On April 30, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported that Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, will present at the Citizens Life Sciences Conference taking place in New York City on Wednesday, May 7, 2025 beginning at 3:30 p.m. Eastern Time (Press release, Quince Therapeutics, APR 30, 2025, View Source [SID1234652391]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be accessible on the Events page under the News & Events heading of Quince’s Investor Relations website at ir.quincetx.com. An archive of the webcast will be available shortly following the end of the live event.

On April 30, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanoparticle-based therapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported the presentation of full results from the completed dose escalation and dose expansion parts of a Phase 1 study evaluating JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer (Press release, Nanobiotix, APR 30, 2025, View Source [SID1234652390]). The study, conducted by The University of Texas MD Anderson Cancer Center, will be presented by principal investigator Dr. Eugene Koay on Sunday, May 4th at 11:00 AM EDT / 5:00 PM CEST during the 2025 Annual Meeting of the European Society for Radiotherapy and Oncology (ESTRO 2025).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PRESENTATION #E25-2265: NANORAY Pancreas: A Phase 1 Study of NBTXR3 (JNJ-1900) Activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Cancer (LAPC or BRPC)
Koay EJ, Liu S, Guerrero P, Stokes E, Katz MHG, Ikoma N, Snyder RA, Tzeng CD, Overman MJ, Pant S, Wolff RA, Javle M, Holliday EB, Ludmir EB, Das P, Noticewala S, Koong AC, Tamm EP, Bhutani M

Nanobiotix ConferenceCall

Nanobiotix will host a conference call and webcast featuring Nanobiotix chief executive officer and chairman of the executive board, Laurent Levy, to discuss the data on Monday May 5th, 2025, at 8:00 AM EDT / 2:00 PM CEST.

Details for the call are as follows:

Webcast link: click here

Audio-only dial-in link: click here

Participants can use the audio-only link above to register and obtain dial-in instructions to listen to the presentation via phone and ask questions during the Q&A session, or participants can use the webcast link to register and listen and watch the slide presentation online; the replay version will be available under the same webcast link shortly after the presentation and will be archived on the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior to the event start. Participants are invited to email their questions in advance to [email protected].

About JNJ-1900 (NBTXR3)

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson company.

On April 30, 2025 Mabqi reported that Sylvain Yon, CEO, will be attending BioEquity Europe 2025, Europe’s leading international event connecting biopharma leaders and financial dealmakers with emerging biotech innovators (Press release, Mabqi, APR 30, 2025, View Source [SID1234652389]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The event will take place from May 12 to 14, 2025, at the Bruges Meeting & Convention Center (BMCC) in Belgium, followed by two days of virtual partnering on May 20 and 21, 2025.

During this key industry meeting, Mabqi will showcase the latest preclinical results of lead candidate MQI-201 and growing portfolio of first-in-class and best-in-class proprietary functional antibodies, including pH-sensitive antibodies and antibody-drug conjugates (ADCs) with strong therapeutic potential in oncology.

"BioEquity Europe offers a unique platform to highlight our innovation, engage with potential partners, and enhance Mabqi’s visibility within the global biotech and investor community."

On April 30, 2025 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported that an abstract for a combination study of givastomig plus nivolumab and chemotherapy has been accepted for a mini-oral presentation at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025, which will be held July 2-5 in Barcelona, Spain (Press release, I-Mab Biopharma, APR 30, 2025, View Source [SID1234652388]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very pleased to receive confirmation that new clinical data for givastomig has been accepted as an oral presentation at the upcoming ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025. As more information becomes available from the conference, we look forward to providing further details about the presentation," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab.

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 ("CLDN18.2")-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line ("1L") metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential combined effect of proximal interaction between CLDN18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents.

The Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment is progressing well in the second dose expansion cohort (n=20). The study builds on positive Phase 1 monotherapy data.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

On April 30, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today reported financial results for the quarter ended March 31, 2025 (Press release, Guardant Health, APR 30, 2025, View Source [SID1234652387]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

First Quarter 2025 Financial Highlights

For the three-month period ended March 31, 2025, as compared to the same period of 2024:
•Reported total revenue of $203.5 million, an increase of 21%, driven by:
◦Oncology revenue of $150.6 million, an increase of 20%, and approximately 59,000 oncology tests, an increase of 25%
◦Screening revenue of $5.7 million, and approximately 9,000 Shield screening tests
◦Biopharma & Data revenue of $45.4 million, an increase of 21%
•Increased Guardant360 ASP to a new range of $3,000 to $3,100 per test
•Achieved positive gross margins for both Guardant Reveal and Shield

