8/9/2023

speaker
Operator
Conference Call Operator

Thank you for standing by, and welcome to Max Sikes' second quarter 2023 earnings call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. To remove yourself from the question queue, please press star 1-1 again. I would now like to hand the call over to the head of investor relations, Sean Menardis. Please go ahead.

speaker
Sean Menardis
Head of Investor Relations, MaxSight

Thank you, Lateef, and good afternoon, everyone. My name is Sean Menardez, and I'm the Head of Investor Relations at MaxSight. Thank you all for participating in today's conference call. On the call from MaxSight, we have Doug Dorfler, President and Chief Executive Officer, and Douglas J. Swirsky, Chief Financial Officer. Earlier today, MaxSight released financial results for the second quarter ended June 30, 2023, a copy of the press release available on the company's website. Before we begin, I need to read the following statement. Statements or comments made during this call may be forward-looking statements within the meeting of federal securities laws. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. Actual results may differ materially from those expressed or implied in any forward-looking statements due to a variety of factors which are discussed in detail in our SEC filings. The company has no obligation to publicly update any forward-looking statements, whether because of new information, future events, or otherwise. And with that, I'll turn the call over to Doug.

speaker
Doug Dorfler
President and Chief Executive Officer, MaxSight

Thank you, Sean. Good afternoon, everyone, and thank you for joining MaxSight's second quarter 2023 earnings call. I will begin with a discussion about business and operational highlights during the quarter, followed by a detailed financial review from DJ, our chief financial officer. We will then open up the call for questions. MaxSight reported $9 million of revenue in the second quarter as we experienced softness in the cell therapy industry. The cell therapy industry has prioritized pipeline programs, which has resulted in nominal growth in R&D spending. Less R&D spending in the industry, we believe, has resulted from a challenging and evolving macroeconomic environment. Despite this, we are confident in our updated annual outlook for 2023 and continue to be excited about the health of our long-term business. Our partnership pipeline is robust, highlighted by our five partnerships so far this year. Customer engagement remains high. And I remain extremely excited about the opportunities for MaxLight's platform as the premier cell engineering technology and support for the growing industry. You'll note that our second quarter revenues, including our core business revenues, are down from the same quarter last year. As discussed on last quarter's call, 2023 has been a challenging year for the industry, which has been impacted by multiple macroeconomic factors, including the challenging capital markets environment. The biotech industry continues to prioritize pipeline assets for R&D investment, especially with small development stage cell therapy companies focused on programs in late stage preclinical and early stage clinical trials. With this backdrop, we are seeing continued cautiousness in capital investments from our customers, resulting in extended purchasing cycles for instruments and processing assemblies. Our negative growth rate in the first half of 2023 were exacerbated by difficult year-over-year comparisons, which DJ will discuss in a few minutes. While some of our customers are narrowing their investments, we are encouraged by our clinical SBL partners' progress, where we are generally enabling their lead or second assets. These assets remain our partners' active focus for their development, investment, and progression through the clinic. Outside of these evolving headwinds, the cell therapy industry continues to move briskly toward non-viral cell engineering approaches with an increased focus on more complex engineered cell therapies, often including multiple engineering steps and molecules across an expanding variety of cells and disease types. We believe these industry trends play to the strength of the MagSight platform, which has driven a continued high-level engagement from current and prospective customers. Our robust pipeline has led to five SPL partnerships being signed this year, which supports our view of the value derived from our platform. In July and August, we announced three new SPL partnerships, including Lyle Immunopharma, Vitoria Biotherapeutics, and Prime Medicine. Our partnerships with Lyle and Vitoria diversify our portfolio into new therapeutic modalities, expanding our exposure to next-generation autologous CAR-Ts from previously only allogeneic CAR-Ts. In addition, Lyo expands our exposure to solid tumor indications, which opens up a significant commercial revenue opportunity for MaxCyc. First-generational taligus CAR-Ts, including S-card and Kimraya, consists of one engineering set, inserting or transducing the CAR into T-cells with a viral vector. As the field evolves to expand the applications for cell therapy, Developers are focusing on more complex approaches with additional edits and unique gene editing tools, which has further accelerated the shift in non-viral cell engineering approaches. Furthermore, as highlighted in the Lyle and Vittoria partnerships, the field continues to advance complex non-viral cell engineered techniques in both autologous and allogeneic settings. MaxSight is well-positioned to address these evolving market trends. The breadth of our SPL partnership funnel is the result of broad engagement with academic clinical translational centers and commercial customers. We have developed new SPL partnerships in both customer segments, with Vittoria being a recent example of our work with the University of Pennsylvania's GMP Translational Center. Vittoria is working toward commercializing their proprietary cell