What changed in this filing

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Item 1A. Risk Factors

2020-08-11 compared with 2020-05-12 · 149 added, 67 removed, 1152 unchanged (16% of the section changed)

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Since inception in April 2016, we have incurred significant net losses and have never generated any revenue from product sales.

Our net loss was $77.2 million and $28.7 million for the three months ended March 31, 2020 and 2019, respectively.

As of March 31, 2020, we had an accumulated deficit of $445.8 million.

Although we completed our initial public offering, or IPO, in October 2019 raising net proceeds of $126.4 million after deducting underwriting discounts, commissions and offering expenses and we issued 6,626,027 shares of our common stock to GGL (an affiliate of GSK) in April 2020 for an aggregate purchase price of approximately $250.0 million, we expect to continue to incur significant expenses and increasing net losses for the foreseeable future.

Our net loss was $108.4 million and $62.6 million for the six months ended June 30, 2020 and 2019, respectively.

As of June 30, 2020, we had an accumulated deficit of $476.9 million.

We expect to continue to incur significant expenses and increasing net losses for the foreseeable future.

Since inception, we have devoted substantially all of our efforts to identifying, researching and conducting preclinical and clinical activities of our product candidates, acquiring and developing our technology platforms and product candidates, organizing and staffing our company, business planning, raising capital and establishing our intellectual property portfolio.

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add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts;

experience delays or interruptions to preclinical studies, clinical trials, our receipt of services from third-party service providers or our supply chain due to the COVID-19 pandemic;

incur additional costs associated with operating as a public company.

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Consequently, any predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history.

We currently have four technology platforms and five product candidates in our development pipeline.

We currently have four technology platforms and eight product candidates in our development pipeline.

We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives, including with respect to our technology platforms and product candidates.

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If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.

As of March 31, 2020, excluding restricted cash, we had cash, cash equivalents and investments of $361.8 million.

We believe that our existing cash, cash equivalents and investments as of March 31, 2020 will fund our current operating plans through at least the next 12 months from the issuance date of the condensed consolidated financial statements.

As of June 30, 2020, excluding restricted cash, we had cash, cash equivalents and short-term investments of $552.4 million.

Based upon our current operating plan, we believe that our existing cash, cash equivalents and short-term investments as of June 30, 2020 and the proceeds from our subsequent sale of common stock in connection with our follow-on offering in July 2020 will fund our current operating plans through at least the next 12 months from the issuance date of our condensed consolidated financial statements for the period ended June 30, 2020.

However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned.

Moreover, it is particularly difficult to estimate with certainty our future expenses given the dynamic and rapidly evolving nature of our business and the COVID-19 pandemic environment generally.

We will also need to raise additional capital to complete the development and commercialization of our product candidates and fund certain of our existing manufacturing and other commitments.

We expect to finance our cash needs through public or private equity or debt financings, third-party (including government) funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches.

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Accordingly, we will need to continue to rely on additional financing to achieve our business objectives.

The COVID-19 pandemic continues to rapidly evolve and has already resulted in a significant disruption of global financial markets.

If the disruption persists and deepens, we could experience an inability to access additional capital, which could in the future negatively affect our capacity for certain corporate development transactions or our ability to make other important, opportunistic investments.

Adequate additional financing may not be available to us on acceptable terms, or at all.

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If we are unable to raise additional capital when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise develop and market ourselves.

Our pursuit of a potential therapy for COVID-19, the disease caused by the virus SARS-CoV-2, is at an early stage, and we are committing substantial financial resources and personnel and making substantial capital commitments with third parties in furtherance thereof.

In response to the recent outbreak of COVID-19, the disease caused by the virus SARS-CoV-2, we are pursuing various potential therapies to address the disease, including through mAbs using our antibody platform (in collaboration with several partners), such as VIR-7831 and VIR-7832, and siRNA using our siRNA platform (in collaboration with Alnylam), such as VIR-2703.

Our testing and development of these potential therapies is in early stages, and we may be unable to produce a therapy that successfully treats the virus in a timely manner, if at all.

For example, we have not yet initiated any clinical trials for VIR-7831, VIR-7832 or VIR-2703, although we plan to commence a Phase 2/3 clinical trial in August 2020 for VIR-7831, for which we anticipate initial clinical data to be available before the end of the year, commence a Phase 2 clinical trial later this year for VIR-7832 and continue pre-clinical studies for VIR-2703.

We are also committing substantial financial resources, both internally and externally, and personnel to the development of a potential therapy for COVID-19, which may cause delays in or otherwise negatively impact our other development programs, despite uncertainties surrounding the longevity and extent of COVID-19 as a global health concern.

In particular, our ability to develop an effective therapy will depend on the success of our manufacturing capabilities, for which we are dependent on third-party manufacturing organizations and which will require significant additional funding.

For example, in April 2020 we entered into a binding letter agreement , or the Samsung Letter Agreement, with Samsung Biologics Co.

Ltd., or Samsung, pursuant to which we were obligated to pay directly to Samsung, prior to our assignment of such agreement, a total of approximately $362.0 million for a firm and binding capacity reservation for a specified number of manufacturing slots in 2021 and 2022 for our SARS-CoV-2 antibody program regardless of whether we utilize such manufacturing slots.

In June 2020, we entered into a binding letter of intent , or the WuXi Biologics Letter Agreement, with WuXi Biologics (Hong Kong) Limited, or WuXi Biologics , pursuant to which we committed to purchase a firm and binding capacity reservation for the manufacture of a specified number of batches of drug substance of our SARS-CoV-2 antibody in 2020 and 2021.

