I-Mab Provides Business and Corporate Updates and Reports Financial Results for the Year Ended December 31, 2021
- Financial results demonstrate strong fundamentals
- Twenty key clinical milestones achieved year-to-date, including positive data readouts for lemzoparlimab, uliledlimab and felzartamab
- Seven business development deals, including a
US$315M strategic commercial partnership with Jumpcan on eftansomatropin alfa - Global pipeline comprised of 10 clinical stage assets, mostly in phase 2 and phase 3 clinical trials, and 10 pre-clinical programs
- Accelerated development of lemzoparlimab with respect to its expected safety profile and encouraging efficacy signals in multiple clinical trials
- Expected pipeline progress to include 3 to 4 registrational trials, 11 phase 2 and 3 phase 1 clinical trials by the year end
- Expected BLA or product launch in 2023 - 2025 to include felzartamab, eftansomatropin alfa and potentially lemzoparlimab with a possible addition of a pre-BLA product to be in-licensed
- Total cash position of
US$671 million (RMB 4.28 billion )[1], when combined with cash flow from expected upcoming milestone payments of previous deals, sufficient to fund business operations through 2025
During the reporting period,
Secondly, on the corporate development front, the Company has achieved the expected corporate milestones towards its goal to become an innovative global biopharma. The Phase One GMP manufacturing facility in
Thirdly, during the reporting period, the Company has accelerated its dual listing process and expanded its global R&D footprint with a newly established R&D site in
"With tremendous passion and commitment,
These milestones will include initiation of one to two registrational trials for lemzoparlimab in
"As the Company's pipeline advances rapidly, a near-term product portfolio has emerged to potentially include 3 to 4 BLA submissions or market launches in
[1] Including cash and cash equivalents, and short-term investments. |
Updated Pipeline Highlights and Upcoming Milestones
(1) Core assets
Lemzoparlimab: AML/MDS/NHL, end of phase 2 (EOP2) to start 1 or 2 registrational trials in 2022
Uliledlimab: Solid tumors, multiple ongoing phase 2 trials and new combo trials planned
Felzartamab: r/r MM, BLA ready for 3L, phase 3 for 2L, new IND for potentially 1L
Eftansomatropin alfa: PGHD, phase 3, patient recruitment completion in 2Q 2022
Efineptakin alfa: Solid tumors, two phase 2 ongoing
Enoblituzumab: Solid tumors, phase 2 and new combo trials planned
Lemzoparlimab (TJC4): a novel CD47 antibody being developed through a comprehensive clinical development plan for hematologic malignancies and solid tumors in
In terms of the safety profile of lemzoparlimab, the Company conducted a systemic data analysis and safety review based on a larger patient population (over 180 patients) who were treated with lemzoparlimab. As of
- Lemzoparlimab in combination with rituximab for non-Hodgkin's lymphoma (NHL): The Company presented interim dose escalation data of lemzoparlimab in combination with rituximab in relapsed and refractory (r/r) NHL at the 2021
American Society of Hematology (ASH) Annual Meeting. The preliminary data was generated from nine patients with r/r NHL who received at least two prior lines of therapies, with a median of four lines. Safety findings of lemzoparlimab at doses of 20 mg/kg and 30 mg/kg weekly, without a priming dose, are consistent with what were observed at lower doses and no dose-limiting toxicity (DLT) was observed. Positive clinical activity was observed in heavily pretreated patients who had progressed on prior anti-CD20 therapies. Among seven efficacy-evaluable patients, four achieved complete response (CR) [1 transformed FL-DLBCL +3 FL], one partial response (PR) of FL were observed (ORR=71%); two reported stable disease (SD); and the disease control rate (DCR) is 100%. Tumor shrinkage was observed in all evaluable patients. The median time to response was 50 days and response lasted from 61 to 236 days. A high level (80% and 90%) of intra-tumoral distribution measured by IHC of tumor biopsy was reached at 20 mg/kg and 30mg/kg weekly. The dose expansion trial is ongoing to enroll more patients in theU.S. and at additional clinical sites inChina . The Company expects to report additional data in 2H2022 and, pending approval by the NMPA, potentially initiate a pivotal trial in patients with NHL inChina . - Lemzoparlimab in combination with AZA for AML and MDS: Over 70 patients with newly diagnosed MDS and AML have been dosed with lemzoparlimab at 30 mg/kg in combination with AZA. An interim analysis was conducted recently in 47 MDS patients on treatment for various treatment duration. The preliminary results are encouraging, though not conclusive, and showed that overall response and complete response rate in 22 MDS patients with median treatment duration ≥ 4 months is comparable to that of magrolimab. The full data analysis is expected in
June 2022 when all data are matured.Th Company plans to present the complete study at a selected scientific conference 2H/2022. Based on the safety and efficacy results, a registrational trial in patients with MDS is being planned to start in 2022, pending approval by the NMPA. - Lemzoparlimab in combination with PD-1 therapy for solid tumors: A clinical trial in combination with pembrolizumab is ongoing in patients with selected solid tumors in the
U.S. In January, 2022, the first patient was dosed in a phase 2 trial of lemzoparlimab in combination with a PD-1 antibody toripalimab (TUOYI®) in patients with advanced solid tumors. The ongoing phase 2 clinical trial is designed as a basket study. - Lemzoparlimab global clinical trials by AbbVie, including combination therapy with AZA and venetoclax, in patients with AML or MDS and another combination therapy with a CD38 antibody in patients with refractory and relapsing multiple myeloma (r/r MM), are being conducted in the
U.S. I-Mab and AbbVie are working closely to accelerate lemzoparlimab clinical development globally. The AML/MDS trial has the potential to lead to a global pivotal clinical trial whereI-Mab will participate for the purpose of simultaneous registration for the AML indication inChina .
