Resultados provisionales
30 de enero de 2024
Scancell Holdings plc
("Scancell" o la "Compañía")
Resultados provisionales de los seis meses finalizados el 31 de octubre de 2023
Strong clinical progress in the SCOPE trial with 85% ORR reported from the first 13 patients with unresectable melanoma
Post-period end capital raise of £11.9m to support important clinical milestones in 2024
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces its interim results for the six months ended 31 October 2023 and provides a business update on progress achieved to date.
Aspectos destacados (incluido el período posterior):
SCIB1 (SCOPE trial)
· SCIB1, an oncology vaccine, reported positive data from the first stage of its Phase 2 SCOPE trial for advanced melanoma.
· SCIB1 in combination with checkpoint inhibitors (CPIs) showed an 85% objective response rate (ORR)
to treatment in 13 patients, exceeding the target of 70% ORR and accompanied by meaningful tumour
volume reduction. One patient achieved a complete response following treatment.
· In the real word setting in patients receiving doublet standard of care CPI therapy alone, the ORR is 50% with a progression free survival of 11.5 months.
· Recruitment in the second stage is expected to be complete in Q1 2024 with highly anticipated data available in Q3 2024.
· The addition of iSCIB1+ to the SCOPE trial has been approved by the MHRA. Recruitment in this third cohort is expected to start in Q1 2024 with early data available in Q3 2024. iSCIB1+ includes additional melanoma-specific epitopes so it has the potential to be even more effective in a broader patient population.
· A clear development pathway for registration and approval of SCIB1/ iSCIB1+ in the medium term for advanced melanoma has been mapped out.
· This represents a potential $1.5 billion per annum market and we anticipate significant interest from potential partners.
Modi-1 (ModiFY trial)
· In July 2023, the ModiFY trial moved into the expansion cohorts, following approval by the safety review committee.
· Early data from patients receiving Modi-1 as a monotherapy showed good T cell responses, safety and tolerability, with no dose limiting toxicities observed in dose escalation cohorts. Similar to SCIB1 monotherapy in metastatic disease, one patient achieved a partial response and 60% of patients showed stable disease in response to Modi-1 monotherapy.
· Modi-1 to be assessed in renal cell carcinoma in combination with double CPI therapy in the ModiFY study pending protocol amendment by the MHRA.
· Early clinical data from patients treated with Modi-1 plus CPIs is anticipated in 2024.
Anticuerpos:
· Development of SC129, out licensed to Genmab, continues on track towards potential clinical development.
· GlyMab® y AvidiMab® platforms provide potential out licensing opportunities with active discussions ongoing with pharmaceutical and biotech companies.
Sector empresarial
· Sath Nirmalananthan appointed as Chief Financial Officer
· Dr Mandeep Sehmi appointed as Head of Business Development
Financiera:
· In December 2023, the Company raised gross proceeds of £11.9 million in aggregate (before expenses) through the capital raise with significant participation from both existing and new healthcare specialist investors.
· Group cash balance at 31 October 2023 was £13.1 million (April 2023: £19.9 million) with cash funding through to important clinical milestones on clinical assets.
Profesora Lindy Durrant, directora ejecutiva de Scancell, comentado: "The Scancell team continues to produce highly-significant data across its pipeline of cancer vaccines and we have made strong progress in all parts of the business in the first six months of the year. Most notably, we were pleased to announce exceptional data from the first stage of the SCOPE trial with SCIB1 showing an 85% ORR to treatment in 13 patients, exceeding 70% ORR expectations. With important clinical milestones expected this year, including further data from both the SCOPE and ModiFY trials, and with the recently secured funding in place, the company's prospects in 2024 are exciting."
Professor Lindy Durrant, Chief Executive Officer, and Sath Nirmalananthan, Chief Financial Officer, will also host a live webcast and Q&A session for analysts and investors today at 14:00 GMT. If you would like to join the webcast, please follow this link:
https://www.lsegissuerservices.com/spark/ScancellHoldings/events/f581274b-146c-4a89-af15-05bcae874775
Poco después estará disponible una repetición del webcast.
Se puede encontrar una copia completa del anuncio en el sitio web de Scancell: www.scancell.es
Este anuncio contiene información privilegiada a los efectos del artículo 7 del Reglamento (UE) 596/2014 (MAR).
