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 third quarter of 2023.
“I am pleased by the consistent and strong data
within our HB-200 program; not only is our mechanism delivering
powerful antigen-specific T cell responses, but it has also helped
our patients continue their fight against cancer with promising
objective response rate and disease control rate. With these
encouraging data, we are busy finalizing plans for the randomized
trial expected to begin next year,” said Joern Aldag, Chief
Executive Officer at HOOKIPA Pharma. “We also have significant, and
achievable, upcoming milestones across our portfolio of programs, a
testament to the potential of arenaviral platform technology to
address unmet needs in cancer and infectious diseases.”
Business Highlights and Recent
Developments
Oncology
- In October, HOOKIPA announced
positive preliminary Phase 2 data on additional patients for
HB-200 in combination with pembrolizumab, in patients with
recurrent/metastatic Human Papillomavirus 16-positive (HPV16+) head
and neck cancers, which was consistent with the preliminary data
HOOKIPA announced in May 2023. Data from the ongoing study
(NCT04180215), which was presented at the European Society for
Medical Oncology Congress 2023, showed a 42 percent objective
response rate for 19 evaluable checkpoint inhibitor (CPI)-naïve
patients treated with HB-200 in combination with pembrolizumab.
These data represent a doubling of the historical response rate (19
percent) reported for pembrolizumab alone and are consistent with
previously reported data from the Phase 2 trial. HOOKIPA is
preparing to start a randomized trial of HB-200 in combination with
pembrolizumab in the 1st-line setting for patients with
recurrent/metastatic HPV16+ head and neck cancers in mid-2024.
- Enrollment continued in the 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). 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 the five mutations that are the
primary causes of lung, pancreatic and colon cancers.
Infectious disease
- In August, The Journal of
Infectious Disease, published peer-reviewed preclinical data on
HB-400, an investigational therapeutic vaccine for chronic
hepatitis B (HBV). The data show that HB-400 (NCT05770895) induced
robust, HBV-specific T cell and antibody responses in non-human
primates and cleared detectable serum HBV antigens in a mouse model
for chronic HBV infection, with near elimination of detectable HBV
antigen positive hepatocytes in the liver. HB-400 currently being
evaluated in a Phase 1 trial and 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 HBV product
candidate.
- HOOKIPA’s HB-500 program, also
partnered with Gilead, is progressing towards an anticipated IND
filing in the fourth quarter 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.
Anticipated Milestones
- Phase 2 HB-200 in HPV16+ head and
neck cancers
- 1st-line follow-up data in
combination with pembrolizumab: H1 2024
- Start of 1st-line randomized study in combination with
pembrolizumab: mid-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 Q4
2023
Third Quarter 2023 Financial
ResultsCash Position: HOOKIPA’s cash,
cash equivalents and restricted cash as of
September 30, 2023 was $108.1 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 follow-on financing in
June 2023.
Revenue: Revenue was
$6.9 million for the three months ended
September 30, 2023 and $2.2 million for the three
months ended September 30, 2022. This increase was
primarily due to higher partial recognition of the upfront and
milestone payments under the Gilead and Roche collaborations, cost
reimbursements for activities related to the preparation of a first
human trial under the Roche collaboration, partially offset by
lower cost reimbursements received under the Restated Gilead
Collaboration Agreement.
Research and Development
Expenses: HOOKIPA’s research and development expenses were
$24.6 million for the three months ended
September 30, 2023, compared to $18.3 million for
the three months ended September 30, 2022. The primary
drivers of the increase in research and development expenses by
$6.3 million were higher clinical study expenses for our
HB-200 program and increased spending for our Roche partnered
program.
General and Administrative
Expenses: General and administrative expenses amounted to
$4.9 million for the three months ended
September 30, 2023 and the three months ended
September 30, 2022, respectively. General and
administrative expenses remained constant.
Net Loss: HOOKIPA’s net loss
was $19.1 million for the three months ended
September 30, 2023, compared to a net loss of
$18.3 million for the three months ended
September 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 September 30, |
|
Nine months ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
Revenue from collaboration and licensing |
|
$ |
6,867 |
|
|
$ |
2,230 |
|
|
$ |
12,722 |
|
|
$ |
6,421 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(24,625 |
) |
|
|
(18,286 |
) |
|
|
(65,262 |
) |
|
|
(51,053 |
) |
General and administrative |
|
|
(4,912 |
) |
|
|
(4,937 |
) |
|
|
(14,259 |
) |
|
|
(14,935 |
) |
Total operating expenses |
|
|
(29,537 |
) |
|
|
(23,223 |
) |
|
|
(79,521 |
) |
|
|
(65,988 |
) |
Loss from
operations |
|
|
(22,670 |
) |
|
|
(20,993 |
) |
|
|
(66,799 |
) |
|
|
(59,567 |
) |
Total interest,
other income and taxes, net |
|
|
3,604 |
|
|
|
2,713 |
|
|
|
10,037 |
|
|
|
6,963 |
|
Net loss |
|
$ |
(19,066 |
) |
|
$ |
(18,280 |
) |
|
$ |
(56,762 |
) |
|
$ |
(52,604 |
) |
Net loss per share
— basic and diluted |
|
|
(0.17 |
) |
|
|
(0.25 |
) |
|
|
(0.64 |
) |
|
|
(0.83 |
) |
Condensed
Balance Sheets (Unaudited)(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
As of |
|
|
|
|
September 30, |
|
|
|
December 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
Cash, cash equivalents and
restricted cash |
|
$ |
108,095 |
|
|
$ |
113,444 |
|
Total assets |
|
|
164,010 |
|
|
|
170,454 |
|
Total liabilities |
|
|
68,959 |
|
|
|
67,937 |
|
Total stockholders’
equity |
|
|
95,051 |
|
|
|
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 “anticipates”, “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, plans and timelines for the preclinical and clinical
development of its product candidates, including the therapeutic
potential, clinical benefits and safety thereof, expectations
regarding timing, success and data announcements of current ongoing
preclinical and clinical trials, the ability to initiate new
clinical programs, the risk that the results of current preclinical
studies and clinical trials may not be predictive of future results
in connection with current or future preclinical and clinical
trials, including those for HB-200, HB-300 HB-400, HB-700 and
HB500, 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 Annual Report on Form 10-K for the year ended
December 31, 2022 and most recent quarterly report on
Form 10-Q, and as well as discussions of potential risks,
uncertainties, and other important factors in HOOKIPA’s subsequent
filings with the Securities and Exchange Commission, which are
available on the SEC’s website at www.sec.gov and HOOKIPA’s
website at www.hookipapharma.com. All information in this
press release is as of the date of the release, and HOOKIPA
undertakes no duty to update this information unless required by
law.
Availability of Other Information About
HOOKIPA
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 |
Michael Kaiser, Investor Relations |
hookipa@instinctif.com |
michael.kaiser@hookipapharma.com |
+44 (0) 7457 2020 |
+1 (917) 984 7537 |
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