HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing
a new class of immunotherapies based on its proprietary arenavirus
platform, today reported financial results for the second quarter
of 2022 and Company updates.
“We continued to observe validation of our novel
arenaviral platform in the second quarter with key Phase 1 data
presented at ASCO for HB-200 in head and neck cancer and our plans
to move forward with the Phase 2 program,” said Joern Aldag, Chief
Executive Officer at HOOKIPA. “We have expanded our clinical
portfolio with the concurrent FDA acceptance of our investigational
new drug application for HB-300 in prostate cancer and our Drug
Master File. The Drug Master File is significant as it supports the
implementation of our platform approach, facilitating reduced cycle
time between preclinical studies and clinical entry of our pipeline
projects across various cancer types.”
HOOKIPA Portfolio
Highlights
- In July, HOOKIPA announced that the
US FDA accepted HOOKIPA’s Investigational New Drug Application for
HB-300 for the treatment of metastatic castration-resistant
prostate cancer. A Drug Master File was also accepted, facilitating
reduced cycle time between completion of preclinical studies and
clinical entry of HOOKIPA’s pipeline projects.
- In June, HOOKIPA announced positive
Phase 1 data and Phase 2 plans for HB-200 for the treatment of
advanced head and neck cancers at the American Society of Clinical
Oncology (ASCO) Annual Meeting. Alternating 2-vector therapy showed
superior antigen-specific T cell responses, more robust anti-tumor
activity and similar tolerability vs. single-vector therapy. The
Phase 2 trial will proceed with alternating 2-vector therapy alone
and in combination with pembrolizumab, which will help inform the
randomized Phase 2 trial planned to start in the first half of
2023.
- In June, HOOKIPA presented
preclinical data on its novel arenaviral HIV therapeutic vaccines.
The data were presented at the Keystone Symposium and highlighted
robust and high-quality immune responses following administration
of arenaviral therapeutic vaccines in a preclinical setting.
Alternating 2-vector therapy induced greater immune response than
single-vector therapy, translating to a significant reduction in
viral load.
- In April, new data were announced
at the American Association for Cancer Research (AACR) Annual
Meeting showing HOOKIPA’s arenaviral immunotherapies induced potent
T cell responses in novel combinations and against tumor
self-antigens. Preclinical data also expanded evidence on
arenaviral immunotherapy targeting self-antigens, reinforcing the
scientific approach for the HB-300 program in prostate cancer.
HOOKIPA Leadership Updates
- In May, HOOKIPA announced the
promotion of Christine D. Baker to Chief Operating Officer. Baker
was previously Chief Business Officer for HOOKIPA.
- In June, HOOKIPA announced several
executive leadership changes. Igor Matushansky, Chief Medical
Officer and Global Head of Research and Development transitioned to
Chair of HOOKIPA’s Scientific Advisory Board. Katia Schlienger,
Senior Vice President and Head of Immuno-oncology was promoted to
Executive Vice President, Clinical Development. Roman Necina, Chief
Technology Officer, was appointed to the newly created role of
Chief Development Officer.
Upcoming Anticipated Milestones
- Phase 2 HB-200 data in combination
with pembrolizumab in HPV16+ head and neck cancer:
- First-line initial data expected in
the second half of 2022
- Second-line initial data expected
in the second half of 2022
- Randomized Phase 2 HB-200 study in
combination with pembrolizumab in first-line for HPV16+ HNSCC:
First half of 2023 (Fast Track designation)
- Hepatitis B therapeutic IND: 2022
(Gilead-led)
- Prostate cancer First Patient
Enrolled expected in first quarter of 2023
Second Quarter 2022 Financial
Results
Cash Position: HOOKIPA’s cash,
cash equivalents and restricted cash as of June 30, 2022
was $118.9 million compared to $66.9 million as of
December 31, 2021. The increase was primarily
attributable to funds resulting from the amended and restated
Gilead collaboration agreement and the follow-on financing in
March 2022, partly offset by cash used in operating
activities.
Revenue was $2.7 million for the three
months ended June 30, 2022, compared to $5.4 million
for the three months ended June 30, 2021. The decrease
was primarily due to lower cost reimbursements received under the
Collaboration Agreement with Gilead. The $4.0 million
milestone payment and the $15.0 million initiation fee received in
the three months ended March 31, 2022 largely remained
recorded as deferred revenue to be recognized in future accounting
periods.
Research and Development
Expenses: HOOKIPA’s research and development expenses were
$16.1 million for the three months ended
June 30, 2022, compared to $19.6 million for the
three months ended June 30, 2021. The decrease for the
three months ended June 30, 2022 compared to the three
months ended June 30, 2021 was primarily driven by lower
manufacturing expenses for our HB-200 and Gilead partnered
programs, a decrease in personnel-related expenses including
stock-based compensation, and a decrease in laboratory consumables
that was partially offset by an increase in professional and
consulting fees and an increase in training and recruitment
expenses.
General and Administrative
Expenses: General and administrative expenses for the
three months ended June 30, 2022 were $5.0 million,
compared to $5.1 million for the three months ended
June 30, 2021. The decrease was primarily due to a
decrease in personnel-related expenses and a decrease in other
expenses that was partially offset by an increase in professional
and consulting fees. The decrease in personnel-related expenses
resulted from decreased stock compensation expenses and the
conversion of a portion of the base salaries of the Company’s
executive team for the six months ended June 30, 2022
into common stock with a fair value below the conversion rate, that
was partially offset by a growth in headcount along with increased
salaries in our general and administrative functions.
