Vaccitech Reports First Quarter 2022 Financial Results and Recent Corporate Developments
May 11 2022 - 04:15PM
GlobeNewswire Inc.
Vaccitech plc (NASDAQ: VACC) today announced its financial results
for the first quarter ended March 31, 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.
“We’ve already made solid progress across the Company this year
and are excited to share our plans to advance our recently acquired
SNAPvax platform into the clinic in multiple disease indications
including HPV cancer and celiac disease,” said Bill Enright,
Vaccitech’s CEO. “These are devastating diseases where we believe
this novel platform provides a unique opportunity for potential
cures. In addition, we expect to announce efficacy data in our
chronic infectious disease programs in both HBV and HPV later this
year. Finally, the royalty and milestone payments that we have
begun to receive related to the sales of AstraZeneca’s SARS CoV2
vaccine will contribute non-dilutive capital to these efforts.”
First Quarter 2022 and Recent Corporate
Developments
- On April 6, 2022, the Company announced the notification of the
commencement of royalty payments relating to commercial sales of
Vaxzevria®. The Company’s share of milestone and royalty payments
received by OUI from AstraZeneca in the first quarter of 2022
amounted to $15.0 million.
- In April, the Company launched a program in HPV-associated
cancer utilizing the SNAPvax™ platform and moved forward with an
immunotherapeutic designed to induce regulatory T cells in patients
with celiac disease. IND applications are expected to be filed for
both programs during the first quarter of 2023.
- On April 29, 2022, the Company received scientific advice from
the EMA defining a licensure pathway for the candidate MERS
vaccine, VTP-500, which allows the Company to estimate expenses of
the development pathway more accurately.
Upcoming Milestones
- In the second quarter of 2022, the Company expects to present
additional Phase 1b/2a interim efficacy data on VTP-300 in patients
with chronic HBV infection at the European Association for the
Study of the Liver (EASL) International Liver Congress on June 22
to 26, 2022, which is also expected to be followed by full efficacy
data in the second half of this year.
- In the third 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 fourth quarter of 2022, the Company intends to conduct
an interim efficacy review of HPV001, a Phase 1b/2 clinical trial
of VTP-200, a potential non-invasive treatment for low grade
HPV-related cervical lesions.
First Quarter 2022 Financial Highlights:
- Cash position: As of March 31, 2022, cash and
cash equivalents were $200.6 million, compared to $214.1 million as
of December 31, 2021. The decrease in cash was primarily due to
$6.6 million of net cash being used in operating activities and a
$5.6 million negative effect of exchange rates on cash and cash
equivalents.
- Research and development expenses: Research
and development expenses were $10.7 million in the first quarter of
2022 compared to $4.6 million in the comparable period of the prior
year. The increase in R&D expenses was primarily due to
increased spending on the development of VTP-200, VTP-300, VTP-850
and VTP-600 and an increase in R&D personnel-related
costs.
- General and administrative expenses: General
and administrative expenses were $3.7 million in the first quarter
of 2022 compared to $1.8 million in the comparable period of the
prior year. The first quarter of 2022 includes $4.3 million of
personnel expenses, including a share-based payment charge of $3.1
million, and a $5.3 million unrealized foreign exchange gain on
revaluation of Company’s cash balances. Net of this gain, the
increase in general and administrative expenses between the periods
was mainly attributable to higher personnel costs, reflecting an
increase in the Company’s headcount over the period, and higher
insurance costs associated with operating as a public company.
- Net Income: For the first quarter of 2022, the
Company generated a net income of $2.6 million, or $0.07 per share
on both basic and fully diluted bases, compared to a net loss of
$15.4 million, or $1.90 per share on both basic and fully diluted
bases, for the comparable period of the prior year.
