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 third quarter ended September 30,
2019 and provides a corporate update.
“In the third quarter, HOOKIPA has made
significant progress toward achieving its corporate objectives.
Highlights include demonstrating the potential of our TheraT®
technology with the presentation of robust preclinical data at the
CICON cancer immunotherapy conference in Paris. We also welcome two
new individuals to our Executive Team who have very strong
manufacturing expertise and business development capabilities,”
commented Joern Aldag, HOOKIPA’s Chief Executive Officer. “Looking
ahead, we reaffirm our plan to initiate our first clinical program
for TheraT® in oncology before the end of 2019 and hope that the
preclinical results showcased at CICON translate into positive
results for cancer patients.”
R&D Pipeline Update and Clinical
Progress
HB-101, lead product candidate in
infectious diseases HOOKIPA’s VaxWave®-based prophylactic
Cytomegalovirus vaccine candidate, HB-101, is currently in a
Phase 2 randomized, double-blinded clinical trial in
cytomegalovirus-negative patients awaiting kidney transplantation
from Cytomegalovirus-positive donors. The majority of sites have
been activated. HOOKIPA expects safety and immunogenicity data in
the first half of 2020 from the first cohorts enrolled. Preliminary
efficacy data scheduled to follow late in the second half of
2020.
HB-201 and HB-202, programs for the
treatment of Human Papillomavirus-positive cancers HB-201
and HB-202, HOOKIPA’s lead oncology product candidates, are in
development for the treatment of Human Papillomavirus
(HPV)-positive 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
HPV-positive cancers was accepted by the U.S. Food and Drug
Administration (FDA). HOOKIPA reaffirms its plan to initiate a
Phase 1/2 clinical trial of HB-201 in patients with
treatment-refractory HPV16+ cancers before the end of the year.
This trial will be HOOKIPA’s first clinical trial in
immuno-oncology.
The HB‑202 IND filing with the FDA is planned
for the first half of 2020. 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 is expected to
commence in late 2020.
During the CICON Cancer Immunotherapy Conference
in September in Paris, HOOKIPA presented four posters highlighting
the robust preclinical data and broad therapeutic potential for
TheraT®-based immunotherapies.
Strategic Collaborations
Progress under Gilead collaboration for
therapeutic hepatitis B virus (HBV) and human immunodeficiency
virus (HIV) In May 2019, HOOKIPA achieved a $2.0 million
research milestone for HBV by designing and delivering 10
research-grade vectors to Gilead Sciences, Inc., 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.
Management Update
Christine D. Baker and Roman Necina
joined HOOKIPA’s Executive Team In September 2019, HOOKIPA
announced the hiring of Christine D. Baker as Chief Business
Officer (CBO) and Roman Necina, PhD, as Chief Technology Officer
(CTO).
Ms. Baker joined HOOKIPA from EpicentRx in
August, where she was the CBO and previously Novartis Oncology,
where she was a leader in oncology business development and
M&A. At HOOKIPA, Ms. Baker will be responsible for the
company’s business development, alliance management, and commercial
planning and is based in HOOKIPA’s New York City office. Dr. Necina
joined HOOKIPA in November from Takeda, where he was a Senior Vice
President for Technical Development and Chief Strategist. He is
based in Vienna and will be responsible for HOOKIPA’s manufacturing
operations including analytical and process development.
Third Quarter 2019 Financial
Results
HOOKIPA’s net loss for the three months ended
September 30, 2019 was $11.4 million, compared to a net loss of
$4.0 million for the three months ended September 30, 2018. This
increase was due to an increase in research and development
expenses, mainly driven by the progression of HOOKIPA’s oncology
programs, and an increase in general and administrative expenses
following HOOKIPA’s IPO.
Revenue was $2.0 million for the three months
ended September 30, 2019, compared to $1.9 million for the three
months ended September 30, 2018.