Para más información, por favor póngase en contacto con: | |
Scancell Holdings plc | +44 0 20 3709 5700 |
Profesora Lindy Durrant, directora ejecutiva | |
Dr. Jean-Michel Cosséry, presidente no ejecutivo | |
Stifel Nicolaus Europa limitada (Asesor designado y conjunto Broker) | +44 0 20 7710 7600 |
Nicolás Moore/Samira Essebiyea/William Palmer-Brown (Banca de Inversión en Salud) Nick Adams/Nick Harland (corretaje corporativo) | |
WG Partners LLP (Conjunto Broker) David Wilson/Claes Spang/Sathesh Nadarajah/Erland Sternby | +44 0 20 3705 9330
|
Panmure Gordon (Reino Unido) Limited (Articulación Broker) | +44 0 20 7886 2500 |
Freddy Crossley / Emma Earl (Finanzas corporativas) | |
Rupert Dearden (Corretaje corporativo) | |
Consejo ICR Mary-Jane Elliott/Matthew Neal/ Chris Welsh | +44 0 20 3709 5700 |
Sobre Scancell
Scancell es una compañía biofarmacéutica en etapa clínica que está aprovechando su investigación patentada, desarrollada durante muchos años de estudio del sistema inmunitario adaptativo humano, para generar medicamentos novedosos para tratar necesidades importantes no satisfechas en cáncer y enfermedades infecciosas. La Compañía está construyendo una cartera de productos innovadores utilizando sus cuatro plataformas tecnológicas: Moditope® e ImmunoBody® para vacunas y GlyMab® y AvidiMab® para anticuerpos.
Las respuestas inmunitarias adaptativas incluyen anticuerpos y células T (CD4 y CD8), que pueden reconocer células dañadas o infectadas. Para destruir dichas células cancerosas o infectadas, Scancell utiliza vacunas para inducir respuestas inmunitarias o anticuerpos monoclonales (mAb) para redirigir las células inmunitarias o los fármacos. El enfoque único de la Compañía es que sus productos innovadores apuntan a modificaciones de proteínas y lípidos. Para las vacunas (Moditope® e ImmunoBody®) esto incluye la citrulinación y la homocitrulación de proteínas, mientras que su cartera de mAb se dirige a los glicanos o azúcares que se agregan a las proteínas y/o lípidos (GlyMab®) o mejora la potencia de los anticuerpos y su capacidad para destruir directamente las células tumorales (AvidiMab®).
Para obtener más información sobre Scancell, visite: https://www.scancell.co.uk/
DECLARACIÓN DEL DIRECTOR EJECUTIVO JEFE
I am pleased to report the Group's interim results for the six-month period ended 31 October 2023. During the period, Scancell achieved important clinical milestones in the SCOPE trial with highly encouraging results giving us strong confidence in the SCIB1/iSICB1+ vaccines for advanced melanoma. We are now well positioned to conclude the SCOPE trial and progress towards the registration Phase 2/3 study. In addition, we intend to investigate Modi-1 in renal cancer in combination with ipilimumab (Yervoy®) más nivolumab (Opdivo®) checkpoint inhibitors as a new cohort in the ModiFY study. The recent capital raise of £11.9m in gross proceeds with significant participation from existing and new healthcare investors helps maintain our momentum and progress towards these value creating clinical milestones.
A continuación se muestra un resumen del progreso que se ha logrado en nuestras plataformas innovadoras y patentadas de vacunas y anticuerpos.
VACUNAS
Inmunocuerpo® plataforma
ImmunoBody de Scancell® immunotherapy platform uses the body's immune system to identify, attack and destroy tumours. This is achieved by delivering a DNA plasmid to enhance the uptake and presentation of cancer antigens to harness high avidity T cell responses, offering the potential for enhanced efficacy and safety compared with more conventional approaches. These vaccines have the potential to be used as monotherapy or in combination with checkpoint inhibitors (CPIs) and other agents. This platform has the potential to enhance tumour destruction, prevent disease recurrence and extend survival.
SCIB1
SCIB1 is the lead product from Scancell's ImmunoBody® immunotherapy platform. It is currently being evaluated in the SCOPE trial, a Phase 2 open-label, multi-cohort, multicentre trial in the UK, in combination with CPIs for the treatment of advanced melanoma. The trial includes a cohort of advanced melanoma patients who will receive SCIB1 plus doublet therapy consisting of ipilimumab (Yervoy®) más nivolumab (Opdivo®) además de la cohorte que recibirá SCIB1 con pembrolizumab (Keytruda®). Esto refleja el panorama de tratamiento actual para pacientes con melanoma metastásico irresecable. El estudio de fase 2 está diseñado para evaluar si la adición del tratamiento SCIB1 al estándar de atención de CPI da como resultado una mejora en los resultados de los pacientes con enfermedad metastásica. Los objetivos principales del ensayo son la tasa de respuesta tumoral, la supervivencia libre de progresión y la supervivencia general en pacientes con melanoma avanzado. La vacuna SCIB1 se administra a través de PharmaJet® inyección sin aguja, que proporciona una mayor aceptación del paciente en comparación con la electroporación.
In Septiembre y posteriormente en Noviembre 2023, the SCOPE trial reported exceptional results to date with 11 out of 13 patients showing at least a partial response which is an objective response rate (ORR) of 85%, which is better than 70% ORR that the trial was configured to show. This compares to an ORR of 50% reported in patients just receiving this doublet CPI therapy in the real world setting with a progression free survival time of 11.5 months. These responses have been verified in nine patients with a second scan at 19 weeks. Significantly, one of the patients has achieved a complete response following treatment.
