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NuCana(NCNA) - 2023 Q2 - Quarterly Report
2023-08-16 20:08
Exhibit 99.1 NUCANA PLC UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | | | For the Three Months Ended March 31, | | | --- | --- | --- | --- | | | Notes | 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 | | (8,86 ...
NuCana (NCNA) Investor Presentation - Slideshow
2023-04-06 17:19
A New Era in Oncology Limitations of Nucleoside Analogs Peak Year Sales 16 FDA Approved Anti-Cancer Nucleoside Drugs Activation Inefficient generation of anti-cancer metabolites 4 HIV Genvoya® 150 mg / 150 mg 200 mg / 10 mg film-coated tablets Elvitegravir/cobicistat/ Genvoya® emtricitabine/ tenofovir alafenamide 50 mg / 150 mg 30 film-coated tablets ericitabin Grail use (I GILEAD ¹ Sovaldi + Harvoni + Epclusa + Vosevi cumulative sales through 31 December 2022 2 Genvoya + Descovy + Odefsey + Biktarvy + Symt ...
NuCana(NCNA) - 2022 Q4 - Annual Report
2023-04-04 20:21
Financial Performance - For the year ended December 31, 2022, the company reported a net loss of £32.0 million, compared to a net loss of £40.5 million in 2021, reflecting a decrease of 21%[32] - Research and development expenses for 2022 were £36.4 million, slightly down from £36.8 million in 2021[32] - As of December 31, 2022, the company had cash and cash equivalents of £41.9 million, a decrease from £60.3 million in 2021[33] - The total assets of the company as of December 31, 2022, were £58.3 million, down from £77.5 million in 2021[33] - The accumulated deficit increased to £180.6 million as of December 31, 2022, compared to £149.7 million in 2021[33] - The basic and diluted loss per share for 2022 was £0.61, an improvement from £0.78 in 2021[32] - As of December 31, 2022, the company had £41.9 million in cash and cash equivalents, which is projected to fund operations for at least the next twelve months[64] - The company has not yet generated any product revenues and relies on the successful development and commercialization of its product candidates, which may take several years[100] Clinical Trials and Product Development - The company is currently conducting clinical trials for its product candidates NUC-3373 and NUC-7738, with NUC-3373 in a Phase 1b/2 trial for advanced colorectal cancer[47] - The company expects to continue incurring significant operating losses for the foreseeable future due to ongoing clinical trials and development expenses[48] - The company has invested substantially in the development of product candidates NUC-3373 and NUC-7738, with no current revenues from product sales expected for several years, if ever[53] - The company plans to seek regulatory approval for NUC-3373 and NUC-7738 in the United States and the European Union, facing varying regulatory requirements across jurisdictions[57] - The company has not submitted any New Drug Applications (NDA) or Marketing Authorization Applications (MAA) for its product candidates and does not expect to do so in the foreseeable future[56] - The success of NUC-3373 and NUC-7738 is contingent upon demonstrating safety and efficacy to regulatory authorities, which may require additional trials and increase costs[54] - The company may face significant delays or inability to commercialize product candidates if it cannot overcome regulatory and manufacturing challenges[55] - Clinical trials for NUC-3373 and NUC-7738 are ongoing, with NUC-3373 in two Phase 1b/2 trials and a Phase 2 trial, while NUC-7738 is in the Phase 2 part of a Phase 1/2 trial[105] - The company faces significant risks in drug development, including potential delays and increased costs due to unforeseen events during clinical trials[107] - The FDA's guidance on "Project Optimus" may impact the company's ability to initiate pivotal clinical trials if dose efficacy and safety are not sufficiently demonstrated[107] - The company may incur additional costs if required to conduct more clinical trials or studies beyond current plans, impacting product development costs[110] Regulatory and Compliance Risks - The company relies on third parties for clinical trials and manufacturing, which poses risks to its ability to commercialize product candidates[44] - The company anticipates substantial additional funding will be required to complete the development and commercialization of its product candidates[63] - The company may need to raise additional capital, which could dilute shareholder ownership and restrict operational flexibility[69] - The company has not yet demonstrated the ability to successfully complete large-scale clinical trials or obtain marketing approvals, which are critical for future revenue generation[62] - The company is dependent on third parties for clinical trials and commercialization, which may impact its ability to bring products to market[59] - The company faces risks associated with international operations, including economic weakness, differing regulatory requirements, and potential reduced protection for intellectual property rights[81] - Disruptions at the FDA and other regulatory agencies could slow the review and approval process for new drugs, adversely affecting the company's business[73] - Regulatory changes could impose new costs and