HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing
a new class of immunotherapeutics targeting infectious diseases and
cancers based on its proprietary arenavirus platform, today reports
its financial results and corporate update for the first quarter
ended March 31, 2020.
“The current unusually challenging times are
impacting our industry significantly. HOOKIPA continues to progress
well in areas which are under our control,” commented Joern Aldag,
HOOKIPA’s Chief Executive Officer. “The HOOKIPA team is continuing
to activate sites for our oncology candidate HB-201 and patients
are accruing. We expect to submit the combined HB-202/201 IND to
the U.S. Food and Drug Administration in the first half of 2020, as
previously forecasted. For HB-101, although enrollment of kidney
transplant patients is currently hampered by the impact of
COVID-19, we expect to report preliminary safety and immunogenicity
data in July 2020 and efficacy data by the end of 2020, roughly at
the same time we expect to report preliminary safety and efficacy
for HB-201. With approximately $105 million in cash and cash
equivalents, we believe that we are well funded beyond multiple
clinical data points across our programs. In addition, I am
particularly proud of the remarkable contribution of the HOOKIPA
team voluntarily accepting a significant reduction of their fixed
salaries and thereby extending our cash runway.”
R&D Pipeline Update and Clinical
Progress
HB-101, lead product candidate in
infectious diseases HOOKIPA’s VaxWave®-based prophylactic
Cytomegalovirus (CMV) vaccine candidate, HB‑101, is in a randomized,
double‑blinded Phase 2 clinical trial in patients
awaiting kidney transplantation who are at risk for CMV-associated
complications post-transplant. Due to the COVID-19 pandemic, nearly
all ongoing Phase 2 trial sites have suspended patient enrollment,
and it remains unclear when kidney organ transplants will resume at
any of the trial sites.
By the end
of July 2020, HOOKIPA expects to report safety data (on
approximately one-third of the total 150 patients to be enrolled)
as well as immunogenicity data (on approximately one-quarter of the
total patients to be enrolled). The immunogenicity data will focus
on CMV-neutralizing antibody responses. Analyses of cellular immune
responses, including CD8+ T cells, have been limited to date
due to the complexities of sample collection, transport, and
analysis. HOOKIPA reiterates its guidance to deliver preliminary
efficacy data by the end of 2020. Due to the COVID-19-impacted
accrual, the timing of study completion will be
delayed.
HB-201 and HB-202, programs for the
treatment of Human Papillomavirus-positive cancers
HOOKIPA’s lead oncology product candidates, HB‑201 and HB‑202, are
in development for the treatment of Human Papillomavirus‑positive
(HPV+) cancers. In December 2019, HOOKIPA initiated the Phase 1/2
clinical trial for HB-201 and expects preliminary results in late
2020 or early 2021. The open label, dose escalating Phase 1/2
clinical trial is evaluating HB-201 in HPV16+ cancers, alone and in
combination with an approved checkpoint inhibitor. HOOKIPA plans to
enroll 100 patients in total with 20 patients in each dose
escalation and expansion group, respectively. Enrollment of the
first group of patients receiving the intravenously administered
first dose level has been completed and the trial is accruing
patients at the next higher dose level.
HOOKIPA remains on track to file the HB‑202/201
Initial New Drug (IND) submission with the U.S. Food and Drug
Administration in the first half of 2020. The planned clinical
trial combining HB-202 with HB-201, also in patients with HPV16+
cancers, is an open label, dose escalation Phase 1/2 trial
with the primary endpoint to evaluate safety and tolerability. That
trial is expected to commence later in 2020.
Strategic Collaborations
Gilead Sciences Collaboration for HIV
and HBV Therapeutic Vaccines During 2019, HOOKIPA received
$6.0 million in milestone payments from Gilead for the
delivery of research vectors and for advancing the programs towards
clinical trials. Based on preclinical data generated to date,
Gilead committed to preparations to advance the HBV and HIV vectors
toward development, with the HBV development decision triggering a
milestone payment of $4.0 million, which the Company received
in early 2020. To enable the development activities and expanded
research programs, Gilead agreed to reserve manufacturing capacity
and increase reimbursement budgeted for the Company’s expanded
resources allocated to the Gilead collaboration.
OtherAt HOOKIPA’s New York City
headquarters, all employees will continue to work from home and are
fully operational. The Austrian government has removed some of the
previously mandated COVID-19 restrictions that it put in place
during March 2020, and this has allowed HOOKIPA’s Austrian site to
ramp up its activities. The Company plans to increase its lab
capacity to the extent safe and reasonable, and at the same time
encourages all employees who can reasonably work from home to
continue to do so.
First Quarter 2020 Financial
Results
Cash Position:HOOKIPA’s cash,
cash equivalents and restricted cash as of March 31, 2020 was
$104.9 million compared to $113.6 million as of December 31,
2019. The decrease was primarily attributable to cash used in
operating activities.
Revenue was $3.7 million for the three months
ended March 31, 2020 compared to $2.2 million for the three months
ended March 31, 2019. Revenue was driven by the recognition of
milestone payments and partial recognition of the upfront payment
as well as cost reimbursements received under the Collaboration
Agreement with Gilead.
Research and Development
Expenses:HOOKIPA’s research and development expenses were
$11.5 million for the three months ended March 31, 2020 compared to
$10.2 million for the three months ended March 31, 2019.
