Exhibit 99.2
January 2025 NASDAQ: HOOK HOOKIPA Pharma Next - generation Immunotherapies for the Treatment of Cancer and Other Serious Diseases
This presentation contains “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 , as amended, including statements regarding HOOKIPA's expectations regarding the terms, benefits, impacts and timing of the proposed combination (the "Proposed Combination") between HOOKIPA and Poolbeg Pharma plc (" Poolbeg ") and the proposed private placement, as well as statements regarding any or all of the following (assuming completion of the Proposed Combination and proposed private placement, as applicable) : the success, cost and timing of HOOKIPA's product development activities and clinical trials ; the timing, scope or likelihood of regulatory filings and approvals, including accelerated approval of HB - 200 by the U . S . Food and Drug Administration (“FDA”), and final FDA, European Medicines Agency or other foreign regulatory authority approval of HOOKIPA's current and future product candidates ; key milestones for HOOKIPA's product candidates ; HOOKIPA's ability to develop and advance its current and future product candidates and programs into, and successfully complete, clinical trials, including for HB - 700 , POLB - 001 , HB - 500 and HB - 200 ; the potential of HOOKIPA's arenavirus platform to treat additional HPV 16 + tumors and its applicability to additional antigens ; the expected timing of patient enrollment and dosing in clinical trials, completing clinical trials, and the availability of data from clinical trials ; expected revenue from clinical, regulatory and commercial milestones for HOOKIPA's partnered programs, including HB - 500 and HB - 400 ; the market opportunity for HOOKIPA's product candidates, if approved, in the indications they seek to treat, including the blockbuster potential of HB - 700 and the market opportunity for POLB 001 ; the potential of POLB 001 to receive orphan drug designation ; the potential of POLB 001 as an adjunct therapy for to bispecific and CAR T treatment ; HOOKIPA's expected capital needs, sufficiency of resources to achieve anticipated milestones, and cash runway ; the potential to develop product candidates in partnerships with third parties ; and other statements that are not historical fact . Forward - looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would,” “will” or similar expressions and the negative of those terms . HOOKIPA has based these forward - looking statements on its current expectations and projections about future events and financial trends that it believes may affect its business, financial condition and results of operations . Although HOOKIPA believes that such statements are based on reasonable assumptions, forward - looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk . Because forward - looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond HOOKIPA's control, you should not rely on these forward - looking statements as predictions of future events . These risks and uncertainties include, among others : outcomes of HOOKIPA's planned and ongoing clinical trials and preclinical studies may not be favorable or may not be predictive of future results in preclinical studies or clinical trials ; that one or more of HOOKIPA's product candidate programs will not proceed as planned for technical, scientific or commercial reasons ; uncertainty about regulatory approval to conduct clinical trials or to market products ; uncertainties regarding intellectual property protection ; the availability of funding sufficient for HOOKIPA's foreseeable and unforeseeable operating expenses and capital expenditure requirements ; the outcomes of due diligence and ongoing negotiations for the Proposed Combination and whether a firm offer will be made or the parties are otherwise able to reach binding agreement on terms ; the ability of the parties to satisfy (or waive) conditions to the consummation of the Proposed Combination ; effects on the market price of HOOKIPA's or Poolbeg's stock prices or operating results as a result of the announcement of the Proposed Combination or failure to agree to binding terms or to otherwise consummate the Proposed Combination ; the effect of the announcement of the Proposed Combination on HOOKIPA's or Poolbeg's business relationships, operating results and businesses generally ; whether the expected benefits of the Proposed Combination will ultimately be realized ; and those risk and uncertainties described under the heading “Risk Factors” in HOOKIPA's Annual report on Form 10 - K filed with the U . S . Securities and Exchange Commission on March 22 , 2024 and in any other subsequent filings made by HOOKIPA with the U . S . Securities and Exchange Commission, which are available at www . sec . gov . Existing and prospective investors are cautioned not to place undue reliance on these forward - looking statements, which speak only as of the date they are made . HOOKIPA disclaims any obligation or undertaking to update or revise any forward - looking statements contained in this presentation, other than to the extent required by law . Disclaimer 2
