OXFORD, United Kingdom, Aug. 10, 2023 (GLOBE NEWSWIRE) — Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel T cell immunotherapeutics designed to harness the power of the immune system to treat chronic infectious diseases, cancer and autoimmunity, today announced its financial results for the second quarter of 2023 and provided an overview of the Company’s progress.
“In the second quarter of 2023, Vaccitech achieved important clinical milestones for two of our lead programs in HPV and HBV, which included the final analysis for the Phase 1b/2a trial of VTP-300 presented at EASL,” said Bill Enright, Vaccitech’s Chief Executive Officer. “Looking ahead, we remain steadfast in our focus on HBV and are eagerly anticipating interim data from our ongoing Phase 2 trials which we expect to announce by the end of the year. We have been able to extend our cash runway into the second quarter of 2025, demonstrating Vaccitech’s ethos of agility and efficiency across our broad portfolio of programs.”
Second Quarter 2023 and Recent Corporate Developments
Clinical developments
Key operational updates
Upcoming Milestones
Q2 2023 Financial Highlights
Three months ended June 30, 2023 |
Three months ended March 30, 2023 | Change | |||||||||
$ | 000 | $ | 000 | $ | 000 | ||||||
Direct research and development expenses by program: | |||||||||||
VTP-200 HPV | 1,837 | 1,338 | 499 | ||||||||
VTP-300 HBV | 3,757 | 2,118 | 1,639 | ||||||||
VTP-600 NSCLC1 | 79 | 275 | (196 | ) | |||||||
VTP-850 Prostate cancer | 242 | 215 | 27 | ||||||||
VTP-1000/VTP-1100 Celiac/HPV Cancer | 3,018 | 1,572 | 1,446 | ||||||||
Other and earlier stage programs | 701 | 280 | 421 | ||||||||
Total direct research and development expenses | 9,634 | 5,798 | 3,836 | ||||||||
Internal research and development expenses: | |||||||||||
Personnel-related (including share-based compensation) | 3,388 | 3,601 | (213 | ) | |||||||
Facility-related | 202 | 371 | (169 | ) | |||||||
Other internal costs | 319 | 44 | 275 | ||||||||
Total internal research and development expenses | 3,909 | 4,016 | (107 | ) | |||||||
Total research and development expense | 13,543 | 9,814 | 3,729 |
1 The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK.
About Vaccitech
Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel T cell immunotherapeutics designed to harness the power of the immune system to treat chronic infectious diseases, cancer and autoimmunity. 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 potential IND application for VTP-1000, statements regarding the presentation of interim data, including with respect to VTP-300, 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 statements.
VACCITECH PLC | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS) | |||||||
(UNAUDITED) | |||||||
June 30, | December 31, | ||||||
2023 | 2022 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 173,030 | $ | 194,385 | |||
Accounts receivable | — | 323 | |||||
Accounts receivable – related parties | 349 | 5,524 | |||||
Research and development incentives receivable | 3,137 | 4,541 | |||||
Prepaid expenses and other current assets | 8,261 | 8,268 | |||||
Total current assets | 184,777 | 213,041 | |||||
Goodwill | 12,209 | 12,209 | |||||
Property and equipment, net | 13,741 | 7,957 | |||||
Intangible assets, net | 26,688 | 28,269 | |||||
Right of use assets, net | 7,707 | 7,753 | |||||
Other assets | 1,006 | 976 | |||||
Total assets | $ | 246,128 | $ | 270,205 | |||
LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 2,429 | $ | 3,748 | |||
Accrued expenses and other current liabilities | 8,547 | 8,061 | |||||
Operating lease liability – current | 1,135 | 433 | |||||
Total current liabilities | 12,111 | 12,242 | |||||
Non-Current liabilities: | |||||||
Operating lease liability | 11,044 | 8,340 | |||||
Contingent consideration | 2,117 | 1,711 | |||||
Deferred tax liability, net | 2,094 | 3,746 | |||||
Other non-current liabilities | 1,300 | 965 | |||||
Total liabilities | $ | 28,666 | $ | 27,004 | |||
Commitments and contingencies (Note 14) | |||||||