We were obligated to pay directly to WuXi, prior to our assignment of such agreement, a total of approximately $130.0 million for such capacity reservation, if all batches are manufactured, inclusive of estimated raw material costs, with between 70% and 80% of the batch production fees owed to WuXi Biologics on a take-or-pay basis regardless of whether we utilize such manufacturing slots.

In July 2020, we assigned each of the Samsung Letter Agreement and the WuXi Biologics Letter Agreement to GlaxoSmithKline Trading Services Limited , or GSKTSL , and GSKTSL entered into a Master Services Agreement with Samsung , or the Samsung MSA, and a non-exclusive Master Services Agreement for Commercial Manufacture of Drug Substance with WuXi Biologics , or the WuXi Biologics MSA, thereby superseding each of the Samsung Letter Agreement and the WuXi Biologics Letter Agreement , and pursuant to which , among other things, Samsung and WuXi Biologics will perform development and manufacturing services for clinical and commercial supply of antibody products under our SARS-CoV-2 antibody program under each of the Samsung MSA and WuXi Biologics MSA.

In accordance with the terms of the definitive c ollaboration a greement with Glaxo Wellcome UK Limited and Beecham S.A.

(collectively referred to as GSK ) , we will continue to be responsible for 72.5% of the costs under each of the Samsung MSA and WuXi Biologics MSA , and GSK will bear 27.5% of such costs, subject to certain conditions and exceptions.

In May 2020, we entered into a clinical development and manufacturing agreement with Biogen Inc., or Biogen, pursuant to which we could be required to pay approximately $100.0 million to Biogen as an “access fee” based on our current working assumptions of manufacturing yield per batch if we successfully manufacture all batches of SARS-CoV-2 antibody drug substance under the Samsung MSA , in addition to other payments to Biogen pursuant to statements of work under the Biogen agreement.

Our current estimated aggregate commitments to GSK under the Samsung MSA and WuXi Biologics MSA for drug substance, drug product and raw material are approximately $482 .0 million , excluding the approximate “access fee” payable to Biogen.

While we believe securing such manufacturing capacity and technological expertise is crucial to the potential success of our SARS-CoV-2 antibody development programs, such capital commitments, in the aggregate, currently exceed our available cash and cash equivalents and short-term investments.

We may also need to enter into additional manufacturing arrangements in the future in order to create an effective supply chain for our COVID-19 product candidates that will adequately support demand.

We will need to raise substantial additional capital to fund the development of our product candidates and meet our capital commitments to our manufacturing partners in connection therewith.

There can be no assurance that sufficient funds will be available to us on attractive terms or at all.

If we are unable to obtain additional funding from these or other sources, it may be necessary to significantly reduce our rate of spending through reductions in staff and delaying, scaling back, or stopping certain research and development programs.

Insufficient liquidity may also require us to relinquish rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose.

Our business could be negatively impacted by our allocation of significant resources to a global health threat that is unpredictable and could rapidly dissipate or against which our potential therapies, if developed, may not be partially or fully effective, and may ultimately prove unsuccessful or unprofitable.

Furthermore, there are no assurances that our therapy will be approved for inclusion in government stockpile programs, which may be material to the commercial success of the approved product candidate, either in the United States or abroad.

In addition, another party may be successful in producing a more efficacious therapy for SARS-CoV-2 or in producing a therapy in a more timely manner, which may also lead to the diversion of funding away from us and toward other companies or lead to decreased demand for our potential therapies.

There are efforts by several public and private entities to develop a therapy for COVID-19, including Johnson & Johnson, AstraZeneca plc, Sanofi S.A., Pfizer Inc.

and Moderna, Inc., some of which are further along in the clinical development process than we are.

These other entities may be more successful at developing, manufacturing or commercializing a therapy for COVID-19.

Several of these other organizations are much larger than we are and have access to larger pools of capital, including U.S.

government funding, and broader manufacturing infrastructure.

In addition, several organizations have already secured significant commitments from goverments to purchase COVID-19 vaccines.

The success or failure of other entities, or perceived success or failure, may adversely impact our ability to obtain any future funding for our development and manufacturing efforts or to ultimately commercialize a therapy for COVID-19, if approved.

Risks Related to the Development and Commercialization of Our Product Candidates

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We may face unforeseen challenges in our product development strategy, and we can provide no assurances that our product candidates will be successful in clinical trials or will ultimately receive regulatory approval.

We have only recently initiated clinical trials for two product candidates.

We have only recently initiated clinical trials for three product candidates.

We have not obtained regulatory approval for any product candidate, and it is possible that any product candidates we may seek to develop in the future will not obtain regulatory approval.

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Monotherapy with each of these agents may provide a functional cure in some patients, while combination therapy may be necessary for others.

We are planning trials that combine VIR-2218 with VIR-3434, as well as combine VIR-2218 with other immunotherapy agents and direct acting antiviral agents.

We recently initiated a Phase 2 clinical trial to combine VIR-2218 with pegylated interferon-alpha and we are planning trials that combine VIR-2218 with VIR-3434.

We are also evaluating additional combinations with other immunotherapy agents and direct acting antiviral agents.

Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or similar regulatory authorities outside of the United States could revoke approval of the therapy used in combination with our product candidate.

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If the FDA or similar regulatory authorities outside of the United States do not approve these other drugs or revoke their approval of, or if safety, efficacy, manufacturing or supply issues arise with, the drugs we choose to evaluate in combination with any product candidate we develop, we may be unable to obtain approval.

