Vaccitech Reports Second Quarter 2022 Financial Results and Recent Corporate Developments
10 August 2022 - 6:15AM
Vaccitech plc (NASDAQ: VACC) today announced its financial results
for the second quarter ended June 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.
“The highlight of another productive quarter was interim data
from our ongoing Phase 1b/2a clinical trial of VTP-300 in patients
with chronic hepatitis B,” said Bill Enright, Vaccitech’s CEO. “We
saw not only a robust T Cell response, but also sustained HBsAg
reductions with a single treatment - interim data points that, to
our knowledge, have not been observed together in clinical trials
of other immunotherapeutics in this indication. This quarter we
have recognized further royalty and milestone payments related to
the sales of Vaxzevria®, AstraZeneca’s COVID-19 vaccine, which have
contributed significant non-dilutive capital to support the
company’s clinical and preclinical programs going forward.”
Second Quarter 2022 and Recent Corporate
Developments
License revenue:
- On April 6, 2022, the Company announced that it had been
notified of the commencement of royalty payments related to
commercial sales of Vaxzevria®. The Company’s share of milestone
and royalty payments received by Oxford University Innovation, or
OUI, from AstraZeneca in the second quarter of 2022 amounted to
$17.1 million, relating to commercial sales of Vaxzevria® during
the first quarter of 2022.
Clinical developments:
- On April 29, 2022, the Company received scientific advice from
the EMA defining a licensure pathway for its MERS vaccine
candidate, VTP-500.
- In May, the Company completed enrollment for a Phase 1b/2a
clinical trial, HBV002, to evaluate the safety and immunogenicity
of VTP-300 with or without an anti-PD-1 therapy in patients with
chronic Hepatitis B (HBV) infection whose infection has been
suppressed with oral antiviral medication.
- In June, Arbutus Biopharma Corporation (Arbutus) and the
Company dosed the first patient in a randomized, multi-center,
blinded Phase 2a clinical trial to evaluate the safety, antiviral
activity, and immunogenicity of the combination of Arbutus’ RNAi
therapy, AB-729, with the Company’s immunotherapy, VTP-300, plus
standard of care for the treatment of patients with virologically
suppressed chronic HBV infection.
- In June, at the 2022 EASL International Liver Congress™, the
Company presented data showing that VTP-300, both as monotherapy
and in combination with a single low-dose of nivolumab at the time
of the booster dose, induced sustained reductions of HBV surface
antigen (HBsAg) in some patients, and a robust T cell response, of
which CD8+ T cells were predominant, against all encoded antigens
in patients with chronic HBV infection.
- In July, the Company enrolled the 60th patient into the
Company’s Phase 1b/2 clinical trial of VTP-200, HPV001, to evaluate
a potential treatment for persistent high-risk HPV infection.
Pre-clinical development:
- In April, the Company launched a program for the treatment of
HPV-associated cancers and moved forward with a second
immunotherapeutic program designed to induce regulatory T cells in
patients with celiac disease, both utilizing the SNAPvax™
platform.
Upcoming Milestones
- In the fourth quarter of 2022, the Company expects to report
additional data from the ongoing Phase 1b/2a clinical trial of
VTP-300 in patients with chronic HBV infection.
- In the fourth quarter of 2022, the Company expects to initiate
dosing of HBV003, a Phase 2b clinical trial of VTP-300 in patients
with chronic HBV infection.
- In the fourth quarter of 2022, the Company expects to initiate
dosing in a Phase 1/2 clinical trial of VTP-850 in patients with
prostate cancer.
- In the first quarter of 2023, the Company 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.
- In 2023, the Company expects to submit Investigational New Drug
(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.
Second Quarter 2022 Financial Highlights:
- Cash position: As of June 30, 2022, cash and
cash equivalents were $192.3 million, compared to $214.1 million as
of December 31, 2021. The decrease in cash was primarily due to
$15.0 million of net cash used in operating activities, $3.1
million of net cash used in investing activities, and an effect of
$3.5 million from exchange rate movements on cash and cash
equivalents.
- Revenues: Revenues were $17.1 million in the
second quarter of 2022 compared to $15.0 million in the first
quarter of 2022. Revenues comprised the Company’s share of
milestone and royalty payments received by OUI from AstraZeneca
related to commercial sales of Vaxzevria®.
- Research and development expenses: Research
and development expenses were $9.7 million in the second quarter of
2022 compared to $10.7 million in the first quarter of 2022. The
decrease in R&D expenses from the previous quarter was
primarily due to lower R&D personnel-related costs and
decreased spending on the development of VTP-200 and VTP-850.
