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Immunocore(IMCR) - 2022 Q1 - Quarterly Report
2022-03-03 12:01
[Overview and Key Highlights](index=1&type=section&id=Overview%20and%20Key%20Highlights) 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 initiated[2](index=2&type=chunk)[5](index=5&type=chunk) - The European Medicines Agency's CHMP issued a **positive opinion** for KIMMTRAK, with regulatory submissions also under review in the UK, Canada, and Australia[2](index=2&type=chunk)[10](index=10&type=chunk) - The company plans to report **Phase 1 data** from its clinical candidates targeting PRAME in **Q3 2022** and MAGE-A4 in **Q4 2022**[2](index=2&type=chunk)[6](index=6&type=chunk) - Cash position was approximately **$321 million** as of December 31, 2021[3](index=3&type=chunk) [Management Commentary](index=2&type=section&id=Management%20Commentary) 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 diseases[8](index=8&type=chunk) - 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 year[9](index=9&type=chunk) [Clinical Pipeline and Program Updates](index=2&type=section&id=Clinical%20Pipeline%20and%20Program%20Updates) Immunocore advances its multi-program clinical pipeline, with KIMMTRAK achieving regulatory milestones and key oncology and infectious disease programs progressing [KIMMTRAK® (tebentafusp-tebn)](index=2&type=section&id=KIMMTRAK%C2%AE%20%28tebentafusp-tebn%29) 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](index=11&type=chunk) - Received a **positive CHMP opinion** in Europe in **February 2022**, with an anticipated launch in **Q2 2022** upon final EMA decision[10](index=10&type=chunk) - 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](index=12&type=chunk) - An **exclusive multi-regional agreement** was signed with Medison Pharma to commercialize tebentafusp in Canada, Central Eastern Europe, and Israel[15](index=15&type=chunk) [IMC-C103C targeting MAGE-A4](index=3&type=section&id=IMC-C103C%20targeting%20MAGE-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](index=16&type=chunk) - An **expansion arm initiated** in high-grade serous ovarian carcinoma at 140 micrograms/weekly in **Q4 2021**[16](index=16&type=chunk) - The company plans to report data from the MAGE-A4 program in the **fourth quarter of 2022**[16](index=16&type=chunk) [IMC-F106C targeting PRAME](index=3&type=section&id=IMC-F106C%20targeting%20PRAME) 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 cancers[17](index=17&type=chunk) - Early pharmacodynamic data indicate that IMC-F106C monotherapy is demonstrating **biological activity**[17](index=17&type=chunk) - The company plans to report the initial Phase 1 data in the **third quarter of 2022**[17](index=17&type=chunk) [Infectious Disease Programs (ImmTAV®)](index=3&type=section&id=Infectious%20Disease%20Programs%20%28ImmTAV%C2%AE%29) 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 patients[18](index=18&type=chunk) - **HIV (IMC-M113V):** A clinical trial application (CTA) was accepted in the UK, with plans to dose the first patient in **Q2 2022**[19](index=19&type=chunk) [Financial Results](index=4&type=section&id=Financial%20Results) 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 tebentafusp[21](index=21&type=chunk)[24](index=24&type=chunk) - 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, 2020[25](index=25&type=chunk) [About KIMMTRAK® and Important Safety Information](index=4&type=section&id=About%20KIMMTRAK%C2%AE%20and%20Important%20Safety%20Information) 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 antigen[26](index=26&type=chunk) - 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 choice[28](index=28&type=chunk) - **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 4[29](index=29&type=chunk) - The **most common adverse reactions (≥30%)** were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting[33](index=33&type=chunk) [About Immunocore and its Technology](index=6&type=section&id=About%20Immunocore%20and%20its%20Technology) 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 **ImmTAX**[37](index=37&type=chunk) - The proprietary **ImmTAC® technology** generates bispecific biologics designed to redirect T cells to recognize and kill cancerous cells by targeting intracellular cancer antigens[36](index=36&type=chunk) - The company has a deep pipeline with **five clinical-stage programs** in oncology and infectious disease[37](index=37&type=chunk) [Consolidated Financial Statements](index=8&type=section&id=Consolidated%20Financial%20Statements) 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](index=8&type=section&id=Consolidated%20Statement%20of%20Loss) 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](index=10&type=section&id=Consolidated%20Statement%20of%20Cash%20Flows) 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](index=11&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) 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) presents at JP Morgan 40th Annual Virtual Healthcare Conference (Slideshow)
2022-01-14 17:46
IMMUNOCORE | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|--------------|-----------------------------------------------------------------|-------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 40th | | Corporate Presentation Annual J.P. Morgan Healthcare Conference | | | | | | | | | | January 2022 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Forward-Looking Statements This presentation contains fo ...
Immunocore (IMCR) Investor Presentation - Slideshow
2021-06-11 18:32
IMMUNOCORE Corporate Presentation June 2021 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "believe," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this presentation may include statements ...
Immunocore(IMCR) - 2020 Q4 - Annual Report
2021-03-25 11:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ 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, 2020 OR Date of event requiring this shell company report Commission File Number 001-39992 Immunocore Holdings plc (Exact name of Registrant as specified in its charter and translation of Regis ...