NuCana plc (NASDAQ: NCNA) announced financial results for the
fourth quarter and year ended December 31, 2023 and provided an
update on its broad clinical development program with its
transformative ProTide therapeutics.
As of December 31, 2023, NuCana had cash and cash equivalents of
£17.2 million compared to £17.8 million as of September 30, 2023
and £41.9 million as of December 31, 2022. NuCana continues to
advance its various clinical programs and reported a net loss of
£7.7 million for the quarter ended December 31, 2023, as compared
to a net loss of £15.2 million for the quarter ended December 31,
2022. Net loss for the year ended December 31, 2023 was £27.6
million, compared to a net loss of £32.0 million for the year ended
December 31, 2022. Basic and diluted loss per share was £0.14 for
the quarter and £0.53 for the year ended December 31, 2023, as
compared to £0.29 per share for the comparable quarter and £0.61
for the year ended December 31, 2022.
“In 2023, we announced data that demonstrated encouraging
signals of efficacy and favorable safety profiles for our ProTides,
NUC-3373 and NUC-7738,” said Hugh S. Griffith, NuCana’s Founder and
Chief Executive Officer. “Working towards our mission of improving
treatment outcomes for patients with cancer by developing more
effective and safer medicines, we look forward to providing
important data readouts across our pipeline in 2024.”
Mr. Griffith continued: “Our development programs for both
NUC-3373 and NUC-7738 are progressing well. NUC-3373, our ProTide
transformation of 5-FU, is being evaluated in three ongoing
clinical studies. Our randomized Phase 2 study is comparing
NUC-3373 in combination with irinotecan, leucovorin and bevacizumab
(NUFIRI + bev) with the standard of care, 5-FU in combination with
irinotecan, leucovorin and bevacizumab (FOLFIRI + bev) for the
second-line treatment of patients with advanced colorectal cancer.
We have now fully recruited all 171 patients to the study and we
remain on track to announce data from this study in 2024.
Additionally, we are completing our Phase 1b/2 study of NUFIRI +
bev and NUFOX + bev in patients with metastatic colorectal cancer.
We recently presented data from this study demonstrating that
NUFIRI + bev and NUFOX + bev showed a favorable safety profile and
encouraging signs of efficacy, including tumor volume reductions.
In addition, several patients achieved a longer progression-free
survival (PFS) on NUC-3373-based regimens as compared to the PFS
achieved in their first-line treatment with 5-FU-based therapy.
Lastly, we remain on track to announce data in 2024 from our Phase
1b/2 study of NUC-3373 in combination with pembrolizumab in
patients with solid tumors and in combination with docetaxel in
patients with lung cancer.”
Mr. Griffith continued: “Moving to NUC-7738, we recently
presented data from the Phase 2 part of the Phase 1/2 study of
NUC-7738 in combination with pembrolizumab in patients with
melanoma. These data showed tumor volume reductions and prolonged
time on treatment and 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 from this study in
2024.”
Mr. Griffith concluded, “With a cash runway that is expected to
extend into 2025, we look forward to providing a number of
important data updates in the coming year as we continue to advance
our pipeline of ProTides.”
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 advanced colorectal
cancer;
- Announce data from the Phase 1b/2 (NuTide:302) study of NUFIRI
+ bev and NUFOX + bev for the second-line treatment of patients
with advanced colorectal cancer; and
- Announce data from the Phase 1b/2 (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.
- NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)
In 2024, NuCana expects to:
-
- Announce data from the Phase 2 part of the Phase 1/2 study
(NuTide:701) 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, 2023 filed with the Securities
and Exchange Commission (“SEC”) on March 20, 2024, 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.
