Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP;
"Cyclacel" or the "Company"), a biopharmaceutical company
developing innovative medicines based on cancer cell biology, today
reported financial results and business highlights for the third
quarter 2019. The Company's net loss applicable to common
shareholders for the three months ended September 30, 2019 was $2.0
million. As of September 30, 2019 cash and cash equivalents totaled
$13.0 million.
“The investigators evaluating CYC065, our CDK2/9 inhibitor, as a
single agent have reported that a heavily pretreated patient with
MCL1 amplified endometrial cancer achieved a partial response (PR)
with tumor shrinkage of 48%,” said Spiro Rombotis, President and
Chief Executive Officer of Cyclacel. “If this PR is confirmed with
a follow up scan, it will provide further support that MCL1
dependent cancers may be sensitive to CYC065. We have previously
reported that CYC065 durably suppresses MCL1 in cancer patients and
believe that it is a leader amongst MCL1 suppressing medicines. In
parallel, we have enrolled our first patient with an oral form of
CYC065 and are continuing to recruit patients in Phase 1 studies
evaluating CYC065 in combination with venetoclax in patients with
relapsed or refractory AML, CLL or MDS. Altogether we are dosing
patients in five clinical studies in pursuit of our strategy of
overcoming cancer resistance through combinations of our candidates
with approved drugs. With projected cash to the end of 2020 we look
forward to delivering on multiple data outcomes from our ongoing
studies.”
Key Company Highlights
- Reported anticancer activity in part 2 of 065-01, the Phase 1
study of CYC065 as a single agent; a patient with MCL1 amplified
endometrial cancer achieved partial response with 48% tumor
shrinkage after 4 cycles of treatment at 213mg as reported by the
investigators;
- Reached the second dose level in part 3 of 065-01 evaluating an
oral form of CYC065 in patients with advanced cancers;
- Enrolled eight patients in the 065-03 Phase 1 study evaluating
CYC065 in combination with venetoclax in patients with relapsed or
refractory AML/MDS;
- Opened two new sites in the 065-02 study of CYC065 in
combination with venetoclax in patients with relapsed/refractory
CLL;
- Data from three ongoing studies have been selected for
presentation at the 61st American Society of Hematology Annual
Meeting. The presentations will provide updates for CYC065 in
combination with venetoclax in patients with relapsed or refractory
AML/MDS or CLL and sapacitabine in combination with venetoclax in
patients with relapsed or refractory AML/MDS; and
- Continued enrollment in part 2 of the 682-11 Phase 1/2 study
evaluating an oral regimen of sapacitabine in combination with
venetoclax in patients with relapsed or refractory AML/MDS.
Key Upcoming Business Objectives
- Presentations at the 61stAmerican Society of Hematology Annual
Meeting;
- Report updated safety, pharmacokinetics and efficacy of CYC065
Phase 1 data with frequent dosing schedule in patients with
advanced solid cancers;
- Report initial safety and PK data from the Phase 1 study of an
oral formulation of CYC065;
- Report initial safety and proof of concept data from the
CYC065-venetoclax Phase 1 study in relapsed/refractory AML and
MDS;
- Report initial safety and proof of concept data from the
CYC065-venetoclax Phase 1 study in relapsed/refractory CLL;
- Report initial data from the sapacitabine-venetoclax Phase 1/2
study in patients with relapsed or refractory AML or MDS;
- Report initial data from the CYC140 Phase 1 First-in-Human
study in relapsed or refractory leukemias;
- Report data from the IST Phase 1b/2 trial of
sapacitabine-olaparib combination in patients with BRCA mutant
metastatic breast cancer when reported by the investigators;
and
- Determine regulatory pathway and submissibility of sapacitabine
in elderly AML patients.
Financial Highlights
As of September 30, 2019, cash and cash equivalents totaled
$13.0 million compared to $17.5 million as of December 31, 2018.
The decrease of $4.5 million was primarily due to net cash used in
operating activities of $8.3 million, offset by net proceeds from a
Common Stock Sales Agreement with H.C. Wainwright & Co., LLC of
$4.1 million. In October 2019, we received $1.2 million in United
Kingdom, research & development tax credits not included in the
above amounts.
Research and development expenses were $1.1 million for the
three months ended September 30, 2019 compared to $1.2 million for
the same period in 2018.
General and administrative expenses were $1.3
million for each of the three months ended September 30, 2019 and
2018.
Other income, net for the three months ended September 30, 2019
was $0.2 million compared to $0.1 million for the same period of
the previous year.
The accrued United Kingdom research and development tax credit
was $0.3 million for each of the three months ended September 30,
2019 and 2018.
Net loss for the three months ended September 30, 2019 was $1.9
million compared to $2.1 million for the same period in 2018. With
the projected cash-sparing benefits accruing from the alliance with
The University of Texas MD Anderson Cancer Center, the
Company believes that cash and marketable securities, which were
approximately $13.0 million as of September 30, 2019, will be
sufficient to finance operations through the end of 2020.
Conference call information:
US/Canada call: (877) 493-9121 / international call: (973)
582-2750 US/Canada archive: (800) 585-8367 / international
archive: (404) 537-3406 Code for live and archived conference
call is 8636118
For the live and archived webcast, please visit the Corporate
Presentations page on the Cyclacel website at www.cyclacel.com. The
webcast will be archived for 90 days and the audio replay for 7
days.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical
company developing innovative cancer medicines based on cell cycle,
transcriptional regulation and DNA damage response biology.
