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 for the second quarter ended June 30, 2020
and provides a corporate update.
“In the second quarter, we released positive
interim safety and immunogenicity results from our Phase 2 trial of
HB-101 to prevent Cytomegalovirus (CMV) infections. HB-101 was
observed to be well tolerated and immunogenic in patients with
end-stage kidney disease. Antibody and T cell immunogenicity data
confirm our Phase 1 results,” commented Joern Aldag, HOOKIPA’s
Chief Executive Officer. “Furthermore, our immuno-oncology trial
using HB-201 monotherapy for patients with HPV16+ tumors is
progressing well and has recently completed enrollment at the
second dose level in the intravenous group. The HB-202
Investigational New Drug (IND) was cleared by the U.S. Food and
Drug Administration (FDA), allowing the alternating use of two
vectors (HB-202 + HB-201) in this trial. We expect to begin
treating HPV16+ patients with this new alternating, two-vector
therapy in late 2020. We plan to report further data on the HB-101
program by the end of 2020 and initial data from the HB-201
monotherapy program by late 2020/early 2021.”
R&D Pipeline Update and Clinical
Progress
HB-101, lead product candidate in
infectious diseasesHOOKIPA’s 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.
In June 2020, HOOKIPA announced positive Phase 2 interim data on
the trial’s primary endpoints: safety, and B cell and T cell
immunogenicity. The interim data demonstrated that HB‑101 was well
tolerated, with a lower rate of adverse events in patients with
end-stage kidney disease than in the Phase 1 healthy volunteer
trial. Patients who received the protocol recommended three doses
of HB‑101 showed comparable immunogenicity levels to those measured
in the Phase 1 healthy volunteer trial. HOOKIPA continues to accrue
patients, and plans to report preliminary efficacy and updated
safety and immunogenicity data by the end of 2020.
HB-201 and HB-202, lead programs in
immuno-oncology treating Human Papillomavirus-positive
cancersHOOKIPA’s lead oncology product candidates, HB‑201
and HB‑202, are in development for the treatment of Human
Papillomavirus 16‑positive (HPV16+) cancers. In December 2019,
HOOKIPA initiated the Phase 1/2 clinical trial for HB-201. 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 patients at the intravenously
administered first and second dose levels has been completed.
HOOKIPA expects to report preliminary safety and efficacy data in
late 2020 or early 2021.
In June 2020, HOOKIPA announced that the FDA
cleared its IND Application for HB-202. With the IND clearance,
HOOKIPA will be able to examine not only the safety and efficacy of
HB‑201 alone but also HB-201 in combination with HB-202 as an
alternating, two-vector therapy. 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.
In August 2020, the United States Patent and
Trademark Office (USPTO) and the European Patent Office issued
patents to the University of Geneva, licensed exclusively to
HOOKIPA, that cover HOOKIPA´s proprietary replicating arenavirus
technology (TheraT®), including HB-201 and HB-202. The USPTO also
granted a patent specifically related to HB-201 and HB-202 product
candidates.
Strategic Collaborations
Gilead Sciences Collaboration for HIV and HBV Therapeutic
VaccinesSince the start of the collaboration in 2018,
HOOKIPA received $21.0 million in upfront and milestone
payments from Gilead for the delivery of research vectors and for
advancing the programs towards clinical trials, including a
milestone payment of $4.0 million, which the Company received
in early 2020. Based on preclinical data generated to date, Gilead
committed to advancing the HBV and HIV vectors toward development.
To enable the development activities and expanded research
programs, Gilead agreed to reserve manufacturing capacity and
increase reimbursement planned for the Company’s expanded resources
allocated to the Gilead collaboration. The HOOKIPA team has
continued to meet all milestones agreed with Gilead on time despite
the pandemic.
COVID-19HOOKIPA continues to
monitor the COVID-19 situation closely and to adapt to the COVID-19
measures and recommendations issued by the US and Austrian
governments. For disclosures of risks and uncertainties
resulting from the COVID-19 disease outbreak, including the impact
on the enrollment of patients and timing of clinical results, see
HOOKIPA’s quarterly report on Form 10-Q for the quarter ended June
30, 2020.
Second Quarter 2020 Financial
Results
Cash Position:HOOKIPA’s cash,
cash equivalents and restricted cash as of June 30, 2020 was
$93.3 million compared to $113.6 million as of December 31,
2019. The decrease was primarily attributable to cash used in
operating activities.
