- TuHURA is planning to advance a single Phase 3 trial for
IFx-2.0 personalized cancer vaccine as adjunctive therapy with
Keytruda® in first-line therapy for advanced Merkel cell carcinoma
in 2H 2024 under FDA's accelerated approval pathway
- $31 million subscribed financing
by TuHURA in connection with the merger agreement expected to
provide cash runway into late 2025
- TuHURA's first-in-class bifunctional Antibody Drug Conjugates
(ADCs) represents potential upside partnering opportunities
- Companies are to hold a joint conference call and webcast
today, Wednesday, April 3 at
8:30 AM ET
SAN
DIEGO and TAMPA,
Fla., April 3, 2024 /PRNewswire/ -- Kintara
Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara"), a biopharmaceutical
company investigating REM-001 in an NIH-sponsored and funded open
label study in cutaneous metastatic breast cancer, and TuHURA
Biosciences, Inc. ("TuHURA"), a Phase 3 registration-stage
immune-oncology company developing novel technologies to overcome
resistance to cancer immunotherapy, today announced that they have
entered into a definitive agreement for an all-stock transaction
forming a company with expertise and resources to advance a risk
diversified late-stage oncology pipeline. The combined company will
focus on advancing TuHURA's personalized cancer vaccine(s) and
first-in-class bi-functional ADCS, two technologies that seek to
overcome the major obstacles that limit the effectiveness of
current immunotherapies in treating cancer. The combined company is
expected to operate under the name "TuHURA Biosciences, Inc." and
to trade on The Nasdaq Capital Market ("Nasdaq") under the ticker
"HURA". The transaction is expected to close in the third quarter
of 2024.
Robert E. Hoffman, Kintara's
President and Chief Executive Officer, commented, "Following a
thorough review and evaluation of opportunities to rebuild value
for Kintara shareholders, we believe merging with TuHURA, a Phase 3
immuno-oncology company focused in two compelling areas of
research, represents the best path forward for our stockholders and
has the potential to deliver near and long-term value. Our board
believes that the combined company will be well-positioned to
develop powerful new therapies with the potential to overcome
resistance to current immunotherapies, an area of significant unmet
need."
TuHURA's technologies are being developed to overcome primary
and acquired resistance-- two major obstacles to cancer
immunotherapy's ability to treat and cure cancer.
- Immune Fx (IFx) Personalized Cancer Vaccines Harnessing
the Power of the Innate Immune Response: TuHURA's IFx
technology utilizes a proprietary plasmid DNA ("pDNA") or messenger
RNA ("mRNA") which, when introduced into a tumor cell, results in
the expression of a highly immunogenic bacterial protein (emm55) on
the surface of the tumor cell. TuHURA's lead program, IFx-2.0, is
designed to harness the power of the patient's innate immune
response, which has evolved over time to detect foreign pathogens
like bacterial proteins. By making the surface of a tumor look like
a bacterium, IFx-2.0 is designed to use the tumor itself as the
source of foreign tumor neoantigens to prime and initiate an innate
immune response against the tumor, thereby restoring the cancer
immunity cycle and allowing checkpoint inhibitors like Keytruda® to
work where they previously failed to work.
- IFx-2.0 expects to be entering a Phase 3 trial as
adjunctive therapy with the checkpoint inhibitor Keytruda®, to
improve tumor response rate when compared to Keytruda® alone in the
first line treatment of patients with advanced or metastatic Merkel
cell carcinoma. This single, placebo-controlled registration
directed trial is expected to be conducted under the FDA's
Accelerated Approval Pathway and is expected to begin enrollment in
2H-2024. The FDA instituted its Accelerated Approval Program to
allow for earlier approval of drugs that treat serious conditions
and fill an unmet medical need based on a surrogate endpoint like
Overall Response Rate.
- Bi-Functional Antibody Drug Conjugates ("ADCs"): Targeting
Myeloid Derived Suppressor Cells ("MDSCs") to Modulate Their
Immunosuppressive Effects on the Tumor Microenvironment:
Leveraging its proprietary Delta receptor technology, TuHURA is
developing first-in-class bi-functional ADCs that target MDSCs,
which are cells that are responsible for creating an immunologic
sanctuary for the tumor through their immunosuppressing effects on
the tumor microenvironment ("TME"). The TME is the tissue
surrounding a tumor, and MDSCs are cells that are characterized by
the ability to suppress both innate and adaptive immune responses
and are generally believed to be responsible for T cell exhaustion
and acquired resistance to checkpoint inhibitors and cellular
therapies. Utilizing its bi-functional ADCs to inhibit the immune
suppressing effects of MDSCs, while localizing an immune checkpoint
inhibitor or T cell activator in the TME, TuHURA believes it may be
able to prevent T cell exhaustion and acquired resistance to
checkpoint inhibitors and cellular therapies, allowing them to
continue working while potentially reducing off-tumor severe side
effects resulting from checkpoint released indiscriminate T cell
toxicity to normal tissues.