challenges that may adversely affect the company's operations and development plans[96] - The company must successfully manage clinical trial enrollment and completion to avoid delays in product development and commercialization[103] - The company may face delays in obtaining marketing approval for product candidates due to regulatory requirements and potential safety concerns[109] Tax and Financial Incentives - As of December 31, 2022, the company had cumulative carry forward tax losses of £84.6 million, which may be utilized to offset future operating profits subject to certain restrictions[74] - The UK government announced a new tax credit rate for R&D intensive companies, which will amount to a payable tax credit of up to 26.97% for eligible expenditures incurred on or after April 1, 2023[75] - The company expects to qualify as an R&D intensive company for 2022 and 2023, benefiting from enhanced tax relief on qualifying R&D expenditures[75] - The company may benefit from the UK's "patent box" regime, allowing certain profits from patented products to be taxed at an effective rate of 10%[77] - Changes in the tax system could materially adversely affect the company's financial condition and results of operations[80] Market and Competitive Landscape - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may hinder its market position[201] - If NUC-3373 and NUC-7738 are approved, they will compete with existing chemotherapies and multiple approved drugs, which are often less expensive[202] - The company may face unfavorable pricing regulations and reimbursement policies that could delay product launches and impact revenue generation[206] - Coverage and adequate reimbursement from government and private insurers are critical for the successful commercialization of product candidates[207] - Future growth may depend on the ability to penetrate foreign markets, which presents additional risks and uncertainties[163] Manufacturing and Supply Chain Risks - The company does not own manufacturing facilities and is dependent on third-party manufacturers, which could impact the ability to meet market demand[183] - There is a risk that the company may not successfully scale up manufacturing of product candidates, potentially delaying development and commercialization[189] - The company relies on single-source suppliers for active pharmaceutical ingredients, which poses a risk if these suppliers cannot meet demand[190] - The company intends to identify and qualify additional manufacturers for API, formulations, and drug products prior to NDA submission, which may cause delays if replacement suppliers are needed[192] Intellectual Property and Legal Risks - The company relies on obtaining and maintaining patents to protect proprietary technology, with the current patent portfolio including both patents and applications[216] - The patent prosecution process is expensive and time-consuming, and the company may not be able to file all necessary patent applications in a timely manner[217] - Third-party patent applications may conflict with the company's patents, potentially restricting commercial viability and leading to costly litigation[226] - BrightGene has pursued patent claims related to Acelarin, with some claims rejected by the USPTO but issued in other jurisdictions, which may require costly legal challenges[227] - Changes in patent laws and recent court rulings may weaken patent protection, impacting the company's ability to secure and enforce patents[222]
NuCana(NCNA) - 2023 Q1 - Quarterly Report
2023-04-04 20:07
Financial Performance - The net loss for Q4 2022 was £15.2 million, compared to a net loss of £13.6 million for Q4 2021; the net loss for the year 2022 was £32.0 million, an improvement from £40.5 million in 2021[3]. - Basic and diluted loss per share for Q4 2022 was £0.29, compared to £0.26 for Q4 2021; for the year 2022, it was £0.61, down from £0.78 in 2021[3]. - The operating loss for the year was £17,248,000, compared to £15,737,000 in 2021, indicating an increase in losses of 10%[10]. - The loss for the period was £15,199,000, compared to £13,644,000 in 2021, which is an increase of 11%[10]. - Basic and diluted loss per share for the year was £0.29, compared to £0.26 in the previous year, indicating a worsening of 12%[10]. - The company reported a net loss for the period of £40.5 million, compared to £33.3 million in the previous year, indicating a year-over-year increase of approximately 21.6% in losses[12]. Cash and Liquidity - As of December 31, 2022, NuCana reported cash and cash equivalents of £41.9 million, down from £50.8 million as of September 30, 2022, and £60.3 million at December 31, 2021[3]. - NuCana's cash runway is anticipated to fund operations into 2025, supporting ongoing clinical programs[4][9]. - Cash used in operations was £30.4 million, a decrease from £33.7 million in the prior year, reflecting an improvement in operational efficiency[12]. - The company experienced a net cash used in investing activities of £120,000, compared to £3.5 million in the previous year, showing a significant reduction in investment outflows[12]. - Interest received was £6.3 million, a notable increase from £1.2 million year-over-year, indicating improved cash