On March 5, 2024 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics and innovative bioprocessing applications, reported revenue guidance for the full year of 2024 and reaffirmed 2023 preliminary results previously announced in January (Press release, MaxCyte, MAR 5, 2024, View Source [SID1234640785]).

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2023 Preliminary Results

Total revenue for the fiscal year of 2023 is expected to be between $41.1 million and $41.3 million, compared to $44.3 million for fiscal year 2022.

● Core revenue is expected to be between $29.6 million and $29.8 million, compared to $39.6 million for fiscal year 2022.
● SPL Program-related revenue is expected to be approximately $11.4 million, compared to $4.6 million for fiscal year 2022.

Total cash, cash equivalents, and investments as of December 31, 2023 is expected to be approximately $210 million.

2024 Guidance

Management is providing initial 2024 revenue guidance for core business revenue and SPL program-related revenue:

● Core revenue is expected to be flat to 5% growth compared to 2023.
● SPL Program-related revenue is expected to be approximately $3 million for the year.

Our outlook does not include SPL Program-related revenue from the sale of Vertex/CRISPR’s CASGEVY.

Management expects to end 2024 with $175 million in total cash, cash equivalents and investments.

"We are looking forward to continuing to execute across our business and provide best in class support to our customers in 2024 and the years to come. This year, MaxCyte has already signed three SPLs in which our cell and gene therapy clients will use our Flow Electroporation technology and ExPERT platform to further their pre-clinical and clinical programs," said Maher Masoud, President and Chief Executive Officer at MaxCyte. "As we continue to expand our SPL portfolio this year, we remain confident in our ability to support our current and prospective clients as new waves of next-generation cell therapies come to market."

Cowen Healthcare Conference

MaxCyte will be presenting at the 44th Annual Cowen Conference at 9:10 a.m. Eastern Time on Tuesday, March 5, 2024. A live and archived webcast of the Cowen presentation will be available on the "Event" section of the MaxCyte investor relations website at View Source

Fourth Quarter Earnings Conference Call Details

MaxCyte plans to release final financial results for the fourth quarter and full year 2023 after the U.S. market close on Tuesday, March 12, 2024. Company management will host a conference call to discuss financial results that day at 4:30 p.m. Eastern Time on Tuesday, March 12, 2024.

Investors interested in listening to the conference call are required to register online. It is recommended to register at least a day in advance. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source

On March 5, 2024 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported the completion of patient recruitment for the Phase 2a clinical trial[1] sponsored by AP-HP[2] and in collaboration with INRAE and Institut Gustave Roussy, evaluating MaaT013, the Company’s lead product candidate, in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy) and nivolumab (Opdivo) (Press release, MaaT Pharma, MAR 5, 2024, View Source [SID1234640784]).

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A total of 70 patients have been enrolled in 5 different centers in France in the randomized controlled Phase 2a PICASSO trial, which started in April 2022. The Company provided MaaT013 drug candidate and placebo and will contribute to the microbiome profiling of patients using its proprietary gutPrint research engine. The unblinding will be done at Week 27 (W27) to assess the primary endpoint which is safety. In parallel, the first efficacy data will be made available, assessed by the best overall response rate, rated by immunological Response Evaluation Criteria in Solid Tumors (iRECIST; 19).

Having reached this key recruitment milestone, the first publication will be submitted at the end of 2024 or in the first quarter of 2025.

The PICASSO trial is funded by the Directorate of Health Care Supply (DGOS: Direction Générale de l’Offre de Soins) and operated by the French National Cancer Institute (INCa: Institut National du Cancer) as part of a call for projects (project PHRC-K19-183).

[1] NCT04988841: Prospective randomIzed clinical trial assessing the tolerance and clinical benefit of feCAl tranSplantation in patientS with melanOma treated with CTLA-4 and PD-1 inhibitors.

[2] AP-HP: Assistance Publique – Hôpitaux de Paris

About MaaT013

MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, enema Microbiome Ecosystem TherapyTM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal (GI)-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

On March 5, 2024 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors, reported that three abstracts of new nonclinical data have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 taking place in San Diego, CA, April 5-10 (Press release, Lyell Immunopharma, MAR 5, 2024, View Source [SID1234640783]).

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One oral and two poster presentations will highlight data from Lyell’s product pipeline and research programs, including:

An oral presentation on Lyell’s rejuvenation technology which has shown the potential to turn back the epigenetic clock to generate more stem-like T cells with reduced epigenetic age and enhanced proliferation ability
A poster presentation of nonclinical data on LYL119, Lyell’s second-generation ROR1-targeted CAR T-cell product candidate
A poster presentation on technology being advanced through a collaboration between Lyell and Outpace to enable tumor-restricted IL-12 activity to enhance solid tumor T cell therapies
Details on the presentations are below.