Important Information This presentation relates to a proposed business combination (the "Proposed Combination") of HOOKIPA Pharma Inc . (“HOOKIPA”) and Poolbeg Pharma plc (" Poolbeg ”) . If a firm offer is made or the parties otherwise agree to binding terms with respect to the Proposed Combination, HOOKIPA expects to file a proxy statement on Schedule 14 A, including any amendments and supplements thereto (the “Proxy Statement”) with the U . S . Securities and Exchange Commission (“SEC”) . To the extent the parties effect the Proposed Combination as a scheme of arrangement under the laws of England and Wales (the “Scheme”), the Proxy Statement will include a Scheme Document and the offer and issuance of shares by HOOKIPA to Poolbeg shareholders would not be expected to require registration under the U . S . Securities Act of 1933 , as amended, and the rules and regulations promulgated thereunder (the “Securities Act”), pursuant to an exemption provided by Section 3 (a)( 10 ) under the Securities Act . In the event that the parties determine to conduct the Proposed Combination in a manner that is not exempt from the registration requirements of the Securities Act, HOOKIPA would file a registration statement with the SEC containing a prospectus with respect to the issuance of its shares . This presentation is not a substitute for the Proxy Statement or any other document that HOOKIPA may file with the SEC or send to its shareholders in connection with the Proposed Combination . INVESTORS AND SHAREHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING THE SCHEME DOCUMENT) ANY AMENDMENTS OR SUPPLEMENTS THERETO AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED COMBINATION, INCLUDING ANY DOCUMENTS INCORPORATED BY REFERENCE THEREIN, CAREFULLY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PARTIES TO THE SCHEME, THE PROPOSED COMBINATION AND RELATED MATTERS . The Proxy Statement, if and when filed, as well as HOOKIPA's other public filings with the SEC, may be obtained without charge at the SEC's website at www . sec . gov and at HOOKIPA's website at www . hookipapharma . com . HOOKIPA shareholders and investors will also be able to obtain, without charge, a copy of the Proxy Statement (including the Scheme Document) and other relevant documents (when available) by directing a written request to HOOKIPA Pharma Inc . , Attn : Investor Relations, 350 Fifth Avenue, Suite 7240 , New York, NY 10118 , or by contacting Chuck Padala at Chuck@LifeSciAdvisors . com . Disclaimer (Cont’d) 3
Participants in the Solicitation HOOKIPA, Poolbeg , and their respecitve directors and executive officers may be deemed “participants” in any solicitation of proxies from HOOKIPA's shareholders with respect to the Proposed Combination . Information regarding the identity of HOOKIPA's directors and executive officers, and their direct and indirect interests, by security holdings or otherwise, in HOOKIPA securities is contained in HOOKIPA's Definitive Proxy Statement on Schedule 14 A for HOOKIPA's 2024 annual meeting of stockholders, which was filed with the SEC on April 26 , 2024 . Information regarding subsequent changes to the holdings of HOOKIPA's securities by HOOKIPA's directors and executive officers can be found in filings on Forms 3 , 4 , and 5 , which are available on HOOKIPA's website at www . hookipapharma . com or through the SEC's website at www . sec . gov . Additional information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, will be set forth in the Proxy Statement relating to the Proposed Combination if and when it is filed with the SEC . The Proxy Statement, if and when filed, as well as HOOKIPA's other public filings with the SEC, may be obtained without charge at the SEC's website at www . sec . gov and at HOOKIPA's website at www . hookipapharma . com . Information regarding the identity of Poolbeg's directors and executive officers is included in Poolbeg's annual report for the year ended December 31 , 2023 . Poolbeg's annual report for the year ended December 31 , 2023 , as well as Poolbeg's other regulatory announcements, may be obtained without charge at Poolbeg's website at www . poolbegpharma . com . No Offer or Solicitation of Securities This presentation is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the Proposed Combination or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law . In the United Kingdom and the European Union, this presentation is only available to persons who are ( i ) in the United Kingdom, "qualified investors" within the meaning in Article 2 (e) of Prospectus Regulation (EU) 2017 / 1129 (to the extent the same forms part of English law by virtue of the European Union (Withdrawal) Act 2018 ) acting as principal or in circumstances to which section 86 ( 2 ) of the Financial Services and Markets Act 2000 applies and who fall within the definitions in Article 19 ( 5 ) or Article 49 ( 2 )(a) to (d) of the Financial Services and Markets Act 2000 (Financial Promotion) Order ("FPO"), (ii) in the European Union, "qualified investors" within the meaning in Article 2 (e) of Prospectus Regulation (EU) 2017 / 1129 , and (iii) otherwise permitted to receive it (all such persons being together referred to as "Relevant Persons") . This presentation must not be acted on or relied upon by persons who are not Relevant Persons . Any investment or investment activity to which this presentation relates is available only to Relevant Persons and will be engaged in only with such persons . Solicitations resulting from this presentation will only be responded to if the person concerned is a Relevant Person . Disclaimer (Cont’d) 4
