EX-99.2 3 ef20022689_ex99-2.htm EXHIBIT 99.2
Exhibit 99.2

 Transformative immunomodulating medicines for patients  4Q 2023 & FY 2023 Financial Results  & Business Update 
 

 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, Immunocore’s capabilities across oncology, autoimmune and infectious disease therapeutic areas and its ability to grow, maximize and further develop the KIMMTRAK platform, and advance the clinical and pre-clinical programs, including the PRAME franchise, PIWIL 1 target other programs; the estimated market size and patient population for KIMMTRAK and Immunocore’s other product candidates; the three potential growth areas of KIMMTRAK including HLA-A02+ melanoma, metastatic cutaneous melanoma and adjuvant uveal melanoma; the outlook for 2024 and growth drivers for the commercial performance of KIMMTRAK including the momentum of KIMMTRAK in the United States, planned launches in additional countries, expanded access to KIMMTRAK in the United States and globally, early patient identification and indication expansion; 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; the ability to enter into pricing agreements and to translate such pricing agreement into a successful launch; the accrual assumptions regarding the outcome of price negotiations in France; the potential benefits and advantages KIMMTRAK and Immunocore’s other product candidates will provide for patients; expectations regarding the design, progress, timing, enrollment, scope, expansion, and results of Immunocore’s existing and planned clinical trials, those of Immunocore’s collaboration partners or the combined clinical trials with Immunocore’s collaboration partners; the timing and sufficiency of clinical trial outcomes to support potential approval of any of Immunocore’s product candidates or those of, or combined with, its collaboration partners; Immunocore’s goals to develop and commercialize product candidates based on its KIMMTRAK platform alone or with collaboration partners; Immunocore’s vision for the clinical benefit of its ImmTAAI platform; and Immunocore’s expectations regarding the use of its cash and cash equivalents, including the net proceeds from the convertible note financing. 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 Immunocore’s control. These risks and uncertainties include, but are not limited to, the impact of worsening macroeconomic conditions on Immunocore’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 health epidemics or pandemic, war in Ukraine, the conflict between Hamas and Israel, 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 war in Ukraine, the conflict between Hamas and Israel, 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 10- K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on February 28, 2024, as well as discussions of potential risks, uncertainties, and other important factors in Immunocore’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.  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.  2  Forward Looking Statements 
 

 Agenda  Overview & 2023 highlights  Bahija Jallal, CEO  Maximizing potential of KIMMTRAK®  Ralph Torbay, Head of Commercial  Advancing clinical portfolio & innovating for sustainable growth  David Berman, Head of R&D  Delivering on our promise  Bahija Jallal, CEO  Q&A Session  3  4Q23 & FY23 financial results  Brian Di Donato, CFO & Head of Strategy 
 

 4  We want to radically improve outcomes for patients with cancer, infectious diseases,  and autoimmune diseases, by pioneering and delivering transformative  immunomodulating medicines 
 

 $238.7M FY23 net sales with 3 Additional Growth Opportunities  US Community & global  expansion (mUM)  Ph 2/3 trial in 2L+ advanced melanoma (TEBE-AM)  Ph 3 trial in adjuvant uveal melanoma (ATOM)  Maximizing potential of KIMMTRAK  Up to 6K potential patients1  9 Active Clinical  & Pre-clinical Programs  PRAME: Start Ph 3 1L advanced melanoma, Ph 1 data throughout 2024 and expand franchise  PIWIL1: Novel target for colorectal  Targeting functional cure for HIV  Advancing clinical portfolio  Up to 150K PRAME patients  Novel Programs in 3 Therapeutic Areas  NEW autoimmune candidates:  Type 1 diabetes candidate  Universal candidate for dermatology  Innovating for sustainable growth  Large patient opportunities  5  1 Includes HLA-A02:01+ patients in metastatic uveal melanoma (mUM), adjuvant uveal (or ocular) melanoma and second-line or later patients with cutaneous melanoma. KIMMTRAK is currently only approved in HLA- A02:01+ patients with mUM.  Advancing our strategic pillars 
 

 Delivering across our three strategic pillars  Ralph Torbay  Head of Commercial  Maximizing potential of KIMMTRAK  Innovating for sustainable growth  Advancing clinical portfolio  6 
 

 7  1 Early Access Program (EAP). 2 US, Germany, France, Israel, Italy, Austria, Finland, Belgium, Switzerland, Slovenia, Australia and Canada. 3 Hassel, J., Piperno-Neumann, S. et al. New England Journal of Medicine 2023; 10.1056/NEJMoa2304753  We continue to reach more patients with KIMMTRAK  1L  standard of care in launched markets  Approved in  38  countries  Launched in  12  countries2  Treated  >2K  patients in trials, EAP1 & commercial  Published  3 yr  OS in NEJM3 
 

