Vaccitech Reports Full-Year 2021 Financial Results and Recent Corporate Developments
2022年3月25日 - 8:15PM
Vaccitech plc (NASDAQ: VACC) today announced its financial results
for the full year ended December 31, 2021 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 and cancer.
“2021 was a pivotal year for Vaccitech during which we achieved
a number of strategic, operational, and financial objectives,
advanced multiple immunotherapeutic and prophylactic candidates in
clinical development and strengthened and expanded our T cell
activating discovery engine platform via the acquisition of Avidea
Technologies,” commented Bill Enright, Vaccitech’s CEO. “All of
this progress puts us in a strong position to deliver on our
long-term plans. We anticipate that 2022 will be a year where we
continue to advance our product pipeline with key data readouts in
several programs. We look forward to reporting on these
developments throughout the year.”
2021 and Recent Corporate Developments
- Raised $166.5 million of proceeds in a Series B private
financing, including $41.2 million from previously issued
convertible loan notes that converted into Series B shares.
- Completed a public listing on NASDAQ, raising gross proceeds of
$110.5 million through an offering of American Depository
Shares.
- Initiated patient dosing in HPV001, a Phase 1/2 clinical trial
of VTP-200, an immunotherapeutic candidate in development for the
treatment of persistent infection with high-risk HPV.
- Signed a clinical trial collaboration agreement with Arbutus
Biopharma Corporation to evaluate an innovative therapeutic
combination for the treatment of patients with chronic Hepatitis B
virus (HBV) infection who are already receiving standard-of-care
nucleos(t)ide reverse transcriptase inhibitor, or Nrtl, therapy.
The Phase 2a clinical trial will evaluate the safety,
pharmacokinetics, immunogenicity, and antiviral activity of
Arbutus’s RNAi therapeutic, AB-729, followed by Vaccitech’s
immunotherapy candidate, VTP-300, in Nrtl-suppressed patients with
chronic HBV infection.
- Signed a lease for 31,000 square feet within the Zeus
development at Harwell Science and Innovation Campus in
Oxfordshire, United Kingdom. The site will house Vaccitech’s
headquarters, state-of-the-art wet laboratory, and offices.
Vaccitech anticipates completing the relocation by mid-2022.
- Online publication in The Lancet Microbe results of a Phase 1
clinical trial of VTP-500, a vaccine candidate in development to
prevent Middle East Respiratory Syndrome (MERS). The study,
sponsored and conducted by researchers at The King Abdullah
International Medical Research Centre in Saudi Arabia in
partnership with Oxford University, showed that the vaccine
candidate was generally well tolerated and induced both humoral and
cellular immune responses.
- Presented at the AASLD The Liver Meeting® data from a Phase 1
(HBV001) and Groups 1 and 2 of a Phase 1/2a (HBV002) clinical trial
demonstrating that VTP-300 was tolerated and induced T cells
against targeted HBV antigens in both healthy volunteers and
patients with chronic HBV infection.
- Reported efficacy data from an interim analysis of the HBV002
clinical trial of VTP-300 in patients with chronic HBV infection.
The data from 27 patients who completed three months in the trial
demonstrated reductions in surface antigen (HbsAg) levels in
patients receiving VTP300 both alone and in combination with
nivolumab.
- Acquired Avidea Technologies, Inc. in a cash and stock
transaction that added complementary synthetic T cell boosting
technologies and expands Vaccitech’s pipeline to include
autoimmunity to its current infectious disease and oncology
therapeutic areas of focus. The transaction also furthers
Vaccitech’s scientific expertise and establishes U.S.-based
research and development capabilities.
- Cancer Research UK and the Ludwig Institute for Cancer Research
initiated patient dosing in a Phase 1/2a clinical trial to test the
safety and initial efficacy of VTP-600, an immunotherapeutic
candidate in development for the treatment of non-small cell lung
cancer. The therapeutic candidate employs Vaccitech’s viral vector
prime-boost platform to induce T cell immunity against two
cancer-associated proteins, MAGE-A3 and NY-ESO-1, found on some
tumor cells.
Upcoming Milestones
- In the second quarter of 2022, the Company expects to present
additional Phase 1/2a interim efficacy data of VTP-300 in patients
with chronic HBV infection at the International Liver Congress on
June 22 to 26, 2022, which is also expected to be followed by Phase
1/2a full efficacy clinical trial 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 and also expects to initiate dosing of a Phase 2
clinical trial of VTP-300 in patients with chronic HBV
infection.
