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 fourth quarter
and full year 2019.
“In 2019, HOOKIPA achieved its development
progress and financial goals,” commented Joern Aldag, HOOKIPA’s
Chief Executive Officer. “We dosed our first patient in HB-201, our
first immuno-oncology clinical trial in Human
Papillomavirus-positive cancers, continued enrolling our
Cytomegalovirus prophylaxis trial HB-101, progressed our
collaboration with Gilead for HBV and HIV, and executed our Series
D and IPO early in the year to fund our clinical trials beyond
proof of concept. Well prepared for an important, data-rich year
2020, we now have to assume that the coronavirus pandemic will very
likely affect how we will operate in order to fully execute our
2020 strategic plan in order to remain on track for our previously
announced clinical milestones. Focusing first on our people and
then on business continuity, we have instituted a work from home
policy for those who do not need the company infrastructure for
their work. We maintain our labs for business critical projects and
stay in close connection with manufacturers and clinical trial
sites. Our people are remarkable in doing everything under our
control to deliver in the context of this situation.”
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, continues to
enroll patients in a Phase 2 randomized, double-blinded
clinical trial in CMV-negative patients awaiting kidney
transplantation from CMV-positive donors. Based on HB-101’s
tolerability profile in the target patient population dosed to date
and to gain further insights that will inform the Phase 3 trial
design, the Company added a new cohort of CMV-positive recipients
awaiting kidney transplantation from CMV-positive or -negative
donors to the trial protocol in early 2020. HOOKIPA expects to
report safety and immunogenicity data in the first half of 2020
from approximately one-third of the total 150 patients to be
enrolled, including placebo recipients. The immunogenicity data set
will contain both CMV-specific antibody (gB) and CMV-specific CD8+
T cell responses. Preliminary efficacy data is on track 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 TheraT®-based lead oncology product
candidates, are in development for the treatment of Human
Papillomavirus serotype 16-positive (HPV16+) cancers. HOOKIPA dosed
the first patient in an open label, dose escalating Phase 1/2
clinical trial for HB-201 in December 2019, HOOKIPA’s first
clinical trial in immuno-oncology. The Company expects preliminary
results in late 2020 or early 2021. HOOKIPA’s second planned
Phase 1/2 clinical trial will assess the safety and efficacy
of the combination of HB‑201 and HB‑202 in HPV16+ cancers, with or
without an approved checkpoint inhibitor. HOOKIPA remains on track
to file the HB‑202 Initial New Drug submission with the U.S. Food
and Drug Administration in the first half 2020. The planned
HB-202/201 clinical trial 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 advancing the programs closer to
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.
Fourth Quarter and Full Year 2019
Financial Results
Cash Position: HOOKIPA’s cash,
cash equivalents and restricted cash as of December 31, 2019 was
$113.6 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.
Revenue was $3.6 million for the three
months ended December 31, 2019, and $11.9 million for the full
year ended December 31, 2019 compared to $5.1 million for the
three months ended December 31, 2018 and $7.6 million for the
full year ended December 31, 2018. 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
$11.2 million for the three months ended December 31, 2019,
and $46.3 million for the full year ended December 31, 2019
compared to $4.6 million for the three months ended December
31, 2018 and $22.0 million for the full year ended December
31, 2018.
The primary drivers of the increase for 2019
were an increase in direct research and development expenses by
$19.9 million, and an increase in personnel expenses by
$3.1 million. Direct research and development expenses
increased primarily due to the costs for conducting a Phase 2
clinical trial for the Company’s HB-101 program the preparation
costs of clinical trials for HOOKIPA’s HB-201 and HB‑202 programs,
expansion of earlier stage programs and costs in connection with
securing manufacturing capacity for production of clinical trial
material. In addition, costs related to HOOKIPA’s collaboration
with Gilead contributed to the increase in direct expenses.
General and Administrative
Expenses: General and administrative expenses were
$5.7 million for the three months ended December 31, 2019, and
$16.7 million for the full year ended December 31, 2019,
compared to $2.7 million for the three months ended December
31, 2018 and $6.8 million for the full year ended December 31,
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.
Net Loss: HOOKIPA’s net loss
was $10.2 million for the three months ended December 31, 2019
and $43.0 million for the full year ended December 31, 2019,
compared to a net loss of $1.9 million for the three months
ended December 31, 2018 and $16.2 million for the full year ended
December 31, 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.
Conference Call
The Company will host a live conference call and
webcast at 8:00 a.m. EDT to discuss its financial results and
corporate update. To access the live conference call, please dial
+1 631 510 7495 (from the US) or
+44 207 192 8000 (international) and refer to
conference ID 1769733. A live audio webcast of the event will also
be available within the Investors & Media section of HOOKIPA’s
website at https://ir.hookipapharma.com/events. An archived replay
will be accessible for 30 days following the event.