Uliledlimab (TJD5): a highly differentiated CD73 antibody being developed for solid tumors. Phase 1 clinical trial conducted in the
- Differentiated mechanism of action: the Company presented detailed data at the 2021
American Association for Cancer Research (AACR) Annual Meeting in April that highlighted the unique binding epitopes and structure of uliledlimab that enabled the complete CD73 enzymatic inhibition without the "hook effect". Pre-clinical studies have shown that when combined with a PD-(L)1 antibody, uliledlimab exhibited a superior and synergistic inhibitory effect on tumor growth as compared to PD-(L)1 mono-therapy. - Positive phase 1 results in patients with advanced solid tumors: the Company presented detailed
U.S. phase 1 clinical data of uliledlimab in combination with atezolizumab (Tecentriq®) in patients with advanced solid tumors at the 2021American Society of Clinical Oncology (ASCO) Annual Meeting. The combination therapy is safe and well-tolerated with no dose-limiting toxicity. All treatment-related adverse events were either grade 1 or 2. Uliledlimab demonstrated a linear pharmacokinetic (PK) profile and reached full receptor occupancy on B cells at the middle and high dose levels with no "hook effect." Among the 13 efficacy-evaluable patients dosed at ≥ 10 mg/kg, three patients had complete or partial responses (ORR = 23%) and three had stable disease (DCR = 46%). The clinical activity was observed in both PD-(L)1 treatment naïve and refractory cancer patients, including one partial response patient who previously failed nivolumab. Tumor types of patients who had complete or partial responses or stable disease included ovarian clear cell carcinoma, non-small cell lung cancer, and a few other cancers. The three responders were identified as the only patients who exhibited higher co-expression of tumor CD73 and PD-L1 as compared to non-responders, indicating a correlation between higher CD73 expression and clinical activity of uliledlimab and a potential role of CD73 as a predictive biomarker to warrant further investigation. The abstract was selected as a "Top 12" research abstract at the conference. China phase 2 clinical trial: A phase 2 basket trial of uliledlimab in combination with toripalimab (a marketed PD-1 antibody) is ongoing in patients with advanced solid tumors inChina . Preliminary data from this study has been submitted to 2022 ASCO.U.S. phase 2 clinical trial: phase 2 clinical trial of uliledlimab in combination with atezolizumab (Tecentriq®) in patients with ovarian cancer and other selected advanced or metastatic solid tumors is progressing in theU.S. In one cohort, mandatory pre- and post-treatment biopsy was implemented in an attempt to gain further insights into potential correlation between the CD73 expression and efficacy and its potential future application as a predictive biomarker.
Felzartamab (TJ202/MOR202): a differentiated CD38 antibody for the treatment of relapsing and refractory multiple myeloma (MM) and potentially autoantibody-mediated autoimmune diseases such as systemic lupus erythematosus (SLE).
