3/20/2024

speaker
Operator
Conference Operator

quarter and full year 2023 financial results and business update conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the call over to Kurt Gustafson, OmniApp Incorporated Chief Financial Officer. You may begin. Thank you.

speaker
Kurt Gustafson
Chief Financial Officer

Thank you, Operator, and good afternoon to everyone. As he said, this is Kurt Gustafson, And I want to thank you all for joining our fourth quarter and full year 2023 financial results conference call. There are slides to accompany today's prepared remarks, and they're available in the investors section of our website at omniab.com. Before we begin, I'd like to remind listeners that comments made during this call will include forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from any anticipated results. These forward-looking statements are qualified by the cautionary statements contained in today's press release and our SEC filings. Importantly, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast today, March 20, 2024. Except as required by law, OMNIAB undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call. Joining me on the call today is Matt Foer, OmniApp's president and CEO. During today's call, Matt and I will provide highlights on the company's operations, partner and technology updates, and our recent financial results. At the conclusion of the prepared remarks, we'll open the call to questions. With that, let me turn the call over to Matt.

speaker
Matt Foer
President and CEO

Thanks, Kurt, and good afternoon, everyone, and thanks for joining our fourth quarter and full year 2023 conference call. As we kick off the call today, I'd like to mention that our clear mission here at OmniAb is to enable the rapid development of innovative therapeutics by pushing the frontiers of drug discovery technologies. We do this within a pure play licensing business that is partnering focused and that's designed to be efficient, scalable, highly leverageable, and that we believe is now poised for growth to meet what we see as an enduring and global need in the pharmaceutical industry. Our technology offering addresses the most critical challenges of antibody-based drug discovery. We have a highly differentiated suite of technologies that are proven and increasingly leverageable. Better industry success rates and other factors are driving an acceleration of antibody-based investment by the pharmaceutical industry, and we think we're well-positioned to meet increased demand for cutting-edge antibody-focused discovery technologies. OmniApp grew significantly in 2023, making substantial progress across key elements of our business. This included expansion of our partnership base and our pipeline of partner programs, advancements of key late-stage programs by some of our partners, and global expansion of our business development team. We now have BD team members in the U.S. and in Asia, based out of Singapore, and in Europe. We're focused on and dedicated to continued innovation and executed extremely well on that in 2023 with two successful new technology launches, including OmniDeep, which is our suite of in silico AI and machine learning technologies and capabilities that are woven throughout our technology stack and that marry extremely well with the biological intelligence of our transgenic animals. In November, we launched OmniDAB, which is our latest example of a novel transgenic animal, and I'll talk more about that shortly. We had an impressive list of achievements in our first full year as an independent public company, but our focus remains on pushing the boundaries of technologies to continue to meet the needs of our partners now and in the future. We have an increasingly efficient internal technology innovation engine that helps frame how we believe we'll create long-term value for all of our stakeholders. And building on this momentum from 2023, we're looking forward to continued growth in the year ahead. Here now on slide number five, you can see some of our business metrics. And these graphs in many ways speak for themselves and I think clearly show that 2023 was another year of substantial growth and progress in our business. Despite sector-related and macro headwinds last year, our key performance indicators continued to perform extremely well. Our active partners grew to 77 from 69 a year ago, representing a 12% increase. Our active partner programs also grew by 12%, with an increase to 325 from 291. And lastly, our active clinical and approved programs increased by 23% as we had 32 at the end of 2023 compared with 26 at the end of 2022. I want to stress that all of these numbers here are net of attrition. And I note that attrition is obviously natural and it's expected in pharmaceutical discovery and development. I'll now talk about our partnership base in a little more detail here on slide number six. 2023 was highly productive in new partner additions as our number of active partners continued to grow net of attrition. We saw multiple factors driving this expansion, including platform visibility and clinical and commercial validation of our technologies and expanded business development and marketing presence that's backed by our cutting-edge science and our new technology launches. As we continue to focus on licensing to align our interest with our partners, we're attracting and bringing in a diverse set of partners to bolster the next wave of discovery and preclinical candidates advancing to the clinic. Moving now to slide number seven, here we're providing a further breakdown of our new platform licensing deals from last year. We signed 10 new licenses in 2023. And today we're disclosing new platform deals with Enable Life Sciences, as well as one with a startup company that were both signed in the fourth quarter, along with a previously disclosed Big Pharma partnership that was also executed in Q4. And as I said, we signed 10 new deals in the full year of 2023. As you see here on the chart, two were with well-established global Big Pharma players, as well as deals with new biotech partners and academic partners. We added four new deals with startup partners, and I want to highlight that 40% of our deals were done with startup companies despite the significant drop in funding for smaller or new biotech companies in 2023. We see this diversity of new partners as a strength in