NuCana plc (NASDAQ: NCNA) announced financial results for the third
quarter ended September 30, 2024 and provided an update on its
clinical development program with its two lead anti-cancer
medicines.
“We announced encouraging data from our ongoing
clinical studies of both NUC-7738 and NUC-3373, underscoring the
potential of our pipeline,” said Hugh S. Griffith, NuCana’s Founder
and Chief Executive Officer. “At the European Society for Medical
Oncology (ESMO) Congress 2024 in September, we presented promising
data on NUC-7738, a novel agent that profoundly impacts gene
expression in cancer cells and targets multiple aspects of the
tumor microenvironment. The data from the Phase 2 part of the
NuTide:701 study in PD-1 inhibitor-resistant melanoma showed that 9
of the 12 patients achieved disease control when treated with
NUC-7738 in combination with pembrolizumab. One of these patients,
who had received two prior lines of PD-1 inhibitor-based therapy
and had progressed on their latest treatment of ipilimumab plus
nivolumab within two months, achieved a 55% reduction in tumor
volume. Given the typically poor outcomes in this patient
population, with a median progression-free survival of just two to
three months under current standard care, we are highly encouraged
by the results showing a median progression-free survival of over
five months for patients receiving NUC-7738 plus
pembrolizumab.”
Mr. Griffith added, “We also announced the
issuance of a new patent by the United States Patent and Trademark
Office covering NUC-7738’s composition of matter. This patent
(US12,054,510) is expected to serve as a key component of the
intellectual property protection for NUC-7738, which currently
consists of over 80 issued patents worldwide.”
Mr. Griffith continued, “We recently announced
initial data from the ongoing Phase 1b/2 NuTide:303 study of
NUC-3373, a targeted thymidylate synthase inhibitor with immune
modulating properties, in a manuscript authored by the study’s lead
investigators. In this study, NUC-3373 is being combined with
pembrolizumab in patients with advanced solid tumors and with
docetaxel in patients with lung cancer. Results from the study
indicate that NUC-3373 may promote an anti-tumor immune response
and potentiate the activity of immune checkpoint inhibitors. We
were particularly encouraged to see significant tumor volume
reductions and prolonged progression free survival, including a
patient with urothelial bladder cancer who achieved 100% reduction
in their target lesions. While we were disappointed with the
previously announced discontinuation of the NuTide:323 study in
patients with metastatic colorectal cancer, we remain optimistic
about the potential of NUC-3373.”
Mr. Griffith concluded, “Our unwavering
commitment to improving treatment outcomes for patients with cancer
drives our relentless pursuit of the development of new anti-cancer
agents. We look forward to progressing these exciting new medicines
and sharing future development plans for NUC-7738 and
NUC-3373.”
2025 Anticipated Milestones
- NUC-7738
- Initiate an expansion of the Phase
1/2 study (NuTide:701) of NUC-7738 in combination with
pembrolizumab in patients with melanoma;
- Announce data from the Phase 1/2
expansion study (NuTide:701) of NUC-7738 in combination with
pembrolizumab; and
- Obtain regulatory guidance from the
U.S. Food and Drug Administration on pivotal study design for
NUC-7738 in melanoma.
- NUC-3373
- Initiate an expansion of the Phase
1b/2 modular study (NuTide:303) of NUC-3373 in combination with
pembrolizumab in patients with solid tumors; and
- Announce data from the Phase 1b/2
modular study (NuTide:303) of NUC-3373 in combination with
pembrolizumab in patients with solid tumors.
Third Quarter 2024 Financial Highlights
and Cash Position
As of September 30, 2024, NuCana had cash and
cash equivalents of £11.4 million compared to £11.6 million as of
June 30, 2024 and £17.2 million at December 31, 2023. The reduction
in cash and cash equivalents during the third quarter was primarily
the result of cash used in operating activities, partially offset
by £4.7 million in net proceeds raised through its at-the-market
(ATM) offering. Subsequent to September 30, 2024, NuCana has raised
an additional £1.8 million in net proceeds through its ATM
offering. NuCana expects that its cash and cash equivalents as of
September 30, 2024, together with amounts raised through its ATM
offering subsequent to that date, will be sufficient to fund its
planned operations into Q2 2025.