 USD millions  Q1 Net Revenues1  $51.6M  Q2 Net Revenues1  $56.9M  Q3 Net Revenues1  $62.6M  Q4 Net Revenues1  $67.6M  8  Q1 23 Q2 23 Q3 23 Q4 23  1 Q1, Q2, Q3 & Q4 net revenues are unaudited  2 International denotes countries where Immunocore is commercializing through a partner  3 Final price negotiations continue in France, sales based on accrual assumption  KIMMTRAK growth in 2023  $238.7M  FY 2023 net sales in US GAAP  2024 Outlook  Growth Drivers  Continued US momentum  Global launches (including Canada, Australia and EU countries)3  Early patient identification  International 2 Europe United States 
 

 9  1 ctDNA is a dual primary endpoint for the Phase 2 portion. 2 EORTC: European Organisation for Research and Treatment of Cancer  KIMMTRAK expansion opportunities in two late-stage trials  Phase 2 topline data expected by 4Q 2024  Key endpoints  Primary: Relapse-Free Survival (RFS)  Secondary: Overall survival  Treatment phase  1:1 Randomization  KIMMTRAK  (tebentafusp) (Q1W IV)  Observation  R  Key Endpoints  EORTC expected to start randomization  in 2H 2024  Treatment phase  1:1:1 Randomization  KIMMTRAK  (tebentafusp)  KIMMTRAK +  anti-PD-1  R  Key Endpoints  Key endpoints  Primary: OS  Secondary: ctDNA response1  Straight to follow-up  TEBE-AM  Phase 2/3 Trial in 2L+ Advanced Melanoma  ATOM  EORTC2 led Phase 3 Trial in Adjuvant Uveal (or Ocular) Melanoma 
 

 10  1 Estimated number of HLA-A*02:01 positive patients per year in the US and EU  KIMMTRAK’s  3 growth areas  Continued growth in US and global launches (incl. EU)  (FY23 net sales ~$239M)  Phase 2/3 trial in 2L+ advanced cutaneous melanoma (TEBE-AM)  (Phase 2 data expected 4Q 2024)  Phase 3 trial in adjuvant  uveal melanoma (ATOM)  (Phase 3 expected to start 2H 2024)  Today  Adjuvant Uveal Melanoma  ~1,200 pts1  2L+ Advanced  Cutaneous Melanoma  ~2,000 - 4,000 pts1  Metastatic  Uveal Melanoma  ~1,000 pts1  KIMMTRAK Estimated Market Opportunity 
 

 Delivering across our three strategic pillars  David Berman  Head of Research & Development  Innovating for sustainable growth  Maximizing potential of KIMMTRAK  Advancing clinical portfolio  11 
 

 PRAME is negative prognostic marker in multiple tumors  PRAME broadly expressed in multiple  tumors including:  12  PRAME franchise opportunity spans multiple solid tumors  Cutaneous Melanoma  NSCLC  Ovarian  Endometrial  Candidate  Opportunity  IMC-F106C  Up to 150,000  patients/year  PRAME HLA-A02  IMC-P115C  Half Life Extension  Half-life Extended (HLE);  less frequent dosing  PRAME HLA-A24  IMC-T119C  Up to 50,000 additional patients per year beyond HLA-A02 
 

 13  IMC-F106C (PRAME HLA-A02) next steps  Phase 1 2024 Data Plan  Next Steps  Phase 1 Data  Cutaneous melanoma  2Q – Monotherapy and anti-PD1 combination  1Q - Start PRISM-MEL301  1L Melanoma  Ovarian  3Q – Monotherapy and chemotherapy combination  NSCLC  4Q – Monotherapy and combination data  Endometrial  Enrolling  KIMMTRAK combination  Enrolling  40 mcg dose optimization  (Project Optimus)  Enrolling 
 

 14  PRISM-MEL301: First-line advanced cutaneous melanoma  First Phase 3 trial with IMC-F106C | Clinical trial collaboration and supply agreement with BMS  1 Use of nivolumab or nivolumab + relatlimab as control will be country specific. 2 BICR: blinded independent committee review  Treatment phase  Follow-up  Randomization  R  Key endpoints Primary: PFS by BICR2 Secondary: OS, ORR Exploratory: ctDNA  IMC-F106C + nivolumab (q4w)  Nivolumab (q4w) or  Nivolumab + relatlimab (q4w)1  N~325  N~325  q1w 12 wks  q2w To 1 year  q4w To 2 years  Randomization expected to start 1Q 2024 
 

