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 second quarter of 2023.
“A key highlight was reporting our positive
preliminary Phase 2 data on HB-200 in combination with
pembrolizumab for advanced head and neck cancer. We continue to
collect evidence that our novel arenaviral technology may help
address unmet needs in cancer, with greater objective response
rates than the current standard of care and clear trends towards
duration of clinical benefit,” said Joern Aldag, Chief Executive
Officer at HOOKIPA Pharma. “We’re pleased investors also
acknowledged the strength of our data with the $50 million capital
raise. We’re now focused on preparing for the randomized trial of
HB-200 in combination with pembrolizumab to start in the first half
of 2024, as well as continuing to advance our clinical programs and
diverse pipeline overall.”
Quarter highlights
Oncology
- In May, HOOKIPA announced positive
preliminary Phase 2 data on HB-200 in combination with
pembrolizumab in patients with recurrent/metastatic Human
Papillomavirus 16-positive (HPV16+) head and neck cancers. Data
from the ongoing study (NCT04180215) showed a 43 percent objective
response rate with HB-200 in combination with pembrolizumab in
checkpoint inhibitor (CPI)-naïve patients, doubling the response
rate for pembrolizumab alone. HOOKIPA plans to share more data at a
medical conference later this year and is preparing to start a
randomized trial of HB-200 with pembrolizumab in the 1st-line
setting in 2024.
- In June, HOOKIPA presented a
trial-in-progress presentation at the 2023 American Society of
Clinical Oncology (ASCO) Annual Meeting on its ongoing Phase 1/2
study (NCT05553639) of HB-300 for the treatment of advanced
prostate cancer. HB-300 is an arenaviral immunotherapy that targets
two well-defined self-antigens of prostate cancer, prostatic acid
phosphatase (PAP) and prostate-specific antigen (PSA). The ability
to break immune tolerance and mount a strong T cell response
against these self-antigens remains an unmet need in prostate
cancer. Preclinical studies have demonstrated the ability of
HOOKIPA’s arenaviral technology to break tolerance and elicit a
strong immune response against self-antigens. Initial safety,
tolerability and immunogenicity data from the ongoing Phase 1 study
of HB-300 are expected in the first half of 2024.
- HOOKIPA’s HB-700 program, in
collaboration with Roche, is progressing to an expected
Investigational New Drug (IND) application filing in the first half
of 2024. HB-700 is a novel arenaviral immunotherapy for
KRAS-mutated cancers, including lung, pancreatic and colon
cancers.
Infectious disease
- In May, HOOKIPA announced that the
first participant had been dosed in a Gilead’s Phase 1 clinical
trial (NCT05770895) of HB-400, an investigational therapeutic
vaccine for chronic hepatitis B using HOOKIPA’s arenaviral
platform. HB-400 is one of two independent development programs in
HOOKIPA’s collaboration and license agreement with Gilead Sciences,
Inc. Gilead is solely responsible for further development and
commercialization of the hepatitis B product candidate.
- HOOKIPA’s HB-500 program, partnered
with Gilead, is progressing towards an anticipated IND filing in
the second half of 2023 and is expected to commence a Phase 1
clinical trial in 2024. HB-500 is a novel arenaviral vaccine that
will be assessed as part of a potential functional curative regimen
for HIV.
Corporate
- In June, HOOKIPA completed a $50
million public offering of common stock and non-voting convertible
preferred stock. The net proceeds will support the randomized study
of HB-200 in combination with pembrolizumab, as well as other
clinical programs.
- In August, the board of directors
approved an exchange offer to eligible employees, excluding
executive officers, members of the board of directors and members
of HOOKIPA’s scientific advisory board, for certain underwater
stock options. A total of 627,632 options with an exercise price
per share greater than $6.50 will be eligible for exchange into up
to a total of 315,505 new stock options with modified terms and an
exercise price per share equal to the closing price on the grant
date of the new option, but not less than $1.00. The exchange offer
shall be made pursuant and subject to a tender offer statement,
including an offer to exchange, to be filed with the Securities and
Exchange Commission (SEC) today, which shall be the only basis for
such offer.
Upcoming Milestones
- Phase 2 HB-200 in HPV16+ head and
neck cancers
- 1st-line follow-up data in
combination with pembrolizumab: H1 2024
- 2nd+-line follow-up data in
combination with pembrolizumab: Q1 2024
- Start of 1st-line randomized study in combination with
pembrolizumab: H1 2024 (Fast Track designation)
- Phase 1 HB-300 in prostate cancer
- Preliminary safety and
immunogenicity data: H1 2024
- HB-700 in KRAS-mutated cancers: IND
filing H1 2024
- HB-400 in hepatitis B: to be
determined by Gilead
- HB-500 in HIV: IND filing 2023
Second Quarter 2023 Financial
ResultsCash Position: HOOKIPA’s cash,
cash equivalents and restricted cash as of June 30, 2023
was $136.0 million compared to $113.4 million as of
December 31, 2022. The increase was primarily
attributable to funds resulting from the follow-on financing in
June 2023, partly offset by cash used in operating activities.
