EX-99.4 5 brhc20057078_ex99-4.htm EXHIBIT 99.4

Exhibit 99.4
 2Q 2023 Financial Results & Business Update  Thursday, August 10, 2023 
 

 Forward Looking Statements  2  This presentation contains “forward-looking statements” within the meaning of the safe harbor provisions 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. All statements, other than statements of historical facts, included in this presentation are forward-looking statements. These statements include, but are not limited to, the commercial performance of KIMMTRAK including planned launches in additional countries; the potential benefits KIMMTRAK will provide for patients; the number of patients Immunocore aims to reach per year by 2025; the expected submission of investigational new drug applications or clinical trial applications; the potential regulatory approval, expected clinical benefits and availability of Immunocore’s product candidates; expectations regarding the design, progress, timing, enrollment, scope, expansion, and results of Immunocore’s existing and planned clinical trials; potential growth opportunities and trends, including in connection with product launches in future quarters; and the Immunocore’s expected cash runway. Any forward-looking statements are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual events or results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company’s control. These risks and uncertainties include, but are not limited to, the impact of worsening macroeconomic conditions on the Company’s business, financial position, strategy and anticipated milestones, including Immunocore’s ability to conduct ongoing and planned clinical trials; Immunocore’s ability to obtain a clinical supply of current or future product candidates or commercial supply of KIMMTRAK or any future approved products, including as a result of the COVID-19 pandemic, war in Ukraine or global geopolitical tension; Immunocore’s ability to obtain and maintain regulatory approval of its product candidates, including KIMMTRAK; Immunocore’s ability and plans in continuing to establish and expand a commercial infrastructure and to successfully launch, market and sell KIMMTRAK and any future approved products; Immunocore’s ability to successfully expand the approved indications for KIMMTRAK or obtain marketing approval for KIMMTRAK in additional geographies in the future; the delay of any current or planned clinical trials, whether due to patient enrollment delays or otherwise; Immunocore’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; competition with respect to market opportunities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or future regulatory approval; Immunocore’s need for and ability to obtain additional funding, on favorable terms or at all, including as a result of worsening macroeconomic conditions, including changes inflation and interest rates and unfavorable general market conditions, and the impacts thereon of the COVID-19 pandemic, war in Ukraine and global geopolitical tension; Immunocore’s ability to obtain, maintain and enforce intellectual property protection for KIMMTRAK or any product candidates it is developing; and the success of Immunocore’s current and future collaborations, partnerships or licensing arrangements. These and other risks and uncertainties are described in greater detail in the section titled "Risk Factors" in Immunocore’s filings with the Securities and Exchange Commission, including Immunocore’s most recent Annual Report on Form 20-F for the year ended December 31, 2022 filed with the Securities and Exchange Commission on March 1, 2023, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission.  All forward looking statements contained in this presentation speak only as of the date on which they were made and should not be relied upon as representing its views as of any subsequent date. Except to the extent required by law, Immunocore undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.  Such risks may be amplified by pandemics or epidemics, war in Ukraine and related geopolitical tension, and their potential impacts on Immunocore’s business and the overall global economy. All forward looking statements contained in this presentation speak only as of the date on which they were made and should not be relied upon as representing its views as of any subsequent date. Except to the extent required by law, Immunocore undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.  Certain information contained in this presentation relates to or is based on studies, publications, surveys, and other data obtained from third party sources and Immunocore’s own internal estimates and research. While Immunocore believes these third party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy, or completeness of, any information obtained from third party sources.  KIMMTRAK™ is a trademark owned or licensed to Immunocore. 
 

 Agenda  3  Overview & 2Q Highlights  Bahija Jallal, PhD – Chief Executive Officer  2Q Financial Results  KIMMTRAK® Commercial Execution  Pipeline & PRISM Phase 3 Trial Design  Looking Ahead  Brian Di Donato – Chief Financial Officer & Head of Strategy  Ralph Torbay – Head of Commercial  David Berman, MD, PhD – Head of R&D  Bahija Jallal, PhD – Chief Executive Officer  Q&A Session 
 

 4  Our mission  To radically improve outcomes for patients with cancer, infectious diseases, and autoimmune conditions by pioneering and delivering transformative medicines 
 