- General and administrative expenses: General
and administrative expenses were a gain of $6.4 million (after
including a foreign exchange gain of $15.2 million) in the second
quarter of 2022, compared to an expense of $3.9 million (after
including a foreign exchange gain of $5.3 million) in the previous
quarter. Excluding the foreign exchange gain, G&A expenses were
$8.8 million in the second quarter of 2022, which were mainly
attributable to personnel expenses of $4.3 million, including the
share-based payment charge of $2.1 million, insurance costs of $1.6
million, and legal and professional fees of $1.0 million. Excluding
the foreign exchange gain, G&A expenses for the previous
quarter were $9.2 million and were mainly attributable to personnel
expenses of $4.3 million, including the share-based payment charge
of $3.1 million, insurance costs of $1.7 million, and legal and
professional fees of $1.3 million.
- Net Income: For the second quarter of 2022,
the Company generated a net income attributable to its shareholders
of $15.7 million, or $0.41 per fully diluted share and $0.42 per
basic share, compared to a net income attributable to shareholders
of $2.6 million, or $0.068 per fully diluted share and $0.070 per
basic share, for the previous quarter.
About Vaccitech
Vaccitech 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
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 “may,” “will,” “could,” “if,” “forward,”
“expect,” “intend,” “believe,” “estimate,” “potential,” “on track,”
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, andVTP-850, statements regarding the timing for
the potential IND applications for the Company’s two lead SNAPvax
candidates, VTP1000 and VTP 1100, statements regarding the updated
interim analysis from the HBV002 study, 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.
VACCITECH PLCCONDENSED
CONSOLIDATED BALANCE SHEETS(IN THOUSANDS, EXCEPT
NUMBER OF SHARES AND PER SHARE
AMOUNTS)(UNAUDITED)
|
|
June 30, 2022 |
|
December 31,2021 |
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
192,327 |
|
$ |
214,054 |
|
Accounts receivable |
|
- |
|
|
20 |
|
Accounts receivable - related parties |
|
17,048 |
|
|
- |
|
Research and development incentives receivable |
|
5,217 |
|
|
6,229 |
|
Prepaid expenses and other current assets |
|
11,699 |
|
|
6,462 |
|
Total current assets |
|
226,291 |
|
|
226,765 |
|
Goodwill |
|
12,630 |
|
|
12,630 |
|
Property and equipment,
net |
|
7,044 |
|
|
1,829 |
|
Intangible assets, net |
|
29,850 |
|
|
31,430 |
|
Right of use assets, net |
|
8,339 |
|
|
7,257 |
|
Other assets |
|
902 |
|
|
804 |
|
Total assets |
$ |
285,056 |
|
$ |
280,715 |
|
|
|
|
|
|
LIABILITIES AND
SHARESHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ |
4,475 |
|
$ |
2,419 |
|
Accrued expenses and other current liabilities |
|
7,256 |
|
|
7,875 |
|
Deferred revenue |
|
136 |
|
|
182 |
|
Current portion of lease liability |
|
299 |
|
|
523 |
|
Debt |
|
- |
|
|
159 |
|
Total current liabilities |
|
12,166 |
|
|
11,158 |
|
Lease liability – non
current |
|
8,314 |
|
|
6,540 |
|
Contingent consideration |
|
2,727 |
|
|
2,371 |
|
Deferred tax liability,
net |
|
6,306 |
|
|
8,084 |
|
Other non-current
liabilities |
|
776 |
|
|
- |
|
Total liabilities |
$ |
30,289 |
|
$ |
28,153 |
|
Commitments and
contingencies |
|
|
|
|
Shareholders’ equity: |
|
|
|
|
Ordinary shares, £0.000025 nominal value; 37,216,162 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) |
|
01 |
|
|
01 |
|
Additional paid-in capital |
|
375,835 |
|
|
369,103 |
|
Accumulated deficit |
|
(90,296 |
) |
|
(108,585 |
) |
Accumulated other comprehensive loss – foreign currency translation
adjustments |
|
(31,233 |
) |
|
(8,488 |
) |
Total shareholders’ equity attributable to Vaccitech plc