The primary drivers of this increase were $1.3
million higher personnel expenses along with a general increase in
internal research and development expenses, partially offset by an
overall decrease in direct research and development expenses by
$0.6 million. The latter reduction was a consequence of reduced
activity around our earlier stage programs; in addition,
preparation costs of clinical trials for our HB-201 and HB-202
programs were lower than in the same period last year. This
decrease was partially offset by an increase in the direct costs
related to our collaboration with Gilead due to an acceleration
program and a modest increase in direct expenses for the HB-101
Phase 2 trial.
General and Administrative
Expenses: General and administrative expenses amounted to
$4.6 million for the three months ended March 31, 2020 compared to
$2.7 million for the three months ended March 31, 2019. The
increase was mainly due to personnel related expenses, an increase
in professional and consulting fees, as well as costs related to
being a public company, such as premiums for directors and officers
liability insurance.
Net Loss: HOOKIPA’s net loss
was $10.9 million for the three months ended
March 31, 2020 compared to a net loss of
$9.3 million for the three months ended
March 31, 2019. This increase was driven by higher
research and development expenses, in particular for HOOKIPA’s
oncology programs, and an increase in general and administrative
expenses following HOOKIPA’s IPO.
About
HOOKIPAHOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical
stage biopharmaceutical company developing a new class of
immunotherapeutics targeting infectious diseases and cancers based
on its proprietary arenavirus platform that is designed to
reprogram the body’s immune system.
HOOKIPA’s proprietary arenavirus-based
technologies, VaxWave®, a replication-deficient viral vector, and
TheraT®, a replication-attenuated viral vector, are designed to
induce robust antigen specific CD8+ T cells and
pathogen-neutralizing antibodies. Both technologies are designed to
allow for repeat administration to augment and refresh immune
responses. TheraT® has the potential to induce CD8+ T cell response
levels previously not achieved by other immuno-therapy approaches.
HOOKIPA’s “off-the-shelf” viral vectors target dendritic cells in
vivo to activate the immune system.
HOOKIPA’s VaxWave®-based prophylactic
Cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2
clinical trial in CMV-negative patients awaiting kidney
transplantation from living CMV-positive donors as well as
CMV-positive patients awaiting kidney transplantation from
CMV-positive or -negative donors. To expand its infectious disease
portfolio, HOOKIPA has entered into a collaboration and licensing
agreement with Gilead Sciences, Inc. to jointly research and
develop functional cures for HIV and chronic Hepatitis B
infections.
In addition, HOOKIPA is building a proprietary
immuno-oncology pipeline by targeting virally mediated cancer
antigens, self-antigens and next-generation antigens. The TheraT®
based lead oncology product candidates, HB-201 and HB-202, are in
development for the treatment of Human Papilloma Virus 16-positive
cancers. The Phase 1/2 clinical trial for HB-201 was initiated in
December 2019. The HB-202 IND submission is intended for the first
half of 2020.
Find out more about HOOKIPA online at
www.hookipapharma.com.
HOOKIPA 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 for HB-101 and other programs, and
other matters that could affect the sufficiency of existing cash to
fund operations and HOOKIPA’s ability to achieve the milestones
under the agreement with Gilead. 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, 2020 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.
HOOKIPA Pharma
Inc.Consolidated Statements of Operations
(Unaudited)(In thousands, except share and per
share data)
|
|
Three months ended March 31, |
|
|
2020 |
|
|
2019 |
|
Revenue from collaboration and licensing |
|
$ |
3,696 |
|
|
$ |
2,235 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
(11,526 |
) |
|
|
(10,179 |
) |
General and administrative |
|
|
(4,629 |
) |
|
|
(2,711 |
) |
Total operating expenses |
|
|
(16,155 |
) |
|
|
(12,890 |
) |
Loss from operations |
|
|
(12,459 |
) |
|
|
(10,655 |
) |
Total interest, other income
and taxes, net |
|
|
1,533 |
|
|
|
1,326 |
|
Net loss |
|
$ |
(10,926 |
) |
|
$ |
(9,329 |
) |
Net loss per share — basic and
diluted |
|
|
(0.43 |
) |
|
|
(9.27 |
) |
Weighted average common shares
outstanding — basic and diluted |
|
|
25,630,007 |
|
|
|
1,006,595 |
|
|
|
|
|
|
|
|
|
|
Condensed Balance Sheets
(Unaudited)(In thousands)
|
|
As of |
|
As of |
|
|
March 31, |
|
December 31, |
|
|
2020 |
|
2019 |
Cash, cash equivalents and
restricted cash |
|
$ |
104,877 |
|
$ |
113,575 |
|
Total assets |
|
|
135,967 |
|
|
143,745 |
|
Total liabilities |
|
|
26,985 |
|
|
25,846 |
|
Total stockholders’
equity |
|
|
108,982 |
|
|
117,899 |
|
|
|
|
|
|
|
|
|
For further information, please contact:
Media
Nina Waibel
Senior Director - Communications
nina.waibel@hookipapharma.com |
|
InvestorsMatt Beck Executive Director -
Investor Relationsmatthew.beck@hookipapharma.com |
|
|
|
Media enquiries Instinctif Partners
hookipa@instinctif.com +44 (0)20 7457 2020 |
|
|
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