Merger Transaction Overview 5 • Proposed all stock transaction where HOOKIPA acquires Poolbeg Pharma plc • HOOKIPA remains TopCo with existing Nasdaq listing • Concurrent Financing: Private placement of up to approximately $30M to be funded into HOOKIPA immediately following transaction close • Implied ownership split pre - merger w ithout PIPE on a fully - diluted basis: POLB shareholders 55.0% / HOOKIPA shareholders 45.0% • In addition, CVR's for HB - 200, HB - 400 & HB - 500 Programs (for pre - PIPE HOOKIPA shareholders) • POLB expected to apply for cancellation of its shares on AIM Market at transaction close and become a private sub of HOOKIPA Transaction Structure Capitalization and Use of Proceeds Transaction Timeline Post - Closing • Combined company expected to have sufficient capital to realize meaningful value inflection points ‒ HB - 700: Phase 1 interim data expected in H1 2026 ‒ POLB 001: Phase 2a topline data expected in H2 2026 ‒ HB - 500: Phase 1b Primary completion expected in H2 2025 • Expected to provide cash runway through year - end 2026* • Possible offer announcement in line with Rule 2.4 of the UK City Code on Takeovers and Mergers • HOOKIPA to either announce a firm intention to make an offer for POLB, or not, under Rule 2.7 of the UK City Code on Takeovers and Mergers • Concurrent financing contingent on transaction close • Combined company anticipates benefiting from a strong international leadership team comprised of individuals with both signif ica nt industry experience and a track record of success *Statement: assumes the receipt of future expected R&D grant proceeds by the Austrian government, which Hera has received in pre vious years, for qualifying research and development expenses and capital expenditures
HOOKIPA - Poolbeg Merger Would Diversify Clinical Pipeline and Bolsters Near - Term Catalysts 6 Combined Leadership Team Bolsters Near - Term Clinical Data Catalysts Diversifies Pipeline Next - generation cancer immunotherapy portfolio led by multi - KRAS - targeting HB - 700 and Phase 2 - ready small molecule POLB 001 Experienced in successfully developing and commercializing medicines with focus on execution & operational excellence
HOOKIPA: Immunotherapy Focused Programs & Pipeline Opportunities 7 Infectious Disease Immunotherapy for HBV Immunotherapy for HIV HB - 400 HB - 500 Oncology HB - 700 POLB 001 Next - generation multi - KRAS targeting cancer immunotherapy with blockbuster potential Potentially breakthrough orally delivered p38 MAPK inhibitor to prevent cancer immunotherapy - induced CRS Eseba - vec (HB - 200) Immunotherapy for HPV16+ HNSCC GLP - 1 Program Oral GLP - 1R agonist for diabetes and obesity AI Programs For influenza and RSV AI: Artificial Intelligence. HBV: Hepatitis B Virus. HIV: Human Immunodeficiency Virus. GLP - 1: Glucagon - like peptide - 1. GLP - 1R: GLP - 1R receptor Immuno - Infectious Disease Immuno - Oncology Additional Programs Portfolio Opportunity
HOOKIPA is Advancing Differentiated Immunotherapies in Well - Defined Populations with Large Market Potential 8 GLP - 1R: Glucagon - like peptide - 1 receptor. POC: Proof of concept; 1: HB - 400 (GS - 2829): https://clinicaltrials.gov/study/NCT05770895?term=GS - 2829&rank=1 ; 2: HB - 500 (GS - 6779) https://clinicaltrials.gov/study/NCT06430905?term=hb - 501&rank=1 HB - 700 POLB 001 Strategic Partnerships Additional Programs Next - generation multi - KRAS targeting cancer immunotherapy with blockbuster potential Antigen - specific T cell activation for deep, durable, and robust anti - tumor activity Phase 1 - ready; derisked by clinical POC with platform asset eseba - vec (HB - 200) Interim Phase 1 data expected H1 2026 Phase 2 - ready asset designed to prevent immunotherapy - induced CRS Potential >$10B U.S. market opportunity Topline Phase 2 data expected H2 2026 Up to $417.5 M potential future opt - in, development and commercial milestones and significant sales royalties HB - 400 1 in Gilead - led Phase 1b trial for HBV with expected primary completion H1 2025 HB - 500 2 in HOOKIPA - led Phase 1b trial for HIV with expected primary completion H2 2025 Eseba - vec : Pivotal Phase 2/3 - ready asset in HPV16+ HNSCC Final Phase 2 data expected H2 2025 Oral GLP - 1R agonist Clinical topline POC data expected H1 2026
Proposed Team with Proven Execution and Operational Leadership 9 Mark Winderlich , PhD Chief Development Officer Ian O’Connell Chief Financial Officer, Poolbeg Co - Founder John McEvoy Chief Legal Officer Malte Peters, MD, PhD Chief Executive Officer Cathal Friel Executive Chairman, Poolbeg Co - Founder David Allmond Chief Business Officer
Key Milestone Phase 3 Phase 2 Phase 1 Preclinical Indication Modality Product Oncology Programs FPD in Phase 1 trial expected mid - 2025 KRAS Mutated T umors Next - generation immunotherapy HB - 700 FPD in Phase 2 trial expected H2 2025 Immunotherapy - induced CRS p38 MAPK inhibitor POLB 001 Partnered Programs in Infectious Disease Primary completion expected H1 2025 HBV Next - generation immunotherapy HB - 400 1 Primary completion expected H2 2025 HIV Next - generation immunotherapy HB - 500 2 HOOKIPA Has a Diversified Core Immunotherapy Pipeline 10 HOOKIPA - led Phase 1 ongoing Gilead - led Phase 1 ongoing Phase 2 - ready 1: HB - 400 (GS - 2829): https://clinicaltrials.gov/study/NCT05770895?term=GS - 2829&rank=1 ; 2: HB - 500 (GS - 6779) https://clinicaltrials.gov/study/NCT06430905?term=hb - 501&rank=1 Phase 1 - ready