Shareholders’ equity: | |||||||
Ordinary shares, £0.000025 nominal value; 38,524,059 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) | — | 0 | |||||
Additional paid-in capital | 385,636 | 379,504 | |||||
Accumulated deficit | (145,225 | ) | (103,243 | ) | |||
Accumulated other comprehensive loss – foreign currency translation adjustments | (23,289 | ) | (33,460 | ) | |||
Total shareholders’ equity attributable to Vaccitech plc shareholders’ | 217,209 | 242,896 | |||||
Noncontrolling interest | 253 | 305 | |||||
Total shareholders’ equity | $ | 217,462 | $ | 243,201 | |||
Total liabilities and shareholders’ equity | $ | 246,128 | $ | 270,205 | |||
1indicates amount less than thousand
VACCITECH PLC | ||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS) | ||||||||||||||||
(UNAUDITED) | ||||||||||||||||
Three months ended | Six months ended | |||||||||||||||
June 30, 2023 | June 30, 2022 | June 30, 2023 | June 30, 2022 | |||||||||||||
License revenue (1) | $ | 334 | $ | 17,063 | $ | 802 | $ | 32,072 | ||||||||
Research grants and contracts | — | — | — | 9 | ||||||||||||
Total revenue | 334 | 17,063 | 802 | 32,081 | ||||||||||||
Operating expenses | ||||||||||||||||
Research and development | 13,543 | 9,720 | 23,357 | 20,421 | ||||||||||||
General and administrative | 13,128 | (5,892 | ) | 25,266 | (2,156 | ) | ||||||||||
Total operating expenses | 26,671 | 3,828 | 48,623 | 18,265 | ||||||||||||
(Loss)/income from operations | (26,337 | ) | 13,235 | (47,821 | ) | 13,816 | ||||||||||
Other income (expense): | ||||||||||||||||
Interest income | 522 | 669 | 2,110 | 752 | ||||||||||||
Interest expense | (14 | ) | (7 | ) | (14 | ) | (8 | ) | ||||||||
Research and development incentives | 559 | 826 | 1,716 | 1,874 | ||||||||||||
Other income | 310 | 51 | 310 | 51 | ||||||||||||
Total other (expense) income | 1,377 | 1,539 | 4,122 | 2,669 | ||||||||||||
(Loss)/profit before income tax | (24,960 | ) | 14,774 | (43,699 | ) | 16,485 | ||||||||||
Tax benefit | 1,136 | 915 | 1,652 | 1,778 | ||||||||||||
Net (loss)/income | (23,824 | ) | 15,689 | (42,047 | ) | 18,263 | ||||||||||
Net loss attributable to noncontrolling interest | 22 | 4 | 65 | 26 | ||||||||||||
Net (loss)/income attributable to Vaccitech plc shareholders | (23,802 | ) | 15,693 | (41,982 | ) | 18,289 | ||||||||||
Weighted-average ordinary shares outstanding, basic | 38,407,672 | 37,202,600 | 38,211,625 | 37,196,843 | ||||||||||||
Weighted-average ordinary shares outstanding, diluted | 38,407,672 | 38,174,426 | 38,211,625 | 38,260,579 | ||||||||||||
Net (loss)/income per share attributable to ordinary shareholders, basic | $ | (0.62 | ) | $ | 0.42 | $ | (1.10 | ) | $ | 0.49 | ||||||
Net (loss)/income per share attributable to ordinary shareholders, diluted | $ | (0.62 | ) | $ | 0.41 | $ | (1.10 | ) | $ | 0.48 | ||||||
Net (loss)/income | $ | (23,824 | ) | $ | 15,689 | $ | (42,047 | ) | $ | 18,263 | ||||||
Other comprehensive gain/(loss) – foreign currency translation adjustments | 5,604 | (16,807 | ) | 10,184 | (22,790 | ) | ||||||||||
Comprehensive loss | (18,220 | ) | (1,118 | ) | (31,863 | ) | (4,527 | ) | ||||||||
Comprehensive loss attributable to noncontrolling interest | 15 | 34 | 52 | 71 | ||||||||||||
Comprehensive loss attributable to Vaccitech plc shareholders | $ | (18,205 | ) | $ | (1,084 | ) | $ | (31,811 | ) | $ | (4,456 | ) |
(1)Includes license revenue from related parties for the three and six month periods ended June 30, 2023 of $0.3 million and $0.8 million, respectively and for the three and six month periods ended June 30, 2022 of $17.1 million and $32.1 million, respectively.
IR contacts: | |
Christopher M. Calabrese Managing Director LifeSci Advisors +1 917-680-5608 ccalabrese@lifesciadvisors.com |
Kevin Gardner Managing Director LifeSci Advisors +1 617-283-2856 kgardner@lifesciadvisors.com |
Media contact: Audra Friis Sam Brown, Inc. +1 917-519-9577 audrafriis@sambrown.com |
|
Company contact: Jonothan Blackbourn IR & PR Manager Vaccitech IR@vaccitech.co.uk |
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