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
reported recent clinical progress highlights and financial results
for the second quarter ended June 30, 2019.
“In the second quarter of 2019, HOOKIPA achieved a number of
major milestones, including clearance to initiate our first
clinical trial in immuno-oncology and acceptance by Gilead of a set
of 10 HBV viral vectors for further testing,” stated Joern Aldag,
HOOKIPA’s Chief Executive Officer. “With the FDA’s clearance of our
IND application for HB-201, we are advancing our oncology program
into clinical development, and are also aiming to demonstrate that
our technology can effectively super-charge the natural defense
mechanisms in humans and deliver prevention or cure for the benefit
of seriously ill patients.”
R&D Pipeline Update and Clinical
Progress
HB-101, a prophylactic vaccine for
cytomegalovirus HOOKIPA’s lead product candidate in
infectious diseases, HB-101, is in a Phase 2 clinical trial in
cytomegalovirus-negative patients awaiting kidney transplantation
from living cytomegalovirus-positive donors. The majority of sites
have been activated and HOOKIPA expects safety and immunogenicity
data from the first cohorts enrolled in the first half of 2020,
with preliminary efficacy data to follow in the second half of
2020.
HB-201 and HB-202, a program for the treatment of HPV
associated cancers In July 2019, HOOKIPA announced that
its Investigational New Drug (IND) Application for a Phase 1/2
clinical trial of HB-201, a TheraT®-based immunotherapy for the
treatment of Human Papilloma Virus (HPV)-positive cancers, became
effective following the clearance by the U.S. Food and Drug
Administration (FDA). HOOKIPA plans to initiate a Phase 1/2
clinical trial of HB-201 in patients with treatment-refractory
HPV16+ cancers in the second half of 2019. This will be HOOKIPA’s
first clinical trial in immuno-oncology.
In addition, HOOKIPA intends to file an IND application with the
FDA for HB‑202 in the first half of 2020, and to commence a
Phase 1/2 trial combining HB-201 and HB-202, both with and
without a checkpoint inhibitor, in patients with
treatment-refractory HPV16+ cancers in late 2020.
Strategic collaborations
Progress under Gilead collaboration for therapeutic
hepatitis B virus (HBV) and human immunodeficiency virus
(HIV) In May 2019, HOOKIPA achieved a $2m research
milestone for HBV by designing and delivering 10 research-grade
vectors to Gilead Sciences, Inc., or Gilead, along with the
characterization of these vectors and delivery of a data package
for the HBV program. These research vectors will be subject to
further pre-clinical testing in order to validate a clinical
candidate for novel combination therapies for the treatment of HBV.
This follows the delivery of 14 research-grade vectors for the HIV
program in January 2019.
Board and management
David Kaufman joined HOOKIPA’s Board of
Directors In April 2019, HOOKIPA announced the appointment
of David R. Kaufman, M.D., Ph.D., to its Board of Directors.
Dr. Kaufman currently serves as Chief Medical Officer of The Bill
& Melinda Gates Medical Research Institute. Dr. Kaufman’s
expertise as an immunologist and in oncology research and
development are expected to be a tremendous addition to help
maximize the potential of HOOKIPA’s proprietary arenavirus platform
to target infectious diseases and cancers.
Second Quarter 2019 Financial Results
HOOKIPA’s net loss for the three months ended June 30, 2019 was
$12.1 million, compared to a net loss of $5.8 million for the three
months ended June 30, 2018.
Revenue was $4.1 million for the three months ended June 30,
2019, compared to $0.6 million for the three months ended June 30,
2018. The increase was due to recognition of revenue under the
Collaboration Agreement with Gilead.
HOOKIPA’s research and development expenses for the three months
ended June 30, 2019, were $13.9 million, compared to $6.2 million
for the three months ended June 30, 2018. The primary driver of the
increase was an increase in direct research and development
expenses of $6.4 million. Direct research and development expenses
increased primarily due to the preparation costs of clinical trials
for HOOKIPA’s HB-201 and HB-202 programs and the expansion of
earlier stage programs. In addition, costs related to HOOKIPA’s
collaboration with Gilead contributed to the increase in direct
expenses. Internal research and development expenses increased by
$1.3 million, primarily as a result of increased research and
development headcount.
General and administrative expenses for the three months ended
June 30, 2019 were $3.8 million, compared to $1.4 million for the
three months ended June 30, 2018. The increase was mainly due to
the growth in headcount in HOOKIPA’s general and administrative
functions and an increase in professional and consulting fees as
well as costs associated with ongoing business activities and costs
to operate as a public company.