Our pursuit of a potential therapy for COVID-19, the disease caused by the virus SARS-CoV-2, is at an early stage.

Our testing and development of these potential therapies is in early stages, and we may be unable to produce a therapy that successfully treats the virus in a timely manner, if at all.

For example, we have not yet initiated any clinical trials for VIR-7831 and VIR-7832, although we plan to proceed directly into a Phase 2 clinical trial this summer pending regulatory review.

We are also committing financial resources and personnel to the development of a potential therapy for COVID-19, which may cause delays in or otherwise negatively impact our other development programs, despite uncertainties surrounding the longevity and extent of COVID-19 as a global health concern.

For example, in April 2020, we entered into a binding letter agreement with Samsung Biologics Co., Ltd.

pursuant to which we are obligated to pay a total of approximately $362 million for a firm and binding capacity reservation for a specified number of manufacturing slots in 2021 and 2022 for our SARS-CoV-2 antibody program.

Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials and we cannot assure you that any ongoing, planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals.

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delays in reaching agreement on acceptable terms with prospective clinical research organizations, or CROs, and clinical trial sites;

delays of failures by our manufacturing partners to comply with current good manufacturing practices, or cGMP;

delays or failures by our manufacturing partners to comply with current good manufacturing practices, or cGMP;

the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, participants may drop out of these clinical trials at a higher rate than we anticipate or fail to return for post-treatment follow-up or we may fail to recruit suitable patients to participate in a trial;

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we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

disruptions caused by man-made or natural disasters or public health pandemics or epidemics or other business interruptions, including the recent outbreak of COVID-19.

disruptions caused by man-made or natural disasters or public health pandemics or epidemics or other business interruptions, including the current COVID-19 pandemic and future outbreaks of the disease.

Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue from future product sales or other sources.

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Identifying and qualifying patients to participate in our clinical trials is critical to our success.

We are developing VIR-2218 and VIR-3434 for the treatment of HBV, VIR-2482 for the prevention of influenza A, VIR-1111 for the prevention of human immunodeficiency virus, or HIV, VIR-2020 for the prevention of tuberculosis, or TB, and VIR-7831 and VIR-7832 for the treatment of COVID-19.

In particular, clinical trials for prophylaxes tend to require enrollment of a larger number of subjects than clinical trials for treatments.

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Patient enrollment and retention in clinical trials depends on many factors, including the size of the patient population, the nature of the trial protocol, the existing body of safety and efficacy data, the number and nature of competing treatments and ongoing clinical trials of competing therapies for the same indication, the proximity of patients to clinical sites and the eligibility criteria for the trial.

In addition, enrollment and retention of patients in clinical trials could be disrupted by man-made or natural disasters, or public health pandemics or epidemics or other business interruptions, including, the recent outbreak of COVID-19.

Our efforts to build relationships with patient communities may not succeed, which could result in delays in patient enrollment in our clinical trials.

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In partial consideration for the options granted by us to Brii Bio, Brii Bio Parent and Brii Bio granted us, with respect to up to four of Brii Bio Parent’s or Brii Bio’s programs, an exclusive option to be granted exclusive rights to develop and commercialize compounds and products arising from such Brii Bio programs in the United States for the Field of Use.

Neither we nor Brii Bio has exercised an option under the Brii Agreement.

In June 2020 , Brii Bi o exercised its option to obtain exclusive rights to develop and commercialize compounds and products arising fro m VIR-2218 in the China Territory pursuant to the Brii Agreement .

We cannot be certain that, following the exercise of an option by Brii Bio or by us, we will achieve any benefits from our collaboration with Brii Bio.

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These advantages could render our product candidates obsolete or non-competitive before we can recover the costs of such product candidates’ development and commercialization.

For example, there are efforts by several public and private entities to develop a therapy for COVID-19, including Johnson & Johnson, AstraZeneca plc, Sanofi S.A., Pfizer Inc.

and Moderna, Inc., some of which are further along in the clinical development process than we are.

These other entities may be more successful at developing, manufacturing or commercializing a therapy for COVID-19.

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors.

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business interruptions resulting from geopolitical actions, including war and terrorism or natural disasters including earthquakes, typhoons, floods and fires;

disruptions resulting from the impact of public health pandemics or epidemics (including, for example, the recent outbreak of COVID-19) on us or our strategic partners, third-party manufacturers, suppliers and other third parties upon which we rely.

disruptions resulting from the impact of public health pandemics or epidemics (including, for example, the ongoing COVID-19 pandemic) on us or our strategic partners, third-party manufacturers, suppliers and other third parties upon which we rely.

We have no prior experience in these areas.

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Risks Related to Regulatory Compliance

The regulatory pathways for our product candidates targeting SARS-CoV-2, the virus that causes COVID-19, are continually evolving, and may result in unexpected or unforeseen challenges.

Our product candidates targeting SARS-CoV-2, the virus that causes COVID-19, are in the early testing and development stages.

VIR-7831, a SARS-CoV-2-neutralizing mAb, is planned to initiate a Phase 2/3 clinical trial in August 2020, VIR-7832, also a SARS-CoV-2-neutralizing mAb, is planned to initiate a Phase 2 clinical trial later this year, and VIR-2703, a SARS-CoV-2-targeting siRNA, is planned to continue pre-clinical studies.

The speed at which companies and institutions are acting to create and test many therapeutics and vaccines for COVID-19 is unusual, and evolving or changing plans or priorities within the FDA, including changes based on new knowledge of COVID-19 and how the disease affects the human body, may significantly affect the regulatory timelines for our COVID-19 product candidates.