- Third-line MM: The registrational trial has been completed, and the topline data have met the preset primary and secondary endpoints. More importantly, the clinical data have confirmed the clinical advantages of felzartamab in terms of lower infusion-related reaction rate and shorter infusion time, which has made it possible for its use in an out-patient clinic setting etc. In January, 2022, the Company signed a partnership agreement with the Hangzhou Qiantang Government in
China to manufacture felzartamab locally to accelerate its commercialization. The local manufacturing plan is expected to significantly reduce the cost of goods and render felzartamab commercially more competitive. With the new local manufacturing plan integrated, the Company is making all efforts to submit the BLA package in 2022. Further, a commercialization team has been assembled to prepare for the launch readiness of felzartamab inChina . - Second-line MM: Patient enrollment for a randomized, open-label, parallel-controlled phase 3 registrational trial of felzartamab in combination with lenalidomide for second-line MM was completed in September, 2021. The topline data package, when fully matured, is expected to support BLA submission.
- Potential first-line MM: A new IND application is planned in 2022 to initiate a PoC (Proof-of-Concept) clinical trial for the novel combination of felzartamab with another
I-Mab asset as a potential future first-line treatment for MM. The rationale of this combination trial is strongly supported by the pre-clinical evidence. - SLE: Phase 1b trial of felzartamab in patients with systemic lupus erythematosus (SLE) has started to recruit patients.
Eftansomatropin alfa (TJ101): A differentiated long-acting growth hormone for pediatric growth hormone deficiency (PGHD). Eftansomatropin alfa is the only rhGH in its proprietary fusion protein format (pure protein-based molecule) and is not chemically linked with PEG or other linkers. Its safety, tolerability, and efficacy have been well demonstrated in a phase 2 clinical trial in the EU.
- Phase 3 clinical trial for PGHD: This phase 3 registrational trial (TALLER) of eftansomatropin alfa as a weekly treatment for PGHD patients is ongoing in
China . Completion of patient enrollment (N=165) is expected in 2Q 2022 to enable a planned BLA submission in 2023/2024. - Strategic commercial partnership with Jumpcan: In
November 2021 , the Company announced a strategic commercial partnership with Jumpcan, a leading domestic pharmaceutical company specialized in and committed to pediatric medicines, to accelerate the commercialization of eftansomatropin alfa.I-Mab will be the marketing authorization holder (MAH) of the product and supply the product at agreed cost to Jumpcan. Jumpcan will be responsible for commercializing the product and developing new indications in collaboration withI-Mab in mainlandChina . Jumpcan has made an upfront payment ofRMB 224 million toI-Mab . Upon achievement of development, registration and sales milestones, certain milestone payments of up toRMB 1.792 billion will be made, with total non-royalty payments up toRMB 2.016 billion . In addition,I-Mab and Jumpcan will share profits generated from commercialization of the product in mainlandChina on a 50/50 basis, pursuant to whichI-Mab will be entitled to receive tiered low double-digit royalties on net sales. This partnership deal represents one of the largest regardingChina biopharma market.
Efineptakin alfa (TJ107): The world's first and only long-acting recombinant human interleukin-7 ("rhIL-7"). This phase 2 clinical-stage asset is positioned as a monotherapy for the treatment of cancer patients with lymphopenia because of its unique properties of increasing tumor-attacking T cell numbers and as a combination immunotherapy with a PD-1 or PD-L1 antibody because of its potential synergism with PD-1/PDL-1 therapy.
- Efineptakin alfa clinical development in
China byI-Mab : (1) A phase 1 clinical trial inChina in patients with advanced solid tumors is completed with topline safety and PK/PD data presented at the 2021Chinese Society of Clinical Oncology (CSCO) Annual Meeting. (2) A phase 2 clinical trial is ongoing in patients with newly diagnosed glioblastoma multiforme (GBM) treated with standard concurrent chemoradiotherapy. An interim data readout is expected in 2H 2022. (3) Another phase 2 clinical trial of efineptakin alfa in combination with pembrolizumab (Keytruda®) in advanced solid tumors is ongoing. The study includes patients with triple-negative breast cancer (TNBC) and squamous cell cancer of the head and neck (SCCHN). - Clinical data published by Genexine/NeoImmuneTech: (1) According to the data from the NIT-110 dose-escalation trial presented at ASCO 2021, the combination of efineptakin alfa and pembrolizumab is safe and well-tolerated in patients with advanced solid tumors. It significantly increased T cell numbers in both tumor specimens and the peripheral blood in patients treated with efineptakin alfa. (2) Data from phase 1b/2 Keynote-899 study, presented at SITC 2020, showed that combination treatment of efineptakin alfa at 1200 ug/kg with pembrolizumab (Keytruda®) induced 27.8% ORR in patients with metastatic TNBC. (3) Interim results from phase 1 trial (NCT03687957) in newly diagnosed patients with high-grade gliomas (GBM) that had undergone chemoradiotherapy showed that absolute lymphocyte count (ALC) increased by 1.3 – 4.1 fold at week 4 in a dose-dependent manner and lasted up to 12 weeks after injection, with an one-year survival rate of 83.3%.