HOOKIPA’s cash and cash equivalents as of June 30, 2019 were
$135.2 million compared to $48.6 million as of December 31, 2018.
The increase was primarily attributable to $37.3 million in net
proceeds received from the issuance of shares of Series D
convertible preferred stock in February 2019, and $74.6 million in
net proceeds received from HOOKIPA’s initial public offering in
April 2019, offset by cash used in operating and investing
activities. On April 23, 2019, HOOKIPA completed an initial public
offering of its common stock by issuing 6.0 million shares of its
common stock, at $14.00 per share.
Upcoming Investor Events
- Wells Fargo 2019 Healthcare Conference, September 4 - 5,
2019
- BioCentury Conference NewsMakers in the Biotech Industry,
September 6, 2019
- Bank of America Merrill Lynch Global Healthcare Conference,
September 18-20, 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 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 while maintaining an immune
response. TheraT® has the potential to induce CD8+ T cell response
levels previously not achieved by other published 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 vaccine candidate is currently in a Phase 2
clinical trial in patients awaiting kidney transplantation from
living cytomegalovirus-positive 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 Hepatitis B infections.
HOOKIPA is building a proprietary immuno-oncology pipeline by
targeting virally mediated cancer antigens, self-antigens and
next-generation antigens.
TheraT® and VaxWave® are not approved anywhere
globally and their safety and efficacy have not been
established.
Find out more about HOOKIPA online at
www.hookipapharma.com.
*Registered in Europe; Pending in the US.
HOOKIPA Forward Looking
StatementsCertain 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 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, 2019 which is
available on the Security and Exchange Commission’s website at
www.sec.gov and HOOKIPA’s website at www.hookipapharma.com.
|
HOOKIPA
Pharma Inc.Condensed Consolidated Statements of
Operations (Unaudited)(In thousands, except share
and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Revenue from collaboration and licensing |
|
$ |
4,051 |
|
|
$ |
649 |
|
|
$ |
6,286 |
|
|
$ |
649 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(13,929 |
) |
|
|
(6,211 |
) |
|
|
(24,108 |
) |
|
|
(11,180 |
) |
General and administrative |
|
|
(3,751 |
) |
|
|
(1,413 |
) |
|
|
(6,462 |
) |
|
|
(2,893 |
) |
Total operating expenses |
|
|
(17,680 |
) |
|
|
(7,624 |
) |
|
|
(30,570 |
) |
|
|
(14,073 |
) |
Loss from operations |
|
|
(13,629 |
) |
|
|
(6,975 |
) |
|
|
(24,284 |
) |
|
|
(13,424 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
|
1,544 |
|
|
|
1,384 |
|
|
|
2,736 |
|
|
|
3,455 |
|
Interest income |
|
|
511 |
|
|
|
0 |
|
|
|
575 |
|
|
|
0 |
|
Interest expense |
|
|
(210 |
) |
|
|
(191 |
) |
|
|
(423 |
) |
|
|
(384 |
) |
Other income and expenses, net |
|
|
(195 |
) |
|
|
(36 |
) |
|
|
88 |
|
|
|
(14 |
) |
Total other income (expense), net |
|
|
1,650 |
|
|
|
1,157 |
|
|
|
2,976 |
|
|
|
3,057 |
|
Net loss before tax |
|
|
(11,979 |
) |
|
|
(5,818 |
) |
|
|
(21,308 |
) |
|
|
(10,367 |
) |
Income tax expense |
|
|
(100 |
) |
|
|
(1 |
) |
|
|
(100 |
) |
|
|
(25 |
) |
Net loss |
|
$ |
(12,079 |
) |
|
$ |
(5,819 |
) |
|
$ |
(21,408 |
) |
|
$ |
(10,392 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2019 |
|
As of December 31, 2018 |
Cash, cash
equivalents and restricted cash |
|
$ |
135,213 |
|
|
$ |
48,580 |
|
Total assets |
|
|
168,095 |
|
|
|
68,251 |
|
Total liabilities |
|
|
32,062 |
|
|
|
23,852 |
|
Redeemable convertible preferred stock |
|
|
- |
|
|
|
104,774 |
|
Total stockholders' equity |
|
|
136,033 |
|
|
|
(60,375) |
|
|
|
|
|
|
|
|
|
|
For further information, please contact:
HOOKIPA Nina Waibel Senior Director -
Communications Nina.Waibel@HookipaPharma.com
Media enquiries Sue Charles/ Ashley Tapp
Instinctif Partners Hookipa@Instinctif.com +44 (0)20 7457 2020
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