Results from our continued development and planned clinical trials may raise new questions and require us to redesign proposed clinical trials, including revising proposed endpoints or adding new clinical trial sites or cohorts of subjects.

Discussions with the FDA regarding the design of the anticipated Phase 2/3 clinical trial for VIR-7831 are ongoing and important aspects of the trial design have yet to be determined, including the number of patients to be enrolled in the trial, the specific endpoints of the trial and the methods for obtaining and testing samples in the trial and discussions with the FDA regarding the anticipated Phase 2 clinical trial for VIR-7832 are in the initial stages.

As part of these ongoing discussions, the FDA may require us to conduct additional pre-clinical studies and/or clinical trials than we originally anticipated, which could result in significant delay in our development program for these product candidates.

The FDA has the authority to grant an Emergency Use Authorization to allow unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when, based on the totality of scientific evidence, there is evidence of effectiveness of the medical product, and there are no adequate, approved, and available alternatives.

If we are granted an Emergency Use Authorization for one of our COVID-19 product candidates, we would be able to commercialize such candidate prior to FDA approval.

Furthermore, the FDA may revoke an Emergency Use Authorization where it is determined that the underlying health emergency no longer exists or warrants such authorization, and we cannot predict how long, if ever, an Emergency Use Authorization would remain in place.

Such revocation could adversely impact our business in a variety of ways, including if one of our COVID-19 product candidates is not yet approved by the FDA and if we and our manufacturing partners have invested in the supply chain to provide one of our COVID-19 product candidates under an Emergency Use Authorization.

If any of our future small molecule product candidates obtain regulatory approval, additional competitors could enter the market with generic versions of such products, which may result in a material decline in sales of affected products.

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Other legislative changes have been proposed and adopted in the United States since the ACA was enacted.

These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013 and, due to subsequent legislative amendments to the statute, including the BBA, which will remain in effect through 2030 unless additional Congressional action is taken.

The Coronavirus Aid, Relief and Economic Security Act, or CARES Act, which was signed into law in March 2020 and is designed to provide financial support and resources to individuals and businesses affected by the COVID-19 pandemic, suspended the 2% Medicare sequester from May 1, 2020 through December 31, 2020, and extended the sequester by one year, through 2030.

The American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several types of providers, including hospitals and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013.

The Coronavirus Aid, Relief and Economic Security Act, or CARES Act, which was signed into law in March 2020 and was designed to provide financial support and resources to individuals and businesses affected by the COVID-19 pandemic, suspended these reductions from May 1, 2020 through December 31, 2020, and extended the sequester through 2030.

In addition, the American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several types of providers, including hospitals and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

Additional changes that may affect our business include the expansion of new programs such as Medicare payment for performance initiatives for physicians under the Medicare Access and CHIP Reauthorization Act of 2015, which established a quality payment program , also referred to as the Quality Payment Program.

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At this time, it is unclear how the introduction of the Medicare Quality Payment Program will impact overall physician reimbursement.

Further, in the United States there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug and biological product pricing, reduce the cost of prescription drugs and biologic al products under government payor programs and review the relationship between pricing and manufacturer patient programs.

Further, in the United States there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug and biological product pricing, reduce the cost of prescription drugs and biological products under government payor programs and review the relationship between pricing and manufacturer patient programs.

At the federal level, the Trump administration’s budget proposals for fiscal years 2 021 includes a $135 billion allowance to support legislative proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic and biosimilar drugs .

On March 10, 2020, the Trump administration sent “principles” for drug pricing to Congress, calling for legislation that would, among other things, cap Medicare Part D beneficiary out-of-pocket pharmacy expenses, provide an option to cap Medicare Part D beneficiary monthly out-of-pocket expenses, and place limits on pharmaceutical price increases.

In addition, the Trump administration previously released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contain ed proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by consumers.

The Department of Health and Human Services has solicited feedback on some of these measures and has implemented others under its existing authority.

For example, in May 2019, CMS issued a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020.

In addition, the Trump administration previously released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contained proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by consumers.

The Department of Health and Human Services, or HHS, has solicited feedback on some of these measures and has implemented others under its existing authority.

For example, in May 2019, CMS issued a final rule to allow

Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020.

This final rule codified a CMS policy change that was effective January 1, 2019.

On July 24, 2020, the Trump administration announced four executive orders related to prescription drug pricing that attempt to implement several of the administration’s proposals, including a policy that would tie Medicare Part B drug prices to international drug prices;

one that directs HHS to finalize the Canadian drug importation proposed rule previously issued by HHS and makes other changes allowing for personal importation of drugs from Canada;

one that directs HHS to finalize the rulemaking process on modifying the anti-kickback law safe harbors for plans, pharmacies, and pharmaceutical benefit managers;

and one that reduces costs of insulin and epipens to patients of federally qualified health centers.

While some of these measures may require additional authorization to become effective, the U.S.

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We have not yet manufactured our product candidates on a commercial scale, and we do not yet have sufficient information to reliably estimate the cost of the commercial manufacturing of our product candidates.

Certain of our product candidates may have to compete with existing and future products, such as the annual flu vaccine, that may have a lower price point.

Certain of our product candidates may have to compete with existing and future products, such as the annual flu vaccine or any potential COVID-19 vaccine, that may have a lower price point.

The actual cost to manufacture our product candidates could materially and adversely affect the commercial viability of our product candidates.

