On January 9, 2024 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported unaudited preliminary financial results for the fourth quarter and fiscal year 2023 ahead of its presentation at the 42nd Annual J.P. Morgan Healthcare Conference on January 9, 2024 at 9:00am Pacific Time (12:00pm Eastern Time) (Press release, Illumina, JAN 9, 2024, View Source [SID1234639157]). The webcast can be accessed through the Investor Info section of Illumina’s website at investor.illumina.com.

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Preliminary financial results
•Consolidated revenue of approximately $1,115 million for Q4 2023, up 3% from Q4 2022, and approximately $4,497 million for fiscal year 2023, down 2% from fiscal year 2022
•Core Illumina revenue of approximately $1,090 million for Q4 2023, up 2% from Q4 2022, and approximately $4,431 million for fiscal year 2023, down 3% from fiscal year 2022
•Shipped 79 NovaSeq X instruments in Q4 2023 and 352 instruments for fiscal year 2023
•Consolidated GAAP operating margin of approximately (15.5%) for Q4 2023 and approximately (24.0%) for fiscal year 2023
•Consolidated non-GAAP operating margin of approximately 3.8% for Q4 2023 and approximately 5.3% for fiscal year 2023
•Core Illumina GAAP operating margin of approximately 2.4% for Q4 2023 and approximately 12.3% for fiscal year 2023
•Core Illumina non-GAAP operating margin of approximately 18.0% for Q4 2023 and approximately 19.8% for fiscal year 2023

As previously announced, the company expects to report its full fourth quarter and fiscal year 2023 results following the close of market on Thursday, February 8, 2024. The unaudited results in this press release are preliminary and subject to the completion of accounting and annual audit procedures and are therefore subject to adjustment.

Statement regarding use of non-GAAP financial measures
The company reports non-GAAP results for diluted earnings per share, net income, gross margin, operating expenses, including research and development expense, selling general and administrative expense, and from time to time, as applicable, legal contingencies and settlement, and goodwill and intangible impairment, operating income (loss), operating margin, gross profit (loss), other income (expense), tax provision, constant currency revenue growth, and free cash flow (on a consolidated and, as applicable, segment basis for our Core Illumina and GRAIL segments) in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include substantial charges such as amortization of acquired intangible assets among others that are listed in the itemized reconciliations between GAAP and non-GAAP financial measures included in this press release, as well as the effects of currency translation. Management has excluded the effects of these items in non-GAAP measures to assist investors in analyzing and assessing past and future operating performance, including in the non-GAAP measures related to our Core Illumina and GRAIL segments. Additionally, non-GAAP net income and diluted earnings per share are key components of the financial metrics utilized by the company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

On January 9, 2024 Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE: PFE) reported that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy (Press release, Genmab, JAN 9, 2024, View Source [SID1234639156]). The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of May 9, 2024.

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The sBLA is supported by efficacy and safety data from the global, randomized Phase 3 innovaTV 301 trial (NCT04697628), in which tisotumab vedotin-tftv demonstrated superior overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR), as assessed by the investigator, in patients with recurrent or metastatic cervical cancer compared to chemotherapy. The safety profile of tisotumab vedotin-tftv in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information. In October 2023, results from the innovaTV 301 study were presented during the Presidential Symposium at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

"Therapeutic options for metastatic cervical cancer that not only demonstrate a survival advantage but also include a novel approach to treating this condition are needed," said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab. "This milestone underscores our commitment to continuing to deliver TIVDAK as a treatment option to women in the U.S. diagnosed with cervical cancer whose disease has progressed after first-line treatment."

"The Phase 3 innovaTV 301 trial demonstrated a favorable benefit/risk profile, including improvement in overall survival, and adds to the overall data supporting TIVDAK as a treatment option for people with recurrent and metastatic cervical cancer who have limited treatment options," said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. "The FDA acceptance of our sBLA for review is important progress toward continuing to offer an option that can extend the lives of more adults with cervical cancer."

About Cervical Cancer
Cervical cancer remains a disease with high unmet need despite advances in effective vaccination and screening practices to prevent and diagnose pre-/early-stage cancers for curative treatment. Recurrent and/or metastatic cervical cancer is a particularly devastating and mostly incurable disease; up to 15 percent of adults with cervical cancer are diagnosed with metastatic disease at diagnosis1,2 and, for adults diagnosed at earlier stages who receive treatment, up to 31.5 percent will experience disease recurrence.3 It was estimated that, in 2023, more than 13,960 new cases of invasive cervical cancer were diagnosed in the U.S. and 4,310 adults would die from the disease.4

About the innovaTV 301 Trial
The innovaTV 301 trial (NCT04697628) is a global, randomized, open-label Phase 3 trial evaluating tisotumab vedotin-tftv versus investigator’s choice of chemotherapy alone (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) in 502 patients with recurrent or metastatic cervical cancer who received no more than two prior systemic regimens in the recurrent or metastatic setting.

Patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and disease progression during or after treatment with chemotherapy doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible) are included. The primary endpoint is overall survival. The main secondary outcomes are progression-free survival, confirmed objective response rate, time to response, and duration of response, as assessed by the investigator, as well as safety and quality of life outcomes.

The study was conducted by Seagen, recently acquired by Pfizer, in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT, study number ENGOT cx-12) and the Gynecologic Oncology Group (GOG) Foundation (study number GOG 3057). For more information about the Phase 3 innovaTV 301 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

About TIVDAK (tisotumab vedotin-tftv)
TIVDAK (tisotumab vedotin-tftv) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Determination of TF expression is not required. Nonclinical data suggest that the anticancer activity of tisotumab vedotin-tftv is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin-tftv also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

TIVDAK was granted accelerated approval in the U.S. by the FDA in September 2021. The accelerated approval is based on tumor response and durability of response from the innovaTV 204 pivotal Phase 2 single-arm clinical trial evaluating TIVDAK as monotherapy in patients with previously treated recurrent or metastatic cervical cancer. The data from innovaTV 301 will support global regulatory submissions.

On January 9, 2024 Evogene presented its corporate presentation (Presentation, Evogene, JAN 9, 2024, View Source [SID1234639155])

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On January 9, 2024 Erasca presented its corporate presentation (Presentation, Erasca, JAN 9, 2024, View Source [SID1234639154]).

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On January 9, 2024 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the company’s key 2024 milestones ahead of its presentation at J.P. Morgan’s 42nd annual healthcare conference (Press release, Cogent Biosciences, JAN 9, 2024, View Source [SID1234639152]).

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"Given the foundation that was established in 2023, we are well positioned to move Cogent forward aggressively this year, including a cash runway expected to carry us into 2026," said Andrew Robbins, President and CEO of Cogent Biosciences. "We strongly believe in bezuclastinib’s potential to become the best-in-class cKIT exon 17/18 inhibitor, and in 2024, we plan to complete enrollment in both the PEAK and APEX trials, each of which have the potential, if successful, to support a regulatory approval for bezuclastinib. In addition, we are excited to further describe the differentiation that bezuclastinib offers patients when presenting the results from the complete SUMMIT Part 1 at AAAAI, setting us up to initiate our third bezuclastinib pivotal trial in the first half of the year. Beyond bezuclastinib, the Cogent Research team is creating exceptional molecules, including a growing portfolio of potential best-in-class breast cancer programs."

In 2024, the Company plans to achieve the following milestones:

Bezuclastinib – Systemic Mastocytosis (SM)

Present data from the complete SUMMIT Part 1 trial in patients with Non-Advanced Systemic Mastocytosis (NonAdvSM) at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) annual conference in February
Initiate SUMMIT Part 2 in 1H 2024, a global, registration-directed, randomized, placebo-controlled trial of bezuclastinib in NonAdvSM patients
Finalize, including alignment with regulators, Cogent’s MS2D2, a novel patient reported outcomes (PRO) tool designed to measure symptomatic severity and improvement for patients enrolled in the SUMMIT study. Once available, provide Total Symptom Score (TSS) results from SUMMIT Part 1 utilizing MS2D2
Complete enrollment in the registration-directed APEX Phase 2 trial in patients with Advanced Systemic Mastocytosis (AdvSM)
Bezuclastinib – Gastrointestinal Stromal Tumors (GIST)

Complete enrollment of global, randomized Phase 3 PEAK trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in imatinib-resistant GIST patients
CGT4859 (FGFR2 inhibitor)

Initiate Phase 1 trial of the first Cogent-discovered pipeline program, designed as a potent, selective, reversible FGFR2 inhibitor with best-in-class potential
Preclinical Pipeline

Initiate IND-enabling studies for lead candidate from potent, selective ErbB2 program, highlighted by potential best-in-class brain penetrant properties
Select lead candidate and initiate IND-enabling studies from ongoing PI3Kα program, designed to potently and selective target the H1047R driver mutation, which affects >30,000 cancer patients each year
J.P. Morgan Presentation Details
Cogent will participate in a presentation and Q&A session at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco today, Tuesday, January 9, 2024, beginning at 4:30 p.m. PT (7:30 p.m. ET). A live webcast will be accessible in the "Investors & Media" section of the company’s website, www.cogentbio.com, and will be archived for 30 days following the event.