Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP)
("Cyclacel" or the "Company"), a biopharmaceutical company
developing oral therapies that target the various phases of cell
cycle control for the treatment of cancer and other serious
disorders, today reported its financial results and business
highlights for the third quarter ended September 30, 2017.
The Company's net loss applicable to common
shareholders for the three months ended September 30, 2017 was $8.9
million, which includes a $7.0 million charge in the quarter
related to accounting for the Series A Convertible Preferred Stock
issued in the July financing, or $0.91 per share, compared to net
loss applicable to common shareholders of $3.0 million, or $0.86
per share, for the third quarter of 2016. As of September 30, 2017,
cash and cash equivalents totaled $26.0 million.
“Following selection of a recommended Phase 2 dose,
or RP2D, for our CYC065 CDK inhibitor, we are advancing our
clinical programs, led by CYC065 in selected, patient populations
relevant to the drug’s mechanism,” said Spiro Rombotis, President
and Chief Executive Officer of Cyclacel. “In part 1 of an ongoing,
Phase 1 study, CYC065 demonstrated durable target engagement and
biomarker suppression at well tolerated doses in 11 out of 13
patients treated at the RP2D. Initial anticancer activity was
observed in five patients, which included patients with relevant
tumor molecular features. In parallel, we are progressing
designs for further translational clinical studies to evaluate
CYC065 in combination with venetoclax in chronic lymphocytic
leukemia, or CLL; alone and with standard of care in solid tumors,
in which we believe biomarker suppression may be beneficial; and in
certain pediatric cancers. Data from the Phase 3 SEAMLESS study of
sapacitabine have been selected for oral presentation at the
American Society of Hematology, or ASH, Annual Meeting in December.
The presentation will include additional data emerging from a
comprehensive analysis of prespecified subgroups, e.g. low
peripheral white blood cell count, which will form the basis of the
Company’s consultations with regulatory authorities. Following our
July offering, we project cash resources to fund currently planned
programs through the end of 2019."
Business Highlights
Transcriptional Regulation
Program: CYC065 CDK inhibitor
- Part 2 of the Phase 1 translational study will evaluate
additional dosing schedules in patients with advanced solid tumors,
in particular those with amplification of cyclin E, Mcl-1 or MYC,
including subsets of high grade serous ovarian and uterine cancers.
Biospecimens will be collected for assessment of biomarkers related
to CYC065’s mechanism of action. In part 1 of an ongoing,
first-in-human, single agent, ascending dose, Phase 1 study,
prolonged reduction of Mcl-1 was observed in 11 out of 13 evaluable
patients treated at the RP2D following a single dose of CYC065,
which was generally well tolerated. Preliminary anticancer activity
was observed in 5 patients, of which 4 were treated at the RP2D and
3 of which were reported by investigators to have molecular
features of their cancers associated with CYC065’s mechanism of
action, including overexpression or amplification of Mcl-1, MYC
and/or cyclin E. The trial is being conducted at the Dana Farber
Cancer Institute in Boston.
- Discussions with principal investigators and/or cooperative
groups are progressing with the objective of evaluating CYC065 in
both pediatric and adult patients. One such study, to be conducted
as an investigator sponsored trial, will evaluate the drug in
patients with leukemias, including AML, and in particular those
with mixed lineage leukemia rearrangements, or MLL-r. In
parallel, the Company is discussing with investigators a potential
evaluation of CYC065 in patients with neuroblastoma, a mostly
pediatric life-threatening malignancy, frequently associated with
MYC amplification.
DNA Damage Response
(DDR) Program
- Enrollment has been completed in an extension of the Phase 1
study evaluating the combination regimen of sapacitabine and
seliciclib, our first generation CDK inhibitor, in an enriched
population of approximately 20 patients with BRCA positive advanced
breast cancer.
- Part 3 of this study has been opened for enrolment with the
objective of testing a revised dosing schedule in additional
patients, including BRCA positive, ovarian and pancreatic cancer
patients.
SEAMLESS Phase 3 Study
- Data from the SEAMLESS study of sapacitabine in acute myeloid
leukemia, or AML, have been selected for oral presentation at the
59th ASH Annual Meeting in Atlanta, Georgia, on December 11,
2017.
- The presentation will include additional data from a
comprehensive analysis of the SEAMLESS dataset with the objective
of characterizing the prespecified subgroups of patients, e.g.
those with low peripheral white blood cell count, who appeared to
have clinically relevant benefit from the investigational treatment
regimen.