The transcriptional regulation program is evaluating CYC065
in combination with venetoclax in patients with relapsed or
refractory CLL and AML/MDS. The DNA damage response program is
evaluating an oral combination regimen of sapacitabine and
venetoclax in patients with relapsed or refractory AML/MDS. An IST
is evaluating an oral combination regimen of sapacitabine and
olaparib in patients with BRCA mutant breast cancer. The
anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in
AML/MDS patients. Cyclacel's strategy is to build a diversified
biopharmaceutical business focused in hematology and oncology based
on a pipeline of novel drug candidates. For additional information,
please visit www.cyclacel.com.
Forward-looking Statements
This news release contains certain forward-looking statements
that involve risks and uncertainties that could cause actual
results to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements. Such forward-looking statements include statements
regarding, among other things, the efficacy, safety and intended
utilization of Cyclacel's product candidates, the conduct and
results of future clinical trials, plans regarding regulatory
filings, future research and clinical trials and plans regarding
partnering activities. Factors that may cause actual results to
differ materially include the risk that product candidates that
appeared promising in early research and clinical trials do not
demonstrate safety and/or efficacy in larger-scale or later
clinical trials, trials may have difficulty enrolling, Cyclacel may
not obtain approval to market its product candidates, the risks
associated with reliance on outside financing to meet capital
requirements, and the risks associated with reliance on
collaborative partners for further clinical trials, development and
commercialization of product candidates. You are urged to consider
statements that include the words "may," "will," "would," "could,"
"should," "believes," "estimates," "projects," "potential,"
"expects," "plans," "anticipates," "intends," "continues,"
"forecast," "designed," "goal," or the negative of those words or
other comparable words to be uncertain and forward-looking. For a
further list and description of the risks and uncertainties the
Company faces, please refer to our most recent Annual Report on
Form 10-K and other periodic and other filings we file with the
Securities and Exchange Commission and are available at
www.sec.gov. Such forward-looking statements are current only as of
the date they are made, and we assume no obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contacts
Company: |
Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com |
Investor Relations: |
Russo Partners LLC, Jan Medina, (646) 942-5632,
Jan.Medina@russopartnersllc.com |
© Copyright 2019 Cyclacel Pharmaceuticals, Inc. All Rights
Reserved. The Cyclacel logo and Cyclacel® are trademarks of
Cyclacel Pharmaceuticals, Inc.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS(In $000s, except share and per share
amounts)(Unaudited)
|
|
|
Three Months
Ended |
|
|
|
September
30, |
|
|
|
|
2018 |
|
|
|
2019 |
|
|
|
|
|
|
|
Revenues: |
|
|
|
Total revenues |
|
- |
|
|
|
- |
|
Operating expenses: |
|
|
|
|
Research and development |
|
1,205 |
|
|
|
1,063 |
|
|
General and administrative |
|
1,250 |
|
|
|
1,285 |
|
Total operating expenses |
|
2,455 |
|
|
|
2,348 |
|
Operating loss |
|
(2,455 |
) |
|
|
(2,348 |
) |
Other income (expense): |
|
|
|
|
Foreign exchange gains (losses) |
|
1 |
|
|
|
79 |
|
|
Interest income |
|
85 |
|
|
|
42 |
|
|
Other income, net |
|
- |
|
|
|
53 |
|
|
|
Total other
income (expense), net |
|
86 |
|
|
|
174 |
|
Loss before taxes |
|
(2,369 |
) |
|
|
(2,174 |
) |
Income tax benefit |
|
301 |
|
|
|
273 |
|
Net loss |
|
(2,068 |
) |
|
|
(1,901 |
) |
Dividend on convertible exchangeable preferred shares |
|
(50 |
) |
|
|
(50 |
) |
Net loss applicable to common shareholders |
$ |
(2,118 |
) |
|
$ |
(1,951 |
) |
Basic and diluted earnings per common share: |
|
|
|
Net loss per share – basic and diluted |
$ |
(0.18 |
) |
|
$ |
(0.11 |
) |
Weighted average common shares outstanding |
|
11,997,447 |
|
|
|
17,199,974 |
|
|
|
|
|
|
|
CYCLACEL PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE SHEET(In
$000s, except share, per share, and liquidation preference
amounts) (Unaudited)
|
December 31, |
|
September 30, |
|
2018 |
|
2019 |
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
17,504 |
|
$ |
12,967 |
Prepaid expenses and other current assets |
|
2,283 |
|
|
2,869 |
Total current assets |
|
19,787 |
|
|
15,836 |
|
|
|
|
Property and equipment, net |
|
36 |
|
|
28 |
Right-of-use lease asset |
|
- |
|
|
1,213 |
Total assets |
$ |
19,823 |
|
$ |
17,077 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
2,719 |
|
$ |
887 |
Accrued and other current liabilities |
|
1,732 |
|
|
1,184 |
Total current liabilities |
|
4,451 |
|
|
2,071 |
Lease
liability |
|
- |
|
|
1,154 |
Other
liabilities |
|
100 |
|
|
- |
Total liabilities |
|
4,551 |
|
|
3,225 |
Stockholders’ equity |
|
15,272 |
|
|
13,852 |
Total liabilities and stockholders’ equity |
$ |
19,823 |
|
$ |
17,077 |
|
|
|
|
SOURCE: Cyclacel Pharmaceuticals, Inc.
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