Benuvia, Inc. (“Benuvia” or the “Company”), a leading drug
developer and manufacturer of active pharmaceutical ingredients
focused on cannabinoids, with a growing portfolio of drug products
and intellectual property, and Pono Capital Corp (“Pono”) (Nasdaq:
PONOU), a publicly-traded special purpose acquisition company,
announced today that they have entered into a definitive business
combination agreement that will result, subject to the satisfaction
or waiver of certain closing conditions, in Benuvia becoming a
public company. Benuvia will apply to be listed on Nasdaq.
Benuvia owns the FDA approved cannabinoid drug
SYNDROS® (dronabinol oral solution CII), and one of the largest
synthetic cannabinoid manufacturing facilities in the U.S. SYNDROS®
is FDA approved as a prescription drug for the treatment of
chemotherapy-induced nausea and vomiting in cancer patients and
loss of appetite in AIDS patients who have lost weight. Benuvia is
also pursuing a 505(b)(2) approval pathway with the FDA for three
additional indications, including its previously announced plans to
commence Phase II clinical trials in the 2H 2022 for Alzheimer’s
Disease Agitation (“Agit-AD”).
Investment Highlights
-
SYNDROS®: The
Only Dronabinol
(Tetrahydrocannabinol
(“THC”))
Oral Solution CII
Approved by the FDA – Approved for adults as a
second-line treatment of “CINV” in people whose nausea and vomiting
have not improved with usual anti-nausea medicines and for loss of
appetite in people with AIDS who have lost weight
- Large
Drug Development Opportunity for
Dronabinol Oral
Solutions – Numerous large market
indications exist with unmet needs and high efficacy rates for a
THC-based formulation
- Drug
Development Platform Expedites Timeline to Market
– Leverage SYNDROS® safety and quality profile and
3rd party clinical research and investigational resources to
expedite time to New Drug Application
-
Cannabinoid and Psychedelics Manufacturing Facility and
Portfolio of Drug Master Files
– The Company’s 83,000 square foot manufacturing
facility in Texas is permitted by the U.S. DEA to manufacture and
export Schedule I to III controlled substances, and is FDA
registered and a cGMP facility
-
Experienced Management Team: Leadership with a History of
Execution – Team of executives with a history of execution
in pharmaceuticals, business operations, and corporate
governance
Management Commentary
“With SYNDROS® as a foundation for our platform
of dronabinol oral solutions, we believe Benuvia is well positioned
to become a leading cannabinoid-based drug development company.”
Said Shannon Soqui, Executive Chairman of Benuvia. “Given the
historical efficacy studies on THC, we believe our dronabinol oral
solution (THC) is well suited to treat a broad set of indications,
from Agit-AD to Anorexia in Cancer Patients. With our research lab
and manufacturing facility, we are also able to develop and produce
pharmaceutical formulations to meet our targeted needs under one
roof.”
Dustin Shindo, Chief Executive Officer of Pono
Capital Corp, said, “Benuvia has established a strong position in
the pharmaceutical cannabinoid market with its intellectual
property and manufacturing assets. As we were evaluating potential
partners, we sought a company that is well-positioned for high
growth, that has proprietary technology or competitive advantage,
and with public company potential. With the Benuvia team, we
believe that we have found an excellent merger partner to help
drive long-term value for our stockholders. We are excited to
partner with Benuvia on this exciting journey as they become a
publicly-traded company.”
Transaction Overview
The business combination implies a pro forma
enterprise valuation for Benuvia of $440 million. The transaction
will provide approximately $115 million in estimated gross proceeds
to Benuvia; assuming no redemption by Pono shareholders.
The transaction is expected to close in the
third quarter of 2022, subject to, among other things, the approval
by Pono Capital Corp stockholders, satisfaction or waiver of the
conditions stated in the business combination agreement, and other
customary closing conditions, including a registration statement
being declared effective by the U.S. Securities and Exchange
Commission (the “SEC”) and approval by Nasdaq to list the
securities of the combined company.
Additional information about the proposed
transaction, including a copy of the business combination
agreement, investor presentation and transcript of management
commentary, will be provided in a Current Report on Form 8-K to be
filed by Pono Capital Corp with the SEC and will be available
at www.sec.gov.
Advisors
EF Hutton, division of Benchmark Investments,
LLC, is acting as the exclusive M&A advisor to Benuvia,
Inc.