 1. Projection based on the current business plan, includes projected KIMMTRAK net revenues. Immunocore may have based this estimate on assumptions that are incorrect and may end up using its resources sooner than anticipated, including as a result of increased costs or milestone payments that may become due. 3. Dollar amounts based on conversion rate of approximately 1.2709.  5  1H 2023 Highlights  Strong KIMMTRAK® performance and pipeline expansion  Delivering transformative medicine to patients   Executing and Expanding ImmTAC platform in oncology  KIMMTRAK® net revenue $111 million in 1H  New launches in Italy, Austria, Finland, and Israel  New Phase 3 IMC-F106C (PRAME- A02) 1L cutaneous melanoma trial  IMC-F106C-101 Phase 1/2 recruiting patients and data expected in 1H24   Randomization ongoing in KIMMTRAK Ph 2/3 2L+ cutaneous melanoma trial  3 INDs on track for submission over next 18 months  Advancing infectious diseases candidates  HIV Phase 1 MAD recruiting patients  HBV Phase 1 (now includes hepatocellular carcinoma) recruiting patients 
 

 2Q 2023 Financials   BRIAN DI DONATO  CFO & Head of Strategy  6 
 

 1. Projection based on the current business plan, includes projected KIMMTRAK/tebentafusp net revenues. Immunocore may have based this estimate on assumptions that are incorrect and may end up using its resources sooner than anticipated, including as a result of increased costs or milestone payments that may become due; 2. In millions. $ figures are based on "convenience" rates of 1.2709 for Q2 applied to £ figures reported.   7  Converted to USDmm2  2Q 2023 Financials  Key Figures (currency translated)  2Q 2023  1H 2023  KIMMTRAK net revenue (US)  $41.7  $79.2  KIMMTRAK net revenue (Europe)  $15.5  $31.2  Other (ROW)  $0.6  $0.9  Total net KIMMTRAK® revenue   $57.8  $111.3  Collaboration revenues  $2.9  $6.0  R&D expense  ($36.6)  ($72.7)  Selling & Admin expenses  ($43.1)  ($85.4)  Loss for the period  ($17.9)  ($39.1)  Loss per share  ($0.37)  ($0.81)  Cash and cash equivalents as of June 30  $435.1  QoQ global net sales increase of 11% driven by US growth  Cash increased to $435M  Capitalized to support development plan into 2026, including PRAME expansions and the new PRISM-MEL Phase 3 trial announced today 
 

 KIMMTRAK ® Execution   RALPH TORBAY  Head of Commercial  8 
 

 KIMMTRAK® continues to grow in key markets   1. ROW (International) denotes countries where Immunocore is commercializing through a partner; 2. In millions. $ figures are based on "convenience" rates of 1.3152 for Q1 2022, 1.2162 for Q2 2022, 1.1134 for Q3 2022, 1.2077 for Q4 2022,1.2369 for Q1 2023, and 1.2709 for Q2 2023 applied to £ figures reported.  9  USD millions 2  2Q 23 Net Revenues   $57.8M  35+ countries   with regulatory approval  4 launches in 1H  Italy, Austria, Finland and Israel   11% QoQ growth 
 

 Most prescribed HLA-A02 mUM* medicine in all 7 launch countries  1. ROW (International) denotes countries where Immunocore is commercializing through a partner; 2. In millions. $ figures are based on "convenience" rates of  1.2709 for Q2 2023 applied to £ figures reported. *Commercial launches ongoing in the following 7 countries: United States, Germany, France, Italy, Austria, Finland, and Israel ; * mUM=metastatic uveal melanoma  10  USD millions 2  $57.8M  ~60% KIMMTRAK share of 1L US market  9+ mo KIMMTRAK duration of therapy  <3 mo All patients transitioned to reimbursement in Italy  
 

 KIMMTRAK: Looking ahead  * Subject to reimbursement discussions  1. Recovering Excessive Funds for Unused and Needless Drugs Act of 2021 or the REFUND Act  11  Growth  US community expansion  1L KIMMTRAK 3-yrs OS data expected 4Q  Expansion in Italy  Several additional launches expected in Europe*  Reimbursement   US REFUND1 Act: CMS 2024 proposed rule  Germany: completed price negotiations  UK: NICE update  France: updated price agreement expected in 2024  Aim to reach 1,000 patients per year by 2025 
 

 Pipeline & PRISM-MEL301 Trial   DAVID BERMAN  Head of Research and Development   12 
 