"With IFx-2.0 readying to enter a single Phase 3 registration
trial, we believe this is the optimal time for TuHURA to transition
from a private company to a public company. This proposed merger
with Kintara lets us achieve that goal while combining the
resources of the two companies. Coupled with a $31 million subscribed financing by TuHURA in
connection with the merger agreement, and which is expected to fund
the combined company's operations and development programs through
late 2025, we believe this merger will also allow our
combined company the flexibility to focus our resources and efforts
on advancing IFx-2.0 to market and our other drug candidates toward
human clinical trials," said Dr. James
Bianco, President and Chief Executive Officer of TuHURA.
"This transaction with Kintara serves as a significant next step in
our continued commitment to patients to develop novel therapies to
overcome the major obstacles that limit the effectiveness of
immunotherapies to treat and cure cancer."
About the Proposed Transaction, Management &
Organization
Under the terms of the merger agreement, subject to stockholder
approval, on a pro forma basis, post-merger Kintara equityholders
are expected to collectively own up to approximately 2.85%, or
approximately 5.45% including the shares underlying the contingent
value rights (CVR) to be received by certain of Kintara's
equityholders as described below, of the common stock of
post-merger combined company on a pro forma fully diluted basis.
TuHURA equityholders are expected to collectively own approximately
97.15%, or 94.55% assuming the distribution of the CVR shares, of
the common stock of combined company on a pro forma fully diluted
basis.
Pre-merger Kintara common stockholders, certain warrant holders
and certain preferred stockholders of record of Kintara will
receive a CVR, entitling the holder to receive shares of Kintara
common stock to be issued upon achievement of the CVR
milestone. The Kintara CVR shares will be issued and
distributed once 10 patients are enrolled and tracked in a study to
determine whether a lower dose of REM-001 elicits a treatment
effect similar to that seen in prior REM-001 studies. Once
completed, the company will seek to out-license or identify an
acquirer for the technology.
The merger agreement has been approved by the boards of
directors of both companies and is subject to stockholder approval
of both companies and other customary closing conditions. The
proposed merger is expected to close in the third quarter of
2024.
Following the merger, the combined company will be headquartered
in Tampa, Florida, and the
executive officers are expected to be James
Bianco, MD as President and Chief Executive Officer, and
Dan Dearborn, CPA as Chief Financial
Officer. The merger agreement provides that the board of directors
of the combined company will be composed of five members, with four
members initially designated by TuHURA and one member initially
designated by Kintara.
Lucid Capital Markets, LLC is acting as the exclusive financial
advisor and Lowenstein Sandler LLP is acting as legal counsel to
Kintara. H.C. Wainwright & Co. is acting as the exclusive
financial advisor and Foley & Lardner LLP is acting as legal
counsel to TuHURA.
Conference Call & Webcast Details
The companies plan to hold a joint conference call and webcast
today, April 3, 2024 at 8:30 AM ET to discuss the Merger details.
Interested participants and investors may access the conference
call and webcast via the Investors section of the Kintara website
at www.kintara.com and on TuHURA's website,
tuhurabio.com. A webcast replay will be available following
the live event and will be accessible for 90 days.
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. 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.
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 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
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 antibody drug conjugates (ADCs), targeting Myeloid
Derived Suppressor Cells (MDSCs) 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 intends to file
relevant materials with the U.S. Securities and Exchange Commission
(the "SEC"), including a registration statement on
Form S-4 that will contain a proxy statement/prospectus
of Kintara. This press release is not a substitute for the
registration statement or for any other document that Kintara may
file with the SEC in connection with the Proposed Transaction.
KINTARA URGES INVESTORS AND STOCKHOLDERS TO READ THE REGISTRATION
STATEMENT, PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT
DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS
OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY
IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION ABOUT KINTARA, TUHURA, THE PROPOSED
TRANSACTION AND RELATED MATTERS. 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 proxy statement/prospectus and other
documents filed by Kintara with the SEC, and stockholders are urged
to read the 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 will
be included in the proxy statement/prospectus relating to the
Proposed Transaction when it is filed with the SEC. These documents
can be obtained free of charge from the sources indicated
above.
Forward-Looking Statements
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
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