The SCOPE trial has now successfully transitioned into the second stage, which will recruit a further 27 patients (for a total of 43). The aim is to achieve at least 18 further responses (i.e., 27 responses in total) which would statistically demonstrate that SCIB1, in combination with doublet therapy, exceeds currently achievable ORRs. The second stage of recruitment is expected to be complete by Q1 2024 with highly anticipated data available in Q3 2024.
iSCIB1+
iSCIB1+ is a modified version of SCIB1 developed using Scancell's AvidiMab® platform to enhance its potency compared to SCIB1 and gives 15 years of extended patent protection. iSCIB1+ also includes additional melanoma-specific epitopes so it has the potential to be effective in a broader patient population beyond the 40% of patients with the tissue type treatable with SCIB1, where treatment is HLA dependent.
In January 2024, the Company received MHRA approval to add a third cohort to the SCOPE trial using iSCIB1+. This cohort will recruit 43 advanced unresectable melanoma patients who will receive iSCIB1+ with doublet therapy, consisting of ipilimumab plus nivolumab. Recruitment is expected to start in Q1 2024 with early data available in Q3 2024.
The results from these SCIB1 and iSCIB1+ cohorts, administered in combination with doublet therapy, will enable the Company to make a data-led decision regarding initiation of a randomised Phase 2/3 adapted registration programme in patients with unresectable melanoma, which represents a potential $1.5 billion per annum market. The Phase 2 part of the adapted trial is anticipated to take 18 months, with the potential to generate attractive licensing opportunities.
Moditopo® plataforma
Moditopo® is a versatile proprietary cancer vaccine platform that targets stress-induced post-translational modifications (siPTMs) of proteins. This discovery has allowed Scancell to develop a completely new class of potent and selective therapeutic vaccines. Examples of such modifications include citrullination, an enzyme-based conversion of arginine to citrulline, and homocitrullination, in which lysine residues are converted to homocitrulline. Expression of peptides containing these modifications have been demonstrated to induce potent CD4 cytotoxic T cells that induce anti-tumour activity without any associated toxicity.
modi-1
Modi-1, que se dirige a los antígenos del cáncer citrulinados, es la primera vacuna candidata terapéutica que surge de Moditope de Scancell.® platform. Modi-1 consists of three citrullinated tumour-associated peptides exploiting the normal immune response to stressed cells, which is largely mediated by cytotoxic CD4 T cells.
The ModiFY study is an open-label, multi-cohort, multicentre, adaptive Phase 1/2 trial with Modi-1 being administered alone or in combination with CPIs in patients with head and neck, triple negative breast and renal tumours and as a monotherapy in patients with ovarian cancer, where there are no approved CPI therapies and in patients with the other tumour types where CPIs are not indicated.
The ModiFY trial has completed its dose escalation and safety cohorts. Data from patients receiving the Modi-1 cancer vaccine as a monotherapy showed that it was safe and well tolerated and demonstrated encouraging early efficacy in a head and neck cancer patient and in other hard-to-treat cancers such as high grade serous ovarian carcinoma and triple negative breast cancer. All patients had failed on previous treatments and their disease was actively progressing when they entered the study. Following treatment with Modi-1 60% of patients achieved stable disease for at least eight weeks, with some patients experiencing a longer duration of disease stability for four months or more. The number of patients who have experienced long periods of stable disease following monotherapy with Modi-1 is encouraging and similar to the response rate with SCIB1 monotherapy in advanced disease.
The Company believes that combination therapy with checkpoint inhibitors, could further improve outcomes for this patient group. With this intention we will investigate Modi-1 in renal cancer in combination with ipilimumab (Yervoy®) más nivolumab (Opdivo®) checkpoint inhibitors. This is partly due to a change of standard of care within the treating community and partly because the SCOPE study results suggest that the double checkpoints are ideal in synergising with vaccines.
Early clinical data from patients treated data with Modi-1 plus CPIs is anticipated in 2024.
modi-2
Modi-2, que se dirige a antígenos cancerígenos homocitrulinados, es la segunda vacuna candidata terapéutica del Moditope de la empresa.® plataforma y tiene el potencial de abordar diferentes indicaciones de cáncer para Modi-1, incluidos tumores con un entorno particularmente inmunosupresor.
In November 2022, Scancell in-licensed the SNAPvax? technology from Vaccitech plc, a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapies and vaccines. The agreement allows Scancell to formulate and manufacture Modi-2.
Scancell expects that the combination of Modi-2 with this highly effective platform for inducing T cells will lead to a potentially superior therapeutic vaccine candidate.
Anticuerpos
El GlyMab® y AvidiMab® Las plataformas brindan posibles oportunidades de concesión de licencias con conversaciones activas en curso con empresas farmacéuticas y de biotecnología.
