On November 7, 2022 Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, reported it will present preclinical data highlighting its recent cytoDRiVE platform and pipeline advances during the poster sessions at the upcoming SITC (Free SITC Whitepaper) Annual Meeting 2022 (Press release, Obsidian Therapeutics, NOV 7, 2022, View Source [SID1234623314]). The abstracts have been posted to the SITC (Free SITC Whitepaper) Online Itinerary Planner, will be published in the Journal for ImmunoTherapy of Cancer (JITC) supplement, and are detailed below.

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Obsidian will present data from their cytoDRiVE platform for multiple applications, including novel advancements in cytoTIL engineering. New data to be presented highlight developments in cytoTIL15 therapies, in which engineered TIL expressing both membrane-bound IL15 and a combination-cytokine (either IFN-alpha, IL18 or an undisclosed member of the TNF superfamily) demonstrate in vivo persistence, modulation of the TME and anti-tumor activity. Armoring cytoTIL15 therapies with these potent immune mediators may expand the potential reach of cytoTIL therapies to solid tumors marked by an immunosuppressive TME. Additionally, Obsidian will share digital spatial profiling data showing that in an allogeneic melanoma PDX model, cytoTIL15 cells upregulate cell-killing functions while downregulating exhaustion markers. Obsidian will also present advancements to their cytoDRiVE platform to enable enhanced regulation of IL-12 armored T-cells in preclinical solid tumor models.

"Obsidian’s research advances highlight the versatility of our cytoDRiVE platform to engineer orthogonal features into cytoTIL15 therapies that will remodel the TME and may expand the potential reach of our IL2-free cytoTIL therapies to solid tumors with immunosuppressive microenvironments where clinical development of TIL therapies has been limited," said Jan ter Meulen, M.D. Ph.D., Chief Scientific Officer of Obsidian Therapeutics. "We are pleased with this rapid progress of our pipeline, further building on our lead cytoTIL15 therapy, OBX-115, which is currently enrolling a Phase I clinical trial."

Details of the presentations are as follows:

Title: Enhancers of innate and adaptive immunity combine with membrane bound IL15 to increase the efficacy of tumor infiltrating lymphocyte (TIL) therapy for tumors with immunosuppressive microenvironments
Category, Presentation Date & Location: Cellular Therapies, Thursday Nov. 10, Poster Hall
Abstract No.: 369
Abstract Summary: Engineered TIL expressing both mbIL15 and a combination cytokine (either IFN-alpha, IL18 or TNFSF-X) showed similar fold expansion, immunophenotype and polyfunctionality in vitro compared to TIL expressing only mbIL15. In the absence of IL2, TIL expressing mbIL15 plus cytokine showed similar in vivo antigen-independent persistence to TIL engineered with IL15 alone. T cells expressing IL15 and either IFN-alpha or IL18 showed improved efficacy and TME remodeling, and combining IL15 with TNFSF-X resulted in growth arrest of syngeneic melanoma tumors in mice.

Title: Digital spatial profiling and antigen-dependent phenotypic analysis of IL15-engineered tumor-infiltrating lymphocytes (cytoTIL15 therapy) in an allogeneic melanoma PDX model
Category, Presentation Date & Location: Cellular Therapies, Friday Nov. 11, Poster Hall
Abstract No.: 330
Abstract Summary: Digital spatial profiling and single cell sequencing showed that in an allogeneic melanoma PDX model, cytoTIL15 cells demonstrated enrichment and reactivity for melanoma antigen-specific TCRs, while maintaining TCRβ diversity. cytoTIL15 cells showed a distinct profile of RNA expression and phenotypic markers, consistent with their increased persistence and anti-tumor efficacy.

Title: Pharmacologically-controlled expression of membrane-bound IL-12 results in T-cell therapy with enhanced potency in preclinical solid tumor models
Category, Presentation Date & Location: Cellular Therapies, Thursday Nov. 10, Poster Hall
Abstract No.: 278
Abstract Summary: T-cells armored with a small molecule-controlled membrane bound IL-12 (mbIL-12) under the cytoDRiVE platform drives regulation of pharmacodynamic markers and anti-tumor efficacy in xenograft and syngeneic solid tumor models.