 1. Program is wholly owned, development costs being provided by the Bill & Melinda Gates Foundation (BMGF), Immunocore retains all development and commercialization rights in the developed world. * Platinum refractory or resistant serous ovarian carcinoma  13  Multiple candidates in oncology and infectious diseases  Delivering leading bispecific TCR pipeline  Candidate  Target (HLA type)  Indication  IND-enabling  Phase 1  Phase 2  Phase 3  Approved  Catalyst  gp100 (A02)  Uveal melanoma  EU Launches | YE23  KIMMTRAK  2L+ cutaneous melanoma  Phase 2 Enrolled | 2H24  IMC-F106C  PRAME (A02)  1L cutaneous melanoma   Randomization Start | 1Q24  Multiple solid tumors   Clinical Data | 1H24  Multiple solid tumors  2L+ cutaneous melanoma  PRR ovarian*  Advanced endometrial  2L+ NSCLC  IMC-P115C  PRAME-HLE (A02)  Multiple solid tumors  IND/CTA | 2024  IMC-T119C  PRAME (A24)  Multiple solid tumors  IND/CTA | 2024  IMC-R117C  PIWIL1 (A02)  Colorectal, gastric, pancreatic  IND/CTA | 4Q23  IMC-M113V1  Gag (A02)  Human Immunodeficiency Virus (HIV)  MAD Data | 2024  IMC-I109V  Envelope (A02)  Hepatitis B Virus (HBV)  ONCOLOGY  INFECTIOUS DISEASES  Monotherapy dose exploration  Combinations w/ standards of care  TEBE-AM  PRISM-MEL301  New 
 

 Carvajal, R.D., et. al. Nat Med 28, 2364–2373 (2022)  Sullivan R, et. Al. Cancer Res (2023) 83 (7_Supplement): 1035.  14  ctDNA reduction in 1st line (Ph 3) and 2nd+ line (Ph 2) mUM  KIMMTRAK clinical activity highest in early stage disease   1st line  (N=123)  2nd + line  (N=94)  Where possible, study in earliest line of therapy  Platform insight   13% ctDNA clearance  37% ctDNA clearance  Cleared  ≥50% reduction (not cleared)  <50% reduction 
 

 Sacco J, et al. Cancer Res (2023) 83 (8_Supplement): CT223.  15  Longest OS follow-up for any bispecific TCR therapy  3-yr OS in previously-treated (Ph 2) mUM remains higher than historical   Long term OS benefit emerging – consistent with other IO therapies  Platform insight  KIMMTRAK® (tebentafusp)   (N=127)  Historical   (N=287)  Median OS  16.8 mos  7.8 mos  1-yr OS %  61%  37%  2-yr OS %  36%  15%  3-yr OS %  21%  9%  3-year OS update from first line mUM (Ph 3 trial) expected in 2H 2023 
 

 Hamid O, et al. JITC (2023)  * Patients who received prior anti-PD(L)1 therapy and then received tebentafusp+ durvalumab +/- tremelimumab on Study IMCgp100-201. Included patients relapsed from or refractory to prior anti-PD(L)1  16  AE incidence/severity consistent with that of each therapy alone (IMCgp100-201)  In cutaneous melanoma, tebentafusp active with checkpoints  Durable responses and disease control  Combinable with checkpoints  On active backbone, switch from weekly to monthly dosing  Platform insights  Weekly   Monthly   Dosing frequency   Remained weekly   Durable response  Durable disease control  60 cutaneous melanoma (all had prior anti-PD1) received tebentafusp + durvalumab* 
 

 Endometrial  Monotherapy expansion  NSCLC  Monotherapy expansion  Ovarian  Monotherapy expansion  Cutaneous melanoma  Monotherapy expansion  IMC-F106C (PRAME) clinical program progress  17  Monotherapy  Standards-of-care combinations  Checkpoint inhibitor combinations  ImmTAC  combination  Chemotherapy combinations  Registrational  PRISM-MEL301  New  Opportunity for 10,000 HLA:02+* pts/year  IMC-F106C-101 Study  *HLA-A02:01 
 

 18  Melanoma patients as presented at ESMO 2022 (n=18)   IMC-F106C monotherapy melanoma activity  Durable response  Durable disease control  Melanoma type  PRAME status  Prior therapy  Cutaneous (n=7)  5+, 1 unknown;   1 negative  All prior anti-PD1 & ipilimumab   Uveal (n=5)  All +  Prior tebentafusp   Uveal (n=6)  All +  Tebentafusp naïve   PRAME negative 
 

 Data cut-off May 2023 from live data base  DoR= duration of response  ^ Patient had disease progression after Month 12  19  Update to original ESMO melanoma patients (n=18)  IMC-F106C monotherapy melanoma activity shows durability  Durable response  Radiation to index lesion after this date  DoR = 10 mo^  DoR = 6 mo  DoR = 17 mo  DoR = 16+ mo  DoR = 12 mo  PRAME negative  Durable disease control  Melanoma type  PRAME status  Prior therapy  Cutaneous (n=7)  5+, 1 unknown;   1 negative  All prior anti-PD1 & ipilimumab   Uveal (n=5)  All +  Prior tebentafusp   Uveal (n=6)  All +  Tebentafusp naïve  
 

