INVIVYD, INC. You should read the following discussion and analysis of our financial condition
and results of operations together with our consolidated financial statements
and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and
our Annual Report on Form 10-K for the year ended
Forward-Looking Statements
The information contained in this discussion and analysis or set forth elsewhere
in this Quarterly Report on Form 10-Q, including information with respect to our
plans and strategy for our business and related financing, includes
forward-looking statements and information within the meaning of Section 27A of
the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as
amended, which are subject to the "safe harbor" created by those sections. These
forward-looking statements include, but are not limited to, statements
concerning our strategy, future operations, future financial position, future
revenues, projected costs, prospects and plans and objectives of management. 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 risks set forth in the "Risk Factors" section of this
Quarterly Report on Form 10-Q and in our other filings with the
Overview
Adintrevimab is designed to be a potent, long-acting and broadly neutralizing antibody for both the prevention and treatment of COVID-19. We believe several key attributes combine to potentially differentiate adintrevimab, including breadth, potency, durability of protection, convenient intramuscular, or IM, administration, and potential for broad application across multiple indications, depending on the SARS-CoV-2 variant.
Data from our Phase 1 healthy volunteer study ADG20-1-001 confirmed the extended
half-life of adintrevimab, which we believe may allow for durable protection
against COVID-19, depending on the variant. In
We are assessing adintrevimab in two separate Phase 2/3 clinical trials: our
EVADE trial to evaluate adintrevimab for the prevention of COVID-19 and our
STAMP trial to evaluate adintrevimab for the treatment of COVID-19. Our EVADE
clinical trial is a global Phase 2/3 clinical trial evaluating adintrevimab as a
prevention for COVID-19 in both the post-exposure and pre-exposure settings. Our
STAMP trial is our global Phase 2/3 clinical trial evaluating adintrevimab as a
treatment for COVID-19. Due to the emergence and global spread of the Omicron
variant, against which adintrevimab has reduced in vitro neutralization potency
compared to prior variants, enrollment in both EVADE and STAMP was paused on
In the primary analysis population, patients infected with or exposed to a non-Omicron variant, or the pre-Omicron group, adintrevimab met the primary objectives across all three indications, demonstrating statistically significant and clinically meaningful efficacy. In pre-exposure and post-exposure prophylaxis, adintrevimab was associated with 71% and 75% relative risk reductions compared to placebo, respectively, in the prevention of reverse transcription-polymerase chain reaction, or RT-PCR, confirmed symptomatic COVID-19. In an exploratory analysis of patients exposed to the Omicron variant, or the post-Omicron group, in pre-exposure prophylaxis, adintrevimab was associated with a clinically meaningful reduction in the risk of developing RT-PCR confirmed symptomatic COVID-19 compared with placebo. In treatment, adintrevimab was associated with a 66% relative risk reduction compared to placebo in the incidence COVID-19 related hospitalization or all cause death through Day 29 in the pre-Omicron group. In patients treated within three days of symptom onset, adintrevimab was associated with a reduced risk of COVID-19 hospitalization or death from any cause through Day 29 by 74% compared to placebo. A preliminary analysis of available safety data in each trial revealed a safety profile similar to that of placebo for adintrevimab.
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The Omicron BA.2 variant, which has shown reduced in vitro susceptibility to
monoclonal antibodies, has recently emerged as the current predominant variant
of SARS-CoV-2 in
We are committed to advancing adintrevimab as a potential future therapeutic option in anticipation of the emergence of new variants. We are on-track to have more than one million doses of adintrevimab secured in 2022, in preparation of its potential utility as a prophylaxis and treatment option for COVID-19 in the future.
We are also evaluating additional broadly neutralizing antibodies targeting the receptor binding domain, or RBD, as well as other subdomains within the spike protein for COVID-19. In addition, we plan to leverage our robust antibody discovery and development capabilities and our partnerships that together have enabled our expedited advancement of adintrevimab into clinical trials to develop therapeutic or preventative options for other infectious diseases, such as additional coronaviruses and influenza. We continue to evaluate product candidates for infectious diseases with high unmet medical need through in-licensing opportunities that may leverage our team's expertise and capabilities.
