UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2024
Commission File Number: 001-39173
I-MAB
(Translation of registrant’s name into English)
2440 Research Boulevard, Suite 400
Rockville, MD 20850
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
EXPLANATORY NOTE
I-Mab (the “Registrant”) is filing this Form 6-K to furnish a press release issued on August 28, 2024 announcing is financial results as of and for the three and six months ended, June 30, 2024, which is furnished herewith as Exhibit 99.1, and to furnish an Earnings Presentation with respect to such financial results, which is furnished herewith as Exhibit 99.2. In addition, the Registrant is updating its Investor Presentation, as set forth in Exhibit 99.3 to this Form 6-K.
Exhibit 99.1 to this Report on Form 6-K shall be deemed to be incorporated by reference into the Registrant’s Registration Statements on Form S-8 (File No. 333-239871, File No. 333-256603, File No. 333-265684 and File No. 333-279842) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
Exhibit No. |
Description |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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I-MAB |
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By |
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/s/ Joseph Skelton |
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Name |
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Joseph Skelton |
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Title |
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Chief Financial Officer |
Date: August 28, 2024
Exhibit 99.1
I-Mab Reports 1H 2024
Financial Results, Pipeline Progress, and Business Updates
ROCKVILLE, MD, 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, today announced financial results for the three and six months ended June 30, 2024, and highlighted recent pipeline progress and business updates.
“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 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”) 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 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 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.
Significant Strategic Progress and Corporate Development
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:
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 https://ir.i-mabbiopharma.com/news-events/event-calendar. 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.
About I-Mab
I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer. I-Mab has established operations in the U.S. in Rockville, Maryland. For more information, please visit https://www.i-mabbiopharma.com and follow us on LinkedIn and X.
Use of Non-GAAP Financial Measures
To supplement its consolidated financial statements, which are presented in accordance with U.S. GAAP, the Company uses Non-GAAP adjusted net loss from continuing operations, Non-GAAP adjusted net loss from continuing operations per share attributable to ordinary shareholders and Non-GAAP adjusted net loss from continuing operations per ADS attributable to ordinary shareholders as a non-GAAP financial measure. Non-GAAP adjusted net loss from continuing operations represents net loss from continuing operations before share-based compensation from continuing operations. Non-GAAP adjusted net loss from continuing operations per share attributable to ordinary shareholders and Non-GAAP adjusted net loss from continuing operations per ADS attributable to ordinary shareholders represents net loss from continuing operations per share attributable to ordinary shareholders and per ADS attributable to ordinary shareholders before share-based compensation from continuing operations. The Company's management believes that these non-GAAP measures facilitate understanding of operating results and provides management with a better capability to plan and forecast future periods. For more information on the non-GAAP financial measures, please see the table captioned "Reconciliation of GAAP and Non-GAAP Results" set forth at the end of this press release.
Non-GAAP information is not prepared in accordance with GAAP and may be different from non-GAAP methods of accounting and reporting used by other companies. The presentation of this additional information should not be considered a substitute for GAAP results. A limitation of using adjusted net loss and related per share measures is that adjusted net loss excludes share-based compensation expense that has been and may continue to be incurred in the future. In order to compensate for these limitations, management presents adjusted net loss together with GAAP results.
Exchange Rate Information
Effective April 2, 2024, the Company changed its reporting currency from RMB to USD. The change was made to align the reporting currency with the underlying operations of the Company as the majority of the Company's revenue, expenses, assets, liabilities and shareholders' equity are now denominated in the U.S. dollar. The Company believes that this change will better illustrate its results of operations for each fiscal period. The Company applied the change of reporting currency retrospectively to its historical results of operations and financial statements. All prior periods' comparative financial information have been restated as if the Company has always used the U.S. dollar as its reporting currency.
I-Mab Forward Looking Statements
This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company’s pipeline and capital strategy, including the Company's stock repurchase program; the projected advancement of the Company’s portfolio and anticipated milestones and related timing; the market opportunity and I-Mab’s potential next steps (including the potential expansion, differentiation, or commercialization) for uliledlimab, givastomig and ragistomig; the Company’s expectations regarding the impact of data from ongoing and future clinical trials; the Company's financial condition and results of operations and anticipated changes in the Company’s revenues or expenses; the Company’s expectations regarding its cash runway; timing and progress of studies and trials (including with respect to patient enrollment); and the availability of data and information from ongoing studies and trials. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab’s drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab’s reliance on third parties to conduct drug development, manufacturing and other services; and I-Mab’s limited operating history and I-Mab’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the “Risk Factors” section in I-Mab’s most recent annual report on Form 20-F, as well as discussions of
potential risks, uncertainties, and other important factors in I-Mab’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.
For more information, please contact:
I-Mab Contacts
Tyler Ehler |
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Senior Director, Investor Relations |
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IR@imabbio.com |
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I-Mab
Consolidated Balance Sheets
(All amounts in thousands, except for share data)
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As of June 30, |
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As of December 31, |
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2024 |
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2023 |
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(Unaudited) |
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(Unaudited) |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
151,961 |
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$ |
290,799 |
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Short-term investments |
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55,525 |
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20,172 |
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Prepayments and other current assets |
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22,991 |
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714 |
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Current assets of discontinued operations |
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— |
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17,428 |
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Total current assets |
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230,477 |
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329,113 |
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Property, equipment and software |
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204 |
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1,772 |