HOOKIPA’s research and development expenses for
the three months ended September 30, 2019, were $11.0 million,
compared to $6.2 million for the three months ended September 30,
2018. The primary drivers of the increase were an increase in
direct research and development expenses by $3.6 million and an
increase in personnel expenses by $0.9 million. Direct research and
development expenses increased primarily due to the expansion of
earlier stage programs and the preparation costs of clinical trials
for HOOKIPA’s HB-201 and HB‑202 programs. In addition, costs
related to HOOKIPA’s collaboration with Gilead contributed to the
increase in direct expenses.
General and administrative expenses for the
three months ended September 30, 2019 were $4.6 million, compared
to $1.3 million for the three months ended September 30, 2018. The
increase was mainly due to the growth in personnel related
expenses, 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, cash equivalents and restricted
cash as of September 30, 2019 was $124.0 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
- Jefferies 2019 London Healthcare Conference, November 20 - 21,
2019
- Piper Jaffray 31st Annual Healthcare Conference NY, December 3
- 5, 2019
About
HOOKIPA
HOOKIPA 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 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.
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 Papillomavirus-positive
cancers. The Phase 1/2 clinical trial initiation for HB-201 is
still planned in 2019. The HB-202 IND filing is intended for the
first half of 2020.
Find out more about HOOKIPA online at
www.hookipapharma.com.
*Registered in Europe; Pending in the US.
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 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 September 30, 2019 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.Condensed
Consolidated Statements of Operations
(Unaudited)(In thousands, except
share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenue from collaboration and
licensing |
|
$ |
2,038 |
|
|
$ |
1,900 |
|
|
$ |
8,324 |
|
|
$ |
2,549 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(11,025 |
) |
|
|
(6,170 |
) |
|
|
(35,133 |
) |
|
|
(17,350 |
) |
General and administrative |
|
|
(4,589 |
) |
|
|
(1,282 |
) |
|
|
(11,051 |
) |
|
|
(4,175 |
) |
Total operating expenses |
|
|
(15,614 |
) |
|
|
(7,452 |
) |
|
|
(46,184 |
) |
|
|
(21,525 |
) |
Loss from operations |
|
|
(13,576 |
) |
|
|
(5,552 |
) |
|
|
(37,860 |
) |
|
|
(18,976 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
|
1,258 |
|
|
|
1,762 |
|
|
|
3,994 |
|
|
|
5,217 |
|
Interest income |
|
|
565 |
|
|
|
— |
|
|
|
1,140 |
|
|
|
0 |
|
Interest expense |
|
|
(227 |
) |
|
|
(194 |
) |
|
|
(650 |
) |
|
|
(578 |
) |
Other income and expenses, net |
|
|
604 |
|
|
|
33 |
|
|
|
692 |
|
|
|
19 |
|
Total other income (expense), net |
|
|
2,200 |
|
|
|
1,601 |
|
|
|
5,176 |
|
|
|
4,658 |
|
Net loss before tax |
|
|
(11,376 |
) |
|
|
(3,951 |
) |
|
|
(32,684 |
) |
|
|
(14,318 |
) |
Income tax expense |
|
|
(9 |
) |
|
|
(2 |
) |
|
|
(109 |
) |
|
|
(27 |
) |
Net loss |
|
$ |
(11,385 |
) |
|
$ |
(3,953 |
) |
|
$ |
(32,793 |
) |
|
$ |
(14,345 |
) |
|
|
As of September 30, 2019 |
As of December 31, 2018 |
Cash, cash
equivalents and restricted cash |
|
$ |
124,010 |
$ |
48,580 |
|
|
Total assets |
|
|
152,037 |
|
68,251 |
|
|
Total liabilities |
|
|
26,280 |
|
23,852 |
|
|
Redeemable convertible preferred stock |
|
|
— |
|
104,774 |
|
|
Total stockholders' equity |
|
|
125,757 |
|
(60,375 |
) |
|
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 Sue Charles/ Ashley Tapp
Instinctif Partners hookipa@instinctif.com +44 (0)20 7457 2020
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