IMAB

Givastomig Trial Progress: I-Mab reported positive developments in the Phase 1b trial of givastomig, a novel therapy for first-line gastric cancer, with enrollment ahead of schedule and topline data expected in the second half of 2025.

Financial Position and Strategy: The company has a strong financial position with $173.4 million in cash as of December 31, 2024, allowing it to fund ongoing clinical trials and support its strategic shift towards U.S.-based operations after divesting its Greater China assets.

Analyst Downgrades: Citigroup downgraded Nordstrom and Eastman Chemical, while Baird cut price targets for BRP Inc., LCI Industries, and MasterCraft Boat Holdings, reflecting a generally negative outlook on these stocks.

Analyst Upgrades: Barclays upgraded ADT Inc. and Rosenblatt upgraded Coherent Corp., indicating some positive sentiment in the market despite the overall downgrades.

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I-Mab Participation in Conference: I-Mab, a US-based biotech company focused on precision immuno-oncology for cancer treatment, will participate in the 24th Annual Needham Virtual Healthcare Conference from April 7-10, 2025, with a presentation scheduled for April 7 at 8:45 AM ET.

Company Information: I-Mab operates in Rockville, Maryland, and Short Hills, New Jersey, and provides additional information through their website and social media platforms.

I-Mab's Nasdaq Compliance Issue: I-Mab received a notice from Nasdaq indicating it is not in compliance with the $1.00 minimum bid price requirement, but this does not affect its current listing or operations. The company has until September 15, 2025, to regain compliance by maintaining a bid price of at least $1.00 for ten consecutive business days.

Future Compliance Options: If I-Mab fails to meet the compliance requirements by the deadline, it may be eligible for an additional 180-day period to regain compliance or could face delisting from Nasdaq.

Nasdaq Compliance Notice: I-Mab received a notice from Nasdaq indicating non-compliance with the $1 minimum bid price requirement, with a deadline of September 15, 2025, to regain compliance.

Stock Performance Update: Following updates on its early-stage trial for gastric cancer therapy, I-Mab's stock experienced a 15% increase.

I-Mab's Trial Progress: I-Mab's ADRs rose approximately 11% after announcing faster-than-expected progress in its Phase 1b trial for the gastric cancer therapy, givastomig, which is being tested alongside Bristol Myers Squibb’s nivolumab and chemotherapy.

Enrollment Milestones: The company completed enrollments for the first dose expansion cohort ahead of schedule and is experiencing a similar recruitment rate for the second cohort, with initial results anticipated in H2 2025 and H1 2026.

I-Mab Presentation: I-Mab will present at the Oppenheimer's 35th Annual Healthcare Life Sciences Conference on February 11, 2025, at 4:00 PM ET.

Webcast Access: The live webcast can be accessed through a provided link.

Chairman's Intent to Invest: Wei Fu, Chairman of I-Mab, plans to purchase up to $2 million of the company's American Depository Shares (ADSs) in open market transactions, aiming to enhance shareholder value following a successful corporate strategy execution for 2024.

Clinical Program Updates: I-Mab is prioritizing its lead clinical program, givastomig, with data expected from ongoing studies in 2025 and 2026, while maintaining a cash runway that extends into 2027.

Givastomig Development: I-Mab is prioritizing the development of its lead clinical program, givastomig, a bispecific antibody targeting CLDN18.2 for first-line metastatic gastric cancers, with data from ongoing studies expected in 2025 and 2026.

Financial Position and Strategy: The company has a cash balance of $184.4 million, which is projected to support operations through 2027, while also pausing development on uliledlimab to focus resources on advancing givastomig.

Conference Announcement: The 36th Annual Healthcare Conference will take place in New York from December 3-5, 2024, with I-Mab's management presenting on December 4 at 4:30 p.m. ET.

Company Overview: I-Mab is a U.S.-based biotech company focused on developing immunotherapies for cancer treatment, with operations in Maryland and New Jersey.

