On May 1, 2025 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies, including gene elimination, gene insertion, and gene excision programs, reported that five abstracts detailing Precision’s wholly owned or partnered programs have been accepted for presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting being held May 13-17, 2025, in New Orleans, Louisiana (Press release, Precision Biosciences, MAY 1, 2025, View Source [SID1234652451]).

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"We are pleased to present new data at ASGCT (Free ASGCT Whitepaper) from multiple programs across our in vivo gene editing pipeline, highlighting the potentially unmatched breadth and therapeutic potential of our ARCUS gene editing technology," said Michael Amoroso, President and Chief Executive Officer at Precision BioSciences. "Clinically, we have made progress advancing our lead program, PBGENE-HBV, which is a novel gene editing approach being evaluated in a first-in-human study for chronic hepatitis B, and we look forward to sharing initial safety data from the first two dose cohorts at ASGCT (Free ASGCT Whitepaper). Additionally, we continue to be excited by the promising clinical results generated thus far by our partner iECURE for ECUR-506 in OTC deficiency, which utilizes an ARCUS nuclease and will also be presenting data at this conference."

"We are also excited to share promising preclinical results from two muscle programs, PBGENE-3243 program for m.3243-associated mitochondrial disease and PBGENE-DMD for the treatment of Duchenne Muscular Dystrophy (DMD)," Mr. Amoroso continued. "Collectively, these presentations highlight the progress we are making with ARCUS by deploying a variety of gene edit types, including gene elimination, gene insertion and gene excision across a range of complex genetic diseases as we seek to develop durable, curative treatments for patients."

Clinical Program Presentations:

Title: Initial Safety Data From ELIMINATE-B, the First Clinical Trial of a Gene Editing Treatment for Chronic Hepatitis B
Oral Presentation Session: Gene Therapy Trials – In-Vivo Gene Therapy Modification
Date and Time: Friday, May 16, 2025, 4:00 PM CT
Location: Room 393-396

Title: ARCUS in vivo OTC, Large Gene Insertion (clinical stage partnered program)
Oral Presentation Session: Advances in Genome Editing: Novel Large DNA Insertion Technologies and Their Potential Towards Curative Therapies
Date and Time: Wednesday, May 14, 2025, 8:00 AM CT
Location: NOLA Theater B

Preclinical Program Presentations:

Title: Excision of the C9orf72 Hexanucleotide Repeat Expansion Using a Dual-ARCUS Gene Editing Approach Reduces Neurotoxic RNA Foci and Dipeptides in an In Vivo Model of ALS
Poster Session: Poster Reception
Date and Time: Tuesday, May 13, 2025, 6:00 PM – 7:30 PM CT
Location: Poster Hall I2

Title: Systemic Delivery of a Mitochondria-Targeting ARCUS Gene Editing Nuclease by AAV Eliminates Mutant Mitochondrial DNA, Demonstrating Therapeutically Meaningful Heteroplasmy Shifts In Vivo
Oral Presentation Session: Gene Editing: New Tools and Technology Advances
Date and Time: Wednesday, May 14, 2025, 3:45 PM CT
Location: NOLA Theater A

Title: ARCUS-Mediated Gene Editing Excision of Exons 45-55 of the Human Dystrophin Gene using PBGENE-DMD Leads to Functional Dystrophin Protein and Durable Restoration of Skeletal Muscle-Function In Vivo for the Treatment of Duchenne Muscular Dystrophy
Poster Session: Poster Reception
Date and Time: Wednesday, May 14, 2025, 5:30 PM – 7:00 PM CT
Location: Poster Hall I2

The abstracts are now publicly accessible through the ASGCT (Free ASGCT Whitepaper) website here.

On May 1, 2025 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, reported a business update and provided first quarter 2025 financial results (Press release, NextCure, MAY 1, 2025, View Source [SID1234652450]).

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"With our LNCB74 antibody-drug conjugate ("ADC") program completing cohort 2 in April 2025, we are progressing as planned through the dose escalation portion of the Phase 1 study. We expect to be in a position to initiate backfill cohorts in the second half of the year with 10 active investigator sites, and an additional 3 sites projected to be onboard in May 2025. We plan to provide a proof of concept data readout in the first half of 2026," said Michael Richman, NextCure’s president and CEO.

Business Highlights and Near-Term Milestones

LNCB74 (B7-H4 ADC)

● Dosed our first patient in January 2025 in the Phase 1 trial, cleared cohort 2 in April 2025 and currently dosing cohort 3.
● Expanded clinical footprint for the LNCB74 study with a total of 10 active trial sites.
● Plan to initiate backfill cohorts in the second half of 2025.
● Plan to provide a proof of concept data readout in the first half of 2026.

Preclinical Non-Oncology Programs Seeking Partnering

● Preclinical data for NC181 (ApoE4), a humanized antibody for the treatment of Alzheimer’s disease, has demonstrated amyloid clearance, prevention of amyloid deposition, plaque clearance and reduced neuroinflammation.
● Preclinical data for NC605 (Siglec-15), a humanized antibody for the treatment of osteogenesis Imperfecta (OI), has demonstrated that NC605 treatment reduced bone loss and enhanced bone quality in mice with OI.
● Both programs could lead to investigational new drug (IND) filings within 12 to 18 months if financial support from partners or third parties is secured.

Financial Results for Quarter Ended March 31, 2025

● Cash, cash equivalents, and marketable securities as of March 31, 2025 were $55.9 million as compared to $68.6 million as of December 31, 2024. The decrease of $12.8 million was primarily due to cash used to fund operations. We expect current financial resources to be sufficient to fund operating expenses and capital expenditures into the second half of 2026.
● Research and development expenses were $7.9 million for the three months ended March 31, 2025, as compared to $11.4 million for the three months ended March 31, 2024. The decrease of $3.5 million was due to lower costs related to programs other than LNCB74, lower preclinical development costs and lower personnel-related costs resulting from the restructuring and reduction-in-force announced during the first quarter of 2024 (the "2024 Restructuring").
● General and administrative expenses were $3.7 million for the three months ended March 31, 2025, as compared to $4.4 million for the three months ended March 31, 2024. The decrease of $0.6 million was primarily related to lower personnel costs and lower insurance costs resulting from the 2024 Restructuring.
● There were no restructuring and asset impairment costs for the three months ended March 31, 2025 as compared to $2.5 million for the three months ended March 31, 2024, which costs resulted from the 2024 Restructuring.
● Net loss was $11.0 million for the three months ended March 31, 2025, as compared to a net loss of $17.1 million for the three months ended March 31, 2024 due to lower costs as described above.

On May 1, 2025 Mythic Therapeutics, a clinical-stage biotechnology company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of a wide range of cancers, reported that updated dose escalation results from its Phase 1 KisMET-01 study evaluating its investigational cMET-targeting ADC, MYTX-011, in patients with previously treated, locally advanced or metastatic non-small cell lung cancer (NSCLC), will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Mythic Therapeutics, MAY 1, 2025, View Source;utm_medium=rss&utm_campaign=mythic-therapeutics-to-present-updated-dose-escalation-data-from-phase-1-kismet-01-study-on-mytx-011-at-the-2025-american-society-of-clinical-oncology-asco-annual-meeting [SID1234652449]).

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"We’re encouraged by the updated dose escalation results from the KisMET-01 study, which demonstrate the potential of MYTX-011 to offer a new therapeutic option for patients with advanced NSCLC," said George Eliades Ph.D., President and Chief Executive Officer at Mythic Therapeutics. "We’re excited to share these promising data with the oncology community at ASCO (Free ASCO Whitepaper) and to continue driving the development of MYTX-011 forward."

Details of the presentation are as follows:

Abstract Title: MYTX-011, a cMET-targeting antibody-drug conjugate (ADC), in patients with previously treated, advanced NSCLC: Updated dose escalation results in the phase 1 KisMET-01 study.
Presenter: Rebecca Heist, M.D., M.P.H., Medical Oncologist, Massachusetts General Hospital, Cancer Center
Format: Poster Session
Session Name: Lung Cancer – Non-Small Cell Metastatic
Session Date and Time: Saturday, May 31, 2025, at 1:30 – 4:30 PM CDT
Poster Board Number: 93
Abstract Number: 8613

About MYTX-011

MYTX-011, an investigational cMET-targeting ADC, leverages Mythic’s innovative FateControl technology which is designed to allow ADCs to actively navigate inside of cells, potentially increasing delivery of anti-cancer agents to tumor cells with less impact on healthy cells. This breakthrough approach takes the next step beyond linker-payload technologies and is designed to improve ADC efficacy against a broad set of molecular targets and patient profiles. MYTX-011 is currently being evaluated in the Phase 1 KisMET-01 clinical trial, a first-in-human, open-label, multi-center, dose escalation and dose expansion study enrolling patients with locally advanced, recurrent or metastatic NSCLC (NCT05652868).

On May 1, 2025 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that members of the Company’s management team will participate in the following investor conference this month (Press release, MacroGenics, MAY 1, 2025, View Source [SID1234652448]):

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The Citizens Life Sciences Conference (New York). Members of MacroGenics’ management team will participate in a fireside chat on Thursday, May 8, 2025, at 10:30am ET. Management will also participate in one-on-one meetings.

A webcast of the above presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain an archived replay of the webcast on its website for 30 days.

On May 1, 2025 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, reported that an abstract highlighting new clinical data from the Phase 1/2 trial of LYL314 (formerly IMPT-314) in large B-cell lymphoma will be presented as an oral presentation at the International Conference on Malignant Lymphoma (ICML) 2025 taking place in Lugano, Switzerland June 17-21, 2025 (Press release, Lyell Immunopharma, MAY 1, 2025, View Source [SID1234652447]).

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LYL314 is a dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate in development for patients with aggressive large B-cell lymphoma. LYL314 has received Regenerative Medicine Advanced Therapy and Fast Track designations from the U.S. Food and Drug Administration for the treatment of patients with relapsed and/or refractory diffuse large B-cell lymphoma in the 3rd or later line setting.

Details of the presentation are below:

LYL314, a CD19/CD20 CAR T-cell candidate enriched for CD62L+ stem-like cells, achieves high rates of durable complete responses in R/R large B-cell lymphoma

Session Name: Focus on New Cellular Therapies
Presentation Date & Time: June 18, 2025, 5:40 pm CEST (11:40 am ET)
Presenting Author: Akil Merchant, MD, Associate Professor and Co-Director of the Lymphoma Program at the Samuel Oschin Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA
Presentation Number: 106
Location: Room B