Key Milestone Phase 3 Phase 2 Phase 1 Preclinical Indication Modality Product Additional Programs Final Phase 2 data expected H2 2025 HPV16+ HNSCC Next - generation immunotherapy Eseba - vec (HB - 200) Topline POC data expected H1 2026 Obesity and diabetes GLP - 1R agonist GLP - 1 Program Potential partnership Influenza Novel target discovery AI Programs Potential partnership RSV HOOKIPA Pipeline has Additional Partnership Opportunities 11 CPI: Checkpoint inhibitors. GLP - 1: Glucagon - like peptide - 1. GLP - 1R: GLPR - 1 receptor. POC; Proof - of - Concept Mature Phase 2 data with POC in combo with CPI
HOOKIPA’s Next - Gen Vaccine Platform Designed to Supercharge Immunity 1 - 4 T cell activation platform based on work of Nobel laureate and HOOKIPA co - founder Rolf Zinkernagel 5 1: Lauterbach H, et al. Front Oncol. 2021;11:732166; 2: Fu S, et al. ASCO 2022. Abstract 2517; 3: Bonilla WV, et al. Cell Rep Me d. 2021;2(3):100209; 4: Kallert SM, et al. Nat Commun. 2017;8:15327; 5: www.nobelprize.org/prizes/medicine/1996/zinkernagel/facts/ 12 Heterologous and alternating ‘prime - boost’ arenavirus vectors with target antigens Dendritic cells or macrophages T umor - specific T cell expansion and activation Unprecedented levels of cancer - specific T cells with polyfunctionality & durability with continued treatment Robust anti - tumor activity
13 HB - 700 Next - generation multi - KRAS targeting cancer immunotherapy with blockbuster potential
KRAS is the Most Prevalent Oncogenic Driver NSCLC: Non - small cell lung cancer. CRC: colorectal cancer. PDAC: pancreatic ductal adenocarcinoma Source: Trinity Life Sciences, Kantar, World Cancer Research Fund 14 Targeting KRAS has been challenging due to lack of activity, poor selectivity or treatment resistance G12D G12V G12C G12R G13D ~ 74% CRC ~ 83% NSCLC A pproved standards of care are small molecules targeting a single mutation ~$5 - 6B 2038 global KRAS market size estimate Prevalence of the top 5 KRAS mutations by tumor type ~ 95% PDAC ~1.5M people worldwide are diagnosed annually with KRAS - mutated NSCLC, CRC, or PDAC ~30 - 40% ~30 - 40% All CRC ≥88% All PDACs ~20% All NSCLC KRAS Market Opportunity Unmet needs remain for a therapy that can • Address multiple mutation subtypes • Drive deep and durable responses • Achieve immunogenic tumor cell death
HB - 700: A Novel Multi - KRAS Mutant Targeting Cancer Immunotherapy Designed for uniquely strong anti - tumor T cell activation 15 Large addressable populations in NSCLC, CRC and PDAC KRAS mutation specific T cell activation in humanized mice; preclinical profile supports diverse combinations Dose selection and treatment schedule based on alternating 2 - vector therapy in eseba - vec program Nonclinical development and clinical trial material manufacturing completed 1. artLCMV - KRAS = HB - 703, artPICV - KRAS = HB - 704, HB - 703 and HB - 704 encode 5 × 18 amino acid stretches of KRAS containing single amino acid mutations at position 12 or 13 2. Lauterbach et al 2024, 6th RAS Summit Boston G13D G12V G12C G12D G12R T argets 5 of the most prevalent KRAS mutations 1 Strong preclinical proof - of - concept package 2 D erisked by clinical POC with platform asset eseba - vec Phase 1 - ready Blockbuster commercial potential
HB - 700: Open - Label Phase 1/2 in Metastatic KRAS - Mutated NSCLC Clinical POC in NSCLC followed by expansion in related indications HLA: human leukocyte antigens. RP2D: Recommended Phase 2 dose. ORR: Overall response rate. DCR: Disease control rate. DoR : Duration of Response. PFS: Progression free survival. OS: Overall survival 16 Eligibility Metastatic/ advanced NSCLC PD - L1 scores of TPS ≥50% KRAS - mutated and HLA selected No prior line of therapy Metastatic/advanced NSCLC & CRC KRAS mutated and HLA selected ≥1 prior line SoC Eligibility Phase 1 Dose De - Escalation Phase 1 Dose Expansion 2L+ NSCLC & CRC 2L+ NSCLC HB - 700 Intended dose ; N = 3 + 3 HB - 700 De - escalation NSCLC N = 6 Phase 2 Combination 1L NSCLC HB - 700 + Pembrolizumab N = 30 Primary Endpoint: ORR by RECIST v1.1 Secondary Endpoint: S afety, DCR, DoR , PFS, OS, T cell response and tumor infiltration Expect FPD in Phase 1 trial mid - 2025 with interim Phase 1 data in KRAS mutant tumors in H1 2026 Primary Endpoint: RP2D Secondary Endpoint: Safety, T cell response, initial antitumor activity
PDAC CRC NSCLC 1L Addressable Patient Population (US+EU5) Unmet Need Tumor immune microenvironment HB - 700 KRAS Immunotherapy has Potential for $1.5B Peak Worldwide Net Sales* Across 1L NSCLC, CRC and PDAC, if approved Additional expansion opportunities in 2L and neoadjuvant/adjuvant for locally advanced disease *Assumptions: HLA restriction is included (54% NSCLC, 61% PDAC, 48% CRC) US launch: 2032, 3YTP; EU5 launch: 2033, 5YTP Settings 1L NSCLC, CRC and PDAC with 10 - 18% market share 17 : Source: Trinity Life Sciences Relative Opportunity for HB - 700 Highest Opportunity 18.5K patients 39K patients 27.8K patients
