NuCana Reports First Quarter 2023 Financial Results and Provides Business Update
May 17 2023 - 4:01PM
NuCana plc (NASDAQ: NCNA) announced financial results for the first
quarter ended March 31, 2023 and provided an update on its broad
clinical development program with its transformative ProTide
therapeutics.
As of March 31, 2023, NuCana had cash and cash equivalents of
£31.0 million compared to £41.9 million at December 31, 2022.
NuCana continues to advance its various clinical programs and
reported a net loss of £7.9 million for the quarter ended March 31,
2023, as compared to a net loss of £8.4 million for the quarter
ended March 31, 2022. Basic and diluted loss per share was £0.15
for the quarter ended March 31, 2023, as compared to £0.16 per
share for the comparable quarter ended March 31, 2022.
“Building off of a productive 2022 and executing on a number of
milestones that continued to demonstrate the potential of our
ProTides, we entered 2023 with strong momentum,” said Hugh S.
Griffith, NuCana’s Founder and Chief Executive Officer. “We
continue to advance NUC-3373 and plan to provide data updates in
2023 from each of the three ongoing studies evaluating this
ProTide, which we believe has the potential to replace 5-FU across
multiple tumor types. These studies are: the Phase 2 portion of the
NuTide:302 study evaluating NUC-3373 combined with leucovorin and
either irinotecan (NUFIRI) or oxaliplatin (NUFOX) plus bevacizumab
in patients with second-line colorectal cancer; the randomized
Phase 2 NuTide:323 study of NUFIRI plus bevacizumab compared to the
standard of care FOLFIRI plus bevacizumab in patients with
second-line colorectal cancer; and the Phase 1b/2 NuTide:303
modular study of NUC-3373 both in combination with pembrolizumab in
patients with solid tumors and in combination with docetaxel in
patients with lung cancer.”
Mr. Griffith continued: “We recently presented data on NUC-7738
highlighting its multi-faceted mechanisms of action at the AACR
2023 Annual Meeting, which continues to support our clinical
development strategy. NUC-7738 is based on a novel nucleoside
analogue, 3’-deoxyadenosine, and is being evaluated in the Phase 2
part of the NuTide:701 study both as a monotherapy in patients with
solid tumors and in combination with pembrolizumab in patients with
melanoma. This study is progressing well and we anticipate sharing
additional data later this year.”
Mr. Griffith concluded: “With numerous upcoming value-driving
milestones and a cash runway expected to fund operations into 2025,
we are well positioned and look forward to an exciting year as we
advance our mission of developing safer and more effective
treatment options for patients with cancer.”
2023 Anticipated Milestones
- NUC-3373 (a ProTide transformation of 5-FU)
In 2023, NuCana expects to:
- Announce data from the Phase 2 (NuTide:302) study of NUC-3373
combined with irinotecan and bevacizumab (NUFIRI-bev) and in
combination with oxaliplatin and bevacizumab (NUFOX-bev) in
second-line patients with colorectal cancer;
- Announce data from the randomized Phase 2 (NuTide:323) study of
NUFIRI-bevacizumab versus the standard of care FOLFIRI-bevacizumab
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 2023, NuCana expects to:
- Announce data from the Phase 1 part of the NuTide:701 study of
NUC-7738 in patients with solid tumors; and
- Announce data from the Phase 2 part of the NuTide:701 study of
NUC-7738 both as monotherapy in patients with solid tumors and in
combination with pembrolizumab in patients with melanoma.