About OBX-115
Obsidian’s lead cytoTIL15 program, OBX-115, is a novel engineered tumor-infiltrating lymphocyte (TIL) therapy armed with regulated membrane-bound IL15 that is designed to remove the need for concomitant IL2 therapy, a toxic and costly requirement for conventional TILs. OBX-115 preclinical data have demonstrated enhanced TIL persistence, potency and improved tumor control compared to unengineered TILs plus IL2, which is anticipated to improve clinical outcomes in patients suffering from metastatic melanoma and other solid tumors. FDA granted IND clearance for OBX-115 in July 2022. The Phase I FIH clinical trial for OBX-115 is currently recruiting patients. Information regarding the clinical trial is available at clinicaltrials.gov: NCT05470283.

On November 7, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported financial results for the third quarter ended September 30, 2022 and provided an update on recent operational highlights (Press release, Cyteir Therapeutics, NOV 7, 2022, View Source [SID1234623313]).

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"The Cyteir team continues to make progress with CYT-0851 in the clinic and understanding the optimal target population that will benefit from CYT-0851," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "We are diligently working towards our critical clinical data readouts, while advancing our preclinical synthetic lethality pipeline and preserving cash."

Third Quarter 2022 Business Update

Updates to the CYT-0851 Clinical Program

Enrollment in the first stage of the Phase 2 solid tumor monotherapy cohorts in sarcoma, pancreatic and ovarian cancer recently completed. Initial data from these cohorts are now expected in the first quarter of 2023. The triple-negative breast cancer monotherapy Phase 2 cohort was opened in August 2022 and continues to enroll with initial data expected in the first half of 2023.
Enrollment in the monotherapy Phase 2 cohorts in diffuse large B-cell lymphoma and follicular lymphoma has been delayed due to competition in the treatment landscape. Initial data are now expected in mid-2023.
Enrollment in the Phase 1 dose-escalation cohorts of CYT-0851 in combination with capecitabine or gemcitabine is progressing as expected. Completion of enrollment in the capecitabine dose escalation cohorts is anticipated by year-end 2022. Completion of enrollment in the gemcitabine dose escalation cohorts is expected in the first half of 2023. Initial safety and efficacy data from these cohorts are expected in the first half of 2023.
A poster on the mechanism of action of CYT-0851 was presented at the 34th Annual EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium. Details on the understanding of CYT-0851’s monocarboxylate transporter (MCT) activity were presented as well as additional mechanistic data on CYT-0851. Progress continues towards identification of a biomarker to help identify patients most likely to benefit from CYT-0851 therapy.
Third Quarter 2022 Financial Results

Cash and cash equivalents: Cash and cash equivalents as of September 30, 2022 were $153.9 million. Cash and cash equivalents are expected to fund planned operations into the second half of 2024.

Research and development (R&D) expenses: R&D expenses were $8.3 million in third quarter of 2022 versus $8.2 million for the same period in 2021.

General and administrative (G&A) expenses: G&A expenses were $3.5 million for the third quarter of each 2022 and 2021.

Net loss: Net loss was $11.0 million, or $0.31 per share, in the third quarter of 2022 compared to $11.7 million, or $0.33 per share, for the same period in 2021.

On November 7, 2022 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported financial results for the third quarter ended September 30, 2022 and provided a review of recent business and clinical highlights (Press release, Xencor, NOV 7, 2022, View Source [SID1234623312]).

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"Xencor’s XmAb technologies and protein engineering capabilities enable us to address challenging areas of biology and to continually grow our portfolio, both internally and together with our many partners. Today we presented very encouraging data from our second clinical-stage cytokine program, XmAb564, a regulatory T-cell targeting IL2-Fc fusion protein for development in autoimmune disease. The selective T-cell increases, their durability and the tolerability in our data provide us additional clinical validation for Xencor’s long-acting, low-potency approach to cytokine engineering and offers a potentially differentiated profile for this autoimmune program," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "In the coming weeks, we will also present new data from two additional clinical programs—for vudalimab, data from the safety run-in portion of our Phase 2 prostate cancer study at SITC (Free SITC Whitepaper) and, for plamotamab, updated Phase 1 expansion data in patients with lymphoma at ASH (Free ASH Whitepaper)—as well as preclinical data from emerging platforms."

Dr. Dahiyat continued, "Altogether, these updates reflect Xencor’s steady commitment to the priorities we laid out at the beginning of this year: to execute on development plans for our mid-stage bispecific antibodies, vudalimab and plamotamab; to advance potency-reduced cytokines for oncology and autoimmune disease; and to expand our portfolio with novel formats enabled by our protein engineering expertise and suite of leading XmAb technologies."

