NuCana Reports Second Quarter 2024 Financial Results and Provides Business Update
15 Agosto 2024 - 5:01PM
NuCana plc (NASDAQ: NCNA) announced financial results for the
second quarter ended June 30, 2024 and provided an update on its
broad clinical development program with its transformative ProTide
therapeutics.
As of June 30, 2024, NuCana had cash and cash
equivalents of £11.6 million compared to £12.9 million as of March
31, 2024 and £17.2 million at December 31, 2023. NuCana continues
to advance its numerous clinical programs and reported a net loss
of £7.0 million for the quarter ended June 30, 2024, as compared to
a net loss of £5.4 million for the quarter ended June 30, 2023.
Basic and diluted loss per ordinary share was £0.12 for the quarter
ended June 30, 2024, as compared to £0.10 per ordinary share for
the comparable quarter ended June 30, 2023.
“During the first half of the year, we remained
focused on the execution of our clinical programs, all of which are
on track for data updates this year,” said Hugh S. Griffith,
NuCana’s Founder and Chief Executive Officer. “NUC-3373, a ProTide
transformation of 5-FU, is currently being evaluated in three
clinical studies: NuTide:323, a randomized, 182-patient Phase 2
study for the second-line treatment of patients with metastatic
colorectal cancer; NuTide:302, a Phase 1/2 study in patients with
metastatic colorectal cancer; and NuTide:303, a Phase 1b/2 study in
patients with solid tumors and lung cancer. We are pleased to
report that all three studies are progressing as planned, and we
look forward to sharing data updates in the second half of
2024.”
Mr. Griffith continued: “In addition, NUC-7738,
a ProTide transformation of a novel nucleoside analog,
3’-deoxyadenosine, is being assessed in the Phase 2 part of the
ongoing Phase 1/2 NuTide:701 study in PD-1 inhibitor-resistant
melanoma patients. Following a positive data update at the American
Association for Cancer Research (AACR) Annual Meeting earlier this
year, we plan to announce additional data at the upcoming European
Society for Medical Oncology (ESMO) Congress 2024, being held
September 13-17 in Barcelona, Spain.”
Mr. Griffith concluded, “Our commitment to
improving treatment outcomes for patients with cancer is what
drives us to advance our development programs. We expect to
announce numerous important data readouts in the second half of
this year and look forward to providing updates on our
progress.”
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 + bevacizumab compared to the
standard of care FOLFIRI + bevacizumab for the second-line
treatment of patients with metastatic colorectal cancer;
- Announce data from the Phase 1b/2
(NuTide:302) study of NUFIRI + bevacizumab and NUFOX + bevacizumab
for the second-line treatment of patients with metastatic
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 metastatic 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 which is evaluating NUC-7738 as a
monotherapy in patients with advanced solid tumors and in
combination with pembrolizumab in patients with melanoma.
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 Q1 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.
Unaudited Condensed Consolidated
Statements of Operations
|
|
For the Three Months EndedJune
30, |
|
For the Six Months EndedJune
30, |
|
|
|
|
|
2024 |
|
2023 |
|
|
2024 |
|
2023 |
|
|
|
(in thousands, except per share data) |
|
|
£ |
|
£ |
|
|
£ |
|
£ |
|
Research and development
expenses |
|
(6,769 |
) |
(3,959 |
) |
|
(13,552 |
) |
(10,764 |
) |
Administrative expenses |
|
(1,509 |
) |
(1,754 |
) |
|
(3,090 |
) |
(3,402 |
) |
Net foreign exchange (losses)
gains |
|
(74 |
) |
(564 |
) |
|
21 |
|
(1,259 |
) |
Operating
loss |
|
(8,352 |
) |
(6,277 |
) |
|
(16,621 |
) |
(15,425 |
) |
Finance income |
|
85 |
|
178 |
|
|
211 |
|
465 |
|
Loss before
tax |
|
