SAN
DIEGO, Sept. 11, 2024 /PRNewswire/ -- Kintara
Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara"), a biopharmaceutical
company focused on the development of new solid tumor cancer
therapies, today provided a corporate and REM-001 clinical study
update.
Corporate Updates
- In April 2024, Kintara and TuHURA
Biosciences, Inc. ("TuHURA") entered into definitive merger
agreement (the "Merger Agreement"), pursuant to which Kayak
Mergeco, Inc., Kintara's wholly-owned subsidiary, will merge with
and into TuHURA, with TuHURA surviving the merger and becoming
Kintara's direct, wholly-owned subsidiary (the "Merger").
- Kintara's existing stockholders will own approximately 5.45% of
combined company's common stock at the closing of the proposed
Merger on a pro forma fully diluted basis, inclusive of the
contingent value rights ("CVRs") to receive shares of common stock
of the combined company upon the achievement of enrollment of a
minimum of 10 patients in the REM-001 study with such patients each
completing 8 weeks of follow-up on or before December 31, 2025 (the "Milestone").
- Special Meeting of Stockholders (the "Special Meeting") to
obtain stockholder approval of the proposals set forth in Kintara's
proxy statement for the Special Meeting required to allow for
completion of the proposed Merger with TuHURA will be held
virtually on Friday, September 20,
2024, at 9:00 a.m., Eastern
Time via live audio webcast. In order to attend, register in
advance at www.viewproxy.com/kintarasm/2024 by 11:59 p.m., Eastern Time, on September 19, 2024. Kintara stockholders of
record on August 14, 2024 (the
"Record Date") are eligible to vote even if not a stockholder after
the Record Date.
- Stockholders immediately prior to the closing of the proposed
Merger, even if not a stockholder on the Record Date, are eligible
to receive CVRs, entitling such holders to receive shares of
common stock of the combined company upon achievement of the
Milestone.
- Vote By Phone: Please call Alliance Advisors, Kintara's proxy
solicitor, toll-free, at (866) 619-8907, if in North America. International voters can call
+1 (551) 210-9859. You can also contact Alliance Advisors if you
have any questions about voting.
- Vote By Internet: Vote at www.proxyvote.com using your control
number by following the instructions shared by your broker, bank or
other nominee.
- If you are a Robinhood holder, proxy voting emails are sent by
noreply@robinhood.com and voting is hosted by Say Technologies. You
will be able to vote and view materials directly from your
email.
REM-001 Clinical Study Update
- As of September 10, 2024, the
REM-001 study in patients with cutaneous metastatic breast cancer
(CMBC) has enrolled four of the 10 patients needed to reach the
minimum patient enrollment to assess safety and appropriate Phase 3
dose with several other patients identified as study candidates at
Kintara's clinical sites, the Memorial Sloan Kettering Cancer
Center and the Montefiore Medical Center, the University Hospital
for Albert Einstein College of
Medicine.
- Consistent with REM-001's safety profile, no treatment-related
safety issues have been identified to-date, and assessment of the
appropriate Phase 3 dose is ongoing.
- CMBC represents an unmet medical need, as there currently are
no approved or effective therapies. REM-001 may potentially offer
these patients a much needed treatment option. The majority of the
cost associated with the REM-001 study is being covered by a
$2.0 million Small Business
Innovation Research (SBIR) grant Kintara was awarded previously
from the National Institutes of Health.
Without the completion of the proposed Merger with TuHURA,
Kintara may not have adequate financial resources to continue the
REM-001 study or operate its business and may be required to seek
the protection of the bankruptcy courts. Kintara stockholders are
urged to vote their shares before the Special Meeting on
September 20, 2024.
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. is a Phase 3 registration-stage
immuno-oncology company developing novel technologies to overcome
resistance to cancer immunotherapy. TuHURA's lead product
candidate, IFx-2.0, is designed to overcome primary resistance to
checkpoint inhibitors. TuHURA is preparing to initiate a planned
single randomized placebo-controlled Phase 3 registration trial of
IFx-2.0 administered as an adjunctive therapy to Keytruda®
(pembrolizumab) in first line treatment for advanced or metastatic
Merkel Cell Carcinoma.
In addition, TuHURA is leveraging its Delta receptor technology
to develop novel bi-functional antibody drub conjugates (ADCs)
targeting Myeloid Derived Suppressor Cells to inhibit their immune
suppressing effects on the tumor microenvironment to prevent T cell
exhaustion and acquired resistance to checkpoint inhibitors and
cellular therapies.
