Uliledlimab

Completed divestiture of China operations Uliledlimab IND clearance paves the way for U.S. combination studies in first-line mNSCLC (CD73 antibody) Clinical collaboration and supply agreement with Bristol Myers Squibb strengthens givastomig first-line gastric cancer combination studies (CLDN18.2 X 4-1BB bispecific) Ragistomig presentation at ASCO 2024 highlights encouraging early data (PD-L1 X 4-1BB bispecific) Well-positioned for pipeline advancement with $207.5 million in cash and cash equivalents, and short-term investments as of June 30, 2024, and cash runway expected into 2027 I-Mab will hold a conference call and webcast today, August 28th, at 8:00 AM ET ROCKVILLE, Md., Aug. 28, 2024 /PRNewswire/ -- 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. 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 Webcast: please click here Note that Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. The Call me™ link will be made active 15 minutes prior to the scheduled start time. 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 clicking here. 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 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 SOURCE I-Mab Biopharma

Recently announced agreement to divest assets and business operations in China marks an important milestone for the Company; the transaction is expected to close by the end of March 2024 Uliledlimab (CD73 antibody) on track to file an IND in combination with chemotherapy and checkpoint inhibitors for patients with newly diagnosed NSCLC in 1H 2024 First patient dosed in an ongoing, triplet combination, dose escalation study of givastomig (CLDN18.2x4-1BB bispecific antibody) in 1Q 2024 RMB2.3 billion (US$321.8 million) in cash and cash equivalents, and short-term investments as of December 31, 2023 ROCKVILLE, Md., March 14, 2024 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ: IMAB), a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer, today announced financial results for the full year ended December 31, 2023, and highlighted recent business updates. "2023 was a transitional year for I-Mab and we were pleased to report encouraging clinical results in our two lead global assets in oncology, uliledlimab and givastomig. As we prepare for the closing of the strategic divestiture, we look forward to providing investors with a road map to value creation and believe that our differentiated clinical assets, uliledlimab, givastomig, and ragistomig will achieve critical milestones and trial initiations this year," said Raj Kannan, Director and Chief Executive Officer of I-Mab. Pipeline Overview and Upcoming Milestones: Uliledlimab: Phase 2, with a focus on non-small cell lung cancer (NSCLC) Uliledlimab is designed to target CD73 and promote stronger activation of the patient's immune system against cancer cells. Uliledlimab is potentially differentiated from other products in development due to its non-competitive binding with adenosine monophosphate and the potential for complete inhibition of CD73's immune dampening function. Encouraging results from a Phase 2 study of uliledlimab in combination with toripalimab, presented at the American Society for Clinical Oncology (ASCO 2023) in patients with advanced NSCLC, provided compelling support for further development of uliledlimab. In particular, the subset of patients with both high CD73 expression and PD-L1 TPS>1% showed an impressive 63% overall response rate. Additionally, enrollment of patients with treatment resistant ovarian cancer has been completed, and ongoing efforts will be streamlined to focus on expediting NSCLC development. Upon the receipt of the investigational new drug (IND) approval, the Company plans to initiate the triplet study for uliledlimab in combination with chemotherapy and checkpoint inhibitors in newly diagnosed patients with advanced NSCLC in the second half of 2024. Givastomig (Claudin 18.2 x 4-1BB bispecific antibody): Phase 1b, with a focus on gastric cancer and esophageal adenocarcinoma Givastomig was designed as a bispecific antibody to target Claudin 18.2-positive tumor cells, with conditional activation of pro-immune 4-1BB in the tumor microenvironment. Phase 1 monotherapy data presented at the European Society of Medical Oncology (ESMO 2023) showed encouraging objective responses in patients with gastric cancer and esophageal adenocarcinoma whose tumors progressed or recurred after prior standard treatments, including those with low levels of Claudin 18.2 expression. This program is being jointly developed with ABL Bio. I-Mab owns 50% of the global rights of givastomig. The enrollment of patients from the U.S. and China with newly diagnosed (frontline treatment) gastric and esophageal cancer in combination with chemotherapy and a checkpoint inhibitor began in the first quarter of 2024. Ragistomig (PD-L1 x 4-1BB bispecific antibody): Phase 1 dose escalation, with a focus on solid tumors Ragistomig was designed as a bispecific antibody to address PD-L1 resistant tumors, differentiated by the conditional activation of 4-1BB's pro-immune