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 second
quarter 2019. The Company's net loss applicable to common
shareholders for the three months ended June 30, 2019 was $1.8
million. As of June 30, 2019 cash and cash equivalents
totaled $15.2 million.
“We are excited to report new evidence of anticancer activity
for CYC065. In part 2 of our Phase 1 study of CYC065 as a single
agent, a patient with endometrial cancer with MCL1 amplification
treated on the fourth dose level achieved tumor shrinkage. This
patient was previously treated with liposomal doxorubicin,
carboplatin, and multiple investigational therapies,” said Spiro
Rombotis, President and Chief Executive Officer of Cyclacel.
“Following our recent announcement of the first patient dosed in a
Phase 1/2 study with an oral combination of sapacitabine and
venetoclax in relapsed or refractory AML or MDS, we are now dosing
patients in five clinical studies in pursuit of our strategy of
overcoming cancer resistance mechanisms through combinations of our
candidates with approved drugs. The first two patients in the
relapsed or refractory CLL study evaluating the combination of
CYC065 and venetoclax remain on treatment for 4 and 6 cycles
respectively. A total of 4 patients with BRCA mutant breast cancer
have been treated in the Phase 1/2 investigator sponsored trial
(IST) evaluating sapacitabine and olaparib and one patient has
achieved partial response (PR). 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 first evidence of anticancer activity in part 2 of the
Phase 1 study (065-01) as a single agent testing a frequent dosing
schedule of four, one-hour infusions every three weeks in which a
patient with endometrial cancer with MCL1 amplification treated on
the fourth dose level of 213mg achieved tumor shrinkage;
- Reported that patients with relapsed/refractory CLL treated in
the 065-02 study with CYC065 plus venetoclax are continuing
treatment after ibrutinib front-line failure;
- Announced treatment of the first patient in a Phase 1 study
(065-03) evaluating the safety and effectiveness of CYC065, a
CDK2/9 inhibitor shown to durably suppress MCL1, in combination
with venetoclax, a BCL2 inhibitor, in patients with relapsed or
refractory AML or MDS. Preclinical data confirmed synergy of CYC065
and venetoclax, suggesting that the suppression of both BCL2 and
MCL1 may be more beneficial than inhibiting either one alone;
- Announced treatment of the first patient in part 2 of a Phase
1/2 study (682-11) evaluating the safety and effectiveness of an
oral regimen of sapacitabine in combination with venetoclax in
patients with relapsed or refractory AML or MDS. Sapacitabine is a
nucleoside analogue that is active in AML and MDS relapsed or
refractory to prior therapy such as cytarabine or hypomethylating
agents. Combining sapacitabine with venetoclax may offer an
effective, oral treatment regimen for patients who have failed
front-line therapy;
- Following an amendment of the Phase 1 study (065-01) of single
agent CYC065 in patients with advanced cancers part 3 of the study
will evaluate an oral form of CYC065.
Key Upcoming Business Objectives
- Report initial data from the CYC065-venetoclax Phase 1 studies
in relapsed/refractory leukemias;
- Report initial data from the sapacitabine-venetoclax Phase 1
study in patients with relapsed or refractory AML or MDS;
- Report initial data from the CYC140 Phase 1 First-in-Human
study;
- Report initial data and bioavailability from the Phase 1 study
of an oral formulation of CYC065;
- Report updated CYC065 Phase 1 data with frequent dosing
schedule in patients with advanced solid cancers;
- 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;
- Determine regulatory pathway and submissibility of sapacitabine
in elderly AML patients.
Financial Highlights
As of June 30, 2019, cash and cash equivalents totaled $15.2
million compared to $17.5 million as of December 31, 2018. The
decrease of $2.3 million was primarily due to net cash used in
operating activities of $6.3 million, offset by net proceeds from a
Common Stock Sales Agreement with H.C. Wainwright of $4.1m.
Research and development expenses were $1.2 million for the
three months ended June 30, 2019 compared to $1.2 million for the
same period in 2018.
General and administrative expenses were $1.2
million for the three months ended June 30, 2019 compared to $1.3
million for the same period in 2018.
Other income, net for the three months ended June 30, 2019 was
$0.2 million compared to $0.1 million for the same period of the
previous year.
The United Kingdom R&D tax credit was $0.3 million for the
three months ended June 30, 2019 compared to $0.5 million for the
same period in 2018.
Net loss for the three months ended June 30, 2019 was $1.8
million compared to $1.9 million for the same period in 2018. With
the projected cash-sparing benefits accruing from the MD Anderson
alliance the Company believes that cash and marketable securities,
which were approximately $15.2 million as of June 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 7654539For 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. 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.comInvestor Relations: Russo Partners LLC,
Alexander Fudukidis, (646) 942-5632,
alex.fudukidis@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 |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2018 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
Total
revenues |
|
|
- |
|
|
|
- |
|
Operating
expenses: |
|
|
|
|
|
Research and
development |
|
|
1,182 |
|
|
|
1,153 |
|
|
General and
administrative |
|
|
1,283 |
|
|
|
1,184 |
|
Total
operating expenses |
|
|
2,465 |
|
|
|
2,337 |
|
Operating
loss |
|
|
(2,465 |
) |
|
|
(2,337 |
) |
Other income
(expense): |
|
|
|
|
|
Foreign exchange
gains (losses) |
|
|
(39 |
) |
|
|
21 |
|
|
Interest
income |
|
|
84 |
|
|
|
56 |
|
|
Other income,
net |
|
|
66 |
|
|
|
170 |
|
|
|
Total other income
(expense), net |
|
|
111 |
|
|
|
247 |
|
Loss
before taxes |
|
|
(2,354 |
) |
|
|
(2,090 |
) |
Income tax
benefit |
|
|
502 |
|
|
|
307 |
|
Net
loss |
|
|
|
|
(1,852 |
) |
|
|
(1,783 |
) |
Dividend on
convertible exchangeable preferred shares |
|
|
(50 |
) |
|
|
(50 |
) |
Net loss
applicable to common shareholders |
|
$ |
(1,902 |
) |
|
$ |
(1,833 |
) |
Basic and
diluted earnings per common share: |
|
|
|
|
Net loss per share
– basic and diluted |
|
$ |
(0.16 |
) |
|
$ |
(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, |
|
June 30, |
|
|
|
2018 |
|
2019 |
|
|
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
17,504 |
|
$ |
15,159 |
Prepaid expenses and other current assets |
|
2,283 |
|
|
2,991 |
Total current assets |
|
19,787 |
|
|
18,150 |
|
|
|
|
Property and equipment, net |
|
36 |
|
|
29 |
Right-of-use lease asset |
|
- |
|
|
1,285 |
Total assets |
$ |
19,823 |
|
$ |
19,464 |
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,719 |
|
$ |
1,106 |
Accrued and other current liabilities |
|
1,732 |
|
|
1,394 |
Total current liabilities |
|
4,451 |
|
|
2,500 |
Lease liability |
|
- |
|
|
1,233 |
Other liabilities |
|
100 |
|
|
- |
Total liabilities |
|
4,551 |
|
|
3,733 |
Stockholders’ equity |
|
15,272 |
|
|
15,731 |
Total liabilities and stockholders’ equity |
$ |
19,823 |
|
$ |
19,464 |
|
|
|
|
SOURCE: Cyclacel Pharmaceuticals, Inc.
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