ImmunoPrecise Antibodies Ltd.

ladies and gentlemen thank you for standing by the conference will begin in a couple minutes as we wait for speakers ladies and gentlemen thank you for standing by the conference will begin in a couple minutes as we wait for speakers Thank you. Thank you. © transcript Emily Beynon Thank you. Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to Immunoprecise Antibodies Fiscal Year 2022 Second Quarter Earnings Results and Business Highlights Call. At this time, all participants are in a listen-only mode. Following the presentation, we will answer pre-submitted questions. If anyone has any difficulties hearing the conference, please press the star key followed by zero for operator assistance at any time. I would like to remind everyone that this conference call is being recorded today. December 13th at 430 Eastern Time. I'll now turn the call over to Chris Chiu. Mr. Chiu, please go ahead.

Thank you and welcome. Dr. Jennifer Back, President and Chief Executive Officer of Immuno-Precise, and Ms. Lisa Helbling, Chief Financial Officer, will be the speakers on today's call. A Q&A period answering pre-submitted questions will follow their summary of the quarter, followed by closing remarks. Before Dr. Bass begins, I've been asked by Immunoprecise to read the following safe harbor regarding forward-looking statements. I'd like to remind everyone that Immunoprecise's remarks today contain forward-looking statements about its current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or other future events or developments. In preparing these forward-looking statements, several assumptions were made by ImmunoPrecise, and there are risks that results actually obtained by the company will differ materially from those statements. As a consequence, the company cannot guarantee that any forward-looking statement will materialize, and you are cautioned not to place undue reliance on them. ImmunoPrecise refers current and potential investors to the forward-looking statements, and information section of its management discussion analysis issued today at www.cdar.com and on EDGAR at www.sec.gov. Forward-looking statements represent Amino Precise's expectations as of December 13, 2020-21. Except as may be required by securities laws, Amino Precise does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events, or otherwise. I would now like to turn the conference over to Dr. Bath.

Thank you, Chris. This reporting period and year-to-date have been inspiring and energy-filled for IPA. As awareness continues to grow about the power of our technologies for building translatable and sustainable biotherapeutics in an industry that, to a degree, has been transformed as a direct result of the COVID pandemic. Subsequently, a bright light has been cast onto our industry, and as a result, many eyes are on IPA's scientific and technological capabilities as the world awakens to a new reality in the COVID pandemic. This reality has aided the general public in understanding the importance of life-saving antibody therapeutics and has catalyzed tremendous change in regulatory, clinical, and commercial industries. We open with this backdrop as the threat of Omicron is settling on the world's doorstep. Only days ago, it was reported that Omicron COVID-19 cases in the US have been, for the most part, relatively mild. However, it is now clear that thus far, close to 80% of the cases were in people who were fully vaccinated, and over 40% of those individuals had received a booster dose. In the meantime, the media has been flooded with reports of probable and or potential loss of both vaccine and therapeutic antibody efficacy. Regarding products from companies such as Pfizer, where the Sheba Medical Center in Israel reported that the neutralizing ability of the even three Pfizer shots is four times less effective against Omicron than Delta. And regarding Eli Lilly, where independent researchers at the Fred Hutchinson Cancer Research Center concluded that their dual antibody combo had decreased protection against Omicron. Further, there was a statement released from Regeneron with similar conclusions about its dual antibody treatment, noting that earlier in vitro studies and structural modeling indicate that the Omicron variant may resist both of their antibodies. As we have stated since the emergence of SARS-CoV-2, we anticipated the selective pressures of the human immune system, including those induced by vaccination, as well as limited passive therapy regimes. We specified that our belief that many of these vaccines and therapies would lose efficacy over time due to the continued incorporation of mutations into the SARS-CoV-2 genome. Likely, everyone on this call understands that IPA's polytope was specifically designed to retain relevancy and efficacy against emerging and future SARS-CoV-2 variants. And to date, it has accomplished this. Yes, it was a heavy scientific lift, but by targeting numerous non-overlapping epitopes and engaging varied mechanisms of action and synergistic activity, we believe our cocktail is much less