On April 30, 2025 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology focused medical technology business seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications, reported preliminary financial results for Q1 2025 and that it has entered into a securities purchase agreement with certain investors for shares of its common stock to raise approximately $22.0 million in gross proceeds (Press release, TriSalus Life Sciences, APR 30, 2025, View Source [SID1234652403]). Additionally, as further described below, the Company committed to commence an exchange offer with respect to its outstanding Series A Convertible Preferred Stock (the "Preferred Stock"), which is intended to simplify the Company’s capital structure.

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Preliminary Unaudited First Quarter 2025 Financial Results

Full financial results for the quarter ended March 31, 2025 are in the process of being finalized, however, initial and preliminary results show revenue, driven solely by the TriNav Infusion System, of approximately $9.2 million for the first quarter of 2025. This represents growth of approximately 42% versus the first quarter of 2024.

Private Placement

The private placement is being led by Nantahala Capital and includes investments by Broadfin Holdings and additional healthcare-focused institutional investors. Canaccord Genuity is acting as the sole placement agent for the private placement.

The Company will issue an aggregate of 5,500,000 shares of its common stock at a purchase price of $4.00 per share. The private placement is expected to close on or about May 2, 2025, subject to satisfaction of customary closing conditions. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock issued in the private placement and intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

Simplifying the Capital Structure

In connection with the private placement, TriSalus has entered into a Tender and Support Agreement with certain holders representing approximately 55% of outstanding shares of Preferred Stock. The Company has agreed to:

Launch a registered exchange offer pursuant to a registration statement on Form S-4 to be filed with the SEC to offer all preferred holders the opportunity to exchange their shares of Preferred Stock into a number of shares of common stock calculated based on a fixed value of $10.00 per share of Preferred Stock plus accrued dividends that would have accrued through August 10, 2027, divided by $4.00 per share; and
Convene a special meeting of stockholders to, among other things, vote on an amendment to the Certificate of Designations for the Preferred Stock that would (i) allow TriSalus to call and convert outstanding shares of Preferred Stock under specific terms and (ii) eliminate the conversion price reset provision currently scheduled for July 2027.
The Company expects to launch the exchange offer by the end of the second quarter of 2025 and to hold the special meeting in the third quarter of 2025. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

About Preliminary Financial Results

The preliminary results set forth above are unaudited, are based on management’s initial review of the Company’s results for the quarter ended March 31, 2025, and are subject to revision based upon the Company’s quarter-end closing procedures. Actual results may differ materially from these preliminary unaudited results following the completion of quarter-end closing procedures, final adjustments or other developments arising between now and the time that the Company’s financial results are finalized. In addition, these preliminary unaudited results are not a comprehensive statement of the Company’s financial results for the quarter ended March 31, 2025, should not be viewed as a substitute for full, unaudited financial statements for the quarter ended March 31, 2025, and are not necessarily indicative of the Company’s results for any future period.

On April 30, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported clinical data from the pivotal Phase 3 study of its lead product candidate, Bria-IMT, in metastatic breast cancer (BRIA-ABC; NCT06072612 ) supporting the use of specific biomarkers to predict patients’ clinical response to Bria-IMT treatments (Press release, BriaCell Therapeutics, APR 30, 2025, View Source [SID1234652434]).

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Biomarkers could be utilized to predict and provide better patient outcomes, including response rates and survival benefits with BriaCell’s novel Bria-IMT regimen.

"Using biomarkers as powerful instruments to predict patient responsiveness to the Bria-IMT treatment would allow physicians and oncologists to identify potential responders sooner, providing better clinical outcomes and ultimately extending patients’ lives," stated Carmen Calfa, MD, Clinical Research Lead for the breast site disease group at the University of Miami Miller School of Medicine, Co-Director of the Cancer Survivorship Program at Sylvester Comprehensive Cancer Center, and Principal Clinical Investigator of the Phase 2 Bria-IMT study.

"We are very pleased with our early Phase 3 biomarker data highlighting their importance as important tools in BriaCell’s fight against metastatic breast cancer, a difficult to treat and deadly disease," stated Dr. William V. Williams, BriaCell’s President & CEO.

"The clinical data reported today demonstrates the potential use of certain key biomarkers to predict MBC patients’ clinical response to the Bria-IMT regimen," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We will continue to evaluate these findings as we advance our goal of treating this serious disease."

The poster is summarized below and linked here: View Source .

Title: Bria-ABC [1] vs physician choice in late-stage MBC; early biomarker correlates of the randomized registration trial
Session Title: Late-Breaking Research: Clinical Research 4
Session Date and Time: 4/30/2025 9:00 AM – 12:00 PM CST
Location: Poster Section 49
Poster Board Number: 14
Abstract Presentation Number: LB408

Kaplan Meier analysis of early clinical data (n=62) in this multicenter study showed median progression free survival across all arms of 3.67 months. Prespecified subset analyses of PFS based on biomarker status were reported as follows:

Positive DTH was significantly related to better PFS (4.5 vs 2.5 months, p = 0.001)
Neutrophil-to-lymphocyte ratio (NLR) < 0.7 and ≥ 2.3 following the 1st treatment administration had significantly lower (p = 0.02) median progression-free survival (PFS)
Circulating tumor cells (CTCs) < 1 were significantly related to better PFS values (3.8 months vs 2.4 vs, p = 0.04)
Baseline Cancer-Associated Macrophage-Like Cells (CAML) count ≥ 5 trended toward a higher PFS value (3.7 vs 2.2 months, p = 0.10)
The Bria-IMT regimen remains well-tolerated, with generally manageable treatment-emergent adverse events (TEAEs). There have been no Bria-IMT related treatment discontinuations, underscoring Bria-IMT’s excellent tolerability and favorable safety profile.

