HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing
a new class of immunotherapeutics based on its proprietary
arenavirus platform, today announced that Gilead Sciences
(‘Gilead’) has purchased 15 million shares of HOOKIPA’s common
stock for approximately $21.25 million, at a price of $1.4167 per
share.
In addition, HOOKIPA has the right, subject to
certain terms and conditions, to sell an additional approximately
$8.75 million of common stock to Gilead as pro-rata participation
in potential future equity raises. The agreement with Gilead
replaces the stock purchase agreement that Hookipa entered into
with Gilead in 2022.
“We have a tremendous partnership with Gilead,
who have been incredible believers in our arenavirus platform since
our initial collaboration and license agreement began more than
five years ago,” said Joern Aldag, Chief Executive Officer at
HOOKIPA. “Together, we have made meaningful progress to find a
potential functional cure for HIV. Most recently, we received
clearance from the U.S. Food and Drug Administration of our
Investigational New Drug application for HB-500 and are excited to
begin our Phase 1 trial in the first half of next year. We are
excited to continue our relationship with Gilead, and we are
collectively optimistic about the potential of our partnership to
benefit patients.”
The transaction closed on December 20, 2023.
Following the completion of the stock purchase, Gilead’s ownership
in HOOKIPA increased to 18,759,465 shares, or approximately 19.4%
of HOOKIPA’s outstanding shares of Common Stock.
HB-500 is an alternating, 2-vector arenaviral
therapeutic vaccine that is being evaluated as part of a potential
curative regimen for HIV. One vector is based on lymphocytic
choriomeningitis virus (LCMV) as its arenaviral backbone; another
vector is based on Pichinde virus (PICV). Both encode the same HIV
antigens. The alternating 2-vector approach is designed to further
focus the immune response against the target antigen.
HB-500 is one of two separate development
programs in HOOKIPA’s collaboration and license agreement with
Gilead. HOOKIPA is responsible for advancing the HIV program
through the completion of a Phase 1b clinical trial. Gilead has the
exclusive right to assume further development of the program
thereafter.
For further details, refer to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange
Commission (the ‘SEC’) on December 21, 2023.
This press release shall not constitute an offer
to sell or a solicitation of an offer to buy these securities, nor
shall there be any sale of these securities in any state or other
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to the registration or qualification under the
securities laws of any such state or other jurisdiction. Any
offering of the shares of common stock described above under the
resale registration statement will only be by means of a
prospectus.
About HIVHIV is one of the
world’s most formidable public health challenges. It is estimated
there are more than 38 million people living with HIV worldwide.
The virus infects and kills immune cells, and without effective
ongoing treatment leaves the individual increasingly
immunocompromised over time. While effective treatments have
significantly extended the lives of people living with HIV and
reduced the transmission of the virus, there is no cure for HIV or
AIDS.
About HOOKIPAHOOKIPA Pharma
Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company
focused on developing novel immunotherapies, based on its
proprietary arenavirus platform, which are designed to mobilize and
amplify targeted T cells and thereby fight or prevent serious
disease. HOOKIPA’s replicating and non-replicating technologies are
engineered to induce robust and durable antigen-specific CD8+ T
cell responses and pathogen-neutralizing antibodies. HOOKIPA’s
pipeline includes its wholly owned investigational arenaviral
immunotherapies targeting Human Papillomavirus 16-positive cancers,
prostate cancers, and other undisclosed programs. HOOKIPA is
collaborating with Roche on an arenaviral immunotherapeutic for
KRAS-mutated cancers. In addition, HOOKIPA aims to develop
functional cures of HBV and HIV in collaboration with Gilead.
Find out more about HOOKIPA online
at www.hookipapharma.com.
Forward Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, including, without limitation,
implied and express statements by HOOKIPA regarding: the intended
use of proceeds from the investments and planned commencement of
the HB-500 Phase 1 clinical trial. Forward-looking statements can
be identified by terms such as “will,” “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 public health crises, the impact of
public health crises on the enrollment of patients and timing of
clinical results, 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. 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 period ended December 31, 2022,
quarterly report on Form 10-Q for the quarter ended
September 30, 2023 and other important factors in
HOOKIPA’s subsequent filings with the Securities and Exchange
Commission, which are available on the SEC’s website
at www.sec.gov and HOOKIPA’s website
at www.hookipapharma.com. In addition, any forward-looking
statements represent HOOKIPA’s views only as of today and should
not be relied upon as representing its views as of any subsequent
date. HOOKIPA explicitly disclaims any obligation to update any
forward-looking statements. No representations or warranties
(expressed or implied) are made about the accuracy of any such
forward-looking statements.
Availability of Other Information About
HOOKIPAInvestors 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.
For further information, please contact:
InvestorsMichael Kaiser, Investor
Relationsmichael.kaiser@hookipapharma.com + 1 (917) 984 7537
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