GlyMab®
El GlyMab® La plataforma proporciona un enfoque potente y versátil para generar nuevos candidatos a fármacos con anticuerpos para nuestra propia línea clínica, pero también para crear asociaciones iniciales, de hito y generadoras de ingresos con otras empresas en áreas como la selección de fármacos para capitalizar la experiencia de otros grupos. El GlyMab® antibodies bind to sugar motifs, rather than peptide epitopes, found on the surface of glycosylated proteins and lipids expressed by cancer cells. The Company currently has a pipeline of five anti-glycan monoclonal antibodies (mAbs): SC129, SC134, SC2811, SC88 and SC27 that target solid tumours including pancreatic, small cell lung, colorectal and gastric cancers. All of these drug candidates have now been successfully humanised and are ready for the next stage of development.
En octubre de 2022, Scancell firmó su primer acuerdo de licencia comercial con Genmab. A Genmab se le concedió una licencia mundial para un anticuerpo monoclonal antiglicano generado a través del GlyMab, propiedad de Scancell.® platform, for the development and commercialisation of novel therapeutic products. The Company received £5.3 million in up front payment as well as potential milestone payments of up to $208 million for each product developed and commercialised, up to a maximum of $624 million if Genmab develops and commercialises products across all defined modalities. The Company will also receive low single digit royalties from Genmab on net sales of all commercialised products. Development of this antibody remains on track as it progresses towards potential clinical development.
AvidiMab®
AvidiMab® is a versatile proprietary platform technology that can enhance the avidity and thereby the potency of any antibody. To date, the Scancell has used AvidiMab® en sus programas internos para:
· Diseñe los mAb antiglicanos para mejorar su capacidad de matar directamente las células tumorales.
· Diseñar otros mAb para mejorar su potencia y/o extender su vida útil de patente.
· Aumente la amplitud de respuesta y la potencia de ImmunoBody de Scancell® productos contra el cancer
· Aumentar la potencia de la respuesta de las células T en la vacuna COVID-19 de Scancell, lo que a su vez debería conducir a mejoras en la protección a largo plazo y la memoria inmunológica.
The AvidiMab® platform has been successfully applied to internal programmes, including iSCIB1+ and COVIDITY, and holds potential to enhance the efficacy of third-party antibodies.
REVISIÓN FINANCIERA
Estado de Pérdidas y Ganancias y Otros Resultados Integrales
The Group made an operating loss for the six-month period to 31 October 2023 of £8.12 million (six-month period to 31 October 2022: loss of £1.97 million).
Development expenditure has increased to £5.69 million (2022: £4.35 million) as a result of increased costs on the SCOPE and ModiFY clinical trials.
There was a small increase in administrative expenditure to £2.43 million (2022: £2.37 million).
Interest payable of £0.49 million (2022: £0.57 million) largely relates to the interest on the Convertible Loan Notes (CLNs).
The finance gain on revaluation of £4.86 million (2022: expense: £3.48 million) relates to the derivative liability and is the fair value adjustment of the derivative liability at the respective period ends. The finance gain is not a cash item and has no impact on the Company's cashflow.
The loss before taxation for the period amounted to £3.59 million (2022: £5.9 million). The R&D tax credit increased slightly to £1.04 million (2022: £0.98 million) in spite of an increase in development expenditure. This is because the Government has reduced the amount of tax credits payable to companies.
Overall, the loss post tax for the six-month period was £2.55 million (2022: £4.96 million).
Estado de situación financiera
At 31 October 2023, the net liabilities of the Group amounted to £8.4 million (30 April 2023: £6.2 million) including cash at bank of £13.1 million (30 April 2023: £19.9 million). Post period in December 2023, the Company announced it raised gross proceeds of £11.9 million in aggregate (before expenses) through a capital raise with significant participation from both existing and new healthcare specialist investors.
Current assets include tax receivable due at the end of the period of £3.9 million (April 2023: £4.7 million) and relate to the R&D tax credit for the year ended 30 April 2023 amounting to £2.4 million plus an estimate of the amount recoverable at 31 October 2023.
Dentro de los pasivos se encuentran los CLN y los Pasivos Derivados. El importe total de los CLN que siguen pendientes es de £19.65 millones y deben reembolsarse en agosto de 2025 (£1.75 millones) y noviembre de 2025 (£17.9 millones).
Los Pasivos Derivados representan el valor razonable de la característica de conversión del CLN en el momento de la emisión de los CLN y los cambios en el valor se muestran en el Estado de Resultados y Otros Resultados Integrales Consolidado como un crédito o gasto financiero.
The current Trade and other payables have reduced to £1.7 million (April 2023: £3.0 million). All balances owing to suppliers at the end of the six-month period were paid in accordance with their terms and conditions.
Estado de flujo de efectivo consolidado
As at 31 October 2023, Company bank balances amounted to £13.1 million (April 2023: £19.9 million). The reduction in bank balances during the six-month period is primarily due to net cash used in operating activities of £8.5 million (30 April 2023: £9.4 million). This expenditure has been offset by the R&D tax credit received of £1.7 million (30 April 2023: £1.2 million).
