SAN
DIEGO, Sept. 27, 2022 /PRNewswire/ -- Kintara
Therapeutics, Inc. (Nasdaq: KTRA)
("Kintara" or the "Company"), a biopharmaceutical
company focused on the development of new solid tumor cancer
therapies, today announced financial results for its fiscal year
ended June 30, 2022 and provided a
corporate update.
CORPORATE HIGHLIGHTS AND RECENT DEVELOPMENTS
- Announced that three posters were accepted for data
presentation at the 2022 Society for Neuro-Oncology ("SNO") Annual
Meeting. The 2022 SNO Annual Meeting will be held from
November 16 through November 20, 2022
in Tampa, Florida
(September).
- Received a Study May Proceed letter from the United States Food
and Drug Administration ("FDA") to begin a 15-patient study
evaluating REM-001 Photodynamic Therapy ("PDT") for the treatment
of cutaneous metastatic breast cancer ("CMBC"). This study is
intended to aid in the design of a planned Phase 3 registrational
study (August).
- Entered into a purchase agreement with Lincoln Park Capital
Fund, LLC ("Lincoln Park"), pursuant
to which Lincoln Park has committed
to purchase up to $20.0 million of
shares of the Company's common stock, subject to the satisfaction
of the conditions contained in the agreement as well certain
limitations contained therein (August).
- Received notice from the FDA that the Company was granted Fast
Track Designation for VAL-083 for the treatment of patients with
newly-diagnosed, unmethylated glioblastoma ("GBM") (June).
- Received written notification from the Listing Qualification
Department of The Nasdaq Stock Market LLC ("Nasdaq") granting the
Company's request for a 180-day extension to regain compliance with
Nasdaq's minimum bid price requirement. The Company has until
November 28, 2022 to meet the
requirement (June).
- Announced that the Company's first European site, University
Hospital Zurich in Zurich,
Switzerland, had been activated for the VAL-083 treatment
arm in the Global Coalition for Adaptive Research ("GCAR")
registrational Phase 2/3 clinical trial for GBM, titled
Glioblastoma Adaptive Global Innovative Learning Environment ("GBM
AGILE Study") (May).
"This last quarter was a very productive quarter - on the
financing side we put in place a $20.0
million equity facility with Lincoln
Park to help bolster our balance sheet. On the regulatory
front we received our second Fast Track Designation from the FDA
for VAL-083 and the GBM-AGILE Study continues to exceed our
expectations," commented Robert E.
Hoffman, Kintara's President and Chief Executive Officer.
"Moving our REM-001 CMBC program back into the clinic is also an
important step for us to deliver on our mission of serving cancer
patients where there is a clear unmet medical need. We believe we
remain on track to start enrolling patients in the CMBC study
around the end of September
2022."
SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR ENDED
JUNE 30, 2022
At June 30, 2022, Kintara had cash
and cash equivalents of approximately $11.8
million. During the year ended June
30, 2022, the Company completed two registered direct
offerings for aggregate net proceeds to the Company of
approximately $21.6 million.
For the year ended June 30, 2022,
Kintara reported a net loss of approximately $22.7 million, or $0.52 per share, compared to a net loss of
approximately $38.3 million, or
$1.60 per share, for the year ended
June 30, 2021. The decreased net loss
for the year ended June 30, 2022
compared to the year ended June 30,
2021 was largely due to the recognition of $16.1 million of non-cash expenses related to the
acquisition of in-process research and development costs associated
with the Adgero transaction in August
2020.
