You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes appearing elsewhere in this unaudited Quarterly Report on Form 10-Q and our audited financial statements and related notes thereto for the year endedDecember 31, 2021 included in our Annual Report on Form 10-K for the year endedDecember 31, 2021 , which was filed with theSEC onMarch 25, 2022 . Some of the information contained in this discussion and analysis or set forth elsewhere in this report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks, uncertainties, and assumptions. Factors that might cause future results to differ materially from those projected in the forward-looking statements include, but are not limited to, those set forth in our Annual Report on Form 10-K and in other filings with theSEC .
Overview
We are a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases, cancer, and autoimmunity. We aim to treat and prevent infectious diseases and cancer by using our proprietary platforms to develop product candidates that stimulate powerful, targeted immune responses against pathogens, infected cells, and tumor cells. We design these product candidates to stimulate immune responses that are robust, highly specific, and are differentiated by the magnitude of the T cell populations induced, which exhibit critical functionality and durability. In the field of autoimmunity, we use our proprietary platform to develop product candidates that are designed to induce regulatory T cells to suppress specific immune responses and prevent/reverse autoimmunity. We are focused on applying our platform capabilities and the expertise of our team to address significant unmet medical needs in two settings - the therapeutic setting, for the treatment of chronic infectious diseases, cancer, and autoimmunity and the prophylactic setting, for the prevention of infectious diseases, based on our platform's ability to respond rapidly to epidemic and pandemic threats. We have a broad pipeline of both clinical and preclinical stage therapeutic and prophylactic programs. Our current therapeutic programs include VTP-300 for the treatment of chronic hepatitis B infection, or CHB, VTP-200 for the treatment of human papilloma virus infection, or HPV, VTP-850 for the treatment of prostate cancer, VTP-600 for the treatment of non-small cell lung cancer, or NSCLC, VTP-1000 for treatment of celiac disease, and VTP-1100 for treatment of HPV-associated cancers. The latter two programs are designed to utilize our SNAPvax platform. Our current prophylactic programs include VTP-400 for the prevention of herpes zoster, or shingles, and VTP-500 for the prevention ofMiddle East respiratory syndrome, or MERS. In addition, we co-invented a COVID-19 vaccine with theUniversity of Oxford , the rights to which we assigned toOxford University Innovation , or OUI, to facilitate the license of those rights by OUI toAstraZeneca UK Limited , or AstraZeneca. The vaccine, formerly referred to as AZD1222, is now authorized for use under the marketing name Vaxzevria in a number of countries. AstraZeneca has exclusive worldwide rights to develop and commercialize Vaxzevria. OnMay 4, 2021 , we completed our initial public offering, or IPO, pursuant to which we issued and sold 6,500,000 American Depository Shares, or ADSs, at a public offering price of$17.00 per ADS, resulting in net proceeds of$102.8 million , after deducting underwriting discounts and commissions and offering expenses. Prior to our IPO, we funded our operations primarily from private placements of our ordinary and preferred shares, private placements of loan notes convertible into ordinary shares, as well as from grants and licensing agreements, research tax credit payments, investments from non-controlling interest, and a$2.4 million upfront payment from OUI inJuly 2020 in connection with the Amendment, Assignment and Revenue Share Agreement, or the OUI License Agreement Amendment, related to the licensing of the COVID-19 vaccine, Vaxzevria. We do not expect to generate revenue from any of our own product candidates, excluding Vaxzevria, until we obtain regulatory authorization for one or more of such product candidates, if at all, and commercialize our products, or we enter into out-licensing agreements with third parties. OnMarch 28, 2022 , pursuant to the OUI License Agreement Amendment, we were notified of the commencement of payments, arising from AstraZeneca's commercial sales of Vaxzevria. Under the terms of an exclusive worldwide license agreement between OUI and AstraZeneca, we understand OUI is entitled to milestone payments and royalties on commercial sales of Vaxzevria that began after the pandemic period. As part of the assignment from us to OUI, we are entitled to receive approximately 24% of payments received by OUI from AstraZeneca. Our share of payments in the three and nine months endedSeptember 30, 2022 , recognized as revenue amount to approximately$6.2 million and$38.2 million , respectively, representing the amounts we have been notified of as due by OUI to date. Because of the limited history and continued volatility of receipts and the lack of visibility we have of the arrangements between AstraZeneca and OUI, we continue to fully constrain any revenue beyond the amounts that we have been notified of by OUI to date. There is, however, no guarantee that such payments will continue in the future and, if they do, that we will 16
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be notified of such payments in a timely manner. If we do not receive notification of our share of the payments in a timely manner, we may not be able to recognize the payments as revenue in the quarter they are earned.
OnAugust 9, 2022 , we filed a Registration Statement on Form S-3, as amended, or the Shelf, with theSecurities and Exchange Commission in relation to the registration and potential future issuance of ordinary shares, including ordinary shares represented by ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to$200.0 million . The Shelf was declared effective onAugust 17, 2022 . We also simultaneously entered into a sales agreement withJefferies LLC , as sales agent, providing for the offering, issuance and sale by us of up to an aggregate of$75.0 million of our ordinary shares represented by ADSs from time to time in "at-the-market" offerings under the Shelf. As ofSeptember 30, 2022 , we have not issued or sold any ordinary shares represented by ADSs under the sales agreement. We have incurred net losses each year since inception through toDecember 31, 2021 . For the nine months endedSeptember 30, 2022 , we generated net income of$26.5 million . For the nine months endedSeptember 30, 2021 , we incurred net losses of$35.9 million . As ofSeptember 30, 2022 , we had an accumulated deficit of$82.1 million and we do not currently expect positive cash flows from operations in the foreseeable future. We expect to incur net operating losses for at least the next several years as we advance our product candidates through clinical development, seek regulatory approval, prepare for approval, and in some cases proceed to commercialization of our product candidates, as well as continue our research and development efforts and invest to establish a commercial manufacturing facility, as and when appropriate. At this time, we cannot reasonably estimate, or know the nature, timing and estimated costs of all of the efforts that will be necessary to complete the development of any of our product candidates that we develop through our programs. We are also unable to predict when, if ever, material net cash inflows will commence from sales of product candidates we develop, if at all. This is due to the numerous risks and uncertainties associated with developing product candidates to approval and commercialization, including the uncertainty of:
? successful completion of preclinical studies and clinical trials;
? sufficiency of our financial and other resources to complete the necessary
preclinical studies and clinical trials;
? acceptance of investigational new drug applications, or INDs, for our planned
clinical trials or future clinical trials;
? successful and timely enrollment and completion of clinical trials;
data from our clinical program supporting approvable and commercially ? acceptable risk/benefit profiles for our product candidates in the intended
populations;
receipt and maintenance of necessary regulatory and marketing approvals from ? applicable regulatory authorities, in the light of the commercial environment
then existent;
availability and successful procurement of raw materials required to ? manufacture our products for clinical trials, scale-up of our manufacturing
processes and formulation of our product candidates for later stages of
development and commercial production;
establishing either our own manufacturing capabilities or satisfactory ? agreements with third-party manufacturers for clinical supply for later stages
of development and commercial manufacturing;
? entry into collaborations where appropriate to further the development of our
product candidates;
obtaining and maintaining intellectual property and trade secret protection or ? regulatory exclusivity for our product candidates as well as qualifying for,
maintaining, enforcing and defending such intellectual property rights and
claims;
? successfully launching or assisting with the launch of commercial sales of our
product candidates following approval;
? acceptance of each product's benefits and uses by patients, the medical
community and third-party payors following approval;
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? the prevalence and severity of any adverse events experienced with our product
candidates in development;
? establishing and maintaining a continued acceptable safety profile of
the product candidates following approval;
? obtaining and maintaining healthcare coverage and adequate reimbursement from
third-party payors if necessary or desirable; and
? effectively competing with other therapies.
