SAN
DIEGO, July 1, 2024 /PRNewswire/ -- Kintara
Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara"), a biopharmaceutical
company focused on the development of new solid tumor cancer
therapies, and TuHURA Biosciences, Inc. ("TuHURA"), a Phase 3
registration-stage immune-oncology company developing novel
technologies to overcome resistance to cancer immunotherapy, today
provided an overview of Kintara's and TuHURA's recent corporate and
clinical advancements and outlined upcoming expected near term
milestones.
Recent Corporate Achievements
- In April 2024, Kintara and 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").
- The Merger is expected to close in the third quarter of
2024.
- Kintara's existing stockholders will own approximately 5.5% of
combined company's common stock at the closing of the Merger,
inclusive of the contingent value right ("CVR") linked to 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.
- TuHURA to advance a single Phase 3 trial for IFx-2.0
personalized cancer vaccine as adjunctive therapy
with Keytruda® in first-line treatment for advanced
Merkel cell carcinoma in the second half of 2024 under FDA's
accelerated approval pathway.
- TuHURA's first-in-class bifunctional Antibody Drug
Conjugates (ADCs) represent potential upside partnering
opportunities.
- $31 million subscribed financing
by TuHURA in connection with the Merger Agreement expected to
provide cash runway into late 2025.
- On June 12, 2024, Kintara
received a 180-day extension until December
9, 2024 from The Nasdaq Stock Market LLC to regain
compliance with the minimum bid price requirement for continued
listing on The Nasdaq Capital Market, in accordance with Nasdaq
Listing Rule 5810(c)(3)(A).
Recent Clinical Advancements
- Advanced enrollment, dosing and clinical site expansion in
Kintara's open label 15-patient REM-001 study in cutaneous
metastatic breast cancer (CMBC).
- As of June 26, 2024, four
patients have been dosed in the open label 15-patient REM-001 study
in CMBC.
- In addition to Memorial Sloan Kettering Cancer Center,
Montefiore Medical Center, the University Hospital for Albert Einstein College of Medicine, will soon
begin screening patients.
- The majority of the costs to run this study will be covered by
the $2.0 million Small Business
Innovation Research (SBIR) grant Kintara was awarded from the
National Institutes of Health (NIH).
- In March 2024, Kintara expanded
inclusion criteria in the open label 15-patient REM-001 study
in CMBC to include patients receiving pembrolizumab
(KEYTRUDA®) for at least three months at screening. This is
expected to significantly increase the pace of enrollment.
Expected Near-term Milestones
- Q3 2024: Close Merger with TuHURA.
- Q4 2024: Complete enrollment and 8 week follow-up of 10
patients in the REM-001 study.
- 2H 2024: Commence TuHURA's Phase 3 trial for IFx-2.0
personalized cancer vaccine for advanced Merkel cell carcinoma
under FDA's accelerated approval pathway.
About Kintara
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. The Company'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.
For more information, please visit www.kintara.com or
follow us on X
at @Kintara_Thera, Facebook and LinkedIn.
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 personalized
cancer vaccine candidate, IFx-2.0, is designed to overcome primary
resistance to checkpoint inhibitors. TuHURA is preparing to
initiate a 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 to its cancer vaccine product candidates, TuHURA is
leveraging its Delta receptor technology to develop first-in-class
bi-functional 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.
No Offer or Solicitation
This communication is not intended to and shall 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 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 the U.S. Securities Act of 1933, as
amended.