About Vaccitech
Vaccitech (“the Company”) is a clinical-stage biopharmaceutical
company engaged in the discovery and development primarily of novel
immunotherapies for the treatment of chronic infectious diseases,
cancer 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 a few prophylactic viral vaccine programs. Vaccitech co-invented
a COVID-19 vaccine with the University of Oxford, now approved for
use in many territories and exclusively licensed worldwide to
AstraZeneca through Oxford University Innovation, or OUI. Vaccitech
is entitled to receive a share of all milestone and royalty income
received by OUI from AstraZeneca.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding the timing and advancement of the Company’s programs,
including the clinical trials of VTP-200, VTP-300, VTP-600, and
VTP-850, the expected benefits of the acquisition of Avidea
Technologies, the benefits of the collaboration with Arbutus
BioPharma Corporation and the Company’s cash runway. The words
“may,” “will,” “could,” “would,” “should,” “expect,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. 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: 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
Quarterly Report on Form 10-Q for the third quarter of 2021 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)
|
|
|
|
|
|
March 31,2022 |
|
December 31,2021 |
ASSETS |
|
|
|
Current
assets: |
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
|
$ |
200,596 |
|
$ |
214,054 |
|
|
Accounts
receivable |
|
|
|
18,011 |
|
|
20 |
|
|
Research and
development incentives receivable |
|
|
|
4,778 |
|
|
6,229 |
|
|
Prepaid expenses
and other current assets |
|
|
|
7,398 |
|
|
6,462 |
|
|
|
Total current assets |
|
|
|
230,783 |
|
|
226,765 |
|
Goodwill |
|
|
|
12,630 |
|
|
12,630 |
|
Property and
equipment, net |
|
|
|
4,583 |
|
|
1,829 |
|
Intangible assets,
net |
|
|
|
30,640 |
|
|
31,430 |
|
Right of use
assets, net |
|
|
|
6,699 |
|
|
7,257 |
|
Other assets |
|
|
|
788 |
|
|
804 |
|
|
|
Total assets |
|
|
$ |
286,123 |
|
$ |
280,715 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts
payable |
|
|
$ |
4,660 |
|
$ |
2,419 |
|
|
Accrued expenses
and other current liabilities |
|
|
|
11,330 |
|
|
7,875 |
|
|
Deferred
revenue |
|
|
|
162 |
|
|
182 |
|
|
Current portion of
lease liability |
|
|
|
331 |
|
|
523 |
|
|
Debt |
|
|
|
- |
|
|
159 |
|
|
|
Total current
liabilities |
|
|
|
16,483 |
|
|
11,158 |
|
Lease liability –
non current |
|
|
|
6,404 |
|
|
6,540 |
|
Contingent
consideration |
|
|
|
2,444 |
|
|
2,371 |
|
Deferred tax
liability, net |
|
|
|
7,221 |
|
|
8,084 |
|
Other non-current
liabilities |
|
|
|
434 |
|
|
- |
|
|
|
Total
liabilities |
|
|
$ |
32,986 |
|
$ |
28,153 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Shareholders’
equity: |
|
|
|
|
|
|
|
Ordinary shares,
£0.000025 nominal value; 37,193,367 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 |
|
|
|
373,087 |
|
|
369,103 |
|
|
Accumulated
deficit |
|
|
|
(105,989 |
) |
|
(108,585 |
) |
|
Accumulated other
comprehensive loss – foreign currency translation adjustments |
|
|
|
(14,456 |
) |
|
(8,488 |
) |
|
Noncontrolling
interest |
|
|
|
400 |
|
|
437 |
|
|
|
Total
shareholders’ equity |
|
|
$ |
253,137 |
|
$ |
252,562 |
|
Total liabilities
and shareholders’ equity |
$ |
286,123 |
|
$ |
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 |
|
|
|
March 31, 2022 |
|
|
March 31, 2021 |
|
License
revenue |
|
$ |
15,009 |
|
$ |
16 |
|
Service
revenue |
|
|
- |
|
|
21 |
|
Research grants
and contracts |
|
|
9 |
|
|
178 |
|
|
Total revenue |
|
|
15,018 |
|
|
215 |
|
Operating
expenses |
|
|
|
|
|
|
Research and
development |
|
|
10,701 |
|
|
4,610 |
|
|
General and
administrative |
|
|
3,663 |
|
|
1,777 |
|
|
Total operating expenses |
|
|
14,364 |
|
|
6,387 |
|
Income/(loss)
from operations |
|
|
654 |
|
|
(6,172 |
) |
Other income
(expense): |
|
|
|
|
|
|
Change in fair
value of derivatives |
|
|
- |
|
|
5,994 |
|
|
Unrealized
exchange gain on convertible loan notes |
|
|
- |
|
|
209 |
|
|
Loss on
extinguishment of convertible loan notes |
|
|
- |
|
|
(13,789 |
) |
|
Interest
income |
|
|
83 |
|
|
2 |
|
|
Interest
expense |
|
|
(74 |
) |
|
(2,650 |
) |
|
Research and
development incentives |
|
|
1,048 |
|
|
955 |
|
|
Total other income (expense) |
|
|
1,057 |
|
|
(9,279 |
) |
Tax
benefit |
|
|
863 |
|
|
65 |
|
Net
income/(loss) |
|
|
2,574 |
|
|
(15,386 |
) |
|
Net
loss attributable to noncontrolling interest |
|
|
22 |
|
|
118 |
|
Net
income/(loss) attributable to Vaccitech plc Shareholders |
|
|
2,596 |
|
|
(15,268 |
) |
|
|
|
|
|
|
Weighted-average
ordinary shares outstanding, basic |
|
|
37,191,022 |
|
|
8,057,216 |
|
Weighted-average
ordinary shares outstanding, diluted |
|
|
38,346,668 |
|
|
8,057,216 |
|
Net income/(loss)
per share attributable to ordinary shareholders, basic |
|
$ |
0.070 |
|
$ |
(1.90 |
) |
Net income/(loss)
per share attributable to ordinary shareholders, diluted |
|
$ |
0.068 |
|
$ |
(1.90 |
) |
|
|
|
|
|
|
Net
income/(loss) |
|
$ |
2,574 |
|
$ |
(15,386 |
) |
Other
comprehensive loss - foreign currency translation adjustments |
|
|
(5,983 |
) |
|
(1,416 |
) |
Comprehensive
loss |
|
|
(3,409 |
) |
|
(16,802 |
) |
Comprehensive
loss attributable to noncontrolling interest |
|
|
37 |
|
|
114 |
|
Comprehensive
loss attributable to Vaccitech Plc Shareholders |
|
$ |
(3,372 |
) |
$ |
(16,688 |
) |
Investors:Vaccitech Investor Relations
ir@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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