Recent Portfolio Highlights

XmAb564 (IL2-Fc): Today, Xencor announced initial results from its single-dose Phase 1a study of XmAb564, administered subcutaneously in healthy volunteers. XmAb564 is a wholly owned, monovalent interleukin-2 Fc (IL-2-Fc) fusion protein, engineered to selectively activate and expand regulatory T cells (Tregs) for the potential treatment of patients with autoimmune diseases. XmAb564 is engineered with reduced binding affinity for IL-2’s beta receptor and increased binding affinity for its alpha receptor (CD25). The study enrolled 48 subjects, with six dose-level cohorts each randomizing six subjects to XmAb564 and two subjects to placebo.

The study demonstrated that a single dose of XmAb564 is well tolerated and generates durable, dose-dependent and selective expansion of Tregs. In the highest dose cohort (0.065 mg/kg; Cohort 6), a 117-fold mean peak expansion over baseline in CD25bright cells was observed, with an 8-fold expansion in the bulk Treg population. The ratio of Tregs to conventional T cells also increased significantly in a dose-dependent manner. At day 21, both CD25bright and total Treg counts remained markedly elevated, potentially supporting a multi-week dosing profile. All adverse events (AEs) were either Grade 1 or 2 and resolved without intervention. Injection site reaction was the most reported AE.

Xencor has dosed the first patient in a newly initiated Phase 1b, multiple-ascending dose study of XmAb564 in patients with atopic dermatitis and psoriasis.

Vudalimab (PD-1 x CTLA-4): Xencor is advancing vudalimab, a selective dual checkpoint inhibitor, in multiple Phase 2 clinical studies. Xencor is conducting a Phase 2 study of vudalimab in patients with metastatic castration-resistant prostate cancer (mCRPC), as a monotherapy or in combination with standard-of-care chemotherapy or a PARP inhibitor. Initial data from the first patients in the study will be presented in a trials-in-progress poster at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) this month. Xencor is also conducting a Phase 2 monotherapy study in patients with advanced gynecologic and clinically-defined high-risk mCRPC.

Plamotamab (CD20 x CD3): Xencor is advancing plamotamab as part of highly active chemotherapy-free regimens across B-cell cancers. The Phase 2 study of plamotamab in combination with tafasitamab plus lenalidomide is currently enrolling patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Data from expansion cohorts in the first-in-human, Phase 1 monotherapy study in patients with relapsed or refractory non-Hodgkin’s lymphoma will be presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on Monday, December 12, 2022. These expansion cohorts are actively recruiting patients with relapsed or refractory DLBCL and follicular lymphoma and are dosing using the intravenous recommended Phase 2 regimen to evaluate the safety and efficacy of plamotamab monotherapy. Subcutaneous administration of plamotamab is currently being incorporated into the study.

Preclinical Data Presentations: New data from four preclinical-stage programs, including Xencor’s IL-18-Fc and LAG3-targeted IL-15-Fc cytokine programs, CD28 trispecific antibodies targeting PDL1 and PDL2 and its NK cell engager platform, will also be presented at the SITC (Free SITC Whitepaper) Annual Meeting.
Progress Across Partnerships

Vir Biotechnology, Inc.: In the third quarter of 2022, Xencor reported $17.8 million in royalty revenue under the Company’s agreement with Vir. Sotrovimab, an antibody that targets the SARS-CoV-2 virus and incorporates Xencor’s Xtend Fc domain for longer duration of action, has been made available by Vir and its partner GSK. Sotrovimab currently has emergency use authorization, temporary authorization or marketing approval (under the brand name Xevudy️) for early treatment of COVID-19 in more than 40 countries, and remains in use outside of the U.S. For the first nine months of 2022, the Company has received $110.1 million in royalty revenue under the Vir Agreement.

Zenas Biopharma Ltd.: Today, Zenas announced that it raised $118 million in additional capital in connection with the issuance of Series B shares. Xencor had owned a warrant and a convertible note in Zenas, which as a result of the financing converted into additional equity. Zenas also announced plans to initiate a global Phase 3 registration study of obexelimab, which was acquired from Xencor, in patients with IgG4-related disease in late 2022.
Corporate: In September, Xencor appointed Nancy Valente, M.D., to its board of directors. Dr. Valente is a recognized and accomplished biotechnology executive with broad expertise in late-stage oncology clinical development, and she served a critical role for numerous product launches. She most recently served as a senior vice president at Genentech, a member of the Roche Group, and as its global head and co-lead of global product development of its oncology and hematology therapeutic area.

