HOOKIPA Pharma Inc. (“HOOKIPA”), a company developing a new class
of immunotherapeutics, targeting infectious diseases and cancers
based on its proprietary arenavirus platform, today reported recent
business highlights and financial results for the first quarter
ended March 31, 2019.
“HOOKIPA’s achievements since the start of 2019 have
demonstrated our ability to execute and deliver on key company
goals. We reached the first milestones of our collaborative HIV and
Hepatitis B programs with Gilead, further validating our technology
in the area of infectious diseases. Our Series D financing in
February and our initial public offering in April allowed us to
continue to expand our strong shareholder base. Also, we now have
the financial strength to achieve major milestones on our journey
to translate great science into clinical programs. We continue to
deliver on our mission to reprogram the immune system to
fight severe infectious diseases and cancer,” said Joern
Aldag, HOOKIPA’s Chief Executive Officer.
Business Highlights
- In May 2019, HOOKIPA achieved a second research milestone under
its collaboration and license agreement with Gilead for development
of a therapeutic hepatitis B virus vaccine. Based on the terms of
the agreement, HOOKIPA is entitled to a milestone payment from
Gilead. HOOKIPA previously completed a first research milestone for
HIV in its collaboration with Gilead in December 2018.
- In April 2019, HOOKIPA completed its initial public offering
(IPO), raising $84 million in gross proceeds, and commenced trading
on the Nasdaq Global Select Market under the ticker symbol
“HOOK”.
- In February, HOOKIPA completed a $37.4 million Series D
Financing, which was led by Redmile Group with participation of
additional new investors Invus and Samsara BioCapital, as well as a
number of current investors.
- Michael A. Kelly, an experienced financial and biotech
executive with more than 25 years of industry experience, and David
R. Kaufman, currently serving as Chief Medical Officer of The Bill
& Melinda Gates Medical Research Institute, were appointed to
HOOKIPA’s Board of Directors.
R&D Pipeline Update HB-101, a prophylactic vaccine
for Cytomegalovirus HB-101, HOOKIPA’s prophylactic
cytomegalovirus vaccine candidate, is currently in a Phase 2
clinical trial in patients awaiting kidney transplantation from
living cytomegalovirus-positive donors. HOOKIPA expects safety and
immunogenicity data from the first cohorts enrolled in this trial
in the first half of 2020, and preliminary efficacy data to follow
in the second half of 2020.
HB-201 and HB-202, a program for the treatment of HPV -
associated head and neck cancers HOOKIPA plans to initiate
a Phase 1/2 clinical trial for HB-201 in patients with
treatment-refractory HPV16+ cancers in the second half of 2019. In
addition, HOOKIPA also plans to combine HB-201 with a checkpoint
inhibitor 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 the second half of
2020.
First Quarter 2019 Financial Results HOOKIPA’s
net loss for the three months ended March 31, 2019 was $9.3
million. This compares to a net loss of $4.6 million, respectively,
for the same period in 2018.
Revenue was $2.2 million for the three months ended March 31,
2019, with no revenue recognized for the three months ended March
31, 2018. The increase was due to recognition of revenue under the
Collaboration Agreement with Gilead, which we entered into in June
2018.
HOOKIPA’s research and development expenses for the three months
ended March 31, 2019, were $10.2 million, compared to $5.0 million
for the three months ended March 31, 2018. The primary driver of
the increase were direct research and development expenses for the
preparation of clinical trials for our HB-201 and HB-202 programs
and the expansion of earlier stage projects. In addition, costs
related to the Company’s collaboration with Gilead, also
contributed to the increase in direct expenses.
General and administrative expenses for the three months ended
March 31, 2019 and 2018 were $2.7 million and $1.5 million,
respectively. The increase in general and administrative expenses
was primarily due to an increase in headcount in our general and
administrative functions and increase in professional and
consulting fees as well as costs associated with ongoing business
activities and our preparations to operate as a public company.
HOOKIPA’s cash and cash equivalents as of March 31, 2019 were
$70.5 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 our Series D
convertible preferred stock in February 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, for
gross proceeds of $84.0 million.
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, VaxWave® and TheraT®, 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 has completed a Phase 1 trial of a
VaxWave®-based prophylactic vaccine to protect against
cytomegalovirus infection and has started dosing patients in a
Phase 2 trial in cytomegalovirus-negative patients awaiting kidney
transplantation from 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, including, but not limited to, statements regarding (i)
clinical trials (including, without limitation, the timing of
filing of clinical trial applications and INDs, any approvals
thereof and the timing of commencement of clinical trials) and
development timelines; (ii) the number of patients that will be
evaluated, the anticipated date by which enrollment will be
completed and the data that will be generated by ongoing and
planned clinical trials; (iii) the scope and timing of ongoing and
potential future clinical trials; and (v) the sufficiency of
HOOKIPA’s cash resources. 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. HOOKIPA undertakes no obligation to update or revise
any forward-looking statements. Additional risks and uncertainties
that could affect our future results are included in the section
titled “Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” in our Prospectus
dated April 17, 2019, which is available on the SEC’s website at
www.sec.gov and our website at www.hookipapharma.com. Additional
information on potential risks will be made available in other
filings that we make from time to time with the SEC.
|
HOOKIPA
Pharma Inc. |
Condensed
Consolidated Statements of Operations (Unaudited) |
(In thousands, except share and
per share data) |
|
|
Three months ended March 31, |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
Revenue from collaboration and
licensing |
$ |
2,235 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
(10,179 |
) |
|
|
(4,969 |
) |
General and administrative |
|
(2,711 |
) |
|
|
(1,480 |
) |
|
|
|
|
|
|
|
|
Total operating expenses |
|
(12,890 |
) |
|
|
(6,449 |
) |
|
|
|
|
|
|
|
|
Loss from operations |
|
(10,655 |
) |
|
|
(6,449 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Grant income |
$ |
1,192 |
|
|
$ |
2,071 |
|
Interest income |
|
64 |
|
|
|
— |
|
Interest expense |
|
(213 |
) |
|
|
(193 |
) |
Other income and expenses, net |
|
283 |
|
|
|
22 |
|
|
|
|
|
|
|
|
|
Total other income (expense), net |
|
1,326 |
|
|
|
1,900 |
|
|
|
|
|
|
|
|
|
Net loss before tax |
|
(9,329 |
) |
|
|
(4,549 |
) |
|
|
|
|
|
|
|
|
Income tax expense |
|
(0 |
) |
|
|
(24 |
) |
|
|
|
|
|
|
|
|
Net loss |
$ |
(9,329 |
) |
|
$ |
(4,573 |
) |
|
|
|
|
|
|
|
|
Net loss per share—basic and
diluted |
$ |
(9.27 |
) |
|
$ |
(5.02 |
) |
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding — basic and diluted |
|
1,006,595 |
|
|
|
911,777 |
|
|
|
|
|
|
|
|
|
For further information, please contact:
HOOKIPA Nina Waibel Head of 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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