HB - 700 Potential to Combine with Diverse Approved and Emerging Therapies 18 Checkpoint Inhibitor Combination clinical POC on combination with anti - PD1 and eseba - vec 1 KRAS Inhibitor Combination potential to work synergistically with immunotherapy likely by remodelling the TME making it more susceptible to immune attack (e.g. AMG510+aPD1) 2 KRAS Degrader Combination enhanced antigen presentation may lead to augmented CD8+ T cell activation multi KRAS Combination Potential to potentiate/boost the immune response and reach a vast majority of patients with KRAS mutated solid tumors Adoptive T Cell Transfer Combination artARENA Technology potential to effectively activate and augment adoptively transferred T cells 3 G12C G12D inhibitors Multi KRAS CPIs Adoptive T cell transfer G12D degrader HB - 700 G13D G12V G12C G12D G12R G13D G12V G12C G12D G12R TME: Tumor microenvironment. 1 Presented at ASCO 2024; 2 Oya et al., Lung Cancer, 2024; 3 Purde MT et al 2024
19 POLB 001 Potentially breakthrough orally delivered p38 MAPK inhibitor to prevent cancer immunotherapy - induced CRS
CRS Associated with Immunotherapies is a High Unmet Need Effective prophylaxis represents a >$10B market opportunity 20 Cytokine Release Syndrome (CRS) A s evere , potentially life - threatening side effect of cancer immunot hera pies No a pproved therapies for prevention Approved options for CRS management (tocilizumab) have not adequately* prevented Grade 2+ CRS in clinical trials >70% 1 of patients experience CRS on certain CAR T / bispecific antibody therapies and are restricted to specialist cancer centers Estimated $5B annually 2 - 3 in direct costs to US health systems by 2030 CRS of all grades can require hospitalisation 1. Average rate from Summary of Product Characteristics ( SmPCs ) for Yescarta , Tecartus , Abecma , Kymriah, Carvykti , Breyanzi , Elrexfio , Columvi , Epkinly , Tecvayli and Talvey . 2. Datamonitor Healthcare. Forecast: Diffuse Large B - Cell Lymphoma and Multiple Myeloma, 2023 . 3. Abramson JS et al. Blood Adv. 2021 Mar 23;5(6):1695 - 1705. *In this context, adequately is defined as both not completely preventing grade 2+ CRS and potentially sufficient to support active clinical development to wards a regulatory approval of a medicine. Grade 2 CRS is defined as described by Lee et al, Biol Blood Marrow Transplant . 2019 Apr;25(4):625 - 638. janssenscience.com & doi.org/10.1182/blood - 2022 - 159381
POLB 001: Potential to Make Immunotherapies Safer & More Accessible *CRS score is a 0 - 4 system of physical observations where 0 is normal and 4 is moribund. MAPK: Mitogen Activated Protein Kinase. TNF: Tumour necrosis factor, IL - 6: Interleukin - 6 21 Selective p38 MAPK Inhibitor Strong P reclinical & C linical D ata Significant Market Opportunity • Selectively prevent excessive inflammation without immunosuppression • Oral agent • Strong patent portfolio • Phase 2 - ready • Favorable safety and tolerability profile • Potent TNF - α inhibition shown in two Phase 1 trials • Potent inhibition of IL - 6 and other key inflammatory markers in clinical & preclinical models • >$10B market opportunity • Potential for Orphan Drug Designation • No approved therapy for CRS prevention
LPS Human Challenge: Potent Inhibition of Excessive Inflammation Supportive of potential of POLB 001 as a prophylactic for cancer immunotherapy - induced CRS 22 Trial design : Single site, randomized placebo controlled LPS challenge trial. Healthy males administered BID oral POLB 001 or vehicle onl y c ontrol & challenged with local dermal LPS on day 4 and systemic IV LPS on day 6 to evaluate effect of POLB 001 on local and systemic inflammatory responses respectively. n=9 per group, all endpoints were exploratory. Clinically meaningful parameters such as temperature, heart rate, C - reactive protein and blood pressure were monitored, along with target i nhibition and a range of exploratory biomarkers. TNF - α : Tumour necrosis factor α , IL - 6: Interleukin 6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 0 POLB 001 Dosing D4 Single ID dose LPS D6 Single IV dose LPS D1 to D7 Day 73.5% and 56.2% maximal reduction compared to placebo for 70 mg and 150 mg doses respectively ( p = 0.0003) LPS IV 57.4% and 63.5% maximal reduction for 70 mg and 150 mg doses respectively ( p = 0.0002) Placebo 30 mg POLB 001 70 mg POLB 001 150 mg POLB 001 TNF - α IL - 6 Trial design Potential to effectively prevent CRS while preserving key immune system functionality
Planned POLB 001 Phase 2a Investigator Initiated Trial for Prevention of CRS in R/R Multiple Myeloma Patients Receiving Bispecific Ab Expect FPD in Phase 2 trial H2 2025 with topline data expected in H2 2026 23 Phase 2a IIT *Clinical trial collaboration and supply agreements with a large pharma company expected for approved BsAb BID = Twice Daily; BsAb = Bispecific antibody; CRS = Cytokine Release Syndrome; FTD = First treatment Dose; QW = Weekly Dosing; R/R = Relapsed/ Refractory; SoC = Standard of Care; SU = Step up dose, … 1 2 3 4 5 6 7 … 14 … - 4 BsAb SU1 POLB 001 Day SU2 FTD QW Single Arm SoC BsAb * N = 30 - 40 Single dose level BID Oral POLB 001 Key Objectives/ Endpoints Trial design Incidence of Grade 2+ CRS Incidence of CRS all grades Confirm safety and pharmacokinetics Exploratory biomarker analysis