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Additionally, the biopharmaceutical industry in particular in China is strictly regulated by the Chinese government.

Changes to Chinese regulations affecting biopharmaceutical companies are unpredictable and may have a material adverse effect on our partnerships in China which could have an adverse effect on our business, financial condition, results of operations and prospects.

Changes to Chinese regulations or government policies affecting biopharmaceutical companies are unpredictable and may have a material adverse effect on our partnerships in China which could have an adverse effect on our business, financial condition, results of operations and prospects.

Evolving changes in China’s economic, political, and social conditions could also negatively impact our ability to manufacture our product candidates for our planned clinical trials, which could adversely affect our financial condition and cause us to delay our clinical development programs.

Further, our reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured product candidates ourselves, including:

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costs and validation of new equipment and facilities required for scale-up;

inability of our third-party manufacturers to execute our manufacturing procedures and other logistical support requirements appropriately;

inability of our third-party manufacturers to execute technology transfers, manufacturing procedures and other logistical support requirements appropriately;

inability to negotiate manufacturing agreements with third parties under commercially reasonable terms, if at all;

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disruptions to operations of our third-party manufacturers or suppliers by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier;

disruptions caused by man-made or natural disasters or public health pandemics or epidemics, including, for example, the recent outbreak of COVID-19;

disruptions caused by man-made or natural disasters or public health pandemics or epidemics, including, for example, the ongoing COVID-19 pandemic;

carrier disruptions or increased costs that are beyond our control.

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We may in the future be required to make these payments, which could adversely affect our financial condition.

For example, as a result of the achievement of a certain development milestone achieved in June 2020, we paid an aggregate of $10.0 million to Humabs securityholders.

Acquisitions could also result in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our operating results.

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We expect to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.

As of March 31, 2020, we had 237 full-time employees.

As of June 30, 2020, we had 253 full-time employees.

As the clinical development of our product candidates progresses, we also expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of research, development, regulatory affairs and, if any of our product candidates receives marketing approval, sales, marketing and distribution.

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Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.

Our operations, and those of our CDMO, CROs and other contractors and consultants, could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, public health pandemics or epidemics (including, for example, the recent outbreak of COVID-19), and other natural or man-made disasters or business interruptions, for which we are predominantly self-insured.

Our operations, and those of our CDMO, CROs and other contractors and consultants, could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, public health pandemics or epidemics (including, for example, the ongoing COVID-19 pandemic), and other natural or man-made disasters or business interruptions, for which we are predominantly self-insured.

The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses.

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The ultimate impact on us, our significant suppliers and our general infrastructure of being located near major earthquake faults and fire zones and being consolidated in certain geographical areas is unknown, but our operations and financial condition could suffer in the event of a major earthquake, fire or other natural disaster.

Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the recent outbreak of COVID-19 , in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations, or materially affect our operations globally, including at our headquarters in the San Francisco Bay Area , which is currently subject to a state executive order and a shelter-in-place order, and at our clinical trial sites, as well as the business or operations of our manufacturers, CROs or other third parties with whom we conduct business .

Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the recent outbreak of COVID-19, which was declared by the World Health Organization as a global pandemic, and is resulting in travel and other restrictions to reduce the spread of the disease, including a California executive order, a San Francisco Bay Area and several other state and local orders across the country, which, among other things, direct individuals to shelter at their places of residence, direct businesses and governmental agencies to cease non-essential operations at physical locations, prohibit certain non-essential gatherings, and order cessation of non-essential travel.

The San Francisco Bay Area shelter-in-place will continue until May 31, 2020, unless further extended, and the California executive order will continue for an indefinite period of time.

Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the current outbreak of COVID-19 pandemic and future outbreaks of the disease, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations, or materially affect our operations globally, including at our headquarters in the San Francisco Bay Area, which is currently subject to a state executive order and a shelter-in-place order, and at our clinical trial sites, as well as the business or operations of our manufacturers, CROs or other third parties with whom we conduct business.

Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the current outbreak of COVID-19 pandemic and future outbreaks of the disease, which was declared by the World Health Organization as a global pandemic, and is resulting in travel and other restrictions to reduce the spread of the disease, including a California executive order, a San Francisco Bay Area and several other state and local orders across the country, which, among other things, direct individuals to shelter at their places of residence, direct businesses and governmental agencies to cease non-essential operations at physical locations, prohibit certain non-essential gatherings, and order cessation of non-essential travel.

The San Francisco Bay Area shelter-in-place order took effect in March 2020, has been amended, and has no current expiration date.

Similarly, the March 2020 California executive order will continue for an indefinite period of time.

In addition, our Humabs BioMed S.A.

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As a result of these recent developments, we have implemented work-from-home policies for most of our employees.

The effects of the state executive order, a local shelter-in-place order, government-imposed quarantines and our work-from-home policies may negatively impact productivity, disrupt our business and delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course.

Although we have recently implemented plans to reopen our offices to allow employees to return when appropriate, there is uncertainty regarding recent phased reopenings, which may be rolled back and restrictions reimplemented.

The effects of the state executive order, a local shelter-in-place order, government-imposed quarantines and our work-from-home policies, including the evolving nature of such policies, may negatively impact productivity, disrupt our business and delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course.

These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition.

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Similarly, our ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, has been delayed or disrupted, which has adversely impacted our clinical trial operations.

As previously disclosed, clinical trials for our VIR-3434, VIR-1111 and VIR-2482 product candidates have been delayed due to the COVID-19 pandemic.