Enoblituzumab (TJ271): A humanized B7-H3 antibody as an immuno-oncology treatment agent. Enoblituzumab works through a unique dual mechanism, i.e. ADCC and immune activation.
- Enoblituzumab clinical development in
China byI-Mab : A phase 2 clinical trial of enoblituzumab in combination with pembrolizumab (Keytruda®) in patients with selected solid tumors, including non-small cell lung cancer (NSCLC), urothelial carcinoma (UC), and other selected cancers, is ongoing. - Clinical data published by MacroGenics: According to phase 1 cohort expansion trial presented at SITC 2018, enoblizutumab in combination with PD-1 antibody achieved an objective response rate (ORR) of 33.3% in SCCHN patients and of 35.7% in NSCLC patients who had PD-L1 expression less than 1%. Currently, MacroGenics is conducting a phase 2 study of enoblituzumab in combination with retifanlimab (PD-1 antibody) or tebotelimab (PD-1 & LAG-3 bispecific DART® molecule) for first-line treatment of patients with recurrent or metastatic SCCHN.
(2) Other clinical assets
Plonmarlimab (TJM2): a monoclonal antibody targeting human granulocyte-macrophage colony-stimulating factor (GM-CSF), a cytokine that plays a critical role in acute and chronic inflammation and cytokine release syndrome (CRS) associated with CAR-T and severe COVID-19.
- CRS associated with severe COVID-19: In August, 2021, the Company reported positive interim analysis from phase 2/3 trial of plonmarlimab to treat patients with severe COVID-19. Plonmarlimab treatment resulted in a higher mechanical ventilation free (MVF) rate (83.6% vs. 76.7%) by day 30, a lower mortality rate (4.9% vs. 13.3%) by day 30, higher recovery rates (68.9% vs. 56.7% at day 14 and 80.3% vs. 70.0% at day 30), as well as reduced time to recovery and hospitalization duration, as compared to placebo. Biomarker results were consistent with the observed clinical outcome and indicated patients treated with plonmarlimab had a reduction in plasma levels of pro-inflammatory cytokines and chemokines critically involved in CRS, including TARC, IP10, GCSF, IL10, IL6, MCP1, IL1RA, TNF-alpha but not interferon-gamma. A transient increase in Neutrophil to Lymphocyte Ratio (NLR) that is commonly associated with disease exacerbation was only observed in placebo. Plonmarlimab was well tolerated in all patients with no significant safety concerns. The clinical data obtained so far have validated the effect of plonmarlimab on CRS, paving the way to continue exploring the therapeutic indications where CRS is a critical element of the diseases. Additional clinical data are being analyzed to determine the next step development plan.
TJ210/MOR210: A novel monoclonal antibody targeting C5aR1 to treat cancers through myeloid-derived suppressor cells and modulation of tumor micro-environment in favor of enhanced anti-tumor immune response as a novel mechanism of action. The pre-clinical studies have provided ample scientific evidence for the role of TJ210 in the treatment of cancers. Research is continuing, through in vitro and in vivo experimental systems, to identify and validate the most effective combo partner(s) for TJ210 to guide further clinical development of TJ210.
- Phase 1 clinical trial in patients with advanced solid tumors in the
U.S. andChina byI-Mab : Phase 1 study is ongoing in US and patient recruitment for dose escalation will complete in Q2 2022. Another non-overlapping phase 1 clinical trial has been approved by China NMPA and is expected to commence in early Q2 2022. - IND for phase 2a clinical trial of TJ210 in combination with toripalimab (a marketed PD-1 antibody) is planned for submission in Q2 2022.
TJ-CD4B/ABL111: A novel Claudin 18.2 and 4-1BB bispecific antibody capable of binding to tumor cells expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer cells, and stimulating intra-tumoral T cells by the 4-1BB arm designed to become active only upon tumor engagement to avoid systemic toxicity.
- Phase 1 clinical trial of TJ-CD4B in patients with advanced or metastatic solid tumors is ongoing in the
U.S. The dose escalation part of the study reached 3mg/kg without dose limited toxicity. More data are being generated as the trial progresses. - Additional clinical sites in
China will now join the study in Q1 2022, enrolling primarily patients with gastric cancer, gastroesophageal junction carcinoma, esophageal adenocarcinoma and pancreatic ductal adenocarcinoma.
