HOOKIPA Pharma Inc.

Good morning. This is Matthew Beck, the Head of Investor Relations for Huquipa. A slide deck accompanying today's call is available in the events section of the Huquipa website. Please manually advance the slides as we prompt you through them. Turning to slide two, the Huquipa executive team is here with me today, including Chief Executive Officer Yaron Aldag, Chief Financial Officer Reinhard Kandera, Chief Medical Officer and Head of Global Research and Development Igor Matyshansky, Chief Business Officer, Christine Baker, and Chief Technology Officer, Roman Messina. Turning to slide three, our Safe Harbor slide. During today's call, we'll 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 results 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. Your caution 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. Reinhard will offer high-level comments on our financials, and then we'll open up the call to Q&A. With that, I'll pass the call to Yearn.

Hey, good morning, everyone. Nice to talk to you. Very welcome to Keep Us Earnings call. Please turn to slide four. We had a strong year in 2020, culminating with promising clinical data in both our oncology and our infectious disease spaces, and a follow-on offering that has secured our cash runway through to the end of 2022. The data we presented make us proud early clinical proof of concept in HPV-positive cancers in checkpoint inhibitor refractory patients in a monotherapy setting, and secondly, immunogenicity and signs of efficacy in the CMV prophylactic setting. In addition, we raised $81 million and extended our runway to year-end 2022. We're expecting a lot more data this year in both programs, beginning at AACR next month where we will disclose early clinical translational data supporting our mechanism of antigen-specific T cell generation. We hope to show you at AACR for the first time that patients with cancer who were injected systemically with HB201 or HB202 at dose level two will have had an increase in key systemic pro-inflammatory cytokines and chemokine levels, which would suggest a virus-induced immune activation and a strong and persistent induction of HPV16, E7, E6-specific T cells. At ASCO, we hope to show initial data from our alternating dual vector treatments in patients, hopefully boosting T cell responses even more. Data from higher doses will be explored and demonstrated in the second half of 2021. Also antibody T cell and efficacy data from more CMV patients will be shown publicly in the second half of 2021. Please turn to slide five. Despite the COVID pandemic, our oncology accrual dynamics were very positive and faster than expected. As a reminder, our initial oncology therapies built from our replicating technology and expressing the E76 fusion protein from HPV16 are being tested in an ongoing phase 1-2 trial. Worth repeating, HB201 is currently tested as a monotherapy or standalone treatment, no checkpoint inhibitors, targeting advanced metastatic patients who have progressed on checkpoint inhibitors or platinum-based therapy or both. I'm sure you'll agree with me that showing an effect in such a setting is a great result. In June 2020, we also filed our IND submission for our HB202 program, and in October, we dosed the first patient in our HB201, HB202 alternating two-vector program. We know from preclinical testing that by combining HB202 and HB201 in an alternating sequence, we generate stronger immune responses than using a single vector. HB202 carries the same E76 antigen as HB201, but it's based on a different vector backbone. Like HB201 alone, our HB201, HB202 is being tested in a dose escalation phase one trial of late stage HPV 16 positive metastatic patients who have progressed on checkpoint inhibitors and or platinum containing regimens. Please turn to slide six. The initial clinical data from our HB201 phase one trial, which included patients on the first two dose levels, showed a favorable tolerability profile. In terms of efficacy, In the 15 evaluable patients, we saw one complete response, one partial response, and numerous stable disease patients. The efficacy for the first two doses in the phase one escalation shows a remarkable trend. The 73% disease control rate and 18% response rate from the head and neck squamous cell carcinoma HPV 16 positive subgroup are comparable or better than response rates from studies of PD-1 inhibitors in earlier line head and neck cancer patients. So specifically we compared to nivolumab and pembrolizumab. The December interim analysis data were generated with our initial two dose levels. We're continuing to explore additional dose regimens and levels as we optimize for the recommended phase two dose. In that data set, we highlighted one patient who, after progressing twice on prior rounds of PEMBRO, clinically progressed on HP201 monotherapy. The investigator asked to keep the patient on his HP201 regimen while adding Pembrolizumab in combination. As of the data cutoff, the patient had begun to respond with visible and radiological signs of tumor shrinkage. With the off-protocol addition of PEMBRO, the patient is no longer included in our recorded HB201 data. However, it is encouraging sign to see a synergistic response with the combination of HB201 and a checkpoint inhibitor and see that this is safe. We plan to explore the simultaneous HB201 or HB201-202 combination and checkpoint inhibitor combination of the trial. Two weeks ago, we announced that the preclinical data on our Hb2122 alternating two-vector program was published in Cell Reports Medicine. These preclinical data showed that alternating IV administration of two replicating arena viral vectors induced tumor-specific responses exceeding 50% of the circulating CD8 T cells which resulted in tumor cures and long-term immunity against tumor rechallenge. Please turn to slide seven. As I mentioned earlier, we're currently analyzing and will report early translational data on our HB201 and HB202 vectors at the upcoming virtual AACR conference in April. The abstract title of preliminary analysis of immunogenicity of HB201 and HB202 in arena virus-based cancer immunotherapy in patients with advanced HPV16 positive cancers was released last week. We will report on in vivo CD8 T cell proliferation and biomarker data from patients treated with single HB201 or HB202 vectors. We also plan to update clinical data from the HB201 program and report initial safety, tolerability, and efficacy data from the HB201, HB202 program at the ASCO conference in June. This might be the first time that we show patients data which demonstrates the superiority of the alternating two-vector approach over the single-vector approach with regards to T cell induction and efficacy. We expect to identify the recommended phase two dose in Q4 of 2021. Please turn to slide eight. Switching gears now to CMV. HB101 is a preventative vaccine based on our non-replicating technology designed to stimulate the immune system against cytomegalovirus infection or reactivation in organ transplant situations. From the ongoing phase two trial in kidney transplant patients, we reported late last year positive safety, immunogenicity, and preliminary efficacy data that exhibited reductions in CMV viremia, the use of antivirals and CMV disease in post-transplant patients, and in line with our expectations. Also, we have confirmed our mechanism of action of driving T-cell and antibody responses. Enrollment in this Phase II trial continues slower than expected. COVID is the primary driver of the difficult accrual. Many transplant sites either shut down or drastically slowed their transplant schedules for many months to avoid immunosuppressing patients during the intense outbreak periods. We plan to wind down accrual no later than the third quarter of this year, by which time we will have recruited approximately 100 patients against an original target of 150. As you may recall, our trial protocol includes monitoring patients and their outcomes for 12 months post-transplant. The next data release, planned for the second half of this year, will provide further efficacy data to inform about the path forward for this program. We're in the process of analyzing the opportunities in the CMV space beyond kidney transplant, looking at liver transplant, hematopoietic stem cell transplants, and prophylaxis of congenital CMV infections. Our collaboration with Gilead, in which we're seeking therapeutic cures for chronic hepatitis B and HIV, continues to progress and is further approaching the clinic. We anticipate reaching select milestones, including one request for development for the HIV program, in 2021. We believe we're progressing to the satisfaction of Gilead, however, are unable to provide development timelines as Gilead is controlling those. With that, I will turn over to Reinhardt for comments on our financials. Go to slide nine, please.