Revenue was $6.7 million for the three months
ended June 30, 2020 compared to $4.1 million for the three months
ended June 30, 2019. The increase was primarily due to higher cost
reimbursements received under the collaboration agreement with
Gilead and the partial recognition of a milestone payment we
received from Gilead in February 2020.
Research and Development
Expenses:HOOKIPA’s research and development expenses were
$11.6 million for the three months ended June 30, 2020 compared to
$13.9 million for the three months ended June 30, 2019.
The primary drivers of the decrease compared to
2019 were a decrease in manufacturing and quality control expenses
of $2.0 million along with a general decrease in other direct
R&D expenses of $1.1 million.
General and Administrative
Expenses:General and administrative expenses amounted to
$4.3 million for the three months ended June 30, 2020 compared to
$3.8 million for the three months ended June 30, 2019. The increase
was primarily due to an increase in personnel-related expenses and
in costs associated with ongoing business activities and operating
as a public company, which was partially offset by a decrease in
professional and consulting fees which resulted from the prior-year
effect related to the closing of the Company’s initial public
offering in April 2019.
Net Loss: HOOKIPA’s net loss
was $7.1 million for the three months ended June 30, 2020
compared to a net loss of $12.1 million for the three months
ended June 30, 2019.
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 reprograms the body’s
immune system.
HOOKIPA’s proprietary arenavirus-based
technologies, non-replicating (VaxWave®) and replicating (TheraT®),
induce robust antigen-specific CD8+ T cells and
pathogen-neutralizing antibodies. HOOKIPA’s “off-the-shelf” viral
vectors target antigen presenting cells in vivo to activate the
immune system. Both technologies enable repeat administration to
augment and refresh immune responses. As a monotherapy, our
replicating arenavirus technology has the potential to induce CD8+
T cell response levels previously not achieved by other
immuno-therapy approaches.
HOOKIPA’s non-replicating prophylactic
Cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2
clinical trial for patients awaiting kidney transplantation. To
expand its infectious disease portfolio, HOOKIPA entered into a
collaboration and licensing agreement with Gilead Sciences, Inc. to
research arenavirus-based 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 lead
replicating arenavirus 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 application was
cleared by the FDA in June 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 June 30, 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 June 30, |
|
Six months ended June 30, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenue from collaboration and
licensing |
|
$ |
6,685 |
|
|
$ |
4,051 |
|
|
$ |
10,381 |
|
|
$ |
6,286 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(11,564 |
) |
|
|
(13,929 |
) |
|
|
(23,090 |
) |
|
|
(24,108 |
) |
General and administrative |
|
|
(4,347 |
) |
|
|
(3,751 |
) |
|
|
(8,976 |
) |
|
|
(6,462 |
) |
Total operating expenses |
|
|
(15,911 |
) |
|
|
(17,680 |
) |
|
|
(32,066 |
) |
|
|
(30,570 |
) |
Loss from operations |
|
|
(9,226 |
) |
|
|
(13,629 |
) |
|
|
(21,685 |
) |
|
|
(24,284 |
) |
Total interest, other income
and taxes, net |
|
|
2,134 |
|
|
|
1,550 |
|
|
|
3,667 |
|
|
|
2,876 |
|
Net loss |
|
$ |
(7,092 |
) |
|
$ |
(12,079 |
) |
|
$ |
(18,018 |
) |
|
$ |
(21,408 |
) |
Net loss per share — basic and
diluted |
|
|
(0.28 |
) |
|
|
(0.63 |
) |
|
|
(0.70 |
) |
|
|
(2.10 |
) |
Weighted average common shares
outstanding — basic and diluted |
|
|
25,647,819 |
|
|
|
19,240,977 |
|
|
|
25,638,913 |
|
|
|
10,174,157 |
|
Condensed Balance Sheets (Unaudited)(In
thousands)
|
|
As of |
|
As of |
|
|
June 30, |
|
December 31, |
|
|
2020 |
|
2019 |
Cash, cash equivalents and
restricted cash |
|
$ |
93,282 |
|
$ |
113,575 |
Total assets |
|
|
133,268 |
|
|
143,745 |
Total liabilities |
|
|
29,353 |
|
|
25,846 |
Total stockholders’
equity |
|
|
103,915 |
|
|
117,899 |
For further information, please contact:
Media |
Investors |
Nina Waibel |
Matt Beck |
Senior Director - Communications |
Executive Director - Investor Relations |
nina.waibel@hookipapharma.com |
matthew.beck@hookipapharma.com |
|
|
Media enquiries |
|
Instinctif Partners |
|
hookipa@instinctif.com |
|
+44 (0)20 7457 2020 |
|
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