As previously disclosed, clinical trials for our VIR-1111 and VIR-2482 product candidates were delayed due to the COVID-19 pandemic.

Further delays to our trials may occur.

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For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

On May 13, 2020, the Federal Bureau of Investigation (“FBI”) and the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (“CISA”) announced that the FBI was investigating the targeting and compromise of U.S.

organizations conducting COVID-19-related research by cyber actors affiliated with the People’s Republic of China.

On July 16, 2020, the National Security Agency, National Cyber Security Center, Communications Security Establishment and CISA released a joint cybersecurity advisory detailing the targeting by Russian Intelligence Services of organizations involved in COVID-19 vaccine development in the United States, Canada and the United Kingdom.

To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, including but not limited to information related to our product candidates targeting SARS-CoV-2, we could incur liability, our competitive and reputational position could be harmed, and the further development and commercialization of our product candidates could be delayed.

In addition, our internal computer and information technology systems, cloud-based computing services and those of our current and any future collaborators, service providers and other contractors or consultants are potentially vulnerable to data security breaches, whether by employees, contractors, consultants, malware, phishing attacks or other cyber-attacks, that may expose confidential information, intellectual property, proprietary business information or personal information to unauthorized persons.

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Furthermore, federal, state and international laws and regulations, such as the GDPR, can expose us to enforcement actions and investigations by regulatory authorities, and potentially result in regulatory penalties and significant legal liability, if our information technology security efforts fail.

We receive, process, store and use personal information and other data, which subjects us to governmental regulation and other legal obligations, liability and risks related to privacy, security, and data protection, and our actual or perceived failure to comply with such obligations could harm our business.

We receive, process, store and use personal information and other data about our patients, employees, partners and others.

We receive, process, store and use personal information and other data about our clinical trial participants, employees, partners and others.

We must comply with numerous foreign and domestic laws and regulations regarding privacy and the storing, sharing, use, processing, disclosure, security, and protection of personal information and other data, such as information that we collect about patients and healthcare providers in connection with clinical trials in the United States and abroad.

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however new laws, policies, codes of conduct and legal obligations may arise, continue to evolve, be interpreted and applied in a manner that is inconsistent from one jurisdiction to another and conflict with one another.

Any failure or perceived failure by us or third parties working on our behalf to comply with applicable laws and regulations, any privacy and data security obligations pursuant to contract, our stated privacy or security policies or obligations to third parties may result in governmental enforcement actions (including fines, penalties, judgments, settlements, imprisonment of company officials and public censure), civil claims, litigation, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, operations and financial performance.

Any failure or perceived failure by us or third parties working on our behalf to comply with applicable laws and regulations, any privacy and data security obligations pursuant to contract or pursuant to our stated privacy or security policies or obligations to third parties may result in governmental enforcement actions (including fines, penalties, judgments, settlements, imprisonment of company officials and public censure), civil claims, litigation, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, operations and financial performance.

With substantial uncertainty over the interpretation and application of these laws, regulations and other obligations, we may face challenges in addressing their requirements and making necessary changes to our policies and practices, and may incur significant costs and expenses in our efforts to do so.

The global data protection landscape is rapidly evolving, and we expect that there will continue to be new and proposed laws, regulations and industry standards concerning privacy, data protection and information security, and we cannot yet determine the impact that such future laws, regulations and standards may have on our business.

For example, in May 2018 the GDPR went into effect in the E uropean U nion .

The GDPR imposes stringent data protection requirements for processing the information of EU subjects, including clinical trial data, and to date, has increased compliance burdens on us, including by mandating burdensome documentation requirements and granting certain rights to individuals to control how we collect, use, disclose, retain and process information about them.

The processing of sensitive personal data, such as physical health condition, may impose heightened compliance burdens under the GDPR and is a topic of active interest among foreign regulators.

For example, in May 2018 the GDPR went into effect in the European Union.

The GDPR imposes stringent data protection requirements for processing the information of individuals in the European Union, including clinical trial data, and to date, has increased compliance burdens on us, such as requiring the following:

establishing a legal basis for processing personal data, mandating burdensome documentation requirements, adopting administrative, physical and technical safeguards to protect personal data, providing notification if a data breach were to occur to appropriate data protection authorities or individuals, taking certain measures when engaging third-party data processors, and granting certain rights to individuals to control how we collect, use, disclose, retain and process information about them.

The processing of sensitive personal data, such as health information, may impose heightened compliance burdens under the GDPR and is a topic of active interest among foreign regulators.

The GDPR increases our obligations with respect to clinical trials conducted in Europe (including the European Economic Area, or EEA, United Kingdom and Switzerland) by expanding the definition of personal data to include coded data and requiring changes to informed consent practices and more detailed notices for clinical trial subjects and investigators.

The GDPR also provides for more robust regulatory enforcement and greater penalties for noncompliance than previous data protection laws, including fines of up to €20 million or 4% of global annual revenue of any noncompliant company for the preceding financial year, whichever is higher.

Further, Brexit has created uncertainty with regard to the regulation of data protection in the United Kingdom, including with respect to whether laws or regulations will apply to us consistent with the GDPR in the future and how data transfers to and from the United Kingdom will be regulated.

Further, the United Kingdom’s decision to leave the European Union, often referred to as Brexit, has created uncertainty with regard to the regulation of data protection in the United Kingdom, including with respect to whether laws or regulations will apply to us consistent with the GDPR in the future and how data transfers to and from the United Kingdom will be regulated.