A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and/or timing associated with the development of that product candidate or could prevent continuation of that program being in the company's interests. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we might be required to expend significant additional financial resources and time on the completion of clinical development. In some circumstances, such as the emergence of a significantly more effective therapy from a competitor, it may be appropriate to discontinue a product candidate program. We expect that our cash balance as ofSeptember 30, 2022 will enable us to fund our operating expenses and capital requirements into the first quarter of 2025. Recent Developments
On
OnOctober 27, 2022 , we announced the publication of research from VTP-1100 in Cell online that demonstrates anti-tumor activity achieved with intravenous, or IV, vaccination of a SNAPvax construct in an animal model. The study demonstrates that IV administration of SNAPvax primes and expands antigen-specific T cells and reverses suppression in the tumor microenvironment, which promotes T cell infiltration and tumor cell killing. An IND application submission is expected during the first half of 2023 for HPV related cancer. OnOctober 31, 2022 , we announced the dosing of the first patient in HBV003, a Phase 2b clinical trial of VTP-300 to evaluate the optimal timing of low dose nivolumab and the impact of additional doses of the MVA boost for a sustained decline in HBsAG. OnNovember 7, 2022 Dr. Young-Suk Lim, Professor of Gastroenterology in the Liver Center atUniversity of Ulsan College of Medicine presented a poster Phase 1b/2a clinical trial data on VTP-300 at theAmerican Association for the Study of Liver Disease , or AASLD, Liver Meeting. The poster presentation showed VTP-300 immunotherapy, as monotherapy and when combined with low dose nivolumab at the boosting time point, was immunogenic and showed a reduction in HBsAg in well-controlled CHB patients, while exhibiting an excellent safety profile. Two of five patients dosed in cohort 3 (ChAdOx1-HBV + MVA-HBV with low dose nivolumab given at the boost) with starting HBSAg levels below 100, achieved non-detectable levels of surface antigen.
Impact of COVID-19
COVID-19 continues to have an impact, both directly and indirectly, on our business and operations, including continuing disruption to our clinical trial activities. Our study protocols have been amended so that participants who have previously received Vaxzevria (or any other adenovirus-based vaccine) wait for a minimum of three months between their last adenovirus vaccine and injection with our immunotherapeutic product candidates to prevent prior vector immunity affecting the study. In the VTP-200 program, participant recruitment was delayed, and the last patient's first visit is anticipated to be in the fourth quarter of 2022 with the last visit due by the end of 2023. Initial data is expected to be available in the first quarter of 2023. For our Phase 1 (HBV001) clinical trial for VTP-300, recruitment of patients with Chronic Hepatitis B (CHB) in theUK was challenging, due to COVID-19 lockdowns. We completed recruitment for all cohorts in first quarter of 2022. For our Phase 1b/2a (HBV002) clinical trial for VTP-300, CHB patient recruitment was delayed inTaiwan ,South Korea , and theUnited Kingdom due to the ongoing COVID-19 restrictions in those countries. Patient recruitment was also delayed inSouth Korea due to the roll out of Vaxzevria vaccine and vaccine hesitancy. Patient recruitment was completed inMay 2022 , an update to the interim efficacy data was announced onJune 22, 2022 and updated efficacy data was presented
at AASLD onNovember 7, 2022 . 18 Table of Contents We continue to assess our business plans and the impact the COVID-19 is having on our ability to advance the development of our product candidates as a result of adverse impacts on the research sites, service providers, vendors, or suppliers on whom we rely, or to raise financing to support the development of our ongoing product candidate development. No assurances can be given that this analysis will enable us to avoid part or all of any impact from COVID-19, including downturns in business sentiment generally or in our sector in particular. The impact of government regulations, vaccine adoption rates (including boosters), the effectiveness of vaccines, and the continuing economic effects of the pandemic and containment measures may also further adversely impact our business. We cannot currently predict the scope and severity of any potential business shutdowns or disruptions, but if we or any of the third parties on whom we rely or with whom we conduct business were to experience shutdowns or other business disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially and adversely impacted.
Impact of the Ukraine Crisis
In respect of the international situation inUkraine , we have assessed the impact on the Company as minimal. We have no operations or suppliers based inUkraine ,Belarus , orRussia , and there is consequently no additional risk or negative impact on the unaudited condensed consolidated financial statements.
Impact of Global Economic Conditions and Inflationary Pressures
Instability in global economic conditions and geopolitical matters, as well as volatility in financial markets, could have a material adverse effect on the Company's results of operations and financial condition. These inflationary pressures and rising interest rates inthe United States , theUnited Kingdom and elsewhere have given rise to increasing concerns that theU.S. ,U.K. and other economies are now in, or may soon enter, economic recession. Sustained inflationary pressures, increased interest rates, an economic recession or continued or intensified disruptions in the global financial markets could adversely affect our future financing capability or ability to access the capital markets. Additionally, we may incur future increases in operating costs due to additional inflationary increases.
Components of Our Operating Results
Revenue
To date, we have not generated any revenue from direct product sales and do not expect to do so in the near future, if at all. Most of our revenue to date has been derived from a research grant from theBiomedical Advanced Research and Development Authority , or BARDA, a research collaboration and license agreement withEnara Bio , and the OUI License Agreement Amendment with OUI relating to Vaxzevria. InApril 2020 , we entered into the OUI License Agreement Amendment with OUI in respect of our rights to use the ChAdOx1 technology in COVID-19 vaccines to facilitate the license of those rights by OUI to AstraZeneca. Under this agreement, we are entitled to receive from OUI a share of payments, including royalties and milestones, received by OUI from AstraZeneca in respect of this vaccine. As a direct result of the OUI License Agreement Amendment, we received a payment of$2.4 million , of which we recognized$2.4 million as revenue during the year endedDecember 31, 2020 . InMarch 2022 , we were notified of the commencement of payments relating to commercial sales of Vaxzevria. Our share of payments for the three and nine month periods endedSeptember 30, 2022 , amount to approximately$6.2 million and$38.2 million respectively, representing the amounts we have been notified of as due by OUI to date. Because of the limited history of receipts and the lack of visibility we have of the arrangements between AstraZeneca and OUI, we continue to fully constrain any revenue beyond the amounts that we have been notified of by OUI to date. We determined that we have no further performance obligations under the terms of the OUI License Agreement Amendment, which comprised the transfer of intellectual property rights only. Accordingly, we plan to recognize these and any future amounts as revenue when earned, and it is probable that a significant reversal of revenue will not occur.
