Full Press Release Details
Vaccitech Reports First Quarter 2023 Financial
Results and Recent Corporate Developments
OXFORD, United Kingdom, May 12, 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 the first quarter of 2023 and an overview of the Company's progress.
"2023 has kicked off strongly for Vaccitech. In the first quarter,
we strengthened our leadership team with the addition of Dr. Nad ge Pelletier as our new Chief Scientific Officer, we generated
positive final proof of concept data from one of our hepatitis B (HBV) trials, and very promising interim data from our human papillomavirus
(HPV) program - both disease areas of high unmet medical need," said Bill Enright, Vaccitech's Chief Executive Officer.
"Overall, this has been an incredibly active quarter and we expect to sustain this momentum as we push towards additional data from
our wider hepatitis B program as the year progresses."
Dr. Meg Marshall, Vaccitech's Chief Medical Officer, commented,
"This quarter has seen the achievement of important milestones for both of our lead product candidates in HBV and HPV. Our HBV002
trial for VTP-300 met its primary and secondary endpoints. The topline final data support proof of concept and have shown a generally
favorable tolerability profile and meaningful sustained reductions in hepatitis B surface antigen (HBsAg), supporting our belief that
VTP-300 has potential to be a critical component of a functional cure for patients that are chronically infected with hepatitis B. Additionally,
the interim data from APOLLO, our HPV clinical trial, showed a favorable tolerability and promising immunogenicity profile, highlighting
VTP-200's potential for women with persistent high-risk HPV infections, who currently have no treatment options until they develop
high grade lesions."
First Quarter 2023 and Recent Corporate Developments
Clinical developments
Q1 2023 Financial Highlights
| Three months ended March 31, 2023 | Three months ended March 31, 2022 | Change | ||||||||||
| $000 | $000 | $000 | ||||||||||
| Direct research and development expenses by program: | ||||||||||||
| VTP-200 HPV | 1,338 | 1,156 | 182 | |||||||||
| VTP-300 HBV | 2,118 | 4,185 | (2,067 | ) | ||||||||
| VTP-600 NSCLC 1 | 275 | 162 | 113 | |||||||||
| VTP-850 Prostate cancer | 215 | 1,339 | (1,124 | ) | ||||||||
| VTP-1000/VTP-1100 (SNAPvax candidates) | 1,572 | - | 1,572 | |||||||||
| Other and earlier stage programs | 280 | 739 | (459 | ) | ||||||||
| Total direct research and development expenses | 5,798 | 7,581 | (1,783 | ) | ||||||||
| Internal research and development expenses: | ||||||||||||
| Personnel-related (including share-based compensation) | 3,601 | 2,726 | 875 | |||||||||
| Facility-related | 371 | 340 | 31 | |||||||||
| Other internal costs | 44 | 54 | (10 | ) | ||||||||
| Total internal research and development expenses | 4,016 | 3,120 | 896 | |||||||||
| Total research and development expense | 9,814 | 10,701 | (887 | ) |
1 The VTP-600 NSCLC Phase 1/2a trial is sponsored by
Vaccitech 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 treat and cure chronic infectious
diseases, autoimmune diseases, and cancer. The Company stands apart through a proprietary, multi-platform approach that has shown the
ability to induce higher magnitudes of T cells compared with other technologies. Vaccitech is uniquely 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 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 candidate designed to restore 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 statement
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,
statements regarding the timing for the potential IND application for VTP-1000, statements regarding the presentation of data at future
conferences, and statements regarding the Company's capital, including its cash runway. 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
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND
| March 31, 2023 | December 31, 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 191,328 | $ | 194,385 | ||||
| Accounts receivable | 172 | 323 | ||||||
| Accounts receivable - related parties | 768 | 5,524 | ||||||
| Research and development incentives receivable | 2,501 | 4,541 | ||||||
| Prepaid expenses and other current assets | 5,896 | 8,268 | ||||||