 Negative prognostic marker in multiple cancers, role in tumor progression  Expressed in CRC1, historically insensitive to IO, and across major subgroups2  25% CRC have broad PIWIL1 expression (with > 75% of tumor cells positive)  15  IMC-R117C: First-in-class target PIWIL1 for colorectal & GI cancers  European Union CTA submitted in December 2023  PIWIL1, piwi-like protein1. 1 CRC, colorectal cancer. 2 Estimated across colorectal, esophageal, gastric, pancreatic, ovarian, endometroid cancers  PIWIL1 RNA in situ hybridization  Normal colon Colon adenocarcinoma  PIWIL1 detected  ~20K colorectal + ~15K other tumors  patients positive for PIWIL1 and HLA-A02  Phase 1 start expected in 2H 2024 
 

 16  Ongoing clinical trial exploring potential functional cure in HIV  Evaluating anti-viral activity of IMC-M113V before and after withdrawal of anti-retroviral therapy (ART)  1 Fun, Axel et al. Scientific reports vol. 7 43231. 2017. 2 Pardons M et al. PLoS Pathog 15(2), 2019, e1007619  Phase 1 goal is to determine safety and antiviral activity  Antiviral endpoints: reservoir quantification (blood) and viral rebound (magnitude and kinetics)  Flow cytometry of CD4+ T cells from peripheral blood  IMC-M113V Phase 1 MAD trial ongoing  Rare HIV-infected T cells (reservoir) persist despite ART1,2  Goal of immunotherapy is to eliminate reservoir  Phase 1 data expected 2H 2024 
 

 Delivering across our three strategic pillars  Advancing clinical portfolio  Maximizing potential of KIMMTRAK  Innovating for sustainable growth  David Berman  Head of Research & Development  17 
 

 18  Platform candidates NOW across 3 therapeutic areas  Oncology  ImmTAC  Immune mobilizing monoclonal TCRs Against Cancer  Infectious Diseases  ImmTAV  Immune mobilizing monoclonal TCRs  Against Virus  Autoimmune Diseases  ImmTAAI  Immune mobilizing monoclonal TCRs Against AutoImmune diseases  Activation  of the immune system     Downmodulation   of the immune system 
 

 19  ImmTAAI: tissue-specific, down modulation of the immune system  Vision  Current Systemic immune suppression, even if  inflammation in single tissue  Future  Down modulation of immune system localized to tissue under attack  ImmSPECT: target peptide discovery engine  >250K  Unique peptides that are  tissue-specific  2  Initial candidates  Brain Breast Heart Stomach Kidney Pancreas Ovary Bladder  Esophagus  Lung Liver Uterus Colon Blood 
 

 20  ImmTAAI: off-the-shelf, down modulation of immune system  Suppress T-cells only when ImmTAAI is tethered to target tissue  2. PD1 agonist  suppresses T cells     3. Fc fusion  infrequent dosing  Designed for long half- life, infrequent dosing  Suppresses T cell and NK cell activation  Promotes T cell exhaustion  Non-competitive with natural PDL-1  Does not interfere with Treg  1. Tissue-tethered targeting of HLA-antigen  Only active when tethered to target tissue 
 

 21  IMC-S118AI (PPIxPD1) for type 1 diabetes  Pancreas-tethered ImmTAAI (HLA-A02) protects against killing by autoreactive T cells  1 Quantity measured as area under the curve. 2 Current Diabetes Reports (2023) 23:277–291 (~700K in US & ~700K in EU5)  ImmTAAI binds specifically to pre-pro-insulin (PPI) peptide on pancreatic β-cells  Potent protection of β-cells from killing by autoreactive T cells  60  80  100  120  140  160  10 100  0.001 0.01 0.1 1 [ImmTAAI] nM  β cell number1  Immune system attacks and kills the beta cells responsible for  controlling glucose levels through the release of insulin  ~1.4M  HLA-A2+ type 1 diabetes patients (US + EU5)2  Autoreactive killing  Protection  PPI ImmTAAI  Non-tethered ImmTAAI  β-cells alone  β-cells + T cells  β-cell  marker 
 

 ImmTAAI binds specifically to APC in skin  22  Universal (non-HLA restricted) candidate for dermatology  Antigen presenting cell (APC) tethered ImmTAAI inhibits T cell activation  Potent inhibition of cytokine release  Non-tethered ImmTAAI  Tethered ImmTAAI  ImmTAAI (nM)  IL-2 release (%stim control)  Potential dermatological diseases: atopic dermatitis, psoriasis, and other skin diseases 
 

 4Q23 & FY23  financial results  Brian Di Donato  Chief Financial Officer & Head of Strategy  23 
 

