Fulgent Data at ASCO 2024 Highlights Antitumor Activity from Lead Therapeutic Oncology Candidate, FID-007, in Head and Neck Cancer

Fulgent Pharma, a subsidiary of Fulgent Genetics, Inc. (NASDAQ:FLGT) and a leading nanobiotechnology company specializing in innovative cancer therapeutics, today announced that Phase 1 clinical data on its lead therapeutic development candidate, FID-007, to treat Head and Neck cancer, was presented at the American Society for Clinical Oncology (ASCO) Annual Meeting on June 2, 2024 in Chicago, Illinois.

Of eleven head and neck squamous cell carcinoma (HNSCC) evaluable patients with weekly dose levels from 15 mg/m2 to 160 mg/m2, five (45%) had a partial response and three (27%) had stable disease by RECIST. Three out of five HNSCC patients with PR had previously been treated with taxane. The duration of follow-up (months), median (range) is 4.0 (1.0 – 15.0). No high-grade neuropathy has been noted to date. FID-007 demonstrates preliminary evidence of anti-tumor activity in heavily pre-treated HNSCC patients across different primary tumor sites, with an overall response rate of 45%. Phase 2 study of FID-007 combination with cetuximab in patients with HNSCC has begun enrollment.

Commenting on the data, Ming Hsieh, Chairman of the Board and Chief Executive Officer, said, "We are very encouraged by the data from these Head and Neck cancer patients, in particular the preliminary evidence of relatively lower toxicity and improved treatment tolerance with FID-007 compared to prior therapies. These data support the Phase 2 clinical study we recently began in head and neck squamous cell carcinoma, and we look forward to bringing FID-007 to more patients as we continue enrollment."

The poster is available on the News & Events section of the company's Investor Relations website at https://ir.fulgentgenetics.com/.

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 began as part of Fulgent LLC in Temple City, California, established in June 2011. As the company progressed into the sphere of precision medicine, it also started delving into clinical genetic and genomic testing - a natural complement. In 2016, Fulgent LLC split into two separate entities - Fulgent Pharma and Fulgent Genetics - in order to better pursue their independent objectives. In 2022, Fulgent Pharma was acquired by Fulgent Genetics to synergistically advance personalized cancer genomics and precision oncology therapeutics. 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. For more information visit FulgentGenetics.com.

About Fulgent Genetics

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; Fulgent Pharma's research and development efforts, including any implications that the results of earlier clinical trials will be representative or consistent with later clinical trials, the expected timing of enrollment and regulatory filings for these trials and the availability of data or results of these trials, including any implication that interim or preliminary data will be representative of final results. Forward-looking statements are statements other than historical facts and relate to future events or circumstances or Fulgent Pharma's future performance, and they are based on management's current assumptions, expectations, and beliefs concerning future developments and their potential effect on Fulgent Pharma'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 success of Fulgent Pharma's development efforts, including its ability to progress its candidates through clinical trials on the timelines expected; its compliance with the various evolving and complex laws and regulations applicable to its business and its industry; and its 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 Fulgent Pharma and Fulgent Genetics assume 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.

Fulgent Genetics, Inc.'s reports filed with the U.S. Securities and Exchange Commission, or the SEC, including its annual report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 28, 2024, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on the Fulgent Genetics' website upon their filing with the SEC. These reports contain more information about Fulgent Genetics and Fulgent Pharma, their business and the risks affecting their business.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240603406357/en/