at risk to escape mutations. This is thus far born true when testing all variants of concern as well as variants of interest. In fact, it's possible that polytope is the only first-generation anti-SARS-CoV-2 therapeutic to retain efficacy against all variants of concern to date. Based on in silico sequence and structural analysis, we anticipate that IPAs polytope will retain activity against the highly mutated Omicron variant as well. as we have observed in in vitro models with all other variants of concern identified previously. Given the significant potential health crisis resulting from the emergence of Omicron, IPA is conducting in vitro studies to empirically evaluate the binding and neutralization of polytope against Omicron. Initial data from these studies is anticipated by mid-January. While COVID-19 is only one disease of many that Immunoprecise and TALM tackle with our leading-edge technologies, it is representative of the scientific insight and rigor that now defines our company, showcasing technologies that have helped lead our industry by producing a high-profile, sustainable therapy, which required a level of antibody sequence and functional diversity that most companies, large and small, did not readily produce in their products. Equally important, the ongoing pandemic has led to transformation and opportunity in the industry with new paths, partnerships, and opportunities arising for IPA and TALM as a result. To illustrate this point, on December 3rd, the Wall Street Journal published an article calling attention to the importance of scientific advances as a result of innovations that occurred while the industry raced to develop technology platforms to tackle COVID. The article went on to indicate that the same science powering the COVID vaccine development is seeding real hope in the treatment of other infectious diseases and even cancer and MS. It was the opinion of the author that the national dispute over vaccines has veiled an even more important part of that story, which is the sheer magnitude and promise of messenger RNA technology and the enormous potential for medical applications, which is expected to extend far beyond COVID. We concur at IPA based on our experience as we have continued to take advantage of opportunities for collaborations and technology expansions during this time. Our leading discovery platforms utilizing diverse animal repertoires and cutting edge technologies offer unique benefits that can be leveraged far beyond infectious disease. And since these technologies serve as a cornerstone for both our CRO and also our TALIM pipeline development, They enable not only our continued organic revenue growth, but our ongoing expansion into new categories of partnerships. We clearly continue growing as a preferred partner for research companies as we rapidly expand our commitment to R&D initiatives through both internal development and selective partnerships. We've begun to expand those partnership opportunities into some of the same new sector diversifications targeted by our CRO. and are negotiating partnerships to leverage unique RNA technologies for therapeutic antibody assets, with companies focused on shifting attention to novel therapies based on recent regulatory approvals and possibly less hindered patent landscapes. IPA is poised to meet these partnering needs with management expertise in nucleic acid design, manufacturing, and delivery, and collaborative efforts over the past two quarters focusing on the potential use and delivery methods to enable more rapid production and improve delivery routes for therapeutics. We're happy to announce we continue to grow in serving the top 20 biopharmaceutical companies across the globe. In the quarter, we initiated the first antibody discovery projects for two additional top 20 companies, which we had not previously served. Further, to support the growth initiatives at our Canada and Netherlands sites, we've hired two new research technicians and a project team leader at the IPA Europe site in Oost, and a new laboratory assistant and protein expression scientist at the IPA Canada site in Victoria. Toward the end of this quarter, IPA Canada began the renovation and expansion of its animal care facility. Expansion of the facility will double our current vivarium footprint and increase our capacity to house both wild pies and transgenic animals used for both our CRO operations and our TALIM asset development. The renovations will also increase the facility's compliance with the Canadian Council on Animal Care Guidelines and the Public Health Agency of Canada Biosafety Level 2 regulations. The estimated completion date for the facility is early in IPA's fourth fiscal year quarter. The ongoing renovations will not cause disruption to any aspects of IPA's business. As mentioned before, a major shift in marketing activities has taken place at IPA as a result of the pandemic. Many of the annual conferences that we would normally attend in person had been held completely virtually. IPA's client relations team attended the first in-person conferences