Financial Performance: I-Mab reported its Q3 2024 earnings, highlighting a total cash position of $184.4 million and an increase in R&D expenses due to clinical trial costs, while also appointing Dr. Sean Fu as the permanent CEO.

Strategic Developments: The company is advancing its immunotherapy pipeline with upcoming phase 2 trials for uliledlimab and givastomig, alongside a collaboration with Sanofi, despite a net loss of $38.9 million for the nine-month period.

Pipeline Progress and Financial Overview: I-Mab reported encouraging monotherapy data for its cancer therapies, with plans to initiate a Phase 2 study of uliledlimab in first-line mNSCLC by mid-2025. The company has a strong cash position of $184.4 million, expected to fund operations into 2027.

Leadership Changes and Strategic Developments: Dr. Sean Fu has been appointed as the permanent CEO effective November 1, 2024, following his interim role since July 2024. Additionally, I-Mab has entered a collaboration agreement with Sanofi for uliledlimab's development in Greater China, potentially yielding significant milestone payments.

New CEO Appointment: I-Mab has appointed Dr. Sean Fu as its permanent Chief Executive Officer effective November 1, 2024, after serving as Interim CEO since July 2024. His leadership is expected to advance the company's mission in developing immunotherapies for cancer.

Dr. Fu's Background: Dr. Fu brings over 20 years of experience in the life sciences industry, having held various leadership roles and co-founding companies focused on innovative therapeutics, which positions him well to lead I-Mab towards achieving its clinical goals.

Financial Results Announcement: I-Mab plans to release its third quarter financial results for 2024 on November 14, 2024, but will not host a conference call for this announcement.

Future Investor Update: The company intends to hold an investor update call alongside its full-year financial results to discuss its clinical pipeline and corporate strategy.

Presentation at SITC 2024: I-Mab will present a poster on November 9, 2024, showcasing Phase 1 dose estimation data for givastomig, a novel bispecific antibody targeting Claudin18.2 and 4-1BB, at the Society for Immunotherapy of Cancer conference in Houston, Texas.

About Givastomig: Givastomig is designed to activate T cells in tumors expressing CLDN18.2 while minimizing systemic toxicity; it has received Orphan Drug Designation from the FDA for gastric cancer treatment and is currently being evaluated in combination with nivolumab and chemotherapy in ongoing studies.

I-Mab's Upcoming Investor Meetings: I-Mab, a US-based biotech company focused on cancer immunotherapies, will hold one-on-one and small group meetings with investors at the Truist Securities BioPharma Symposium on November 7, 2024.

Management Participation: Key management participants include Interim CEO Sean Fu, CFO Joe Skelton, CMO Phillip Dennis, and Senior Director of Investor Relations Tyler Ehler.

Givastomig Study Results: I-Mab's Phase 1 monotherapy study of givastomig, a bispecific antibody for gastric cancers, showed a 16.3% objective response rate with partial responses in seven out of 43 patients, and a disease control rate of 48.8%.

Safety and Pharmacokinetics: Givastomig was well tolerated at doses up to 18 mg/kg, with no dose-limiting toxicity observed, and demonstrated linear pharmacokinetics with a dose-dependent increase in soluble 4-1BB levels.

Clinical Trial Updates: I-Mab presented pharmacokinetic/pharmacodynamic modeling data for uliledlimab at the WCLC 2024, indicating a positive correlation between drug concentration and overall response rate in metastatic non-small cell lung cancer (mNSCLC) patients. A Phase 2 study combining uliledlimab with pembrolizumab and chemotherapy is expected to start in early 2025.

Drug Mechanism and Efficacy: Uliledlimab targets CD73 to enhance anti-tumor immunity by overcoming adenosine-induced immunosuppression. The data from three Phase 1 studies support its potential as a best-in-class CD73 inhibitor, showing effective dosing strategies and promising safety and efficacy profiles.