European data protection laws, including the GDPR, generally restrict the transfer of personal data from Europe, including the EEA, United Kingdom and Switzerland, to the United States and most other countries unless the parties to the transfer have implemented specific safeguards to protect the transferred personal data.

One of the primary safeguards allowing U.S.

companies to import personal data from Europe has been certification to the EU-U.S.

Privacy Shield and Swiss-U.S.

Privacy Shield frameworks administered by the U.S.

Department of Commerce.

However, the Court of Justice of the European Union recently invalidated the EU-U.S.

Privacy Shield framework.

The same decision also raised questions about whether one of the primary alternatives to the EU-U.S.

Privacy Shield, namely, the European Commission’s Standard Contractual Clauses, can lawfully be used for personal data transfers from Europe to the United States or most other countries.

At present, there are few, if any, viable alternatives to the EU-U.S.

Privacy Shield and t he Standard Contractual Clauses .

Authorities in the U nited K ingdom and Switzerland, whose data protection laws are similar to those of the European Union, may similarly invalidate use of the EU-U.S.

Privacy Shield and Swiss-U.S.

Privacy Shield, respectively, as mechanisms for lawful personal data transfers from those countries to the United States.

As such, if we are unable to implement a valid solution for personal data transfers from Europe, including, for example, obtaining individuals’ explicit consent to transfer their personal data from Europe to the United States or other countries, we will face increased exposure to regulatory actions, substantial fines and injunctions against processing personal data from Europe.

Inability to import personal data from the EEA , U nited K ingdom or Switzerland may also restrict our clinical trials activities in Europe;

limit our ability to collaborate with contract research organizations as well as other service providers, contractors and other companies subject to European data protection laws;

and require us to increase our data processing capabilities in Europe at significant expense.

Additionally, other countries outside of Europe have enacted or are considering enacting similar cross-border data transfer restrictions and laws requiring local data residency, which could increase the cost and complexity of delivering our services and operating our business.

The type of challenges we face in Europe will likely also arise in other jurisdictions that adopt laws similar in construction to the GDPR or regulatory frameworks of equivalent complexity .

Further, various states, such as California and Massachusetts, have implemented similar privacy laws and regulations that impose restrictive requirements regulating the use and disclosure of health information and other personally identifiable information.

Further, various states, such as California and Massachusetts, have implemented similar privacy and data protection laws and regulations that impose restrictive requirements regulating the use and disclosure of health information and other personally identifiable information.

These laws and regulations are not necessarily preempted by HIPAA, particularly if a state affords greater protection to individuals than HIPAA.

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In addition to fines and penalties imposed upon violators, some of these state laws also afford private rights of action to individuals who believe their personal information has been misused.

For example, California recently enacted legislation, the California Consumer Privacy Act, or CCPA, that will, among other things, require covered companies to provide new disclosures to California consumers, and afford such consumers new abilities to opt-out of certain sales of personal information, that became effective on January 1, 2020.

For example, California recently enacted legislation that became effective on January 1, 2020, the California Consumer Privacy Act, or CCPA, that, among other things, requires covered companies to provide new disclosures to California residents, affords California residents new abilities to opt-out of certain disclosures of personal information, and allows for a new cause of action for data breaches.

The CCPA was amended several times throughout 2018 and 2019, and it is unclear whether further modifications will be made to this legislation or how it will be interpreted.

In addition, the CCPA requires covered companies to provide new disclosures to consumers in California, and affords some consumers new data protection rights, including the ability to opt-out of the sale of their personal information.

Although there are limited exemptions for clinical trial data under the CCPA, the CCPA and other similar laws could impact our business activities depending on how it is interpreted and exemplifies the vulnerability of our business to the evolving regulatory environment related to personal data.

The GDPR, CCPA and many other laws and regulations relating to privacy and data protection are still being tested in courts, and they are subject to new and differing interpretations by courts and regulatory officials.

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It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our practices and our efforts to comply with the evolving data protection rules may be unsuccessful.

We cannot guarantee that we or our vendors may be in compliance with all applicable international laws and regulations as they are enforced now or as they evolve.

For example, our privacy policies may be insufficient to protect any personal information we collect, or may not comply with applicable laws.

We cannot guarantee that we, our third-party collaborators, or our vendors are in compliance with all applicable data protection and privacy laws and regulations as they are enforced now or as they evolve.

Further, for example, our privacy policies may be insufficient to protect any personal information we collect, or may not comply with applicable laws.

Our non-compliance could result in government-imposed fines or orders requiring that we change our practices, which could adversely affect our business.

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In addition, if we are unable to properly protect the privacy and security of protected health information, we could be found to have breached our contracts.

Our actual or perceived failure to adequately comply with applicable laws and regulations relating to privacy and data protection, or to protect personal data and other data we process or maintain, could result in regulatory enforcement actions against us, including fines, imprisonment of company officials and public censure, claims for damages by affected individuals, other lawsuits or reputational and damage, all of which could materially affect our business, financial condition, results of operations and growth prospects.

Our actual or perceived failure to adequately comply with applicable laws and regulations relating to privacy and data protection, or to protect personal data and other data we process or maintain, could result in regulatory enforcement actions against us, including fines, penalties, orders that require a change in our practices, additional reporting requirements and/or oversight, imprisonment of company officials and public censure, claims for damages by affected individuals, other lawsuits or reputational and damage, all of which could materially affect our business, financial condition, results of operations and growth prospects.

Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.

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On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, which provides temporary relief from certain aspects of the Tax Act that had imposed limitations on the utilization of certain losses, interest expense deductions, and minimum tax credits.