since the beginning of 2020 in the months of September and October. Further in-person conferences have been scheduled for the third quarter of this fiscal year. IPA's new marketing framework has been designed to support rapid growth and targeted commercialization opportunities and is now securely in place. Bold marketing initiatives have been developed with a sense of urgency in order to gain a competitive edge, but with a stepwise-based approach. where the planning or resource allocation and assessing investments and measuring performance has been taking place at a return. Brand architecture and revitalization is underway to ensure that we are positioned to compete and win new business, which will be evaluated for effectiveness each quarter. Other elements of the Q2 marketing strategy included development of an IPA master marketing and commercialization plan, Taking the lead on the multi-channel co-marketing campaign entitled Challenge Us, together with Eurofins, at an antibody engineering conference in San Diego this week. Maintaining a scientific content calendar in order to fuel sales and marketing events. And a new AI-powered database with lead generation software that enables us to grow into the future with data-driven insights and real-time performance metrics tied to our CRM. Additionally, planning is underway to host an antibody summit in May of next year at the Protein Engineering and Cell Therapy Summit, which is held annually in Boston. On October 7th, TALM announced a multi-year, multi-target antibody discovery research collaboration with Pierre Farbra, the second largest private French pharmaceutical group. Together, we aim to discover and develop therapeutic antibodies for up to nine different targets. The strategic collaboration is expected to help expand Tollum's portfolio of novel antibodies across oncology. It also adds to the variety of diverse relationships that the IPA group of companies holds across the pharmaceutical and biotechnology sector. The antibodies developed through this research collaboration against selected targets will be jointly owned by Tollum and Pierre-Farbera. And following the completion of each target-specific research program, PRF-RBO will have the option to obtain an exclusive worldwide license to TALM's interest in those jointly discovered antibodies. In turn, TALM would be eligible to receive certain upfront and contingent downstream payments. In addition, if licensed, PRF-RBO will be responsible for the preclinical and clinical development, as well as the commercialization of jointly discovered antibodies. This past quarter, two new experts were also hired to support partnering related activities, including a scientific writer and a non-clinical study director. Both hires will further support advancements of our internal programs, in addition to assisting with the identification and evaluation of new targets. Although some of our TALM programs are slightly delayed due to a recent COVID-related disruption in the supply of materials and reagents, We are happy to share that we are finalizing the high throughput functional characterization of our TATX112 program in oncology and neurodegenerative disease and our TATX21 program in cardiovascular disease to select the best performing clones for anticipated mode of action. For TATX112, we are currently performing in vitro proof of concept studies for antibody drug conjugates that are known as ADC approaches. Regarding our collaborative program with TWIST, TATX 115, with a potential use in oncology, we are subjecting our target binders to functional analysis as we seek to nominate the lead candidates. As the intended clinical approach relies on two different mode mechanisms, we aim for transferring two categories of leads to TWIST for full optimization to develop clinically fit antibody therapeutics. As announced just before the start of the year, we have joined the CobraValp Consortium along with two Dutch academic partners, the Radboud University Medical Center and the Eindhoven University of Technology. This opportunity is yet another example of how we have identified new capabilities and strengths and enriched additional infrastructure at IPA while supporting the fight against COVID. This consortium is focused on the development of a SARS-CoV-2 specific therapeutic nanomedicine delivered intranasally. Leveraging the expertise of our partners in VHH antibodies, which are the smallest naturally occurring antigen binding fragments, they have successfully integrated our VHHs targeting the SARS-CoV-2 spike protein into nanoparticles. We have now confirmed that the initial research batches of SARS-CoV-2 targeting VHH nanoparticles do in fact bind spike tremor. Apart from the ability to deliver nanoparticles directly to the lungs, this approach is anticipated to induce virus aggregation and subsequent virus clearance by the host immune system. As this approach relies on other mechanism of action compared to compounds directly interfering with host cell infection by the virus, its sustainability might be significantly higher by selecting