SARS-CoV-2 has given rise to a global pandemic that swept rapidly throughout the world in 2020. Of significant current concern is the continued emergence of a number of SARS-CoV-2 variants with increased transmissibility, pathogenicity, and/or the ability to evade neutralizing antibodies. In addition to the emergence of these variants, there are multiple factors that we believe contribute to the likelihood of COVID-19 becoming an endemic threat, including: (1) viral transmission before symptom onset; (2) uneven global rollout of vaccinations; (3) ongoing vaccine hesitancy; (4) limited duration of immunity conferred by both natural infection and vaccination; (5) limited vaccine efficacy against certain SARS-CoV-2 variants; (6) uncertain impact of vaccines on transmission; and (7) variable implementation of virus mitigation behaviors, such as wearing masks and social distancing. We also believe that future pandemics similar to the COVID-19 pandemic are likely because, in many parts of the world, humans live in close proximity to animal species harboring coronaviruses that are capable of infecting humans.
Our vision is to discover, develop and commercialize differentiated products for the prevention and treatment of infectious diseases. To enable this vision, our current discovery efforts are focused on unique antibody-based product candidates that we optimize to improve breadth, potency, half-life, where applicable, and developability. Key elements that we believe differentiate our approach include: (1) recognition of the importance of and identification of broadly neutralizing antibodies; (2) industry-leading B cell mining, protein engineering and developability screening capabilities through our internal expertise and collaborations; and (3) reducing risk of clinical resistance.
We were formed in
Since our inception, we have devoted substantially all of our resources to
organizing and staffing, building an intellectual property portfolio, business
planning, conducting research and development, establishing and executing
arrangements with third parties for the manufacture of our product candidates
and raising capital. We rely heavily on partnerships, external consultants and
contract research organizations, or CROs, to conduct our discovery,
non-clinical, preclinical and clinical activities. Additionally, we are
currently dependent on WuXi Biologics (
Since our inception, we have financed our operations with net proceeds of
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Since our inception, we have incurred significant losses, including a net loss
of
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continue to conduct our ongoing clinical trials of adintrevimab, including advancement through late-stage global clinical trials, as well as initiate and complete additional clinical trials of future product candidates or current product candidates in new indications or patient populations;
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continue to advance the preclinical development of our other product candidates and our preclinical and discovery programs;
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seek regulatory approval for any product candidates that successfully complete clinical trials;
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pursue marketing approvals or EUA and reimbursement for our product candidates;
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acquire or in-license other product candidates, intellectual property and/or discovery technologies;
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validate our commercial-scale current good manufacturing practices, or cGMP, manufacturing process;
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manufacture material under cGMP at our contracted manufacturing facilities for clinical trials and potential EUA, regulatory approval and commercial sales;
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maintain, expand, enforce, defend and protect our intellectual property portfolio;
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comply with regulatory requirements established by the applicable regulatory authorities;
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establish a sales, marketing and distribution infrastructure to commercialize any product candidates for which we may obtain regulatory approval or EUA;
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hire and retain additional personnel, including research, clinical, development, manufacturing, quality control, quality assurance, regulatory and scientific personnel;
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add operational, financial, corporate development, management information systems and administrative personnel, including personnel to support our product development and planned future commercialization efforts; and
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incur additional legal, accounting and other expenses in operating as a public company, including expenses related to corporate governance matters and stockholder proposals for our 2022 annual meeting of stockholders.
We do not anticipate generating revenue from product sales, including government supply contracts, unless and until we successfully complete clinical development and obtain marketing approvals or EUA for one or more of our product candidates. We are currently establishing our commercial infrastructure to support the anticipated marketing and distribution of our product candidates. Subject to receiving marketing approval or EUA for any of our product candidates for the prevention and/or treatment of COVID-19, we expect to enter into arrangements with third parties for the sale, marketing and distribution of our product candidates. Accordingly, if we obtain marketing approval or EUA for any of our product candidates, we will incur significant additional commercialization expenses related to product manufacturing, marketing, sales and distribution.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, government or private-party grants, debt financings, collaborations with other companies and strategic alliances. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions.
