Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, today announced data from two poster presentations being presented tomorrow, November 4, 2023, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA.

“These data support our mission to build a holistic platform to provide comprehensive solutions and services across the cancer care continuum, including early detection, diagnostics, and monitoring, as well as drug discovery and development,” said Ming Hsieh, Chairman and CEO of Fulgent Genetics and co-founder of Fulgent Therapeutics. “We see strong momentum in our precision diagnostics business as a driver of core revenue, and we are encouraged by the steady progress of our therapeutic development for FID-007 in oncology indications.”

The poster titled, “Critical clinical evaluation of plasma to tumor tissue concordance by cancer type using Illumina’s cell-free ctTSO500 commercial liquid biopsy assay,” explores the critical role of comparing ctDNA variants detected in plasma with those found in tissue, shedding light on the practical implementation of liquid biopsy technology. The research presents a meticulous analysis of plasma-to-tissue concordance across various cancer types, offering valuable insights into the considerations for validation, using Illumina's cutting-edge ctTSO500 commercial liquid biopsy assay. The clinical research findings, based on a comprehensive examination of 124 cases across different cancers, reveal significant concordance variations, often linked to the cancer stage and the timing of biopsy and blood sample collection. In uterine cancers, the researchers detected 65.9% of the SNV/indel variants in plasma that were also in FFPE, 47% in colon cancer, 67% in gastric cancer, 56% in bladder cancer, 51% in larynx cancer, and 41% in prostate. The study calls for the involvement of certified labs, highlighting the need for stringent quality management and regulatory alignment. The research ultimately underscores the reproducibility, sensitivity, and practical importance of Illumina's ctTSO500 liquid biopsy, particularly for patients who either cannot or prefer not to undergo traditional solid biopsies for cancer screening.

The poster titled, “FID-007: Nanoencapsulated Paclitaxel Derived from a Novel Nano-Drug Delivery Platform,” highlights progress for Fulgent Pharma’s lead therapeutic oncology candidate, FID-007, in various cancers. Similar to data presented at the ASCO Annual Meeting in June, of 40 evaluable patients with weekly dose levels from 15 mg/m2 to 160 mg/m2, 7 (18%) had a partial response (PR) by RECIST 1.1 (pancreatic, biliary tract, and HNSCC) and 14 (35%) had stable disease. Three out of 4 HNSCC patients with PR had previously been treated with taxane. The duration of follow-up (months), median (range) is 12.0 (0.4 - 38.9). No high-grade neuropathy has been noted to date. Preliminary clinical data suggests FID-007 may have anti-tumor activity in heavily pre-treated patients across various tumor types. Based on the lack of adverse events, pharmacokinetics, and early indications of treatment effect, 125 mg/m2 has been chosen as the recommended Phase 2 dose. In addition, subgroup analysis based on 7 patients for Head and Neck cancer and 4 patients for Ampullary/Pancreatic cancer showed 57% and 50% objective response rate, respectively.

The posters will be available on the Investor Relations section of the company’s website at https://ir.fulgentgenetics.com/presentations.

About FID-007

FID-007 consists of paclitaxel encapsulated in a polyethyloxazoline (PEOX) polymer excipient designed to enhance PK, biodistribution, and tolerability. In addition to allowing the drug to remain in solution until it can enter a cancer cell, the PEOX nanoparticle is designed to preferentially deliver paclitaxel to the tumor through the leaky hyperpermeable vasculature.

About Fulgent Pharma

Fulgent Pharma has developed and possesses a novel nanoencapsulation technology, which includes over 40 patents and a targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile of both new and existing cancer drugs. Fulgent Pharma began as Fulgent Therapeutics in Temple City, California, in June 2011. As the company progressed into the sphere of personalized medicine, it also started delving into clinical genetic testing – a natural complement. In 2016, Fulgent Therapeutics split into two separate entities – Fulgent Pharma and Fulgent Genetics – in order to better pursue their independent objectives. Today, Fulgent Pharma is fully focused on perfecting drug candidates for treating a broad range of cancers. Its partners in this endeavor include the University of Southern California, Moffitt Cancer Center, and ANP Technologies.

About Fulgent

Fulgent is a technology-based company with a well-established clinical diagnostic business and a therapeutic development business. Fulgent’s clinical diagnostic business offers molecular diagnostic testing services, comprehensive genetic testing, and high-quality anatomic pathology laboratory services designed to provide physicians and patients with clinically actionable diagnostic information to improve the quality of patient care. Fulgent’s therapeutic development business is focused on developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile of new and existing cancer drugs. The Company aims to transform from a genomic diagnostic business into a fully integrated precision medicine company.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: future performance; guidance regarding expected quarterly and annual financial results, core revenues, GAAP loss, and non-GAAP loss; evaluations and judgments regarding the stability of certain revenue sources, momentum, vision, future opportunities and future growth the Company’s testing services and technologies and expansion; the Company’s identification and evaluation of opportunities and its ability to capitalize on opportunities, capture market share, or expand its presence in certain markets; and the Company’s ability to continue to grow its business.

Forward-looking statements are statements other than historical facts and relate to future events or circumstances or the Company’s future performance, and they are based on management’s current assumptions, expectations, and beliefs concerning future developments and their potential effect on the Company’s business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the market potential for, and the rate and degree of market adoption of, the Company’s tests, including its Beacon787 panel; its ability to maintain turnaround times and otherwise keep pace with rapidly changing technology; the Company’s ability to maintain the low internal costs of its business model; the Company’s ability to maintain an acceptable margin; risks related to volatility in the Company’s results, which can fluctuate significantly from period to period; risks associated with the composition of the Company’s customer base, which can fluctuate from period to period and can be comprised of a small number of customers that account for a significant portion of the Company’s revenue; the Company’s level of success in obtaining coverage and adequate reimbursement and collectability levels from third-party payors for its tests and testing services; the Company’s level of success in establishing and obtaining the intended benefits from partnerships, strategic investments, joint ventures, acquisitions, or other relationships; the success of the Company’s development efforts, including the Company’s ability to progress its candidates through clinical trials on the timelines expected; the Company’s compliance with the various evolving and complex laws and regulations applicable to its business and its industry; and the Company’s ability to protect its proprietary technology and intellectual property. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events.

The forward-looking statements made in this press release speak only as of the date of this press release, and the Company assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law.

The Company’s reports filed with the U.S. Securities and Exchange Commission, or the SEC, including its annual report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 28, 2023, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on the Company’s website upon their filing with the SEC. These reports contain more information about the Company, its business and the risks affecting its business, as well as its results of operations for the periods covered by the financial results included in this press release.

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