Full Press Release Details
Vaccitech Reports Full-Year 2022 Financial Results
and an Update on Corporate Developments
OXFORD, United Kingdom, March 24, 2023 (GLOBE NEWSWIRE) -- Vaccitech
plc (NASDAQ: VACC) (the Company, we or us), 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, today announced its
financial results for year end 2022 and an overview of the Company's progress.
represented an extremely active year at Vaccitech in which the company continued to advance its exciting pipeline and strengthen the
infrastructure necessary to support this and future growth. We announced the completion of enrollment of three clinical trials, and
initiated dosing in three new trials. This, combined with the announcement of new, state-of-the-art laboratories and offices
in the US and the UK, and a 121% increase in staff focused on R&D, clinical and manufacturing activities, highlights
Vaccitech's progress towards our goal of becoming a global leader in immunotherapies that leverage T cell immune
responses," said Bill Enright, Vaccitech's Chief Executive Officer. "2023 is shaping up to be an even more
exciting year with Dr. Nad ge Pelletier joining us as our new Chief Scientific Officer, key data readouts anticipated in
the first and fourth quarters, and additional milestones to come beyond that. We continue to invest strategically in our programs to
ensure that we are focused on reaching successful outcomes, both clinically and financially."
"Our clinical programs have advanced substantially in 2022, and
we have already seen promising interim data from VTP-200 in our persistent HPV program in the first quarter of 2023, where we are working
to clear HPV infection before it causes cancer. We also expect to see final data from VTP-300, our chronic Hepatitis B program, where
we are seeking a component to a functional cure, before the end of the quarter," commented Meg Marshall, Vaccitech's Chief
Medical Officer. "Moving forward we expect to see first patient first visit (FPFV) for VTP-850, our prostate cancer program, in
the near term, as well as additional data for VTP-300 later in the year. We believe 2023 is going to be a big year for Vaccitech as we
continue to advance our pipeline."
2022 Corporate Developments
Clinical developments
Pre-clinical developments:
Key operational updates:
2022 Financial Highlights
| Year ended December 31, 2022 | Year ended December 31, 2021 | Change | ||||||||||
| $ 000 | $ 000 | $ 000 | ||||||||||
| Direct research and development expenses by program: | ||||||||||||
| VTP-200 HPV | 4,050 | 3,061 | 989 | |||||||||
| VTP-300 HBV | 13,700 | 6,431 | 7,269 | |||||||||
| VTP-600 NSCLC 1 | 532 | 687 | (155 | ) | ||||||||
| VTP-800/850 Prostate cancer | 5,011 | 2,433 | 2,578 | |||||||||
| VTP-1000/VTP-1100 (SNAPvax candidates) | 5118 | - | 5,118 | |||||||||
| Other and earlier stage programs | 1,916 | 1,382 | 534 | |||||||||
| Total direct research and development expenses | 30,327 | 13,994 | 16,333 | |||||||||
| Internal research and development expenses: | ||||||||||||
| Personnel-related (including share-based compensation) | 10,424 | 5,787 | 4,637 | |||||||||
| Facility-related | 1,308 | 410 | 898 | |||||||||
| Other internal costs | 291 | 180 | 111 | |||||||||
| Total research and development expense | 42,350 | 20,371 | 21,979 |
VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK
is a clinical-stage biopharmaceutical company focused on the development of novel T cell immunotherapeutics designed to utilize the power
of the immune system to potentially treat and cure chronic infectious diseases, autoimmune diseases, and cancer. The Company believes
that its proprietary, multi-platform approach has the ability to induce higher magnitudes of T cells compared with other technologies.
The Company believes that it is well positioned to address the needs of large, underserved patient populations through a diverse clinical-stage
pipeline of investigational therapies targeting life-threatening diseases that pose significant public health risk and have limited treatment
options. The Company's lead product candidates include VTP-300, an immunotherapy candidate designed as a component of a potential
component of a functional cure for chronic hepatitis B viral (HBV) infection; VTP-200, a non-invasive, early-stage investigational treatment
for persistent, high-risk human papillomavirus (HPV); VTP-850, a novel T cell investigational therapy for prostate cancer; and VTP-1000,
a preclinical T cell therapeutic product candidate for immune tolerance in celiac disease. Vaccitech has proven drug development and
scientific expertise in the field of immunization, co-inventing a COVID-19 vaccine with the University of Oxford, which is now approved
and exclusively licensed worldwide to AstraZeneca. For more information, visit www.vaccitech.co.uk.