Recent Operating Highlights

•Received ADLT status from CMS for Shield, increasing the Medicare pricing to $1,495
•Received first Shield payor coverage for average-risk individuals age 45 and older from the VA Community Care Network, representing over 9 million beneficiaries
•Presented Shield multi-cancer data across ten cancer types at AACR (Free AACR Whitepaper) 2025, demonstrating 60% overall sensitivity, 98.5% specificity, and 89% accuracy for cancer site of origin prediction
•Launched upgraded Guardant360 Tissue, representing the first broad multiomic tissue CGP test to incorporate DNA, RNA, AI-powered PD-L1, and genome-wide methylation
•Announced a multi-year global collaboration with Pfizer to support development and commercialization of new cancer therapies utilizing the Infinity smart liquid biopsy platform
•Announced first publication of Reveal breast cancer data in Clinical Cancer Research demonstrating 83% sensitivity and 99.5% specificity for triple-negative breast cancer patients
"We started the year with very strong momentum across our portfolio, fueled by ground-breaking product upgrades and new tests introduced in 2024 which leverage our smart liquid biopsy platform," said Helmy Eltoukhy, co-founder and co-CEO. "Earlier this week, we were excited to launch our upgraded Guardant360 Tissue, a first-of-its-kind multiomic CGP product with expanded genomic and epigenomic breadth that complements our industry-leading Guardant360 liquid products. We are also very pleased to achieve positive gross margins for both Reveal and Shield in the first quarter due to significant reductions in testing costs."
"We were pleased by the robust traction for Shield during the first quarter and are excited by the positive impact we are having on patient lives," said AmirAli Talasaz, co-founder and co-CEO. "We meaningfully raised our full year screening revenue guidance given our increased expectations for both salesforce productivity and ASP now that Shield has received ADLT status. In addition, we were excited to share strong data for Shield multi-cancer in partnership with the National Cancer Institute, which we believe establishes Guardant as a leader in the field of multi-cancer detection."

First Quarter 2025 Financial Results

Revenue was $203.5 million for the first quarter of 2025, a 21% increase from $168.5 million for the corresponding prior year period. Oncology revenue grew 20% to $150.6 million for the first quarter of 2025, from $125.7 million for the corresponding prior year period, driven primarily by an increase in oncology test volume, which grew 25% over the prior year period. The increase in oncology revenue was also attributable to an increase in reimbursement for our Guardant360 and Reveal tests, partially offset by a reduction in revenue related to performance obligations satisfied in prior periods. Screening revenue was $5.7 million for the first quarter of 2025, generated from approximately 9,000 Shield screening tests. Biopharma and data revenue grew 21% to $45.4 million for the first quarter of 2025, from $37.6 million for the corresponding prior year period, driven primarily by an increase in tests performed for biopharmaceutical customers. Licensing and other revenue was $1.9 million for the first quarter of 2025, compared to $5.2 million for the corresponding prior year period.

Gross profit, or total revenue less cost of revenue, was $128.7 million for the first quarter of 2025, an increase of $25.6 million from $103.2 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 63%, as compared to 61% for the corresponding prior year period.
Non-GAAP gross profit was $131.3 million for the first quarter of 2025, an increase of $26.0 million, from $105.3 million for the corresponding prior year period. Non-GAAP gross margin was 65% for the first quarter of 2025, as compared to 63% for the corresponding prior year period.
Operating expenses were $239.8 million for the first quarter of 2025, as compared to $202.9 million for the corresponding prior year period. The year-over-year increase in operating expenses was primarily related to commercial team expansion and marketing activities to support existing products and the Shield product launch, as well as an increase in stock-based compensation expense. Non-GAAP operating expenses were $199.6 million for the first quarter of 2025, as compared to $176.5 million for the corresponding prior year period. The year-over-year increase in non-GAAP operating expenses was primarily related to commercial team expansion and marketing activities to support existing products and the Shield product launch.
Net loss was $95.2 million for the first quarter of 2025, as compared to $115.0 million for the corresponding prior year period. Net loss per share was $0.77 for the first quarter of 2025, as compared to $0.94 for the corresponding prior year period.
Non-GAAP net loss was $61.1 million for the first quarter of 2025, as compared to $56.4 million for the corresponding prior year period. Non-GAAP net loss per share was $0.49 for the first quarter of 2025, as compared to $0.46 for the corresponding prior year period.
Adjusted EBITDA loss was $58.5 million for the first quarter of 2025, as compared to a $61.1 million loss for the corresponding prior year period.
Free cash flow for the first quarter of 2025 was $(67.1) million, as compared to $(37.2) million for the corresponding prior year period. The year-over-year difference was due to a change in timing of the payout of the company’s annual bonus, which was made in the first quarter of 2025 and in the second quarter of 2024.
Cash, cash equivalents, and restricted cash were $803.9 million as of March 31, 2025.
2025 Guidance
Guardant Health now expects full year 2025 revenue to be in the range of $880 to $890 million, representing growth of 19% to 20% compared to full year 2024. This compares to the prior range of $850 to $860 million, representing growth of 15% to 16%.
Within this revenue range:
•Oncology revenue is now expected to grow approximately 18% year over year in 2025, compared to prior guidance of approximately 15% year over year growth. Oncology volume is now expected to accelerate to greater than 25% growth in 2025 compared to 20% growth in 2024.
•Screening revenue is now expected to be in the range of $40 to $45 million, driven by Shield volume of 52,000 to 58,000 tests. This compares to the prior range of $25 to $30 million, driven by Shield volume of 45,000 to 50,000 tests.
•Guardant Health continues to expect biopharma & data revenue growth to be in the low double-digit range.
Guardant Health continues to expect full year 2025 non-GAAP gross margin to be in the range of 62% to 63%, compared to 62% in 2024. Guardant Health now expects total non-GAAP operating expenses to be in the range of $830 to $840 million, an increase compared to the prior range of $815 to $825 million due to the reinvestment of incremental Screening gross profit to accelerate the Screening commercial infrastructure build out. Guardant Health continues to expect free cash flow burn to be in the range of $225 to $235 million, an improvement compared to $275 million for the full year 2024. This includes approximately $200 million of screening net cash burn. Guardant Health continues to expect the remainder of the business excluding screening to reach free cash flow breakeven in the fourth quarter of 2025.
Webcast Information
Guardant Health will host a conference call to discuss the first quarter 2025 financial results after market close on Wednesday, April 30, 2025 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.