PANORAMA
Given the significant clinical and commercial milestones achieved in the period, positive early efficacy data, and with sufficient resources to fund our current strategy, the Company is confident it will achieve its near-term clinical milestones. Key near-term milestones include:
· Second stage of SCOPE study in advanced melanoma with SCIB1 anticipated to complete recruitment in Q1 2024 with data available in Q3 2024
· iSCIB1+ cohort of the SCOPE study to start recruitment in Q1 2024 with clinical data expected in Q3 2024
· Phase 2/3 randomised adaptive registration trial readiness with trial to begin H2 2024
· ModiFY trial data, including renal cell carcinoma with double checkpoint inhibitors expected in 2024
· Continue to progress out-licensing opportunities for the GlyMab® y AvidiMab® platforms providing a source of non-dilutive cash to drive the Company's other assets forward in development.
The Board is pleased with the progress that the Company has achieved over the period and would like to thank our investors and staff for their continued support.
Professor Lindy Durrant
Director Ejecutivo 29 de enero de 2024
Scancell Holdings plc
Estado de Ganancias o Pérdidas y Otros Resultados Integrales Consolidados
para el período de 6 meses hasta el 31 de octubre de 2023
Sin auditar | Sin auditar | auditado | ||
6 meses | 6 meses | Año hasta | ||
31/10/2023
| 31/10/2022 Replanteado[ 1 ] | 30/04/2023
| ||
000 £ | 000 £ | 000 £ | ||
Operaciones continuas | ||||
Ingresos | - | 5,271 | 5,271 | |
El costo de ventas | - | (525) | (525) | |
Beneficio bruto | - | 4,746 | 4,746 | |
Gastos de desarrollo | (5,693) | (4,347) | (11,645) | |
Gastos administrativos | (2,427) | (2,373) | (5,021) | |
PÉRDIDA OPERATIVA | (8,120) | (1,974) | (11,920) | |
Intereses por cobrar e ingresos similares | 161 | 81 | 284 | |
Intereses por pagar | (493) | (567) | (1,215) | |
Finance gain/ (expense) relating to revaluation of derivative liability | 4,864 | (3,476) | (1,453) | |
Ganancia por modificación sustancial de pagarés de préstamo convertibles | - | - | - | |
(PÉRDIDA)/BENEFICIO ANTES DE IMPUESTOS | (3,588) | (5,936) | (14,304) | |
Impuesto sobre la pérdida de actividades ordinarias | 1,040 | 980 | 2,368 | |
(LOSS) FOR THE PERIOD |
| (2,548) | (4,956) | (11,936) |
GANANCIA POR ACCIÓN ORDINARIA (PENCES) Nota 2 | ||||
| ||||
Basic | (0.31) p | (0.61) págs. | (1.46) p | |
Scancell Holdings plc
Estado de cambios en el patrimonio neto consolidado
para el período de 6 meses hasta el 31 de octubre de 2023
| Compartir | Compartir |
|
| |
Compartir | producto de más alta calidad. | opción | retenido | Total | |
capital | cuenta | reserva | ganancias | Equidad | |
000 £ | 000 £ | 000 £ | 000 £ | 000 £ | |
| Sin auditar | Sin auditar | Sin auditar | Sin auditar | Sin auditar |
A 1 de mayo de 2023 | 819 | 65,181 | 2,123 | (74,356) | (6,233) |
Compartir asunto | 1 | 34 | - | - | 35 |
(Pérdida) para el período | - | - | - | (2,548) | (2,548) |
Costos de opciones sobre acciones | - | - | 383 | - | 383 |
Al 31 de octubre de 2023 | 820 | 65,215 | 2,506 | (76,904) | (8,363) |
A 1 de mayo de 2022 | 815 | 65,019 | 1,395 | (49,119) | 18,110 |
Prior Period Restatement | - | - | - | (13,301) | (13,301) |
At 1 May 2022 (Restated)1 | 815 | 65,019 | 1,395 | (62,420) | 4,809 |
Pérdida del período | - | - | - | (4,956) | (4,956) |
Costos de opciones sobre acciones | - | - | 481 | - | 481 |
Al 31 de octubre de 2022 | 815 | 65,019 | 1,876 | (67,376) | 334 |
auditado | auditado | auditado | auditado | auditado | |
A 1 de mayo de 2022 | 815 | 65,019 | 1,395 | (62,420) | 4,809 |
Compartir asunto | 4 | 162 | - | - | 166 |
(Pérdida) del año | - | - | - | (11,936) | (11,936) |
Costos de opciones sobre acciones | - | - | 728 | - | 728 |
Al 30 de abril de 2023 | 819 | 65,181 | 2,123 | (74,356) | (6,233) |
Scancell Holdings plc
Estado de Situación Financiera Consolidado
al 31 de octubre de 2023
Sin auditar | Sin auditar | auditado | ||
31/10/2023
| 31/10/2022 Replanteado1 | 30/04/2023
| ||
000 £ | 000 £ | 000 £ | ||
