SAN FRANCISCO and TEL AVIV, Israel, Aug. 31, 2017 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSXV:KALY)
(OTCQB:KALTF), a clinical-stage pharmaceutical company developing cannabinoid therapeutics for Graft versus Host Disease (“GvHD”), today reported financial results for the quarter ended June
30, 2017. (All dollars U.S. unless otherwise noted.)
Second Quarter 2017 Result Highlights
As of June 30, 2017, the Company had cash and cash equivalents of $1.5 million, compared with $0.7 million as of December 31,
2016.
As of August 21, 2017, Kalytera had 129,235,053 common shares outstanding.
Research and development expenses were $1 million for the quarter ended June 30, 2017 compared with $0.7 million for the quarter
ended June 30, 2016.
The increase in research and development expenses from the same period last year was due in part to laboratory and regulatory
consulting expenses incurred in preparation for the Company’s planned Phase 2 clinical study to evaluate cannabidiol (“CBD”) in the
prevention of GvHD. The Company is reviewing a number of alternatives to further finance this study, including discussions with
certain potential sources of debt or equity financing, though there can be no assurance at this time that any such financing will
be successfully obtained or available on favourable terms.
General and administrative expenses were $0.9 million for the quarter ended June 30, 2017 compared with $0.4 million for the
quarter ended June 30, 2016. The increase resulted primarily from a higher level of operations.
Net loss for the quarter ended June 30, 2017 was $1.9 million compared with a net loss of $1.1 million for the quarter ended
June 30, 2016.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
Kalytera Therapeutics, Inc. |
| |
| U.S. dollars in thousands |
|
June 30,
2017 |
|
December 31,
2016 |
| |
|
Unaudited |
|
Audited |
| ASSETS |
|
|
|
|
| CURRENT ASSETS: |
|
|
|
|
| Cash and cash equivalents |
|
$ |
1,466 |
|
|
$ |
673 |
|
| Other receivables and prepaid expenses |
|
|
92 |
|
|
|
4,141 |
|
| |
|
|
1,558 |
|
|
|
4,814 |
|
| |
|
|
|
|
| NON-CURRENT ASSETS: |
|
|
|
|
| Investment in Talent Biotechs Ltd. |
|
|
16,258 |
|
|
|
- |
|
| Total assets |
|
$ |
17,816 |
|
|
$ |
4,814 |
|
| |
|
|
|
|
| |
|
|
|
|
| LIABILITIES AND EQUITY |
|
|
|
|
| Accounts payable |
|
$ |
1,129 |
|
|
$ |
1,351 |
|
| Other payables and accrued expenses |
|
|
512 |
|
|
|
456 |
|
| Total current liabilities |
|
|
1,641 |
|
|
|
1,897 |
|
| |
|
|
|
|
| EQUITY: |
|
|
|
|
| Contributed surplus |
|
|
32,777 |
|
|
|
15,994 |
|
| Accumulated deficit |
|
|
(16,602 |
) |
|
|
(13,077 |
) |
| Total equity |
|
|
16,175 |
|
|
|
2,917 |
|
| Total liabilities and equity |
|
$ |
17,816 |
|
|
$ |
4,814 |
|
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF
PROFIT OR LOSS AND
OTHER COMPREHENSIVE INCOME |
| |
| U.S. dollars in thousands,
except shares and per share data |
| |
| |
|
Three months
ended
June 30, |
|
Six months
ended
June 30, |
| |
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
| |
|
Unaudited |
| |
|
|
|
|
|
|
|
|
| Operating expenses: |
|
|
|
|
|
|
|
|
| Research and development expenses |
|
$ |
1,024 |
|
|
$ |
715 |
|
|
$ |
1,428 |
|
|
$ |
871 |
|
| General and administrative expenses |
|
|
890 |
|
|
|
415 |
|
|
|
2,099 |
|
|
|
779 |
|
| Total operating expenses |
|
|
1,914 |
|
|
|
1,130 |
|
|
|
3,527 |
|
|
|
1,650 |
|
| Operating loss |
|
$ |
1,914 |
|
|
$ |
1,130 |
|
|
$ |
3,527 |
|
|
$ |
1,650 |
|
| Finance expense, net |
|
|
(10 |
) |
|
|
- |
|
|
|
(2 |
) |
|
|
- |
|
| |
|
|
|
|
|
|
|
|
| Loss before income taxes |
|
|
1,904 |
|
|
|
1,130 |
|
|
|
3,525 |
|
|
|
1,650 |
|
| Income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
| Net loss and comprehensive loss |
|
$ |
1,904 |
|
|
$ |
1,130 |
|
|
$ |
3,525 |
|
|
$ |
1,650 |
|
Basic and diluted loss per share (in U.S.