TJ-L14B/ABL503: A differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon local tumor engagement.
- Phase 1 clinical trial of TJ-L14B is ongoing in the
U.S. in patients with advanced or metastatic solid tumors. The dose escalation reached 3mg/kg without severe adverse events. More data are being generated as the trial progresses.
(3) Pre-clinical assets and programs
The Company has been working on generating additional bi-functional or bi-specific antibody molecules with unique properties that rely on synergism of two given targets. The overarching goal behind these bi-specific molecules is to stimulate the immune responses within the tumor environment to convert immunologically non-responsive 'cold' tumors into responsive 'hot' tumors. The company has made steady progress in the past year culminating in successful candidate selection of two bispecific molecules.
TJ-L1IF is a next-generation PD-L1/IFN-α antibody-cytokine fusion protein, which is specifically designed for the treatment of solid tumors, especially for PD1/PD-L1 resistant tumors, through addition of a strong immune adjuvant IFN-α to convert "cold" tumor to "hot" tumor on top of a PD-L1 antibody to achieve superior anti-tumor activity than PD-(L)1 antibody monotherapy. IFN-α was the first cytokine approved for cancer treatment, but its use has been limited due to considerable systemic toxicity. TJ-L1IF is composed of a PD-L1 VHH nanobody linked with the Fc of human IgG with an engineered IFN-α2b fused at the C-terminus. It is a prodrug in that the IFN-α2b moiety is masked by a PEG group through a protease-cleavable linker rendering the drug inactive in the systemic circulation, thus strongly reducing systemic toxicity. Once the drug reaches the tumor by PDL1 antibody targeting, the linker can be removed by tumor-associated proteases to achieve tumor-site specific activation. This unique property of TJ-L1IF has been confirmed in a series of in vitro and in vivo studies, in which TJ-L1IF demonstrated plasma stability, good safety in cynomolgus monkeys, and superior activity against solid tumors in mouse models, particularly for the PD1/PD-L1 resistant tumors, than that could be achieved by PD-L1 antibody or IFN-α used either alone or in combination. TJ-L1IF was developed using Affinity's TMEA technology, and is now under pre-clinical development.
TJ-C64B is the third bispecific molecule developed leveraging our conditional 4-1BB platform which has the advantage of systemic safety and minimizing liver toxicity. It is specifically designed to simultaneously target tumor-associated antigen Claudin 6 (CLDN6) and 4-1BB for CLDN6+ solid tumor treatment. CLDN6 is regarded as an attractive cancer target due to its tumor-specific expression pattern: it is aberrantly expressed in a variety of tumor types, especially those with limited response to PD-1/PD-L1 immunotherapy, such as ovarian cancer, but is hardly detectable in normal adult tissues. We have now demonstrated that TJ-C64B activates T cells through 4-1BB stimulation only upon CLDN6 engagement, providing a more localized activation of the immune system with good efficacy and reduced systemic toxicity. Owing to a competent Fc, TJ-C64B has an added advantage of specifically depleting CLDN6-expressing tumor cells and intratumor regulatory T cells which are typically 4-1BB high, which differentiates it from other 4-1BB bispecific antibodies under clinical development. Compelling immune activation and tumor inhibition have been observed both in vitro and in vivo towards cancer cell lines with different CLDN6 expression levels. Importantly, no significant changes in liver enzymes following repeated administrations in mice and cynomolgus monkeys, suggesting little risks for liver toxicity commonly seen by other 4-1BB agonist antibodies. TJ-C64B is currently under pre-clinical development, and some of the pre-clinical data will be published at 2022 AACR.
At the discovery front, the 'super antibody' partnership initiatives we recently launched are making good progress, especially in the masked antibody and AI-guided cytokine drug design areas. Together with internal discovery with a focus on novel targets for macrophage phagocytosis and T cell activation, they form the discovery engine that drives future pipeline growth. This growing new portfolio of novel drug candidates represents our strong commitment to sustaining the global competitiveness of our pipeline through continued innovation and complements the existing clinical programs.