O’Melveny & Myers LLP is acting as legal
advisor to Benuvia, Inc. Nelson Mullins Riley & Scarborough LLP
is acting as legal advisor to Pono Capital Corp.
About
Benuvia, Inc.
Benuvia, Inc. is a leading drug developer and
manufacturer of active pharmaceutical ingredients focused on
cannabinoids, with a growing portfolio of drug products and
intellectual property. Benuvia owns the FDA approved cannabinoid
drug SYNDROS® (dronabinol oral solution CII). SYNDROS® is FDA
approved as a prescription drug for the treatment of
chemotherapy-induced nausea and vomiting in cancer patients and
loss of appetite in AIDS patients who have lost weight. Benuvia is
pursuing 505(b)(2) fast-track approval with the FDA for
Investigational New Drugs (“INDs”) for its dronabinol oral
solution, with a focus on large opportunities that have significant
unmet needs with industry research and studies supporting targeted
efficacy endpoints. Benuvia manufactures active pharmaceutical
ingredients in its 83,000 square foot cannabinoid manufacturing
facility that is permitted by the US DEA for Schedule I to III
Controlled Substances, is FDA registered and a cGMP facility.
Benuvia has a robust portfolio of patents and patents pending and
is pursuing new intellectual properties for its drug products.
About Pono
Capital Corp
Pono Capital Corp is a blank check company
formed for the purpose of effecting a merger, share exchange, asset
acquisition, stock purchase, reorganization, or similar business
combination with one or more businesses. In August 2021, Pono
Capital Corp consummated a $115 million initial public offering
(the “IPO”) of 1.15 million units (reflecting the underwriters’
exercise of their over-allotment option in full), each unit
consisting of one of the Company’s Class A ordinary shares and
three-quarters of one warrant, each whole warrant enabling the
holder thereof to purchase one Class A ordinary share at a price of
$11.50 per share. Pono Capital Corp’s securities are quoted on
Nasdaq under the ticker symbols PONOU, PONO and PONOW.
Additional Information and
Where to Find It
Pono Capital Corp intends to file with the SEC a
registration statement on Form S-4 with a proxy statement
containing information about the proposed transaction and the
respective businesses of Benuvia and Pono Capital Corp. Pono
Capital Corp will mail a final prospectus and definitive proxy
statement and other relevant documents after the SEC completes its
review. Pono Capital Corp stockholders are urged to read the
preliminary prospectus and proxy statement and any amendments
thereto and the final prospectus and definitive proxy statement in
connection with the solicitation of proxies for the special meeting
to be held to approve the proposed transaction, because these
documents will contain important information about Pono Capital
Corp, Benuvia, and the proposed transaction. The final prospectus
and definitive proxy statement will be mailed to stockholders of
Pono Capital Corp as of a record date to be established for voting
on the proposed transaction. Stockholders of Pono Capital Corp will
also be able to obtain a free copy of the proxy statement, as well
as other filings containing information about Pono, without charge,
at the SEC’s website (www.sec.gov) or by calling 1-800-SEC-0330.
Copies of the proxy statement and Pono Capital Corp’s other filings
with the SEC can also be obtained, without charge, by directing a
request to: info@Ponospac.com. The information contained in, or
that can be accessed through, Benuvia’s website is not incorporated
by reference in, and is not part of, this press release.
No Offer or Solicitation
This press release does not constitute (i) a
solicitation of a proxy, consent, or authorization with respect to
any securities or in respect of the proposed business combination,
or (ii) an offer to sell or the solicitation of an offer to buy any
securities, or a solicitation of any vote or approval, nor shall
there be any sale of securities in any jurisdiction in which such
offer, solicitation, or sale would be unlawful prior to
registration or qualification under the securities laws of any such
jurisdiction. No offering of securities shall be made except by
means of a prospectus meeting the requirements of the U.S.
Securities Act.
Participants in the
Solicitation
Benuvia and Pono Capital Corp and their
respective directors and officers and other members of management
and employees may be deemed participants in the solicitation of
proxies in connection with the proposed business combination. Pono
Capital Corp stockholders and other interested persons may obtain,
without charge, more detailed information regarding directors and
officers of Pono Capital Corp in Pono Capital Corp’s initial public
offering prospectus, which was declared effective the SEC on August
10, 2021. Information regarding the persons who may, under SEC
rules, be deemed participants in the solicitation of proxies from
Pono Capital Corp’s stockholders in connection with the proposed
business combination will be included in the definitely proxy
statement/prospectus the Pono Capital Corp intends to file with the
SEC.