dollars) |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.06 |
) |
Weighted average number of Common
shares outstanding |
|
|
129,235,053 |
|
|
|
27,582,228 |
|
|
|
118,072,534 |
|
|
|
27,333,383 |
|
| INTERIM CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS |
| |
| U.S. dollars in thousands |
| |
| |
|
Six months
ended
June 30, |
| |
|
2017 |
|
2016 |
| |
|
Unaudited |
| Cash flows from operating activities: |
|
|
|
|
| |
|
|
|
|
| Net loss |
|
$ |
3,525 |
|
|
$ |
1,650 |
|
| Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
| Share-based compensation |
|
|
(51 |
) |
|
|
(199 |
) |
| Increase in other receivables and prepaid expenses |
|
|
70 |
|
|
|
- |
|
| Decrease (increase) in trade payables |
|
|
222 |
|
|
|
(467 |
) |
| Decrease (increase) in other payables and accrued expenses |
|
|
34 |
|
|
)90) |
| |
|
|
|
|
| Net cash used in operating activities |
|
|
(3,800 |
) |
|
|
(894 |
) |
| |
|
|
|
|
| Cash flows from investing activities: |
|
|
|
|
| |
|
|
|
|
| Cash paid upon acquisition of Talent Biotechs Ltd. |
|
|
(10,000 |
) |
|
|
- |
|
| |
|
|
|
|
| Net cash used in investing activities |
|
|
(10,000 |
) |
|
|
- |
|
| |
|
|
|
|
| Cash flows from financing activities: |
|
|
|
|
| |
|
|
|
|
Net proceeds from issuance of Common shares and warrants in
January-February 2016 |
|
|
- |
|
|
|
230 |
|
| Net proceeds from issuance of Common shares in February 2017 |
|
|
10,458 |
|
|
|
- |
|
| Net proceeds from issuance of Common shares in December 2016 |
|
|
4,119 |
|
|
|
- |
|
| Proceeds from issuance of Common shares upon exercise of warrants |
|
|
16 |
|
|
|
- |
|
| |
|
|
|
|
| Net cash provided by financing activities |
|
|
14,593 |
|
|
|
230 |
|
| |
|
|
|
|
| Increase (decrease) in cash and cash equivalents |
|
|
793 |
|
|
|
(494 |
) |
| Cash and cash equivalents at the beginning of the period |
|
|
673 |
|
|
|
622 |
|
| |
|
|
|
|
| Cash and cash equivalents at the end of the period |
|
$ |
1,466 |
|
|
$ |
128 |
|
| |
|
|
|
|
| Non-cash transactions: |
|
|
|
|
| |
|
|
|
|
| Issuance of Common shares upon acquisition of Talent Biotechs Ltd. |
|
$ |
6,258 |
|
|
$ |
- |
|
About Kalytera Therapeutics
Kalytera Therapeutics is a clinical-stage pharmaceutical company developing cannabinoid therapeutics. Through its proven
leadership, drug development expertise, and growing intellectual property portfolio, Kalytera seeks to establish a leading position
in the development of novel cannabinoid medicines for a range of important unmet medical needs, with an initial focus on Graft versus Host Disease (“GvHD”).
Kalytera is also developing proprietary cannabidiol (“CBD”) prodrugs intended for commercialization as FDA and EMEA-approved
prescription medications. CBD has shown activity against a number of pharmacological targets. However, there are limitations
associated with CBD, including its poor oral bioavailability. Kalytera’s CBD prodrugs have been designed to overcome these
limitations. In addition to licensed IP rights, Kalytera has filed composition of matter and method of use patents covering its
inventions to reinforce its position in the market.
Safe Harbor
This news release contains “forward-looking information” within the meaning of applicable securities laws, including in respect
of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives,
management goals, capital raising abilities and other statements included in this news release of a forward-looking nature.
Although Kalytera believes in light of the experience of its officers and directors, current conditions and expected future
developments and other factors that have been considered appropriate, that the expectations reflected in this forward-looking
information are reasonable, undue reliance should not be placed on them because Kalytera can give no assurance that they will prove
to be correct. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments
may differ materially from those contemplated by these statements. The statements in this press release are made as of the date of
this release. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third-parties in respect
of Kalytera, its securities, or its respective financial or operating results (as applicable). Kalytera disclaims any intent or
obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or
otherwise, other than as required by applicable securities laws.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Company Contact Robert Farrell President and Interim CEO Phone: (888) 861-2008 Email: ir@kalytera.co