Business Development and Partnership Deals
During the reporting period, the Company has completed 7 research, biomarker and commercial partnership deals. The deals are strategically focused on the following business areas. (1) Research partnerships were aimed to build the next wave of innovative assets that are enabled by transformative technologies. The five active partnerships allow
(2) Commercial partnerships are designed to enhance the Company's commercialization capability for upcoming product launches and co-commercialization of selected products. In November, 2021,
(3) In-licensing and out-licensing deals are part of the Company's pipeline strategy to either enrich its late-stage and near-term product portfolio through selective in-licensing or co-development or partner the ex-
Near-Term Product Portfolio and Commercialization
With the rapid progress of the pipeline,
The Company's near-term product portfolio has significant commercial potential. Firstly, the total annual incidences for three disease entities of major hematologic malignancies, i.e. multiple myeloma, leukemia (AML/MDS), and lymphoma, are estimated to be approximately 173,000 (Globocan, 2020) in
Steps Towards Becoming a Specialized Global Biopharma
(1) Global footprint. The Company has been expanding its global R&D and corporate footprint and is now globally connected with six sites or offices across
(2) Manufacturing facility. To support the rapidly growing and maturing pipeline for the manufacturing needs, substantial progress has been made in the construction of a state-of-the-art GMP manufacturing facility in
The Phase Two commercial production facility is being constructed to accommodate up to 8 x 4,000L commercial production lines and is on track to be completed by 2024. The
(3) Dual listing. The Company is accelerating its effort to pursue a dual listing to complement its Nasdaq investor base. The
Updates Regarding Holding Foreign Companies Accountable Act (HFCAA)
The
In
Nevertheless,
Additionally, the Company is considering all viable options to offer the Company's existing shareholders additional trading flexibility and will make public announcement(s) to disclose any material updates and progress with respect to its efforts in this regard when appropriate. As previously disclosed in the Company's press release dated
The Company cautions its shareholders and others considering trading the Company's securities that substantial uncertainties remain with respect to the future development of the issue and there may be a number of factors out of the Company's control.
ESG Update
In
Also in
In
Corporate Development
I-Mab was added to the MSCI China All Shares Index inMay 2021 , demonstratingI-Mab's growing profile and recognition among the global investor communities.I-Mab further strengthened its senior management team. Dr.Andrew Zhu , an internationally renowned oncologist, was appointed as President and board director to lead the Company's R&D organization, focusing on global pipeline development. Founder and Chairman Dr.Jingwu Zang was named Acting Chief Executive Officer.John Long was appointed as the Company's Chief Financial Officer.Mr. Long oversees the Company's global finance team and leads capital markets activities, investor relations, and all aspects of financial management. Mr. Jielun Zhu (former CFO) was appointed as the Company's Chief Strategy Officer. In his new role,Mr. Zhu is responsible for planning and execution of corporate development strategy, strategic initiatives (including global partnerships, strategic investments, and potential M&A) and venture activities.I-Mab further strengthened its board of directors through new appointments of Ms.Lan Kang , who is currently a managing director atCBC Group , Ms.Liu Xi , who is currently a partner atHony Life Sciences Ventures , Dr.Andrew Zhu (President), Mr.John Long (new CFO), and Dr.Ruyi He and ProfessorRong Shao as independent board members. Each of the new members of the board carries a wealth of experience and expertise that is critical to the development of the Company.I-Mab received many international recognition and awards. Among them, the "2021 Executive of the Year" by Scrip Awards, the "2021 Company of the Yea" and "2020 Deal of the Year" by BioCentury and BayHelix, the "Honored Companies" and "Best CFO" categories by the leading global financial publication Institutional Investor, the "2021 Entrepreneur of the Year" by Ernst&Young, the "T+ Excellent Employer" Award, "2021 Top 50 Enterprises ofTechnology Power " byFrost & Sullivan and LeadLeo, the "2021 Top10 Innovative Biologics" by China Health Industry Summit, and the "Top10 Innovative Therapies" by SINA Medical.
Full-Year 2021 Financial Results
Cash Position
As of
Net Revenues
Total net revenues for the full year of 2021 were RMB 88.0 million (
Research & Development Expenses
Research and development expenses for the full year of 2021 were
Administrative Expenses
Administrative expenses for the full year of 2021 were
Other Income (Expenses), net
Net other income for the full year of 2021 was
Equity in loss of affiliates
Equity in loss of affiliates for the full year of 2021 was
Net Income (Loss)
Net loss for the full year of 2021 was
Non-GAAP Net Income (Loss)
Non-GAAP adjusted net loss, which excludes share-based compensation expenses, for the full year of 2021 was
Conference Call and Webcast Information
The Company's management will host conference calls to discuss the results and updates, and a Mandarin session conference call will be held at
Meeting URL: |
https://i-mabbiopharma.zoom.us/j/96418354928?pwd=c2VNd05CaVJlbGpCNk1XZ2hnWnhWZz09 |
Meeting ID: |
964 1835 4928 |
Password: |
196013 |
English Session
Meeting URL: |
https://i-mabbiopharma.zoom.us/j/91551271577?pwd=dzVRTENUdFlJVTFHNGV5eGExTTZydz09 |
Meeting ID: |
915 5127 1577 |
Password: |
953415 |
About
I-Mab Forward Looking Statements
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the
Use of Non-GAAP Financial Measures
To supplement its consolidated financial statements which are presented in accordance with
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 that has been and may continue to be incurred in the future.