Selected Balance Sheet Data (in thousands)
|
|
June
30,
2022
|
|
|
June 30,
2021
|
|
|
|
$
|
|
|
$
|
|
Cash and cash
equivalents
|
|
|
11,780
|
|
|
|
10,537
|
|
Working
capital
|
|
|
9,268
|
|
|
|
9,013
|
|
Total assets
|
|
|
15,948
|
|
|
|
13,543
|
|
Total stockholders'
equity
|
|
|
11,795
|
|
|
|
10,581
|
|
Selected Statement of Operations Data (in thousands, except
per share data)
For the years ended
|
|
June
30,
|
|
|
June
30,
|
|
|
|
2022
|
|
|
2021
|
|
|
|
$
|
|
|
$
|
|
Research and
development
|
|
|
15,173
|
|
|
|
11,815
|
|
|
General and
administrative
|
|
|
7,059
|
|
|
|
9,757
|
|
|
Merger costs
|
|
|
—
|
|
|
|
500
|
|
|
In-process research and
development
|
|
|
—
|
|
|
|
16,094
|
|
|
Other (income)
loss
|
|
|
(21)
|
|
|
|
132)
|
|
|
Net loss for the
period
|
|
|
(22,661)
|
|
|
|
(38,298)
|
|
|
Deemed dividend
recognized on beneficial conversion features of Series C Preferred
stock issuance
|
|
|
—
|
|
|
|
(3,181)
|
|
|
Series A Preferred cash
dividend
|
|
|
(8)
|
|
|
|
(8)
|
|
|
Series B Preferred
stock dividend
|
|
|
—
|
|
|
|
(17)
|
|
|
Series C Preferred
stock dividend
|
|
|
(2,462)
|
|
|
|
—
|
|
|
Net loss attributable
to common stockholders
|
|
|
(25,131)
|
|
|
|
(41,504)
|
|
|
Basic and fully diluted
weighted average number of shares
|
|
|
48,702
|
|
|
|
25,886
|
|
|
Basic and fully diluted
loss per share
|
|
|
(0.52)
|
|
|
|
(1.60)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kintara's financial statements as filed with the U.S. Securities
Exchange Commission can be viewed on the Company's website at:
http://ir.kintara.com/sec-filings.
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 two late-stage, Phase 3-ready therapeutics for clear
unmet medical needs with reduced risk development programs.
The two programs are VAL-083 for GBM and REM-001 for CMBC.
VAL-083 is a "first-in-class", small-molecule
chemotherapeutic with a novel mechanism of action that has
demonstrated clinical activity against a range of cancers,
including central nervous system, ovarian and other solid tumors
(e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical
trials sponsored by the National Cancer Institute ("NCI"). Based on
Kintara's internal research programs and these
prior NCI-sponsored clinical studies, Kintara is
currently advancing VAL-083 in the GBM AGILE Study to support the
development and commercialization of VAL-083 in GBM.
Kintara is also advancing its proprietary, late-stage PDT
platform that holds promise as a localized cutaneous, or visceral,
tumor treatment as well as in other potential indications.
REM-001 therapy 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. With clinical
efficacy to date of 80% complete responses of CMBC evaluable
lesions, and with an existing robust safety database of
approximately 1,100 patients across multiple indications, Kintara
is advancing the REM-001 CMBC program to late-stage
pivotal testing.
For more information, please visit www.kintara.com or
follow us on Twitter
at @Kintara_Thera, Facebook and Linkedin.
SAFE HARBOR STATEMENT
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995, including statements regarding the status of the
Company's clinical trials and the GBM AGILE Study. Any
forward-looking statements contained herein are based on current
expectations but are subject to a number of risks and
uncertainties. The factors that could cause actual future
results to differ materially from current expectations include, but
are not limited to, risks and uncertainties relating to the outcome
of the Company's clinical trials and the GBM AGILE Study, the
impact of the COVID-19 pandemic on the Company's operations and
clinical trials; the Company's ability to develop, market and sell
products based on its technology; the expected benefits and
efficacy of the Company's products and technology; the availability
of substantial additional funding for the Company to continue its
operations and to conduct research and development, clinical
studies and future product commercialization; and, the Company's
business, research, product development, regulatory approval,
marketing and distribution plans and strategies. These and
other factors are identified and described in more detail in the
Company's filings with the SEC, including the Company's Annual
Report on Form 10-K for the year ended June
30, 2022, the Company's Quarterly Reports on Form 10-Q, and
the Company's Current Reports on Form 8-K.
CONTACTS
IR@kintara.com
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SOURCE Kintara Therapeutics