Operating Expenses
Our operating expenses since inception have consisted of research and development costs and general administrative costs.
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Research and Development Expenses
Since our inception, we have focused significant resources on our research and development activities, including establishing and building on our adenovirus platform, further enhancing our in-licensed ChAdOx1, ChAdOx2 and MVA vectors, developing a new next-generation adenoviral vector, conducting preclinical studies, developing various manufacturing processes, and advancing clinical development of our programs including Phase 2 clinical trials for VTP-100, which we subsequently discontinued development of, as well as initiating the clinical trials for VTP-200, VTP-300, and VTP-600 and readying VTP-850 and VTP-500 for clinical trials. Research and development activities account for the major portion of our operating expenses, and we expect research and development expenses to increase in the future. Research and development costs are expensed as incurred. These costs include:
? salaries, benefits, and other related costs, including share-based
compensation, for personnel engaged in research and development functions;
expenses incurred in connection with the development of our programs including ? preclinical studies and clinical trials of our product candidates, under
agreements with third parties, such as consultants, contractors, academic
institutions and CROs;
the cost of manufacturing drug products for use in preclinical development and ? clinical trials, including under agreements with third parties, such as CMOs,
consultants and contractors;
? laboratory costs; and
? leased facility costs, equipment depreciation and other expenses, which include
direct and allocated expenses.
General and Administrative Expenses
Our general and administrative expenses consist primarily of personnel costs, including share-based compensation, in our executive, finance, business development and other administrative functions. Other general and administrative expenses include consulting fees and professional service fees for auditing, tax, and legal services, rent expenses related to our offices, depreciation, foreign exchange gains and losses on our cash balances and other central non-research costs. We expect our general and administrative expenses to continue to increase in the future as we expand our operating activities in both theUnited Kingdom andUnited States and potentially prepare for manufacturing and/or commercialization of our current and future product candidates. These costs would normally increase as our headcount rises to allow full support for our operations as a public company, including increased expenses related to legal, accounting, regulatory and tax-related services associated with maintaining compliance with requirements of the Nasdaq Global Market and theSecurities and Exchange Commission , directors' and officers' liability insurance premiums and investor relations activities. 20 Table of Contents Other Income (Expense) Change in Fair Value For the three and nine months endedSeptember 30, 2022 , we recognized a change in fair value in relation to the updated assumptions in the assessment of the contingent consideration fair value recognized from the acquisition ofAvidea Technologies, Inc. , or Avidea, onDecember 10, 2021 . Significant judgment is used to determine the probability of success of achievement of the milestone and the date of the expected milestone. We recognized a change in fair value in relation to the conversion and redemption features embedded in the convertible loan notes in the condensed consolidated statements of operations and comprehensive loss for the nine months endedSeptember 30, 2021 . We had an embedded derivative liability related to the conversion features, the cash redemption feature on maturity and the cash redemption feature upon an exit event that settles in noncash consideration embedded in convertible loan notes. The fair value of the embedded derivatives is a Level 3 valuation with the significant unobservable inputs being the probability of exercise of conversion and cash redemption features. Significant judgment is employed in determining the appropriateness of certain of these inputs.
Loss on Extinguishment of Convertible Loan Notes
OnMarch 15, 2021 , we issued 28,957 Series B preferred shares, or Series B Shares, amounting to$125.2 million . Each Series B Share is convertible into 309 ordinary shares and nine deferred shares at the holders' option at any time. The Series B funding constituted a qualified equity financing in accordance with the terms of the convertible loan notes. As a result, the convertible loan notes were converted onMarch 15, 2021 into 12,421 Series B Shares with the conversion price being 0.8 times the Series B Shares issue price. The conversion was accounted for as an extinguishment of the convertible loan notes. As a result, the 12,421 Series B preferred shares issued on conversion were recognized at the settlement-date fair value of the Series B shares and a loss was recognized in earnings for the difference between (1) the fair value of those shares and (2) the sum of the carrying amounts of the convertible loan notes and the bifurcated conversion and redemption feature liability.
Interest Expense
Interest expense results primarily from our convertible loan notes, which carry a market rate of interest. These notes were issued between July andNovember 2020 and converted onMarch 15, 2021 into 12,421 Series B Shares with the conversion price being 0.8 times the Series B Shares issue price.
Interest Income
Interest income results primarily from the interest earned on our short-term cash deposits and cash balances held byVaccitech (UK) Limited inUnited States dollars.
Research and Development Incentives
Research and development incentives contain payments receivable from theUnited Kingdom government related to corporation tax relief on research and development projects incentive programs in theUnited Kingdom . We account for such relief received as other income. The Company benefits from theUnited Kingdom research and development tax credit regime, being the Small and Medium-sized Enterprises R&D tax relief program, or SME Program, and, to the extent that our projects are grant funded or relate to work subcontracted to us by third parties, the Research and Development Expenditure Credit program, or RDEC Program. Under the SME program, the Company is able to surrender some of its trading losses that arise from qualifying research and development activities for a cash rebate of up to 33.35% of such qualifying research and development expenditure. Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects. Certain subcontracted qualifying research and development expenditures are eligible for a cash rebate of up to 21.67%. A large portion of costs relating to research and development, clinical trials and manufacturing activities are eligible for inclusion within these tax credit
cash rebate claims. 21 Table of Contents The Company may not be able to continue to claim research and development tax credits under the SME program in the future because it may no longer qualify as a small or medium-sized company. In addition, the EU State Aid cap limits the total aid claimable in respect of a given project to €7.5 million which may impact the Company's ability to claim R&D tax credits in future. Further, theU.K. Finance Act of 2021 introduced a cap on payable credit claims under the SME Program in excess of £20,000 with effect fromApril 2021 by reference to, broadly, three times the total Pay As You Earn, or PAYE, andNational Insurance Contributions, or NICs, liability of the company, subject to an exception which prevents the cap from applying. That exception requires the company to be creating, taking steps to create or managing intellectual property, as well as having qualifying research and development expenditure in respect of connected parties, which does not exceed 15% of the total claimed. If such exception does not apply, this could restrict the amount of payable credit that we claim. UnsurrenderedUK losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% ofUK taxable profits.