For more information, please visit tuhurabio.com and
connect with TuHURA on Facebook, X,
and LinkedIn.
ABOUT KINTARA THERAPEUTICS, INC.
Located in San Diego,
California, Kintara is dedicated to the development of novel
cancer therapies for patients with unmet medical needs. Kintara is
developing therapeutics for clear unmet medical needs with reduced
risk development programs. Kintara's lead program is REM-001
Therapy for cutaneous metastatic breast cancer (CMBC).
Kintara has a proprietary, late-stage photodynamic therapy
platform that holds promise as a localized cutaneous, or visceral,
tumor treatment as well as in other potential indications. REM-001
Therapy, which consists of the laser light source, the light
delivery device, and the REM-001 drug product, has been previously
studied in four Phase 2/3 clinical trials in patients with CMBC who
had previously received chemotherapy and/or failed radiation
therapy. In CMBC, REM-001 has a clinical efficacy to date of 80%
complete responses of CMBC evaluable lesions and an existing robust
safety database of approximately 1,100 patients across multiple
indications.
Kintara Therapeutics, Inc. is headquartered in San Diego, California. For more information,
visit www.kintara.com or follow us on X
at @Kintara_Thera, Facebook and LinkedIn.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to buy any securities or a solicitation of
any proxy, consent, authorization, 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 Section 10 of the U.S.
Securities Act of 1933, as amended (the "Securities Act").
Additional Information About the Proposed Merger and Where to
Find It
This communication does not constitute an offer to buy or sell
or the solicitation of an offer to buy or sell any securities or a
solicitation of any vote or approval. This communication relates to
the proposed merger of Kintara and TuHURA (the "proposed Merger").
In connection with the proposed Merger, Kintara has filed relevant
materials with the SEC, including a Registration Statement on Form
S-4 that contains a definitive proxy statement and final prospectus
of Kintara (the "proxy statement/prospectus"). This Registration
Statement was declared effective on August
13, 2024 and Kintara has filed or may file other documents
regarding the proposed Merger with the SEC. This press release is
not a substitute for the Registration Statement or for any other
document that Kintara has filed or may file with the SEC in
connection with the proposed Merger. No offering of securities
shall be made, except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act. INVESTORS AND
SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, THE
DEFINITIVE PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT
DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR
SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY,
WHEN THEY BECOME AVAILABLE, BECAUSE THEY CONTAIN AND THEY WILL
CONTAIN IMPORTANT INFORMATION ABOUT KINTARA, TUHURA, THE PROPOSED
MERGER AND RELATED MATTERS THAT STOCKHOLDERS SHOULD CONSIDER BEFORE
MAKING ANY DECISION REGARDING THE PROPOSED MERGER. A definitive
proxy statement/prospectus has been sent to Kintara's stockholders.
Investors and security holders will be able to obtain the proxy
statement/prospectus and other documents filed by Kintara with the
SEC (when available) free of charge from the SEC's website at
www.sec.gov. In addition, investors and stockholders should note
that Kintara communicates with investors and the public using its
website (www.kintara.com), the investor relations website
(https://www.kintara.com/investors) where anyone will be able to
obtain free copies of the definitive proxy statement/prospectus and
other documents filed by Kintara with the SEC, and stockholders are
urged to read the definitive proxy statement/prospectus and the
other relevant materials (when they become available) before making
any voting or investment decision with respect to the proposed
Merger.
Participants in the Solicitation
Kintara, TuHURA and their respective directors and executive
officers and other members of management and employees and certain
of their respective significant stockholders may be deemed to be
participants in the solicitation of proxies from Kintara
stockholders in respect of the proposed Merger. Information about
Kintara's directors and executive officers is available in
Kintara's proxy statement, which was filed with the SEC on
May 17, 2024 for the 2024 Annual
Meeting of Stockholders, Kintara's Annual Report on Form 10-K for
the fiscal year ended June 30, 2023,
which was filed with the SEC on September
18, 2023 and the definitive proxy statement/prospectus.