 Reasons to initiate IMC-F106C + anti-PD1 Ph3 trial in 1L melanoma   20  Successful Type B FDA meeting – Agreement to Ph3 trial & dose optimization (Project Optimus)  Monotherapy durable responses and disease control in heavily pre-treated melanoma, supportive of PFS (supported by emerging data in new patients)  Well tolerated and combinable with checkpoints, supported by ongoing study and from tebentafusp + checkpoint study   Focus on 1L melanoma, a large opportunity, with goal to support full approval in all HLA‑A02 melanoma   Platform has greatest benefit in earlier lines and amenable to less frequent dosing on backbone of active therapy 
 

 a. Use of nivolumab or nivolumab+relatlimab as control will be country specific  b. Represents target dose after intra-patient dose escalation  c. ITT: intent to treat  21  Design based on Type B FDA meeting  PRISM-MEL301: First line advanced, cutaneous melanoma Phase 3  Previously untreated, advanced melanoma  HLA-A*02:01   No prospective PRAME testing   Key inclusion criteria  AJCC M stage  Prior anti-PD1 adjuvant therapy  BRAF V600 status   Stratification factors  IMC-F106C + nivolumab (q4w)  Nivolumab (q4w) or  Nivolumab + relatlimab (q4w)a  N~325  N~325  Key Endpoints:  Primary: PFS by BICR  Secondary: OS, ORR   Exploratory: ctDNA  IMC-F106C q1w  12 wks  IMC-F106C q2w  To 1 year  IMC-F106C q4w  To 2 years  Control arm  40 mcg IMC-F106Cb + nivolumab  160 mcg IMC-F106Cb + nivolumab  Initial randomization includes comparison of two IMC-F106C regimens (~90 patients or 30/arm)  Interim analysis of two experimental arms  No pause in randomization during review  Drop one experimental arm  All patients in the ‘go-forward’ arm included in ITTC analysis 
 

 Executing across core areas for PRAME program  22  Endometrial  Monotherapy expansion  NSCLC  Monotherapy expansion  Ovarian  Monotherapy expansion  Cutaneous melanoma  Monotherapy expansion  Monotherapy  Standard-of-care combinations  Checkpoint inhibitor combinations  Chemotherapy combinations  40 mcg dose optimization  (Project Optimus)  IMCF106C-101 Study  ImmTAC  combination  Data to be presented in 1H 2024  Registrational Studies  PRISM-MEL301  New  Opportunity for 10,000 HLA:02+ pts/year  Randomization in 1Q 2024  Building Franchise  PRAME-A02   Half Life Extended (HLE)  PRAME-A24  IND/CTA in   2024 
 

 Looking Ahead  Bahija Jallal  Chief Executive Officer  23 
 

 Commercial Milestones  Planned Commercial Milestones  KIMMTRAK®  Commercial launch in Italy, Austria, Finland, and Israel  Launches in several additional European countries  Pricing reimbursement agreement in Germany  Pricing reimbursement agreement in France  CLINICAL Milestones  Planned Commercial Milestones  KIMMTRAK®  Complete randomization of Phase 2 2L+ cutaneous melanoma (TEBE-AM)  PRAME  First patient randomized in registrational 1L cutaneous melanoma (PRISM-MEL301)  Clinical data from Phase 1 PRAME trial   ImmTAC  IND/CTA for PIWIL1 (First patient dosed expected 1H24)  IND/CTA for PRAME-HLE trial  IND/CTA for PRAME-A24 trial  Infectious Diseases  Complete enrollment in Phase 1 HIV MAD/POC trial  Enroll Phase 1 HBV MAD (now including HCC) trial   1H 2023  4Q 2023  3Q 2023  2H 2024  1Q 2024  1H 2024  4Q 2023  2024  2024  2024  2024  Milestones  24  2024 
 

 BAHIJA JALLAL PhD  Chief Executive Officer  Q&A Session  BRIAN   DI DONATO  Chief Financial Officer and Head of Strategy  DAVID BERMAN MD, PhD  Head of Research and Development  RALPH   TORBAY  Head of Commercial  25  MOHAMMED DAR MD  SVP, Clinical Development and Chief Medical Officer 
 

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