- In the fourth quarter of 2022, the Company intends to conduct
an interim efficacy review of HPV001, a Phase 1/2a clinical trial
of VTP-200, a potential non-invasive treatment for low grade
HPV-related cervical lesions.
Full Year 2021 Financial Highlights:
- Cash position: As of December 31, 2021, cash
and cash equivalents were $214.1 million, compared to $43.3 million
as of December 31, 2020. The increase was primarily due to
completion of the Series B financing in the first quarter of 2021,
which raised gross proceeds of $125.2 million, and to the initial
public offering in the second quarter, which raised gross proceeds
of $110.5 million. The Company believes its cash and cash
equivalents are sufficient to fund operations into the second half
of 2024.
- Research and development expenses: Research
and development expenses were $20.4 million in 2021 compared to
$14.4 million in the prior year. The increase in R&D expenses
was primarily due to increased spending on the development of
VTP-200, VTP-300, and VTP-850.
- General and administrative expenses: General
and administrative expenses were $25.1 million in 2021 compared to
$10.5 million in the prior year. This includes the share-based
payment charge of $14.2 million and $6.0 million unrealized foreign
exchange gain on revaluation of Company’s cash balances recorded in
2021. 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 loss: The Company generated a net loss
attributable to its shareholders of $50.9 million, or $1.96 per
share on both basic and fully diluted bases in 2021, compared to a
net loss of $17.7 million, or $2.24 per share on both basic and
fully diluted bases, for 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
PLCCONSOLIDATED BALANCE SHEETS(IN
THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE
AMOUNTS)
|
|
|
|
|
As of December 31, 2021 |
|
As of December 31, 2020 |
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
214,054 |
|
$ |
43,266 |
|
|
Accounts
receivable |
|
|
20 |
|
|
518 |
|
|
Research and
development incentives receivable |
|
|
6,229 |
|
|
2,708 |
|
|
Prepaid expenses
and other current assets |
|
|
6,462 |
|
|
1,409 |
|
|
|
Total current assets |
|
|
226,765 |
|
|
47,901 |
|
Goodwill |
|
|
12,630 |
|
|
- |
|
Property and
equipment, net |
|
|
1,829 |
|
|
629 |
|
Intangible assets,
net |
|
|
31,430 |
|
|
- |
|
Right of use
assets, net |
|
|
7,257 |
|
|
2,136 |
|
Other assets |
|
|
804 |
|
|
- |
|
|
|
Total assets |
|
$ |
280,715 |
|
$ |
50,666 |
|
Liabilities, Redeemable Convertible Preferred Shares And
Shareholders’ Equity (Deficit) |
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts
payable |
|
$ |
2,419 |
|
$ |
4,667 |
|
|
Accrued expenses
and other current liabilities |
|
|
7,875 |
|
|
2,537 |
|
|
Deferred
revenue |
|
|
182 |
|
|
245 |
|
|
Current portion of
lease liability |
|
|
523 |
|
|
192 |
|
|
Debt |
|
|
159 |
|
|
- |
|
|
|
Total current
liabilities |
|
|
11,158 |
|
|
7,641 |
|
Convertible loan
notes – non current |
|
|
- |
|
|
44,700 |
|
Lease liability –
non current |
|
|
6,540 |
|
|
1,472 |
|
Contingent
consideration |
|
|
2,371 |
|
|
- |
|
Deferred tax
liability, net |
|
|
8,084 |
|
|
- |
|
|
|
Total
liabilities |
|
|
28,153 |
|
|
53,813 |
|
Commitments and
contingencies |
|
|
|
|
|
Series A
redeemable convertible preferred shares; £0.10 nominal value; no
shares issued and outstanding; (December 31,2020: issued and
outstanding: 22,065) |
|
|
- |
|
|
33,765 |
|
Series B
redeemable convertible preferred shares (Series B shares); £0.10
nominal value; no shares issued and outstanding; (December 31,
2020: issued and outstanding: no shares issued or outstanding) |
|
|
- |
|
|
- |
|
Shareholders’
equity (deficit): |
|
|
|
|
|
|
Ordinary shares,
