On August 28, 2024 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer, reported financial results for the three and six months ended June 30, 2024, and highlighted recent pipeline progress and business updates (Press release, I-Mab Biopharma, AUG 28, 2024, View Source [SID1234646158]).
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!
"I-Mab is delivering on its strategic plan, as demonstrated by our corporate development and pipeline progress in 2024, said Sean Fu, PhD, interim CEO and Board Member of I-Mab. "I am very pleased to report that we are executing on our Board’s vision by establishing a new operating model as a U.S.-based global biotech company and completing the divestiture of our operations in China, streamlining the organization, transitioning to U.S.-based auditors, and building out a U.S.-based leadership team with the additions of Phillip Dennis, MD, PhD, a renowned lung cancer expert, as Chief Medical Officer, and Joseph Skelton, an experienced investment banker, as Chief Financial Officer."
Dr. Fu continued, "In addition, we have significantly advanced our three oncology programs, with an IND clearance for uliledlimab, a new clinical collaboration with Bristol Myers Squibb for givastomig, and the presentation of promising early clinical results at the American Society for Clinical Oncology ("ASCO") Annual Meeting 2024 for ragistomig. We are excited about our differentiated pipeline and its potential to achieve clinical milestones over the next year, driven by ongoing and potential future clinical studies. In addition, we are actively evaluating strategic in-licensing opportunities to further strengthen our innovative pipeline."
Pipeline Overview and Potential Upcoming Milestones:
Uliledlimab (CD73 antibody)
Phase 2 combination studies, focused on first-line metastatic non-small cell lung cancer ("mNSCLC")
Uliledlimab (TJ004309) is an antibody designed to target CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. Blocking CD73 allows anti-tumor immunity to proceed without the presence of an adenosine-induced "immunological fog". I-Mab owns worldwide rights for uliledlimab, excluding China.
A previous single-arm Phase 2 study evaluating the combination of uliledlimab with toripalimab (results were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting 2023) in patients with mNSCLC and showed that treatment with uliledlimab produced an overall response rate ("ORR") of 63% in patients with high CD73 expression and PD-L1 TPS≥1%.
Uliledlimab is also being evaluated in an ongoing, randomized Phase 2 study conducted by I-Mab’s collaborator, TJ Biopharma, comparing uliledlimab plus toripalimab to pembrolizumab alone and toripalimab alone. The primary endpoint is progression free survival ("PFS"), and data are expected in the 2H 2025.
To extend development in first-line mNSCLC, I-Mab has received IND clearance to proceed with a randomized Phase 2 study testing multiple doses of uliledlimab plus pembrolizumab/chemotherapy vs. pembrolizumab/chemotherapy alone. Patient enrollment is expected to begin in the 1H 2025.
Givastomig (Claudin 18.2 x 4-1BB bispecific antibody)
Ongoing Phase 1b dose expansion and combination studies, focused on first-line metastatic gastric cancer
Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2-positive tumor cells that conditionally activates T cells via 4-1BB in the tumor microenvironment where Claudin 18.2 is expressed. This program is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding China and South Korea, equally with ABL Bio.
Phase 1 monotherapy data presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) ("ESMO") Congress 2023 showed encouraging objective responses in patients with metastatic gastric cancer whose tumors progressed or recurred after prior standard treatments, including those with low levels of Claudin 18.2 expression.
As part of the ongoing Phase 1b trial, the Company entered into a clinical collaboration and supply agreement with Bristol Myers Squibb to evaluate givastomig in combination with nivolumab and chemotherapy as a potential first-line treatment for patients with advanced Claudin 18.2-positive metastatic gastric cancer. The study’s primary endpoint is safety, with secondary endpoints including ORR, and data are expected in the 2H 2025.
Updated clinical data from the dose expansion portion of the Phase 1 monotherapy study of givastomig will be presented at the ESMO (Free ESMO Whitepaper) Congress 2024.
Ragistomig (PD-L1 x 4-1BB bispecific antibody)
Ongoing Phase 1 dose escalation and dose expansion in advanced solid tumors
Ragistomig (TJ-L14B / ABL503) is a bispecific antibody designed to provide anti-PD-L1 activity and 4-1BB-driven T cell activation in one molecule. The combination of an Fc-silent antibody with conditional 4-1BB engagement is intended to produce safety benefits, including the potential for lower hepatotoxicity compared to traditional 4-1BB agonists. This program is being jointly developed through a global partnership with ABL Bio, in which ABL Bio is the lead party and shares worldwide rights, excluding China and South Korea, equally with I-Mab.
Early observations reported by I-Mab’s development partner, ABL Bio, at ASCO (Free ASCO Whitepaper) 2024 showed promising objective responses in patients with various solid tumors whose tumors progressed or recurred after prior standard treatments, including in patients with relapsed or refractory cancer after prior PD-L1 inhibitors. These early efficacy results are encouraging, and enrollment in the Phase 1 study is ongoing in selected indications within the PD-L1 positive tumor expansion portion of the study.