shareholders’ |
|
254,401 |
|
|
252,125 |
|
Noncontrolling interest |
|
366 |
|
|
437 |
|
Total shareholders’ equity |
$ |
254,767 |
|
$ |
252,562 |
|
Total liabilities and
shareholders’ equity |
$ |
285,056 |
|
$ |
280,715 |
|
1
indicates amount less than thousand |
|
|
|
|
|
|
|
|
|
|
|
|
|
VACCITECH PLCCONDENSED
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, 2022 |
|
June 30, 2021 |
|
June 30, 2022 |
|
June 30, 2021 |
License revenue (1) |
$ |
17,063 |
|
$ |
16 |
|
$ |
32,072 |
|
$ |
32 |
|
Service revenue |
|
- |
|
|
- |
|
|
- |
|
|
21 |
|
Research grants and contracts |
|
- |
|
|
19 |
|
|
9 |
|
|
197 |
|
Total revenue |
|
17,063 |
|
|
35 |
|
|
32,081 |
|
|
250 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
9,720 |
|
|
4,509 |
|
|
20,421 |
|
|
9,119 |
|
General and administrative |
|
(6,445 |
) |
|
12,371 |
|
|
(2,782 |
) |
|
14,148 |
|
Total operating expenses |
|
3,275 |
|
|
16,880 |
|
|
17,639 |
|
|
23,267 |
|
Income/(Loss) from operations |
|
13,788 |
|
|
(16,845 |
) |
|
14,442 |
|
|
(23,017 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
Change in fair value of derivatives embedded in convertible loan
notes |
|
- |
|
|
- |
|
|
- |
|
|
5,994 |
|
Change in fair value of contingent consideration |
|
(626 |
) |
|
- |
|
|
(626 |
) |
|
- |
|
Unrealized exchange gain on convertible loan notes |
|
- |
|
|
- |
|
|
- |
|
|
209 |
|
Loss on extinguishment of convertible loan notes |
|
- |
|
|
- |
|
|
- |
|
|
(13,789 |
) |
Interest income |
|
669 |
|
|
- |
|
|
752 |
|
|
2 |
|
Interest expense |
|
66 |
|
|
- |
|
|
(8 |
) |
|
(2,650 |
) |
Research and development incentives |
|
826 |
|
|
875 |
|
|
1,874 |
|
|
1,830 |
|
Other |
|
51 |
|
|
(3 |
) |
|
51 |
|
|
(3 |
) |
Total other (expense) income |
|
986 |
|
|
872 |
|
|
2,043 |
|
|
(8,407 |
) |
Tax
benefit /(expense) |
|
915 |
|
|
(12 |
) |
|
1,778 |
|
|
53 |
|
Net
Income/(loss) |
|
15,689 |
|
|
(15,985 |
) |
|
18,263 |
|
|
(31,371 |
) |
Net loss attributable to noncontrolling interest |
|
4 |
|
|
58 |
|
|
26 |
|
|
176 |
|
Net
income/(loss) attributable to Vaccitech plc shareholders |
|
15,693 |
|
|
(15,927 |
) |
|
18,289 |
|
|
(31,195 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average ordinary
shares outstanding, basic |
|
37,202,600 |
|
|
24,897,665 |
|
|
37,196,843 |
|
|
16,523,961 |
|
Weighted-average ordinary
shares outstanding, diluted |
|
38,174,426 |
|
|
24,897,665 |
|
|
38,260,579 |
|
|
16,523,961 |
|
Net income (loss) per share
attributable to ordinary shareholders, basic |
$ |
0.42 |
|
$ |
(0.64 |
) |
$ |
0.49 |
|
$ |
(1.89 |
) |
Net income (loss) per share
attributable to ordinary shareholders, diluted |
$ |
0.41 |
|
$ |
(0.64 |
) |
$ |
0.48 |
|
$ |
(1.89 |
) |
|
|
|
|
|
|
|
|
|
Net
Income/(loss) |
$ |
15,689 |
|
$ |
(15,985 |
) |
$ |
18,263 |
|
$ |
(31,371 |
) |
Other comprehensive
(loss)/income – foreign currency translation adjustments |
|
(16,807 |
) |
|
86 |
|
|
(22,790 |
) |
|
(1,330 |
) |
Comprehensive loss |
|
(1,118 |
) |
|
(15,899 |
) |
|
(4,527 |
) |
|
(32,701 |
) |
Comprehensive loss attributable to noncontrolling interest |
|
34 |
|
|
55 |
|
|
71 |
|
|
169 |
|
Comprehensive loss attributable to Vaccitech plc Shareholders |
$ |
(1,084 |
) |
$ |
(15,844 |
) |
$ |
(4,456 |
) |
$ |
(32,532 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes license revenue from related
parties for the 3 and 6 month period ended June 30, 2022 of $17.1
million and $32.1 million,
respectively.Investors:Vaccitech Investor
Relationsir@vaccitech.co.uk
Vaccitech Media Contacts:
Katja Stout, Scius Communications (EU)Direct: +44 (0)
7789435990Email: katja@sciuscommunications.com
Katie Larch / Robert Flamm, Ph.D., Burns McClellan, Inc.
(U.S.)Email: klarch@burnsmc.com / rflamm@burnsmc.com
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