I-Mab Provides Business and Corporate Updates and Reports Financial Results for the Six Months Ended June 30, 2021
- 13 significant clinical milestones achieved year-to-date, including critical positive data readout events for felzartamab (TJ202/MOR202), lemzoparlimab (TJC4), uliledlimab (TJD5), and plonmarlimab (TJM2) and more milestone achievements are expected before the year-end 2021
- Felzartamab (TJ202/MOR202) is on track for Biologic License Application (BLA) submission in Q4 2021 and eftansomatropin alfa (TJ101) phase 3 trial on track for completion of patient enrollment and potential commercial collaboration
- Growing pipeline with eight highly differentiated and clinically advanced assets in phase 2/3, followed by next generation of immuno-oncology assets, including bi-specific antibodies in phase 1 or pre-clinical stage and novel drug candidates enabled by transformative technologies for unique drug properties, e.g. AI-guided targeting, antibody by mRNA delivery, intracellular targeting and tumor-site activation
- Inclusion of the MSCI China All Shares Index, preparation of potential dual listing on
China's STAR Market, and receiving of a high rating from the MSCI ESG assessment (the highest newly initiated rating amongChina -based biotech companies) - Progress in building the manufacturing and commercialization capabilities as part of Company's transformation to a global biopharma
During the reporting period,
"With the corporate focus and execution by our highly committed team,
"The progress we have made so far has placed us firmly on track to deliver the rest of the critical milestones and has effectively secured our overall development plan for the key assets such as felzartamab, eftansomatropin alfa, lemzoparlimab, uliledlimab, and plonmarlimab. We are very excited and confident to succeed in our journey to transition from a clinical stage biotech now to a global biopharma within the next few years,"
Recent Pipeline Highlights and Upcoming Milestones
(1) Phase 3/pre-BLA assets
Felzartamab (TJ202/MOR202): A differentiated CD38 antibody for the treatment of multiple myeloma (MM) and potentially autoantibody-mediated autoimmune diseases such as systemic lupus erythematosus (SLE).
Felzartamab for MM third-line treatment is on track for BLA submission in Q4 2021 and MM second-line registrational trial is on track. The Company plans to submit a new IND application in Q3 2021 to explore the combination of felzartamab with another I-Mab clinical asset as a potential first-line treatment for MM. The rationale of this combination study is strongly supported by the pre-clinical evidence.
- Third-line MM: The topline data of the registrational trial have met the primary and secondary endpoints. More importantly, the data have confirmed the clinical advantages of felzartamab with respect to its lower infusion-related reaction rate, shorter infusion time for out-patient administration etc. BLA submission is on track for Q4 2021. Under the leadership of
Mr. Zhu , Chief Commercial Officer, the Company has assembled an integrated multi-functional team to focus on the launch readiness of felzartamab inChina . - Second-line MM: Phase 3 registrational trial of felzartamab in combination with lenalidomide for second-line MM is on track. The Company expects to complete patient enrollment in
September 2021 . The topline data package is expected to support a BLA submission in 2023. - Potential first-line MM: A new IND application is planned in Q3 2021 to initiate a clinical trial for the combination of felzartamab with another
I-Mab clinical asset as a potential first-line treatment for MM. - SLE: in
June 2021 ,The Center for Drug Evaluation (CDE) of theChina National Medical Products Administration (NMPA) has approved the Company's IND application to initiate Phase 1b trial of felzartamab in patients with SLE in Q4 2021.
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.
- PGHD: in
February 2021 , the first patient was dosed in Phase 3 registrational trial (TALLER) of eftansomatropin alfa as a weekly treatment for PGHD patients inChina . Complete patient enrollment (N=165) is expected in early 2022 to be on track for a planned BLA submission in 2023. - In parallel, the Company is under active discussions with potential commercial partners for the commercialization of eftansomatropin alfa in
China .
(2) Core clinical assets
Lemzoparlimab (TJC4): A highly differentiated CD47 antibody being developed through a comprehensive clinical development plan for hematologic malignancies and solid tumors in
- Lemzoparlimab in combination with rituximab for Non-Hodgkin's lymphoma (NHL): The clinical trial is ongoing to enroll more patients in the
U.S. with additional clinical sites joining inSeptember 2021 inChina . The preliminary clinical data is promising in terms of safety and efficacy signals in patients with NHL. The clinical results have been summarized and submitted for presentation at the 2021American Society of Hematology (ASH) Annual Meeting. The Company expects to, pending approval by the NMPA, initiate a pivotal trial in patients with NHL in 2022 inChina . - Lemzoparlimab in combination with AZA in AML and MDS: In
May 2021 , the first patient was dosed in an abbreviated phase 2 combination clinical trial in patients with newly diagnosed AML or MDS inChina . Patient enrollment is on track to be completed in Q4 2021. Based on the preliminary clinical efficacy signal seen in patients on the study, it is expected that this study will potentially lead to a pivotal clinical trial, pending approval by the NMPA, in 2022 inChina . - Lemzoparlimab in combination with pembrolizumab in patients with solid tumor: A phase 1b clinical trial is ongoing in the
U.S. in patients with selected solid tumors. The preliminary clinical results are expected by the end of 2021 or early 2022. A "basket" clinical trial of lemzoparlimab in combination with a PD-1 antibody in patients with advanced solid tumors is expected to commence inChina in Q4 2021. - Lemzoparlimab global phase 1b study, including combination with venetoclax, in patients with AML/MDS is being conducted in the
U.S. by AbbVie. The study has the potential to lead to a global pivotal clinical trial whereI-Mab will participate for the purpose of simultaneous registration of AML inChina .
