Full Press Release Details
Vaccitech Reports Third Quarter 2022 Financial
Results and Recent Corporate Developments
United Kingdom, November 10, 2022 - Vaccitech plc (NASDAQ: VACC) today announced its financial results for the third quarter
ended September 30, 2022 and provided an overview of the Company's 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, autoimmunity, and cancer.
has been a very exciting quarter at Vaccitech. During the past three months we have made significant progress on our clinical programs,
strengthened our balance sheet and leadership team, and continued to actively engage with investors," remarked Bill Enright, CEO
of Vaccitech. "We dosed the first patient in our Phase 2b clinical trial of VTP-300 in HBV and reported the findings of our Phase
1b/2a study of VTP-300 at the American Association for the Study of Liver Disease (AASLD) Liver meeting. In addition, we published a paper
in Cell showing the activation of two key pathways with intravenous (IV) vaccination of a SNAPvax construct, which led to
improved T cell mediated tumor killing in a pre-clinical model. We were also very pleased to announce the promotion of Gemma Brown to
the role of CFO. I would also like to note that that this quarter's royalty and milestone payments from the sales of Vaxzervria ,
AstraZeneca's COVID-19 vaccine, have assisted in extending our cash runway into the first quarter of 2025. All told, this
was a very active quarter for us, and we look forward to continuing our progress and outreach in the coming quarter and year."
"We have made excellent progress in our clinical programs
in the past quarter and expect to reach a number of important clinical milestones in 2023," stated Dr. Meg Marshall, Chief
Medical Officer of Vaccitech. "We expect to have initiated our Phase 1/2a clinical study in the fourth quarter of 2022 with the
first patient first visit (FPFV) for VTP-850, our prostate cancer program, early in the first quarter of 2023, and FPFV for VTP-1100,
our HPV-Cancer program, early in the third quarter of next year. FPFV for VTP-1000, our program in Celiac disease, is slated for the fourth
quarter of 2023. We also plan to present data from multiple ongoing studies of VTP-300 in HBV next year as well. So, we are looking forward
to a 2023 filled with exciting clinical advances."
Third Quarter 2022 Financial Highlights
| three months ended September 30, 2022 | three months ended June 30, 2022 | Change | ||||||||||
| $ | 000 | $ | 000 | $ | 000 | |||||||
| Direct research and development expenses by program: | ||||||||||||
| VTP-200 HPV | 1,310 | 804 | 506 | |||||||||
| VTP-300 HBV | 2,418 | 4,361 | -1,943 | |||||||||
| VTP-600 NSCLC 1 | 111 | 77 | 34 | |||||||||
| VTP-800/850 Prostate cancer | 1,160 | 460 | 700 | |||||||||
| Other and earlier stage programs | 1,687 | 1,508 | 179 | |||||||||
| Total direct research and development expenses | 6,686 | 7,210 | -524 | |||||||||
| Internal research and development expenses: | ||||||||||||
| Personnel-related (including share-based compensation) | 2,626 | 2,197 | 429 | |||||||||
| Facility related | 308 | 240 | 68 | |||||||||
| Other internal costs | 124 | 73 | 51 | |||||||||
| Total research and development expense | 9,744 | 9,720 | 24 |
The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK
Recent Corporate Developments
Clinical developments:
Pre-clinical developments:
| On October 27, 2022, we announced the publication of research from VTP-1100 in Cell that demonstrates anti-tumor activity achieved with intravenous (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 Investigational New Drug (IND) application submission is expected during the first half of 2023 for HPV related cancer. | ||
| On November 7, 2022 Dr. Young-Suk Lim, Professor of Gastroenterology in the Liver Center at University of Ulsan College of Medicine, presented a poster reporting Phase 1b/2a clinical trial data on VTP-300 at AASLD. 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 sustained reduction in HBsAg in well-controlled CHB patients, and was administered with no treatment related SAEs and infrequent transient transaminitis. 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 at the data cutoff. |
| Intends to conduct an interim efficacy review of HPV001, a Phase 1b/2 clinical trial of VTP-200, a potential treatment for low grade HPV-related cervical lesions | ||
| Expects to have FPFV for VTP-850 in our prostate cancer program | ||
| Intends to move its U.S. team into a new, state of the art facility in Germantown, Maryland |
| Submit IND applications for its two lead SNAPvax candidates, VTP-1000 for the treatment of celiac disease and VTP-1100 for the treatment of HPV-associated cancers | ||
| Have FPFV for VTP-1100 in our HPV cancer program | ||
| Have FPFV for VTP-1000 in our Celiac disease program | ||
| Present data from multiple ongoing clinical studies at AASLD and The European Association for the Study of the Liver (EASL) conferences |
plc ("the Company") is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics
and vaccines for the treatment of chronic infectious diseases, cancer, autoimmunity, and other diseases where the T cell arm of the immune
system is believed to play an important role. The company's proprietary platforms include modified simian adenoviral vectors (ChAdOx1
and ChAdOx2), other viral vectors including the well-validated Modified vaccinia Ankara (MVA), and synthetic nano-particle technologies
(SNAPvax and Syntholytic ). The combination of different technologies in a mix and match approach (heterologous prime-boost)
consistently generates significantly higher magnitudes of T cells compared with other technologies and approaches. The Company has a broad
pipeline of both clinical and preclinical stage therapeutic programs to treat solid tumors, chronic viral infections as well as additional
prophylactic viral vaccine programs. Vaccitech co-invented a COVID-19 vaccine, Vaxzevria , with the University of Oxford, now approved
for use in many territories and exclusively licensed worldwide to AstraZeneca through OUI. Vaccitech is entitled to receive a share of
all milestone and royalty income received by OUI from AstraZeneca related to Vaxzevria .