CRS Preventative Therapy: > $ 10B US Market Opportunity 3 A significant opportunity exists for POLB 001 as an adjunct therapy to bispecific and CAR T treatment 24 1 st , 2 nd and 3 rd line+ MM and DLBCL patients in the US and EU5, receive CAR T cell and bispecific antibody therapy 1 An effective primary prophylactic for CRS could enable outpatient administration and broader uptake of immunotherapies 2 Potential across additional hematological malignancies, solid tumors and new areas like severe influenza CAR T: Chimeric Antigen Receptor T - cell therapy. MM: Multiple Myeloma . DLBCL: Diffuse Large B - Cell Lymphoma . 1. Datamonitor Healthcare. Forecast: Diffuse Large B - Cell Lymphoma and Multiple Myeloma, 2023. 2. Hansen DK et al., Cancers (Basel). 2023. 7;1 5(24):5746. 3. Independent research by Decisive Consulting Limited. https://teamdecisive.com/meet - the - team n = ~500,000 patients 1 71% 29% MM DLBCL Addressable MM and DLBCL population by 2030 in the US and EU5 Estimate encompasses solely MM & DLBCL due to rapid advancements in bispecific & CAR T treatment for these indications. Conservative price estimate versus market peers
25 Gilead Strategic Partnerships HB - 400 and HB - 500
Gilead – HOOKIPA: Aim to Develop Functional Cures for HBV and HIV E ntered into a strategic collaboration in June 2018 26 HB - 400 For the treatment of Hepatitis B A lternating , two - vector non - replicating arenaviral HBV immunotherapy High Potential candidate in Gilead’s efforts to develop a curative regimen of treatments Phase 1 enrollment completed Primary completion expected H1 2025 HB - 500 For the treatment of HIV A lternating , two - vector replicating arenaviral HIV immunotherapy Ongoing Phase 1b study FPD July 1, 2024, with enrollment expected to complete by Jan 2025 Primary completion expected H2 2025 Leveraging HOOKIPA’s immunotherapy platform to induce robust and durable immunity
HOOKIPA’s Immunotherapies are a Key Partner in Gilead’s HBV & HIV Cure Development Programs Using combination strategies and novel mechanisms with the goal to drive viral suppression and durable immunity 1 - 4 bNAbs : broadly neutralizing antibodies. siRNA: small interfering ribonucleic acid. ASO: Antisense oligonucleotides. 1: Therapeutic Po tential of TLR8 Agonist GS - 9688 ( Selgantolimod ) in Chronic Hepatitis B: Remodeling of Antiviral and Regulatory Mediators – PubMed ; 2: GILD - Virology - Deep - Dive - 17 - February - 2022.pdf ; 3: Progress in vaccine development for infectious diseases - a Keystone Symposia report – PubMed ; 4: GILD - Q324 - Earnings - Presentation - 6 - November - 2024 27 HOOKIPA’s immunotherapies have potential to build long - term immune responses HBV Cure Regimen siRNA / ASO for Antigen Reduction Immune Modulator Vaccine - Based Therapy HIV Cure Regimen bNAbs Immune Modulator Vaccine - Based Therapy
HB - 500 for HIV HOOKIPA - Gilead Partnership Offers Significant Revenue Potential 28 HB - 400 for HBV Gilead responsible for clinical development Next milestone payment: start of Phase 2 HOOKIPA Responsibilities • Vector design • Manufacturing and supply of clinical material Terms • $185M potential future development + commercialization milestones • High - single digit to mid - teen % royalties • All costs borne by Gilead, including HOOKIPA spend Gilead retains exclusive option post Phase 1 HOOKIPA Responsibilities • Vector design • Conducting Phase 1b clinical trial Terms • $232.5M potential future opt - in, development + commercial milestones • Mid - single digit to low double - digit % royalties
29 Additional Programs Eseba - vec (HB - 200), Oral GLP - 1, AI Programs
Eseba - vec (HB - 200) in Recurrent/Metastatic HPV16+ HNSCC Strong scientific thesis with mature Phase 2 data and POC in combination with checkpoint inhibitors ORR: Objective response rate. SOC: Standard of care (pembrolizumab monotherapy). HNSCC: Head and Neck Squamous Cell Carcinoma . P OC: Proof of concept 1 Trinity Life Sciences analyses; 2 Phase 1/2 data as of 30 - Sep - 2024 cut - off, presented at 2024 SITC conference 30 Leading Phase 2 Data in HPV16+ R/M OPC CPS ≥ 20 Clearly Defined Registrational Path • 52% response rate in CPS ≥ 20, best among vaccine approaches 2 • 16% complete response in CPS ≥ 20 HNSCC patients 2 • Durable responses leading to progression free survival of 16.3 months 2 • Favorable safety profile and well tolerated • FDA - endorsed strategy for potential accelerated approval • EMA PRIME designation received • Robust clinical and preclinical data package Large Addressable Market with Expansion Opportunities • Initial opportunity: ~1,500 - 3,000 patients with 1L HPV16+ R/M OPC (CPS ≥ 20) 1 • Potential expansion across HPV16+ OPC continuum • Other HPV16+ cancers (non - OPC HNSCC, anal, cervical, penile, vulvar, vaginal) • Additional ~17,500 - 20,000 patient opportunity 1
GLP - 1 Program – Oral GLP - 1R agonist Additional Pipeline Programs in Large Market Opportunities 31 RSV and Influenza Preclinical assets Computational Platform Opportunity 2 Integrates proprietary m ulti - parametric clinical data to identify novel host response targets Discussions ongoing in respect to collaborations GLP - 1: Glucagon - like peptide - 1. GLP - 1R: GLPR - 1 receptor. 1 poolbegpharma.com/pipeline/glp - 1r - agonist - 2/. 2 poolbegpharma.com/pipeline/artificial - intelligence/ Obesity and Diabetes Treatment Phase 1 asset Proprietary Delivery Technology Potential to overcome oral delivery challenges of peptide - based biologicals 1 Phase 1 initiation expected H1 2025 AI Programs – Novel Targets