stimulation when it binds to its PD-L1 target. Early observations reported by our development partner, ABL Bio, 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 signs of efficacy are encouraging, and enrollment in the Phase 1 study continues. This program is being jointly developed with ABL Bio. I-Mab owns 50% of the global rights of ragistomig (TJ-L14B/ABL503). Top-line Phase 1 dose escalation and dose expansion results are expected to be presented at a major medical conference in the first half of 2024. Impact of Strategic Transaction on Pipeline The agreement to divest assets and business operations in China, previously announced in a press release on February 7, 2024, is expected to be completed by the end of March 2024. Upon the closing of the transaction, the Greater China rights for assets including eftansomatropin alfa, felzartamab, uliledlimab, and givastomig will be transferred to I-Mab Biopharma (Hangzhou) Co., Ltd., an unconsolidated affiliate (the " Hangzhou Company"). I-Mab will no longer bear future development costs of these divested assets in China and may receive an aggregate consideration of the RMB equivalent of up to US$80 million, contingent on the Hangzhou Company group's achievement of certain future regulatory and sales-based milestone events relating to these divested assets in China. The transaction, if closed, will also extinguish existing repurchase obligations owed by a wholly-owned subsidiary of the Company in the amount of approximately US$183 million. As a result of the closing of the transaction, the Company will cease consolidation of the divested entities, assets, and businesses as well as their corresponding financial results. The Company's financial condition and results of operations will be materially affected and the Company's historical results will not be indicative of future financial condition or results of operations. Full-Year 2023 Financial Results Cash Position As of December 31, 2023, the Company had cash, cash equivalents, and short-term investments of RMB2.3 billion (US$321.8 million), compared with RMB3.5 billion as of December 31, 2022. Share Buyback In August 2023, the Board of Directors of the Company authorized a new share repurchase program under which the Company may repurchase up to US$40 million of American Depository Shares ("ADSs"), each ten ADSs representing 23 ordinary shares of the Company, or ordinary shares in aggregate over a 12-month period. During the period ended December 31, 2023, the Company repurchased US$8.6 million of its ADSs, equating to 4,633,386 ADSs or 10,656,794 ordinary shares. As of December 31, 2023, the Company had issued and outstanding ordinary shares of 185,613,662, representing the equivalent of 80,701,592 ADSs assuming the conversion of all ordinary shares into ADSs. Net Revenues Total net revenues for the full year of 2023 were RMB27.6 million (US$3.9 million), compared with RMB-221.6 million (US$-32.1 million) for the full year of 2022. Total net revenues in 2023 consisted of revenues recognized in connection with the strategic collaboration with AbbVie Inc. (AbbVie) and revenues generated from the supply of investigational products to AbbVie and Human Immunology Biosciences, Inc. The negative figure for net revenue in 2022 was primarily due to a one-time, non-cash accounting treatment of US$-48.0 million (equivalent to RMB-314.2 million) recorded in the second half of 2022 following the amendment to the original license and collaboration agreement with AbbVie in August 2022. This amendment led to a reduced probability of achieving a key milestone that was included in the consideration of revenue recognition in prior years. Research & Development Expenses Research and development expenses for the full year of 2023 were RMB810.6 million (US$114.2 million), compared with RMB904.9 million (US$131.2 million) for the full year of 2022. The decrease was primarily due to reduced payroll expenses related to headcount optimization as a result of asset prioritization and reduced share-based compensation expenses. Share-based compensation expense was RMB66.8 million (US$9.4 million) for the full year of 2023, compared with RMB117.9 million (US$17.1 million) for the full year of 2022. Administrative Expenses Administrative expenses for the full year of 2023 were RMB453.0 million (US$63.8 million), compared with RMB815.8 million (US$118.3 million) for the full year of 2022. The decrease was primarily due to reduced payroll expenses related to decreased headcount as a result of resource optimization and reduced share-based compensation expenses for management personnel, reduced expenses for professional services, and reduced legal expenses in relation to the disputes with Tracon Pharmaceuticals, Inc. of RMB95.5 million (US$13.5 million). Share-based compensation expense was RMB126.2 million (US$17.8 million) for the full year of 2023, compared with RMB239.3 million (US$34.7 million) for the full year of 2022. Other Expenses, Net Net other expenses for the full year of 2023 were RMB38.1 million (US$5.4 million), compared with RMB126.6 