Condensed Consolidated Statements of
Operations
| |
For the Three Months EndedDecember
31, |
|
For the Year EndedDecember
31, |
|
|
2023 |
|
2022 |
|
|
2023 |
|
2022 |
|
| |
(in thousands, except per share data) |
| |
(unaudited) |
|
|
|
| |
£ |
|
£ |
|
|
£ |
|
£ |
|
| Research and development
expenses |
(6,859 |
) |
(13,188 |
) |
|
(25,062 |
) |
(36,426 |
) |
| Administrative expenses |
(1,286 |
) |
(1,535 |
) |
|
(6,063 |
) |
(7,291 |
) |
| Impairment of intangible
assets |
(503 |
) |
(292 |
) |
|
(503 |
) |
(292 |
) |
| Net foreign exchange (losses)
gains |
(459 |
) |
(2,233 |
) |
|
(1,156 |
) |
4,887 |
|
| Operating
loss |
(9,107 |
) |
(17,248 |
) |
|
(32,784 |
) |
(39,122 |
) |
| Finance income |
137 |
|
289 |
|
|
754 |
|
669 |
|
| Loss before
tax |
(8,970 |
) |
(16,959 |
) |
|
(32,030 |
) |
(38,453 |
) |
| Income tax credit |
1,315 |
|
1,760 |
|
|
4,398 |
|
6,432 |
|
| Loss for the
period |
(7,655 |
) |
(15,199 |
) |
|
(27,632 |
) |
(32,021 |
) |
| |
|
|
|
|
|
| Basic and diluted loss per
share |
(0.14 |
) |
(0.29 |
) |
|
(0.53 |
) |
(0.61 |
) |
| |
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Financial Position
At
|
|
December 31, 2023 |
|
December 31, 2022 |
|
|
|
(in thousands) |
|
|
|
£ |
|
£ |
|
| Assets |
|
|
|
|
| Non-current
assets |
|
|
|
|
|
Intangible assets |
2,128 |
|
2,365 |
|
| Property, plant and
equipment |
521 |
|
866 |
|
| Deferred tax asset |
143 |
|
103 |
|
| |
2,792 |
|
3,334 |
|
| Current
assets |
|
|
| Prepayments, accrued income and
other receivables |
2,671 |
|
3,957 |
|
| Current income tax
receivable |
5,123 |
|
6,367 |
|
| Other assets |
- |
|
2,684 |
|
| Cash and cash equivalents |
17,225 |
|
41,912 |
|
| |
25,019 |
|
54,920 |
|
| Total
assets |
27,811 |
|
58,254 |
|
| |
|
|
| Equity and
liabilities |
|
|
| Capital and
reserves |
|
|
| Share capital and share
premium |
143,420 |
|
143,203 |
|
| Other reserves |
79,173 |
|
75,872 |
|
| Accumulated deficit |
(207,706 |
) |
(180,573 |
) |
| Total equity
attributable to equity holders of the Company |
14,887 |
|
38,502 |
|
| |
|
|
| Non-current
liabilities |
|
|
| Provisions |
58 |
|
46 |
|
| Lease liabilities |
190 |
|
396 |
|
| |
248 |
|
442 |
|
| Current
liabilities |
|
|
| Trade payables |
3,375 |
|
4,803 |
|
| Payroll taxes and social
security |
155 |
|
162 |
|
| Accrued expenditure |
8,940 |
|
10,002 |
|
| Lease liabilities |
206 |
|
243 |
|
| Provisions |
- |
|
4,100 |
|
| |
12,676 |
|
19,310 |
|
| Total
liabilities |
12,924 |
|
19,752 |
|
| Total equity and
liabilities |
27,811 |
|
58,254 |
|
| |
Condensed Consolidated Statements of Cash
Flows
| |
For the Year Ended December 31, |
|
|
2023 |
|
|
2022 |
|
| |
(in thousands) |
| |
£ |
|
|
£ |
|
| Cash flows from operating
activities |
|
|
|
| Loss for the period |
(27,632 |
) |
|
(32,021 |
) |
| Adjustments for: |
|
|
|
| Income tax credit |
(4,398 |
) |
|
(6,432 |
) |
| Amortization, depreciation and
loss on disposal |
575 |
|
|
732 |
|
| Impairment of intangible
assets |
503 |
|
|
292 |
|
| Movement in provisions |
(4,109 |
) |
|
4,100 |
|
| Finance income |
(754 |
) |
|
(669 |
) |
| Interest expense on lease
liabilities |
29 |
|
|
21 |
|
| Share-based payments |
3,857 |
|
|
4,890 |
|
| Net foreign exchange losses
(gains) |
1,176 |
|
|
(5,014 |
) |
| |
(30,753 |
) |
|
(34,101 |
) |
| Movements in working
capital: |
|
|
|
| Decrease in prepayments, accrued
income and other receivables |
1,234 |
|
|
307 |
|
| (Decrease) increase in trade
payables |
(1,428 |
) |
|
2,974 |
|
| (Decrease) increase in payroll
taxes, social security and accrued expenditure |
(1,087 |
) |
|
442 |
|
| Movements in working capital |
(1,281 |
) |
|
3,723 |
|
| Cash used in
operations |
(32,034 |
) |
|
(30,378 |
) |
| Net income tax received |
5,595 |
|
|
7,220 |
|
| Net cash used in
operating activities |
(26,439 |
) |
|
(23,158 |
) |
| Cash flows from investing
activities |
|
|
|
| Interest received |
770 |
|
|
638 |
|
| Payments for property, plant and
equipment |
(4 |
) |
|
(12 |
) |
| Payments for intangible
assets |
(474 |
) |
|
(506 |
) |
| Repayment of other assets |
2,596 |
|
|
- |
|
| Net cash from investing
activities |
2,888 |
|
|
120 |
|
| Cash flows from financing
activities |
|
|
|
| Payments for lease
liabilities |
(270 |
) |
|
(227 |
) |
| Proceeds from issue of share
capital – exercise of share options |
4 |
|
|
66 |
|
| Proceeds from issue of share
capital |
249 |
|
|
- |
|
| Share issue expenses |
(36 |
) |
|
- |
|
| Net cash used in
financing activities |
(53 |
) |
|
(161 |
) |
| Net decrease in cash and cash
equivalents |
(23,604 |
) |
|
(23,199 |
) |
| Cash and cash equivalents
at beginning of year |
41,912 |
|
|
60,264 |
|
| Effect of exchange rate changes
on cash and cash equivalents |
(1,083 |
) |
|
4,847 |
|
| Cash and cash equivalents
at end of year |
17,225 |
|
|
41,912 |
|
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
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