32 Combined Company and Financial Overview
HOOKIPA: Global Company with Strong Patents and Cash Runway 33 Offering Size Up to approximately US$30M Expected to be Debt Free with Cash Runway Through YE 2026* Combined company expected to have operations in EU, UK & US Robust patent portfolio covering: • Platform patents • Product - specific patents • Oncology platform patents Expected to fund key inflection points HB - 700 Phase 1 interim data expected H1 2026 POLB 001 Phase 2a topline data expected H2 2026 HB - 500 Phase 1b primary completion expected H2 2025 HOOK (NASDAQ) *Statement: assumes the receipt of future expected R&D grant proceeds by the Austrian government, which Hera has received in pre vious years, for qualifying research and development expenses and capital expenditures
Clinical Milestones in High Interest Areas Over the Next 24 Months Cash runway expected to be extended through YE2026* including HB - 700, POLB 001 & HB - 500 milestones IIT: Investigator Initiated Trial. FPI: First Patient In. GLP - 1: Glucagon - like peptide - 1. POC: Proof of Concept 1: Management estimate based on currently available data; 2: HB 400 ; 3: HB 500 ; *Statement: assumes the receipt of future expected R&D grant proceeds by the Austrian government, which Hera has received in pre vious years, for qualifying research and development expenses and capital expenditures 34 2027 2026 2025 H2 H1 H2 H1 H2 H1 Indication Program KRAS Mutated T umors HB - 700 1 Immunotherapy - induced CRS POLB 001 1 HBV HB - 400 2 HIV HB - 500 2 HPV16+ HNSCC Eseba - vec 3 Oral GLP - 1 GLP - 1 Program 1 Phase 1/2 FPI Phase 2 FPI Phase 1 interim data Phase 1/2 full readout Phase 2 topline data Phas e 1b p rimary completion Final Phase 2 readout Phase 1b primary completion POC trial FPI POC trial topline data
Well - Positioned to Advance Next - Generation Immunotherapies for Cancer and Serious Diseases 35 Diverse Pipeline Merger would add Phase 2 - ready POLB 001 to expand immunotherapy portfolio in oncology Unprecedented T Cell Activation Antigen - specific T cell activation designed to produce durable, robust anti - tumor activity Multiple Near - Term Data Catalysts Clinical data expected in multiple programs over next 24 months in large therapeutic areas with unmet medical needs Merger Would Strengthen Balance Sheet Cash runway expected to be extended through year - end 2026 including HB - 700, POLB 001 and HB - 500 milestones* Strategic Partnerships in Infectious Diseases Gilead - partnered HBV and HIV programs in Phase 1 with potential to drive meaningful milestone & royalty revenues Differentiated Multi - KRAS Immunotherapy HB - 700 is an IND - cleared/Ph 1 - ready asset t argeting the 5 most prevalent KRAS mutations with blockbuster potential *Statement: assumes the receipt of future expected R&D grant proceeds by the Austrian government, which Hera has received in pre vious years, for qualifying research and development expenses and capital expenditures
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HOOKIPA - Poolbeg Merger Brings a New Management Team with a Track Record of Delivering Shareholder Returns DLBCL: diffuse large B cell lymphoma. EB: epidermolysis bullosa. FL: Follicular lymphoma. MF: myelofibrosis. PI3K: Phosphoino sit ide 3 - kinases. 1st L: first line. 2nd L: second line. 37 • Mark Winderlich and Malte Peters co - led development and approval strategy of tafasitamab in combination with lenalidomide in 2L+ DLBCL in US, EU, and other countries using real - world data • Assembled an experienced development team, that successfully led 3 large Phase 3 studies in 1 st L DLBCL, 2 nd L FL, 1 st L MF, leading to the acquisition of Morphosys by Incyte and Novartis • Led felzartamab clinical development in oncology & AI, which was acquired by hBIO , later Biogen. • World class rare and orphan focused biopharma co - founded and comprising of Poolbeg senior management team • Listed 2016 c.$50M and acquired in 2023 for $1.48B • Restructured and fixed underperforming assets, driving development & commercial success across multiple markets • Made strategic choices to rapidly generate substantial value for shareholders, including: 1. Approval of Filsuvez for EB and market launch 2. In - licensing of Lomitapide 3. Acquisition of Aegerion Pharmaceuticals 4. Acquisition of Chiasma Inc • Poolbeg’s co - founders Cathal Friel and Ian O’Connell took control of distressed hVIVO via a vehicle they co - founded called Open Orphan (later renamed hVIVO ). • Grew sales revenue from c.$30M in 2019 to an expected c.$77M for 2024, and market cap from c.$15M to c.$175M • Restructured to refocus operations on core strengths and implement efficiencies to drive revenue growth • Poolbeg Pharma spun - out of Open Orphan, bringing virology expertise • Malte Peters was responsible for the development and approvals of a PI3K inhibitor, BRAF/MEK inhibitor, CDK4 inhibitor, c - MET inhibitor, and other molecules • Introduced the concept of patient selection based on molecular profiles, leading to proof of concept and accelerated approvals from Phase 1 and 2 trials • Led the clinical team at Sandoz, Novartis’ generic division, to achieve approval of rituximab and Enbrel biosimilars