Forward Looking Statements
press release contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, as amended,
which can generally be identified as such by use of the words "would," "forward," "expect," "plan,"
"intend," "believe," "potential," "continue," and similar expressions, although not all
forward-looking statements contain these identifying words. These forward looking statements include express or implied statements
regarding the Company's future expectations, plans and prospects, and include, without limitation, statements regarding the timing
and advancement of the Company's programs, including the clinical trials of VTP-200, VTP-300, and VTP-850, statements regarding
the timing for the initiation of dosing of VTP-300, VTP-850, and the Company's two lead SNAPvax candidates, VTP-1000 and VTP-1100,
statements regarding the timing for the potential IND applications for VTP-1000 and VTP-1100, statements regarding the presentation of
data at future conferences, and statements regarding the Company's capital. Any forward-looking statements in this press release
are based on management's 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, risks and uncertainties related to: the success, cost and timing of the Company's
product development activities and planned and ongoing clinical trials, the Company's ability to execute on its strategy, regulatory
developments, the Company's ability to fund its operations, global economic uncertainty and the impact that the current ongoing
COVID-19 pandemic will have on the Company's clinical trials, preclinical studies and access to capital and other risks identified
in the Company's filings with the Securities and Exchange Commission (the "SEC"), including its Annual Report on Form 10-K
for the year ended December 31, 2021, its Quarterly Report on Form 10-Q for the second quarter of 2022 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.
Consolidated Balance SheetS
THOUSANDS, except Number of shares and per share AMOUNTS)
| September 30, 2022 | December 31, 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 200,104 | $ | 214,054 | ||||
| Accounts receivable | 26 | 20 | ||||||
| Accounts receivable - related parties | 6,152 | - | ||||||
| Research and development incentives receivable | 4,091 | 6,229 | ||||||
| Prepaid expenses and other current assets | 8,248 | 6,462 | ||||||
| Total current assets | 218,621 | 226,765 | ||||||
| Goodwill | 12,630 | 12,630 | ||||||
| Property and equipment, net | 6,766 | 1,829 | ||||||
| Intangible assets, net | 29,059 | 31,430 | ||||||
| Right of use assets, net | 7,558 | 7,257 | ||||||
| Other assets | 847 | 804 | ||||||
| Total assets | $ | 275,481 | $ | 280,715 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,411 | $ | 2,419 | ||||
| Accrued expenses and other current liabilities | 11,323 | 7,875 | ||||||
| Deferred revenue | 111 | 182 | ||||||
| Operating lease liability - current | 186 | 523 | ||||||
| Debt | - | 159 | ||||||
| Total current liabilities | 14,031 | 11,158 | ||||||
| Operating lease liability - non current | 8,071 | 6,540 | ||||||
| Contingent consideration | 2,836 | 2,371 | ||||||
| Deferred tax liability, net | 5,680 | 8,084 | ||||||
| Other non-current liabilities | 711 | - | ||||||
| Total liabilities | $ | 31,329 | $ | 28,153 | ||||
| Commitments and contingencies | ||||||||
| Shareholders' equity: | ||||||||
| Ordinary shares, 0.000025 nominal value; 37,291,492 shares authorized, issued and outstanding (December 31, 2021: authorized, issued and outstanding: 37,188,730) | 1 | 1 | ||||||
| Deferred A shares, 1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2021: authorized, issued and outstanding: 63,443) | 86 | 86 | ||||||
| Deferred B shares, 0.01 nominal value; 570,987 shares authorized, issued and outstanding (December 31, 2021: authorized, issued and outstanding: 570,987) | 8 | 8 | ||||||
| Deferred C shares, 0.000007 nominal value, 27,828,231 shares authorized, issued and outstanding (December 31, 2021: authorized, issued and outstanding: 27,828,231) | 0 | 1 | 0 | 1 | ||||