Exchange Rate Information
This announcement contains translations of certain RMB amounts into
For more information, please contact:
E-mail: IR@i-mabbiopharma.com
E-mail: PR@i-mabbiopharma.com
Investor Inquiries:
E-mail: emilie@thepiacentegroup.com
Office line: + 86 21 6039 8363
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Consolidated Balance Sheets |
|||||
(All amounts in thousands, except for share and per share data, unless otherwise noted) |
|||||
As of |
|||||
2020 |
2021 |
||||
RMB |
RMB |
US$ |
|||
Assets |
|||||
Current assets |
|||||
Cash and cash equivalents |
4,758,778 |
3,523,632 |
552,935 |
||
Accounts receivable |
130,498 |
33,081 |
5,191 |
||
Contract assets |
227,391 |
253,780 |
39,824 |
||
Short-term investments |
31,530 |
753,164 |
118,188 |
||
Inventories |
- |
27,237 |
4,274 |
||
Prepayments and other receivables |
195,467 |
190,824 |
29,944 |
||
Total current assets |
5,343,664 |
4,781,718 |
750,356 |
||
Property, equipment and software |
25,272 |
45,716 |
7,174 |
||
Operating lease right-of-use assets |
14,997 |
112,781 |
17,698 |
||
Intangible assets |
120,444 |
119,666 |
18,778 |
||
|
162,574 |
162,574 |
25,511 |
||
Investments accounted for using the equity |
664,832 |
380,342 |
59,684 |
||
Other non-current assets |
2,010 |
26,634 |
4,179 |
||
Total assets |
6,333,793 |
5,629,431 |
883,380 |
||
Liabilities and shareholders' equity |
|||||
Current liabilities |
|||||
Accruals and other payables |
560,558 |
593,335 |
93,107 |
||
Operating lease liabilities, current |
8,058 |
30,669 |
4,813 |
||
Deferred subsidy income |
7,509 |
- |
- |
||
Total current liabilities |
576,125 |
624,004 |
97,920 |
||
Put right liabilities |
116,006 |
96,911 |
15,207 |
||
Contract liabilities |
- |
224,000 |
35,150 |
||
Operating lease liabilities, non-current |
5,542 |
81,786 |
12,834 |
||
Other non-current liabilities |
8,975 |
14,934 |
2,343 |
||
Total liabilities |
706,648 |
1,041,635 |
163,454 |
||
Shareholders' equity |
|||||
Ordinary shares ( |
114 |
126 |
20 |
||
Additional paid-in capital |
7,701,116 |
9,129,013 |
1,432,541 |
||
Accumulated other comprehensive loss |
(50,793) |
(186,510) |
(29,267) |
||
Accumulated deficit |
(2,023,292) |
(4,354,833) |
(683,368) |
||
Total shareholders' equity |
5,627,145 |
4,587,796 |
719,926 |
||
Total liabilities and shareholders' equity |
6,333,793 |
5,629,431 |
883,380 |
||
|
||||||||
Consolidated Statements of Comprehensive Income (Loss) |
||||||||
(All amounts in thousands, except for share and per share data, unless otherwise noted) |
||||||||
Year Ended |
||||||||
2019 |
2020 |
2021 |
||||||
RMB |
RMB |
RMB |
US$ |
|||||
Revenues |
||||||||
Licensing and collaboration revenue |
30,000 |
1,542,668 |
40,115 |
6,295 |
||||
Supply of investigational products |
- |
- |
47,911 |
7,518 |
||||
Total revenues |
30,000 |
1,542,668 |
88,026 |
13,813 |
||||
Cost of revenues |
- |
- |
(46,432) |
(7,286) |
||||
Gross profit |
30,000 |
1,542,668 |
41,594 |
6,527 |
||||
Expenses |
||||||||
Research and development expenses (Note 1) |
(840,415) |
(984,689) |
(1,212,958) |
(190,340) |
||||
Administrative expenses (Note 2) |
(654,553) |
(402,409) |
(899,943) |
(141,221) |
||||
Income (loss) from operations |
(1,464,968) |
155,570 |
(2,071,307) |
(325,034) |
||||
Interest income |
30,570 |
24,228 |
21,333 |
3,348 |
||||
Interest expense |
(2,991) |
(957) |
- |