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Operating lease right-of-use assets |
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3,682 |
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3,768 |
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Investments accounted for using the cost method |
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19,000 |
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— |
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Other non-current assets |
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464 |
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248 |
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Non-current assets of discontinued operations |
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— |
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33,127 |
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Total assets |
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$ |
253,827 |
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$ |
368,028 |
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Liabilities and shareholders’ equity |
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Current liabilities |
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Accruals and other payables |
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$ |
11,259 |
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$ |
8,555 |
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Operating lease liabilities, current |
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737 |
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624 |
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Put right liabilities, current |
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1,976 |
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— |
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Current liabilities of discontinued operations |
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— |
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48,824 |
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Total current liabilities |
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13,972 |
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58,003 |
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Put right liabilities, non-current |
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— |
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13,819 |
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Operating lease liabilities, non-current |
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3,222 |
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3,253 |
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Other non-current liabilities |
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— |
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105 |
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Non-current liabilities of discontinued operations |
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— |
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50,851 |
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Total liabilities |
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$ |
17,194 |
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$ |
126,031 |
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Shareholders’ equity |
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Ordinary shares (US$0.0001 par value, 800,000,000 shares authorized |
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19 |
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19 |
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Treasury stock |
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(6,369 |
) |
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(8,001 |
) |
Additional paid-in capital |
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1,459,005 |
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1,380,918 |
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Accumulated other comprehensive income |
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40,448 |
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42,013 |
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Accumulated deficit |
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(1,256,470 |
) |
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(1,172,952 |
) |
Total shareholders’ equity |
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236,633 |
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241,997 |
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Total liabilities and shareholders’ equity |
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$ |
253,827 |
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$ |
368,028 |
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I-Mab
Consolidated Statements of Comprehensive Loss
(All amounts in thousands, except for share and per share data)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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(Unaudited) |
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(Unaudited) |
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Revenues |
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Licensing and collaboration revenue |
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$ |
— |
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$ |
159 |
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$ |
— |
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$ |
312 |
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Total revenues |
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— |
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159 |
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— |
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312 |
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Expenses |
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Research and development expenses (Note 1) |
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(3,137 |
) |
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(4,289 |
) |
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(10,789 |
) |
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(9,021 |
) |
Administrative expenses (Note 2) |
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(11,871 |
) |
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(7,920 |
) |
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(14,312 |
) |
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(14,034 |
) |
Loss from operations |
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(15,008 |
) |
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(12,050 |
) |
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(25,101 |
) |
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(22,743 |
) |
Interest income |
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1,921 |
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2,889 |
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|
|
2,840 |
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|
|
4,506 |
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Other income (expenses), net |
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6,277 |
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|
|
(16,411 |
) |
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|
5,480 |
|
|
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(11,481 |
) |
Equity in loss of affiliates (Note 3) |
|
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— |
|
|
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(1,986 |
) |
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|
(1,038 |
) |
|
|
(8,191 |
) |
Loss from continuing operations before income tax expense |
|
|
(6,810 |
) |
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|
(27,558 |
) |
|
|
(17,819 |
) |
|
|
(37,909 |
) |
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
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Loss from continuing operations |
|
$ |
(6,810 |
) |
|
$ |
(27,558 |
) |
|
$ |
(17,819 |
) |
|
$ |
(37,909 |
) |
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Discontinued operations: |
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Loss from operations of discontinued operations (Note 4) |
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$ |
— |
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|
$ |
(33,908 |
) |
|
$ |
(6,779 |
) |
|
$ |
(68,664 |
) |
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Gain on sale of discontinued operations |
|
|
31,936 |
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|
|
— |
|
|
|
31,936 |
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|
|
— |
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Income (loss) from discontinued operations |
