HOOKIPA Pharma Inc.

Thank you. A slide deck accompanying today's call is available through the webcast and in the events section of the WhoKeepa website. Please manually advance the slides as we prompt you through them. Joining me today are Chief Executive Officer Iren Aldag, Chief Financial Officer Reinhard Kandera, and Chief Medical Officer Katia Schlanger. During today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety, and intended utilization of investigational agents, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development, and possible intended use of cash and investments. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change and involve risks and uncertainty that may cause the actual results to differ materially from those contained in the forward-looking statement. These and other risks are described in our periodic filings made with the SEC, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's dates. The company disclaims any obligation to update such statements. For today's call, Jern will provide opening remarks. Reinhard will offer high-level comments on our financials, and then we'll open the call to Q&A. With that, I'll pass the call to Jern.

Okay, good morning, everyone. I'd like to focus first on our accomplishments in 2022, and second, highlight what's coming in 2023. At Utipa, we're leveraging our RNA viral platform to create therapies that deliver unprecedented antigen-specific CD8 T cells to combat disease. In 2022, we saw progress both in and toward the clinic across four different programs in areas of considerable unmet need. Please go to slide three, which is our portfolio slide. Key developments in 22 were the progress of our HPV-positive cancer drug, HB200, in a Phase II single-arm cohort in combination with Fembrolizumab. The acceptance of an IND for 300, a prostate cancer therapeutic targeting self-antigens. A material collaboration with Roche for a novel approach to target shared neoantigens in cancers for lung, pancreas, and colon cancers with KRAS mutations. and achieving phase one readiness for our Gilead-partnered hepatitis B therapeutic vaccine. Let me give you a bit more background on these major achievements. Our phase one dose escalation study showed that HP200 was generally well-tolerated, rapidly induced a high magnitude of tumor-specific T cells, and showed early anti-tumor activity and difficult to treat patients as a monotherapy. We progressed to testing HP200 and HPV16 positive head and neck squamous cell carcinoma patients in phase two. We're currently enrolling patients in three dose expansion cohorts, a cohort in the non-randomized first line setting in combination with PEMBRO, a cohort in the non-randomized second-line setting and second-line plus setting in combination with femoral, and a cohort of patients in the post-standard of care setting at the recommended phase 2 dose. Regarding the HP200 trial, I reaffirm our Q2 data guidance. We will disclose data from 10 to 20 patients each. in the first and second line settings in combination with PEMBRO, and we will provide an update on our monotherapy dose escalation cohort. We will present an update on this trial and all three cohorts in a press release and an investor call in the second quarter and inform about the likely path forward. As a reminder, our HP200 trial, which targets an oncoviral antigen, supports the first pillar of our three-part strategy in oncology. The second pillar in our oncology strategy is targeting self-antigens, which we are pursuing with our HP300 program in prostate cancer. The trial is now open for enrollment as per our guidance to start the trial in Q1 2023. Targeting neoantigens is the third pillar of our oncology strategy. In October, we announced a collaboration in this field with Walsh to advance our HP700 asset targeting KRAS mutations in multiple indications, and an option to develop a second undisclosed candidate. We're pleased by the progress across our oncology portfolio, as well as the acceptance by the FDA last July of our drug master file. The information from that master file can be used to support new IND filings using our platform, leading to reduced preclinical cycle times. Regarding our Gilead collaboration, much progress has been made. After restarting the HIV program, HP500, under our control to bring it to the end of Phase 1b, we're working with our academic collaborators and plan an IND filing in 2023. The Hepatitis B program progressed well. As planned, we completed the HOKIPA contributions for IND preparations in 2022. triggering a $5 million milestone payment. Gilead guided to the start of the trial of this HPV program in 2023. So what's in our plans for 2023? The readout of all three HP200 Phase II expansion cohorts in the second quarter of 2023 shall guide our decision to move into a randomized HP200 trial in combination with PEMBRO versus PEMBRO alone. We have fast-track designation for such a trial and a supply agreement for PEMBRO with Merck, US. In our HB300 phase one trial targeting prostate cancer, we're recruiting now. We'll start dosing patients. Expect initial data in the first half of 2024. We had a good start into 2023 with two significant milestone payments reflecting significant progress in our collaborations. First one, $5 million from Gilead for the completion and delivery of a regulatory support package for their Phase 1 clinical trial of a therapeutic cure for chronic hepatitis B using HP400. And the second, a $10 million payment from Roche for starting GMP manufacturing of the KRAS therapeutic, an important step before filing the IND, which we expect to happen in the first half of 2024. We expect to file our HP500 HIV therapeutic cure candidate, IND, in 2023. We will continue our work for Roche, both on the KRAS therapeutic as well as on the option package for an additional target, which Roche may decide to exercise in 2024. In summary, we've made significant progress in 2022, and we are positioned for an exciting 2023. with material news flow to come from our key programs. Finally, I'd like to highlight that we have significantly strengthened our cash balance, with $113 million at year-end 2022 were well-funded for many major data readouts. With that, I'll turn the call over to our CFO for more financial details.

Thanks, Jeroen. Good morning, everyone. So I want to give you a few highlights of our financial results for the fourth quarter and the full year 2022. As shown on slide four of our presentation, we ended the year with a strong water in revenues, which amounted to $7.8 million and included the milestone payment from Gilead and the start of the recognition of the $25 million upfront payment received under the Roche collaboration. Our Q4 spending was very much in line with the average of the previous quarters, leading to a quarterly net loss of $12.3 million for Q4. For the 2022 results, I want to start by pointing out our significantly strengthened cash position, which we achieved through our $75 million capital raise in the first quarter and cash inflows from partnering. including $19 million from Gilead and $25 million from Roche. I'm also proud to report that we were able to achieve the significant 2022 R&D progress that Jörn has just detailed at a 17% lower spend compared to 2021. Our G&A expenses moderately increased, but the increase was more than offset by higher grant and interest income. Bottom line, we reported a full year 2022 net loss of slightly less than $65 million, which is 14% below 2021. We continue to manage our burn rate tightly and to rely on partnerships to support our spending. We expect to moderately increase our expenses in 2023 as the pipeline progresses. The financial contributions from partnerships were already evidenced in the first quarter of 2023 by the receipt of a total of 15 million in milestone payments. With a cash balance of 113.4 million at the end of 2022, plus the 15 million in partner milestone income already achieved in 2023, we consider ourselves well-funded to reach beyond important upcoming pipeline catalysts. With that, I'd like to hand back to Jörn for some closing remarks.