An oral presentation titled "Rejuvenation of Tumor Infiltrating Lymphocytes: A novel strategy to revitalize TIL antitumor function for cell therapy" will highlight Lyell’s rejuvenation technology which has shown the potential to generate T cells with reduced epigenetic age, more stem-like properties and enhanced proliferation ability. Previously published studies have demonstrated the decline in T-cell function as a person ages. These new nonclinical data show tumor infiltrating lympyocytes (TIL) rejuvenated with Lyell’s technology retain a broad T-cell receptor repertoire and demonstrate sustained proliferation and improved antitumor activities in vivo.

Presentation details:

Session Date/Time: Tuesday Apr 9, 2024 2:30 PM – 4:30 PM
Abstract Number: 6593
Session Category: Immunology
Session Title: New Insights for Therapies Modulating Antitumor T-Cell Responses
New nonclinical data on LYL119, Lyell’s second-generation ROR1-targeted CAR T-cell therapy, will be presented in a poster titled "LYL119, a Preclinical ROR1-Targeted CAR T-Cell Product Incorporating Four Novel Reprogramming Technologies Designed for Effective Cell Therapy for Solid Tumors." LYL119 incorporates four of Lyell’s complementary, stackable T-cell reprogramming technologies and is designed to create potent ROR1-targeted CAR T cells with durable function. In this study, LYL119 demonstrated superior in vivo antitumor efficacy in a mouse xenograft tumor model across a 10-fold dose range, including at very low cell doses. In addition, following repeated rounds of tumor cell killing, LYL119, displayed reduced expression of exhaustion-related gene signatures and retained unique cell subsets characterized by upregulation of memory and effector-associated gene signatures.

Presentation details:

Session Date and Time: Sunday Apr 7, 2024 1:30 PM – 5:00 PM
Abstract Number: 49
Session Category: Immunology
Session Title: Adoptive Cell Therapies 2: CAR-T Cells
A poster presentation titled "Development of Tumor-restricted IL-12 With Antigen-dependent Expression and Localized IL-12 Activity" highlights an innovative tumor-restricted IL-12 (trIL-12) technology that delivers potent IL-12 stimulation at the tumor site while avoiding systemic exposure. IL-12 is an immune-stimulatory cytokine that can induce potent anti-tumor activity, but unregulated systemic delivery of IL-12 has been shown to have a limited therapeutic window. trIL-12 was designed leveraging Outpace’s OUTSMART technology to rapidly auto-inactivate IL-12 after inducible secretion from engineered T cells with the aim of achieving safe, local delivery of IL-12 activity in the tumor microenvironment. trIL-12 is being advanced under a collaboration between Lyell and Outpace with the goal of improving efficacy for T-cell therapies by harnessing the therapeutic potential of IL-12.

Presentation details:

Session Date and Time: Tuesday Apr 9, 2024 9:00 AM – 12:30 PM
Abstract Number: 4067
Session Category: Immunology
Session Title: Immune Modulation with Cytokines

On March 5, 2024 Kronos Bio, Inc. (the "Company") reported that it has amended its protocol for its clinical trial of KB-0742, an oral CDK9 inhibitor in a phase 1/2 dose escalation and expansion trial in solid tumors (Press release, Kronos Bio, MAR 5, 2024, View Source [SID1234640782]).

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To date, anti-tumor activity has been observed without grade 3/4 neutropenia in patients treated with KB-0742 at doses ranging from 10 mg to 80 mg using the current three-days-on, four-days-off dosing schedule. The Company has seen target engagement, tumor regressions and an acceptable safety profile at 60 mg dosed three-days-on, four-days-off, and have subsequently cleared 80 mg three-days-on, four-days-off.

Moving forward, the Company is pursuing a four-days-on, three-days-off dosing schedule to further increase patient time on KB-0742 at or above a therapeutic threshold. In a 3+3 design, the Company plans to dose escalate through doses of 60 mg, four-days-on, three-days-off, and 80 mg, four-days-on, three-days-off, before enrolling expansion cohorts at the latter dose and schedule (80 mg, four-days-on, three-days-off). KB-0742 clinical data from existing dose escalation and ongoing expansion cohorts are still expected in mid-2024. In the third quarter of 2024, the Company expects to provide an update from the new four-days-on, three-days-off dosing schedule and announce its plans for the dose expansion phase of the Phase 1/2 clinical trial of KB-0742. The Company currently contemplates the expansion cohort will include patients with either small cell or non-small cell lung cancer, ovarian cancer, or triple negative breast cancer and expects to announce topline data from the expansion phase in the first half of 2025.

On March 5, 2024 Keros Therapeutics, Inc. ("Keros") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins, reported that Keros’ President and Chief Executive Officer Jasbir S. Seehra, Ph.D., will participate in a fireside chat presentation at the Leerink Partners 2024 Global Biopharma Conference on Tuesday, March 12, 2024 at 3:00 p.m. Eastern time (Press release, Keros Therapeutics, MAR 5, 2024, View Source [SID1234640781]).

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A live audio webcast of the fireside chat presentation will be available at View Source and an archived replay will be accessible in the Investors section of the Keros website at View Source for up to 90 days following the conclusion of the event.