| Total current assets | 200,665 | 213,041 | ||||||
| Goodwill | 12,209 | 12,209 | ||||||
| Property and equipment, net | 12,712 | 7,957 | ||||||
| Intangible assets, net | 27,479 | 28,269 | ||||||
| Right of use assets, net | 7,723 | 7,753 | ||||||
| Other assets | 1,028 | 976 | ||||||
| Total assets | $ | 261,816 | $ | 270,205 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,327 | $ | 3,748 | ||||
| Accrued expenses and other current liabilities | 7,012 | 8,061 | ||||||
| Operating lease liability - current | 649 | 433 | ||||||
| Total current liabilities | 11,988 | 12,242 | ||||||
| Non-Current liabilities: | ||||||||
| Operating lease liability | 10,005 | 8,340 | ||||||
| Contingent consideration | 1,710 | 1,711 | ||||||
| Deferred tax liability, net | 3,230 | 3,746 | ||||||
| Other non-current liabilities | 1,314 | 965 | ||||||
| Total liabilities | $ | 28,247 | $ | 27,004 | ||||
| Commitments and contingencies (Note 14) | ||||||||
| Shareholders' equity: | ||||||||
| Ordinary shares, 0.000025 nominal value; 38,357,025 shares authorized, issued and outstanding (December 31, 2022: authorized, issued and outstanding: 37,683,531) | 1 | 1 | ||||||
| Deferred A shares, 1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2022: authorized, issued and outstanding: 63,443) | 86 | 86 | ||||||
| Deferred B shares, 0.01 nominal value; nil shares authorized, issued and outstanding (December 31, 2022: authorized, issued and outstanding: 570,987) | - | 8 | ||||||
| Deferred C shares, 0.000007 nominal value, nil shares authorized, issued and outstanding (December 31, 2022: authorized, issued and outstanding: 27,828,231) | - | 01 | ||||||
| Additional paid-in capital | 383,523 | 379,504 | ||||||
| Accumulated deficit | (121,423 | ) | (103,243 | ) | ||||
| Accumulated other comprehensive loss - foreign currency translation adjustments | (28,886 | ) | (33,460 | ) | ||||
| Total shareholders' equity attributable to Vaccitech plc shareholders' | 233,301 | 242,896 | ||||||
| Noncontrolling interest | 268 | 305 | ||||||
| Total shareholders' equity | $ | 233,569 | $ | 243,201 | ||||
| Total liabilities and shareholders' equity | $ | 261,816 | $ | 270,205 |
1 indicates amount less than thousand.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(IN THOUSANDS, EXCEPT
NUMBER OF SHARES AND PER SHARE AMOUNTS)
| Three months ended | ||||||||
| March 31, 2023 | March 31, 2022 | |||||||
| License revenue 1 | $ | 468 | $ | 15,009 | ||||
| Research grants and contracts | - | 9 | ||||||
| Total revenue | 468 | 15,018 | ||||||
| Operating expenses | ||||||||
| Research and development | 9,814 | 10,701 | ||||||
| General and administrative | 12,138 | 3,663 | ||||||
| Total operating expenses | 21,952 | 14,364 | ||||||
| (Loss)/income from operations | (21,484 | ) | 654 | |||||
| Other income/(expense): | ||||||||
| Interest income | 1,588 | 83 | ||||||
| Interest expense | - | (74 | ) | |||||
| Research and development incentives | 1,157 | 1,048 | ||||||
| Total other income/(expense) | 2,745 | 1,057 | ||||||
| (Loss)/profit before income tax | (18,739 | ) | 1,711 | |||||
| Tax benefit | 516 | 863 | ||||||
| Net (loss)/income | (18,223 | ) | 2,574 | |||||
| Net loss attributable to noncontrolling interest | 43 | 22 | ||||||
| Net (loss)/income attributable to Vaccitech plc shareholders | (18,180 | ) | 2,596 | |||||
| Weighted-average ordinary shares outstanding, basic | 38,013,399 | 37,191,022 | ||||||
| Weighted-average ordinary shares outstanding, diluted | 38,013,399 | 38,346,668 | ||||||
| Net (loss)/income per share attributable to ordinary shareholders, basic | $ | (0.48 | ) | $ | 0.070 | |||
| Net (loss)/income per share attributable to ordinary shareholders, diluted | $ | (0.48 | ) | $ | 0.068 | |||
| Net (loss)/income | $ | (18,223 | ) | $ | 2,574 | |||
| Other comprehensive gain/(loss) - foreign currency translation adjustments | 4,580 | (5,983 | ) | |||||
| Comprehensive loss | (13,643 | ) | (3,409 | ) | ||||
| Comprehensive loss attributable to noncontrolling interest | 37 | 37 | ||||||
| Comprehensive loss attributable to Vaccitech plc shareholders | $ | (13,606 | ) | $ | (3,372 | ) |
1 Includes license revenue from related parties for the
three month periods ended March 31, 2023 and 2022, of $0.5 million and $15.0 million, respectively.