Overview and Key Highlights Immunocore achieved FDA approval and launched KIMMTRAK for mUM, advanced its clinical pipeline, and ended 2021 with $321 million cash - KIMMTRAK® (tebentafusp-tebn) received FDA approval for unresectable or metastatic uveal melanoma (mUM) and the US commercial launch has been initiated25 - The European Medicines Agency's CHMP issued a positive opinion for KIMMTRAK, with regulatory submissions also under review in the UK, Canada, and Australia210 - The company plans to report Phase 1 data from its clinical candidates targeting PRAME in Q3 2022 and MAGE-A4 in Q4 202226 - Cash position was approximately $321 million as of December 31, 20213 Management Commentary Management highlighted KIMMTRAK's approval as platform validation, prioritizing its commercial rollout and accelerating pipeline programs with upcoming data - The CEO stated that KIMMTRAK's approval provides an important validation of the ImmTAX platform and opens doors for further discoveries in cancer and other diseases8 - Priorities for the new year include the commercial roll-out of KIMMTRAK and accelerating the clinical programs, with updates from PRAME and MAGE-A4 programs planned for later in the year9 Clinical Pipeline and Program Updates Immunocore advances its multi-program clinical pipeline, with KIMMTRAK achieving regulatory milestones and key oncology and infectious disease programs progressing KIMMTRAK® (tebentafusp-tebn) KIMMTRAK received FDA approval for mUM, a positive CHMP opinion, and is being explored for mCM with a new commercialization agreement - Received FDA approval in January 2022 for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM)11 - Received a positive CHMP opinion in Europe in February 2022, with an anticipated launch in Q2 2022 upon final EMA decision10 - A Phase 1b trial in metastatic cutaneous melanoma (mCM) showed preliminary evidence of clinical activity in patients who had prior anti-PD(L)1 therapy, with a 1-year overall survival rate of 76%12 - An exclusive multi-regional agreement was signed with Medison Pharma to commercialize tebentafusp in Canada, Central Eastern Europe, and Israel15 IMC-C103C targeting MAGE-A4 IMC-C103C's Phase 1 trial showed manageable safety and durable responses, with an expansion arm initiated and further data expected in Q4 2022 - Initial Phase 1 data showed a manageable safety profile and clinical activity with confirmed durable responses in ovarian cancer and head and neck squamous cell carcinoma (HNSCC)16 - An expansion arm initiated in high-grade serous ovarian carcinoma at 140 micrograms/weekly in Q4 202116 - The company plans to report data from the MAGE-A4 program in the fourth quarter of 202216 IMC-F106C targeting PRAME IMC-F106C's Phase 1/2 trial enrolled 39 patients, showing early biological activity, with initial Phase 1 data expected in Q3 2022 - As of December 16, 2021, 39 patients have been enrolled in the Phase 1 study for multiple solid tumor cancers17 - Early pharmacodynamic data indicate that IMC-F106C monotherapy is demonstrating biological activity17 - The company plans to report the initial Phase 1 data in the third quarter of 202217 Infectious Disease Programs (ImmTAV®) Immunocore advances its ImmTAV® platform for infectious diseases, with ongoing Phase 1 enrollment for HBV and a CTA accepted for HIV with Q2 2022 dosing - HBV (IMC-I109V): The global Phase 1 single ascending dose trial continues to enroll patients18 - HIV (IMC-M113V): A clinical trial application (CTA) was accepted in the UK, with plans to dose the first patient in Q2 202219 Financial Results Immunocore's FY2021 operating loss increased to £135.2 million, revenue decreased to £26.5 million, but cash and equivalents significantly increased to £237.9 million Financial Performance Summary | Metric | Q4 2021 | Q4 2020 | FY 2021 | FY 2020 | | :--- | :--- | :--- | :--- | :--- | | Revenue | £6.6M | £7.4M | £26.5M | £30.1M | | R&D Expenses | £20.1M | £17.2M | £73.2M | £74.8M | | Admin Expenses | £24.4M | £14.2M | £88.4M | £45.7M | | Operating Loss | £37.8M | £20.2M | £135.2M | £86.2M | | Loss per Share | £0.90 | £0.69 | £3.10 | £2.79 | - The increase in operating loss was primarily driven by higher employee costs from a non-cash share-based payment charge and pre-commercial expenditure for tebentafusp2124 - Cash and cash equivalents increased to £237.9 million (approx. $321.1 million) as of December 31, 2021, compared to £129.7 million as of December 31, 202025 About KIMMTRAK® and Important Safety Information KIMMTRAK is a first-in-class bispecific T cell receptor therapeutic, approved based on Phase 3 data showing overall survival benefit, with a boxed warning for Cytokine Release Syndrome - KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function, targeting the gp100 antigen26 - The pivotal Phase 3 trial demonstrated an unprecedented overall survival benefit with a Hazard Ratio (HR) of 0.51 (95% CI: 0.37, 0.71; p< 0.0001) favoring KIMMTRAK over investigator's choice28 - BOXED WARNING: KIMMTRAK can cause Cytokine Release Syndrome (CRS), which may be serious or life-threatening. CRS occurred in 89% of patients, with 0.8% being grade 3 or 429 - The most common adverse reactions (≥30%) were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting33 About Immunocore and its Technology Immunocore is a commercial-stage biotech company pioneering ImmTAX TCR bispecific immunotherapies, utilizing its ImmTAC platform for oncology, autoimmune, and infectious diseases, with five clinical-stage programs - Immunocore is a commercial-stage biotech company developing a novel class of TCR bispecific immunotherapies called ImmTAX37 - The proprietary ImmTAC® technology generates bispecific biologics designed to redirect T cells to recognize and kill cancerous cells by targeting intracellular cancer antigens36 - The company has a deep pipeline with five clinical-stage programs in oncology and infectious disease37 Consolidated Financial Statements Immunocore's 2021 consolidated financial statements show a net loss of £131.5 million, year-end cash of £237.9 million, total assets of £301.8 million, and total equity of £171.5 million Consolidated Statement of Loss Immunocore's FY2021 loss increased to £131.5 million from £74.1 million, with Q4 loss widening to £39.4 million, primarily due to increased expenses Full Year Consolidated Statement of Loss | (in thousands £) | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Revenue | 26,520 | 30,114 | | Operating loss | (135,162) | (86,193) | | Loss for the period | (131,523) | (74,093) | Quarter Ended Consolidated Statement of Loss | (in thousands £) | Quarter Ended Dec 31, 2021 | Quarter Ended Dec 31, 2020 | | :--- | :--- | :--- | | Revenue | 6,593 | 7,420 | | Operating loss | (37,832) | (20,160) | | Loss for the period | (39,389) | (18,880) | Consolidated Statement of Cash Flows Net cash used in operating activities was £96.1 million, offset by £204.6 million from financing, resulting in year-end cash of £237.9 million Consolidated Statement of Cash Flows Summary | (in thousands £) | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Net cash flows used in operating activities | (96,110) | (61,250) | | Net cash flows from financing activities | 204,631 | 115,941 | | Cash and cash equivalents at end of period | 237,886 | 129,716 | Consolidated Statements of Financial Position As of December 31, 2021, Immunocore reported total assets of £301.8 million, total liabilities of £130.2 million, and total equity of £171.5 million Consolidated Statements of Financial Position Summary | (in thousands £) | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Total non-current assets | 39,047 | 44,263 | | Total current assets | 262,726 | 152,931 | | Total assets | 301,773 | 197,194 | | Total equity | 171,547 | 55,346 | | Total non-current liabilities | 69,046 | 86,850 | | Total current liabilities | 61,180 | 54,998 | | Total liabilities | 130,226 | 141,848 |
Immunocore(IMCR) - 2022 Q1 - Quarterly Report