Revenue: Revenue was
$2.7 million for the three months ended
June 30, 2023 and for the three months ended
June 30, 2022. A decrease of cost reimbursements received
under the Restated Gilead Collaboration Agreement, was largely
offset by higher partial recognition of the upfront and milestone
payments under the Gilead collaboration and Roche
collaboration.
Research and Development
Expenses: HOOKIPA’s research and development expenses were
$19.7 million for the three months ended
June 30, 2023, compared to $16.1 million for the
three months ended June 30, 2022. The primary drivers of
the increase in research and development expenses by
$3.6 million compared to the three months ended
June 30, 2022 were higher clinical study expenses for our
HB-200 and HB-300 programs as well as increased spending for our
Gilead and Roche partnered programs.
General and Administrative
Expenses: General and administrative expenses amounted to
$4.4 million for the three months ended
June 30, 2023, compared to $5.0 million for the
three months ended June 30, 2022. The decrease was
primarily due to a decrease in other expenses, and a decrease in
personnel-related expenses, partially offset by an increase in
professional and consulting fees. The decrease in personnel-related
expenses resulted from decreased stock compensation expenses,
partially offset by a growth in headcount along with increased
salaries in our general and administrative functions as well as
expenses for contractors.
Net Loss: HOOKIPA’s net loss
was $18.0 million for the three months ended
June 30, 2023, compared to a net loss of
$16.4 million for the three months ended
June 30, 2022. This increase was primarily due to an
increase 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, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue from collaboration and licensing |
|
$ |
2,679 |
|
|
$ |
2,746 |
|
|
$ |
5,855 |
|
|
$ |
4,191 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(19,706 |
) |
|
|
(16,147 |
) |
|
|
(40,637 |
) |
|
|
(32,767 |
) |
General and administrative |
|
|
(4,445 |
) |
|
|
(5,026 |
) |
|
|
(9,347 |
) |
|
|
(9,998 |
) |
Total operating expenses |
|
|
(24,151 |
) |
|
|
(21,173 |
) |
|
|
(49,984 |
) |
|
|
(42,765 |
) |
Loss from operations |
|
|
(21,472 |
) |
|
|
(18,427 |
) |
|
|
(44,129 |
) |
|
|
(38,574 |
) |
Total interest, other income
and taxes, net |
|
|
3,456 |
|
|
|
2,071 |
|
|
|
6,433 |
|
|
|
4,250 |
|
Net loss |
|
$ |
(18,016 |
) |
|
$ |
(16,356 |
) |
|
$ |
(37,696 |
) |
|
$ |
(34,324 |
) |
Net loss per share — basic and
diluted |
|
|
(0.22 |
) |
|
|
(0.23 |
) |
|
|
(0.49 |
) |
|
|
(0.58 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Balance Sheets (Unaudited)(In
thousands)
|
|
As of |
|
As of |
|
|
June 30, |
|
December 31, |
|
2023 |
2022 |
Cash, cash equivalents and
restricted cash |
|
$ |
136,009 |
|
$ |
113,444 |
Total assets |
|
|
191,110 |
|
|
170,454 |
Total liabilities |
|
|
78,780 |
|
|
67,937 |
Total stockholders’
equity |
|
|
112,330 |
|
|
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.
Important Note Regarding the Stock Option
Exchange
The description of the stock option exchange
contained in this release is provided for informational purposes
only and is neither an offer to exchange nor a solicitation of an
offer to exchange any of the Company’s securities. The offer to
exchange and the solicitation of securities eligible to be
exchanged will be made only pursuant to an offer to exchange and
other related materials which will be disseminated to eligible
persons and filed with the SEC later today pursuant to a Tender
Offer Statement on Schedule TO (the “Tender Offer Statement”).
Option holders should read those materials and the documents
referenced therein carefully when they become available because
they will contain important information, including the various
terms and conditions of the stock option exchange. The Tender Offer
Statement, including the Offer to Exchange and other related
materials, will be available to option holders, at no charge, on
the SEC’s website at www.sec.gov.
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 public health crises, the impact of
public health crises 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, 2023, which is available on the SEC’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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