BIENES | ||||
Activos no corrientes | ||||
Inmovilizado material | 983 | 1,467 | 1,246 | |
Activos por derecho de uso | 845 | 1,124 | 1,003 | |
Goodwill | 3,415 | 3,415 | 3,415 | |
5,243 | 6,006 | 5,664 | ||
Activos circulantes | ||||
Cuentas comerciales y otras cuentas por cobrar | 476 | 5,612 | 538 | |
Activos por impuesto sobre la renta | 3,454 | 2,760 | 4,148 | |
Efectivo y equivalentes de efectivo | 13,079 | 24,035 | 19,920 | |
17,009 | 32,407 | 24,606 | ||
LOS ACTIVOS TOTALES | 22,252 | 38,413 | 30,270 | |
PASIVO | ||||
Pasivos no corrientes | ||||
Nota de préstamo convertible | (18,947) | (18,396) | (18,481) | |
Pasivo derivado | (9,136) | (16,022) | (14,000) | |
Pasivos por arrendamiento | (562) | (831) | (746) | |
| (28,645) | (35,249) | (33,227) | |
Pasivo circulante | ||||
Comerciales y otras cuentas a pagar | (1,664) | (2,511) | (2,970) | |
Pasivos por arrendamiento | (306) | (319) | (306) | |
(1,970) | (2,830) | (3,276) | ||
RESPONSABILIDAD TOTAL | (30,615) | (38,079) | (36,503) | |
NET (LIABILITIES)/ASSETS | (8,363) | 334 | (6,233) | |
EQUIDAD TOTAL | ||||
Llamado capital social | 820 | 815 | 819 | |
Compartir cuenta premium | 65,215 | 65,019 | 65,181 | |
Reserva de opciones sobre acciones | 2,506 | 1,876 | 2,123 | |
Ganancias retenidas | (76,904) | (67,376) | (74,356) | |
(8,363) | 334 | (6,233) | ||
Scancell Holdings plc
Estado de flujo de efectivo consolidado
para el período de 6 meses hasta el 31 de octubre de 2023
Sin auditar | Sin auditar | auditado | |
6 meses | 6 meses | Año hasta | |
31/10/2023
| 31/10/2022 Replanteado1 | 30/04/2023
| |
000 £ | 000 £ | 000 £ | |
flujos de efectivo por actividades operacionales | |||
(Pérdida) antes de impuestos del período | (3,588) | (5,936) | (14,304) |
Ajustes para: | |||
Ingresos financieros | (161) | (81) | (284) |
Intereses de arrendamiento pagados | 24 | 28 | 54 |
Interés del pagaré de préstamo convertible | 468 | 539 | 1,161 |
Finance (gain)/expense relating to derivative | (4,864) | 3,476 | 1,453 |
Ganancia por modificación sustancial de los CLN | - | - | - |
Depreciación | 276 | 261 | 536 |
Amortización del activo por derecho de uso | 158 | 197 | 366 |
Cargo por pago basado en acciones | 383 | 481 | 728 |
Efectivo utilizado en operaciones antes de cambios en el capital de trabajo | (7,304) | (1,035) | (10,290) |
Disminución / (aumento) de cuentas por cobrar comerciales y otras | 62 | (4,965) | 111 |
(Disminución) / aumento de cuentas comerciales y otras cuentas por pagar | (1,306) | 373 | 829 |
Efectivo utilizado en operaciones | (8,548) | (5,627) | (9,350) |
Créditos fiscales recibidos | 1,734 | 1,210 | 1,210 |
Efectivo neto utilizado en actividades operativas | (6,814) | (4,417) | (8,140) |
Flujos de efectivo de actividades de inversión | |||
Compra de inmovilizado material | (13) | (149) | (203) |
Ingresos financieros | 161 | 81 | 284 |
El efectivo neto utilizado en actividades de inversión | 148 | (68) | 81 |
Actividades de financiación | |||
Producto de la emisión de capital social | 35 | - | 166 |
Intereses pagados del préstamo convertible | - | - | (537) |
Pagos de arrendamiento | (210) | (205) | (375) |
Efectivo neto generado por actividades de financiamiento | (175) | (205) | (746) |
Aumento / (disminución) neto de efectivo y equivalentes de efectivo | (6,841) | (4,690) | (8,805) |
|
|
| |
Efectivo y equivalentes de efectivo al inicio del año | 19,920 | 28,725 | 28,725 |
|
|
| |
Efectivo y equivalentes de efectivo al final del período | 13,079 | 24,035 | 19,920 |
Scancell Holdings plc
Notas a los estados financieros intermedios
para el período de 6 meses hasta el 31 de octubre de 2023
1 Base de preparación
Este estado intermedio para el período de 6 meses hasta el 31 de octubre de 2023 no está auditado y fue aprobado por los Consejeros el 29 de enero de 2024. La información financiera contenida en el informe intermedio ha sido preparada de acuerdo con las políticas contables establecidas en el informe anual y cuentas del año finalizado el 30 de abril de 2023.
