SAN
DIEGO, Feb. 14, 2024 /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 second quarter ended December 31,
2023, and provided a corporate update.
RECENT CORPORATE DEVELOPMENTS
- Announced the initiation of an open label 15-patient study in
cutaneous metastatic breast cancer (CMBC) patients which is
evaluating REM-001, a second-generation photodynamic therapy (PDT)
photosensitizer agent, and is designed to test the 0.8 mg dose as
well as optimize the study design in advance of a Phase 3 trial
initiation. The primary endpoint in the study is Best Overall
Objective Response Rate (bORR) (complete response or partial
response) of the target treatment fields at any time from treatment
up to, and including, week 24. 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).
(February 2024)
- Announced that Kintara's Board of Directors has initiated a
process to explore and review a range of strategic alternatives
focused on maximizing stockholder value and has engaged Ladenburg
Thalmann & Co. Inc. to act as financial advisor for this
process. (December 2023)
- Announced that preliminary topline results from the
Glioblastoma Adaptive Global Innovative Learning Environment (GBM
AGILE) study showed that VAL-083 did not perform better than the
current standards of care in glioblastoma. These topline results
included preliminary safety data for VAL-083 that was similar to
that of the current standards of care used to treat glioblastoma.
As a result, Kintara terminated the development of VAL-083 and
turned its focus to its REM-001 program. (October 2023)
"We are pleased to have recently initiated our 15 patient
REM-001 study for cutaneous metastatic breast cancer, a disease
with little or no current treatment options" commented Robert E. Hoffman, Kintara's President and Chief
Executive Officer. "We have strengthened our balance sheet
primarily with net proceeds from our at-the-market (ATM) facility
and aggressive cost-cutting efforts. We continue to evaluate
strategic options with the goal of maximizing shareholder
value."
SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2023 SECOND
QUARTER ENDED DECEMBER 31,
2023
As of December 31, 2023, Kintara
had cash and cash equivalents of approximately $0.7 million. From January
1, 2024, to February 12, 2024,
the Company has received net proceeds of approximately $6.1 million from the sale of common stock,
primarily from its ATM facility.
For the three months ended December 31,
2023, Kintara reported a net loss of approximately
$1.0 million, or $0.24 per share, compared to a net loss of
approximately $3.5 million, or
$2.10 per share, for the three months
ended December 31, 2022. The
decreased net loss for the three months ended December 31, 2023, compared to the three months
ended December 31, 2022, was largely
attributed to lower research and development expenses which was
primarily due to lower clinical development costs. General and
administrative costs were also lower during the same period
primarily due to a reduction in personnel.
Selected Balance
Sheet Data (in thousands)
|
|
|
|
December
31, 2023
|
|
|
June 30,
2023
|
|
|
|
$
|
|
|
$
|
|
Cash and cash
equivalents
|
|
|
658
|
|
|
|
1,535
|
|
Working capital
(deficiency)
|
|
|
(684)
|
|
|
|
188
|
|
Total assets
|
|
|
1,885
|
|
|
|
3,979
|
|
Total stockholders'
equity (deficiency)
|
|
|
(164)
|
|
|
|
731
|
|
|
Selected Statement
of Operations Data (in thousands, except per share
data)
|
For the three months
ended
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
2023
|
|
|
2022
|
|
|
|
$
|
|
|
$
|
|
Research and
development
|
|
|
111
|
|
|
|
2,059
|
|
General and
administrative
|
|
|
908
|
|
|
|
1,440
|
|
Other loss
(income)
|
|
|
4
|
|
|
|
(45)
|
|
Net loss for the
period
|
|
|
(1,023)
|
|
|
|
(3,454)
|
|
Series A Preferred cash
dividend
|
|
|
(2)
|
|
|
|
(2)
|
|
Net loss for the period
attributable to common stockholders
|
|
|
(1,025)
|
|
|
|
(3,456)
|
|
Basic and fully diluted
weighted average number of shares
|
|
|
4,337
|
|
|
|
1,643
|
|
Basic and fully diluted
loss per share
|
|
|
(0.24)
|
|
|
|
(2.10)
|
|
For the six months
ended
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
2023
|
|
|
2022
|
|
|
|
$
|
|
|
$
|
|
Research and
development
|
|
|
1,970
|
|
|
|
5,230
|
|
General and
administrative
|
|
|
2,011
|
|
|
|
2,915
|
|
Other loss
(income)
|
|
|
4
|
|
|
|
(95)
|
|
Net loss for the
period
|
|
|
(3,985)
|
|
|
|
(8,050)
|
|
Series A Preferred cash
dividend
|
|
|
(4)
|
|
|
|
(4)
|
|
Series C Preferred
stock dividend
|
|
|
(173)
|
|
|
|
(362)
|
|
Net loss for the period
attributable to common stockholders
|
|
|
(4,162)
|
|
|
|
(8,416)
|
|
Basic and fully diluted
weighted average number of shares
|
|
|
3,027
|
|
|
|
1,554
|
|
Basic and fully diluted
loss per share
|
|
|
(1.37)
|
|
|
|
(5.42)
|
|
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 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.
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 Company's REM-001
15-patient clinical trial in CMBC patients; the topline results of
the GBM AGILE Study; and the Company's review of strategic
alternatives. 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
Company's ability to develop, market and sell products based on its
technology; the status of the Company's clinical trials; the
topline results of the GBM AGILE Study; 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; the Company's
business, research, product development, regulatory approval,
marketing and distribution plans and strategies; and global unrest.
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, 2023, the Company's Quarterly Reports on
Form 10-Q, and the Company's Current Reports on Form 8-K.
CONTACTS
Investors
Robert E.
Hoffman
Kintara Therapeutics
rhoffman@kintara.com
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SOURCE Kintara Therapeutics