Caution Concerning Forward-Looking
Statements
Certain statements herein are “forward-looking
statements” made pursuant to the safe harbor provisions of the
United States Private Securities Litigation Reform Act of 1995.
Actual results may differ from their expectations, estimates, and
projections and, consequently, you should not rely on these
forward-looking statements as predictions of future events. In some
cases, you can identify forward-looking statements through the use
of words or phrases such as “may”, “should”, “could”, “predict”,
“potential”, “believe”, “will likely result”, “expect”, “continue”,
“will”, “anticipate”, “seek”, “estimate”, “intend”, “plan”,
“projection”, “would” and “outlook”, or the negative version of
those words or phrases or other comparable words or phrases of a
future or forward-looking nature, but the absence of such words
does not mean that a statement is not forward-looking. These
forward-looking statements are not historical facts and are based
upon estimates and assumptions that, while considered reasonable by
Pono Capital Corp and its management, and Benuvia and its
management, as the case may be, are inherently uncertain. Factors
that may cause actual results to differ materially from current
expectations include, but are not limited to: (1) the occurrence of
any event, change or other circumstances that could give rise to
the termination of negotiations and any subsequent definitive
agreements with respect to the proposed business combination; (2)
the outcome of any legal proceedings that may be instituted against
Pono Capital Corp, Benuvia, the combined company or other following
the announcement of the proposed business combination and any
definitive agreements with respect thereto; (3) the inability to
complete the proposed business combination due to the failure to
obtain approval of the stockholders of Pono Capital Corp, to obtain
financing to complete the proposed business combination or to
satisfy other conditions to closing; (4) changes to the proposed
structure of the proposed business combination that may be required
or appropriate as a result of applicable laws or regulations or as
a condition to obtaining regulatory approval of the proposed
business combination; (5) the ability to meet stock exchange
listing standards following the consummation of the proposed
business combination; (6) the risk that the proposed business
combination disrupts current plans and operations of Pono Capital
Corp or Benuvia as a result of the announcement and consummation of
the proposed business combination; (7) the ability to recognize the
anticipated benefits of the proposed business combination, which
may be affected by, among other things, competition and the ability
of the combined company to grow and manage growth profitably,
maintain relationships with customers and retain its management and
key employees; (8) costs related to the proposed business
combination; (9) changes in applicable laws or regulations and
delays in obtaining, adverse conditions contained in, or the
inability to obtain regulatory approvals required to complete the
proposed business combination; (10) Benuvia’s estimates of expenses
and profitability and underlying assumptions with respect to
stockholder redemptions and purchase price and other adjustments;
(11) Benuvia’s inability to market its existing drug and develop
new drugs for FDA approval; (12) the addressable market Benuvia
intends to target does not grow as expected; (13) increased
regulatory costs and compliance requirements in connection with
drug development; (14) Benuvia’s inability to expand and diversify
its manufacturing customer base; (15) the loss of any key
executives; (16) the loss of any relationships with key partners;
(17) the loss of any relationships with key suppliers; (18) the
inability to protect Benuvia’s patents and other intellectual
property; (19) lower than expected adoption rates for SYNDROS®;
(20) new FDA approved drugs that compete with Benuvia in targeted
indications; (21) the inability to initiate and increase engagement
with distributors; (22) fluctuations in results of Benuvia’s major
manufacturing customers; (23) Benuvia’s ability to execute its
business plans and strategy; (24) Benuvia’s ability to maintain
sufficient inventory and capacity to meet customer demand; (25)
Benuvia’s inability to deliver expected cost and manufacturing
efficiencies; (26) general economic conditions and geopolitical
uncertainty; and (27) other risks and uncertainties indicated from
time to time in other documents filed or to be filed with the SEC
by Pono Capital Corp. See “Risk Considerations” in the corporate
presentation, which will be provided in a Current Report on Form
8-K to be filed by Pono Capital Corp with the SEC and available at
www.sec.gov.
Benuvia Investor
Contact:
Erik Fordyce, Head of Investor RelationsEmail:
efordyce@benuvia.com
Pono Investor Contact:
Dustin ShindoPono Capital CorpPhone: (808) 892-6611
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