Forward Looking Statements
This 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," "aim," "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, approval of the Company's product candidates, the
Company's ability to fund its operations, global economic uncertainty, including disruptions in the banking industry, and the impact
that the COVID-19 pandemic may 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, 2022, its Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
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
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
| As of December 31, 2022 | As of December 31, 2021 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 194,385 | $ | 214,054 | ||||
| Accounts receivable | 323 | 20 | ||||||
| Accounts receivable - related parties | 5,524 | - | ||||||
| Research and development incentives receivable | 4,541 | 6,229 | ||||||
| Prepaid expenses and other current assets | 8,268 | 6,462 | ||||||
| Total current assets | 213,041 | 226,765 | ||||||
| Goodwill | 12,209 | 12,630 | ||||||
| Property and equipment, net | 7,957 | 1,829 | ||||||
| Intangible assets, net | 28,269 | 31,430 | ||||||
| Right of use assets, net | 7,753 | 7,257 | ||||||
| Other assets | 976 | 804 | ||||||
| Total assets | $ | 270,205 | $ | 280,715 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,748 | $ | 2,419 | ||||
| Accrued expenses and other current liabilities | 8,061 | 7,875 | ||||||
| Deferred revenue | - | 182 | ||||||
| Operating lease liability - current | 433 | 523 | ||||||
| Debt | - | 159 | ||||||
| Total current liabilities | 12,242 | 11,158 | ||||||
| Non-Current liabilities: | ||||||||
| Operating lease liability | 8,340 | 6,540 | ||||||
| Contingent consideration | 1,711 | 2,371 | ||||||
| Other non-current liabilities | 965 | - | ||||||
| Deferred tax liability, net | 3,746 | 8,084 | ||||||
| Total liabilities | $ | 27,004 | $ | 28,153 | ||||
| Commitments and contingencies (Note 17) | ||||||||
| Shareholders' equity: | ||||||||
| Ordinary shares, 0.000025 nominal value; 37,683,531 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 | 379,504 | 369,103 | ||||||
| Accumulated deficit | (103,243 | ) | (108,585 | ) | ||||
| Accumulated other comprehensive loss - foreign currency translation adjustments | (33,460 | ) | (8,488 | ) | ||||
| Total shareholders' equity attributable to Vaccitech plc shareholders' | 242,896 | 252,125 | ||||||
| Noncontrolling interest | 305 | 437 | ||||||
| Total shareholders' equity | $ | 243,201 | $ | 252,562 | ||||
| Total liabilities and shareholders' equity | $ | 270,205 | $ | 280,715 |
Indicates amount less than one thousand.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
| As of December 31, 2022 | As of December 31, 2021 | |||||||
| License revenue 1 | $ | 44,694 | $ | 63 | ||||
| Service revenue | - | 21 | ||||||
| Research grants and contracts | 9 | 184 | ||||||
| Total revenue | 44,703 | 268 | ||||||
| Operating expenses | ||||||||
| Research and development | 42,350 | 20,371 | ||||||
| General and administrative | 6,394 | 25,118 | ||||||
| Total operating expenses | 48,744 | 45,489 | ||||||
| Loss from operations | (4,041 | ) | (45,221 | ) | ||||
| Other income (expense): | ||||||||
| Change in fair value of derivatives embedded in convertible loan notes | - | 5,994 | ||||||
| Unrealized foreign exchange gain on convertible loan notes | - | 209 | ||||||
| Loss on extinguishment of convertible loan notes | - | (13,789 | ) | |||||
| Interest income | 3,103 | 2 | ||||||
| Interest expense | (19 | ) | (2,668 | ) | ||||
| Research and development incentives | 1,240 | 4,001 | ||||||
| Other income, net | 567 | 332 | ||||||
| Total other income/(expense) | 4,891 | (5,919 | ) | |||||
| Profit/(loss) before income tax | 850 | (51,140 | ) | |||||
| Tax benefit | 4,471 | 28 | ||||||
| Net income/(loss) | 5,321 | (51,112 | ) | |||||
| Net loss attributable to noncontrolling interest | 21 | 247 | ||||||
| Net income/(loss) attributable to Vaccitech plc shareholders | $ | 5,342 | $ | (50,865 | ) | |||
| Weighted-average ordinary shares outstanding, basic | 37,248,126 | 25,894,375 | ||||||
| Weighted-average ordinary shares outstanding, diluted | 38,169,307 | 25,894,375 | ||||||
| Net income/(loss) per share attributable to ordinary shareholders, basic | $ | 0.14 | $ | (1.96 | ) | |||
| Net income/(loss) per share attributable to ordinary shareholders, diluted | $ | 0.14 | $ | (1.96 | ) | |||
| Net income/(loss) | $ | 5,321 | $ | (51,112 | ) | |||
| Other comprehensive loss - foreign currency translation adjustments | (25,083 | ) | (7,248 | ) | ||||
| Comprehensive loss | (19,762 | ) | (58,360 | ) | ||||
| Comprehensive loss attributable to noncontrolling interest | 132 | 250 | ||||||
| Comprehensive loss attributable to Vaccitech plc shareholders | $ | (19,630 | ) | $ | (58,110 | ) |
Includes license revenue from related parties for the year ended December 31, 2022, totaling
$43.7 million (December 31, 2021: $nil).