NuCana continues to advance its clinical
programs and reported a net loss of £4.5 million for the quarter
ended September 30, 2024, as compared to a net loss of £6.7 million
for the quarter ended September 30, 2023. Basic and diluted loss
per ordinary share was £0.07 for the quarter ended September 30,
2024, as compared to £0.13 per ordinary share for the comparable
quarter ended September 30, 2023.
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 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 novel anti-cancer agent that disrupts
RNA polyadenylation, profoundly impacts gene expression in cancer
cells and targets multiple aspects of the tumor microenvironment.
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 and cash equivalents to fund its planned
operations into Q2 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 EndedSeptember
30, |
|
For the Nine Months EndedSeptember
30, |
| |
|
|
|
|
|
2024 |
|
2023 |
|
|
2024 |
|
2023 |
|
| |
|
(in thousands, except per share data) |
| |
|
£ |
|
£ |
|
|
£ |
|
£ |
|
| Research and development
expenses |
|
(3,736 |
) |
(7,439 |
) |
|
(17,288 |
) |
(18,203 |
) |
| Administrative expenses |
|
(1,358 |
) |
(1,375 |
) |
|
(4,448 |
) |
(4,777 |
) |
| Net foreign exchange (losses)
gains |
|
(229 |
) |
562 |
|
|
(208 |
) |
(697 |
) |
| Operating
loss |
|
(5,323 |
) |
(8,252 |
) |
|
(21,944 |
) |
(23,677 |
) |
| Finance income |
|
72 |
|
152 |
|
|
283 |
|
617 |
|
| Loss before
tax |
|
(5,251 |
) |
(8,100 |
) |
|
(21,661 |
) |
(23,060 |
) |
| Income tax credit |
|
740 |
|
1,404 |
|
|
3,317 |
|
3,083 |
|
| Loss for the period
attributable to equity holders of the Company |
|
(4,511 |
) |
(6,696 |
) |
|
(18,344 |
) |
(19,977 |
) |
| |
|
|
|
|
|
|
| Basic and diluted loss per
ordinary share |
|
(0.07 |
) |
(0.13 |
) |
|
(0.32 |
) |
(0.38 |
) |
Unaudited Condensed Consolidated
Statements of Financial Position As At
|
|
|
September 30,2024 |
|
December 31, 2023 |
|
|
|
|
(in thousands) |
|
|
|
£ |
|
£ |
|
|
Assets |
|
|
|
|
Non-current assets |
|
|
|
|
Intangible assets |
|
2,230 |
|
|
2,128 |
|
|
Property, plant and equipment |
|
253 |
|
|
521 |
|
| Deferred
tax asset |
|
169 |
|
|
143 |
|
|
|
|
2,652 |
|
|
2,792 |
|
|
Current assets |
|
|
|
|
Prepayments, accrued income and other receivables |
|
1,141 |
|
|
2,671 |
|
| Current
income tax receivable |
|
4,390 |
|
|
5,123 |
|
| Cash and
cash equivalents |
|
11,351 |
|
|
17,225 |
|
|
|
|
16,882 |
|
|
25,019 |
|
| Total
assets |
|
19,534 |
|
|
27,811 |
|
|
|
|
|
|
|
Equity and liabilities |
|
|
|
|
Capital and reserves |
|
|
|
| Share
capital and share premium |
|
149,607 |
|
|
143,420 |
|
| Other
reserves |
|
78,400 |
|
|
79,173 |
|
|
Accumulated deficit |
|
(223,659 |
) |
|
(207,706 |
) |
| Total equity
attributable to equity holders of the Company |
|
4,348 |
|
|
14,887 |
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