•
Top-line Phase 1 dose escalation and dose expansion results demonstrated an ORR of 26.9% (7/26), including six partial responses (PR) and one complete response (CR), and a clinical benefit ratio (CBR) of 69.2% (18/26) at doses of 3 mg/kg and 5 mg/kg.
Significant Strategic Progress and Corporate Development
•
The agreement to divest assets and business operations in China was completed on April 2, 2024. The Company transferred 100% of the outstanding equity interest in I-Mab Biopharma Co., Ltd ("I-Mab Shanghai") to I-Mab Biopharma (Hangzhou) Co., Ltd (now known as "Tianjing Biopharma" or "TJ Biopharma"), on a cash-free and debt-free basis, for an aggregate consideration of the RMB equivalent of up to $80 million, contingent on TJ Biopharma’s achievement of certain future regulatory and sales-based milestone events. Concurrently, in exchange for the transfer of equity interest of TJ Biopharma, repurchase obligations owed by I-Mab Biopharma Hong Kong Limited ("I-Mab Hong Kong") in the amount of approximately $183 million were extinguished. In addition, the Company participated in a Series C fundraising of TJ Biopharma for an equity investment of $19 million.
•
As previously disclosed, certain non-participating shareholders of TJ Biopharma commenced arbitration against I-Mab Hong Kong, and as a result, the RMB equivalent of $17.5 million was placed into court escrow for future redemption obligation settlements which were subsequently settled. The approximately $15 million of remaining redemption obligations to non-participating shareholders are expected to be settled in September 2024. As of June 30, 2024, the fair value of the put right liabilities was $2.0 million and classified as a current liability and represents management’s best estimate of the timing of redemption requests as of that date, compared with a $13.8 million and non-current liability as of December 31, 2023. The $11.8 million change in fair value was recorded as a non-cash item within other income (expenses), net.
•
The Company has been engaged in ongoing litigation related to I-Mab’s trade secret claims against Inhibrx, Inc. ("Inhibrx") and Dr. Brendan Eckelman for misappropriation when Dr. Eckelman served as an expert witness for Tracon Pharmaceuticals, Inc. I-Mab is seeking damages in the form of a reasonable royalty, along with exemplary damages for Inhibrx’s and Dr. Eckelman’s willful and malicious misappropriation of I-Mab’s trade secrets. The trial is currently scheduled to commence at the end of October 2024.
•
The Audit Committee of the Company’s Board of Directors approved the change in independent registered public accountants from PricewaterhouseCoopers Zhong Tian LLP ("PwC China") to PricewaterhouseCoopers LLP ("PwC US") for the fiscal year ending December 31, 2024.
First-Half 2024 Financial Results
Cash Position
As of June 30, 2024, the Company had cash and cash equivalents, and short-term investments of $207.5 million, compared to $311.0 million as of December 31, 2023. There was $10.8 million of cash classified as discontinued operations as of December 31, 2023. The decrease of $103.5 million in cash and cash equivalents, and short-term investments included $49.4 million in one-time outflows associated with the divestiture of the Company’s China operations.
Share Buyback and Shares Outstanding
In August 2023, the Company’s Board of Directors authorized a share repurchase program under which the Company may repurchase up to $40 million of American Depository Shares ("ADSs"), each 10 ADSs representing 23 ordinary shares of the Company, over a 12-month period. During the six months ended June 30, 2024, the Company repurchased $0.3 million of its ADSs, equating to 179,656 ADSs or 413,209 ordinary shares. As of June 30, 2024, the Company had issued and outstanding 187,299,764 ordinary shares, representing the equivalent of 81,434,680 ADSs, assuming the conversion of all ordinary shares into ADSs. Approximately $5.2 million worth of ADSs were repurchased under the share repurchase program, which was in effect from August 15, 2023 through August 14, 2024. The Company’s Board of Directors does not plan to renew the stock repurchase program.
Net Revenues
The Company did not generate revenue during the three and six months ended June 30, 2024, compared to $0.2 million and $0.3 million for the three and six months ended June 30, 2023, respectively. Total net revenues for the 2023 periods consisted of revenues recognized in connection with the collaboration with AbbVie Inc. ("AbbVie"), which was terminated in the fourth quarter of 2023. The Company does not anticipate any revenue for the remainder of 2024.
Research & Development Expenses
Research and development ("R&D") expenses were $3.1 million and $10.8 million for the three and six months ended June 30, 2024, respectively, compared to $4.3 million and $9.0 million for the three and six months ended June 30, 2023, respectively. R&D costs for the three-months ended June 30, 2024 were $1.2 million lower than the comparable period in 2023, primarily due to decreased share-based compensation expense. R&D costs for the six months ended June 30, 2024 were $1.8 million higher than the comparable period in 2023, driven by higher clinical trial costs associated with the preparation of enrollment for the uliledlimab Phase 2 combination study and ongoing givastomig Phase 1b dose expansion study. These higher costs were partially offset by decreased share-based compensation expense.