We are currently in the process of assessing the tax-related provisions of the CARES Act and its potential impact on us.

The enactment of the CARES Act did not result in any material adjustments to our income tax provision for the period.

Our ability to use our net operating losses, or NOLs, to offset future taxable income may be subject to certain limitations.

We have incurred substantial losses since inception and do not expect to become profitable in the near future, if ever.

As of December 31, 2019, we had net operating loss carryforwards of $241.6 million for federal purposes and $118.8 million for state tax purposes.

As of December 31, 2019, we had net operating loss carryforwards of $241.6 million for federal tax purposes and $118.8 million for state tax purposes.

If not utilized, federal carryforwards arising in tax years ending prior to 2018 will begin expiring in 2034 and state carryforwards will begin expiring in 2031.

Our ability to use our federal and state net operating losses to offset potential future taxable income that would otherwise be due is dependent upon our generation of future taxable income before the expiration dates of the net operating losses, and we cannot predict with certainty when, or whether, we will generate sufficient taxable income to use all of our net operating losses.

In general, under Sections 382 and 383 of the Code a corporation that undergoes an “ownership change” (generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period) is subject to limitations on its ability to utilize its pre-change NOLs to offset future taxable income.

We may have experienced ownership changes in the past and may experience ownership changes as a result of the IPO and/or subsequent changes in our stock ownership (some of which shifts are outside our control).

Our ability to use our federal and state net operating losses to offset potential future taxable income is dependent upon our generation of future taxable income before any expiration dates of the net operating losses, and we cannot predict with certainty when, or whether, we will generate sufficient taxable income to use all of our net operating losses.

In general, under Sections 382 and 383 of the Code , a corporation that undergoes an “ownership change” (generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a rolling three-year period) is subject to limitations on its ability to utilize its pre-change NOLs to offset future taxable income.

We may have experienced ownership changes in the past or as a result of the IPO and may experience ownership changes as a result of future offerings and/or subsequent changes in our stock ownership (some of which shifts are outside our control).

In addition, Agenovir has experienced at least one ownership change in the past resulting in a limitation under Section 382 of the Code, which has been accounted for in calculating our available NOL carryforwards.

As a result, if, and to the extent that we earn net taxable income, our ability to use our pre-change NOLs to offset such taxable income may be subject to limitations.

The Tax Act and the CARES Act, among other things, includes changes to U.S.

The Tax Act and the CARES Act includes, among other things, changes to U.S.

federal tax rates and the rules governing NOL carryforwards.

In addition, NOLs arising in tax years ending after December 31, 2017 can be carried forward indefinitely, but the deductibility of such federal NOLs may be limited to 80% of current year taxable income for tax years beginning on or after January 1, 2021.

NOLs generated in tax years beginning before January 1, 2018 will not be subject to the taxable income limitation, and NOLs generated in tax years ending before January 1, 2018 will continue to have a two-year carryback and 20-year carryforward period.

For example, NOLs arising in tax years ending after December 31, 2017 can be carried forward indefinitely, but the deductibility of such federal NOLs may be limited to 80% of current year taxable income for tax years beginning on or after January 1, 2021.

Deferred tax assets for NOLs will need to be measured at the applicable tax rate in effect when the NOL is expected to be utilized.

The changes in the carryforward/carryback periods, as well as the new limitation on use of NOLs may significantly impact our ability to utilize our NOLs to offset taxable income in the future.

The changes in the carryforward periods, as well as the new limitation on use of NOLs may impact our ability to utilize our NOLs to offset taxable income in the future.

Because we have been generating taxable losses since inception, we do not expect any changes resulting from the new NOL provision to the current tax benefit and valuation allowance.

Risks Related to Ownership of Our Common Stock

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Securities and Exchange Commission, or the SEC, and (iv) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

In light of our public float at June 30, 2020, w e expect that we will no longer be an EGC on December 31, 2020.

We cannot predict whether investors will find our common stock less attractive because we will rely on these exemptions.

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For example, on September 30, 2018, then California Governor Jerry Brown signed into law Senator Bill 826, which generally requires public companies with principal executive offices in California to have a minimum number of females on the company’s board of directors.

By December 31, 2019, each public company with principal executive offices in California was required to have at least one female on its board of directors.

By December 31, 2021, each public company is required to have at least two females on its board of directors if the company has at least five directors, and at least three females on its board of directors if the company has at least six directors.

E ach public company with principal executive offices in California i s required to have at least one female on its board of directors , and b y December 31, 2021, will be required to have at least two females on its board of directors if the company has at least five directors, and at least three females on its board of directors if the company has at least six directors.

The new law does not provide a transition period for newly listed companies.

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federal courts have exclusive jurisdiction.

In addition, our amended and restated certificate of incorporation provides that the federal district courts of the United States will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act of 1933, as amended, or the Securities Act, unless we consent in writing to the selection of an alternative forum.

Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions.

Accordingly, both state and federal courts have jurisdiction to entertain such claims.

To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated certificate of incorporation further provides that the federal district courts of the United States will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act of 1933, as amended, or the Securities Act, unless we consent in writing to the selection of an alternative forum.

While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions.

In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our amended and restated certificate of incorporation.

This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.

These exclusive-forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage these types of lawsuits.

Furthermore, the enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find these types of provisions to be inapplicable or unenforceable.

If a court were to find the exclusive-forum provision contained in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business.

If a court were to find the exclusive-forum provision contained in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving such action in other jurisdictions, all of which could harm our business.

Unregistered Sales of Equity Securities and Use of Proceeds.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors