NuCana Reports Third Quarter 2023 Financial Results and Provides Business Update
17 11월 2023 - 6:01AM
NuCana plc (NASDAQ: NCNA) announced financial results for the third
quarter ended September 30, 2023 and provided an update on its
broad clinical development program with its transformative ProTide
therapeutics.
As of September 30, 2023, NuCana had cash and cash equivalents
of £17.8 million compared to £24.6 million at June 30, 2023 and
£41.9 million at December 31, 2022. NuCana continues to advance its
various clinical programs and reported a net loss of £6.7 million
for the quarter ended September 30, 2023, as compared to a net loss
of £4.5 million for the quarter ended September 30, 2022. Basic and
diluted loss per share was £0.13 for the quarter ended September
30, 2023, as compared to £0.09 per share for the comparable quarter
ended September 30, 2022.
“We were excited to have recently presented promising clinical
data for both NUC-3373 and NUC-7738 that continue to support the
potential of our ProTides to transform the treatment of patients
with cancer.” said Hugh S. Griffith, NuCana’s Founder and Chief
Executive Officer. “For NUC-3373, we presented the first data in
second-line patients with colorectal cancer from Part 3 of the
NuTide:302 study. These data supported NUC-3373’s favorable safety
profile and demonstrated encouraging signs of efficacy, including
tumor volume reductions in patients who have failed prior
fluoropyrimidine treatment. The data also showed that most patients
dosed with NUC-3373 in combination with irinotecan, leucovorin and
bevacizumab (NUFIRI-bev) achieved a longer progression free
survival compared to their first-line treatment with a 5-FU-based
therapy. We were also pleased to report that NuTide:323, our
randomized Phase 2 study of NUFIRI-bev compared to the standard of
care FOLFIRI-bev in second-line patients with colorectal cancer
remains on track to reach full enrollment in the coming months and
that no new safety signals have been observed.”
Mr. Griffith continued: “We also presented data from the Phase 2
part of the NuTide:701 study evaluating NUC-7738 both as a
monotherapy in patients with solid tumors and in combination with
the anti-PD-1 therapy pembrolizumab in patients with metastatic
melanoma who had exhausted standard therapies. The data showed
NUC-7738 to be well tolerated with promising signs of efficacy,
including tumor volume reductions and prolonged time on treatment.
Importantly, these data indicated that NUC-7738 may potentiate the
activity of anti-PD-1 agents in patients who were refractory to or
progressed on prior immunotherapy, including anti-PD-1 therapy. We
look forward to sharing additional updates as these data continue
to mature.”
Mr. Griffith concluded, “We have executed on all of our goals
this year and we look forward to providing numerous data updates
throughout 2024, including additional data from the NuTide:323
study. With a cash runway that is expected to extend into 2025, we
are excited as we continue towards our goal of improving treatment
outcomes for patients with cancer.”
2024 Anticipated Milestones
- NUC-3373 (a ProTide transformation of 5-FU)
In 2024, NuCana expects to:
- Announce data from the randomized Phase 2 (NuTide:323) study of
NUFIRI-bev compared to the standard of care FOLFIRI-bev for the
second-line treatment of patients with colorectal cancer;
- Announce data from the Phase 2 (NuTide:302) study of NUC-3373
in combination with irinotecan, leucovorin and bevacizumab
(NUFIRI-bev) and in combination with oxaliplatin, leucovorin and
bevacizumab (NUFOX-bev) for the second-line treatment of patients
with colorectal cancer; and
- Announce data from the Phase 1b (NuTide:303) modular study of
NUC-3373 in combination with pembrolizumab in patients with solid
tumors and in combination with docetaxel in patients with lung
cancer to identify additional indications for development.
- NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)
In 2024, NuCana expects to:
- Announce data from the Phase 2 part of the NuTide:701 study of
NUC-7738 in combination with pembrolizumab in patients with
melanoma.