Xevudy is a registered trademark of the GSK group of companies.

Financial Results for the Third Quarter Ended September 30, 2022

Cash, cash equivalents, receivables and marketable debt securities totaled $654.6 million as of September 30, 2022, compared to $664.1 million on December 31, 2021. During the first nine months of 2022, the Company received royalty and milestone payments from partners of $140.9 million, which offset net spending on operations of $170.3 million through September 30, 2022.

Total revenue for the third quarter ended September 30, 2022 was $27.3 million, compared to $19.7 million for the same period in 2021. Revenues earned in the third quarter of 2022 were primarily royalties from the Alexion and Vir agreements, compared to the same period in 2021, which were primarily from the Janssen collaboration, and royalty revenue from Alexion and Vir. Revenues for the nine months ended September 30, 2022 were $143.0 million, compared to $121.1 million for the same period in 2021. Revenues for the nine-month period in 2022 were primarily from milestone revenue from Astellas and royalty revenue from Alexion, MorphoSys and Vir, compared to the same period in 2021, which were earned primarily from the collaborations with Janssen and Novartis, milestone revenue from MorphoSys and the royalties from Alexion and Vir.

Research and development (R&D) expenses for the third quarter ended September 30, 2022 were $53.3 million, compared to $50.6 million for the same period in 2021. Increased R&D spending for third quarter of 2022 compared to 2021 reflects increased spending on IL-12 and IL-18 cytokine programs offset by lower spending on CD3 programs. R&D expenses for the nine months ended September 30, 2022 were $148.1 million, compared to $141.5 million for the same period in 2021. Increased R&D spending for the first nine months of 2022 reflects additional spending on XmAb808 (B7-H3 x CD28) and cytokine programs offset by lower spending on CD3 programs.

General and administrative (G&A) expenses for the third quarter ended September 30, 2022 were $12.4 million, compared to $10.4 million for the same period in 2021. G&A expenses for the nine months ended September 30, 2022 were $34.7 million, compared to $27.5 million for the same period of 2021. Increased G&A spending for the third quarter and first nine months of 2022 compared to amounts for the same periods in 2021 reflects additional general and administrative staffing and increased spending on professional services and facility costs.

Other income for the third quarter ended September 30, 2022 was $6.7 million compared to $1.1 million in the same period in 2021. Other income for these periods represents unrealized gain from the change in fair value of equity securities and interest income earned on investments. Other expenses for the nine months ended September 30, 2022 were $2.2 million, compared to other income of $57.5 million in the same period in 2021. Other expenses for nine months ended September 30, 2022 consists of unrealized losses from the change in the fair value of equity investments and interest income earned, while other income for the first nine months of 2021 includes realized gains on the sale of an investment equity security and an increase in unrealized gains on the Company’s marketable equity investments.

Non-cash, stock-based compensation expense for the nine months ended September 30, 2022 was $36.2 million, compared to $26.6 million for the same period in 2021.

Net loss for the third quarter ended September 30, 2022 was $32.8 million, or $(0.55) on a fully diluted per share basis, compared to net loss of $40.2 million, or $(0.69) on a fully diluted per share basis, for the same period in 2021. For the nine months ended September 30, 2021, net loss was $43.1 million, or $(0.72) on a fully diluted per share basis, compared to net income of $9.6 million, or $0.16 on a fully diluted per share basis, for the same period in 2021. Net loss reported for the third quarter ended September 30, 2022 compared to the net loss reported for the same period in 2021 is lower due to increased revenue and interest income in 2022 compared to 2021. Net loss for the first nine months of 2022, compared to the net income reported for the same periods in 2021, is primarily due to realized gain on an equity investment and an increase in unrealized gains on marketable equity securities during the nine months ended September 30, 2021.

The total shares outstanding were 59,773,337 as of September 30, 2022, compared to 58,454,811 as of September 30, 2021.

Financial Guidance

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations through the end of 2025. The Company expects to end 2022 with between $575 million and $600 million in cash, cash equivalents, receivables and marketable debt securities.

Conference Call and Webcast

Xencor will host a conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss the third quarter 2022 financial results, provide a corporate update and present results from the Phase 1a study of XmAb564.

The live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website at investors.xencor.com and will be archived for at least 30 days. Active participants in the conference call may receive credentials for telephone access by registering at the following link: https://register.vevent.com/register/BIb8a7d450f24d42068f4bb86e717257fe.