HB - 700 Preclinical Proof of Concept: Highly Immunogenic with Potent Target Cell Killing in Humanized Mice 38 KRAS mut specific T cells exhibit a polyfunctional profile KRAS mut specific T cells are functional and specifically kill target cells WT G12V G12D G12D WT G12V G12D 1 HLA - A*11:01 transgenic mice Source: Lauterbach et al 2024, 6th RAS Summit Boston ; Immunization of HLA - B*07:02 mice shows induction of cytotoxic KRAS G12R/C restricted CD8+ T cell responses (data not shown) SFU spot - forming units measured by IFN - γ ELISpot , WT - wild type, * = p<0.05 Polyfunctionality was determined by intracellular cytokine staining ; Cytotoxicity was measured in an in vivo CTL assay High frequencies of circulating KRAS mutation specific CD8 + T cells G12V
POLB 001: An Oral p38 MAPK Inhibitor That Selectively Targets Key Inflammatory Pathways Without Broad Immunosuppression Phase 2 ready asset with a comprehensive pre - clinical and clinical data package AE = adverse event. FIH = First in human; SAE = Serious adverse events; ECG = Electrocardiogram 39 Favorable Safety and Tolerability Profile 97 subjects dosed during Phase I FIH and LPS Challenge studies No SAEs or discontinuations due to AEs, all were of mild intensity No clinically meaningful findings in clinical laboratory test results, vital signs or ECG Favorable safety & tolerability profile Designed to Prevent Immunotherapy - Induced CRS Suitable for at - home dosing (used in LPS Challenge Study) Hepatic metabolism and biliary excretion profile favorable for multiple myeloma and renally impaired populations BID oral regimen designed to provide targeted protection during CRS risk period Half - life of 7 - 14 hours provides adequate exposure and avoids excessive exposure beyond periods of CRS risk
POLB 001: Benefit in Treatment of LPS - Induced Inflammation Randomized, double - blind, placebo - controlled, inflammatory challenge trial in healthy volunteers 40 Intravenous LPS challenge • Bloods (cytokines, vascular markers, CRP) • Ex - vivo LPS response • Safety & tolerability (inc. vital signs, AE’s, ECG, Hematology) Local inflammatory responses were also measured via intradermal LPS challenge on day 4 CRP: C - reactive Protein Endpoints Trial design Challenge Dosing D4 4 intradermal doses of LPS D6 1 intravenous dose of LPS POLB 001 N=9 Placebo N= 3 POLB 001 N= 9 Placebo N= 3 POLB 001 N=9 Placebo N=3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 0 Day D1 to D7 30mg 70mg 150mg
POLB 001 is Designed to Address a High Unmet Medical Need Effective prevention of CRS by POLB 001 may enable broader access to cancer immunotherapies DLBCL: Diffuse Large B - Cell Lymphoma. KOL: Key opinion leader. MM: Multiple Myeloma. 1. Datamonitor Healthcare. Forecast: Diffuse Large B - Cell Lymphoma and Multiple Myeloma, 2023. 2. Abramson JS et al. Blood Adv. 2021 Mar 23;5( 6):1695 - 1705. 41 ~500,000 Patients "Bottleneck" ca ncer immunotherapy delivery in specialist cent ers limits access Eligible CAR T / bispecific patients in US & EU for DLBCL and MM alone far exceeds treatment capacity 1 CAR T BsAb An effective CRS prevention could remove the bottleneck Estimated US$5B by 2030 In direct costs of managing CRS 2 Bispecific antibodies will only be delivered in specialist cancer centers until there is a way to make them safer. POLB 001 could make treatment safe enough to extend them to a much wider patient population . Professor Gareth Morgan, US “ The development of an oral CRS preventive therapy will mean no or shorter hospital stays. French KOL “
Eseba - vec : Synergistic Activity in Combination with Pembrolizumab Eseba - vec (HB - 200) is a next - generation immunotherapy targeting HPV+ cancers Source: Harrington updated data KEYNOTE - 048 JCO 2023 (median follow - up was 45.0 months, n = 882); Phase 1/2 data as of 30 - Sep - 20 24 cut - off, presented at 2024 SITC conference for the 1L treatment of HPV16+, R/M HNSCC patients 42 Eseba - vec+ Pembro in 1L CPS ≥ 20 N = 25 1 Pembro monotherapy in 1L CPS ≥ 20 N = 133) Eseba - vec monotherapy in 2L+ CPS ≥ 1 N = 27 52% 23% 4% Overall Response Rate 16% 8% No CR Complete Response Rate 84% Not reported 33% % Tumor Shrinkage 80% 53% 44% Disease Control Rate 16.3 mos 3.4 mos ~3.0 mos Median Progression Free Survival
Eseba - vec Exhibits Promising Preliminary PFS In 1L CPS ≥ 20 HPV+ R/M H&NSCC 43 PFS: Progression Free Survival; Source: Phase 1/2 data as of 30 - Sep - 2024 cut - off, presented at 2024 SITC conference; Efficacy da taset includes 27 patients with minimum 4.5 months of follow - up time after first dose as of data cutoff or discontinued early during this period.
Eseba - vec Has Broad Potential Across Multiple HPV16+ Cancers Up to ~20,000 US patients and ~39,000 patients globally 44 *Assuming full expansion beyond initial label (HPV16+ HNSCC and anogenital tumors) E ~17.5 - 20K patients D ~10 - 13K patients C ~4.5 - 8K patients B ~3 - 5.5K patients A ~1.5 - 3K patients Immediate OPC Opportunity 1L HPV16+, CPS > 20 R/M OPC A Expand to CPS 1 - 19 1L HPV16+, CPS >1 R/M OPC B Expand to Neoadjuvant/Adjuvant & 2L+ HPV16+ OPC C Expand to Recurrent/Metastatic Non - OPC HPV16+ HNSCC D Additional 2L+ Anogenital Opportunity HPV16+ Solid Tumors E Cumulative Patient Numbers OPC Opportunities Beyond OPC Source: Trinity Life Sciences