|
$ |
31,936 |
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|
$ |
(33,908 |
) |
|
$ |
25,157 |
|
|
$ |
(68,664 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income (loss) attributable to I-Mab |
|
$ |
25,126 |
|
|
$ |
(61,466 |
) |
|
$ |
7,338 |
|
|
$ |
(106,573 |
) |
Net income (loss) attributable to ordinary shareholders |
|
$ |
25,126 |
|
|
$ |
(61,466 |
) |
|
$ |
7,338 |
|
|
$ |
(106,573 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income (loss) attributable to I-Mab |
|
$ |
25,126 |
|
|
$ |
(61,466 |
) |
|
$ |
7,338 |
|
|
$ |
(106,573 |
) |
Foreign currency translation adjustments net of tax |
|
|
(348 |
) |
|
|
40,597 |
|
|
|
(1,565 |
) |
|
|
22,434 |
|
Total comprehensive income (loss) attributable to I-Mab |
|
$ |
24,778 |
|
|
$ |
(20,869 |
) |
|
$ |
5,773 |
|
|
$ |
(84,139 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss from continuing operations per share attributable |
|
$ |
(0.04 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.20 |
) |
Net loss from continuing operations per ADS attributable |
|
$ |
(0.09 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.46 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income (loss) from discontinued operations per share |
|
$ |
0.17 |
|
|
$ |
(0.18 |
) |
|
$ |
0.14 |
|
|
$ |
(0.36 |
) |
Net income (loss) from discontinued operations per ADS |
|
$ |
0.39 |
|
|
$ |
(0.41 |
) |
|
$ |
0.32 |
|
|
$ |
(0.83 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income (loss) attributable to ordinary shareholders |
|
$ |
0.13 |
|
|
$ |
(0.32 |
) |
|
$ |
0.04 |
|
|
$ |
(0.56 |
) |
Net income (loss) per ADS attributable to ordinary |
|
$ |
0.30 |
|
|
$ |
(0.74 |
) |
|
$ |
0.09 |
|
|
$ |
(1.29 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average number of ordinary shares outstanding |
|
|
186,143,586 |
|
|
|
191,049,393 |
|
|
|
186,001,620 |
|
|
|
191,329,890 |
|
Notes:
(1) Includes share-based compensation expense of $0.0 million and $0.4 million for the three and six months ended June 30, 2024, respectively, compared to $1.3 million and $1.8 million for the three and six months ended June 30, 2023, respectively.
(2) Includes share-based compensation expense of $1.1 million and ($3.5) million for the three and six months ended June 30, 2024, respectively, compared to $2.6 million and $4.8 million for the three and six months ended June 30, 2023, respectively.
(3) Includes share-based compensation expense of $0.0 million and ($0.7) million for the three and six months ended June 30, 2024, respectively, compared to $0.1 million and $0.5 million for the three and six months ended June 30, 2023, respectively.
(4) Includes share-based compensation expense of $0.0 million and ($11.5) million for the three and six months ended June 30, 2024, respectively, compared to $3.0 million and $12.0 million for the three and six months ended June 30, 2023, respectively. The period ended June 30, 2024 includes forfeitures as a result of the divestiture of China operations.
(5) Each 10 ADSs represents 23 ordinary shares.
I-Mab
Reconciliation of GAAP and Non-GAAP Results
(All amounts in thousands, except for share and per share data)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
(Unaudited) |
|
|
(Unaudited) |
|
||||||||||
GAAP net loss from continuing operations |
|
$ |
(6,810 |
) |
|
$ |
(27,558 |
) |
|
$ |
(17,819 |
) |
|
$ |
(37,909 |
) |
Add back: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Share-based compensation expense from continuing |
|
|
1,137 |
|
|
|
3,937 |
|
|
|
(3,741 |
) |
|
|
7,100 |
|
Non-GAAP adjusted net loss from continuing operations |
|
$ |
(5,673 |
) |
|
$ |
(23,621 |
) |
|
$ |
(21,560 |
) |
|
$ |
(30,809 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average number of ordinary shares used |
|
|
186,143,586 |
|
|
|
191,049,393 |
|
|
|
186,001,620 |
|
|
|
191,329,890 |
|
Non-GAAP adjusted loss from continuing operations per |
|
|
|
|
|
|
|
|
|
|
|
|
||||
—Basic and diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.16 |
) |
Non-GAAP adjusted loss from continuing operations per |
|
|
|
|
|
|
|
|
|
|
|
|
||||
—Basic and diluted |
|
$ |
(0.07 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.37 |
) |
Transforming Potential into Reality I-Mab Biopharma 1H 2024 Results August 28, 2024
Disclaimer Legal Disclaimer. This presentation has been prepared by I-Mab (the “Company”) solely for informational purposes. Certain of the information included herein was obtained from various sources, including certain third parties, and has not been independently verified by the Company. By viewing or accessing the information contained in this presentation, you hereby acknowledge and agree that no representations, warranties, or undertakings, express or implied, are made by the Company or any of its directors, shareholders, employees, agents, affiliates, advisors, or representatives as to, and no reliance should be placed on the truth, accuracy, fairness, completeness, or reasonableness of the information or opinions presented or contained in, and omission from, this presentation. Neither the Company nor any of its directors, employees, agents, affiliates, advisors, or representatives shall be responsible or liable whatsoever (in negligence or otherwise) for any loss, howsoever arising from any information presented or contained in this presentation or otherwise arising in connection with the presentation, except to the extent required by applicable law. The information presented or contained in this presentation speaks only as of the date hereof and is subject to change without notice. No Offer or Solicitation. This presentation does not constitute an offer to buy or sell or a solicitation of an offer to buy or sell any securities or instrument of the Company or to participate in any investment activity or trading strategy, nor may it or any part of it form the basis of or to be relied on in connection with any contract or commitment whatsoever. NOTHING HEREIN CONSTITUTES AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY ANY SECURITIES OR INSTRUMENT IN ANY STATE OR JURISDICTION. This presentation does not purport to and does not contain all relevant information relating to the Company or its securities, particularly with respect to the risks and special considerations involved with an investment in the securities of the Company. Nothing contained in this presentation shall be relied upon as a promise or representation as to the past or future performance of the Company. Past performance does not guarantee or predict future performance. You acknowledge that any assessment of the Company that may be made by you will be independent of this presentation and that you will be solely responsible for your own assessment of the market and the market position of the Company, and that you will conduct your own analysis and be solely responsible for forming your own view of the potential future performance of the business of the Company. This presentation includes statistical and other industry and market data that we obtained from industry publications and research, surveys, and studies conducted by third parties, and our own estimates of potential market opportunities. All of the market data used in this presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Our estimates of the potential market opportunities for our product candidates include several key assumptions based on our industry knowledge, industry publications, third-party research, and other surveys, which may be based on a small sample size and may fail to accurately reflect market opportunities. While we believe that our internal assumptions are reasonable, no independent source has verified such assumptions. Forward Looking Statements. This presentation contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “future”, “promising”, “may”, “plans”, “potential”, “will”, “could position”, “promise”, “advance”, “target”, “design”, “strategy”, “pipeline”, and “project”, and similar terms or the negative thereof. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. The forward-looking statements in this presentation include, without limitation, statements regarding the following: the Company’s pipeline and capital strategy; the potential benefits, advantages, promise, attributes, and target usage of uliledlimab; the projected advancement of the Company’s portfolio and anticipated milestones and related timing; the market opportunity and I-Mab’s potential next steps (including the potential expansion, differentiation, or commercialization) for uliledlimab, givastomig and ragistomig; the Company’s expectations regarding the impact of data from ongoing and future trials; the timing of the settlement of remaining redemption obligations; the benefits of the Company’s collaboration with development partners; the Company’s ability to continue to comply with certain audit requirements; the timing and progress of studies (including with respect to patient enrollment and dosing); the availability of data and information from ongoing studies; and the Company’s expectations regarding its cash runway. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the following: I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or new drug application/biologics license application approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab’s drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab’s reliance on third parties to conduct drug development, manufacturing and other services; I-Mab’s limited operating history and I-Mab’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and discussions of potential risks, uncertainties, and other important factors in I-Mab’s most recent annual report on Form 20-F and I-Mab’s subsequent filings with the U.S. Securities and Exchange Commission (the “SEC”). I-Mab may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials, and in oral statements made by its officers, directors, or employees to third parties. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Agenda CEO Remarks and Introduction, Sean Fu R&D Strategy, Phillip Dennis Closing Remarks, Sean Fu Finance and Transition Update, Joseph Skelton
Significant Progress Towards Becoming a U.S.-Based Biotech Completed divestiture of China operations; closed on 04/02/2024 Extinguished ~$200M of redemption obligations and significantly reduced operating expenses; remaining ~$15M of redemption obligations to be settled in Sept-20241 New streamlined organization with U.S. leadership team: key hires in 1H24 included CEO, CFO, and CMO; optimized workforce of 34 FTEs2 Completed transition to U.S.-based auditors, appointed PwC U.S. effective 08/07/2024 I-Mab well positioned to execute on existing pipeline In response to arbitration commenced against I-Mab Biopharma Hong Kong Limited and included in divestiture related expenses, I-Mab placed $17.5M into escrow for future settlement of redemption obligations. As of the date of this presentation, $17.3M of redemption obligations have been settled from funds placed into escrow leaving the remaining obligations to be settled of ~$15M Full-time employees as of 06/30/2024 Strategically evaluating assets with best-in-class potential
Experienced U.S.-Based Management Team Sean Fu, PhD, MBA Interim Chief Executive Officer Scientist with 20+ years in pharma focused on early-stage clinical development in targeted therapeutics Previous Leadership Experience Phillip Dennis, MD, PhD Chief Medical Officer Medical oncologist with 20-year academic career and 10+ years in pharma focused on IO, ADCs, and targeted therapies Joseph Skelton Chief Financial Officer 10 years of experience as an investment banker with a focus on biopharma, leading and closing multiple transactions Claire Xu, MD, PhD VP, Clinical Development 10+ years of oncology clinical development experience, built I-Mab’s clinical team Notes: IO = Immuno-oncology; ADCs = Antibody-drug conjugates
Asset PHASE 1 PHASE 2 PHASE 3 MARKET OPPORTUNITY STATUS/POTENTIAL NEXT STEPS PARTNERSHIPS Uliledlimab CD73 mAb 1L mNSCLC: Target population of 300k+ patients2 1H 2025: First patient dosed in pembrolizumab + chemo combination for 1L mNSCLC 2H 2025: Phase 2 PFS data from ongoing TJBio study (China-only) evaluating combination with toripalimab Givastomig1 CLDN18.2 X 4-1BB Bispecific Ab 1L GC, GEJ, EAC: Target population of 100k+ patients2 Q3 2024: Phase 1 dose expansion monotherapy data at ESMO 2024 2H 2025: Phase 1b data in combination with nivolumab + chemo in 1L GC, GEJ, EAC Ragistomig/ABL5031 PD-L1 X 4-1BB Bispecific Ab Refractory/relapsed cancers: PD-(L)1 progression impacts most patients with metastatic disease2 1H 2024: Phase 1 monotherapy data presented at ASCO 2024 Co-developed with ABL Bio (givastomig also known as ABL111, ragistomig also known as ABL503) Global Data Epidemiology Data, Guidehouse legacy research Notes: CPI = checkpoint inhibitors; mNSCLC = metastatic non-small cell lung cancer; PD-(L)1 refers to inhibitors of PD-L1 or PD-1; Ab = antibody; GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma cancer; 1L = first line; ASCO 2024 = the American Society for Clinical Oncology Annual Meeting in 2024; PFS = progression free survival; ESMO 2024 = the European Society for Medical Oncology Annual Meeting in 2024 Advancing a Differentiated Pipeline TJ Bio
Uliledlimab (targeting CD73) Initial development focused on 1L mNSCLC with potential to expand across multiple indications in combination with immune checkpoint inhibitors Anti-CD73 CD73 Biology Key Advantages CD73 is the rate-limiting enzyme that converts AMP into immunosuppressive adenosine Uliledlimab completely inhibits CD73 activity and the production of adenosine Blocking CD73 activity leads to complete inhibition of the adenosine pathway Uliledlimab targets CD73 non-competitively without the “hook effect” Note: mNSCLC = metastatic non-small cell lung cancer; AMP = adenosine monophosphate
CD73 enzyme activity inhibition Dose-dependent CD73 inhibition without the “hook effect” Uliledlimab: A Differentiated CD73 Antibody Open conformation (inactive) Closed conformation (active) Oleclumab1 Intra-dimer binding mode Inter-dimer binding mode Open conformation (inactive) Closed conformation (active) Unique intra-dimer binding through a C-terminus epitope Uliledlimab inhibits CD73 by binding to the C-terminus and preventing CD73 dimerization Oleclumab inhibits CD73 by binding to the N-terminus and preventing CD73 dimerization Uliledlimab CD73 enzyme activity inhibition Uliledlimab concentration Oleclumab concentration Uliledlimab CD73 dimer Oleclumab CD73 dimer Binding site Binding site Oleclumab (MEDI9447) was internally produced based upon the published sequence Source: I-MAB information on file
Safety profile of combination comparable to CPI monotherapy studies Uliledlimab + Toripalimab Data Supports Patient Selection Based on CD73 Expression and Shows Manageable Toxicity Notes: ORR = objective response rate; MTD = maximally tolerated dose; Q3W = every three weeks; AE = adverse events; CPI = checkpoint inhibitors; TRAEs = treatment-related adverse events; ASCO23 = the American Society of Clinical Oncology 2023 Annual Meeting; toripalimab (used in this study) = Approved/China and the US (Shanghai Junshi Biosciences/Coherus Biosciences) *Patient disposition based on ASCO23 Poster from a cohort of 70 enrolled patients with unresectable/metastatic disease, including 67 efficacy evaluable and 64 patients who received at least one post baseline tumor assessment per iRECIST. Overall study (up to n=190) enrolled 5 cohorts (3 NSCLC sub-types, 1 ovarian, 1 all comers): data in this deck are from the treatment naïve, Stage IV NSCLC patients Well tolerated up to the highest doses tested (45mg/kg Q3W), without MTD Most TRAEs/AEs were Grade 1 or 2 ORR% (n) PD-L1 All PD-L1>1% CD73High 53% (10/19) 63% (10/16) CD73Low 18% (8/45) 20% (5/25) Pembro (KN-042) PD-L1>1% NA 27% (174/637) Phase 2 ORR data from front-line NSCLC Cohort* Safety observations for uliledlimab, administered to >200 patients in combination studies with CPIs
Rationale to Support Uliledlimab + Pembro + Chemotherapy in 1L mNSCLC Samanta D, Park Y, Ni XH, Semenza G. 2017. Chemotherapy induces enrichment of CD47+/CD73+/PDL1+ immune evasive triple-negative breast cancer cells. PNAS Vol. 115, No 6. Notes: mNSCLC = metastatic non-small cell lung cancer; IO = Immuno-oncology The addition of chemotherapy to IO monotherapy extends the benefit of IO to lower levels of PD-L1 expression Uliledlimab has a favorable toxicity profile in combination with IO agents Chemotherapy induces CD73 expression suggesting additional benefit by combining uliledlimab with pembrolizumab + chemotherapy1 Based on this rationale I-Mab plans to dose the first patient with uliledlimab in combination with pembrolizumab + chemotherapy in newly diagnosed patients with mNSCLC in 1H 2025
Uliledlimab Development Plan: Randomized Study Design for Combination with Pembrolizumab + Chemotherapy Notes: mNSCLC = metastatic non-small cell lung cancer; R = randomized; ECOG PS = ECOG Performance Status Scale; TPS = tumor proportion score; ORR = objective response rate; PFS = progression free survival; DOR = duration of response; OS = overall survival; Q3W = dose every three weeks; IDMC = independent data monitoring committee; IND = investigational new drug; Pembro = pembrolizumab; Chemo = chemotherapy; 1L = first line IND application cleared Aug-2024 Eligibility: 1L Advanced mNSCLC ECOG PS 0/1 Stratify By: PD-L1 TPS Histology (n=96) Endpoints Primary: Safety, Efficacy (ORR) Secondary: PFS, DOR, OS IDMC Dose Escalation Lead-In (n=6) Uli Dose Level -1 + Pembro + Chemo (Q3W) SoC (n=15) Pembro + Chemo (Q3W) Uli Dose Level 1 (n=30) Uli Dose Level 1 + Pembro + Chemo (Q3W) R 2:1 IDMC R 2:1 Uli Dose Level 2 or -1 (n=30) Uli Dose Level 2 or -1 + Pembro + Chemo (Q3W) SoC (n=15) Pembro + Chemo (Q3W)
