SAN DIEGO, Feb. 12, 2021 /PRNewswire/ -- Kintara
Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the
"Company"), a biopharmaceutical company focused on the development
of new solid tumor cancer therapies, today announces its financial
results for its fiscal second quarter ended December 31, 2020 and provides a corporate
update.
Second Quarter Highlights and Recent Developments
- Executed a definitive agreement with the Global Coalition for
Adaptive Research (GCAR) to include VAL-083 in its Glioblastoma
Adaptive Global Innovative Learning Environment Study (GBM AGILE),
a registrational Phase 2/3 clinical trial for glioblastoma
multiforme (GBM). GBM AGILE is a patient-centered, adaptive
platform trial evaluating multiple therapies for patients with
newly-diagnosed and recurrent GBM. Kintara will supply GCAR with
the VAL-083 drug along with the funding to support the VAL-083 arm
of the study. In turn, GCAR will manage all operational aspects of
the study, including site activation and patient enrollment.
- Initiated patient recruitment for the VAL-083 study arm of GBM
AGILE.
- Announced that VAL-083 is the only therapeutic agent currently
being evaluated in all three GBM patient subtypes in GBM AGILE:
newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT,
and recurrent.
- Announced positive data updates at the Society of
Neuro-Oncology Annual Meeting from ongoing Phase 2 clinical studies
in newly-diagnosed first-line, newly-diagnosed adjuvant, and
recurrent GBM.
"The second quarter of fiscal year 2021 proved to be an
important period of progress as we continued to advance to the
latter stages of clinical development for VAL-083, our
first-in-class small-molecule chemotherapeutic, and REM-001, our
photodynamic therapy platform that is maintaining development pace
in its confirmatory cutaneous metastatic breast cancer study,"
commented Saiid Zarrabian, Kintara's
President and Chief Executive Officer. "Certainly, receiving
approval from the FDA and GCAR to participate in the GBM AGILE
study was a major milestone for the Company as this is a
registrational trial whereby VAL-083 is being evaluated in all
three GBM patient subtypes."
SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR
2021 SECOND QUARTER ENDED DECEMBER 31,
2020
At December 31, 2020, the Company
had cash and cash equivalents of approximately $17.2 million. The cash and cash
equivalents at December 31, 2020,
along with the proceeds from warrant exercises received subsequent
to December 31, 2020, are expected to
be sufficient to fund the Company's planned operations into the
fourth quarter of calendar year 2021.
For the three months ended December 31,
2020, the Company reported a net loss of approximately
$5.4 million, or $0.22 per share, compared to a net loss of
approximately $1.7 million, or
$0.15 per share, for the three months
ended December 31, 2019. For the six
months ended December 31, 2020, the
Company reported a net loss of approximately $24.9 million, or $1.34 per share, compared to a net loss of
approximately $3.3 million, or
$0.35 per share, for the six months
ended December 31, 2019. The
increased loss for the six months ended December 31, 2020 compared to the six months
ended December 31, 2019 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.
Selected Balance
Sheet Data (in thousands)
|
|
|
|
December
31,
2020
|
|
|
June 30,
2020
|
|
|
|
$
|
|
|
$
|
|
Cash and cash
equivalents
|
|
|
17,158
|
|
|
|
2,392
|
|
Working
capital
|
|
|
14,990
|
|
|
|
176
|
|
Total
assets
|
|
|
20,489
|
|
|
|
2,938
|
|
Total stockholders'
equity
|
|
|
17,585
|
|
|
|
263
|
|
Selected Statement
of Operations Data (in thousands, except per share
data)
|
|
For the three
months ended
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
2020
|
|
|
2019
|
|
|
|
$
|
|
|
$
|
|
Research and
development
|
|
|
2,584
|
|
|
|
712
|
|
General and
administrative
|
|
|
2,794
|
|
|
|
1,054
|
|
Other loss
(income)
|
|
|
35
|
|
|
|
(26)
|
|
Net loss for the
period
|
|
|
5,413
|
|
|
|
1,740
|
|
Series A Preferred
cash dividend
|
|
|
2
|
|
|
|
2
|
|
Series B Preferred
stock dividend
|
|
|
4
|
|
|
|
3
|
|
Net loss attributable
to common stockholders
|
|
|
5,419
|
|
|
|
1,745
|
|
Basic and fully
diluted weighted average number of shares
|
|
|
24,845
|
|
|
|
11,408
|
|
Basic and fully
diluted loss per share
|
|
|
0.22
|
|
|
|
0.15
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months
ended
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
2020
|
|
|
2019
|
|
|
|
$
|
|
|
$
|
|
Research and
development
|
|
|
3,941
|
|
|
|
1,434
|
|
General and
administrative
|
|
|
4,329
|
|
|
|
1,967
|
|
Merger
costs
|
|
|
500
|
|
|
|
-
|
|
In-process research
& development
|
|
|
16,094
|
|
|
|
-
|
|
Other loss
(income)
|
|
|
67
|
|
|
|
(55)
|
|
Net loss for the
period
|
|
|
24,931
|
|
|
|
3,346
|
|
Deemed dividend
recognized on beneficial conversion features of Series C Preferred
stock issuance
|
|
|
3,181
|
|
|
|
-
|
|
Series A Preferred
cash dividend
|
|
|
4
|
|
|
|
4
|
|
Series B Preferred
stock dividend
|
|
|
9
|
|
|
|
5
|
|
Net loss attributable
to common stockholders
|
|
|
28,125
|
|
|
|
3,355
|
|
Basic and fully
diluted weighted average number of shares
|
|
|
20,976
|
|
|
|
9,473
|
|
Basic and fully
diluted loss per share
|
|
|
1.34
|
|
|
|
0.35
|
|
|
|
|
|
|
|
|
|
|
|
|
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 cutaneous metastatic breast cancer (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 conducting clinical trials to support the development and
commercialization of VAL-083 in GBM.
Kintara is also advancing its 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, 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.
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 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,
2020, the Company's Quarterly Reports on Form 10-Q, and the
Company's Current Reports on Form 8-K.
CONTACTS:
Investors:
CORE IR
516-222-2560
ir@coreir.com
Media:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com
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SOURCE Kintara Therapeutics