About NuCana
NuCana is a clinical-stage biopharmaceutical
company focused on significantly improving treatment outcomes for
patients with cancer by applying our ProTide technology to
transform some of the most widely prescribed chemotherapy agents,
nucleoside analogs, into more effective and safer medicines. While
these conventional agents remain part of the standard of care for
the treatment of many solid and hematological tumors, they have
significant shortcomings that limit their efficacy and they are
often poorly tolerated. Utilizing our proprietary technology, we
are developing new medicines, ProTides, designed to overcome the
key limitations of nucleoside analogs and generate much higher
concentrations of anti-cancer metabolites in cancer cells. NuCana’s
pipeline includes NUC-3373 and NUC-7738. NUC-3373 is a new chemical
entity derived from the nucleoside analog 5-fluorouracil, a widely
used chemotherapy agent. NUC-3373 is currently being evaluated in
three ongoing clinical studies: a Phase 1b/2 study (NuTide:302) in
combination with leucovorin, irinotecan or oxaliplatin, and
bevacizumab in patients with metastatic colorectal cancer; a
randomized Phase 2 study (NuTide:323) in combination with
leucovorin, irinotecan, and bevacizumab for the second-line
treatment of patients with advanced colorectal cancer; and a Phase
1b/2 modular study (NuTide:303) of NUC-3373 in combination with the
PD-1 inhibitor pembrolizumab for patients with advanced solid
tumors and in combination with docetaxel for patients with lung
cancer. NUC-7738 is a transformation of 3’-deoxyadenosine, a novel
anti-cancer nucleoside analog. NUC-7738 is in the Phase 2 part of a
Phase 1/2 study in patients with advanced solid tumors which is
evaluating NUC-7738 as a monotherapy and in combination with
pembrolizumab.
Forward-Looking StatementsThis press release
may contain “forward-looking” statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that are based on
the beliefs and assumptions and on information currently available
to management of NuCana plc (the “Company”). All statements other
than statements of historical fact contained in this press release
are forward-looking statements, including statements concerning the
Company’s planned and ongoing clinical studies for the Company’s
product candidates and the potential advantages of those product
candidates, including NUC-3373 and NUC-7738; the initiation,
enrollment, timing, progress, release of data from and results of
those planned and ongoing clinical studies; the Company’s goals
with respect to the development, regulatory pathway and potential
use, if approved, of each of its product candidates; the utility of
prior non-clinical and clinical data in determining future clinical
results; and the sufficiency of the Company’s current cash, cash
equivalents and marketable securities to fund its planned
operations into 2025. In some cases, you can identify
forward-looking statements by terminology such as “may,” “will,”
“should,” “expects,” “plans,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative
of these terms or other comparable terminology. Forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the Company’s actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. These risks and uncertainties include,
but are not limited to, the risks and uncertainties set forth in
the “Risk Factors” section of the Company’s Annual Report on Form
20-F for the year ended December 31, 2022 filed with the Securities
and Exchange Commission (“SEC”) on April 4, 2023, and subsequent
reports that the Company files with the SEC. Forward-looking
statements represent the Company’s beliefs and assumptions only as
of the date of this press release. Although the Company believes
that the expectations reflected in the forward-looking statements
are reasonable, it cannot guarantee future results, levels of
activity, performance or achievements. Except as required by law,
the Company assumes no obligation to publicly update any
forward-looking statements for any reason after the date of this
press release to conform any of the forward-looking statements to
actual results or to changes in its expectations.
Unaudited Condensed Consolidated Statements of
Operations
|
|
For the Three Months EndedSeptember
30, |
|
For the Nine Months EndedSeptember
30, |
|
|
|
|
|
2023 |
|
2022 |
|
|
2023 |
|
2022 |
|
|
|
(in thousands, except per share data) |
|
|
£ |
|
£ |
|
|
£ |
|
£ |
|
Research and development
expenses |
|
(7,439 |
) |
(7,386 |
) |
|
(18,203 |
) |
(23,238 |
) |