- |
||||
Other income (expenses), net |
(20,205) |
412,892 |
83,162 |
13,050 |
||||
Equity in loss of affiliates (Note 3) |
- |
(108,587) |
(367,883) |
(57,729) |
||||
Fair value change of warrants |
5,644 |
- |
- |
- |
||||
Income (loss) before income tax expense |
(1,451,950) |
483,146 |
(2,334,695) |
(366,365) |
||||
Income tax benefit (expense) |
- |
(12,231) |
3,154 |
495 |
||||
Net income (loss) attributable to |
(1,451,950) |
470,915 |
(2,331,541) |
(365,870) |
||||
Deemed dividend to Series C-1 preferred |
(5,283) |
- |
- |
- |
||||
Deemed dividend to Series B-1, B-2 and C preferred |
(27,768) |
- |
- |
- |
||||
Net income (loss) attributable to ordinary shareholders |
(1,485,001) |
470,915 |
(2,331,541) |
(365,870) |
||||
Net income (loss) attributable to |
(1,451,950) |
470,915 |
(2,331,541) |
(365,870) |
||||
Other comprehensive income (loss): |
||||||||
Foreign currency translation adjustments, net of nil |
10,747 |
(120,920) |
(135,717) |
(21,297) |
||||
Total comprehensive income (loss) attributable to |
(1,441,203) |
349,995 |
(2,467,258) |
(387,167) |
||||
|
||||||||
Consolidated Statements of Comprehensive Income (Loss) (Continued) |
||||||||
(All amounts in thousands, except for share and per share data, unless otherwise noted) |
||||||||
Year Ended |
||||||||
2019 |
2020 |
2021 |
||||||
RMB |
RMB |
RMB |
US$ |
|||||
Net income (loss) attributable to ordinary shareholders |
(1,485,001) |
470,915 |
(2,331,541) |
(365,870) |
||||
Weighted-average number of ordinary shares used in |
7,381,230 |
134,158,824 |
174,707,055 |
174,707,055 |
||||
Weighted-average number of ordinary shares used in |
7,381,230 |
157,231,652 |
174,707,055 |
174,707,055 |
||||
Net income (loss) per share attributable to ordinary |
||||||||
—Basic |
(201.19) |
3.51 |
(13.35) |
(2.09) |
||||
—Diluted |
(201.19) |
3.00 |
(13.35) |
(2.09) |
||||
Net income (loss) per ADS attributable to ordinary |
||||||||
—Basic |
(462.74) |
8.07 |
(30.71) |
(4.82) |
||||
—Diluted |
(462.74) |
6.90 |
(30.71) |
(4.82) |
Note: |
(1) Includes share-based compensation expense of |
(2) Includes share-based compensation expense of |
(3) Includes share-based compensation expense of |
(4) Each ten ADSs represents twenty-three ordinary shares. |
|
|||||||
Reconciliation of GAAP and Non-GAAP Results |
|||||||
Year ended |
|||||||
2019 |
2020 |
2021 |
|||||
RMB |
RMB |
RMB |
US$ |
||||
GAAP net income (loss) attributable to |
(1,451,950) |
470,915 |
(2,331,541) |
(365,870) |
|||
Add back: |
|||||||
Share-based compensation expense |
515,203 |
526,171 |
621,876 |
97,586 |
|||
Non-GAAP adjusted net income (loss) attributable |
(936,747) |
997,086 |
(1,709,665) |
(268,284) |
|||
Non-GAAP adjusted income (loss) attributable to |
(969,798) |
997,086 |
(1,709,665) |
(268,284) |
|||
Weighted-average number of ordinary shares used in |
7,381,230 |
134,158,824 |
174,707,055 |
174,707,055 |
|||
Weighted-average number of ordinary shares used in |
7,381,230 |
157,231,652 |
174,707,055 |
174,707,055 |
|||
Non-GAAP adjusted income (loss) per share |
|||||||
—Basic |
(131.39) |
7.43 |
(9.79) |
(1.54) |
|||
—Diluted |
(131.39) |
6.34 |
(9.79) |
(1.54) |
|||
Non-GAAP adjusted income (loss) per ADS |
|||||||
—Basic |
(302.20) |
17.09 |
(22.52) |
(3.53) |
|||
—Diluted |
(302.20) |
14.58 |
(22.52) |
(3.53) |
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