 24  4Q & 2023 GAAP Financials  3Q in US GAAP for comparison (in USD millions, except per share data)  1 Q1, Q2, Q3 & Q4 Financials are unaudited  2 International denotes countries where Immunocore is commercializing through a partner  3 Final price negotiations continue in France, sales based on accrual assumption  Key Figures (currency translated)  3Q 20231  4Q 20231  FY 2023  Comments  KIMMTRAK net revenue (US)  43.4  49.1  169.8  QoQ growth of 13%  KIMMTRAK net revenue (Europe)  18.9  18.3  67.6  Includes France accrual3  Other (International2)  0.3  0.2  1.3  Total net KIMMTRAK revenue  62.6  67.6  238.7  QoQ growth of 8%  Collaboration revenues  2.2  2.6  10.7  R&D expense  43.2  45.6  163.5  SG&A expenses  35.5  41.4  144.5  Net income/(loss) for the period  0.9  (19.7)  (55.3)  Includes currency translation  Earnings/(loss) per share  0.02  (0.40)  (1.13) 
 

 25  Pro-Forma Cash  Unaudited and approximated  Use of Proceeds  We intend to use the net proceeds from the convertible note financing together with our existing cash and cash equivalents, to accelerate our clinical pipeline and for ongoing commercial expansion and repay loan under Pharmakon facility.  Comments  YE 2023 Cash Position  $443M  $402M as of YE '22  2030 Convertible note net proceeds  2.5% fixed rate  $94.70 optional conversion price  $389M  Priced Jan 2024  Pharmakon Loan Repayment  $50M  Expected Nov 2024  Net Pro-forma cash  $782M 
 

 Delivering on our promise  26  Bahija Jallal  Chief Executive Officer 
 

 27  Looking ahead  Commercial milestones  Clinical milestones  KIMMTRAK  Continued global growth driving by the United States and additional launches 2024  KIMMTRAK Expansion  Topline data from Ph 2 2L+ advanced cutaneous melanoma (TEBE-AM) 4Q 2024  First patient randomized in Ph 3 registrational adjuvant uveal melanoma trial (ATOM); led by EORTC 2H 2024  PRAME Franchise  First patient randomized in Ph 3 registrational 1L advanced cutaneous melanoma (PRISM-MEL301) 1Q 2024  Cutaneous melanoma data from Phase 1 PRAME trial 2Q 2024  Serous ovarian data from Phase 1 PRAME trial 3Q 2024  NSCLC data from Phase 1 PRAME trial 4Q 2024  IND/CTA for PRAME-HLE trial Mid-2024  IND/CTA for PRAME-A24 trial 4Q 2024  PIWIL1  First patient dosed in PIWIL1 Phase 1 trial 2H 2024  Infectious Diseases  Data from Ph 1 HIV MAD/POC trial 2H 2024  Enroll Ph 1 HBV MAD (now including HCC) trial 2024  Autoimmune Diseases  Initiating CMC manufacturing for autoimmune candidates 2024 
 

 28  New candidate added to pipeline January 2024. 1 Platinum refractory or resistant serous ovarian carcinoma. 2 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. 3 Program is not HLA restricted (i.e. universal for all populations)  Leading bispecific TCR pipeline in three therapeutic areas  Oncology  Autoimmune Infectious  Candidate  Target (HLA type)  gp100 (A02)  Indication  Uveal (ocular) melanoma  IND-enabling  Phase 1  Phase 2  Phase 3  Approved  Adjuvant uveal (ocular) melanoma  ATOM sponsored  by  2L+ cutaneous melanoma  TEBE-AM  IMC-F106C  PRAME (A02)  1L advanced cutaneous melanoma  PRISM-MEL-301  2L+ cutaneous melanoma  PRR ovarian1  2L+ NSCLC  Advanced endometrial  Multiple solid tumors Mono. & combinati  on arms  IMC-P115C  PRAME-HLE (A02)  Multiple solid tumors  IMC-T119C  PRAME (A24)  Multiple solid tumors  IMC-R117C  PIWIL1 (A02)  Colorectal and GI cancers  IMC-M113V2  Gag (A02)  Human Immunodeficiency Virus (HIV)  IMC-I109V  Envelope (A02)  Hepatitis B Virus (HBV)  IMC-S118AI  PPIxPD1 (A02)  Type 1 Diabetes  Undisclosed  (universal)3  Dermatology 
 

 29  Bahija Jallal PhD  Chief Executive Officer  Ralph Torbay  Head of Commercial  Brian Di Donato  Chief Financial Officer and  Head of Strategy  Mohammed Dar MD  SVP, Clinical Development and Chief Medical Officer  David Berman MD, PhD  Head of Research and  Development  John Goll  SVP, Finance and Chief Accounting Officer  Q&A Session 
 

 Thank you  30