Provisions |
|
28 |
|
|
58 |
|
| Lease
liabilities |
|
136 |
|
|
190 |
|
|
|
|
164 |
|
|
248 |
|
|
Current liabilities |
|
|
|
| Trade
payables |
|
6,043 |
|
|
3,375 |
|
| Payroll
taxes and social security |
|
157 |
|
|
155 |
|
| Accrued
expenditure |
|
8,707 |
|
|
8,940 |
|
| Lease
liabilities |
|
85 |
|
|
206 |
|
|
Provisions |
|
30 |
|
|
- |
|
|
|
|
15,022 |
|
|
12,676 |
|
| Total
liabilities |
|
15,186 |
|
|
12,924 |
|
| Total equity and
liabilities |
|
19,534 |
|
|
27,811 |
|
| |
|
|
|
Unaudited Condensed Consolidated
Statements of Cash Flows
|
|
For the Nine Months EndedSeptember
30, |
|
|
2024 |
|
|
2023 |
|
|
|
(in thousands) |
|
|
£ |
|
£ |
|
| Cash flows from
operating activities |
|
|
| Loss for the period |
(18,344 |
) |
|
(19,977 |
) |
| Adjustments for: |
|
|
| Income tax credit |
(3,317 |
) |
|
(3,083 |
) |
| Amortization and
depreciation |
407 |
|
|
434 |
|
| Movement in provisions |
- |
|
|
(4,109 |
) |
| Finance income |
(283 |
) |
|
(617 |
) |
| Interest expense on lease
liabilities |
14 |
|
|
23 |
|
| Share-based payments |
1,667 |
|
|
3,073 |
|
| Net foreign exchange
losses |
244 |
|
|
661 |
|
|
|
(19,612 |
) |
|
(23,595 |
) |
| Movements in working
capital: |
|
|
| Decrease in prepayments,
accrued income and other receivables |
1,500 |
|
|
531 |
|
| Increase in trade
payables |
2,668 |
|
|
371 |
|
| Decrease in payroll taxes,
social security and accrued expenditure |
(234 |
) |
|
(3,667 |
) |
| Movements in working
capital |
3,934 |
|
|
(2,765 |
) |
| Cash used in
operations |
(15,678 |
) |
|
(26,360 |
) |
| Net income tax received
(paid) |
4,015 |
|
|
(2 |
) |
| Net cash used in
operating activities |
(11,663 |
) |
|
(26,362 |
) |
| Cash flows from
investing activities |
|
|
| Interest received |
299 |
|
|
620 |
|
| Payments for property, plant
and equipment |
(3 |
) |
|
(4 |
) |
| Payments for intangible
assets |
(239 |
) |
|
(377 |
) |
| Repayment of other current
assets |
- |
|
|
2,596 |
|
| Net cash from
investing activities |
57 |
|
|
2,835 |
|
| Cash flows from
financing activities |
|
|
| Payments for lease
liabilities |
(188 |
) |
|
(207 |
) |
| Proceeds from issue of share
capital – exercise of share options |
7 |
|
|
3 |
|
| Proceeds from issue of share
capital |
6,371 |
|
|
224 |
|
| Share issue expense |
(191 |
) |
|
(30 |
) |
| Net cash from (used
in) financing activities |
5,999 |
|
|
(10 |
) |
| Net decrease in cash and cash
equivalents |
(5,607 |
) |
|
(23,537 |
) |
| Cash and cash
equivalents at beginning of period |
17,225 |
|
|
41,912 |
|
| Effect of exchange rate
changes on cash and cash equivalents |
(267 |
) |
|
(572 |
) |
| Cash and cash
equivalents at end of period |
11,351 |
|
|
17,803 |
|
| |
|
|
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)
과거 데이터 주식 차트
부터 11월(11) 2024 으로 12월(12) 2024
NuCana (NASDAQ:NCNA)
과거 데이터 주식 차트
부터 12월(12) 2023 으로 12월(12) 2024