Critical Accounting Policies and Use of Estimates
This discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted inthe United States , or US GAAP. The preparation of financial statements requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to revenue, expenses, accruals and prepayments for external manufacturing of clinical trial material as well as clinical study conduct, fair value of contingent consideration, impairment of goodwill and intangible assets, and the fair value of ordinary shares and share-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates. We believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our financial statements and understanding and evaluating our reported financial results.
Going Concern
The condensed consolidated financial statements included elsewhere herein have been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We have financed our activities principally from the issuance of ordinary and preferred equity securities and convertible loan notes. We have experienced recurring losses since inception through toDecember 31, 2021 and expect to incur additional losses in the future in connection with research and development activities and general and administrative expenses. Our ability to continue as a going concern is dependent upon our ability to raise additional debt and equity capital. There can be no assurance that such capital will be available in sufficient amounts or on terms acceptable to us. We generated a net income of$26.5 million and used$3.1 million in cash to fund our operating activities during the nine months endedSeptember 30, 2022 . During the nine months endedSeptember 30, 2021 , we incurred a net loss of$35.9 million and used$24.6 million in cash to fund our operating activities. We had an accumulated deficit of$82.1 million as ofSeptember 30, 2022 . As ofSeptember 30, 2022 , we had$200.1 million in cash and cash equivalents mainly as a result of equity issuance and the IPO in 2021, and revenues received from Vaxzevria in 2022. Our management believes that we have sufficient cash to support our operations into the first quarter of 2025, without additional financing. If we are unable to obtain additional financing in sufficient amounts or on acceptable terms, we may be forced to delay, reduce, or eliminate some or all of our research and development programs and product portfolio expansion, which could adversely affect our operating results or business prospects. Although our management continues to pursue these plans, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all. After considering the uncertainties, management consider it is appropriate to continue to adopt the going concern basis in preparing the condensed consolidated financial statements.
Convertible Loan Notes and Embedded Derivatives
We review the terms of convertible loan notes and other financing arrangements to determine whether there are embedded derivative instruments, including embedded conversion options that are required to be bifurcated and accounted for separately as a derivative 22 Table of Contents financial instrument. Derivative financial instruments are initially measured at fair value, and then re-valued at each reporting date, with changes in the fair value reported as charges or credits in the condensed consolidated statements of operations and comprehensive loss. To the extent that the initial fair values of the freestanding and/or bifurcated derivative instrument exceed the total proceeds received an immediate charge in the condensed consolidated statements of operations and comprehensive loss is recognized in order to initially record the derivative instrument at fair value. The discount from the face value of the convertible loan notes resulting from allocating some or all of the proceeds to the derivative instruments, together with the stated rate of interest on the instrument, is amortized over the life of the instrument through periodic charges in the condensed consolidated statements of operations and comprehensive loss, using the effective interest method.
Embedded derivatives bifurcated are presented along with the host contract on the condensed consolidated balance sheets.
In 2020, we entered into a series of unsecured convertible loan notes arrangements on various dates between July throughNovember 2020 . The Series B funding onMarch 15, 2021 constituted a qualified equity financing in accordance with the terms of the convertible loan notes. As a result, the convertible loan notes were converted onMarch 15, 2021 into 12,421 Series B Shares with the conversion price being 0.8 times the Series B Shares issue price and are no longer outstanding.
Recognition of Revenue from Contracts with Customers
In 2020, we entered into the OUI License Agreement Amendment with OUI to facilitate the license of our rights to the COVID-19 vaccine we co-invented with OUI to AstraZeneca, which is now known as Vaxzevria. Our performance obligations under the terms of this agreement are limited to the transfer of intellectual property rights (licenses and other rights). Payments by AstraZeneca to OUI under this agreement include an up-front payment, payments based upon the achievement of defined milestones, royalties on product sales, and may include payments of commercial and other milestones, if certain future conditions are met. We are entitled to receive approximately 24% of payments, including royalties and milestones, received by OUI from that license agreement with AstraZeneca as set out in the OUI License Agreement Amendment. We evaluate our collaboration and licensing arrangements pursuant to Accounting Standards Codification 606, or ASC 606. To determine the recognition of revenue from arrangements that fall within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize determinable revenue when, or as, the company satisfies a performance obligation or (if later) when such revenue becomes payable. We use judgment to determine whether milestones or other variable consideration, except for sales-based royalties, should be included in the transaction price. The transaction price is allocated to each performance obligation on a relative standalone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. In validating its estimated standalone selling price, we evaluate whether changes in the key assumptions used to determine its estimated standalone selling price will have a significant effect on the allocation of arrangement consideration between performance obligations. For sales-based and clinical development milestones and royalties, when the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales or milestone achievement occurs or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). This could require management to estimate the amount of revenue to recognize in the period if the actual data has not been provided. Amounts received by us as non-refundable upfront payments prior to satisfying the above revenue recognition criteria would be recorded as deferred revenue in our condensed consolidated balance sheets. Such amounts would be recognized as revenue over the performance period of the respective services on a percent of completion basis for each of the obligations. 23
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Research and Development Costs
Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries and bonuses, share-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation, manufacturing expenses and external costs of vendors engaged to conduct preclinical development activities and clinical trials as well as the cost of licensing technology. Advance payments 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 then expensed as the related goods are delivered or the services are performed. Research and development costs are accrued when the related services or goods are delivered ahead of being billed. All patent-related costs incurred in connection with filing and prosecuting patent applications are classified as research and development costs and expensed as incurred due to the uncertainty about any future recovery of the expenditure. Upfront payments, milestone payments and annual payments made for the licensing of technology are generally expensed as research and development in the period in which they are incurred. Incremental sublicense fees triggered by contracts with customers are capitalized and expensed as research and development expenses over the period in which the relating revenue is recognized.