Additional Information About the Proposed Transaction for
Investors and Shareholders
In connection with the proposed transaction between Kintara and
TuHURA (the "Proposed Transaction"), Kintara has filed relevant
materials with the U.S. Securities and Exchange Commission (the
"SEC"), including a registration statement on Form S-4 that
contains a preliminary proxy statement and preliminary prospectus
of Kintara (the "proxy statement/prospectus"). This registration
statement has not yet been declared effective and Kintara has filed
or may file other documents regarding the Proposed Transaction 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
Transaction. KINTARA URGES INVESTORS AND STOCKHOLDERS TO READ THE
REGISTRATION STATEMENT, THE PRELIMINARY 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 TRANSACTION AND RELATED MATTERS. A definitive proxy
statement/prospectus will be sent to Kintara's stockholders once
available. Investors and stockholders will be able to obtain free
copies of the proxy statement/prospectus and other documents filed
by Kintara with the SEC (when they become available) through the
website maintained by the SEC 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 preliminary
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 Transaction.
Participants in the Solicitation
Kintara, TuHURA and their respective directors and executive
officers may be deemed to be participants in the solicitation of
proxies from stockholders in connection with the Proposed
Transaction. Information about Kintara's directors and executive
officers including a description of their interests in Kintara is
included in Kintara's most recent Annual Report on Form 10-K,
including any information incorporated therein by reference, as
filed with the SEC. Additional information regarding these persons
and their interests in the transaction has been and will be
included in the preliminary proxy statement/prospectus and other
relevant materials filed with the SEC when they become available
relating to the Proposed Transaction. These documents can be
obtained free of charge from the sources indicated above.
Safe Harbor Statement
This news release contains forward-looking statements that are
not historical facts within the meaning of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements are based
only on our current beliefs, expectations and assumptions regarding
the future of our business, future plans and strategies,
projections, anticipated events and other future conditions. In
some cases you can identify these statements by forward-looking
words 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 Proposed Transaction 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 TME modulators
development program, 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. In addition, any statements that refer to
projections, forecasts or other characterizations of future events
or circumstances, including any underlying assumptions, are
forward-looking statements. You are cautioned that such statements
are not guarantees of future performance and that actual results or
developments may differ materially from those set forth in these
forward-looking statements. Factors that could cause actual results
to differ materially from these forward-looking statements
include: the risk that the conditions to the closing or
consummation of the Proposed Transaction are not satisfied,
including the failure to obtain stockholder approval for the
Proposed Transaction; uncertainties as to the timing of the
consummation of the Proposed Transaction and the ability of each of
Kintara and TuHURA to consummate the transactions contemplated by
the Proposed Transaction; risks related to Kintara's and TuHURA's
ability to correctly estimate their respective operating expenses
and expenses associated with the Proposed Transaction, 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; the occurrence of any event, change or
other circumstance or condition that could give rise to the
termination of the Proposed Transaction by either company; the
effect of the announcement or pendency of the Proposed Transaction
on Kintara's or TuHURA's business relationships, operating results
and business generally; costs related to the Merger; 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; the
ability of Kintara or TuHURA to protect their respective
intellectual property rights; competitive responses to the Proposed
Transaction; unexpected costs, charges or expenses resulting from
the Proposed Transaction; whether the combined business of TuHURA
and Kintara will be successful; legislative, regulatory, political
and economic developments; and 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
Transaction filed with the SEC. Additional assumptions, risks
and uncertainties are described in detail in our registration
statements, reports and other filings with the SEC, which are
available on Kintara's website, and at www.sec.gov.
You are cautioned that such statements are not guarantees of
future performance and that our actual results may differ
materially from those set forth in the forward-looking statements.
The forward-looking statements and other information contained in
this news release are made as of the date hereof and Kintara does
not undertake any obligation to update publicly or revise any
forward-looking statements or information, whether as a result of
new information, future events or otherwise, unless so required by
applicable securities laws. Nothing herein shall constitute an
offer to sell or the solicitation of an offer to buy any
securities.
Investor Contacts
Kintara Therapeutics, Inc.
Robert E. Hoffman
Kintara Therapeutics
rhoffman@kintara.com
TuHURA Biosciences, Inc.
Jenene Thomas
JTC Team, LLC
tuhura@jtcir.com
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SOURCE Kintara Therapeutics