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 Virus16-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 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
annual report on Form 10-K for the full year ended December 31,
2019 which will be 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 December 31, |
|
Year ended December 31, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Revenue from collaboration and licensing |
|
$ |
3,618 |
|
|
$ |
5,080 |
|
|
$ |
11,942 |
|
|
$ |
7,629 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(11,179 |
) |
|
|
(4,615 |
) |
|
|
(46,312 |
) |
|
|
(21,965 |
) |
General and administrative |
|
|
(5,664 |
) |
|
|
(2,669 |
) |
|
|
(16,715 |
) |
|
|
(6,844 |
) |
Total operating expenses |
|
|
(16,843 |
) |
|
|
(7,284 |
) |
|
|
(63,027 |
) |
|
|
(28,809 |
) |
Loss from operations |
|
|
(13,225 |
) |
|
|
(2,204 |
) |
|
|
(51,085 |
) |
|
|
(21,180 |
) |
Total interest, other income
and taxes, net |
|
|
2,981 |
|
|
|
312 |
|
|
|
8,048 |
|
|
|
4,943 |
|
Net loss |
|
$ |
(10,244 |
) |
|
$ |
(1,892 |
) |
|
$ |
(43,037 |
) |
|
$ |
(16,237 |
) |
Net loss per share — basic and
diluted |
|
|
(0.40 |
) |
|
|
(2.05 |
) |
|
|
(2.41 |
) |
|
|
(17.76 |
) |
Weighted average common shares
outstanding — basic and diluted |
|
|
25,432,314 |
|
|
|
922,083 |
|
|
|
17,859,935 |
|
|
|
914,375 |
|
Condensed Balance Sheets (Unaudited)(In
thousands)
|
|
|
|
|
|
|
|
|
As of |
|
As of |
|
|
December 31, |
|
December 31, |
|
|
2019 |
|
2018 |
Assets |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash, cash equivalents |
|
$ |
113,151 |
|
|
$ |
48,580 |
|
Accounts receivable |
|
|
1,537 |
|
|
|
4,919 |
|
Receivable research incentives |
|
|
8,190 |
|
|
|
2,329 |
|
Prepaid expenses and other current assets |
|
|
5,139 |
|
|
|
6,483 |
|
Total current assets |
|
|
128,017 |
|
|
|
62,311 |
|
Non-current assets: |
|
|
|
|
|
|
Restricted cash |
|
|
424 |
|
|
|
— |
|
Property and equipment, net |
|
|
5,126 |
|
|
|
4,337 |
|
Operating lease right of use assets |
|
|
7,875 |
|
|
|
— |
|
Finance lease right of use assets |
|
|
1,602 |
|
|
|
— |
|
Other non-current assets |
|
|
701 |
|
|
|
1,603 |
|
Total non-current assets |
|
|
15,728 |
|
|
|
5,940 |
|
Total assets |
|
$ |
143,745 |
|
|
$ |
68,251 |
|
|
|
|
|
|
|
|
Liabilities, convertible
preferred stock and stockholders' equity (deficit) |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
944 |
|
|
$ |
3,656 |
|
Deferred revenues |
|
|
3,591 |
|
|
|
6,619 |
|
Operating lease liabilities, current |
|
|
1,814 |
|
|
|
— |
|
Accrued expenses and other current liabilities |
|
|
8,406 |
|
|
|
4,420 |
|
Total current liabilities |
|
|
14,755 |
|
|
|
14,695 |
|
Non-current liabilities |
|
|
|
|
|
|
Loans payable,
non-current |
|
|
3,495 |
|
|
|
4,392 |
|
Operating lease liabilities, non-current |
|
|
5,290 |
|
|
|
— |
|
Deferred revenues, non-current |
|
|
72 |
|
|
|
1,663 |
|
Other non-current liabilities |
|
|
2,234 |
|
|
|
3,102 |
|
Total non-current
liabilities |
|
|
11,091 |
|
|
|
9,157 |
|
Total liabilities |
|
|
25,846 |
|
|
|
23,852 |
|
Commitments and
contingencies |
|
|
— |
|
|
|
104,774 |
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
Common stock |
|
|
3 |
|
|
|
0 |
|
Class A common stock |
|
|
0 |
|
|
|
— |
|
Additional paid-in capital |
|
|
225,568 |
|
|
|
3,327 |
|
Accumulated other comprehensive loss |
|
|
(4,653 |
) |
|
|
(3,720 |
) |
Accumulated deficit |
|
|
(103,019 |
) |
|
|
(59,982 |
) |
Total stockholders’ equity
(deficit) |
|
|
117,899 |
|
|
|
(60,375 |
) |
Total liabilities, convertible
preferred stock and stockholders’ equity (deficit) |
|
$ |
143,745 |
|
|
$ |
68,251 |
|
For further information, please contact:
MediaNina Waibel Senior Director -
Communications nina.waibel@hookipapharma.com
InvestorsMatt BeckExecutive Director - Investor
Relationsmatthew.beck@hookipapharma.com
Media enquiries Ashley Tapp Instinctif Partners
hookipa@instinctif.com +44 (0)20 7457 2020
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