Administrative expenses |
|
(1,375 |
) |
(1,715 |
) |
|
(4,777 |
) |
(5,756 |
) |
Net foreign exchange gains
(losses) |
|
562 |
|
2,912 |
|
|
(697 |
) |
7,120 |
|
Operating
loss |
|
(8,252 |
) |
(6,189 |
) |
|
(23,677 |
) |
(21,874 |
) |
Finance income |
|
152 |
|
216 |
|
|
617 |
|
380 |
|
Loss before
tax |
|
(8,100 |
) |
(5,973 |
) |
|
(23,060 |
) |
(21,494 |
) |
Income tax credit |
|
1,404 |
|
1,445 |
|
|
3,083 |
|
4,672 |
|
Loss for the period
attributable to equity holders of the Company |
|
(6,696 |
) |
(4,528 |
) |
|
(19,977 |
) |
(16,822 |
) |
|
|
|
|
|
|
|
Basic and diluted loss per
share |
|
(0.13 |
) |
(0.09 |
) |
|
(0.38 |
) |
(0.32 |
) |
|
|
|
|
|
|
Unaudited Condensed Consolidated Statements of Financial
Position as at
|
|
September 30, 2023 |
|
December 31, 2022 |
|
|
(in thousands) |
|
|
£ |
£ |
Assets |
|
|
|
Non-current
assets |
|
|
|
Intangible assets |
|
2,583 |
|
2,365 |
|
Property, plant and
equipment |
|
612 |
|
866 |
|
Deferred tax asset |
|
127 |
|
103 |
|
|
|
3,322 |
|
3,334 |
|
|
|
Current
assets |
|
|
|
Prepayments, accrued income and
other receivables |
|
3,414 |
|
3,957 |
|
Current income tax
receivable |
|
9,428 |
|
6,367 |
|
Other assets |
|
- |
|
2,684 |
|
Cash and cash equivalents |
|
17,803 |
|
41,912 |
|
|
|
30,645 |
|
54,920 |
|
Total
assets |
|
33,967 |
|
58,254 |
|
|
|
|
|
Equity and
liabilities |
|
|
|
Capital and
reserves |
|
|
|
Share capital and share
premium |
|
143,400 |
|
143,203 |
|
Other reserves |
|
78,430 |
|
75,872 |
|
Accumulated deficit |
|
(200,056 |
) |
(180,573 |
) |
Total equity
attributable to equity holders of the Company |
|
21,774 |
|
38,502 |
|
Non-current
liabilities |
|
|
|
Provisions |
|
58 |
|
46 |
|
Lease liabilities |
|
222 |
|
396 |
|
|
|
280 |
|
442 |
|
Current
liabilities |
|
|
|
Trade payables |
|
5,174 |
|
4,803 |
|
Payroll taxes and social
security |
|
165 |
|
162 |
|
Accrued expenditure |
|
6,344 |
|
10,002 |
|
Lease liabilities |
|
230 |
|
243 |
|
Provisions |
|
- |
|
4,100 |
|
|
|
11,913 |
|
19,310 |
|
Total
liabilities |
|
12,193 |
|
19,752 |
|
Total equity and
liabilities |
|
33,967 |
|
58,254 |
|
|
|
|
|
Unaudited Condensed Consolidated Statements of Cash
Flows
|
For the Nine Months EndedSeptember
30, |
|
2023 |
|
2022 |
|
|
(in thousands) |
|
£ |
£ |
Cash flows from operating activities |
|
|
Loss for the period |
(19,977 |
) |
(16,822 |
) |
Adjustments for: |
|
|
Income tax credit |
(3,083 |
) |
(4,672 |
) |
Amortization, depreciation and
loss on disposal |
434 |
|
676 |
|
Movement in provisions |
(4,109 |
) |
- |
|
Finance income |
(617 |
) |
(380 |
) |
Interest expense on lease
liabilities |
23 |
|
11 |
|
Share-based payments |
3,073 |
|
3,900 |
|
Net foreign exchange losses
(gains) |
661 |
|
(7,233 |
) |
|
(23,595 |
) |
(24,520 |
) |
Movements in working capital: |
|
|
Decrease (increase) in
prepayments, accrued income and other receivables |
531 |
|
(2,758 |
) |
Increase in trade payables |
371 |
|
3,785 |
|
Decrease in payroll taxes, social
security and accrued expenditure |
(3,667 |
) |
(101 |
) |
Movements in working capital |
(2,765 |
) |
926 |
|
Cash used in
operations |
(26,360 |
) |
(23,594 |
) |
Net income tax (paid)
received |
(2 |
) |
7,220 |
|
Net cash used in
operating activities |
(26,362 |
) |
(16,374 |
) |
Cash flows from investing activities |
|
|
Interest received |
620 |
|
368 |
|
Payments for property, plant and
equipment |
(4 |
) |
(12 |
) |
Payments for intangible
assets |
(377 |
) |
(396 |
) |
Repayment of other current
assets |
2,596 |
|
- |
|
Net cash from (used
in) investing activities |
2,835 |
|
(40 |
) |
Cash flows from financing activities |
|
|
Payments for lease
liabilities |
(207 |
) |
(189 |
) |
Proceeds from issue of share
capital – exercise of share options |
3 |
|
1 |
|
Proceeds from issue of share
capital |
224 |
|
- |
|
Share issue expense |
(30 |
) |
- |
|
Net cash used in
financing activities |
(10 |
) |
(188 |
) |
Net decrease in cash and cash
equivalents |
(23,537 |
) |
(16,602 |
) |
Cash and cash
equivalents at beginning of period |
41,912 |
|
60,264 |
|
Effect of exchange rate changes
on cash and cash equivalents |
(572 |
) |
7,090 |
|
Cash and cash
equivalents at end of period |
17,803 |
|
50,752 |
|
|
|
|
|
For more information, please contact:
NuCana plcHugh S. GriffithChief Executive Officer +44
131-357-1111 info@nucana.com
ICR WestwickeChris Brinzey+1
339-970-2843chris.brinzey@westwicke.com
NuCana (NASDAQ:NCNA)
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NuCana (NASDAQ:NCNA)
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