Uliledlimab (TJD5): A highly differentiated CD73 antibody being developed for solid tumors. Phase 1 clinical trial conducted in the
- Differentiated mechanism of action (MoA): 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," as well as pre-clinical immuno-regulatory and anti-tumor activity as a single agent and in combination with PD-(L)1 antibodies. - 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 in patients with advanced solid tumors at the 2021 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 grade 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 (objective response rate = 23%) and three had stable disease (disease control rate = 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. - Phase 2 clinical trials: In
February 2021 , the first patient was dosed in a phase 2 clinical trial of uliledlimab in combination with toripalimab (TUOYI®) in patients with advanced solid tumors inChina . In parallel, a phase 2 "basket" clinical trial is expected to be initiated in patients with selected advanced solid tumors in theU.S. in Q4 2021.
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. The Company recently carried out an interim analysis of its phase 2/3 clinical trial for the treatment of cytokine release syndrome (CRS) in patients with severe COVID-19 in the
- The interim analysis showed positive preliminary results in patients who were mechanical ventilation free (MVF) at baseline (N=91). Plonmarlimab treatment resulted in a higher 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. The magnitudes of the clinical improvements are comparable to those observed with lenzilumab in a similar patient population.[1] 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 Company is now continuing the Phase 2/3 clinical study in the
U.S. and has begun to explore other clinical opportunities associated with CRS inChina .
Efineptakin alfa (TJ107): The world's first and only long-acting recombinant human interleukin-7 ("rhIL-7"). This asset is clinically positioned as a monotherapy for the treatment of cancer patients with lymphopenia and as a combination immunotherapy with a PD-1 or PD-L1 antibody for cancer treatment.
- 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 submitted for the 2021Chinese Society of Clinical Oncology (CSCO) Annual Meeting. (2) A phase 2 clinical trial in patients with GBM: InFebruary 2021 , the first patient was dosed, and the study is on track for patient enrollment. (3) Another phase 2 clinical trial of efineptakin alfa in combination with pembrolizumab (Keytruda®) in advanced solid tumors was accepted by NMPA and will start when approved in patients with selected solid tumors, including triple-negative breast cancer (TNBC) and head and neck cancers. - Clinical data published by Genexine/NeoImmune Tech: (1) Triple-Negative Breast Cancer (TNBC): Data from the 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. (2) Glioblastoma multiforme (GBM): Interim results from the phase 1 trial (NCT03687957) in newly diagnosed patients with high-grade gliomas 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 a one-year survival rate of 83.3% being observed so far.
(3) Other clinical assets
Olamkicept (TJ301): A differentiated IL-6 blocker for ulcerative colitis and other autoimmune diseases.
- Ulcerative colitis: in
April 2021 ,I-Mab reported positive topline phase 2 results for olamkicept in ulcerative colitis. The results demonstrated significantly higher clinical response rates after 12 weeks of treatment in patients receiving 600 mg olamkicept as compared with those on placebo (p=0.032). Significantly more patients in the 600 mg olamkicept group achieved clinical remission and mucosal healing than in the placebo group (p<0.001). The detailed data analysis was presented at the 2021 Digestive Disease Week (DDW) in theU.S. and the 2021 European Crohn's andColitis Organisation (ECCO) meeting. A phase 3 clinical trial is being planned.
Enoblituzumab (TJ271): A humanized B7-H3 antibody as an immuno-oncology treatment agent. As an anti-tumor agent, enoblituzumab works through a unique dual mechanism, i.e. ADCC and immune activation. Over the years, MacroGenics has generated sufficient clinical data in cancer patients, which provide a critical guidance for further clinical development of enoblituzumab in the treatment of cancers. In addition,
- The Company plans to submit an IND in Q4 2021 to initiate a phase 2 clinical trial of enoblituzumab in combination with pembrolizumab (Keytruda®) in patients with selected solid tumors in
China . The study is designed as a "basket" clinical trial involving NSCLC and two other selected cancer types based on the previous studies conducted by MacroGenics.
TJ210: 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 relapsed or refractory advanced solid tumors by
I-Mab in theU.S. : InJanuary 2021 , the first patient was dosed, and the study is on track. - Phase 1 clinical trial in
China : inJanuary 2021 , the Company received China NMPA clearance for phase 1 clinical trial of TJ210 in patients with advanced solid tumors.I-Mab expects to commence the study in early 2022.