Anticipated Milestones for Uliledlimab and the Adenosine Pathway Source: Company filings, Wall Street Equity Research; Clinicaltrials.gov Notes: PFS = progression free survival; Pembro = pembrolizumab; Uli = uliledlimab; Chemo = chemotherapy; Tori = toripalimab Uliledlimab Adenosine Pathway 2H 2025 Randomized Phase 2 Uli + Tori PFS Data 2H 2026 Randomized Phase 2 Uli + Pembro + Chemo Data 1H 2026 Phase 3 COAST data for Oleclumab 2H 2026 Phase 2 EDGE-Lung data for Quemliclustat 2H 2024 2025 2026 Q4 2024 Phase 2 data for Inupadenant / Phase 1 data for EOS-984 1H 2025 FPI Randomized Phase 2 Uli + Pembro + Chemo Q3 2024 Phase 1 data for IPH5301 Q3 2024 Phase 2 neo-COAST2 data for Oleclumab
Molecular Design Key Differentiation Binding activity demonstrated across various levels of CLDN18.2 expression Exhibits CLDN18.2 binding even on low expressing tumor cells Higher-affinity binding to CLDN18.2 compared to reference antibody Zolbetuximab Localized T cell activation in TME to minimize 4-1BB-mediated liver toxicity and systemic immune response Givastomig (targeting Claudin 18.2 and 4-1BB) Ongoing combination studies with nivolumab + chemotherapy across a wide range of Claudin 18.2 levels Unique bispecific Ab integrates Claudin 18.2 as a tumor engager and 4-1BB as a conditional T cell activator 4-1BB scFv CLDN18.2 Notes: scFv = single chain Fragment-variable region; TME = tumor microenvironment
Unique Design to Enable Potential Wide Use Plus Favorable Initial Safety Profile Encouraging Responses in Previously Treated Patients, Including Those with Low CLDN18.2 Expression Levels Dose Expansion Data and New Nivolumab + Chemotherapy Combo Study Ongoing Unique Bispecific Design Properties and Monotherapy Data in Gastric Cancers May Position Givastomig as Best-in-Class Claudin 18.2 bispecific Objective responses seen in patients with gastric and esophageal cancer who had received multiple lines of prior treatment, including PD-(L)1, and had low CLDN18.2 levels Response rate and tolerability supports combination in 1L SOC regimens New dose expansion in combination with nivolumab + chemotherapy cohort study began in 1H 2024 in treatment naïve patients with gastric cancers Updated monotherapy dose expansion data in CLDN18.2+ patients with gastric cancers whose disease has progressed after previous treatment to be presented at ESMO 2024 Bispecific design results in CLDN18.2 conditional 4-1BB and T cell activation, potentially limiting toxicity and inducing long-lasting immune memory response Phase 1 dose escalation reached highest planned dose without encountering DLT or liver toxicity signals Notes: Gastric cancers = gastric, gastroesophageal junction and esophageal cancer; ESMO 2024 = the European Society for Medical Oncology Annual Meeting in 2024; SOC = standard of care; DLT = dose limiting toxicity
Givastomig Yields Better Monotherapy Responses in Patients with Low to High CLDN18.2 Expression Compared to Phase 1/2 Zolbetuximab Studies Drug Givastomig (bi-specific) Zolbetuximab (mAb) Phase Phase 1 Phase 1 Phase 2 CLDN18.2 – Expression of the Study Group IHC ≥1+ in ≥1% cells IHC ≥1+ in ≥1% cells IHC ≥ 2+ in ≥ 50% cells Diagnosis Previously treated GC/GEJ/EAC Previously treated GC/GEJ Previously treated GC/GEJ/EAC Efficacy Evaluable 20 15 43 ORR 15% (3/20) Zero 9% (4/43) DCR (CR+PR+SD) 35% (7/20) 1 SD 23% (10/43) Source Givastomig poster #1039P ESMO 2023 U Sahin et al. European Journal of Cancer 100 (2018) 17e26 O Tureci et al. Annals of Oncology 30: 1487–1495, 2019 Notes: mAb = monoclonal antibody; ORR = objective response rate; DCR = disease control rate; CR = complete response; PR = partial response; SD = stable disease; GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal cancer; IHC = immunohistochemistry. Note that the comparisons in the table above are not based on data from head-to-head trials and are not direct comparisons. Differences in trial designs, patient groups, trial endpoints, study sizes and other factors may impact the comparisons
Molecular Design Target Drug Profile Molecule binds to PD-L1 to inhibit PD-1/PD-L1 interaction Targeting PD-L1+ tumor cells Blocking PD-L1/PD-1 immune inhibitory signaling PD-L1-dependent 4-1BB activation at the tumor site Potent tumor-directed 4-1BB activation to enhance anti-tumor immunity Enhances anti-tumor immunity and re-invigorates exhausted T cells1 Localized 4-1BB activation in TME to mitigate liver toxicity and systemic immune response Ragistomig (ABL503/TJ-L14B, targeting PD-L1 and 4-1BB) A novel bispecific integrates PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator 4-1BB scFv PD-L1 IgG Phase 1 efficacy data presented at ASCO 2024 JITC 2021 Notes: scFv = single chain Fragment-variable region; TME = tumor microenvironment; ASCO 2024 = the American Society for Clinical Oncology Annual Meeting in 2024
Phase 1 Data Support Further Development as a Monotherapy and in Combination with Other Agents Overview: 44 efficacy evaluable patients (53 enrolled) with advanced or relapsed/refractory solid tumors (NCT04762641) 64.2% (34/53) of patients enrolled had at least three prior lines of systemic anti-cancer treatment Efficacy Results at 3 and 5 mg/kg Q2W: Objective Response Rate (ORR) of 26.9% (7/26), Clinical Benefit Ratio (CBR) of 69.2% (18/26) One CR, six PRs, eleven SDs 71.4% of responders had received prior anti-PD-(L)-1 inhibitors The CR was observed in a heavily pretreated ovarian cancer patient dosed at 3 mg/kg (seven lines of prior therapy) Conclusion: Compelling clinical data in checkpoint inhibitor relapsed/refractory and IO naïve patients Treatment Duration (Days) CR start PR start On-going PD start 0.7 mg 2 mg/kg 2 mg 3 mg/kg 7 mg 5 mg/kg 0.3 mg/kg 7 mg/kg 1 mg/kg 10 mg/kg Source: ASCO 2024 Notes: Data cut-off as of April 19, 2024. CR = complete response; PR = partial response; PD = progressive disease; SD = stable disease; IO = Immuno-oncology
Manageable Safety Profile MTD established with 7 mg/kg every two-week dosing Most common TRAEs were increased ALT and increased AST None of the transaminase elevations were accompanied by clinically significant, treatment-related bilirubin increases Grade ≥ 3 ALT or AST increases occurred in 24.5% (13/53) of patients and improved with corticosteroids or ragistomig treatment interruption No cytokine release syndrome occurred, and one infusion-related reaction occurred at 5 mg/kg (Grade 2) ABL503 monotherapy Demography All patients (N = 53) All grades, n(%) Grade ≥ 3, n(%) Any TRAE 40 (75.5) 22 (41.5) TRAE occurring in ≥ 10% of patients Alanine aminotransferase increased 17 (32.1) 12 (22.6) Aspartate aminotransferase increased 16 (30.2) 11 (20.8) Pyrexia 8 (15.1) 1 (1.9) Nausea 7 (13.2) - Rash 7 (13.2) 2 (3.8) Fatigue 6 (11.3) 1 (1.9) Platelet count decreased 6 (11.3) 1 (1.9) Source: ASCO 2024 poster, Table 2 Notes: Data cut-off as of April 19, 2024. MTD = maximally tolerated dose; TRAE = treatment-related adverse events; ALT = alanine aminotransferase; AST = aspartate aminotransferase
Asset PHASE 1 PHASE 2 PHASE 3 MARKET OPPORTUNITY STATUS/POTENTIAL NEXT STEPS PARTNERSHIPS Uliledlimab CD73 mAb 1L mNSCLC: Target population of 300k+ patients2 1H 2025: First patient dosed in pembrolizumab + chemo combination for 1L mNSCLC 2H 2025: Phase 2 PFS data from ongoing TJBio study (China-only) evaluating combination with toripalimab Givastomig1 CLDN18.2 X 4-1BB Bispecific Ab 1L GC, GEJ, EAC: Target population of 100k+ patients2 Q3 2024: Phase 1 dose expansion monotherapy data at ESMO 2024 2H 2025: Phase 1b data in combination with nivolumab + chemo in 1L GC, GEJ, EAC Ragistomig/ABL5031 PD-L1 X 4-1BB Bispecific Ab Refractory/relapsed cancers: PD-(L)1 progression impacts most patients with metastatic disease2 1H 2024: Phase 1 monotherapy data presented at ASCO 2024 Co-developed with ABL Bio (givastomig also known as ABL111, ragistomig also known as ABL503) Global Data Epidemiology Data, Guidehouse legacy research Notes: CPI = checkpoint inhibitors; mNSCLC = metastatic non-small cell lung cancer; PD-(L)1 refers to inhibitors of PD-L1 or PD-1; Ab = antibody; GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma cancer; 1L = first line; ASCO 2024 = the American Society for Clinical Oncology Annual Meeting in 2024; PFS = progression free survival; ESMO 2024 = the European Society for Medical Oncology Annual Meeting in 2024 Advancing a Differentiated Pipeline TJ Bio