On November 7, 2022 Personalis, Inc. (Nasdaq: PSNL) reported that the company will share data resulting from expanded features of its NeXT Platform at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, November 8-12 in Boston, with three abstracts that highlight advanced R&D applications of next-generation sequencing (NGS) in immuno-oncology (Press release, Personalis, NOV 7, 2022, View Source [SID1234623311]).

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"To understand the complex dynamics of cancer and ultimately better predict response to therapy, we need to advance the tools we’re using to characterize the tumor microenvironment. We continue to build upon the suite of technologies in our ImmunoID NeXT Platform to enable the high-resolution study of immuno-oncology targets in an array of contexts, including improved neoantigen prediction, immune-composition profiling, and composite biomarker signatures," said Sean Boyle, PhD, Executive Director of Bioinformatics Science at Personalis.

The company will present the following posters at SITC (Free SITC Whitepaper)2022, as well as with customers including the Parker Institute for Cancer Immunotherapy (Abstracts 559 and 587) and Geneos Therapeutics (Abstracts 691 and 692).

Title: A combination of antigen presentation and T-cell recognition features improves neoantigen immunogenicity predictions (Abstract 51)

Overview: Tumor neoantigen burden outperformed tumor mutational burden in prediction of patient response to checkpoint inhibitor immunotherapy by better capturing the biological mechanism underlying response. However, immune recognition of neoantigens by T-cells requires more than antigen presentation, which has been the focus of tumor neoantigen burden thus far. To address this need, we extend the existing SHERPA MHC-presentation framework to predict neoantigen immunogenicity. By combining antigen presentation and T-cell recognition features in a two-tiered model, we can better predict immunogenic neoantigens and make progress towards using neoantigens as biomarkers to assess checkpoint inhibitor efficacy.

Title: Sensitive prediction of immunotherapy response by integrating immune infiltration and neoantigen presentation score in late-stage melanoma (Abstract 119)

Overview: Single-modality biomarkers such as tumor mutational burden (TMB) often fail to reliably predict response to immune checkpoint blockade (ICB), likely due to incomplete characterization of the complex tumor-immune interactions that influence treatment efficacy. We previously developed the composite biomarker, neoantigen presentation score (NEOPS), which integrates neoantigen processing and presentation potency, and showed it outperformed TMB and other single-modality biomarkers in predicting ICB response in melanoma. Here, we combined NEOPS with the assessment of tumor immune infiltration and demonstrated more accurate patient stratification for ICB response.

Title: Transcriptome augmentation provides accurate and sensitive quantification of genes associated with the tumor microenvironment (Abstract 146)

Overview: While malignant cells dictate much of the tumor biology, there is evidence that the tumor microenvironment (TME) also plays a significant role in disease progression and response to therapy. The role of the immune cells is particularly relevant in immunotherapy, and multiple transcriptome-based biomarkers have shown utility in predicting the efficacy of immune checkpoint blockade. However, little is known about the benefits of enhancing the depth and uniformity of transcriptome sequencing coverage for quantifying the TME cell type composition. Using the ImmunoID NeXT Platform, which combines high-quality exome and transcriptome sequencing with advanced informatics to comprehensively characterize the tumor and TME from a single FFPE tumor sample, applying augmented transcriptome coverage to the assessment of TME benefited the identification of marker genes for cell type enrichment analysis without introducing bias.

On November 7, 2022 Fulgent Genetics, Inc. (NASDAQ: FLGT), a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health, reported that it has completed an acquisition of Fulgent Pharma Holdings, Inc. ("Fulgent Pharma"), an independent clinical-stage, therapeutics development company focused on the development of innovative cancer treatments (Press release, Fulgent Genetics, NOV 7, 2022, View Source [SID1234623310]). Under the terms of the agreement, Fulgent Genetics acquired Fulgent Pharma for a total purchase price of approximately $100 million, subject to adjustments, to be paid with a combination of cash on hand and shares of common stock of Fulgent Genetics.