| Additional paid-in capital | 376,939 | 369,103 | ||||||
| Accumulated deficit | (82,054 | ) | (108,585 | ) | ||||
| Accumulated other comprehensive loss - foreign currency translation adjustments | (51,143 | ) | (8,488 | ) | ||||
| Total shareholders' equity attributable to Vaccitech plc shareholders' | 243,837 | 252,125 | ||||||
| Noncontrolling interest | 315 | 437 | ||||||
| Total shareholders' equity | $ | 244,152 | $ | 252,562 | ||||
| Total liabilities and shareholders' equity | $ | 275,481 | $ | 280,715 |
indicates amount less than thousand
Consolidated StatementS of Operations and Comprehensive Loss
THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
| Three months ended | Nine months ended | |||||||||||||||
| September 30, 2022 | September 30, 2021 | September 30, 2022 | September 30, 2021 | |||||||||||||
| License revenue 1 | $ | 6,165 | 16 | 38,237 | 48 | |||||||||||
| Service revenue | - | - | - | 21 | ||||||||||||
| Research grants and contracts | - | 3 | 9 | 200 | ||||||||||||
| Total revenue | 6,165 | 19 | 38,246 | 269 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 9,744 | 4,371 | 30,165 | 13,490 | ||||||||||||
| General and administrative | (11,132 | ) | 1,184 | (13,914 | ) | 15,332 | ||||||||||
| Total operating expenses | 1,388 | 5.555 | 16,251 | 28,822 | ||||||||||||
| Income/ (loss) from operations | 7,553 | (5,536 | ) | 21,995 | (28,553 | ) | ||||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of derivatives embedded in convertible loan notes | - | - | - | 5,994 | ||||||||||||
| Change in fair value of contingent consideration | (317 | ) | - | (943 | ) | - | ||||||||||
| Unrealized exchange gain on convertible loan notes | - | - | - | 209 | ||||||||||||
| Loss on extinguishment of convertible loan notes | - | - | - | (13,789 | ) | |||||||||||
| Interest income | 1,024 | - | 1,776 | 2 | ||||||||||||
| Interest expense | 11 | - | 3 | (2,650 | ) | |||||||||||
| Research and development incentives | (724 | ) | 959 | 1,150 | 2,789 | |||||||||||
| Other | - | - | 51 | (3 | ) | |||||||||||
| Total other (expense)/ income | (6 | ) | 959 | 2,037 | (7,448 | ) | ||||||||||
| Tax benefit | 674 | 7 | 2,452 | 60 | ||||||||||||
| Net income/(loss) | 8,221 | (4,570 | ) | 26,484 | (35,941 | ) | ||||||||||
| Net loss attributable to noncontrolling interest | 21 | 13 | 47 | 189 | ||||||||||||
| Net income/(loss) attributable to Vaccitech plc shareholders | 8,242 | (4,557 | ) | 26,531 | (35,752 | ) | ||||||||||
| Weighted-average ordinary shares outstanding, basic | 37,247,123 | 34,843,154 | 37,213,787 | 22,697,462 | ||||||||||||
| Weighted-average ordinary shares outstanding, diluted | 38,156,564 | 34,843,154 | 38,226,092 | 22,697,462 | ||||||||||||
| Net income/(loss) per share attributable to ordinary shareholders, basic | $ | 0.22 | (0.13 | ) | 0.71 | (1.58 | ) | |||||||||
| Net income/(loss) per share attributable to ordinary shareholders, diluted | $ | 0.22 | (0.13 | ) | 0.69 | (1.58 | ) | |||||||||
| Net income/(loss) | $ | 8,221 | (4,570 | ) | 26,484 | (35,941 | ) | |||||||||
| Other comprehensive loss - foreign currency translation adjustments | (19.940 | ) | (6,473 | ) | (42,730 | ) | (7,803 | ) | ||||||||
| Comprehensive loss | (11,719 | ) | (11,043 | ) | (16,246 | ) | (43,744 | ) | ||||||||
| Comprehensive loss attributable to noncontrolling interest | 51 | 25 | 122 | 194 | ||||||||||||
| Comprehensive loss attributable to Vaccitech plc shareholders | $ | (11,668 | ) | (11,018 | ) | (16,124 | ) | (43,550 | ) |
license revenue from related parties for the three and nine month periods ended September 30, 2022, of $6.2 million and $38.2 million,
| IR contacts: | |
| Christopher M. Calabrese | Kevin Gardner |
| Managing Director | Managing Director |
| LifeSci Advisors | LifeSci Advisors |
| 917-680-5608 | 617-283-2856 |
| ccalabrese@lifesciadvisors.com | kgardner@lifesciadvisors.com |
| Media contact: | |
| Mike Beyer | |
| SAM BROWN, INC | |
| 312-961-2502 | |
| mikebeyer@sambrown.com | |
| Company contact: | |
| Jonothan Blackbourn | |
| IR & PR Manager | |
| Vaccitech | |
| IR@vaccitech.co.uk |