Share-based Compensation
We grant options and restricted shares to employees and directors and account for share-based compensation using a fair value method. All of these arrangements are settled in equity at a predetermined price and generally vest over a period of three years. All share options have a life of 10 years before expiration. To the extent such incentives are in the form of share options, up until the first quarter of 2021, the options may have been granted pursuant bilateral EMI option awards or unapproved option awards. The EMI option award agreements provide for the grant of potentially tax favored Enterprise Management Incentive, or EMI, options, to ourUnited Kingdom employees and directors. Options issued pursuant to such agreements have an exercise price agreed with HM Revenue & Customs. OnApril 8, 2021 , we adopted theVaccitech plc Share Award Plan 2021 and theVaccitech plc Non-Employee Sub-Plan which is a sub-plan of theVaccitech plc Share Award Plan 2021. Under the terms of theVaccitech plc Share Award Plan 2021, the Board is permitted to grant awards to employees as restricted share units, options, share appreciation rights or restricted shares. Upon adoption of theVaccitech plc Share Award Plan 2021, no further awards are granted pursuant to the bilateral EMI option awards or unapproved option awards. Share based compensation awards are measured at the grant date fair value. For service-based awards, compensation expense is generally recognized over the requisite service period of the awards, usually the vesting period. We apply the "multiple option" method of allocating expense. In applying this method, each vesting tranche of an award is treated as a separate grant and recognized on a straight-line basis over that tranche's vesting period. For performance-based awards where the vesting of the awards may be accelerated upon the achievement of certain milestones, vesting and the related share-based compensation is recognized as an expense when it is probable the milestone will be met. We have elected to recognize the effect of forfeitures on share-based compensation when they occur. Any differences in compensation recognized at the time of forfeiture are recorded as a cumulative adjustment in the period where the forfeiture occurs. We measure share-based awards granted to employees and directors based on the fair value on the date of grant using the Black-Scholes option-pricing model for options. Black-Scholes utilizes assumptions related to expected term, forfeitures, volatility, the risk-free interest rate and the dividend yield (which is assumed to be zero, as we have not paid any cash dividends). For options granted prior to our IPO, we applied a discount for lack of marketability calculated using the Finnerty model. The assumptions used in the Black-Scholes model to determine fair value for the share option grants during the nine months endedSeptember 30, 2022 and 2021 were: Nine months Nine months ended ended September 30, 2022 September 30, 2021 Expected volatility 94.6 % 110.8 % Expected term (years) 6.00 6.31 Risk-free interest rate 2.4 % 1.1 % Expected dividend yield 0.0 % 0.0 % 24 Table of Contents
For the nine months ended
Business Combinations
We acquired Avidea onDecember 10, 2021 and have accounted for the acquisition using the acquisition method of accounting. This required us to assess and make judgments as to whether the acquisition met the criteria of a business combination or an asset acquisition. In determining that the acquisition of Avidea met the criteria of a business combination we first used the "screen test" to assess whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets. As the "screen test" was not met, as the identifiable assets were not substantially all of the fair value of the gross assets acquired, we then applied the "framework" for determining whether the acquired assets included at minimum, an input and substantive process that together significantly contribute to the ability to create output. We concluded that the framework criteria are met because the scientists make up an organized workforce that has the necessary skills, knowledge, or experience to perform processes that when applied to the developed technology (input) is critical to the ability to undertake research and development of a product that can be provided to a customer. The more than-insignificant amount of goodwill (including the fair value associated with the workforce) was also an indicator that management considered in determining that the workforce is performing a critical process. We therefore determined the acquisition to meet the definition of a business combination. We recognize tangible and identifiable intangible assets acquired and liabilities assumed at their estimated fair values as of the acquisition date. Any excess purchase price over the estimated fair value assigned to the net tangible and identifiable intangible assets acquired and liabilities is allocated to goodwill. The estimate of fair value as of the acquisition date required the use of significant assumptions and estimates. The developed technology was valued using the cost approach. The critical assumptions and estimates included, but were not limited to, developer margins, mark up on costs, opportunity costs, discount rates and market rates for salary, bonus and benefits of staff involved in the development of the technology. While we use our best estimates and assumptions to accurately value assets acquired and liabilities assumed at the acquisition date as well as any contingent consideration, we will continue to evaluate certain assets, liabilities and tax estimates that are subject to change within the measurement period (up to one year from the acquisition date). We acquired Avidea for an up-front amount of$33.3 million , of which$12.2 million was payable in cash and$21.1 million in 2,163,694 of American Depositary Shares of the Company. In addition, Avidea's stockholders may be entitled to receive an aggregate of up to$40 million in additional payments, payable in a mixture of cash and ADSs, upon the achievement of certain milestones. This contingent consideration is included within the purchase price and is recognized at its fair value on the acquisition date, and subsequently remeasured to fair value at each reporting date until the contingency is resolved. Changes in fair value are recognized in the condensed consolidated statements of operations and comprehensive loss. The fair value of contingent consideration is based on the probability of pursuit of the activity associated with the milestone, the probability of success of the achievement of the milestone, the expected date of milestone achievement and applying the relevant discount rate.
Transaction costs are expensed as incurred in general and administrative expenses. Results of operations and cash flows of acquired companies are included in our operating results from the date of acquisition.
We test goodwill for impairment at least annually onNovember 30 , or more frequently if events or changes in circumstances indicate that the carrying amount of goodwill may not be recoverable. We have elected to assess goodwill for impairment by first performing a qualitative assessment to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount as a basis of determining whether it is necessary to perform the quantitative goodwill impairment test. We have one reporting unit. Accordingly, our review of goodwill impairment indicators is performed at the entity-wide level. This requires us to assess and make judgments regarding a variety of factors, including clinical data results, business plans, anticipated future cash flows, economic projections and other market data. Because there are inherent uncertainties involved in these factors, significant differences between these estimates and actual results could result in future impairment charges and could materially impact our future financial results. The goodwill of$12.6 million recognized toSeptember 30, 2022 wholly relates to the acquisition of Avidea onDecember 10, 2021 . During the first quarter of 2022, the Company identified qualitative indicators of impairment due to a sustained decline in the price of the Company's American Depositary Shares, whereby the market capitalization fell below the value of the net assets of the Company, which continued through the second and third quarters of 2022. Therefore, the Company performed an interim qualitative assessment as ofSeptember 30, 2022 to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying 25
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amount. Based on this assessment, management determined it is not more likely than not that the fair value of the reporting unit is less than its carrying amount. No additional qualitative indicators of impairment were identified during the three months period endedSeptember 30, 2022 . The Company will perform its annual goodwill impairment test as ofNovember 30, 2022 .
Results of Operations
Comparison of the Three Months Ended
The following table sets forth the significant components of our results of operations (in thousands): Three months Three months ended September ended September 30, 2022 30, 2021 Change
Revenue from Licenses, Grants & Services $ 6,165
19 6,146 Operating expenses: Research & development 9,744 4,371 5,373 General and administrative (11,132) 1,184 (12,316)
Total operating (income)/expenses (1,388) 5,555 (6,943) Income/(loss) from operations 7,553 (5,536) 13,089 Other income (expense) Change in fair value of contingent consideration (317)
- (317) Interest income 1,024 - 1,024 Interest expense 11 - 11
Research and development incentives (724)
959 (1,683) Total other income (6) 959 (965) Tax benefit 674 7 667 Net income/(loss) $ 8,221 (4,570) 12,791 Revenue For the three months endedSeptember 30, 2022 , our revenue primarily consisted of$6.2 million from the OUI License Agreement Amendment with respect to payments from OUI in connection with commercial sales of Vaxzevria. For the three months endedSeptember 30, 2021 , our revenue consisted of service revenue from a research, collaboration and license agreement withEnara Bio .