Strong Corporate Development Progress and Reduction in Expenditures Full-time employees as of 12/31/2023 per the 20-F Full-time employees as of 06/30/2024 Entered into clinical collaboration with Bristol Myers Squibb to evaluate Claudin 18.2 x 4-1BB bispecific antibody givastomig in combination with nivolumab + chemotherapy for the treatment of gastric and esophageal cancer Under the terms of the agreement, the study will be a multi-national Phase 1b study conducted by I-Mab. Bristol Myers Squibb will supply nivolumab Strengthened Study and Secured Drug Supply Engaged PwC as U.S. auditors Enables I-Mab to continue to comply with the audit requirements of the Holding Foreign Companies Accountable Act Engaged U.S. Auditors Streamlined workforce from 220 FTEs1 to 34 FTEs2 Senior leadership team all based in the U.S. Workforce primarily based in the U.S. Optimized Workforce Focused on advancing uliledlimab into Phase 2 in the U.S. and continuing advancement of givastomig through its Phase 1b Divestiture removed two ongoing Phase 3 trials in China (felzartamab and eftansomatropin alfa) Streamlined Pipeline Extinguished ~$200M of potential ~$215M redemption obligations Expect to settle the remaining redemption obligations of ~$15M in Sep-2024 Extinguishment of Redemption Obligations
Reclassification of cash and cash equivalents at I-Mab Shanghai that subsequently remained with divested entity to settle working capital obligations Outflows incurred during the first quarter of 2024 related to the divestiture of China operations including: $19M Series C investment in TJ Biopharma, $17.5M escrow deposit related to dissenting shareholders arbitration and other non-recurring expenses associated with the divestiture Consolidated operating expenses of the I-Mab group pre-closing of the divestiture of China operations Non-recurring expenses associated with the divestiture incurred in the second quarter of 2024 Operating expenses of I-Mab as a standalone entity Inflows of cash attributable to the return of a deposit to support the share buy-back program which the company no longer anticipates renewing, and interest income earned during the second quarter of 2024 Pro Forma Cash Walk from Last Reported Cash Balance Cash and cash equivalents as reported for the fiscal year ended 12/31/2023 per the 20-F Unaudited, cash and cash equivalents as of 12/31/2023 after the $10.8M recast to Discontinued Operations in accordance with (ASC 205-20, Discontinued Operations) Unaudited, pro forma 04/02/2024 balance shown for illustrative purposes Unaudited, includes short-term investments Note: $ in millions 1 Commentary A A B C D E F B C D E F 2 4 Expected cash runway into 2027 supporting multiple potential inflection points 3
Assuming the conversion of all ordinary shares into ADSs Notes: CPI = checkpoint inhibitor; CLDN = Claudin; GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal cancer; ESMO 2024 = the European Society for Medical Oncology Annual Meeting in 2024; PFS = progression free survival; ORR = objective response rate Cash, cash equivalents and short-term investments as of June 30, 2024 were $207.5M Expected cash runway into 2027 supporting multiple potential inflection points Issued and outstanding ordinary shares of 187.3M representing the equivalent of 81.4M ADSs1 Financial Information and Upcoming Milestones Timing Program Milestone Q3 2024 givastomig Updated Phase 1 dose expansion data at ESMO 2024 Monotherapy (CLDN18.2+ patients with GC, GEJ, EAC) data 1H 2025 uliledlimab First patient dosed in Phase 2 Randomized study in combination with pembrolizumab + chemo 2H 2025 uliledlimab Phase 2 PFS data from uliledlimab + toripalimab Randomized study (TJ Bio China-only data) 2H 2025 givastomig Phase 1b in combination with nivolumab + chemo Safety and ORR data in 1L GC, GEJ, EAC Selected Financial Information Anticipated Upcoming Milestones
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Transforming Potential into Reality I-Mab Biopharma August 28, 2024
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The forward-looking statements in this presentation include, without limitation, statements regarding the following: the Company’s pipeline and capital strategy; the potential benefits, advantages, promise, attributes, and target usage of uliledlimab; the projected advancement of the Company’s portfolio and anticipated milestones and related timing; the market opportunity and I-Mab’s potential next steps (including the potential expansion, differentiation, or commercialization) for uliledlimab, givastomig and ragistomig; the Company’s expectations regarding the impact of data from ongoing and future trials; the timing of the settlement of remaining redemption obligations; the benefits of the Company’s collaboration with development partners; the Company’s ability to continue to comply with certain audit requirements; the timing and progress of studies (including with respect to patient enrollment and dosing); the availability of data and information from ongoing studies; and the Company’s expectations regarding its cash runway. 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Asset PHASE 1 PHASE 2 PHASE 3 MARKET OPPORTUNITY STATUS/POTENTIAL NEXT STEPS PARTNERSHIPS Uliledlimab CD73 mAb 1L mNSCLC: Target population of 300k+ patients2 1H 2025: First patient dosed in pembrolizumab + chemo combination for 1L mNSCLC 2H 2025: Phase 2 PFS data from ongoing TJBio study (China-only) evaluating combination with toripalimab Givastomig1 CLDN18.2 X 4-1BB Bispecific Ab 1L GC, GEJ, EAC: Target population of 100k+ patients2 Q3 2024: Phase 1 dose expansion monotherapy data at ESMO 2024 2H 2025: Phase 1b data in combination with nivolumab + chemo in 1L GC, GEJ, EAC Ragistomig/ABL5031 PD-L1 X 4-1BB Bispecific Ab Refractory/relapsed cancers: PD-(L)1 progression impacts most patients with metastatic disease2 1H 2024: Phase 1 monotherapy data presented at ASCO 2024 Co-developed with ABL Bio (givastomig also known as ABL111, ragistomig also known as ABL503) Global Data Epidemiology Data, Guidehouse legacy research Notes: CPI = checkpoint inhibitors; mNSCLC = metastatic non-small cell lung cancer; PD-(L)1 refers to inhibitors of PD-L1 or PD-1; Ab = antibody; GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma cancer; 1L = first line; ASCO 2024 = the American Society for Clinical Oncology Annual Meeting in 2024; PFS = progression free survival; ESMO 2024 = the European Society for Medical Oncology Annual Meeting in 2024 Advancing a Differentiated Pipeline TJ Bio
Uliledlimab (targeting CD73) Initial development focused on 1L mNSCLC with potential to expand across multiple indications in combination with immune checkpoint inhibitors Anti-CD73 CD73 Biology Key Advantages CD73 is the rate-limiting enzyme that converts AMP into immunosuppressive adenosine Uliledlimab completely inhibits CD73 activity and the production of adenosine Blocking CD73 activity leads to complete inhibition of the adenosine pathway Uliledlimab targets CD73 non-competitively without the “hook effect” Note: mNSCLC = metastatic non-small cell lung cancer; AMP = adenosine monophosphate
CD73 is the Rate-Limiting Enzyme in the Adenosine Immunosuppression Pathway All AMP pathways converge at CD73 to generate adenosine Advantages of targeting CD73 for cancer therapy: blocking CD73 activity leads to complete inhibition of the adenosine pathway. Known potential escape pathways (ATP, cyclic AMP, and nicotinamide adenine dinucleotide through separate biochemical pathways) exist when targeting upstream CD39 or downstream adenosine receptors. NAD+ ATP CD39 CD203a ADP CD38 ADPR CD39 AMP CD203a AMP ADO A1AR A2aAR A2bAR A3AR Canonical Alternative Multiple Pathways Multiple Receptors CD73 Rate-limiting Converging Source: I-MAB information on file Notes: ATP = adenosine triphosphate; NAD+ = nicotinamide adenine dinucleotide; ADP = adenosine diphosphate; ADPR = adenosine diphosphate ribose; AMP = adenosine monophosphate; ADO = aldehyde deformylating oxygenase
CD73 enzyme activity inhibition Dose-dependent CD73 inhibition without the “hook effect” Uliledlimab: A Differentiated CD73 Antibody Open conformation (inactive) Closed conformation (active) Oleclumab1 Intra-dimer binding mode Inter-dimer binding mode Open conformation (inactive) Closed conformation (active) Unique intra-dimer binding through a C-terminus epitope Uliledlimab inhibits CD73 by binding to the C-terminus and preventing CD73 dimerization Oleclumab inhibits CD73 by binding to the N-terminus and preventing CD73 dimerization Uliledlimab CD73 enzyme activity inhibition Uliledlimab concentration Oleclumab concentration Uliledlimab CD73 dimer Oleclumab CD73 dimer Binding site Binding site Oleclumab (MEDI9447) was internally produced based upon the published sequence Source: I-MAB information on file