antibody fragments targeting more conserved epitopes. It is also believed that the virus aggregates summit simultaneously to generate an immune response, leading to patient immunity in parallel to viral clearance, potentially leading to a treatment and a vaccine in one product. Holland is currently working on several distinct programs, some of which have been mentioned already in this call, notably TATXO3, or polytoptope antibody cocktail, TATX 112, our antibody panel for applications in oncology and neurodegenerative disease, and TATX 21, our antibody panel for use in cardiovascular disease. Other programs include TATX 114 for oncology, inflammatory, and autoimmune diseases, and TATX 115, 116, 22, and 24 for oncology, as well as TATX 20 for solid tumors. Through TALIM, our more advanced programs, one of our more advanced programs, THX 112 for oncology and neurodegenerative disease, and also THX 21 for cardiovascular disease, are now entering the stage of in vitro proof of concept verification. For THX 112, we have prioritized around one dozen antibodies for a particular functional screening that will help us identify the ideal assets for ADC-based therapies. while a separate high-throughput functional study confirmed that around 50% of the lead candidates are able to strongly activate the target, which was our desired outcome. For TATX112, over 15 lead candidates will be analyzed for their ability to interfere with LDL uptake by endothelial cells, a crucial step in atherosclerotic plaque formation. The earlier stage programs, 114, 116, 20, 22, and 24, with specifically selected antibody pools, are now at different high throughput steps of lead selection. Our scientific team is applying appropriate functional assays for the anticipated diverse clinical approach of each program. TALM has also entered into a research collaboration with an as-of-yet undisclosed biopharmaceutical company to assess the potential suitability of three non-neutralizing COVID-19 antibodies in combination with an antibody drug conjugate. Results of these research are governed by an MTA and are expected in the next couple of weeks. TALM remains active in its partnering activities for its internal assets. mainly TA-TX03, 112, and 21. In recent meetings, we've continued to engage numerous parties in varying degrees of discussion and negotiation regarding the partnership, transfer, and or out-licensing of these assets, including the potential use of ADCs in oncology. On R&D, our two sites in the Netherlands are currently working together to further optimize our obscene by specific antibody platform. as cross-site service leveraging the antibody production and purification capabilities of our site in Utrecht and the analytical expertise of our team in OSE. The optimization will not only streamline the workflow for the bispecific antibody formats, but will also facilitate larger production scales of research grade batches for preclinical in vivo proof of concept studies. Goals energize as IPA continues to receive more requests from clients, partners, and peers, focusing on the unique attributes and targeting capabilities of bispecific therapies. In addition, for customers who do not have access to a bispecific platform, our service allows them to generate proof of concept prior to in-licensing a clinically validated bispecific platform and without having any restrictions regarding IP of the generated data. We are pleased to announce that on November 17th, IPA Canada was awarded an Industrial Research Assistance Program grant from the National Research Council of Canada, titled Development of a Unique Next Generation End-to-End Antibody Discovery Platform. In an ongoing effort to remain industry leaders in single B-cell antibody discovery, the grant will financially support the continuous development of our one-of-a-kind discovery platforms. through the integration of memory B cell, plasma B cell, and repertoire B cell workflows with next-generation sequencing, machine learning, and high-throughput recombinant protein production. For our polytope SARS-CoV-2 program, we entered into the final stage of preclinical work. IND-enabling safety studies, which were reviewed by the FDA, were initiated, and the first round of data is available. Initial observation from the rat dose escalation study revealed no clinical signs of toxicity and mortality after administration of dose levels with a tenfold higher concentration as anticipated for clinical application. In addition, no deviating body temperatures were measured during post-dosing observations. The full dose escalation study report is expected to be available later this month. In parallel, we are in contact with the FDA to fine tune our first in human study protocol. In line with our workflow, but also as a direct request by the FDA, we are generating tools for screening our antibody cocktail in response to the highly mutated Omicron variant and expect to have those requested data sets available by the end of January. With this, I'd like to turn the call over to Lisa to discuss the quarter's financial results.