Research and Development Expenses
The following table summarizes our research and development expenses for the
three months ended
Three months Three months ended September ended September 30, 2022 30, 2021 Change Direct research and development expenses by program: VTP-200 HPV 1,310 787 523 VTP-300 HBV 2,418 1,552 866 VTP-600 NSCLC 111 43 68 VTP-800/850 Prostate cancer 1,160 634 526
Other and earlier stage programs 1,687 (124) 1,811 Total direct research and development expenses 6,686 2,892 3,794 Internal research and development expenses: Personnel-related (including share-based compensation) 2,626
1,376 1,250 Facility related 308 96 212 Other internal costs 124 7 117
Total research and development expense 9,744
4,371 5,373 26 Table of Contents
Our research and development expenses for the three months endedSeptember 30, 2022 and 2021 were$9.7 million and$4.4 million , respectively. Personnel-related expenses were$2.6 million and$1.4 million , respectively, as a result of the relative increase in our headcount across the offices in both theUnited Kingdom andUnited States . Direct research and development expenses for outside services, consultants and laboratory materials increased$3.8 million to$6.7 million for the three months endedSeptember 30, 2022 from$2.9 million for the three months endedSeptember 30, 2021 and mainly comprised of costs for clinical trials, manufacturing of clinical trial materials, as well as costs for external preclinical services and sample testing. Of this,$1.8 million of the increase relates to other and earlier stage programs due to an increase in earlier stage activity including the preclinical programs launched in 2022 for VTP-1000 Celiac disease and VTP-1100 HPV cancer.$0.9 million of the increase pertains to progress in VTP-300, as announced at AASLD.
General and Administrative Expenses
General and administrative expenses for the three months endedSeptember 30, 2022 were a gain of$11.1 million due to the foreign exchange gain of$18.7 million primarily on revaluation of cash balances due to the fluctuations betweenthe United States dollar and pound sterling exchange rates. General and administrative expenses for the three months endedSeptember 30, 2022 excluding foreign exchange were$7.6 million , which were mainly attributable to personnel expenses of$2.8 million , including the share-based payment charge of$0.6 million , insurance costs of$1.5 million and legal and professional fees of$2.3 million . General and administrative expenses for the three months endedSeptember 30, 2021 were$1.2 million , which were mainly attributable to personnel expenses of$4.4 million , including the share-based payment charge of$2.9 million , insurance costs of$1.8 million and legal and professional fees of$0.8 million , offset by unrealized foreign exchange gain on cash revaluation of$5.8 million .
Change in fair value of contingent consideration
For the three months endedSeptember 30, 2022 , we recognized a change in fair value of$0.3 million in relation to the updated assumptions in the fair value assessment of the contingent consideration recognized for the acquisition of Avidea onDecember 10, 2021 . For the three months endedSeptember 30, 2021 , there was no change in fair value of contingent consideration.
Interest Income
For the three months ended
Research and Development Incentives
For the three months ended
Tax benefit
For the three months endedSeptember 30, 2022 and 2021, the tax benefit was$0.7 million and$0.01 million respectively, which primarily relates to movements in deferred tax. 27 Table of Contents
Comparison of the Nine Months Ended
The following table sets forth the significant components of our results of operations (in thousands): Nine months Nine months ended September ended September 30, 2022 30, 2021 Change
Revenue from Licenses, Grants & Services $ 38,246 $
269 37,977 Operating expenses: Research & development 30,165 13,490 16,675 General and administrative (13,914) 15,332 (29,246) Total operating expenses 16,251 28,822 (12,571)
Income/(loss) from operations 21,995 (28,553) 50,548 Other income (expense) Change in fair value of derivatives embedded in convertible loan notes - 5,994 (5,994) Change in fair value of contingent consideration (943) - (943) Unrealized exchange gain on convertible loan notes - 209 (209) Loss on extinguishment of convertible loan notes - (13,789) 13,789 Interest income 1,776 2 1,774 Interest expense 3 (2,650) 2,653
Research and development incentives 1,150
2,789 (1,639) Others 51 (3) 54 Total other income/(expenses) 2,037 (7,448) 9,485 Tax benefit 2,452 60 2,392 Net income/(loss) $ 26,484$ (35,941) 62,425
1 indicates amount less than thousand
Revenue
For the nine months endedSeptember 30, 2022 , our revenue primarily consisted of$38.2 million from the OUI License Agreement Amendment with respect to payments from OUI in connection with commercial sales of Vaxzevria. For the nine months endedSeptember 30, 2021 , our revenue consisted of$0.2 million of reimbursement of research and development expenses from BARDA and$0.05 million of service revenue from a research, collaboration and license agreement withEnara Bio .
Research and Development Expenses
The following table summarizes our research and development expenses for the
nine months ended
Nine months Nine months ended September ended September 30, 2022 30, 2021 Change Direct research and development expenses by program: VTP-200 HPV 3,271 2,192 1,079 VTP-300 HBV 10,964 4,630 6,334 VTP-600 NSCLC 349 628 (279) VTP-800/850 Prostate cancer 2,959 1,342 1,617
Other and earlier stage programs 3,933 609 3,324 Total direct research and development expenses 21,476 9,401 12,075 Internal research and development expenses: Personnel-related (including share-based compensation) 7,549 3,821 3,728 Facility related 888 182 706 Other internal costs 252 86 166
Total research and development expense $ 30,165 $
13,490 16,675 28 Table of Contents Our research and development expenses for the nine months endedSeptember 30, 2022 and 2021 were$30.2 million and$13.5 million , respectively. Personnel-related expenses were$7.5 million and$3.8 million , respectively, as a result of the increase in our headcount across the offices in both theUnited Kingdom andUnited States . Direct expenses for outside services and consultants and laboratory materials increased$12.1 million to$21.5 million for the nine months endedSeptember 30, 2022 from$9.4 million for the nine months endedSeptember 30, 2021 and were mainly comprised of costs for clinical trials, manufacturing of clinical trial materials, as well as costs for external preclinical services and sample testing.$6.3 million of the increase pertains to progress in VTP-300, having completed the last patient visit in our HBV001 Phase 1 clinical trial in theUnited Kingdom inMay 2022 , and also completing enrollment in HBV002 inMay 2022 . Other and earlier stage programs increased$3.3 million due to an increase in earlier stage activity including the preclinical programs launched in 2022 for VTP-1000 Celiac disease and VTP-1100 HPV cancer.