£0.000025 nominal value; 37,188,730 shares authorized, issued and
outstanding (December 31, 2020: authorized, issued and outstanding:
7,960,458) |
|
|
1 |
|
|
01 |
|
|
Deferred A shares,
£1 nominal value; 63,443 shares authorized, issued and outstanding
(December 31, 2020: no shares issued or outstanding) |
|
|
86 |
|
|
- |
|
|
Deferred B shares,
£0.01 nominal value; 570,987 shares authorized, issued and
outstanding (December 31, 2020: no shares issued or
outstanding) |
|
|
8 |
|
|
- |
|
|
Deferred C shares,
£0.000007 nominal value, 27,828,231 shares authorized, issued and
outstanding (December 31, 2020: authorized, issued and outstanding:
7,960,458) |
|
|
01 |
|
|
01 |
|
|
Additional paid-in
capital |
|
|
369,103 |
|
|
21,660 |
|
|
Accumulated
deficit |
|
|
(108,585 |
) |
|
(57,720 |
) |
|
Accumulated other
comprehensive loss – foreign currency translation adjustments |
|
|
(8,488 |
) |
|
(1,243 |
) |
|
Noncontrolling
interest |
|
|
437 |
|
|
391 |
|
|
|
Total
shareholders’ equity/(deficit) |
|
|
252,562 |
|
|
(36,912 |
) |
Total liabilities,
redeemable convertible preferred shares and shareholders’
equity |
|
$ |
280,715 |
|
$ |
50,666 |
|
1 Indicates amount less than thousand
VACCITECH
PLCCONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS(IN
THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE
AMOUNTS)
|
|
|
Year ended December 31, 2021 |
|
Year ended December 31, 2020 |
License
revenue |
|
$ |
63 |
|
$ |
2,553 |
|
Service
revenue |
|
|
21 |
|
|
405 |
|
Research grants
and contracts |
|
|
184 |
|
|
1,863 |
|
|
Total revenue |
|
|
268 |
|
|
4,821 |
|
Operating
expenses |
|
|
|
|
|
|
Research and development |
|
|
20,371 |
|
|
14,387 |
|
|
General and
administrative |
|
|
25,118 |
|
|
10,480 |
|
|
Total operating expenses |
|
|
45,489 |
|
|
24,867 |
|
Loss from
operations |
|
|
(45,221 |
) |
|
(20,046 |
) |
Other income
(expense): |
|
|
|
|
|
|
Change in fair value of
derivatives |
|
|
5,994 |
|
|
2,039 |
|
|
Unrealized foreign exchange
gain on convertible loan notes |
|
|
209 |
|
|
448 |
|
|
Loss on extinguishment of
convertible loan notes |
|
|
(13,789 |
) |
|
- |
|
|
Interest expense |
|
|
(2,668 |
) |
|
(3,600 |
) |
|
Interest income |
|
|
2 |
|
|
01 |
|
|
Research and development
incentives |
|
|
4,001 |
|
|
3,279 |
|
|
Other income, net |
|
|
332 |
|
|
42 |
|
|
Total other (expense) income |
|
|
(5,919 |
) |
|
2,208 |
|
Tax benefit
(expense) |
|
|
28 |
|
|
(95 |
) |
Net loss |
|
|
(51,112 |
) |
|
(17,933 |
) |
Net loss
attributable to noncontrolling interest |
|
|
247 |
|
|
227 |
|
Net loss
attributable to Vaccitech shareholders |
|
$ |
(50,865 |
) |
$ |
(17,706 |
) |
|
|
|
|
|
|
Weighted-average
ordinary shares outstanding, basic and diluted |
|
|
25,894,375 |
|
|
7,904,529 |
|
Net loss per share
attributable to ordinary shareholders, basic and diluted |
|
$ |
(1.96 |
) |
$ |
(2.24 |
) |
|
|
|
|
|
|
Net loss |
|
$ |
(51,112 |
) |
$ |
(17,933 |
) |
Other
comprehensive loss – foreign currency translation adjustments |
|
|
(7,248 |
) |
|
(776 |
) |
Comprehensive
loss |
|
|
(58,360 |
) |
|
(18,709 |
) |
Comprehensive loss
attributable to noncontrolling interest |
|
|
250 |
|
|
227 |
|
Comprehensive loss
attributable to Vaccitech shareholders |
|
$ |
(58,110 |
) |
$ |
(18,482 |
) |
Investors:Vaccitech Investor
Relationsir@vaccitech.co.uk
Vaccitech Media Contacts:
Katja Stout, Scius Communications (EU)Direct: +44 (0)
7789435990Email: katja@sciuscommunications.com
Robert Flamm, Ph.D. (US) / Katie Larch (US)Email:
rflamm@burnsmc.com / klarch@burnsmc.com
Karim Saleh, VaccitechEmail: karim.saleh@vaccitech.co.uk
Vaccitech (NASDAQ:VACC)
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Vaccitech (NASDAQ:VACC)
過去 株価チャート
から 6 2023 まで 6 2024