La información financiera contenida en el informe intermedio no constituye cuentas legales según se define en el artículo 434 de la Ley de Sociedades de 2006. La información financiera del año anterior completo se basa en las cuentas legales del año que finalizó el 30 de abril de 2023, sobre las cuales los auditores , BDO LLP, emitió una opinión de auditoría sin reservas que no contenía ninguna declaración en virtud del artículo 498(2) o 498(3) de la Ley de Sociedades de 2006. Las cuentas estatutarias auditadas para el año finalizado el 30 de abril de 2023 se han presentado al Registro de Compañías.
Según lo permitido, este informe intermedio ha sido preparado de acuerdo con la Regla 18 de AIM y no de acuerdo con la NIC 34 "Información financiera intermedia", por lo tanto, no cumple plenamente con las NIIF adoptadas por la Unión Europea.
2 Ganancias por acción
La utilidad básica por acción, proveniente de operaciones continuadas, se calcula dividiendo la utilidad atribuible a los accionistas ordinarios entre el promedio ponderado de acciones ordinarias en circulación durante el año.
Los cálculos de las ganancias por acción se basan en las siguientes pérdidas y números de acciones.
meses a 6 | meses a 6 | Año terminado | |
31/10/2023 | 31/10/20221 | 30/04/2023 | |
000 £ | 000 £ | 000 £ | |
(Pérdida) después de impuestos | (2,548) | (4,956) | (11,936) |
Número | Número | Número | |
Número promedio ponderado de acciones utilizadas en EPS básicas |
819,024,113 |
815,218,831 |
816,051,311 |
Ganancias básicas por acción | (0.31) p | (0.61) p | (1.46) p |
Pérdida diluida por acción
As the Group is reporting a loss from continuing operations for all period then, consequentially, the share options are not considered dilutive because the exercise of the share options would have the effect of reducing the loss per share.
At the 31 October 2023 the issued share capital amounted to 819,663,461 ordinary shares.
3 Taxation
La tributación para los 6 meses terminados el 31 de octubre de 2023 se basa en las tasas impositivas efectivas que se estima se aplicarán para el año terminado el 30 de abril de 2024.
4 resultados provisionales
Estos resultados fueron aprobados por el Consejo de Administración el 29 de enero de 2024. Copias del informe intermedio están a disposición del público en el domicilio social del Grupo y en el sitio web del Grupo. www.scancell.es.
5 Prior Period Restatement
The Company reviewed the valuation and accounting for convertible loan notes and identified certain corrections required to the prior periods' Group and company results. This is fully described in note 24 to the consolidated financial statements, included in the Annual Report and Accounts for the year ended 30 April 2023.
This prior period restatement also resulted in adjustments to the cashflow statements, in respect of adjusting loss before tax, non-cash revaluation gains/losses and non-cash interest payable. The restatement impact on the results to 31 October 2022 is shown in appendix 1.
There was no impact on cash itself and the prior period restatement does not impact the convertible loans' notional amounts or maturity dates disclosed. The consolidated financial statements are available on the Company website.
6 Eventos posteriores
In December 2023, the Company announced it raised gross proceeds of £11.9 million in aggregate (before expenses) through a capital raise. This comprised of (i) gross proceeds of £10.7 million in aggregate through the Placing and the Subscription with significant participation from both existing and new healthcare specialist investors and (ii) gross proceeds of £1.2 million through the Open Offer reflecting renewed support from existing shareholders. Following the capital raise, the issued share capital of the company will be 927,819,977.
Appendix 1: Impact of Prior Period Restatement
Estado de Ganancias o Pérdidas y Otros Resultados Integrales Consolidados para el período de 6 meses hasta el 31 de octubre de 2022
reportado | Reexpresión | Replanteado | ||
6 meses |
| 6 meses | ||
31/10/2022
|
| 31/10/2022
| ||
000 £ | 000 £ | 000 £ | ||
Operaciones continuas | ||||
Ingresos | 5,271 | - | 5,271 | |
El costo de ventas | (525) | - | (525) | |
Beneficio bruto | 4,746 | - | 4,746 | |
Gastos de desarrollo | (4,347) | - | (4,347) | |
Gastos administrativos | (2,373) | - | (2,373) | |
PÉRDIDA OPERATIVA | (1,974) | - | (1,974) | |
Intereses por cobrar e ingresos similares | 81 | - | 81 | |
Intereses por pagar | (1,343) | 776 | (567) | |
Finance gain/ (expense) relating to revaluation of derivative liability | (910) | (2,566) | (3,476) | |