Net Loss: HOOKIPA’s net loss
was $16.4 million for the three months ended
June 30, 2022 compared to a net loss of
$17.2 million for the three months ended
June 30, 2021. This decrease was primarily due to a
decrease in research and development expenses.
HOOKIPA Pharma Inc.Consolidated
Statements of Operations (Unaudited)(In thousands,
except share and per share data)
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenue from collaboration and licensing |
|
$ |
2,746 |
|
|
$ |
5,378 |
|
|
$ |
4,191 |
|
|
$ |
10,679 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(16,147 |
) |
|
|
(19,572 |
) |
|
|
(32,767 |
) |
|
|
(39,736 |
) |
General and administrative |
|
|
(5,026 |
) |
|
|
(5,095 |
) |
|
|
(9,998 |
) |
|
|
(9,404 |
) |
Total operating expenses |
|
|
(21,173 |
) |
|
|
(24,667 |
) |
|
|
(42,765 |
) |
|
|
(49,140 |
) |
Loss from operations |
|
|
(18,427 |
) |
|
|
(19,289 |
) |
|
|
(38,574 |
) |
|
|
(38,461 |
) |
Total interest, other income
and taxes, net |
|
|
2,071 |
|
|
|
2,136 |
|
|
|
4,250 |
|
|
|
4,070 |
|
Net loss |
|
$ |
(16,356 |
) |
|
$ |
(17,153 |
) |
|
$ |
(34,324 |
) |
|
$ |
(34,391 |
) |
Net loss per share — basic and
diluted |
|
|
(0.23 |
) |
|
|
(0.52 |
) |
|
|
(0.58 |
) |
|
|
(1.05 |
) |
Condensed Balance Sheets (Unaudited)(In
thousands)
|
|
As of |
|
As of |
|
|
June 30, |
|
December 31, |
|
|
2022 |
|
2021 |
Cash, cash equivalents and restricted cash |
|
$ |
118,859 |
|
$ |
66,912 |
Total assets |
|
|
172,212 |
|
|
126,045 |
Total liabilities |
|
|
40,258 |
|
|
36,453 |
Total stockholders’
equity |
|
|
131,954 |
|
|
89,592 |
About HOOKIPAHOOKIPA Pharma
Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company
focused on developing novel immunotherapies, based on its
proprietary arenavirus platform, which are designed to mobilize and
amplify targeted T cells and thereby fight or prevent serious
disease. HOOKIPA’s replicating and non-replicating technologies are
engineered to induce robust and durable antigen-specific CD8+ cell
responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline
includes its wholly owned investigational arenaviral
immunotherapies targeting HPV16+ cancers, prostate cancer,
KRAS-mutated cancers (including colorectal, pancreatic and lung),
and other undisclosed programs. In addition, HOOKIPA aims to
develop functional cures for HBV and HIV in collaboration with
Gilead.
Find out more about HOOKIPA online
at www.hookipapharma.com.
For further information, please contact: |
|
|
MediaMichael SzumeraExecutive Director -
Communicationsmichael.szumera@hookipapharma.com+1 917 561 8905 |
InvestorsMatt BeckExecutive Director -
Investor Relationsmatthew.beck@hookipapharma.com +1 917 209
6886 |
Forward Looking
StatementsCertain statements set forth in this press
release constitute “forward-looking” statements within the meaning
of the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements can be identified by terms such
as “believes,” “expects,” “plans,” “potential,” “would” or similar
expressions and the negative of those terms. Such forward-looking
statements involve substantial risks and uncertainties that could
cause HOOKIPA’s research and clinical development programs, future
results, performance or achievements to differ significantly from
those expressed or implied by the forward-looking statements. Such
risks and uncertainties include, among others, the uncertainties
inherent in the drug development process, including HOOKIPA’s
programs’ early stage of development, the process of designing and
conducting preclinical and clinical trials, the regulatory approval
processes, the timing of regulatory filings, the challenges
associated with manufacturing drug products, HOOKIPA’s ability to
successfully establish, protect and defend its intellectual
property, risks relating to business
interruptions resulting from the coronavirus (COVID-19) disease
outbreak or similar public health crises, the impact of COVID-19 on
the enrollment of patients and timing of clinical results, and
other matters that could affect the sufficiency of existing cash to
fund operations. HOOKIPA undertakes no obligation to update or
revise any forward-looking statements. For a further description of
the risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as
well as risks relating to the business of the company in general,
see HOOKIPA’s quarterly report on Form 10-Q for the quarter ended
June 30, 2022, which is available on the Security and Exchange
Commission’s website at www.sec.gov and HOOKIPA’s website
at www.hookipapharma.com.
Investors and others should note that we
announce material financial information to our investors using our
investor relations website (https://ir.hookipapharma.com/), SEC
filings, press releases, public conference calls and webcasts. We
use these channels, as well as social media, to communicate with
our members and the public about our company, our services and
other issues. It is possible that the information we post on social
media could be deemed to be material information. Therefore, we
encourage investors, the media, and others interested in our
company to review the information we post on the U.S. social media
channels listed on our investor relations website.
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