therapy 3.0 technology, which was developed out of the University of Pennsylvania. Our partnership with Prime Medicine supports their Prime Editing technology platform, which is a novel, next-generation gene editing tool targeting repair of almost all types of genetic mutations across a broad range of tissues, organs, and cell types. Prime Medicine is another example of these expanding applications in cell therapy, many of which the MaxA platform is at the forefront of enabling. Given the evolving operating environment, IOSPL partners are often narrowing their focus to their lead assets, which they continue to progress through the clinic. The progression through the clinic of such programs and their positive clinical data readouts are critical events in the current funding environment and have led to capital raises in recent months. We are also seeing our existing partners pursue new indications, including, for example, the expansion of CAR-T applications to autoimmune diseases. As cell therapy indications expand into autoimmune or solid tumors, for example, they often require multiple doses. This is where the performance and scalability of the MaxSight platform has a key competitive advantage. Based on our partners' decisions, we believe it is clear that the MaxSight platform is the platform of choice for innovative cell therapy development. We look forward to the first commercial approval of a product enabled by our platforms. Vertex and CRISPR's Exacell program. Earlier this year, the Exacell program announced the completion of a Boeing BLA submission to the FDA for sickle cell disease and transfusion-dependent beta thalassemia. More recently, at the European Hematology Conference, Vertex presented updated data from Exacell showing pivotal trial data for beta thalassemia and sickle cell disease that met primary and key secondary endpoints. The pivotal data was integral to the excess cell receiving PDUFA dates for sickle cell and beta thalassemia of December 8, 2023, and March 30, 2024, respectively. This application approval would be the first non-viral engineered cell therapy product granted by the FDA and would further validate the utility of MaxSight's platform as the premier enabler of non-viral engineered cell therapies. Our unique partnerships provide MaxSight with near, medium-term, and long-term revenue potential where MaxSight has the opportunity to share in the performance of partners' programs as those programs reach commercialization. To provide more context on the scale of our commercial opportunity, we highlighted this potential on new slide 15 in our corporate presentation. As you may be aware, we are approaching the first wave of partner commercial approvals which include the potential launch in 2024 of Exacell in sickle cell disease and beta thalassemia, followed shortly thereafter by a second commercial wave of seven potential therapies with expected launch potential between 2025 and 2027. The second wave of therapy spans across blood cancers, including lymphoma and leukemia, solid tumor, and genetic diseases. The third commercial wave potentially includes eight partner therapies with a launch window between 2028 and 2030. The commercial revenue opportunity for MaxSight from the success of only a portion of these partner programs is substantial, and our portfolio of commercial opportunities continues to grow in preclinical development as well, with more than 20 preclinical programs currently being developed by our partners. Additionally, following the signing of five strategic partnerships to date this year, the total pre-commercial milestone revenue potential has increased by about 30%, or $500 million to approximately $2 billion across 23 announced partnerships. In 2023, we focused on effectively fortifying our position in the market with targeted investments to support our future growth driven by our customers and expanding SPL partner base. These investments include enhancing our process development capabilities and ongoing product and technology development to best serve the market. In addition, we continue to make investments in our applications lab, which will enhance our ability to support next-generation cell therapy innovators that are pursuing complex cell therapies. We believe these are the right investments to ensure the long-term success of MagSight and support the growth of the cell therapy sector. Our expert VLX large-scale transfection system launch continues to be focused on working with early access customers to define the value proposition for applications. The potential of the VLX is across several applications, such as transient protein manufacturing, and is currently focused on preclinical development and early stage clinical trials. The key capabilities of the VLX instrument enable customers a short development timeline and have broad compatibility, including workflow integration and flexibility. We look forward to further engagement with early access customers so we can provide the market with applications data and a large-scale transfection solution to address current bottlenecks in the bioprocessing market. In summary, our team members are working through an evolving and challenging operating environment this year, which will impact the timing of our customers' development programs and capital investments. However, we are confident in our updated full-year outlook and long-term strategic goals. The substantial promise of the cell therapy industry over the long-term remains intact. And importantly, we maintain a high degree of confidence in the value our technology provides to the industry. We are excited by the potential of the SPL partnerships we signed in 2023 and the robust pipeline of additional opportunities. We are honored to support our partners and believe we remain the partner of choice for non-viral cell engineering technology. With that, I will now turn the call over to DJ to discuss our financial results. DJ?

Disclaimer

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