- As previously reported, in the intent-to-treat population, the
investigational arm of the SEAMLESS study did not reach
statistically significant improvement in OS versus an active
control. However, improvement in OS was observed in a
stratified subgroup of patients with low baseline peripheral white
blood cell count. The subgroup comprised approximately two-thirds
of the study's population.
- Following analysis of the full SEAMLESS data set and database
lock, the Company is developing submission materials to support
consultations with European and US authorities with the objective
of determining potential regulatory pathways.
July Underwritten Offering
- On July 21, 2017, the Company announced the closing of an
underwritten offering, with net proceeds of approximately $13.7
million after deducting underwriting discounts and commissions and
other estimated offering expenses, including full exercise of the
underwriters’ overallotment option. The Company issued and
sold in the offering (i) 3,154,000 Class A Units, each consisting
of one share of the Company’s common stock, and a warrant to
purchase one share of common stock, and (ii) 8,872 Class B Units,
each consisting of one share of the Company’s Series A Convertible
Preferred Stock convertible into 500 shares of common stock at the
initial conversion price, and a warrant to purchase a number of
shares of common stock equal to $1,000 divided by the conversion
price. The price to the public in the offering was $2.00 per Class
A Unit and $1,000 per Class B Unit.
- To date, holders of 8,608 (97%) shares out of the 8,872
initially issued shares of Series A Preferred Stock have elected to
convert their shares into 4,304,000 shares of common stock.
Following such conversions, 11,904,521 shares of common stock and
264 (3%) shares of Series A Preferred Stock remain
outstanding.
Business HighlightsAnticipated Upcoming
Milestones
- Initiate CYC065 Phase 1b in relapsed/refractory CLL in
combination with venetoclax, a Bcl-2 inhibitor
- Update mature data from the part 1 extension
sapacitabine/seliciclib DDR study in the BRCA +ve breast cancer
cohort
- Complete part 3 in the sapacitabine/seliciclib DDR study in
patients with BRCA +ve cancers, including ovarian and
pancreatic
- Submit CYC140 (PLK1 inhibitor) IND application
- Update CYC065 Phase 1 data in solid tumors
- Conduct regulatory authority meetings regarding the SEAMLESS
study of sapacitabine in AML
Financial Highlights
Revenues for the three months and year ended September 30, 2017
were $0.0 million compared to $0.2 million for the same period of
the previous year.
As of September 30, 2017, cash and cash equivalents totaled
$26.0 million, compared to $16.5 million as of December 31,
2016.
Research and development expenses were $1.0 million compared to
$2.4 million for the same periods in 2016.
General and administrative expenses for the three months ended
September 30, 2017 decreased to $1.2 million compared to $1.3
million for the same period in 2016.
Other expense, net for the three months ended September 30, 2017
were $0.0 million, compared to $0.1 million for the same period of
the previous year. The increase in other income (expense) is
primarily related to foreign exchange movements.
The UK research & tax credit for the quarter was $0.2
million.
Net loss for the three months September 30, 2017 was $1.9
million compared to $2.9 million for the same period in 2016.
At of the end of the quarter the company had cash of $26.0
million.
Conference call information (November 9, 2017 at 4:30
p.m. ET):
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 4396538
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 using cell cycle, transcriptional regulation and DNA damage
response biology to develop innovative, targeted medicines for
cancer and other proliferative diseases. Cyclacel's transcriptional
regulation program is evaluating CYC065, a CDK inhibitor, in
patients with advanced cancers. The DNA damage response program is
evaluating a sequential regimen of sapacitabine and seliciclib, a
CDK inhibitor, in patients with BRCA positive, advanced solid
cancers. 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.