About the Bria-ABC Study

The multicenter randomized open label study is evaluating overall survival with the Bria-IMT regimen in combination with checkpoint inhibitor, versus Treatment of Patients’/Physicians’ Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available. Fifty-seven clinical sites in the US are actively enrolling patients and additional sites are in various stages of start-up.

Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. BriaCell recently announced positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen . The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612 .

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]).

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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.

On April 30, 2025 Capstan Therapeutics, Inc. ("Capstan"), a biotechnology company dedicated to advancing in vivo reprogramming of cells through RNA delivery using targeted lipid nanoparticles (tLNP), reported that the Company will present at upcoming scientific conferences and showcase new preclinical data on CPTX2309, Capstan’s lead anti-CD19 in vivo CAR-T candidate, at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 28th Annual Meeting in New Orleans, LA (Press release, Capstan Therapeutics, APR 30, 2025, View Source [SID1234652404]).

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"Among the diverse set of presentations showcasing Capstan’s non-viral CellSeeker platform, we are particularly encouraged by new preclinical data in support of our in vivo anti-CD19 CAR-T program, which demonstrate that a compact two-dose cycle was sufficient to induce rapid and deep B cell depletion in blood and tissues of non-human primates," said Adrian Bot, M.D., Ph.D., Chief Scientific Officer and Executive Vice President of R&D at Capstan. "These preclinical data highlight the potency of B cell depletion achievable with a transient in vivo CAR mRNA approach, without the need for lymphodepletion, and set the stage for clinical evaluation of CPTX2309."

Featured Presentation:

American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 28th Annual Meeting
Date: May 13-17, 2025
Location: New Orleans, LA

Oral presentation title: A Two-Infusion Regimen with a Novel In Vivo Non-Viral Chimeric Antigen Receptor (CAR) Achieves up to 90% CD8+ T Cell Engineering and Tissue Depletion of Target Cells in Non-Human Primates (NHPs)
Presenter: Haig Aghajanian, Ph.D., Vice President of Research, Co-founder
Session title: CAR T Innovations in Autoimmune and Infectious Disease and Allergy
Date and time: May 15, 2025, 5:00 p.m. – 5:15 p.m. CT
Location: Room 393-396

Additional Presentations feature progress with our CellSeekerTM platform technology applicable to both mRNA and gene editing payloads:

Cellicon Valley ’25: The Future of Cell and Gene Therapies
Date: Apr 30-May 2, 2025
Location: Philadelphia, PA

Oral Presentation Title: Leading the Charge for In Vivo Cell Therapy for The Treatment of Autoimmune Disorders
Presenter: Laura Shawver, Ph.D., Chief Executive Officer
Session title: Plenary Session 2, Leadership in Cell and Gene Therapies: The XX Factor
Date and Time: May 1, 2025, 10:20 a.m. – 10:30 a.m. ET

International Society of Cell & Gene Therapy (ISCT) 2025
Date: May 7-10, 2025
Location: New Orleans, LA

Poster title: Design and Preclinical Development of a Novel In Vivo Chimeric Antigen Receptor (CAR) Product for B-Cell Involved Diseases
Presenter: Haig Aghajanian, Ph.D., Vice President of Research, Co-founder
Poster number: 901
Session title: Poster Networking Reception 1; Immunotherapy (CAR-T, T Reg, NK Cells, etc.)
Date and time: May 7, 2025, 7:00 p.m. – 8.30 p.m. CT

21st Annual PEGS Boston: The Essential Protein & Antibody Engineering Summit
Date: May 12-16, 2025
Location: Omni Boston Hotel at the Seaport, Boston, MA

Title: Chairperson’s Remarks
Presenter: Adrian Bot, M.D., Ph.D., Chief Scientific Officer
Track: In Vivo CAR T Engineering: Moving into the Clinic
Date and time: May 15, 2025, 8:25 a.m. ET

Oral presentation title: In vivo mRNA-Based CAR T Cell Engineering for Treatment of B Cell Disorders
Presenter: John Rossi, Vice President, Translational Medicine
Track: In Vivo CAR T Engineering: Moving into the Clinic
Date and time: May 15, 2025, 9:00 a.m. ET

American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 28th Annual Meeting
Date: May 13-17, 2025
Location: New Orleans, LA

Science Symposium: Targeted Nanosystems For Gene Transfer And Editing: Beyond Delivery To The Liver
Oral presentation title: In vivo immune cell engineering using targeted nanoparticles
Presenter: Priya Karmali, Ph.D., Chief Technology Officer
Date and time: May 16, 2025, 4:10 p.m. – 4:35 p.m. CT
Location: NOLA Theater B

Poster: Efficient In Vivo Gene Editing of T Cells Utilizing Novel Targeted Lipid Nanoparticles
Presenter: Esther Chen, Ph.D., Principal Scientist, R&D
Session title: Tuesday Poster Reception
Date and time: May 13, 2025, 6:00 p.m. – 7:30 p.m. CT
Location: Poster Hall I2

Poster: Effective Gene Editing in Hematopoietic Stem and Progenitor Cells (HSPCs) through a Novel Targeted Lipid Nanoparticle
Presenter: Esther Chen, Ph.D., Principal Scientist, R&D
Session title: Thursday Poster Reception
Date and time: May 15, 2025, 5:30 p.m. – 7:00 p.m. CT
Location: Poster Hall I2

TIDES USA
Date: May 19-22, 2025
Location: Manchester Grand Hyatt San Diego, San Diego, CA

Oral presentation title: In Vivo Engineering of Cells Using Targeted Lipid Nanoparticles
Presenter: Priya Karmali, Ph.D., Chief Technology Officer
Track: mRNA Technology and Applications
Date and time: May 21, 2025, 2:00 p.m. PT

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]).

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"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.