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Vaccitech Reports Third Quarter 2021 Financial Results and Recent


GlobeNewswire Inc | Nov 12, 2021 07:00AM EST

November 12, 2021

OXFORD, United Kingdom, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ: VACC) today announced its financial results for the third quarter, ended September 30, 2021, and provided an overview of the Companys recent corporate developments. Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer.

We continue to advance our promising pipeline with the recent publication of data on our MERS vaccine program. We also anticipate that initial clinical data on two of our chronic infectious disease therapeutic programs will be presented at scientific conferences next week, commented Bill Enright, Vaccitechs CEO. As we continue to expand and advance our programs, we will need additional lab and office space for our talented staff so we have planned a move mid next year into a new, state of the art facility.

Third Quarter and Recent Corporate Developments

-- Signed a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate an innovative therapeutic combination for the treatment of subjects with chronic hepatitis B virus infection (CHB) who are already receiving standard-of-care nucleoside or nucleotide analog (NA) therapy. The Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutuss RNAi therapeutic, AB-729, followed by the Companys immunotherapy candidate, VTP-300, in NA-suppressed subjects with CHB. -- Preclinical research demonstrated that VTP-600, a ChAdOx1/MVA prime-boost immunotherapeutic, demonstrated potential as an anti-cancer therapeutic. The research was conducted by scientists at the University of Oxford and the Ludwig Institute for Cancer Research. -- Signed a lease for 31,000 square feet within the Zeus development at Harwell Science and Innovation Campus. The site will house the Companys headquarters, state-of-the-art wet laboratory and offices. Vaccitech anticipates completing the relocation by mid-2022. -- Announced online publication in The Lancet Microbe of the results of a Phase 1 clinical trial of VTP-500, a vaccine candidate in development to prevent Middle East Respiratory Syndrome (MERS). The study, conducted by researchers at The King Abdullah International Medical Research Centre and Oxford University, showed that the vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses.

Upcoming Milestones

-- At the virtual AASLDs The Liver Meeting in November, two posters will present safety and immunogenicity data from the Phase 1 and Phase 1b/2a trials of VTP-300: HBV001, in healthy volunteers and patients with chronic hepatitis B (CHB) infection and HBV002 in patients with CHB infection. The posters become available for viewing by attendees at 8 a.m. EST on November 12. -- At the virtual 34th International Papillomavirus Conference in November, the Company expects to present safety and immunogenicity data from the lead-in portion of the Phase 1/2a clinical trial of VTP-200. -- In the fourth quarter, the Company expects to initiate dosing in a Phase 1/2a trial of VTP-600 in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy. The trial is currently open for enrollment. -- In the first quarter of 2022, the Company intends to conduct an interim efficacy review of HBV002, the Phase 1b/2a clinical trial of VTP-300 in patients with chronic HBV infection. -- In the second quarter of 2022, the Company expects to initiate dosing in a Phase 1/2a clinical trial of VTP-800/850, in combination with a checkpoint inhibitor, in patients with prostate cancer. -- In the third quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1/2a clinical trial of VTP-200, a potential non-invasive treatment for persistent high-risk HPV infection.

Third Quarter 2021 Financial Highlights:

-- Cash position: As of September 30, 2021, cash and cash equivalents were $233.9 million, compared to $43.3 million as of December 31, 2021. The increase was primarily due to completion of the Series B financing in the first quarter of 2021, which raised $168 million including the conversion of our previously issued convertible loan notes, and to the initial public offering in the second quarter, which raised gross proceeds of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into the first half of 2024. -- Research and development (R&D) expenses: Research and development expenses were $4.4 million for the third quarter of 2021 compared to $3.7 million for the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on progressing the development of VTP-300 and VTP-850. -- General and administrative expenses: General and administrative expenses were $1.2 million for the third quarter of 2021 compared to $1.0 million for the comparable period of the prior year. The third quarter of 2021 expense includes a $5.8 million unrealized foreign exchange gain on revaluation of Companys cash balances. Net of this gain, the increase in general and administrative expenses between the periods was attributable to higher personnel costs, reflecting an increase in the Companys headcount over the prior period and higher insurance costs associated with operating as a public company. -- Net loss: The Company generated a net loss attributable to its shareholders of $4.6 million, or ($0.13) per share on both basic and fully diluted bases, for the third quarter of 2021 compared to a net income of $0.2 million, or $0.02 per share a basic basis and $0.01 on a fully diluted basis, for the same period of the prior year.

About Vaccitech

Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer. The Companys proprietary platform comprises proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and without the ability to replicate in humans. The combination of a ChAdOx prime treatment with subsequent MVA boost has consistently generated significantly higher magnitudes of CD8+ T cells compared with other technologies and approaches. The company has a broad pipeline of both clinical and preclinical stage therapeutic programs in solid tumors and viral infections and prophylactic viral vaccine programs. Vaccitech co-invented a COVID-19 vaccine with the University of Oxford, now approved for use in many territories and exclusively licensed worldwide to AstraZeneca plc through Oxford University Innovation, or OUI. Vaccitech is entitled to receive a share of the milestones and royalty income received by OUI from AstraZeneca plc.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing and advancement of the Companys programs, including the clinical trials of VTP-200, VTP-300, VTP-600, and VTP-800/850 and the Companys cash runway The words may, will, could, would, should, expect, plan, anticipate, intend, believe, estimate, predict, project, potential, continue and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on managements current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: the success, cost and timing of the Companys product development activities and planned and ongoing clinical trials, the Companys ability to execute on its strategy, regulatory developments, the Companys ability to fund its operations and the impact that the current COVID-19 pandemic will have on the Companys clinical trials and preclinical studies and other risks identified in the Companys filings with the Securities and Exchange Commission (the SEC), including its Quarterly Report on Form 10-Q for the first quarter of 2021 and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