General and Administrative Expenses
General and administrative expenses for the nine months endedSeptember 30, 2022 were a gain of$13.9 million due to the foreign exchange gain of$39.1 million primarily on revaluation of cash balances due to the fluctuations betweenthe United States dollar and pound sterling exchange rates, offset by general and administrative expenses. General and administrative expenses for the nine months endedSeptember 30, 2022 , excluding foreign exchange gain, were$25.2 million , which were mainly attributable to personnel expenses of$12.1 million , including the share-based payment charge of$5.8 million , insurance costs of$4.8 million and legal and professional fees of$4.6 million . General and administrative expenses for the nine months endedSeptember 30, 2021 were$15.3 million , which were mainly attributable to personnel expenses of$15.5 million , including the share-based payment charge of$11.6 million , insurance costs of$3.0 million and legal and professional fees of$2.2 million , offset by unrealized foreign exchange gain on cash balances of$6.2 million . The share-based payment charge includes a one-off expense relating to the RSUs that vested upon the successful completion of our IPO.
Change in fair value of derivatives embedded in convertible loan notes
For the nine months endedSeptember 30, 2022 , the change in fair value of embedded derivatives was $nil. For the nine months endedSeptember 30, 2021 , we recognized a change in fair value of$6.0 million in relation to the conversion and redemption features embedded in the convertible loan notes.
Change in fair value of contingent consideration
The change in fair value of contingent consideration for the nine months endedSeptember 30, 2022 was a$0.9 million expense in relation to the updated assumptions in the fair value assessment of the contingent consideration recognized for the acquisition of Avidea onDecember 10, 2021 . The change in fair value of contingent consideration for the nine months endedSeptember 30, 2021 was $nil.
Loss on extinguishment of convertible loan notes
There was no loss on extinguishment of convertible loan notes for the nine months endedSeptember 30, 2022 . For the nine months endedSeptember 30, 2021 , we recognized a loss of$13.8 million related to conversion of convertible loan notes into 12,421 Series B preferred shares. The loss is a difference between (1) the fair value of those shares ($53.7 million ) and (2) the sum of the carrying amounts of the convertible loan notes of$25.6 million , and the bifurcated conversion and redemption feature liability of$14.4 million .
Interest Expense
For the nine months endedSeptember 30, 2022 , interest expense was$0.003 million , which relates to the interest paid on the debt recognized on the acquisition of Avidea onDecember 10, 2021 , which was repaid in full in the first quarter of 2022. For the nine months endedSeptember 30, 2021 , interest expense was$2.7 million , which primarily relates to our convertible loan notes, which carried a market rate of interest. 29 Table of Contents Interest Income
For the nine months ended
Research and Development Incentives
For the nine months endedSeptember 30, 2022 and 2021, we accrued research and development incentives of$1.2 million and$2.8 million , respectively. Such research and development incentives relate to corporation tax relief on research and development projects incentive programs primarily in theUnited Kingdom . We account for such relief received as other income.
Tax benefit
For the nine months endedSeptember 30, 2022 and 2021, the tax benefit was$2.5 million and$0.06 million respectively, which primarily relates to movements in deferred tax.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have funded our operations primarily through private and public placements of our ordinary and preferred shares as well as from grants and research incentives, various agreements with public funding agencies, and most recently from upfront, royalty and milestone payments from OUI in connection with the OUI License Agreement Amendment and the issuance of convertible loan notes. ThroughSeptember 30, 2022 , we had received gross proceeds of approximately$324.8 million from the issuance of our ordinary and preferred shares and convertible loan notes. As ofSeptember 30, 2022 , we had cash and cash equivalents of$200.1 million . Key financing and corporate milestones include the following:
? In
issuance of our seed round of ordinary shares.
? Between
million from the issuance of our Series A Shares.
? Between
from the issuance of convertible loan notes.
? In
our Series B shares.
? In
offering of our ordinary shares on NASDAQ.
OnAugust 9, 2022 , we filed a Registration Statement on Form S-3, as amended, or the Shelf, with theSecurities and Exchange Commission in relation to the registration and potential future issuance of ordinary shares, including ordinary shares represented by ADSs, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to$200.0 million . The Shelf was declared effective onAugust 17, 2022 . We also simultaneously entered into a sales agreement withJefferies LLC , as sales agent, providing for the offering, issuance and sale by us of up to an aggregate of$75.0 million of our ordinary shares represented by ADSs from time to time in "at-the-market" offerings under the Shelf. As ofSeptember 30, 2022 , we have not issued or sold any ordinary shares represented by ADSs under the sales agreement. We do not currently expect positive cash flows from operations in the foreseeable future, if at all. Historically, we have incurred operating losses as a result of ongoing efforts to develop our heterologous ChAdOx1-MVA prime-boost immunotherapy platform and our product candidates, including conducting ongoing research and development, preclinical studies, clinical trials, providing general and administrative support for these operations and developing our intellectual property portfolio. We expect to continue to incur net negative cash flows from operations for at least the next few years as we progress clinical development, seek regulatory approval, prepare for and, if approved, proceed to manufacture and commercialization of our most advanced product candidates. Operating profits may arise earlier if programs are licensed or sold to third parties before final approval, but this cannot be guaranteed. 30 Table of Contents Cash Flows
The following table sets forth a summary of the primary sources and uses of cash (in thousands) for each period presented:
Nine months Nine months ended September ended September 30, 2022 30, 2021 Net cash used in operating activities (3,088) (24,611) Net cash used in investing activities (5,164) (722) Net cash (used)/provided by financing activities (159) 222,733 Effect of exchange rates on cash and cash equivalents (5,539) (6,795) Net (decrease)/increase in cash and cash equivalents (13,950) 190,605
Cash Used in Operating Activities
During the nine months endedSeptember 30, 2022 , net cash used in operating activities was$3.1 million , primarily resulting from our net income of$26.5 million primarily as a result of$38.2 million in revenue, adjusted by foreign exchange gain on translation of$36.6 million , share based compensation of$7.8 million , depreciation and amortization of$3.1 million , non-cash lease expenses of$0.8 million , and changes in our operating assets and liabilities, net of$2.9 million primarily resulting from the OUI receivable for the third quarter revenue, and an increase in prepaid expenses due to the payment of annual insurance premiums that occurred in the second quarter, netted by an increase in accrued expenses. During the nine months endedSeptember 30, 2021 , net cash used in operating activities was$24.6 million , primarily resulting from our net loss of$35.9 million , adjusted by fair value gain on embedded derivatives of$6.0 million , loss on conversion of convertible loan notes of$13.8 million , share-based compensation of$12.9 million , non-cash interest expense of$0.8 million , depreciation and amortization of$0.3 million , unrealized foreign exchange gain on convertible loan notes of$0.2 million and changes in our operating assets and liabilities, net of$10.2 million .
During the nine months endedSeptember 30, 2022 , cash used in investing activities was$5.2 million primarily resulted from capital expenditures related to our new headquarters in Harwell,United Kingdom . During the nine months endedSeptember 30, 2021 , cash used in investing activities was$0.7 million , which resulted from capital expenditures in connection with laboratory improvements and purchases of property and equipment for our office inOxford, United Kingdom .