Partial inhibition by inter-dimer binding mode Complete inhibition by intra-dimer binding mode Uliledlimab May Completely Inhibit CD73 Function in vitro Whereas Competitor Antibody Does Not Astra Zeneca is evaluating oleclumab in a Phase 3 study in patients with Stage III NSCLC Oleclumab (MEDI9447) was internally produced based upon the published sequence
Inhibition of CD73 Activity & Tumor Growth is Dose-Dependent for Uliledlimab Inhibition of CD73 activity and tumor growth in vivo is limited by oleclumab’s hook effect biology Inhibition of CD73 activity and tumor growth in vivo by uliledlimab is dose-dependent Dose-dependency not observed for oleclumab Source: Data on file (IMAB), based on in vivo study on a PDX mouse model of NSCLC (LU5212, Crown Bioscience) in which CD73 inhibition in tumor was evaluated using an enzyme-histochemistry assay Oleclumab (MEDI9447) was internally produced based upon the published sequence. PDX = patient derived xenograft mouse model
Safety profile of combination comparable to CPI monotherapy studies Uliledlimab + Toripalimab Data Supports Patient Selection Based on CD73 Expression and Shows Manageable Toxicity Notes: ORR = objective response rate; MTD = maximally tolerated dose; Q3W = every three weeks; AE = adverse events; CPI = checkpoint inhibitors; TRAEs = treatment-related adverse events; ASCO 2023 = the American Society of Clinical Oncology 2023 Annual Meeting; toripalimab (used in this study) = Approved/China and the US (Shanghai Junshi Biosciences/Coherus Biosciences) *Patient disposition based on ASCO 2023 Poster from a cohort of 70 enrolled patients with unresectable/metastatic disease, including 67 efficacy evaluable and 64 patients who received at least one post baseline tumor assessment per iRECIST. Overall study (up to n=190) enrolled 5 cohorts (3 NSCLC sub-types, 1 ovarian, 1 all comers): data in this deck are from the treatment naïve, Stage IV NSCLC patients Well tolerated up to the highest doses tested (45mg/kg Q3W), without MTD Most TRAEs/AEs were Grade 1 or 2 ORR% (n) PD-L1 All PD-L1>1% CD73High 53% (10/19) 63% (10/16) CD73Low 18% (8/45) 20% (5/25) Pembro (KN-042) PD-L1>1% NA 27% (174/637) Phase 2 ORR data from front-line NSCLC Cohort* Safety observations for uliledlimab, administered to >200 patients in combination studies with CPIs
Most Tumors Decrease in Size Notes: Response definitions per iRECIST criteria. PR = partial response; SD = stable disease; PD = progressive disease; BOR = best overall response Source: ASCO 2023 Poster Early Phase 2 Data in Treatment Naïve NSCLC Patients
Most Responses are Durable 18 of 21 patients with an objective response remain on treatment with a median follow-up of 10.8 months Notes: Response definitions per iRECIST criteria. PR = partial response; SD = stable disease; PD = progressive disease; iUPD = unconfirmed progressive disease Source: ASCO 2023 Poster
Rationale to Support Uliledlimab + Pembro + Chemotherapy in 1L mNSCLC Samanta D, Park Y, Ni XH, Semenza G. 2017. Chemotherapy induces enrichment of CD47+/CD73+/PDL1+ immune evasive triple-negative breast cancer cells. PNAS Vol. 115, No 6. Notes: mNSCLC = metastatic non-small cell lung cancer; IO = Immuno-oncology The addition of chemotherapy to IO monotherapy extends the benefit of IO to lower levels of PD-L1 expression Uliledlimab has a favorable toxicity profile in combination with IO agents Chemotherapy induces CD73 expression suggesting additional benefit by combining uliledlimab with pembrolizumab + chemotherapy1 Based on this rationale I-Mab plans to dose the first patient with uliledlimab in combination with pembrolizumab + chemotherapy in newly diagnosed patients with mNSCLC in 1H 2025
Uliledlimab Development Plan: Randomized Study Design for Combination with Pembrolizumab + Chemotherapy Notes: mNSCLC = metastatic non-small cell lung cancer; R = randomized; ECOG PS = ECOG Performance Status Scale; TPS = tumor proportion score; ORR = objective response rate; PFS = progression free survival; DOR = duration of response; OS = overall survival; Q3W = dose every three weeks; IDMC = independent data monitoring committee; IND = investigational new drug; Pembro = pembrolizumab; Chemo = chemotherapy; 1L = first line IND application cleared Aug-2024 Eligibility: 1L Advanced mNSCLC ECOG PS 0/1 Stratify By: PD-L1 TPS Histology (n=96) Endpoints Primary: Safety, Efficacy (ORR) Secondary: PFS, DOR, OS IDMC Dose Escalation Lead-In (n=6) Uli Dose Level -1 + Pembro + Chemo (Q3W) SoC (n=15) Pembro + Chemo (Q3W) Uli Dose Level 1 (n=30) Uli Dose Level 1 + Pembro + Chemo (Q3W) R 2:1 IDMC R 2:1 Uli Dose Level 2 or -1 (n=30) Uli Dose Level 2 or -1 + Pembro + Chemo (Q3W) SoC (n=15) Pembro + Chemo (Q3W)
Molecular Design Key Differentiation Binding activity demonstrated across various levels of CLDN18.2 expression Exhibits CLDN18.2 binding even on low expressing tumor cells Higher-affinity binding to CLDN18.2 compared to reference antibody Zolbetuximab Localized T cell activation in TME to minimize 4-1BB-mediated liver toxicity and systemic immune response Givastomig (targeting Claudin 18.2 and 4-1BB) Ongoing combination studies with nivolumab + chemotherapy across a wide range of Claudin 18.2 levels Unique bispecific Ab integrates Claudin 18.2 as a tumor engager and 4-1BB as a conditional T cell activator 4-1BB scFv CLDN18.2 Notes: scFv = single chain Fragment-variable region; TME = tumor microenvironment; Ab = antibody
Early Phase 1 Responses in Heavily Pretreated Patients Provides Support for Further Studies 5 mg/kg 8 mg/kg 12 mg/kg 15 mg/kg Numbers: CLDN18.2 % > Treatment Ongoing PD SD PR Patient Overview: 20 efficacy evaluable patients with CLDN18.2+ GC/GEJ/EAC Three median lines of prior treatment (range 1-10) Dosed at 5-15 mg/kg (defined as the predicted efficacious dosing range, based on preclinical studies) Cohort is a subset of the Phase 1a (NCT04900818) Responses: Three partial response (PR) observed; two of those had received prior anti-PD-(L)1 therapy Stable disease (SD) observed in four patients. Of those, one had a PR on the first scan and subsequently withdrew from the study (counted as SD per RECIST1.1) An additional PR (not on the chart) was observed in a patient with head and neck squamous cell carcinoma receiving 12mg/kg who remained on study 280 days at time of the ESMO 2023 presentation Duration of Treatment in Gastric Cancer Patients > > > > 100 80 80 95 1 50 95 100 30 55 7 20 50 98 25 90 55 99 95 11 Stomach Stomach Stomach Stomach Stomach Gastroesophageal junction Stomach Stomach Gastroesophageal junction Stomach Stomach Stomach Stomach Esophagus Stomach Stomach Stomach Esophagus Stomach Esophagus 0 25 50 75 100 125 150 175 200 225 250 275 300 Study Days (C1D1 to End of Treatment date) Source: ESMO 2023 Notes: Data cut-off as of August 1, 2023; GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma
Safety: Treatment Related AEs Preferred Term (all numbers are n(%)) Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 All Grades Nausea 10 (18.2) 3 (5.5) - - - 13 (23.6) Vomiting 7 (12.7) 2 (3.6) - - - 9 (16.4) Fatigue 7 (12.7) 1 (1.8) - - - 8 (14.5) Anemia 1 (1.8) 4 (7.3) 1 (1.8) - - 6 (10.9) Abdominal pain 2 (3.6) 1 (1.8) - - - 3 (5.5) Alanine aminotransferase increased 2 (3.6) - 1 (1.8) - - 3 (5.5) Diarrhea 3 (5.5) - - - - 3 (5.5) Headache 1 (1.8) 2 (3.6) - - - 3 (5.5) Lymphocyte count decreased 1 (1.8) 1 (1.8) 1 (1.8) - - 3 (5.5) Pruritus 2 (3.6) - 1 (1.8) - - 3 (5.5) Pyrexia 3 (5.5) - - - - 3 (5.5) White blood cell count decreased - 2 (3.6) 1 (1.8) - - 3 (5.5) Treatment-related adverse events (TRAEs) occurred in >5% (n=55) No DLT was reported up to 15mg/kg, and MTD was not reached Most commonly reported TRAEs (>10% of subjects): Grade 1 or 2 nausea (23.6%), vomiting (16.4%), fatigue (14.5%), anemia (10.9%) 10 subjects (18.2%) experienced at least one Grade 3 TRAE. No Grade 3 TRAEs occurred in more than one subject Onset of gastrointestinal TRAEs: generally, after 14 days of treatment, recovery within one week; none led to drug withdrawal Source: ESMO 2023 Notes: Data cut-off as of August 1, 2023; DLT = dose-limiting toxicity, MTD = maximum tolerated dose; AE = adverse event; TRAE = treatment emergent adverse event
Givastomig Yields Better Monotherapy Responses in Patients with Low to High CLDN18.2 Expression Compared to Phase 1/2 Zolbetuximab Studies Drug Givastomig (bi-specific) Zolbetuximab (mAb) Phase Phase 1 Phase 1 Phase 2 CLDN18.2 – Expression of the Study Group IHC ≥1+ in ≥1% cells IHC ≥1+ in ≥1% cells IHC ≥ 2+ in ≥ 50% cells Diagnosis Previously treated GC/GEJ/EAC Previously treated GC/GEJ Previously treated GC/GEJ/EAC Efficacy Evaluable 20 15 43 ORR 15% (3/20) Zero 9% (4/43) DCR (CR+PR+SD) 35% (7/20) 1 SD 23% (10/43) Source Givastomig poster #1039P ESMO 2023 U Sahin et al. European Journal of Cancer 100 (2018) 17e26 O Tureci et al. Annals of Oncology 30: 1487–1495, 2019 Notes: mAb = monoclonal antibody; ORR = objective response rate; DCR = disease control rate; CR = complete response; PR = partial response; SD = stable disease; GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal cancer; IHC = immunohistochemistry. Note that the comparisons in the table above are not based on data from head-to-head trials and are not direct comparisons. Differences in trial designs, patient groups, trial endpoints, study sizes and other factors may impact the comparisons