VACCITECHPLC.CONDENSED CONSOLIDATED BALANCE SHEETS(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)(UNAUDITED)

September30, December31, 2021 2020ASSETS Current assets: Cash and cash equivalents $ 233,871 $ 43,266 Accounts receivable 42 518 Research and development incentives 5,382 2,708 receivablePrepaid expenses and other current 6,684 1,409 assetsTotal current assets 245,979 47,901 Property and equipment, net 1,033 629 Right of use assets, net 8,780 2,136 Deferred tax assets 60 ? Other assets 719 ? Total assets $ 256,571 $ 50,666 LIABILITIES, REDEEMABLE PREFERRED SHARES AND SHAREHOLDERS? DEFICIT Current liabilities: Accounts payable $ 1,337 $ 4,667 Accrued expenses and other current 4,404 2,537 liabilitiesDeferred revenue 196 245 Current portion of lease liability 435 192 Total current liabilities 6,372 7,641 Convertible loan notes ? non current ? 44,700 Lease liability ? non current 7,728 1,472 Total liabilities $ 14,100 $ 53,813 Commitments and contingencies Series A redeemable convertiblepreferred shares (Series A shares);0.10 nominal value; no shares issued $ ? $ 33,765 and outstanding; (December 31, 2020:issued and outstanding: 22,065)Series B redeemable convertiblepreferred shares (Series B shares);0.10 nominal value; no shares issued $ ? $ ? and outstanding; (December 31, 2020:issued and outstanding: no shares issuedor outstanding)Shareholders? equity: Ordinary shares, 0.000025 nominalvalue; 34,328,231 shares authorized,issued and outstanding (December 31, 1 0 2020: authorized, issued andoutstanding: 7,960,458)Deferred A shares, 1 nominal value;63,443 shares authorized, issued and 86 ? outstanding (December 31, 2020: noshares issued or outstanding)Deferred B shares, 1 nominal value;570,987 shares authorized, issued and 8 ? outstanding (December 31, 2020: noshares issued or outstanding)Deferred C shares, 0,000007 nominalvalue, 27,828,231 shares authorized,issued and outstanding (December 31, 0 ^1 0 2020: authorized, issued andoutstanding: 7,960,458)Additional paid-in capital 344,396 21,660 Accumulated deficit (93,472 ) (57,720 )Accumulated other comprehensive loss ? (9,041 ) (1,243 )foreign currency translation adjustmentsNoncontrolling interest 493 391 Total shareholders? equity $ 242,471 $ (36,912 )Total liabilities, redeemableconvertible preferred shares and $ 256,571 $ 50,666 shareholders? equity

1 indicates amount less than thousand

VACCITECHPLC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)(UNAUDITED)

Three months ended Nine months ended September30,2021 September30,2020 September30,2021 September30,2020License revenue $ 16 $ 2,663 $ 48 $ 2,705 Service revenue ? 60 21 376 Research grants 3 528 200 1,386 and contractsTotal revenue 19 3,251 269 4,467 Operating expensesResearch and 4,371 3,702 13,490 11,821 developmentGeneral and 1,184 977 15,332 3,059 administrativeTotal operating 5,555 4,679 28,822 14,880 expensesLoss from (5,536 ) (1,428 ) (28,553 ) (10,413 )operationsOther income (expense):Change in fairvalue of ? 3 5,994 3 derivativesUnrealizedexchange gain on ? 982 209 982 convertible loannotesLoss onextinguishment ? ? (13,789 ) ? of convertibleloan notesInterest income ? ? 2 ? Interest expense ? (969 ) (2,650 ) (969 )Research anddevelopment 959 1,612 2,789 2,989 incentivesOther ? ? (3 ) ? Total other 959 1,628 (7,448 ) 3,005 (expense) incomeTax (expense)/ 7 ? 60 ? benefitNet (loss)/ (4,570 ) 200 (35,941 ) (7,408 )incomeNet loss/(income)attributable to 13 (42 ) 189 157 noncontrollinginterestNet (loss)/incomeattributable to (4,557 ) 158 (35,752 ) (7,251 )Vaccitech plcShareholders Weighted-averageordinary shares 34,843,154 7,937,384 22,697,462 7,886,488 outstanding,basicWeighted-averageordinary shares 34,843,154 15,867,533 22,697,462 7,886,488 outstanding,dilutedNet( loss)/income per shareattributable to ordinaryshareholders,basic $ (0.13 ) $ 0.02 $ (1.58 ) $ (0.92 )Net (loss)/income per shareattributable to ordinaryshareholders,diluted $ (0.13 ) $ 0.01 $ (1.58 ) $ (0.92 ) Net (loss)/ $ (4,570 ) $ 200 $ (35,941 ) $ (7,408 )incomeOthercomprehensive(loss)/ income ? foreign currencytranslationadjustments (6,473 ) 68 (7,803 ) (759 )Comprehensive (11,043 ) 268 (43,744 ) (8,167 )(loss)/ incomeComprehensiveloss/ (income)attributable to 25 (49 ) 194 169 noncontrollinginterestComprehensive(loss)/ income attributable toVaccitech plcshareholders $ (11,018 ) $ 219 $ (43,550 ) $ (7,998 )

Investors: Vaccitech Investor Relations ir@vaccitech.co.uk

Vaccitech Media Contacts:

Katja Stout, Scius Communications (EU)Direct: +44 (0) 7789435990Email: katja@sciuscommunications.com

Robert Flamm, Ph.D. (US) / Harrison Wong, Burns McClellan, Inc.212-213-0006 ext. 364 / 316Email: rflamm@burnsmc.com / hwong@burnsmc.com

Henry Hodge, VaccitechEmail: henry.hodge@vaccitech.co.uk







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