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The combined company plans to offer a vertically integrated solution to combat cancer with the potential to unlock significant long-term upside for both the therapeutic and diagnostic businesses, while effectively managing risk. Fulgent Pharma and Fulgent Genetics were previously both owned by Fulgent Therapeutics until 2016, when the businesses were separated ahead of the Initial Public Offering of Fulgent Genetics. The companies have operated as separate entities since 2016, enabling each business to focus on and achieve core objectives across genetic testing and therapeutic drug development. Over the last year, Fulgent Genetics has established a meaningful presence in the large market for molecular diagnostics and oncologic testing, most notably with the recent acquisitions of CSI Laboratories and Inform Diagnostics, and the opening of a state-of-the-art oncologic testing facility in southern California. Fulgent Pharma has developed a novel nanoencapsulation and targeted therapy platform, which is designed to improve the therapeutic window and pharmacokinetic profile of new and existing cancer drugs. Based on current studies and pre-designated criteria, Fulgent Pharma believes its lead drug candidate, FID-007, has achieved proof-of-concept in preliminary human clinical trials for the treatment of various cancer types, including Head and Neck, Ampullary, Pancreatic, NSCLC, and Breast.

"This acquisition advances 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. "With my commitment and our teams already in place, the combination of these two businesses diversifies our assets and will, we believe, provide sustainable future revenue and margin opportunity through a potentially lucrative target oncology market."

"In addition to FID-007, our proprietary nano-drug delivery platform has generated a deep pipeline of wholly owned drug candidates, focused on additional target cancer indications, including one for colon cancer and one NCE (new chemical entity) targeting the STING pathway. Both have been tested extensively in preclinical studies," said Ray Yin, PhD., President and Chief Scientific Officer of Fulgent Pharma and co-founder of Fulgent Therapeutics. "Through this acquisition, Fulgent Pharma will have access to commercial relationships across the oncology market as well as capital to fund research, development and, assuming the requisite regulatory approvals, commercialization as part of Fulgent Genetics."

Strategic Vision

Attractive Lead Therapeutic Candidate FID-007 and Nanoencapsulation Technology: Fulgent Pharma’s lead program, FID-007, is a proprietary nanoencapsulated formulation of paclitaxel developed to improve the overall solubility profile of paclitaxel. Data observed from studies conducted to date suggest that nanoencapsulation of paclitaxel may improve the biodistribution and bioavailability to target tissues. Such data also demonstrate a favorable profile and further support potential applications in a broad range of indications including Head and Neck, Ampullary, Pancreatic, Lung, Breast, and Ovarian cancers.
Expanded Market Opportunity: FID-007 is currently being developed for 2nd and 3rd line treatment of Head & Neck (H&N) cancer, a potential $2.2+ billion target market opportunity. The company sees further opportunities in large multi-billion markets including NSCLC, Pancreatic, Breast, and Ovarian cancers where currently available therapies are suboptimal.
Strategic and Operational Synergies: Potential long-term value creation driven by the combination of therapeutic candidates and diagnostics expertise, designed to offer a comprehensive oncology-focused solution that enables precision medicine through in-house or partnered therapeutics programs underpinned by genetic data insights. In addition, Fulgent Pharma’s talented scientific team brings unique expertise to the combined businesses and creates a differentiated advantage in the oncology market.
Enhanced Commercial Profile: Following completion of development and regulatory approval, the combined company is positioned to be a "one-stop shop" that spans the life sciences chain and reaches the expanded customer base of Fulgent Genetics through its growing sales organization.
Attractive Capital Allocation Plan: Fulgent Genetics’ strong balance sheet and cash flows from operations are expected to be able to support the advancement of Fulgent Pharma’s R&D pipeline. Fulgent Genetics’ track record of integrating acquisitions, strategic partnerships, and disciplined execution has been a key element in the company’s growth. This acquisition is designed to align with Fulgent Genetics’ strategy to drive long term shareholder value through organic and inorganic initiatives across the genomics and, assuming the requisite regulatory approvals, therapeutics market segments.
Advisors

A special committee comprised of independent members of Fulgent Genetics’ board of directors was established to review this transaction. In consultation with its independent financial and legal advisors, the special committee recommended the board of directors approve the Fulgent Pharma acquisition. The special committee was advised by First Principles Advisory Group and Cooley LLP. Fulgent Genetics was represented in the transaction by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.; and Procopio, Cory, Hargreaves & Savitch LLP acted as legal counsel to Fulgent Pharma.

Conference Call Information

Fulgent Genetics will discuss this transaction during its scheduled third quarter 2022 earnings conference call and webcast being held today at 4:30 PM ET (1:30 PM PT). The call and associated presentation may be accessed through a live audio webcast on the Investor Relations section of the company’s website, View Source An audio replay will be available at the same location.