About NuCanaNuCana 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,
in combination with other agents, is in a Phase 1b/2 study in
patients with metastatic colorectal cancer. NuCana has also
initiated a randomized Phase 2 study of NUC-3373, in combination
with other agents, for the second-line treatment of patients with
advanced colorectal cancer. In addition, NuCana has initiated a
Phase 1b/2 modular study 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 EndedMarch
31, |
|
|
2023 |
|
2022 |
|
|
(in thousands, except per share data) |
|
|
£ |
£ |
Research and development
expenses |
|
(6,805 |
) |
|
(9,446 |
) |
Administrative
expenses |
|
(1,648 |
) |
|
(2,152 |
) |
Net foreign exchange (losses)
gains |
|
(695 |
) |
|
1,131 |
|
Operating
loss |
|
(9,148 |
) |
|
(10,467 |
) |
Finance
income |
|
287 |
|
|
31 |
|
Loss before
tax |
|
(8,861 |
) |
|
(10,436 |
) |
Income tax
credit |
|
994 |
|
|
2,033 |
|
Loss for the
period |
|
(7,867 |
) |
|
(8,403 |
) |
Basic and diluted loss per
share |
|
(0.15 |
) |
|
(0.16 |
) |
Unaudited
Condensed Consolidated Statements of Financial Position as
at |
|
|
March 31, 2023 |
|
December 31, 2022 |
|
|
|
(in thousands) |
|
|
£ |
£ |
Assets |
|
|
|
Non-current
assets |
|
|
|
Intangible assets |
|
2,473 |
|
2,365 |
|
Property, plant and
equipment |
|
791 |
|
866 |
|
Deferred tax asset |
|
107 |
|
103 |
|
|
|
3,371 |
|
3,334 |
|
Current
assets |
|
|
|
Prepayments, accrued income and
other receivables |
|
4,368 |
|
3,957 |
|
Current income tax
receivable |
|
7,354 |
|
6,367 |
|
Other assets |
|
2,658 |
|
2,684 |
|
Cash and cash equivalents |
|
31,001 |
|
41,912 |
|
|
|
45,381 |
|
54,920 |
|
Total
assets |
|
48,752 |
|
58,254 |
|
|
|
|
|
|
|
Equity and
liabilities |
|
|
|
|
|
|
|
Capital and
reserves |
|
|
|
Share capital and share
premium |
|
143,204 |
|
143,203 |
|
Other reserves |
|
76,904 |
|
75,872 |
|
Accumulated deficit |
|
(188,356 |
) |
(180,573 |
) |
Total equity
attributable to equity holders of the Company |
|
31,752 |
|
38,502 |
|
|
|
|
|
|
|
Non-current
liabilities |
|
|
|
Provisions |
|
58 |
|
46 |
|
Lease liabilities |
|
338 |
|
396 |
|
|
|
396 |
|
442 |
|
Current
liabilities |
|
|
|
Trade payables |
|
5,691 |
|
4,803 |
|
Payroll taxes and social
security |
|
166 |
|
162 |
|
Accrued expenditure |
|
6,429 |
|
10,002 |
|
Lease liabilities |
|
264 |
|
243 |
|
Provisions |
|
4,054 |
|
4,100 |
|
|
|
16,604 |
|
19,310 |
|
Total
liabilities |
|
17,000 |
|
19,752 |
|
Total equity and
liabilities |
|
48,752 |
|
58,254 |
|
|
|
|
|
Unaudited
Condensed Consolidated Statements of Cash Flows |
|
For the Three Months EndedMarch
31, |
|
2023 |
|
2022 |
|
|
(in thousands) |
|
£ |
£ |
Cash flows from
operating activities |
|
|
Loss for the period |
(7,867 |
) |
(8,403 |
) |
Adjustments for: |
|
|
Income tax credit |
(994 |
) |
(2,033 |
) |
Amortization and
depreciation |
143 |
|
197 |
|
Movement in provisions |
(55 |
) |
- |
|
Finance income |
(287 |
) |
(32 |
) |
Interest expense on lease
liabilities |
8 |
|
3 |
|
Share-based payments |
1,141 |
|
1,575 |
|
Net foreign exchange losses
(gains) |
726 |
|
(1,149 |
) |
|
(7,185 |
) |
(9,842 |
) |
Movements in working
capital: |
|
|
(Increase) decrease in
prepayments, accrued income and other receivables |
(463 |
) |
390 |
|
Increase in trade
payables |
888 |
|
870 |
|
Decrease in payroll taxes,
social security and accrued expenditure |
(3,575 |
) |
(38 |
) |
Movements in working
capital |
(3,150 |
) |
1,222 |
|
Cash used in
operations |
(10,335 |
) |
(8,620 |
) |
Net income tax received |
- |
|
- |
|
Net cash used in
operating activities |
(10,335 |
) |
(8,620 |
) |
Cash flows from
investing activities |
|
|
Interest received |
322 |
|
31 |
|
Payments for intangible
assets |
(159 |
) |
(166 |
) |
Net cash from (used
in) investing activities |
163 |
|
(135 |
) |
Cash flows from
financing activities |
|
|
Payments for lease
liabilities |
(42 |
) |
(75 |
) |
Proceeds from issue of share
capital |
1 |
|
1 |
|
Net cash used in
financing activities |
(41 |
) |
(74 |
) |
Net decrease in cash and cash
equivalents |
(10,213 |
) |
(8,829 |
) |
Cash and cash
equivalents at beginning of period |
41,912 |
|
60,264 |
|
Effect of exchange rate
changes on cash and cash equivalents |
(698 |
) |
1,126 |
|
Cash and cash
equivalents at end of period |
31,001 |
|
52,561 |
|
|
|
|
|
For more information, please contact:
NuCana plcHugh S. GriffithChief Executive Officer+44 131 357
1111info@nucana.com
Westwicke, an ICR CompanyChris Brinzey+1
339-970-2843chris.brinzey@westwicke.com
NuCana (NASDAQ:NCNA)
Historical Stock Chart
From Aug 2024 to Sep 2024
NuCana (NASDAQ:NCNA)
Historical Stock Chart
From Sep 2023 to Sep 2024