Potential Differentiations of Givastomig from Other Claudin 18.2 Targeted Competitors Givastomig Zolbetuximab ADC – CMG9013 Mechanism of Action CLDN18.2 dependent T cell activation in tumor 4-1BB agonism to increase T cell expansion in tumor and reinvigorate exhausted T cells Bi-specific antibody designed to have conditional 4-1BB activation Direct killing of CLDN18.2 tumor cells by ADCC may also release the tumor antigen CLDN18.2 targeted chemotherapy and direct killing by ADCC Lysis of tumor cells by toxin can release the tumor antigen to mediate immune response Efficacy ~20% monotherapy ORR in previously treated CLDN18.2 + GC/GEJ/EAC ~10% monotherapy ORR in previously treated CLDN18.2 + GC/GEJ/EAC2 33% monotherapy ORR in previously treated CLDN18.2 + GC/GEJ Safety No Grade 3 neutropenia No Grade 3 vomiting 22% Grade 3 vomiting2 20% Grade 3+ Neutropenia 10% Grade 3 vomiting4 Claudin 18.2 Targetable Expression Broad expression due to Giva-mediated bystander tumor-killing1 Limited to targeting higher CLDN-expressing tumors Likely limited to targeting high CLDN-expressing tumors Givastomig-mediated T cell activation by CLDN18.2-positive tumor cells leads to the killing of nearby CLDN18.2-negative tumor cells Annals of Oncology CMG901 is a CLDN18.2 ADC being developed globally by AstraZeneca ASCO Plenary Series 2023 Notes: ORR = objective response rate, GC/GEJ/EAC = gastric cancer, gastroesophageal junction, EAC = esophageal adenocarcinoma, CLDN = claudin, ADCC = antibody dependent cellular cytotoxicity
Unique Design to Enable Potential Wide Use Plus Favorable Initial Safety Profile Encouraging Responses in Previously Treated Patients, Including Those with Low CLDN18.2 Expression Levels Dose Expansion Data and New Nivolumab + Chemotherapy Combo Study Ongoing Unique Bispecific Design Properties and Monotherapy Data in Gastric Cancers May Position Givastomig as Best-in-Class Claudin 18.2 bispecific Objective responses seen in patients with gastric and esophageal cancer who had received multiple lines of prior treatment, including PD-(L)1, and had low CLDN18.2 levels Response rate and tolerability supports combination in 1L SOC regimens New dose expansion in combination with nivolumab + chemotherapy cohort study began in 1H 2024 in treatment naïve patients with gastric cancers Updated monotherapy dose expansion data in CLDN18.2+ patients with gastric cancers whose disease has progressed after previous treatment to be presented at ESMO 2024 Bispecific design results in CLDN18.2 conditional 4-1BB and T cell activation, potentially limiting toxicity and inducing long-lasting immune memory response Phase 1 dose escalation reached highest planned dose without encountering DLT or liver toxicity signals Notes: Gastric cancers = gastric, gastroesophageal junction and esophageal cancer; ESMO 2024 = the European Society for Medical Oncology Annual Meeting in 2024; SOC = standard of care; DLT = dose limiting toxicity
Molecular Design Target Drug Profile Molecule binds to PD-L1 to inhibit PD-1/PD-L1 interaction Targeting PD-L1+ tumor cells Blocking PD-L1/PD-1 immune inhibitory signaling PD-L1-dependent 4-1BB activation at the tumor site Potent tumor-directed 4-1BB activation to enhance anti-tumor immunity Enhances anti-tumor immunity and re-invigorates exhausted T cells1 Localized 4-1BB activation in TME to mitigate liver toxicity and systemic immune response Ragistomig (ABL503/TJ-L14B, targeting PD-L1 and 4-1BB) A novel bispecific integrates PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator 4-1BB scFv PD-L1 IgG Phase 1 efficacy data presented at ASCO 2024 JITC 2021 Notes: scFv = single chain Fragment-variable region; TME = tumor microenvironment; ASCO 2024 = the American Society for Clinical Oncology Annual Meeting in 2024
Phase 1 Data Support Further Development as a Monotherapy and in Combination with Other Agents Overview: 44 efficacy evaluable patients (53 enrolled) with advanced or relapsed/refractory solid tumors (NCT04762641) 64.2% (34/53) of patients enrolled had at least three prior lines of systemic anti-cancer treatment Efficacy Results at 3 and 5 mg/kg Q2W: Objective Response Rate (ORR) of 26.9% (7/26), Clinical Benefit Ratio (CBR) of 69.2% (18/26) One CR, six PRs, eleven SDs 71.4% of responders had received prior anti-PD-(L)-1 inhibitors The CR was observed in a heavily pretreated ovarian cancer patient dosed at 3 mg/kg (seven lines of prior therapy) Conclusion: Compelling clinical data in checkpoint inhibitor relapsed/refractory and IO naïve patients Treatment Duration (Days) CR start PR start On-going PD start 0.7 mg 2 mg/kg 2 mg 3 mg/kg 7 mg 5 mg/kg 0.3 mg/kg 7 mg/kg 1 mg/kg 10 mg/kg Source: ASCO 2024 Notes: Data cut-off as of April 19, 2024. CR = complete response; PR = partial response; PD = progressive disease; SD = stable disease; IO = Immuno-oncology
Manageable Safety Profile MTD established with 7 mg/kg every two-week dosing Most common TRAEs were increased ALT and increased AST None of the transaminase elevations were accompanied by clinically significant, treatment-related bilirubin increases Grade ≥ 3 ALT or AST increases occurred in 24.5% (13/53) of patients and improved with corticosteroids or ragistomig treatment interruption No cytokine release syndrome occurred, and one infusion-related reaction occurred at 5 mg/kg (Grade 2) ABL503 monotherapy Demography All patients (N = 53) All grades, n(%) Grade ≥ 3, n(%) Any TRAE 40 (75.5) 22 (41.5) TRAE occurring in ≥ 10% of patients Alanine aminotransferase increased 17 (32.1) 12 (22.6) Aspartate aminotransferase increased 16 (30.2) 11 (20.8) Pyrexia 8 (15.1) 1 (1.9) Nausea 7 (13.2) - Rash 7 (13.2) 2 (3.8) Fatigue 6 (11.3) 1 (1.9) Platelet count decreased 6 (11.3) 1 (1.9) Source: ASCO 2024 poster, Table 2 Notes: Data cut-off as of April 19, 2024. MTD = maximally tolerated dose; TRAE = treatment-related adverse events; ALT = alanine aminotransferase; AST = aspartate aminotransferase
Ragistomig Results Compared to Acasunlimab Phase 1 Ragistomig (ABL503) Acasunlimab (GEN1046) Phase Phase 1 (NCT04762641) Phase 1 (NCT03917381) Treatment Monotherapy 0.7 mg – 10 mg/kg, Q2W Monotherapy 25 – 1,200 mg, Q3W Diagnosis Advanced or refractory solid tumors Advanced or refractory solid tumors Efficacy Evaluable 26 (sum of 3 mg/kg and 5 mg/kg) 61 (25 – 1,200 mg) 30 (80 – 200 mg) ORR 26.9% (7/26) 6.6% (4/61) 13.3% (4/30, 80 – 200 mg) DCR (CR+PR+SD) 69.2% (18/26) 65.6% (40/61) Safety Grade 3 AST / ALT: 24.5% (13/53) Grade 3 AST / ALT: 10% Source Ragistomig poster ASCO 2024 Cancer Discovery 2022 Notes: Acasunlimab (Genmab) is developing this mAb = monoclonal antibody. ASCO 2024 = American Society for Clinical Oncology Annual Meeting; ORR = objective response rate; DCR = disease control rate; CR complete response; PR = partial response; SD = stable disease; AST = aspartate aminotransferase; ALT = alanine aminotransferase. Note that the comparisons in the table above are not based on data from head-to-head trials and are not direct comparisons. Differences in trial designs, patient groups, trial endpoints, study sizes, and other factors may impact the comparisons
Cash, cash equivalents and short-term investments as of June 30, 2024 were $207.5M Expected cash runway into 2027 supporting multiple potential inflection points Issued and outstanding ordinary shares of 187.3M representing the equivalent of 81.4M ADSs1 Financial Information and Upcoming Milestones Timing Program Milestone Q3 2024 givastomig Updated Phase 1 dose expansion data at ESMO 2024 Monotherapy (CLDN18.2+ patients with GC, GEJ, EAC) data 1H 2025 uliledlimab First patient dosed in Phase 2 Randomized study in combination with pembrolizumab + chemo 2H 2025 uliledlimab Phase 2 PFS data from uliledlimab + toripalimab Randomized study (TJ Bio China-only data) 2H 2025 givastomig Phase 1b in combination with nivolumab + chemo Safety and ORR data in 1L GC, GEJ, EAC Selected Financial Information Anticipated Upcoming Milestones Assuming the conversion of all ordinary shares into ADSs Notes: CPI = checkpoint inhibitor; CLDN = Claudin; GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma; ESMO 2024 = the European Society for Medical Oncology Annual Meeting in 2024; PFS = progression free survival; ORR = objective response rate
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