MaxCyte, Inc.

Good day, and thank you for standing by, and welcome to the MaxSight Third Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to introduce your host for today's call, Sean Menarges, Senior Director of Innovation and Business Development. Please go ahead.

Well, thank you, Justin, and good afternoon, everyone. My name is Sean Menarges. I'm the Director of Innovation and Business Development here at MacSite. Thank you all for participating in today's conference call. On the call from MacSite, we have Doug Zorkler, President and Chief Executive Officer, and Douglas J. Swirsky, Chief Financial Officer. Earlier today, MacSite released financial results for the third quarter ended September 30th 2023. A copy of the press release is 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 meaning 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, and 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.

Thank you, Sean. Good afternoon, everyone, and thank you for joining MaxSight's third quarter 2023 earnings call. I will begin with a discussion of our business and operational highlights during the quarter, followed by a detailed financial review from Doug Swirsky, DJ, our chief financial officer. We will then open the call for questions. MaxSight reported $8 million in total revenue in the third quarter at the high end of our preannounced revenue range. Core revenue was $6.6 million, also at the high end of our preannounced range. Over the last month, the business has performed in line with the expectations we laid out on our call on October 4th, and today we are reiterating our revenue guidance for the full year of 2023. The operating environment for our customers has largely remained unchanged from when we spoke in October. Our primary focus remains on driving commercial execution to improve performance across our business, and the commercial organization at MaxSight is actively working to increase and expand sales opportunities for the balance of 2023 and into 2024. I will briefly revisit some of the challenges we are facing that drove the pre-announced reduction and our revenue guidance, which we pointed to in our call on October 4th. The primary driver of core business performance was softness and processing assemblies, or PA sales. We continue to believe can be attributed to these three factors. Early stage customers in cell therapy and drug discovery conserving spend and reevaluating their pipeline portfolio and R&D initiatives. Customers built up inventory in 2022, and due to the prioritization of programs and reduction in spend, the existing inventory has covered more of their PA needs. And third, clinical SPL partners delaying clinical timelines due to challenges in obtaining additional financing for their clinical operations. Another factor in the weakness of our core business performance was early stage customers becoming incrementally more conservative on capital expenditures as the year has progressed, which has impacted our instrument placements. Though we have seen the macroeconomic operating environment play out unfavorably this year, we continue to see cell therapy industry trends that favor MagSight's platform. The industry continues to move toward non-viral cell engineering, approaches that include multiple pathway engineering steps across many diseases. Specifically, our partners continue to expand their cell therapy indications into new unmet needs, including autoimmune disease, providing us with the opportunity to support our partners as they scale up and scale out their manufacturing process. Furthermore, developers are increasing the complexity of their cell therapy product with multiple edits on the cell, which positions MaxCyte well given the platform's high cell engineering performance across a wide variety of gene edits and gene-edited modalities. Developers are also looking into multiple doses and or increased dosing regiments for complex indications which further supports the market need for engineered large cell volumes. Our customers and partners can leverage our scientific, technical, and regulatory support and capabilities to optimize the clinical manufacturing process for the growing set of cell therapy applications. Just this year, we signed five SBL partnerships, which highlights the value that our platform brings to our customers. We continue to see a healthy pipeline of potential partners, All in all, we are encouraged by the non-viral engineered cell therapy trends in addition to the potential for our partners to make an impact as they progress their programs through the clinic and reach commercialization. We remain highly engaged with our customers, both current and prospective, and are excited by the opportunity to expand our SPL partnership portfolio and grow our revenue. In the third quarter, we reported SPL program-related revenues of $1.4 million and remain confident that we will at least meet our guidance of approximately $6 million this year. We believe this high-value revenue line will continue to be meaningful in the coming years as several waves of different therapies we support potentially come to market. We are excited by partners' progress and look forward to the potential impact of therapies that utilize MaxSight's platform. Looking ahead, there is substantial clinical milestone and commercial revenue opportunity for MaxSight as our partners move toward late-stage clinical development and commercialization. In what would be the first commercially approved product enabled by our platform, CRISPR Vertex Exacell is nearing the PDUFA date of December 8th, 2023 and March 30th, 2024 for sickle cell and beta thalassemia, respectively. Just last week, on October 31st, the FDA held an ADCOM meeting to discuss the treatment, which highlights the therapeutic benefit of Exacell and the important medical advance for the field and for patients. As a reminder, we believe that all necessary investments in manufacturing and regulatory quality have been made on our end to support Exacell's commercial launch. We look forward to the potential FDA approval of the first non-viral engineered cell therapy product validating MaxSight's platform. and which would also result in a significant milestone payment to us under our partnership with Vertex. We continue to be excited about the prospects of the VLX platform and our expansion into the bioprocessing market. To provide some context, we are looking to help our customers improve workflow efficiency and accelerate time for the preclinical and early-stage manufacture of monoclonal antibodies, recombinant proteins, and vaccines. The VLX has a unique capability to enable rapid production of transiently expressed proteins at larger scale for preclinical and early clinical use in a much more efficient time horizon than the standard practice. As a result, customers will be able to evaluate more preclinical leads at an appropriate scale and derive conclusions from late-stage preclinical research activities sooner than they normally would, enabling them to proceed with development in a much faster time frame. The efficiency that VLX brings to the process can potentially accelerate important decisions on late-stage preclinical development to enable developers to prioritize their clinical investments to the most promising assets. We believe that the current market opportunity for the VLX is across approximately 3,000 preclinical assets in monoclonal antibody, recombinant protein, and vaccine development, and we are optimistic about our opportunity in the coming years. To lead this effort, we recently appointed Ali Soleimanizad as Executive Vice President of Bioprocessing. Ali has been an important addition to the leadership team at MaxSight with almost 20 years of experience in biomanufacturing, bioprocessing, and bioanalysis, including serving as Executive Vice President for Separations and Purification at Toso Biosciences prior to joining MaxSight. We firmly believe that he will guide the future of MagSight's bioprocessing business, beginning with the growth of the VLX platform. For the remainder of 2023 and into 2024, we are focused on supporting our customers and partners through targeted investments. We have already made substantial progress in enhancing our infrastructure and scientific and manufacturing capabilities to support customers pursuing complex cell therapies in the clinic, as well as when they reach commercialization. Over time, we believe the investments we are making today will drive substantial incremental value as we support multiple partners at various stages of development and commercial activity. In closing, we continue to navigate the current operating environment with tact and flexibility. MaxSight remains committed to supporting our current SPL partners in their program development and further expanding our portfolio partnerships. With that, I will now turn the call over to DJ to discuss our financial results. DJ?