ContactsCompany: Paul McBarron, (908) 517-7330,
pmcbarron@cyclacel.comInvestor Relations: Russo Partners LLC,
Alexander Fudukidis, (646) 942-5632,
alex.fudukidis@russopartnersllc.com
© Copyright 2017 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, |
|
|
Nine months Ended September
30, |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
2017 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
205 |
|
|
|
$ |
- |
|
|
|
$ |
566 |
|
|
|
$ |
- |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
2,409 |
|
|
|
|
958 |
|
|
|
|
7,545 |
|
|
|
|
3,491 |
|
General and
administrative |
|
|
1,273 |
|
|
|
|
1,154 |
|
|
|
|
4,002 |
|
|
|
|
3,802 |
|
Total operating
expenses |
|
|
3,682 |
|
|
|
|
2,112 |
|
|
|
|
11,547 |
|
|
|
|
7,293 |
|
Operating
loss |
|
|
(3,477 |
) |
|
|
|
(2,112 |
) |
|
|
|
(10,981 |
) |
|
|
|
(7,293 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange gains
(losses) |
|
|
51 |
|
|
|
|
(22 |
) |
|
|
|
369 |
|
|
|
|
(65 |
) |
Interest income |
|
|
8 |
|
|
|
|
30 |
|
|
|
|
31 |
|
|
|
|
59 |
|
Other income, net |
|
|
18 |
|
|
|
|
28 |
|
|
|
|
56 |
|
|
|
|
907 |
|
Total other income |
|
|
77 |
|
|
|
|
36 |
|
|
|
|
456 |
|
|
|
|
901 |
|
Loss before
taxes |
|
|
(3,400 |
) |
|
|
|
(2,076 |
) |
|
|
|
(10,525 |
) |
|
|
|
(6,392 |
) |
Income tax benefit |
|
|
454 |
|
|
|
|
219 |
|
|
|
|
1,573 |
|
|
|
|
793 |
|
Net
loss |
|
|
(2,946 |
) |
|
|
|
(1,857 |
) |
|
|
|
(8,952 |
) |
|
|
|
(5,599 |
) |
Dividend on convertible
exchangeable preferred shares |
|
|
(50 |
) |
|
|
|
(50 |
) |
|
|
|
(150 |
) |
|
|
|
(151 |
) |
Beneficial conversion
feature of Series A convertible stock |
|
|
- |
|
|
|
|
(3,638 |
) |
|
|
|
- |
|
|
|
|
(3,638 |
) |
Conversion of Series A
convertible preferred stock |
|
|
- |
|
|
|
|
(3,373 |
) |
|
|
|
- |
|
|
|
|
(3,373 |
) |
Net loss
applicable to common shareholders |
|
$ |
(2,996 |
) |
|
|
$ |
(8,918 |
) |
|
|
$ |
(9,102 |
) |
|
|
$ |
(12,761 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted earnings per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share – basic and diluted |
|
$ |
(0.86 |
) |
|
|
$ |
(0.91 |
) |
|
|
$ |
(2.89 |
) |
|
|
$ |
(2.06 |
) |
Weighted average common
shares outstanding |
|
|
3,473,696 |
|
|
|
|
9,835,441 |
|
|
|
|
3,145,730 |
|
|
|
|
6,200,783 |
|
|
CYCLACEL PHARMACEUTICALS, INC. |
CONSOLIDATED BALANCE SHEETS |
(In $000s, except share, per share, and
liquidation preference amounts) |
(Unaudited) |
|
|
|
December 31, |
|
|
September 30, |
|
|
|
2016 |
|
|
2017 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
16,520 |
|
|
$ |
26,025 |
|
Prepaid
expenses and other current assets |
|
|
3,097 |
|
|
|
1,792 |
|
Total
current assets |
|
|
19,617 |
|
|
|
27,817 |
|
Property, plant and
equipment (net) |
|
|
45 |
|
|
|
34 |
|
Total
assets |
|
$ |
19,662 |
|
|
$ |
27,851 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
2,497 |
|
|
$ |
1,973 |
|
Accrued
and other current liabilities |
|
|
2,762 |
|
|
|
2,292 |
|
Total
current liabilities |
|
|
5,259 |
|
|
|
4,265 |
|
Other liabilities |
|
|
130 |
|
|
|
128 |
|
Total
liabilities |
|
|
5,389 |
|
|
|
4,393 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value; 5,000,000 shares authorized at
December 31, 2016 and September 30, 2017; 6%
Convertible Exchangeable preferred stock; 335,273 shares issued and
outstanding at December 31, 2016 and September 30, 2017.
Aggregate preference in liquidation of $4,006,512 at
December 31, 2016 and September 30, 2017. |
|
|
— |
|
|
|
— |
|
Series A preferred stock; 0 shares and 664 shares issued and
outstanding at December 31, 2016 and September 30, 2017
respectively. |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 100,000,000 shares authorized
at December 31, 2016 and September 30, 2017; 4,256,829 and
11,697,021 shares issued and outstanding at December 31, 2016
and September 30, 2017 respectively. |
|
|
4 |
|
|
|
12 |
|
Additional paid-in
capital |
|
|
350,051 |
|
|
|
364,843 |
|
Accumulated other
comprehensive loss |
|
|
(743 |
) |
|
|
(762 |
) |
Accumulated
deficit |
|
|
(335,039 |
) |
|
|
(340,635 |
) |
Total
stockholders’ equity |
|
|
14,273 |
|
|
|
23,458 |
|
Total
liabilities and stockholders’ equity |
|
$ |
19,662 |
|
|
$ |
27,851 |
|
|
SOURCE: Cyclacel Pharmaceuticals, Inc.
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