Ganancia por modificación sustancial de pagarés de préstamo convertibles | - | - | - | |
(PÉRDIDA)/BENEFICIO ANTES DE IMPUESTOS | (4,146) | (1,790) | (5,936) | |
Impuesto sobre la pérdida de actividades ordinarias | 980 | - | 980 | |
(LOSS) FOR THE PERIOD |
| (3,166) | (1,790) | (4,956) |
GANANCIA POR ACCIÓN ORDINARIA (PENCES) Nota 2 | ||||
| ||||
Basic | (0.39) p | (0.22) p | (0.61) p |
Appendix 1: Impact of Prior Period Restatement (Continued)
Estado de Situación Financiera Consolidado a 31 de octubre de 2022
reportado | Reexpresión | Replanteado | ||
31/10/2022
|
| 31/10/2022
| ||
000 £ | 000 £ | 000 £ | ||
BIENES | ||||
Activos no corrientes | ||||
Inmovilizado material | 1,467 | - | 1,467 | |
Activos por derecho de uso | 1,124 | - | 1,124 | |
Goodwill | 3,415 | - | 3,415 | |
6,006 | - | 6,006 | ||
Activos circulantes | ||||
Cuentas comerciales y otras cuentas por cobrar | 5,612 | - | 5,612 | |
Activos por impuesto sobre la renta | 2,760 | - | 2,760 | |
Efectivo y equivalentes de efectivo | 24,035 | - | 24,035 | |
32,407 | - | 32,407 | ||
LOS ACTIVOS TOTALES | 38,413 | - | 38,413 | |
PASIVO | ||||
Pasivos no corrientes | ||||
Nota de préstamo convertible | (8,322) | (10,074) | (18,396) | |
Pasivo derivado | (11,005) | (5,017) | (16,022) | |
Pasivos por arrendamiento | (831) | - | (831) | |
| (20,158) | (15,091) | (35,249) | |
Pasivo circulante | ||||
Comerciales y otras cuentas a pagar | (2,511) | - | (2,511) | |
Pasivos por arrendamiento | (319) | - | (319) | |
(2,830) | - | (2,830) | ||
RESPONSABILIDAD TOTAL | (22,988) | (15,091) | (38,079) | |
NET (LIABILITIES)/ASSETS | 15,425 | (15,091) | 334 | |
EQUIDAD TOTAL | ||||
Llamado capital social | 815 | - | 815 | |
Compartir cuenta premium | 65,019 | - | 65,019 | |
Reserva de opciones sobre acciones | 1,876 | - | 1,876 | |
Ganancias retenidas | (52,285) | (15,091) | (67,376) | |
15,425 | (15,091) | 334 | ||
Appendix 1: Impact of Prior Period Restatement (Continued)
Consolidated Cash Flow Statement for the 6-month period to 31 October 2022
reportado | Reexpresión | Replanteado | ||
6 meses | 6 meses | Año hasta | ||
31/10/2022
|
| 31/10/2022 | ||
000 £ | 000 £ | 000 £ | ||
flujos de efectivo por actividades operacionales | ||||
(Pérdida) antes de impuestos del período | (4,146) | (1,790) | (5,936) | |
Ajustes para: | ||||
Ingresos financieros | (81) | - | (81) | |
Intereses de arrendamiento pagados | 28 | - | 28 | |
Interés del pagaré de préstamo convertible | 1,315 | (776) | 539 | |
Finance (gain)/expense relating to derivative | 910 | 2,566 | 3,476 | |
Ganancia por modificación sustancial de los CLN | - | - | - | |
Depreciación | 261 | - | 261 | |
Amortización del activo por derecho de uso | 197 | - | 197 | |
Cargo por pago basado en acciones | 481 | - | 481 | |
Efectivo utilizado en operaciones antes de cambios en el capital de trabajo | (1,035) | - | (1,035) | |
Disminución / (aumento) de cuentas por cobrar comerciales y otras | (4,965) | - | (4,965) | |
(Disminución) / aumento de cuentas comerciales y otras cuentas por pagar | 373 | - | 373 | |
Efectivo utilizado en operaciones | (5,627) | - | (5,627) | |
Créditos fiscales recibidos | 1,210 | - | 1,210 | |
Efectivo neto utilizado en actividades operativas | (4,417) | - | (4,417) | |
Flujos de efectivo de actividades de inversión | ||||
Compra de inmovilizado material | (149) | - | (149) | |
Ingresos financieros | 81 | - | 81 | |
El efectivo neto utilizado en actividades de inversión | (68) | - | (68) | |
Actividades de financiación | ||||
Producto de la emisión de capital social | - | - | - | |
Intereses pagados del préstamo convertible | - | - | - | |
Pagos de arrendamiento | (205) | - | (205) | |
Efectivo neto generado por actividades de financiamiento | (205) | - | (205) | |
Aumento / (disminución) neto de efectivo y equivalentes de efectivo | (4,690) | - | (4,690) | |
|
|
| ||
Efectivo y equivalentes de efectivo al inicio del año | 28,725 | - | 28,725 | |
|
|
| ||
Efectivo y equivalentes de efectivo al final del período | 24,035 | - | 24,035 | |
[ 1 ] Please refer to note 5 for further details on the prior period restatement
RNS puede usar su dirección IP para confirmar el cumplimiento de los términos y condiciones, para analizar cómo interactúa con la información contenida en esta comunicación y para compartir dicho análisis de forma anónima con otros como parte de nuestros servicios comerciales. Para obtener más información sobre cómo RNS y la Bolsa de Valores de Londres utilizan los datos personales que nos proporciona, consulte nuestra Política de privacidad.