our business. Maintaining our business track record of execution, we've also seen nice growth and advancement of active programs, and I'm now on slide number eight. As mentioned, we started 2023 with 291 active programs and grew to 325 active programs net of attrition. You can see the growth reflected on the left-hand side in the bar chart. The pie chart on the right breaks down our 325 active programs by stage of development. By the end of 2023, our growing discovery phase consisted of 278 programs and 15 programs that were in the preclinical stage. And importantly, we define preclinical stage programs as ones that are confirmed to be in pre-IND or IND-enabling studies. During 2023, we had six programs move from preclinical to Phase I clinical trials. So at the end of the year, we had 25 programs in Phase I trials And I note also that one program moved from phase three to its first international registration filing. With these leading positive metrics, it's also good to see that we have kept and are building momentum for the growth in active clinical programs that are shown here on slide number nine. We started off 2023 indicating that we expected three to five new clinical starts by our partners and we ended the year with six new clinical starts. To mention a few just briefly, CGEN announced initiation of a first-in-human Phase I clinical trial of its bispecific SGN-BB228, which is targeting anti-CD228 and 401BB in advanced melanoma and other solid tumors. This program is now in Pfizer's pipeline following the closure of their acquisition of CGEN and going forward will be referenced by its Pfizer project number. Immunovant initiated a Phase I clinical trial of its next-generation anti-FCRN IMVT-1402 in autoimmune diseases, and Cessation began a Phase I study of CSX1004, which is a monoclonal antibody derived from Omnirat designed specifically to prevent fentanyl overdose. During the fourth quarter, BioCity Biopharma announced the first patient was dosed with its first-in-class CDH3-targeting antibody drug conjugate, BC3195, in a Phase I trial in China. A number of our other partners also reported progress on other clinical and commercial stage assets in Q4, and some of those were summarized in our press release that was issued after the market closed today. Based on our dialogue with partners, we see potential for approximately four to six new entries into clinical development for novel OmniAb-derived antibodies in 2024. As I mentioned, we're committed to continued innovation around our platform. And because of the nature of our relationships, we have a great vantage point, not only on where the industry is right now, but where the industry is headed. And that informs the technologies that we develop and deploy. Last year, we launched OmniDeep and OmniDab, and both of those are called out here on slide 10 in the two green boxes on the lower left. I'd like to highlight the OmniDab technology that was launched in Q4, as it's quickly becoming yet another key differentiating technology here at Omnia. A foundation of our business is our novel transgenic animals. We believe novel antibodies that are generated in vivo are superior to ones from other sources because they're naturally optimized through an iterative process that preferentially selects for antibodies with excellent specificity and developability profiles. The ability of the immune system of our engineered transgenic animals to create optimized antibodies for human therapeutics is what we call biological intelligence. And we believe this approach increases efficiency and probability of success for our partners and positions our business extremely well. So Omnidab is our latest example of this. And as described here on slide 11, it's the first and only transgenic chicken producing single-domain antibodies, which is a novel class of antibody found naturally in camelids that's being increasingly exploited for a variety of therapeutic applications. Omnidab is a novel in vivo platform based on a human VH scaffold that affinity matures in a chicken host to provide a functionally diverse immune repertoire of antibodies unavailable from mammalian systems. In a simple sense, single domain antibodies provide modular building blocks and can be assembled into various formats to fit the biology of a desired application. And you can also see on this slide some of the things we hear from our partners about the technology as multiple partners are using it now in active programs. We expect many more will initiate programs with Omnidab this year and next. This is partly because of the unique physical properties of single domain antibodies that are summarized here on slide number 12. It can be expressed independently as a unit, and their compact format opens up new and important opportunities from a scientific and medical perspective. Single-domain antibodies can be leveraged for important applications. They can open up alternate routes of administration that we show here on slide 13. They can lead to increased penetration and tunable clearance, and also to new opportunities and new markets for us in imaging, in diagnostics, in theranostics, and in radiotherapy. And they also have broad therapeutic applications in bi and multispecifics and CAR-T therapy, as well as pursuing therapeutics for CNS and neurodegenerative diseases, which are obviously areas of significant interest for our partners. Now, as we look at the current year here on slide 14, in addition to expecting four to six new clinical programs, we expect we'll see late-stage advancement for a number of key programs at GENMAB, at Immunovant, and others. We also expect that our progress on some of our higher value ion channel programs with global big pharma partners will become more visible to investors and to the research world generally. And we're excited about that. We now have a fully staffed business development team and a more efficient innovation and support engine that we plan to leverage for deal expansion globally. And we'll continue to focus on innovation and expansion of our technology platform and the introduction of new technology, new workflows, and new partner experience enhancements that we'll talk about at scientific and technical conferences through the year. And with that, I will turn the call back over to Kurt to run through the financials. Kurt?

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