SAN DIEGO, Nov. 13, 2020
/PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA)
("Kintara" or the "Company"), a biopharmaceutical company focused
on the development of new solid tumor cancer therapies, announced
its financial results for the first quarter ended September 30, 2020 and provided a corporate
update.
"The first quarter of our fiscal year marked the beginning of a
new era for the company as we completed the acquisition of Adgero,"
commented Saiid Zarrabian, Kintara's
President and Chief Executive Officer. "In conjunction with this
transformational milestone, we strengthened our balance sheet with
a $25 million private placement to
enable us to execute a timely advance of our key programs including
the clinical stage of the GCAR GBM AGILE registrational study
for VAL-083 and the confirmatory cutaneous metastatic breast
cancer study for REM-001."
First Quarter Highlights and Recent Developments
- Consummated the acquisition of Adgero, a privately held
biopharmaceutical company focused on the development of its late
stage photodynamic therapy platform for the treatment of serious
cutaneous oncology indications, which created a diversified
biopharmaceutical company with a robust product pipeline targeting
rare, unmet medical needs in oncology (August 2020).
- Completed a private placement of Series C Convertible Preferred
Stock for aggregate gross proceeds of approximately $25 million, or net proceeds of approximately
$21.6 million (August 2020).
- Executed a definitive agreement with the Global Coalition for
Adaptive Research (GCAR) to include VAL-083 in GCAR's Glioblastoma
Adaptive Global Innovative Learning Environment (GBM AGILE) study,
an adaptive clinical trial platform in glioblastoma multiforme
(GBM). Kintara will supply GCAR with the VAL-083 drug along with
the funding to support the VAL-083 arm of the GBM AGILE
registrational study. In turn, GCAR will manage all operational
aspects of the study, including site activation and patient
enrollment (October 2020).
- Received award notification of a Small Business Technology
Transfer grant to study the use of REM-001 in the prevention of
arteriovenous fistula maturation failure (AFMF), a
cardiovascular-related condition that occurs in hemodialysis
patients. This grant will allow Kintara to further study the use of
REM-001 in the prevention of AFMF in preclinical models
(July 2020).
SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR
2021 FIRST QUARTER ENDED SEPTEMBER 30,
2020
At September 30, 2020, the Company
had cash and cash equivalents of approximately $22.6 million. In August 2020, the Company completed the private
placement of Series C Convertible Preferred Stock for gross
proceeds of approximately $25
million, or net proceeds of approximately $21.6 million. The cash and cash equivalents at
September 30, 2020, along with the
proceeds from warrant exercises received subsequent to September 30, 2020, are expected to be sufficient
to fund the Company's planned operations into the fourth quarter of
calendar year 2021.
For the quarter ended September 30,
2020, the Company reported a net loss of approximately
$19.5 million, or $1.33 per share, compared to a net loss of
approximately $1.6 million, or
$0.21 per share, for the quarter
ended September 30, 2019. The
increase in the current quarter was largely due to the recognition
of $16.0 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)
|
|
|
|
September
30,
2020
|
|
|
June 30,
2020
|
|
|
|
$
|
|
|
$
|
|
Cash and cash
equivalents
|
|
|
22,602
|
|
|
|
2,392
|
|
Working
capital
|
|
|
20,566
|
|
|
|
176
|
|
Total
assets
|
|
|
23,131
|
|
|
|
2,938
|
|
Total stockholders'
equity
|
|
|
20,554
|
|
|
|
263
|
|
Selected Statement
of Operations Data (in thousands, except per share
data)
|
|
For the quarters
ended
|
|
|
|
September
30,
|
|
September
30,
|
|
|
|
|
2020
|
|
2019
|
|
|
|
|
$
|
|
$
|
|
|
Research and
development
|
|
|
1,357
|
|
|
721
|
|
|
General and
administrative
|
|
|
1,534
|
|
|
914
|
|
|
Merger
costs
|
|
|
500
|
|
|
-
|
|
|
In-process research
& development
|
|
|
16,094
|
|
|
-
|
|
|
Other loss
(income)
|
|
|
33
|
|
|
(29)
|
|
|
Net loss for the
period
|
|
|
19,518
|
|
|
1,606
|
|
|
Deemed dividend
recognized on beneficial conversion features of Series C Preferred
stock issuance
|
|
|
3,181
|
|
|
-
|
|
|
Series A Preferred
cash dividend
|
|
|
2
|
|
|
2
|
|
|
Series B Preferred
stock dividend
|
|
|
5
|
|
|
2
|
|
|
Net loss attributable
to common stockholders
|
|
|
22,706
|
|
|
1,610
|
|
|
Basic and fully
diluted weighted average number of shares
|
|
|
17,106
|
|
|
7,539
|
|
|
Basic and fully
diluted loss per share
|
|
|
1.33
|
|
|
0.21
|
|
|
|
|
|
|
|
|
|
|
|
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