BROAD IN VITRO NEUTRALIZING ACTIVITY AGAINST VARIOUS PRE-OMICRON AND OMICRON VARIANTS 1 VARIANT SUBLINEAGE VYD222 WT(D614G) WT(D614G) ✓ Delta B.1.617.2 ✓ BA.1 ✓ BA.4/5 ✓ BA.4.6 ✓ BF.7 ✓ Omicron XBB.1 ✓ XBB.1.5 ✓ XBB.1.5.10 and EG.5 (one of the XBB.1.16 ✓ dominant variants in the U.S.) have the 2-3 same mutations in the spike protein XBB.1.5.10 ✓ References: 1. VYD222 data generated by Labcorp-Monogram Biosciences using the ✓ Neutralizing in standardized in vitro assays pseudovirus PhenoSense® SARS-CoV-2 Neutralizing Antibody Assay; 2. https://covid.cdc.gov/covid-data-tracker/#variant-proportions (accessed Sept 6, 2023); 3. covSPECTRUM.org (accessed Sept 7, 2023) 13
INVIVYD IS RAPIDLY ADVANCING VYD222 FOR THE PREVENTION OF SYMPTOMATIC COVID-19 Dosed first Reported positive Dosed first participant participants in Phase 1 initial Phase 1 in Phase 3 pivotal clinical trial clinical data clinical trial (CANOPY) Q1 2023 Q2 2023 Q3 2023 Q4 2023 Anticipated initial primary Initiated Reached general endpoint data from manufacturing of alignment w/ FDA on potential commercial pathway to potential EUA CANOPY clinical trial inventory late 2023/early Q1 2024 Unique, rapid development pathway for mAbs using immunobridging via serum neutralizing titers could be enabled by previously generated clinical trial data from prototype mAb, when certain criteria are met 14
POSITIVE INITIAL VYD222 PHASE 1 CLINICAL TRIAL DATA SHOW STRONG SERUM NEUTRALIZING TITERS & FAVORABLE SAFETY PROFILE • 30 healthy volunteers enrolled across three different dosing cohorts; in each cohort, participants were randomized 8:2 to VYD222 or placebo • Initial clinical trial data showed that VYD222 was generally well-tolerated at all three dose levels tested • As expected, a dose-dependent increase in serum neutralizing titers against Omicron XBB.1.5 was observed 21000 121-fold rise 18000 15000 Geometric mean serum neutralizing 12000 titers against 93-fold rise Omicron XBB.1.5 9000 16865 6000 39-fold rise 9647 3000 3245 84 85 139 0 Baseline D7 Baseline D7 Baseline D7 Cohort 1 Cohort 2 Cohort 3 1500 mg VYD222 2500 mg VYD222 4500 mg VYD222 15 Reference: ClinicalTrials.gov Identifier: NCT05791318
THE CANOPY PHASE 3 CLINICAL TRIAL OF VYD222 IS DESIGNED TO RAPIDLY GENERATE CLINICAL DATA FOR A POTENTIAL EUA VYD222 4500 mg IV (n=300) COHORT A Open Label Immunocompromised // (N=300) Day 1 Day 28 Month 3 Month 12 (Dosing) (Primary (Redosing) (Last visit) efficacy Primary endpoints: endpoint) • Safety/tolerability • Day 28 serum neutralizing titers against relevant SARS-CoV-2 variants VYD222 4500 mg IV (n=300) COHORT B 2:1 Randomization At risk of SARS-CoV-2 // Month 12 Day 1 Month 3 exposure (N=450) (Last visit) (Dosing) (Redosing) Primary endpoint: • Safety/tolerability Placebo IV (n=150) Day 28 titers from Cohort A, plus safety data from both cohorts, expected to enable clinical data package for a potential VYD222 EUA submission for prevention of symptomatic COVID-19 IV, intravenous 16
DAY 28 SERUM NEUTRALIZING TITERS FROM IMMUNOCOMPROMISED COHORT WILL BE USED IN THE CANOPY PRIMARY EFFICACY ANALYSIS Serum neutralizing titers (either mAb or vaccine-induced) have been shown to correlate with protection against symptomatic COVID-19 The CANOPY clinical trial primary efficacy analysis will use an Vaccines immunobridging approach comparing Reported protection VYD222 data from Cohort A to certain against symptomatic COVID-19 (%) historical data from the company’s Phase 2/3 clinical trial of adintrevimab for the prevention of symptomatic Invivyd’s previously COVID-19 (EVADE) studied mAb candidate (adintrevimab) Geometric mean serum neutralizing titer (FRNT ) 50 Reference: Schmidt Sci Transl Med 2023; FRNT, focus reduction neutralization test 17
VYD222 IS ONE OF MANY ANTIBODIES IN INVIVYD’S ROBUST PIPELINE DISCOVERY/ PROGRAMS PLATFORM INDICATION(S) IND-ENABLING PHASE 1 PHASE 2 PHASE 3 STATUS PRECLINICAL CORONAVIRUSES Initiated Ph 3 clinical trial VYD222 mAb Prevention in Sept 2023 COVID Prevention or Engineering variant mAb candidate #2 treatment matching COVID Prevention or Engineering variant mAb candidate #3 treatment matching COVID Prevention or Engineering variant mAb candidate #4 treatment matching Adintrevimab mAb Prevention Trials concluded; EUA filing dependent on variant susceptibility Adintrevimab mAb Treatment OTHER VIRUSES mAb Influenza Prevention Early discovery combination Investigational therapies are not approved for use by regulatory authorities. The safety and efficacy of pipeline candidates have not been established. 18
MANAGEMENT TEAM WITH EXPERTISE IN INFECTIOUS DISEASES AND TRACK RECORD OF SUCCESS Peter C. Schmidt, M.D., MSc Stacy Price, M.S. William Duke, M.B.A Dave Hering, M.B.A. Chief Medical Officer Chief Technology & Manufacturing Officer Chief Financial Officer Chief Executive Officer & Director Jill Andersen, J.D. Jeremy Gowler Robert Allen, Ph.D. Chief Legal Officer & Corporate Secretary Chief Operating & Commercial Officer Chief Scientific Officer 19
INVIVYD IS POISED TO ENTER A TRANSFORMATIONAL PERIOD, WITH A NEAR-TERM OPPORTUNITY TO DELIVER A MUCH NEEDED THERAPEUTIC Providing vulnerable populations, such as immunocompromised people, with protection from COVID-19 is a compelling, potential long-term value proposition Invivyd is rapidly executing on its VYD222 clinical development plan, with positive initial Phase 1 clinical data delivered in Q2 2023 and initial primary endpoint data from the CANOPY Phase 3 clinical trial anticipated end of 2023/early Q1 2024 Cash, cash equivalents and marketable securities of $298.4 million as of June 30, 2023 expected to support operating runway into the fourth quarter of 2024, excluding potential contribution of commercial product revenue 20
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