(8,267 |
) |
(6,099 |
) |
|
(16,410 |
) |
(14,960 |
) |
Income tax credit |
|
1,272 |
|
685 |
|
|
2,577 |
|
1,679 |
|
Loss for the
period |
|
(6,995 |
) |
(5,414 |
) |
|
(13,833 |
) |
(13,281 |
) |
|
|
|
|
|
|
|
Basic and diluted loss per
ordinary share |
|
(0.12 |
) |
(0.10 |
) |
|
(0.25 |
) |
(0.25 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated
Statements of Financial Position As At
|
|
June 30,2024 |
|
December 31, 2023 |
|
|
|
(in thousands) |
|
|
£ |
|
£ |
|
Assets |
|
|
|
Non-current
assets |
|
|
|
Intangible assets |
|
2,214 |
|
2,128 |
|
Property, plant and
equipment |
|
343 |
|
521 |
|
Deferred tax asset |
|
168 |
|
143 |
|
|
|
2,725 |
|
2,792 |
|
Current
assets |
|
|
|
Prepayments, accrued income
and other receivables |
|
2,044 |
|
2,671 |
|
Current income tax
receivable |
|
3,662 |
|
5,123 |
|
Cash and cash equivalents |
|
11,639 |
|
17,225 |
|
|
|
17,345 |
|
25,019 |
|
Total
assets |
|
20,070 |
|
27,811 |
|
|
|
|
|
Equity and
liabilities |
|
|
|
Capital and
reserves |
|
|
|
Share capital and share
premium |
|
144,870 |
|
143,420 |
|
Other reserves |
|
78,373 |
|
79,173 |
|
Accumulated deficit |
|
(219,443 |
) |
(207,706 |
) |
Total equity
attributable to equity holders of the Company |
|
3,800 |
|
14,887 |
|
|
|
|
|
Non-current
liabilities |
|
|
|
Provisions |
|
58 |
|
58 |
|
Lease liabilities |
|
154 |
|
190 |
|
|
|
212 |
|
248 |
|
Current
liabilities |
|
|
|
Trade payables |
|
6,108 |
|
3,375 |
|
Payroll taxes and social
security |
|
164 |
|
155 |
|
Accrued expenditure |
|
9,659 |
|
8,940 |
|
Lease liabilities |
|
127 |
|
206 |
|
|
|
16,058 |
|
12,676 |
|
Total
liabilities |
|
16,270 |
|
12,924 |
|
Total equity and
liabilities |
|
20,070 |
|
27,811 |
|
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated
Statements of Cash Flows
|
For the Six Months EndedJune
30, |
|
2024 |
|
2023 |
|
|
(in thousands) |
|
£ |
|
£ |
|
Cash flows from
operating activities |
|
|
Loss for the period |
(13,833 |
) |
(13,281 |
) |
Adjustments for: |
|
|
Income tax credit |
(2,577 |
) |
(1,679 |
) |
Amortization and
depreciation |
272 |
|
288 |
|
Movement in provisions |
- |
|
(1,109 |
) |
Finance income |
(211 |
) |
(465 |
) |
Interest expense on lease
liabilities |
10 |
|
16 |
|
Share-based payments |
1,292 |
|
2,195 |
|
Net foreign exchange (gains)
losses |
(112 |
) |
1,285 |
|
|
(15,159 |
) |
(12,750 |
) |
Movements in working
capital: |
|
|
Decrease in prepayments,
accrued income and other receivables |
625 |
|
1,288 |
|
Increase (decrease) in trade
payables |
2,734 |
|
(124 |
) |
Increase (decrease) in payroll
taxes, social security and accrued expenditure |
725 |
|
(4,598 |
) |
Movements in working
capital |
4,084 |
|
(3,434 |
) |
Cash used in
operations |
(11,075 |
) |
(16,184 |
) |
Net income tax received
(paid) |
4,015 |
|
(2 |
) |
Net cash used in
operating activities |
(7,060 |
) |
(16,186 |
) |
Cash flows from
investing activities |
|
|
Interest received |
218 |
|
482 |
|
Payments for property, plant
and equipment |
(3 |
) |
(5 |
) |
Payments for intangible
assets |
(176 |
) |
(291 |
) |
Net cash from
investing activities |
39 |
|
186 |
|
Cash flows from
financing activities |
|
|
Payments for lease
liabilities |
(127 |
) |
(84 |
) |
Proceeds from issue of share
capital – exercise of share options |
3 |
|
1 |
|
Proceeds from issue of share
capital |
1,492 |
|
11 |
|
Share issue expenses |
(45 |
) |
(2 |
) |
Net cash from (used
in) financing activities |
1,323 |
|
(74 |
) |
Net decrease in cash and cash
equivalents |
(5,698 |
) |
(16,074 |
) |
Cash and cash
equivalents at beginning of period |
17,225 |
|
41,912 |
|
Effect of exchange rate
changes on cash and cash equivalents |
112 |
|
(1,194 |
) |
Cash and cash
equivalents at end of period |
11,639 |
|
24,644 |
|
|
|
|
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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