Administrative Expenses
Administrative expenses were $11.9 million and $14.3 million for the three and six months ended June 30, 2024, respectively, compared to $7.9 million and $14.0 million for the three and six months ended June 30, 2023, respectively. The increase of $4.0 million and $0.3 million for the three and six months ended June 30, 2024, respectively, was primarily due to higher legal fees associated with the ongoing Inhibrx litigation and higher costs associated with establishing a new operating model to become a U.S.-based global biotech company. These increases were partially offset by lower employee compensation costs.
Interest Income
Interest income was $1.9 million and $2.8 million for the three and six months ended June 30, 2024, respectively, compared to $2.9 million and $4.5 million for the three and six months ended June 30, 2023, respectively. The $1.0 million and $1.7 million decreases for the three and six months ended June 30, 2024, compared to the same periods in 2023, respectively, were primarily driven by decreases in short-term investments.
Other Income (Expenses), Net
Other income (expenses), net were $6.3 million and $5.5 million for the three and six months ended June 30, 2024, respectively, compared to ($16.4) million and ($11.5) million for the three and six months ended June 30, 2023, respectively. The $22.7 million and $17.0 million decreases in expense for the three and six months ended June 30, 2024, respectively, were primarily driven by smaller impacts from foreign exchange losses and other income recognized from the change in the fair value of the put right liability, partially offset by fixed asset impairments.
Equity in Loss of Affiliates
Prior to the China divestiture, I-Mab’s equity method investee, I-Mab Hangzhou incurred significant losses in prior periods and was written down to zero at December 31, 2023. Accordingly, the losses incurred during 2024 relate to share-based compensation expense associated with prior period grants awarded to its employees. Equity in loss of affiliates was $0.0 million and $1.0 million for the three and six months ended June 30, 2024, respectively, compared to $2.0 million and $8.2 million for the three and six months ended June 30, 2023, respectively. The $2.0 million decrease for the three months ended June 30, 2024 was primarily driven by losses recognized in the prior period related to share-based compensation expenses. The $7.2 million decrease for the six months ended June 30, 2024 was driven by a $3.5 million decrease in losses recognized in relation to the operating performance of I-Mab Hangzhou, and a $3.7 million decrease in share-based compensation expenses.
Net Loss from Continuing Operations
Net loss from continuing operations was $6.8 million and $17.8 million for the three and six months ended June 30, 2024, respectively, compared to $27.6 million and $37.9 million for the three and six months ended June 30, 2023, respectively. Net loss from continuing operations per share attributable to ordinary shareholders was ($0.04) and ($0.10) for the three and six months ended June 30, 2024, respectively, compared to ($0.14) and ($0.20) for the three and six months ended June 30, 2023, respectively. Net loss from continuing operations per ADS attributable to ordinary shareholders was ($0.09) and ($0.23), for the three and six months ended June 30, 2024, respectively, compared to ($0.33) and ($0.46) for the three and six months ended June 30, 2023, respectively.
Discontinued Operations
On April 2, 2024, the Company met all conditions precedent to the China divestiture announced on February 7, 2024 (the "Transaction"), successfully closing the Transaction as of that date. The Company determined that the Transaction represented a strategic shift that had a major effect on the business and therefore, met the criteria for classification as discontinued operations at June 30, 2024. Accordingly, the transfer of 100% of the outstanding equity interest in I-Mab Shanghai, and the carrying value of intellectual property and research and development, assets associated with China business operations are reported as discontinued operations in accordance with ASC 205-20, Discontinued Operations. Amounts applicable to prior years have been recast to conform to the discontinued operations presentation. The Company recognized a gain on the Transaction in the amount of $31.9 million for the three and six months ended June 30, 2024, and a loss from operations of the discontinued component of $0.0 million and $6.8 million for the three and six months ended June 30, 2024, respectively.
Non-GAAP Net Loss from Continuing Operations
Non-GAAP adjusted net loss from continuing operations, which excludes share-based compensation expenses from continuing operations, was ($5.7) million and ($21.6) million, for the three and six months ended June 30, 2024, respectively, compared to ($23.6) million and ($30.8) million for the three and six months ended June 30, 2023, respectively. Non-GAAP adjusted net loss from continuing operations per share attributable to ordinary shareholders was ($0.03) and ($0.12) for the three and six months ended June 30, 2024, respectively, compared to ($0.12) and ($0.16) for the three and six months ended June 30, 2023, respectively. Non-GAAP adjusted net loss from continuing operations per ADS attributable to ordinary shareholders was $(0.07) and ($0.28) for the three and six months ended June 30, 2024, respectively, compared to ($0.28) and ($0.37) for the three and six months ended June 30, 2023, respectively.
Conference Call and Webcast Information
Investors and analysts are invited to join the conference call at 8:00 AM ET on August 28, 2024, via:
•
Domestic Dial-in: 1-877-407-0784
•
International Dial-in: 1-201-689-8560
•
Conference ID: 13747695
A webcast of the call will also be available on the I-Mab website, on the Upcoming Events section of the Investor Relations page, available by visiting View Source A replay of the call will be accessible under the Past Events section of the Investor Relations page and will be archived for 6 months.