HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing
a new class of immunotherapeutics based on its proprietary
arenavirus platform, today reported financial results and business
highlights for the first quarter of 2023.
“We are happy to report continued progress
across our oncology and infectious disease portfolios, as our
HB-300 program for advanced prostate cancer and Gilead-partnered
HB-400 program for the treatment of chronic hepatitis B both
entered the clinic. Further, our HB-700 program in collaboration
with Roche achieved a success-based milestone payment associated
with manufacturing for our clinical supplies,” said Joern Aldag,
Chief Executive Officer at HOOKIPA. “We are on track to report
Phase 2 data from our lead program, HB-200 in combination with
pembrolizumab, in the second quarter of 2023, which is an exciting
step forward as we expect the results to inform our next,
potentially registrational trial.”
Quarter highlights
Oncology
- In February, HOOKIPA announced that
it had achieved a $10 million milestone payment under its
collaboration agreement with Roche to develop HB-700, a novel
arenaviral immunotherapy for KRAS-mutated cancers. The
success-based milestone payment reflects the start of the HB-700
manufacturing process to support a Phase 1 clinical trial.
- In April, HOOKIPA announced the
acceptance of a trial-in-progress presentation at the 2023 American
Society of Clinical Oncology (ASCO) Annual Meeting on its ongoing
Phase 1/2 study of HB-300 for the treatment of advanced prostate
cancer. Enrollment is ongoing and initial data are expected in the
first half of 2024.
Infectious disease
- In January, HOOKIPA received a $5
million milestone payment under its collaboration agreement with
Gilead Sciences for the completion of the regulatory support
package for Gilead’s Phase 1 clinical trial of HB-400, an
alternating, 2-vector non-replicating arenaviral therapeutic
vaccine for the treatment of chronic hepatitis B. The first
participant was dosed in April 2023. Gilead is solely responsible
for further development and commercialization of the hepatitis B
product candidate.
Corporate
- In March, HOOKIPA announced the
appointment of Terry Coelho to its Board of Directors, Audit
Committee and Compensation Committee. Terry brings more than 35
years of experience in business strategy, broad financial
transactions and business development of large pharmaceutical and
smaller biotechnology companies.
Upcoming Milestones
- Phase 2 HB-200 in HPV16+ head and
neck cancers
- 1st-line initial data in
combination with pembrolizumab: 2Q 2023
- 2nd+-line initial data in
combination with pembrolizumab: 2Q 2023
- Post-standard of care monotherapy:
additional data 2Q 2023
- Randomized Phase 2 in 1st-line with
pembrolizumab: study kick-off 2023 (Fast Track designation)
- HB-300 in prostate cancer:
preliminary safety, tolerability and immunogenicity data expected
1H 2024
- HB-700 in KRAS-mutated cancers:
submit IND 1H 2024
- HB-500 in HIV: submit IND 2023
First Quarter 2023 Financial
ResultsCash Position: HOOKIPA’s cash,
cash equivalents and restricted cash as of March 31, 2023
was $110.0 million compared to $113.4 million as of
December 31, 2022. The decrease was primarily
attributable to cash used in operating activities, partly offset by
funds resulting from the Gilead and Roche collaborations.
Revenue: Revenue was
$3.2 million for the three months ended
March 31, 2023 compared to $1.4 million for the
three months ended March 31, 2022. The increase was
primarily due to higher recognition of upfront and milestone
payments under the Gilead and Roche collaborations, partially
offset by lower cost reimbursements received under the Gilead
collaboration.
Research and Development
Expenses: HOOKIPA’s research and development expenses were
$20.9 million for the three months ended
March 31, 2023, compared to $16.6 million for the
three months ended March 31, 2022. The primary drivers of
the increase in research and development expenses by
$4.3 million compared to the three months ended
March 31, 2022 were higher clinical study expenses for
our HB-200 program and higher expenses for research and development
services for our HB-200 program, as well as increased spending for
our Gilead and Roche partnered programs, partially offset by lower
manufacturing expenses for our HB-200 and Gilead partnered
programs.
General and Administrative
Expenses: General and administrative expenses amounted to
$4.9 million for the three months ended
March 31, 2023, compared to $5.0 million for the
three months ended March 31, 2022. The decrease compared
to the three months ended March 31, 2022 was primarily
due to a decrease in professional and consulting fees and in other
expenses, partially offset by an increase in personnel-related
expenses.
Net Loss: HOOKIPA’s net loss
was $19.7 million for the three months ended
March 31, 2023, compared to a net loss of
$18.0 million for the three months ended
March 31, 2022. This increase was primarily due to an
increase in research and development expenses, partially offset by
an increase in revenues from collaboration and licensing, and an
increase in grant income, and a decrease in general and
administrative expenses.
HOOKIPA Pharma Inc. Consolidated
Statements of Operations (Unaudited)(In thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
Three months ended
March 31,(unaudited) |
|
|
2023 |
|
2022 |
Revenue from collaboration and licensing |
|
$ |
3,176 |
|
|
$ |
1,445 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
(20,931 |
) |
|
|
(16,620 |
) |
General and
administrative |
|
|
(4,902 |
) |
|
|
(4,972 |
) |
Total operating expenses |
|
|
(25,833 |
) |
|
|
(21,592 |
) |
Loss from operations |
|
|
(22,657 |
) |
|
|
(20,147 |
) |
Total interest, other income
and taxes, net |
|
|
2,977 |
|
|
|
2,179 |
|
Net loss |
|
$ |
(19,680 |
) |
|
$ |
(17,968 |
) |
Net loss per share — basic and
diluted |
|
|
(0.27 |
) |
|
|
(0.40 |
) |
Condensed Balance Sheets (Unaudited)(In
thousands)
|
|
|
|
|
|
|
|
As of |
|
As of |
|
|
March 31, |
|
December 31, |
|
|
2023 |
|
2022 |
Cash, cash equivalents and restricted cash |
|
$ |
110,021 |
|
$ |
113,444 |
Total assets |
|
|
163,088 |
|
|
170,454 |
Total liabilities |
|
|
79,609 |
|
|
67,937 |
Total stockholders’
equity |
|
|
83,479 |
|
|
102,517 |
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+ T
cell responses and pathogen-neutralizing antibodies. HOOKIPA’s
pipeline includes its wholly owned investigational arenaviral
immunotherapies targeting Human Papillomavirus 16-positive cancers,
prostate cancers, and other undisclosed programs. HOOKIPA is
collaborating with Roche on an arenaviral immunotherapeutic for
KRAS-mutated cancers. In addition, HOOKIPA aims to develop
functional cures of HBV and HIV in collaboration with Gilead.
Find out more about HOOKIPA online
at www.hookipapharma.com.
Forward Looking Statements
Certain 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
March 31, 2023, 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.
For further information, please contact:
Media |
Investors |
Instinctif Partners |
Reinhard Kandera, Chief Financial Officer |
hookipa@instinctif.com |
IR@hookipapharma.com |
+44 (0) 7457 2020 |
|
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