HOOKIPA Pharma Inc.

I'm Matthew Beck, Executive Director, Investor Relations. A slide deck accompanying today's call is available through the webcast and in the events section of the Huquipa website. Please manually advance the slides as we prompt you through them. Looking at slide two, the Huquipa executive team is here with me today, including Chief Executive Officer, Jern Aldag, Chief Financial Officer, Reinhard Kandera, Chief Medical Officer and Global Head of Research and Development, Igor Medeshansky, Chief Scientific Officer Klaus Orlinger, Chief Business Officer Christine Baker, and Chief Technology Officer Roman Nesina. Slide three. 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 uncertainties that may cause the actual events to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Security and Exchange Commission 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 date. The company disclaims any obligation to update such statements. For today's call, Yearn will provide opening remarks. Reinhart will offer high-level comments on our financials, and then we'll open the call to the Q&A. With that, I'll pass the call to Yearn.

Thank you for joining us today in this conference call. 2021 was a year of impressive continuous progress for Huquipa. It was a year in which we have successfully navigated tumultuous financial markets and delivered on the need to drive scientific progress and a financing strategy that supports continued company growth into 2024. We delivered on our claim that we can drive unprecedented levels of antigen-specific T cells in humans. We continue to expand the evidence that our technology applied as a monotherapy helps control the disease in advanced line head and neck cancer patients, motivating us to invest in broadening our pipeline with new oncology indications. Beyond virally driven cancers, we demonstrated the ability to break tolerance in animals, opening to the wide space of self-antigens and driver mutation-based cancers. We see incredible potential for this platform. especially in combination with other oncology modalities, to overcome challenges of many immunotherapies and many different cancer types by providing the missing but essential T-cell induction. We're pushing two high-value programs towards the clinic, prostate cancer candidate HP300 and HP700, targeting the most frequent KRAS mutations. Our science is continuously validated through partnerships with leading pharma organizations. We progressed markedly on the partnering front by, one, renewing our collaboration with Gilead, I'll come back to this, by taking responsibility for the clinical phase 1B of an HIV Q project, and two, signing a supply agreement with Merck for testing Keytruda with HP200. The FDA granted us fast-track designation for this combination trial of HB200 with femoralizumab in the first-line setting. We also advanced partnering discussions in oncology with other prospective collaboration partners. As I mentioned earlier, Gilead, faced with bottlenecks in their development area and knowing the T-cell data of our HIV development candidates and non-human primate models, asked us to take responsibility for the development up to the end of phase 1b of our HIV functional cure collaboration. They wanted an option to take the program back after this phase 1b. And in exchange, we received a non-refundable $15 million upfront in addition to $4 million milestone payment and took down the first $5 million of a $35 million equity facility Gilead provided to us. This transaction helped us execute a well-prepared financing in early 2022, securing $75 million, and a follow-on offering extending our cash runway significantly with high-quality existing and new investors. Our December 31st cash position plus the Gilead and follow-on proceeds give us a performer cash position of $157 million, and adding the additional $30 million from the drawdown facility by Gilead provides us a runway into mid-2024. We believe that these accomplishments speak to the strength of our data and investor faith in our ability to execute in 2022 and beyond. So what's in store for 2022? Slide five. Next month, At AACR, we will share four poster presentations that provide further preclinical, translational, and clinical evidence of the broad potential of our arena viral platform to address unmet needs in various types of cancer, either alone or in combination with other modalities. In mid-year, we will update our Phase I HP200 monotherapy data. We will give a comprehensive overview of the HB200 Phase I dose escalation program, including safety, anti-tumor activity, and additional translational data of HB201 and HB202-201. We will update the status of all patients in the Phase I program and present our selected Phase II dose for the HB202-HB201 alternating two-vector therapy. And we will discuss the clinical path for HB200 in the advanced setting known as third line or post standard of care. To be clear, we will not provide at this time nor comment on any initial phase two data in combination with Fembrolizumab during the phase one update. We will, however, report initial safety and efficacy data results of the HB200 phase two combination trial which combines HP200 and pembrolizumab in the first and second line settings in the second half of this year. We aim to present an initial data set on 10 to 20 patients in total and seek to approximately double the current pembrolizumab monotherapy response rates in first line and second line head and neck cancers. We're also on schedule to file the IND for a prostate cancer program known as HP300, in the third quarter of this year. Current immunotherapy's target PAP, a key tumor agent, provide modest efficacy for people with castrate-resistant prostate cancer. With our versatile arena virus platform, we're exploring incorporating additional tumor targets, PSA and PSMA, to help address the unmet needs and improve the standard of care for these patients. We aim to dose the first patient in the late fourth quarter of this year or early 2023. Last but not least, we have started a KRAS program targeting the main KRAS mutations relevant in several large tumor indications. This program has attracted significant interest from pharma companies. Finally, in our infectious disease programs, we're committed to filing our HIV IND in 2023 And Gilead tells us that they're on schedule to file the HB and the hepatitis B virus functional cure IND by the end of 2022. Though Huquipa is not in control of their timelines, we expect that this is what we can expect. I reiterate that Huquipa is now funded through all of these milestones and beyond. We have bold promises for 2022, and the Huquipa team is invigorated to deliver. Now I'd like to pass the call to Reinhard for some brief comments on our financials. Reinhard.

Thank you, Jörn. Good morning, ladies and gentlemen. I want to give you a few highlights of our financial results for the year 2021, which actually reflect the clinical progress that we have made in that past year. Our revenue line includes milestones and cost reimbursement from our Gilead collaboration. And the continued high level of revenue is evidence of the good progress that we have been making under this collaboration, as both partnered preclinical programs are now moving towards phase one clinical trials. Looking at our operating expenses, we increased our investments in the oncology pipeline and internal research and development resources based on the encouraging early antitumor effects seen in our HP200 trial. The increased spending in these areas was the main driver of the overall increase of our R&D expenses from $55 million in 2020 to $83 million in 2021. A significant portion of the 2021 R&D spending already relates to the 2022 activities for HP200 and HP300 So we expect to be able to maintain this spending level in the coming quarters while executing on those programs. In terms of general and administrative costs, we were able to keep this well under control in 2021 and even to slightly decrease our G&A expense year over year. Other operating income net, which mainly consists of grants and subsidies, was partially offset by currency effects, mainly in the fourth quarter of the year 2021, and is therefore below 2020 levels. Our net loss for the year 2021 was $76 million compared to $44 million in 2020, with this 2021 increase being driven by R&D spending as a result of our clinical progress. Our cash outflow from operations in 2021 was $66 million, and in addition, we made investments of $12 million in property, plant, and equipment, mainly to prepare ourselves for GMP manufacturing requirements in our next growth phase. Our year-end cash was $67 million, and we were able to significantly strengthen this cash position in the first quarter of 2022 by a $75 million follow-on offering and cash inflows from our Gilead transaction. This proceeds leads to a pro forma cash position of $157 million when added to our year-end cash. With that, we see ourselves well-funded through the coming catalysts, but I would want to add that in a difficult funding environment as we see it today, we are putting greater emphasis on non-dilutive funding sources as well and are making good progress in seeking collaborations to potentially increase our revenues. With that short overview, I would like to pass the call back to Jörn for some closing remarks.