Because of the numerous risks and uncertainties associated with pharmaceutical product development and emergence of adintrevimab susceptible SARS-CoV-2 variants of concern, or VOCs, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. We may never obtain regulatory approval for any of our product candidates. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
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Based on our current operating plan, we believe that our existing cash and cash
equivalents of
Impact of COVID-19 on Our Operations
In
In addition, our business and operations may be more broadly adversely affected by the COVID-19 pandemic. The COVID-19 outbreak and government measures taken in response have had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred, supply chains have been disrupted, facilities and production have been suspended and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services has fallen. The global COVID-19 pandemic continues to evolve rapidly, and we will continue to monitor it closely. The ultimate extent of the impact of the COVID-19 pandemic on our business, financial condition, operations and product development timelines and plans remains highly uncertain and will depend on future developments, including the duration and spread of outbreaks and the continued emergence of variants, its impact on our clinical trial design and enrollment, trial sites, contract research organizations, or CROs, contract development and manufacturing organizations, or CDMOs, and other third parties with which we do business, as well as its impact on regulatory authorities and our key scientific and management personnel. To date, we have experienced some delays and disruptions in our development activities as a result of the COVID-19 pandemic. Some of our CROs, CDMOs and other service providers also continue to be impacted. We will continue to monitor developments as we address the disruptions, delays and uncertainties relating to the COVID-19 pandemic. These developments and the impact of the COVID-19 pandemic on the financial markets and the overall economy are highly uncertain and cannot be predicted. If the financial markets and/or the overall economy are impacted for an extended period, our results and operations may be materially adversely affected and may affect our ability to raise capital.
Components of Our Results of Operations
Revenue
To date, we have not generated any revenue from product sales, including government supply contracts, or any other sources. If our development efforts for our product candidates are successful and result in regulatory approval or collaboration or license agreements with third parties, we may generate revenue in the future from product sales or payments from collaboration or license agreements that we may enter into with third parties, or any combination thereof.
Research and Development Expenses
The nature of our business and primary focus of our activities generate a significant amount of research and development costs. Research and development expenses represent costs incurred by us for:
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the non-clinical and preclinical development of our product candidates, including our discovery efforts;
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the procurement of our product candidates from third-party manufacturers; and
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the global clinical development of our product candidates.
Such costs consist of:
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personnel-related expenses, including salaries, bonuses, benefits and other compensation-related costs, including stock-based compensation expense, for employees engaged in research and development functions;
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expenses incurred under agreements with third parties, such as collaborators, consultants, contractors and CROs, that conduct the discovery, non-clinical and preclinical studies and clinical trials of our product candidates and research programs;
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costs of procuring manufactured product candidates for use in non-clinical studies, preclinical studies and clinical trials from third-party CDMOs;
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costs of outside consultants and advisors, including their fees and stock-based compensation;
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payments made under third-party licensing agreements; and
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other expenses incurred as a result of research and development activities.
We expense research and development costs as incurred. Non-refundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the services rendered.
Our primary focus since inception has been the development of adintrevimab. Our research and development costs consist primarily of external costs, such as fees paid to CDMOs, CROs and consultants in connection with our non-clinical studies, preclinical studies and clinical trials. To date, external research and development costs for any individual product candidate have been tracked commencing upon product candidate nomination. We do not allocate employee-related costs, costs associated with our discovery efforts and other internal or indirect costs to specific research and development programs or product candidates because these resources are used and these costs are deployed across multiple programs under development and, as such, are not separately classified.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher and more variable development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Our research and development expenses could increase substantially in the near term as we advance adintrevimab through clinical development on a global basis, pursue regulatory approval of adintrevimab, continue to discover and develop additional product candidates and incur expenses associated with hiring additional personnel to support our research and development efforts, including the associated manufacturing activities.
At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of any of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales or licensing of our product candidates. This is due to the numerous risks and uncertainties associated with drug development, including the uncertainty of:
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the timing and progress of preclinical and clinical development activities;
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the number and scope of preclinical and clinical programs we decide to pursue;
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filing acceptable investigational new drug applications with the FDA or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates;
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sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials, manufacture the product candidates and complete associated regulatory activities;
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our ability to establish and maintain agreements with third-party manufacturers for clinical supply for our clinical trials and successfully develop, obtain regulatory approval or EUA for our product candidates;
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successful enrollment and timely completion of clinical trials, including our ability to generate positive data from any such clinical trials;
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the costs associated with the development of any additional development programs and product candidates we identify in-house or acquire through collaborations;
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the prevalence, nature and severity of adverse events experienced with adintrevimab or any other product candidates;
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the terms and timing of any collaboration, license or other arrangement, including the terms and timing of any milestone payments thereunder;
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our ability to obtain and maintain patent, trademark and trade secret protection and regulatory exclusivity for our product candidates, if and when approved, and otherwise protecting our rights in our intellectual property portfolio;
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receipt of timely marketing approvals from applicable regulatory authorities;
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our ability to maintain compliance with regulatory requirements, including good clinical practices, current good laboratory practices and cGMPs, and to comply effectively with other rules, regulations and procedures applicable to the development and sale of pharmaceutical products;
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potential significant and changing government regulation, regulatory guidance and requirements and evolving treatment guidelines; and
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the impact of any business interruptions to our operations or those of third parties with which we work, particularly in light of the current COVID-19 pandemic.