management strategies[12]. - The company reported a decrease in prepayments and accrued income of £30.7 million, reflecting tighter cash flow management[12]. - The net cash from financing activities was £66.2 million, indicating strong capital raising efforts through share issuance[12]. - Cash and cash equivalents at the beginning of the year were $60.26 million, with an effect of exchange rate changes on cash and cash equivalents amounting to $4.84 million[9]. - Cash and cash equivalents at the end of the year were $41.91 million, reflecting a decrease of $23.19 million[9]. Assets and Liabilities - Total assets as of December 31, 2022, amounted to £58,254,774, which is an increase from £57,474,000 in 2021[11]. - Non-current assets, including intangible assets, were valued at £23,652,410, compared to £24,100,000 in the previous year[11]. - Current assets totaled £39,574,161, showing a growth from £41,616,000 in 2021[11]. - Total equity attributable to equity holders of the company was £38,502,265, up from £35,548,000 in 2021[11]. - Current liabilities, including trade payables, were £48,031,829, reflecting an increase from £48,290,000 in the previous year[11]. - Total liabilities amounted to £19,752,121, which is an increase from £19,926,000 in 2021[11]. - The company reported accumulated deficit of £180,573, compared to £149,726 in the previous year[11]. - Provisions for liabilities were recorded at £4,100,000, consistent with the previous year[11]. - The company’s total equity and liabilities were £58,254,774, indicating a stable financial position[11]. Research and Development - NuCana plans to announce data from three clinical studies of NUC-3373 in 2023, including a Phase 2 study with 171 patients comparing NUFIRI plus bevacizumab to standard care[4][7]. - The company expects to provide updates on the Phase 2 part of the NuTide:701 study for NUC-7738, investigating its use as a monotherapy and in combination with pembrolizumab[4][7]. - The company achieved significant development milestones for NUC-3373 and NUC-7738 in 2022, progressing both to Phase 2 development[4]. - NUC-3373 is being evaluated for its potential to replace 5-FU across multiple tumor types, with ongoing studies aimed at optimizing treatment combinations[4][6]. - The NuTide:323 study aims to provide meaningful data for second-line colorectal cancer patients, potentially influencing future Phase 3 study designs[4][7]. Expenses - Research and development expenses for the year ended December 31, 2022, were £13,188,000, compared to £10,634,000 for the previous year, representing a 24% increase[10]. - Administrative expenses increased to £1,535,000 in 2022 from £2,073,000 in 2021, showing a decrease of 26%[10].
NuCana (NCNA) Investor Presentation - Slideshow
2023-03-10 13:36
Favorable Pharmacokinetic Profile Number of patients | --- | --- | --- | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------| | Metastatic Colorectal Cancer | Metastatic Basal Cell Carci ...
NuCana(NCNA) - 2022 Q3 - Quarterly Report
2022-11-16 21:13
Exhibit 99.1 NUCANA PLC UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | | | For the Three Months Ended | | For the Nine Months Ended | | | --- | --- | --- | --- | --- | --- | | | | September 30, | | September 30, | | | | Notes | 2022 | 2021 | 2022 | 2021 | | | | | (in thousands, except per share data) | | | | | | £ | £ | £ | £ | | Research and development expenses | | (7,386) | (8,971) | (23,238) | (26,200) | | Administrative expenses | | (1,715) | (2,277) | (5,756) | (6,456) | | Net foreign exc ...
NuCana (NCNA) Investor Presentation - Slideshow
2022-09-09 21:19
| --- | --- | |-------|--------------------------------------| | | | | | | | | | | | Corporate Presentation | | | February 2021 Corporate Presentation | | | September 2022 | Disclaimer Forward-Looking Statements This presentation contains "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 ...
NuCana(NCNA) - 2022 Q2 - Quarterly Report
2022-06-02 20:05
NUCANA PLC UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | | | For the Three Months Ended | | | --- | --- | --- | --- | | | | March 31, | | | | Notes | 2022 | 2021 | | | | (in thousands, except per share data) | | | | | £ | £ | | Research and development expenses | | (9,446) | (8,706) | | Administrative expenses | | (2,152) | (2,104) | | Net foreign exchange gains (losses) | | 1,131 | (677) | | Operating loss | | (10,467) | (11,487) | | Finance income | | 31 | 24 | | Loss before tax | | (10,436) ...
NuCana(NCNA) - 2021 Q4 - Annual Report
2022-04-27 20:32
As filed with the Securities and Exchange Commission on April 27, 2022 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT ...
NuCana(NCNA) - 2022 Q1 - Quarterly Report
2022-04-27 20:08
Exhibit 99.1 NuCana Reports Fourth Quarter and Year Ended 2021 Financial Results and Provides Business Update Optimizes Development Strategy with Study Initiations and Data Announcements Expected throughout 2022 Announces Plan to Initiate Randomized Phase 2 Study for NUC-3373 in Colorectal Cancer Extends Anticipated Cash Runway into 2025 Edinburgh, United Kingdom, April 27, 2022 (GLOBE NEWSWIRE) – NuCana plc (NASDAQ: NCNA) announced financial results for the fourth quarter and year ended December 31, 2021 a ...