million (US$18.4 million) for the full year of 2022. The change was primarily driven by unrealized exchange rate losses due to the significant fluctuation in the exchange rate of the Renminbi against the U.S. dollar in 2022. Equity in Loss of Affiliates Equity in loss of affiliates for the full year of 2023 was RMB80.0 million (US$11.3 million), compared with RMB437.5 million (US$63.4 million) for the full year of 2022. The loss was mainly recognized in relation to the operating loss of the Company's investee, I-Mab Biopharma (Hangzhou) Co., Ltd. Impairment of Goodwill For the full year of 2023, the Company recognized an impairment of goodwill of RMB162.6 million (US$22.9 million). The goodwill impairment resulted from the Company's annual impairment analysis, and reflects the continued disconnect between I-Mab's anticipated future performance and present uncertainty reflected in its market valuation. Net Loss Net loss for the full year of 2023 was RMB1,465.7 million (US$206.4 million), compared with RMB2,507.3 million (US$363.5 million) for the year 2022. Net loss per share attributable to ordinary shareholders for the full year of 2023 was RMB7.19 (US$1.01), compared with RMB13.21 (US$1.92) for the full year of 2022. Net loss per ADS attributable to ordinary shareholders for the full year of 2023 was RMB16.54 (US$2.33), compared with RMB30.38 (US$4.41) for the full year of 2022. Non-GAAP Net Loss Non-GAAP adjusted net loss, which excludes share-based compensation expenses and impairment of goodwill, for the full year of 2023 was RMB1,105.3 million (US$155.7 million), compared with RMB2,136.3 million (US$309.7 million) for the full year of 2022. Non-GAAP adjusted net loss per share attributable to ordinary shareholders for the full year of 2023 was RMB5.42 (US$0.76), compared with RMB11.26 (US$1.63) for the full year of 2022. Non-GAAP adjusted net loss per ADS attributable to ordinary shareholders for the full year of 2023 was RMB12.47 (US$1.76), compared with RMB25.90 (US$3.75) for the full year of 2022. Use of Non-GAAP Financial Measures To supplement its consolidated financial statements, which are presented in accordance with U.S. GAAP, the Company uses adjusted net income (loss) as a non-GAAP financial measure. Adjusted net income (loss) represents net income (loss) before share-based compensation and impairment of goodwill. The Company's management believes that adjusted net income (loss) facilitates 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 income (loss) is that adjusted net income (loss) excludes share-based compensation expense and impairment of goodwill that has been and may continue to be incurred in the future. Exchange Rate Information This announcement contains translations of certain Renminbi amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from Renminbi to U.S. dollars of the financial results for the year of 2023 are made at a rate of RMB7.0999 to US$1.00, the rate in effect as of December 29, 2023, published by the Federal Reserve Board. All translations from Renminbi to U.S. dollars of the financial results for the year of 2022 are made at a rate of RMB6.8972 to US$1.00, the rate in effect as of December 30, 2022 published by the Federal Reserve Board. Notes: (1) Includes share-based compensation expense of RMB117,876 thousand (US$17,090 thousand) and RMB66,758 thousand (US$9,403 thousand) for the years ended December 31, 2022 and 2023, respectively. (2) Includes share-based compensation expense of RMB239,272 thousand (US$34,691 thousand) and RMB126,244 thousand (US$17,781 thousand) for the years ended December 31, 2022 and 2023, respectively. (3) Includes share-based compensation expense of RMB13,852 (US$2,008 thousand) and RMB4,815 thousand (US$678 thousand) for the years ended December 31, 2022 and 2023, respectively. (4) Each ten ADSs represents twenty-three ordinary shares. About I-Mab I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer. I-Mab has established operations in the U.S. in Rockville, Maryland, and in San Diego, California. For more information, please visit and follow us on LinkedIn, X, and WeChat. 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 timing of the completion of the expected divestiture of the Company's assets and business operations in China and its anticipated impact on the Company (including the transfer of Greater China rights for assets, including eftansomatropin alfa, felzartamab, uliledlimab, and givastomig to the Hangzhou Company, the expected consideration to be received by I-Mab and the expected extinguishment of an existing repurchase obligation of US$183 million); the Company's expectations regarding providing a road map to value creation and its belief that its clinical oncology programs will achieve critical milestones and trial initiations this year; the Company's pipeline overview and upcoming anticipated milestones, including with respect to uliledlimab, givastomig, and ragistomig, and the intended impact and the Company's plans with respect thereto. 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 SOURCE I-Mab