SAN
DIEGO, May 13, 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 third quarter ended March 31,
2022 and provided a corporate update.
CORPORATE HIGHLIGHTS AND RECENT
DEVELOPMENTS
- Closed a registered direct financing with certain institutional
investors pursuant to which the Company received approximately
$7.9 million in net proceeds after
deducting placement agent fees and other offering expenses payable
by the Company (April).
- Received notice of the U.S. Patent and Trademark Office's
issuance of United States Patent No. 11,234,955 to VAL-083 covering
a method of treating brain tumors including glioblastoma multiforme
(GBM), medulloblastoma, and cancer brain tumor stem cells that has
O6-methyl guanine methyltransferase (MGMT)-driven drug resistance
(February).
- Announced that the Global Coalition for Adaptive Research
(GCAR) GBM Adaptive Global Innovative Learning Environment (AGILE)
registrational Phase 2/3 clinical study (GBM AGILE Study) has
screened over 1,000 patients and that enrollment rates for the
study are 3 to 4 times greater than traditional GBM studies
according to GCAR, with active sites averaging 0.75 to 1 patient
per site per month. As a result of the accelerated enrollment rate,
the Company expects to announce top-line data from the Kintara arm
of the study around the end of calendar year 2023 (January).
- Continued to advance development of REM-001 for the treatment
of Cutaneous Metastatic Breast Cancer (CMBC), including taking
critical steps toward manufacturing sufficient quantity of drug to
allow for initiation and completion of the 15-patient confirmatory
study. Enrollment of the first patient is expected by the middle of
calendar year 2022.
"The enrollment rate in the GBM AGILE Study continues to be
robust and is expected to lead to our announcing top-line data for
the VAL-083 arm of the study around the end of 2023," 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 remain on track to start enrolling
patients in the CMBC study by the middle of calendar year
2022."
SUMMARY OF FINANCIAL RESULTS FOR
FISCAL YEAR 2022 THIRD QUARTER ENDED MARCH
31, 2022
At March 31, 2022, Kintara had
cash and cash equivalents of approximately $8.8 million. In April
2022, Kintara completed a registered direct offering for net
proceeds to the Company of approximately $7.9 million.
For the three months ended March 31,
2022, Kintara reported a net loss of approximately
$5.4 million, or $0.11 per share, compared to a net loss of
approximately $6.6 million, or
$0.23 per share, for the three months
ended March 31, 2021. For the nine
months ended March 31, 2022, Kintara
reported a net loss of approximately $17.2
million, or $0.45 per share,
compared to a net loss of approximately $31.6 million, or $1.47 per share, for the nine months ended
March 31, 2021. The decreased
net loss for the nine months ended March 31,
2022 compared to the nine months ended March 31, 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)
|
|
|
|
March
31,
2022
|
|
|
June 30,
2021
|
|
|
|
$
|
|
|
$
|
|
Cash and cash
equivalents
|
|
|
8,839
|
|
|
|
10,537
|
|
Working
capital
|
|
|
6,853
|
|
|
|
9,013
|
|
Total assets
|
|
|
12,798
|
|
|
|
13,543
|
|
Total stockholders'
equity
|
|
|
9,386
|
|
|
|
10,581
|
|
Selected Statement
of Operations Data (in thousands, except per share
data)
|
|
For the three months
ended
|
|
|
|
March
31,
|
|
March
31,
|
|
|
|
2022
|
|
2021
|
|
|
|
$
|
|
$
|
|
Research and
development
|
|
|
3,474
|
|
|
3,843
|
|
|
General and
administrative
|
|
|
1,884
|
|
|
2,762
|
|
|
Other (income)
loss
|
|
|
(2)
|
|
|
30)
|
|
|
Net loss for the
period
|
|
|
(5,356)
|
|
|
(6,635)
|
|
|
Series A Preferred cash
dividend
|
|
|
(2)
|
|
|
(2)
|
|
|
Series B Preferred
stock dividend
|
|
|
—
|
|
|
(6)
|
|
|
Net loss for the period
attributable to common stockholders
|
|
|
(5,358)
|
|
|
(6,643)
|
|
|
Basic and fully diluted
weighted average number of shares
|
|
|
49,128
|
|
|
29,273
|
|
|
Basic and fully diluted
loss per share
|
|
|
(0.11)
|
|
|
(0.23)
|
|
|
|
|
|
|
|
|
|
|
|
|
For the nine months
ended
|
|
|
|
March
31,
|
|
March
31,
|
|
|
|
2022
|
|
2021
|
|
|
|
$
|
|
$
|
|
Research and
development
|
|
|
11,169
|
|
|
7,784
|
|
|
General and
administrative
|
|
|
6,055
|
|
|
7,091
|
|
|
Merger costs
|
|
|
—
|
|
|
500
|
|
|
In-process research and
development
|
|
|
—
|
|
|
16,094
|
|
|
Other (income)
loss
|
|
|
(9)
|
|
|
97)
|
|
|
Net loss for the
period
|
|
|
(17,215)
|
|
|
(31,566)
|
|
|
Deemed dividend
recognized on beneficial conversion features of Series C Preferred
stock issuance
|
|
|
—
|
|
|
(3,181)
|
|
|
Series A Preferred cash
dividend
|
|
|
(6)
|
|
|
(6)
|
|
|
Series B Preferred
stock dividend
|
|
|
—
|
|
|
(15)
|
|
|
Series C Preferred
stock dividend
|
|
|
(2,462)
|
|
|
—
|
|
|
Net loss attributable
to common stockholders
|
|
|
(19,683)
|
|
|
(34,768)
|
|
|
Basic and fully diluted
weighted average number of shares
|
|
|
43,942
|
|
|
23,701
|
|
|
Basic and fully diluted
loss per share
|
|
|
(0.45)
|
|
|
(1.47)
|
|
|
|
|
|
|
|
|
|
|
|
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
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.
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, 2021, 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