During the nine months endedSeptember 30, 2022 , cash used in financing activities was$0.2 million resulting from the repayment of debt incurred previously by the acquired company Avidea (acquired onDecember 10, 2021 , and subsequently becameVaccitech North America, Inc. ). During the nine months endedSeptember 30, 2021 , cash provided by financing activities was$222.7 million primarily consisting of$121.8 million net proceeds from the issuance of Series B shares and$102.8 million of net proceeds from the IPO.
Effect of exchange rates on cash and cash equivalents
During the nine months endedSeptember 30, 2022 and 2021, the effect of foreign exchange on cash and cash equivalents was losses of$5.5 million and$6.8 million respectively, primarily as a result of fluctuations betweenthe United States dollar and pound sterling exchange rates. 31 Table of Contents Future Funding Requirements To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and conducting clinical trials of our product candidates. As a result, we have incurred losses in each year since our inception in 2016, through toDecember 31, 2021 . We began to be profitable in 2022 but continue to maintain negative operating cash flows. As ofSeptember 30, 2022 , we had an accumulated deficit of$82.1 million . We expect to continue to incur significant losses and negative cash flows from operations for the foreseeable future. We anticipate that our expenses will increase substantially as we:
? pursue the clinical and preclinical development of our current product
candidates;
? use our technologies to advance additional product candidates into preclinical
and clinical development;
? seek marketing authorizations for product candidates that successfully complete
clinical trials, if any;
? attract, hire and retain additional clinical, regulatory, quality control and
other scientific personnel;
establish our manufacturing capabilities through third parties or by ourselves ? and scale-up manufacturing to provide adequate supply for clinical trials and
commercialization, including any manufacturing finishing and logistics personnel;
expand our operational, financial and management systems and increase personnel ? appropriately, including personnel to support our manufacturing and
commercialization efforts and our operations as a public company;
? maintain, expand, enforce, and protect our intellectual property portfolio as
appropriate;
establish sales, marketing, medical affairs and distribution teams and ? infrastructure to commercialize any products for which we may obtain marketing
approval and intend to commercialize on our own or jointly;
? acquire or in-license other companies, product candidates and technologies; and
incur additional legal, accounting and other expenses in operating our ? business, including office expansion and the additional costs associated with
operating as a public company.
Even if we succeed in commercializing one or more of our product candidates, we will continue to incur substantial research and development and other expenditure to develop and market additional product candidates. We may encounter unforeseen expenses, difficulties, complications, delays and other factors that may adversely affect our business. The size of our future net losses will depend on the rate of future growth of our expenses combined with our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our shareholders' equity and working capital unless and until eliminated by revenue growth. We may require substantial additional financing in the future to meet any such unanticipated factors and a failure to obtain this necessary capital could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations. Since our foundation, we have invested a significant portion of our efforts and financial resources in research and development activities for our ChAdOx1, ChAdOx2 and MVA technologies, acquisition of additional complementary platforms, development of new technologies in house, and our product candidates derived from these technologies. Preclinical studies and especially clinical trials and additional research and development activities will require substantial funds to complete. We believe that we will continue to expend substantial resources for the foreseeable future in connection with the development of our current product candidates and programs as well as any future product candidates we may elect to pursue, as well as the gradual gaining of control over our required manufacturing capabilities and other corporate functions. These expenditures will include costs associated with conducting preclinical studies and clinical trials, obtaining regulatory approvals, and potentially in-house manufacturing and supply, as well as marketing and selling any products approved for sale. In addition, other unanticipated costs may arise as outlined above. Because the outcome of any preclinical study or clinical trial is uncertain and the rate of change of third-party costs is also unpredictable, we cannot reasonably 32
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estimate now the actual amounts which will be necessary to complete the development and commercialization of our current or future product candidates successfully.
Our future capital requirements may depend on many factors, including:
the scope, progress, results and costs of researching and developing our ? current and future product candidates and programs, and of conducting
preclinical studies and clinical trials;
the number and development requirements of other product candidates that we may ? pursue, and of other indications for our current product candidates that we may
pursue;
the stability, scale and yield of future manufacturing processes as we scale-up ? production and formulation of our product candidates either internally or
externally for later stages of development and commercialization;
the timing of success achieved and the costs involved in obtaining regulatory
and marketing approvals and developing our ability to establish license or sale ? transactions and/or sales and marketing capabilities, if any, for our current
and future product candidates if clinical trials and approval processes are
successful;
? the success of our collaborations with CanSino, CRUK and the
and any future collaboration partners;
? the success of OUI's licensed product candidate with AstraZeneca;
? our ability to establish and maintain collaborations, strategic licensing or
other arrangements and the financial terms of such agreements;
the cost to the company of commercialization activities for our current and ? future product candidates that we may take on, whether alone or with a
collaborator;
the costs involved in preparing, filing, prosecuting, maintaining, expanding, ? defending and enforcing patent and other intellectual property claims,
including litigation costs and the outcome of such litigation;
? the timing, receipt and amount of sales of, or royalties or other income from,
our future products, if any; and
? the emergence and success or otherwise of competing oncology and infectious
disease therapies and other market developments.
A change in the outcome of any of these or other variables with respect to the development of any of our current and future product candidates could significantly change the costs and timing associated with the development of that product candidate, in either direction. Furthermore, our operating plans may change in the future owing to research outcomes or other opportunities, and we may need additional funds to meet operational needs and capital requirements associated with such altered operating plans. Based on our research and development plans, we expect that the net proceeds from our IPO, together with our existing cash and cash equivalents, will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2025. These estimates are based on assumptions that may prove to be wrong, and we could use our available capital resources more quickly than we expect.
Lease, Purchase, and Other Obligations
We have operating lease obligations related to our property, plant and equipment. The obligations related to both short- and long-term lease arrangements are set forth in Note 15 "Commitment and Contingencies" to our condensed consolidated financial statements.
We enter into contracts in the normal course of business with CROs and other third parties for clinical trials and preclinical research studies and testing. These contracts are generally cancellable by us upon prior notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancellable obligations of our service providers, up
to the date of cancellation. 33 Table of Contents We have contingent payment obligations that we may incur upon achievement of clinical, regulatory and commercial milestones, as applicable, or royalty payments that we may be required to make under our licenses; however, the amount, timing and likelihood of such payments are not known as ofSeptember 30, 2022 .
Emerging Growth Company Status
We are an emerging growth company under the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. As an emerging growth company, we may delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We will remain an emerging growth company until the earliest of (1) the last day of the fiscal year (a) following the fifth anniversary of the date of the closing of our IPO, (b) in which we have total annual gross revenue of at least$1.235 billion , or (c) in which we are deemed to be a "large accelerated filer" as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our ADSs held by non-affiliates exceeded$700.0 million as of the priorJune 30th , and (2) the date on which we have issued more than$1.0 billion in non-convertible debt securities during the prior three-year period.
Recent Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our condensed consolidated financial statements.
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