11/7/2025

speaker
Operator
Conference Operator

and welcome to the Fulgen Genetics Q3 2025 conference call and webcast. At this time, all participants are in listening-only mode. A question-and-answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star 1 on your telephone keypad. If anyone should require operator assistance, please press star 0. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Lauren Sloan, Investor Relations.

speaker
Lauren Sloan
Investor Relations

Please go ahead, Lauren. Good morning, and welcome to Fulgent's third quarter 2025 financial results conference call. On the call are Ming Hsieh, Chief Executive Officer, Paul Kim, Chief Financial Officer, and Brandon Purvis, Chief Commercial Officer. The company's press release discussing the financial results is available on the investor relations section of the company's website, ir.fulgentgenetics.com. A replay of this call will be available shortly after the call concludes on the investor relations section of the company's website. Management's prepared remarks and answers to your questions on today's call will contain forward-looking statements. These forward-looking statements represent management's estimates based on current views, expectations, and assumptions, which may prove to be incorrect. As a result, matters discussed in any forward-looking statements are subject to risks, uncertainties, and changes in circumstances that may cause actual results to differ from those described in the forward-looking statements. The company assumes no obligation to update any of the forward-looking statements it may make today to reflect actual results or changes in expectations. Listeners should not rely on any forward-looking statements as predictions of events and should listen to management's remarks today with the understanding that actual events, including the company's actual future results, may be material or different than what is described in or implied by these forward-looking statements. Please review the more detailed discussion relating these forward-looking statements, including the discussions of some of the risk factors that may cause results to differ from those described in the forward-looking statements contained in the company's filings with the Securities and Exchange Commission including the previously filed 10-K for the year ended December 31, 2024, and subsequently filed reports, which are available on the company's investor relations website. Management prepared remarks, including discussion of profit, loss, margin, earnings, and earnings per share, contain financial measures not prepared in accordance with accounting principles generally accepted in the United States or GAAPs. Management has presented these non-GAAP financial measures because it believes they may be useful to investors for various reasons. But these measures should not be viewed as a substitute for or superior to the company's financial results prepared in accordance with GAAP. Please see the company's press release discussing its financial results for the third quarter of 2025 for more information, including the description of how the company calculates non-GAAP income loss non-GAAP earnings loss per share, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating profit and loss, and margin and adjusted EBITDA, and the reconciliation of these financial measures to income and loss, earnings loss per share, and operating margin, the most directly comparable GAAP financial measures. With that, I'd now like to turn it over to Ming. Please go ahead.

speaker
Ming Hsieh
Chief Executive Officer

Thank you, Lauren. Good morning. and thank you for joining our call today. I will start with some comments on the third quarter of 2025 and our two business lines. Dan Brandon will review our product and go-to market updates for our laboratory services business. Ann Powell will conclude with financial and guidance before we take your questions. We are pleased with our third quarter results and sustained momentum in the business. As we move through the year, our results are testament to the progress we have made on our strategic objectives in both our laboratory services and the therapeutic development business. We have shown both sequential and year-over-year growth and efficiency in laboratory services. With our investment in AI and digital pathology solutions, while making strong pipeline progress, our clinical candidates as a result of momentum in our business. We are raising our outlook for the remainder of 2025. Our therapeutic development pipeline is on track and progressing well. Our first clinical candidate, FID-007, is progressing through a phase two clinical trial in combination with cetuximab in a patient with a recurring or metastatic head and neck sarcoma cell carcinoma. with 39 patients that have been randomized and 36 have received at least one dose of study treatment as of the big cutoff date of September 25th, 2025. The preliminary data was presented at the ESMO Congress on October 20th, 2025. FID-07 combined with cetaximab demonstrate the meaningful anti-cancer efficacy at both dose level for the first-line and the second-line treatment of RM-HNSCC. Of the 35 patients then available for the efficacy at a time this preliminary data was reviewed. The objective response rate, or ORR, for the 75 milligram per square meter arm and 125 milligram per square meter arm were 44 percent and 59 percent, respectively, and 51 percent overall when both arms are combined. The median progression survival for the 75 milligram arm and 125 milligram arm were 9.2 months and 7.8 months, respectively. The overall PFS was 7.8 months compared to the historical 2.3 months of the standard care therapies. FIT-07 also exhibit manageable safety and tolerability profile. Particularly, no grade three and above peripheral neuropathy has been reported today. As of today, we have a total of 43 patients enrolled and expect to complete patient enrollment by end of 2025, with a full data readout in 2026. Our second candidate, FID0022, began a phase one trial, and the first dose level has been successfully completed, while the second dose level or comments this month. FID-022 is a nanoencapsulated SN38 for the treatment of solid tumors, including potentially colon, pancreatic, ovarian, and bile duct cancers. I'm encouraged by the continued progress of our clinical pipelines and the potential for both FID-07 and FID-022. These drug candidates address heavily treated patients with very few options left, and I hope we were able to provide alternatives to better their lives. Overall, I'm pleased with the progress we have made this year in both our business area. Our pharma R&D efforts are progressing faster, better, and more cost-effective than planned. Additionally, our laboratory services is greatly benefited from our investment in AI technology, which makes our services more efficient and more precise, as Brandon will discuss shortly. I would like to thank our employees, partners, and stakeholders for your hard work and your loyalty. in the great quarter of our business. We look forward to further progress in the remainder of 2025. I will now turn over the call over to Brandon Perthes, our chief credential officer, to talk more about our laboratory services business. Brandon.

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