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A change in the outcome of any of these variables with respect to the
development of any of our product candidates could significantly change the
costs and timing associated with the development of that product candidate. We
may elect to discontinue, delay or modify clinical trials of some product
candidates or focus on others. We may never succeed in obtaining regulatory
approval or EUA for any of our product candidates. In addition, in the absence
of a declaration by the
Acquired in-process research and development, or IPR&D, expenses consist
primarily of the upfront costs we incurred in
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of salaries, bonuses, benefits, third-party fees and other related costs, including stock-based compensation, for our personnel and external contractors involved in our executive, finance, legal, business development and other administrative functions as well as our commercial function. Selling, general and administrative expenses also include costs incurred for outside services associated with such functions, including legal fees relating to patent and corporate matters; professional fees for accounting, auditing, tax and administrative consulting services; insurance costs; market research costs; and other selling, general and administrative expenses. These costs relate to the operation of the business, unrelated to the research and development function, or any individual program.
Our selling, general and administrative expenses could increase in the future as our business expands and we increase our headcount to support the expected growth in our research and development activities and the potential commercialization of our product candidates. In particular, we could incur additional commercialization expenses prior to any regulatory approval or EUA of our product candidates as we continue to expand our commercial function to support potential future product launches. We also anticipate that we will continue to incur increased expenses associated with operating as a public company, including increased costs of accounting, audit, legal, regulatory and tax-related services, director and officer insurance premiums, and investor and public relations costs. We also expect to incur additional intellectual property-related expenses as we file additional patent applications to protect innovations arising from our research and development activities.
Through
Other Income (Expense), Net
Other income (expense), net consists of interest income earned from our cash, cash equivalents and marketable securities and the net amortization or accretion of premiums and discounts related to our marketable securities. We expect our interest income to vary each reporting period depending on our average bank deposits, money market funds and investment balances during the period and market interest rates.
Income Taxes
Since our inception, we have not recorded any income tax expense or realized benefits for the net losses we have incurred or for the research and development tax credits generated in each period as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss, or NOL, carryforwards and tax credit carryforwards will not be realized.
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Results of Operations
Comparison of the three months ended
The following table summarizes our results of operations for the three months
ended
Three Months Three Months
Ended Ended
March 31, March 31,
(in thousands) 2022 2021 Change
Operating expenses:
Research and development $ 92,035 $ 34,032 $ 58,003
Acquired in-process research and development - 1,000 (1,000 )
Selling, general and administrative 8,704 3,677 5,027
Total operating expenses 100,739 38,709 62,030
Loss from operations (100,739 ) (38,709 ) (62,030 )
Other income (expense):
Other income (expense), net 73 9 64
Total other income (expense), net 73 9 64
Net loss $ (100,666 ) $ (38,700 ) $ (61,966 ) The following discussion presents the components of our expenses for the periods presented:
Research and Development Expenses
Three Months Three Months
Ended Ended
March 31, March 31,
(in thousands) 2022 2021 Change
Direct, external research and development
expenses by program:
Adintrevimab $ 77,583 $ 30,652 $ 46,931
Unallocated research and development
expenses:
Personnel-related costs 9,512 2,260 7,252
External discovery-related and other costs 4,940 1,120 3,820
Total research and development expenses
Research and development expenses were
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The increase in direct costs related to our adintrevimab program of
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Personnel-related costs, including salaries, bonuses, benefits and other
compensation-related costs were
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The increase in external discovery-related and other costs of
There was no IPR&D expense recognized during the three months ended
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Acquired IPR&D expenses of
Selling, General and Administrative Expenses
Three Months Three Months
Ended Ended
March 31, March 31,
(in thousands) 2022 2021 Change
Personnel-related costs $ 1,643 $ 1,494 $ 149
Professional and consultant fees 6,661 1,969 4,692
Other 400 214 186
Total selling, general and administrative expenses
Selling, general and administrative expenses were
•
Personnel-related costs, including salaries, bonuses, benefits and other
compensation-related costs were
•
The increase in professional services and consultant fees of
•
Other costs remained relatively consistent between periods.