Thank you, Jörn. Good morning, everyone. On the financial side of our business as well, we are looking back to a very successful year 2020. Despite the progress that we made in our clinical studies, our loss increased only marginally, and our operating cash flow even slightly decreased compared to 2019. Most importantly, with our successful $81 million follow-on financing in December, we are advancing to the next development phase with a solid cash balance. Slide 9 summarizes our fourth quarter and full year 2020 financial results, and I will focus on the full year results. As you can see there, we had an increase in revenues by more than 60% to almost $20 million, which is proof of the progress that we are making in our collaboration with Gilead, which is currently our only source of revenue. These revenues include cost reimbursements of $13 million and more than $6 million from recognition of upfront and milestone payments. Our R&D expenses increased by 18% to approximately $55 million, and the main cost driver in 2020 was our HPV16 positive cancer program, followed by the costs under our Gilead collaboration and the CMV program. We expect our R&D costs to continue to grow in 2021 as we continue to progress on these programs. Our G&A expenses grew as we continued to expand our operations. The main driver of the increase were personal expenses, including non-cash stock compensation expense. Our other income of more than $9 million includes approximately $6.5 million in grants, as well as exchange rates and currency translation gains. Bottom line, we show the net loss of $44 million in 2020, slightly up from $43 million in 2019. Our 2020 operating cash outflow was $39.3 million, which compares to $41.7 million in 2019. Our year-end cash balance was $143.2 million at the end of 2020, which gives us a solid financial footing to further grow our spending as we progress our R&D programs. I'd like to pass back to Joran.