Information regarding the persons who may, under the rules of the
SEC, be deemed participants in the proxy solicitation and a
description of their direct and indirect interests, by security
holding or otherwise, has been and will be contained in the
definitive proxy statement/prospectus and other relevant materials
to be filed with the SEC regarding the proposed Merger when they
become available. Investors should read the definitive proxy
statement/prospectus carefully when it becomes available before
making any voting or investment decisions. You may obtain free
copies of these documents from the SEC and Kintara as indicated
above.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements based
upon Kintara's and TuHURA's current expectations. This
communication contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are identified by terminology such as
"believe," "may," "will," "estimate," "continue," "anticipate,"
"intend," "could," "should," "would," "project," "plan," "expect,"
"goal," "seek," "future," "likely" or the negative or plural of
these words or similar expressions. Examples of such
forward-looking statements include but are not limited to express
or implied statements regarding Kintara's or TuHURA's management
team's expectations, hopes, beliefs, intentions or strategies
regarding the future including, without limitation, statements
regarding: the ability or likelihood of the Milestone being
achieved with respect to the REM-001 study, the proposed Merger and
the expected effects, perceived benefits or opportunities and
related timing with respect thereto, expectations regarding
clinical trials and research and development programs, in
particular with respect to TuHURA's IFx-Hu2.0 product candidate and
its novel bifunctional ADVCs, and any developments or results in
connection therewith; the anticipated timing of the results from
those studies and trials; expectations regarding the use of capital
resources, including the net proceeds from the financing that
closed in connection with the signing of the definitive agreement,
and the time period over which the combined company's capital
resources will be sufficient to fund its anticipated operations;
and the expected trading of the combined company's stock on the
Nasdaq Capital Market. These statements are only predictions.
Kintara and TuHURA have based these forward-looking statements
largely on their then-current expectations and projections about
future events, as well as the beliefs and assumptions of
management. Forward-looking statements are subject to a number of
risks and uncertainties, many of which involve factors or
circumstances that are beyond each of Kintara's and TuHURA's
control, and actual results could differ materially from those
stated or implied in forward-looking statements due to a number of
factors, including but not limited to: (i) the risk that the
conditions to the closing or consummation of the proposed Merger
are not satisfied, including the failure to obtain Kintara
stockholder approval for the proposed Merger; (ii) uncertainties as
to the timing of the consummation of the proposed Merger and the
ability of each of Kintara and TuHURA to consummate the
transactions contemplated by the proposed Merger; (iii) risks
related to Kintara's and TuHURA's ability to correctly estimate
their respective operating expenses and expenses associated with
the proposed Merger, as applicable, as well as uncertainties
regarding the impact any delay in the closing would have on the
anticipated cash resources of the resulting combined company upon
closing and other events and unanticipated spending and costs that
could reduce the combined company's cash resources; (iv) the
occurrence of any event, change or other circumstance or condition
that could give rise to the termination of the proposed Merger by
either Kintara or TuHURA; (v) the effect of the announcement or
pendency of the proposed Merger on Kintara's or TuHURA's business
relationships, operating results and business generally; (vi) costs
related to the proposed Merger; (vii) the outcome of any legal
proceedings that may be instituted against Kintara, TuHURA, or any
of their respective directors or officers related to the Merger
Agreement or the transactions contemplated thereby; (vii) the
ability of Kintara or TuHURA to protect their respective
intellectual property rights; (viii) competitive responses to the
proposed Merger; (ix) unexpected costs, charges or expenses
resulting from the proposed Merger; (x) whether the combined
business of TuHURA and Kintara will be successful; (xi)
legislative, regulatory, political and economic developments; (xii)
additional risks described in the "Risk Factors" section of
Kintara's Annual Report on Form 10-K for the fiscal year ended
June 30, 2023, and the Registration
Statement on Form S-4 related to the proposed Merger filed with the
SEC; and (xiii) the risk that the Milestone will not be achieved
with respect to the REM-001 study. Additional assumptions, risks
and uncertainties are described in detail in Kintara's registration
statements, reports and other filings with the SEC, which are
available on Kintara's website, and at www.sec.gov. Accordingly,
you should not rely upon forward-looking statements as predictions
of future events. Neither Kintara nor TuHURA can assure you that
the events and circumstances reflected in the forward-looking
statements will be achieved or occur, and actual results could
differ materially from those projected in the forward-looking
statements. The forward-looking statements made in this
communication relate only to events as of the date on which the
statements are made. Except as required by applicable law or
regulation, Kintara and TuHURA undertake no obligation to update
any forward-looking statement to reflect events or circumstances
after the date on which the statement is made or to reflect the
occurrence of unanticipated events. Investors should not assume
that any lack of update to a previously issued "forward-looking
statement" constitutes a reaffirmation of that statement.
INVESTOR INQUIRIES:
Robert E. Hoffman
Kintara Therapeutics
rhoffman@kintara.com
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SOURCE Kintara Therapeutics