Other Income (Expense), Net
Other income (expense), net was less than
Liquidity and Capital Resources
Sources of Liquidity
Since our inception in
As of
Cash Flows
The following table summarizes our sources and uses of cash for each of the
periods presented:
Three Months Three Months
Ended Ended
March 31, March 31,
(in thousands) 2022 2021
Net cash used in operating activities
49,000 -
Net cash provided by financing activities 45 -
Net decrease in cash and cash equivalents
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Operating Activities
During the three months ended
During the three months ended
In all periods presented, other changes in prepaid expenses and other current assets, accounts payable, accrued expenses and other liabilities not described above were generally due to growth in our business, the advancement of our research programs, and the timing of vendor invoicing and payments.
Investing Activities
Net cash provided by investing activities during the three months ended
We had no cash used in or provided by investing activities for the three months
ended
Financing Activities
Net cash provided by financing activities during the three months ended
We had no cash used in or provided by financing activities for the three months
ended
Funding Requirements
Our expenses could increase in connection with our ongoing activities, particularly as we advance the non-clinical and preclinical studies and the current and future clinical trials of our product candidates, including any associated manufacturing activities, and potential commercialization efforts. Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including:
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the rate of progress in the development of adintrevimab and our other product candidates;
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the scope, progress, results and costs of discovery, non-clinical studies, preclinical development, laboratory testing and clinical trials for adintrevimab and future product candidates and associated development programs;
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the extent to which we develop, in-license or acquire other product candidates and technologies in our pipeline;
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the scope, progress, results and costs of manufacturing and validation activities associated with adintrevimab and with the development and manufacturing of our future product candidates and other programs as we advance them through preclinical and clinical development;
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the number and development requirements of product candidates that we may pursue;
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the costs, timing and outcome of regulatory review of our product candidates;
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our headcount growth and associated costs as we expand our research and development capabilities and establish a commercial infrastructure;
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the timing and costs of securing sufficient capacity for clinical and commercial supply of our potential future product candidates, or the raw material components thereof;
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the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval or EUA;
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the costs necessary to obtain regulatory approvals, if any, for products in
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the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
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the continuation of our existing licensing and collaboration arrangements and entry into new collaborations and licensing arrangements, if at all;
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the need and ability to hire additional research, clinical, development, scientific and manufacturing personnel;
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the costs we incur in maintaining business operations;
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the need to implement additional internal systems and infrastructure;
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the effect of competing technological, product and market developments;
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the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;
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the costs of operating as a public company; and
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the progression of the COVID-19 pandemic and emergence of potential outbreaks of other coronaviruses, including the impact of any business interruptions to our operations or to those of our contract manufacturers, suppliers or other vendors resulting from the COVID-19 pandemic or other similar public health crises.
As of
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, government or private-party grants, debt financings, collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may include liquidation or other preferences and anti-dilution protections that adversely affect your rights as a common stockholder. Additional debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring debt, making acquisitions or capital expenditures or declaring dividends, which could adversely constrain our ability to conduct our business, and may require the issuance of warrants, which could potentially dilute your ownership interest. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or through other sources, when needed, we may be required to delay, limit, reduce or terminate our product development programs or any future commercialization efforts or grant rights to develop and market product candidates to third parties that we would otherwise prefer to develop and market ourselves.
Contractual Obligations and Commitments
During the three months ended
Critical Accounting Policies and Significant Judgments and Estimates
Our financial statements are prepared in accordance with generally accepted
accounting principles in
Recently Issued Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations and cash flows is disclosed in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
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Emerging Growth Company Status
The Jumpstart Our Business Startups Act of 2012 permits an "emerging growth company" such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected not to "opt out" of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to "opt out" of such extended transition period or (ii) no longer qualify as an emerging growth company. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.
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