Pipeline New-Comers as Bi-Specific Antibodies Driven by 2nd Wave Innovation and as "Super Antibodies" by 3rd Wave Innovation Through Transformative Technologies
(1) Bi-Specific Antibodies
The Company's bispecific antibodies are novel and designed to address the current unmet medical need in oncology where the majority of cancer patients respond poorly to checkpoint inhibitors as their tumors are often characterized as immunologically 'cold' tumor type.
TJ-CD4B: 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 functionally active only upon tumor engagement whilst silent elsewhere.
- Pre-clinical studies have demonstrated superior tumor-dependent immune activation with TJ-CD4B compared to 4-1BB monoclonal antibody. The anti-tumor activity is only achieved locally at the tumor site with no hepatotoxicity or systemic side effects that are commonly seen with 4-1BB monoclonal antibodies when used alone. Studies have also demonstrated a memory response that can resist tumor rechallenge for a long-lasting treatment effect.
In
TJ-L14B: 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.
- Pre-clinical animal model studies of TJ-L14B have demonstrated a superior anti-tumor effect attributable to the synergism of the two antibody arms in activating intra-tumoral T cells. The 4-1BB arm utilizes the same bispecific antibody format as in TJ-CD4B, aiming to minimize systemic toxicity as a class effect.
- In
April 2021 , the first patient was dosed in a phase 1 clinical trial of TJ-L14B in theU.S. in patients with advanced or metastatic solid tumors. The study is on track.
In addition, other novel bispecific antibodies are currently under pre-clinical development and are expected to advance to the clinical studies in 2022, including:
- TJ-C4GM is a fortified CD47 antibody with GM-CSF cytokine. This antibody-cytokine fusion is designed to enhance the anti-tumor effect of CD47 antibody for solid tumors by activating and converting pro-tumor M2 macrophages to anti-tumor M1 macrophages through the GM-CSF arm.
- TJ-L1C4 belongs to
I-Mab's PD-L1 based bispecific antibody family and uses CD47 antibody as the other arm. - TJ-L1I7 is an antibody-cytokine fusion protein with the anti-PDL1 antibody fused with IL-7, which is designed to increase both the number and functionality of T cells drawn to the tumor thereby turning "cold" tumor into a more immune-responsive "hot" tumor.
(2) Super Antibodies Enabled by Transformative Technologies
The Company recently launched a discovery initiative (the third wave innovation) to build a new portfolio of next generation of innovative drug candidates characterized as novel "super antibodies". These super antibodies are structurally different from monoclonal or bi-specific antibodies and uniquely enabled by transformative technologies such as an mRNA-based antibody, masked antibody, cell-penetrating antibody and AI-guided cytokine drugs etc. The Company has gained the access to these cutting-edge technology platforms through collaborations as described below. This growing new portfolio of novel drug candidates represents
- In collaboration with
Complix , an EU-based biotech company, to discover and develop Cell Penetrating Alphabodies (CPAB) for otherwise intractable intracellular drug targets. - In collaboration with Affinity, a
Shanghai -based biotech company, to discover and develop masked antibodies for targeted tumor-site activation. - In collaboration with Immorna, an mRNA biotech company, to discover and develop self-replicating mRNA for in vivo synthesized therapeutic biologics.
- In collaboration with neoX Biotech, an AI-enabled R&D biotech company, to accelerate the R&D process of novel targets and modalities.
The Company continues to drive innovation and scientific leadership in immuno-oncology globally. These collaborations are expected to be followed by additional partnering deals that are under discussion, which are designed to propel the discovery engine to drive future pipeline growth.
Business Development and Partnering deals
During the reporting period, the Company has completed 7 licensing and partnering deals that are geared to support the next generation of innovative assets. In addition, the Company is in discussion or business negotiation with potential partners on the following opportunities: (1) Eftansomatropin alfa (TJ101) for a commercial partnering deal with a potential partner at a term-sheet stage, for which
Transitioning from a Clinical Stage Biotech to Become a Global Biopharma
Expanding global footprint
(1) A new R&D facility is being established in
Building manufacturing capability in
To support its growing pipeline and planned production of the upcoming commercial products, the Company has made substantial progress in the construction of a state-of-the-art GMP manufacturing facility in
Expanding the commercialization capability for the market launch of felzartamab and other upcoming products
During the reporting period, the Company has advanced to expand the initial commercialization capability in the following four areas. (1) The key commercial strategy for
ESG Update
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.- To support its long-term growth,
I-Mab's Board of Directors approved a preliminary proposal for the potential dual listing of the Company's newly issued shares on the Science and Technology Innovation Board of theShanghai Stock Exchange (STAR Market). The Company is also considering equity listing on the Main Board of theHong Kong Stock Exchange under Chapter 18A of the Hong Kong Listing Rules. I-Mab's appointment of Ms.Lan Kang as a new member of the Company's board of directors onAugust 31, 2021 .Ms. Kang is currently a managing director atCBC Group , where she is responsible for managing all the portfolio companies of the Group. Prior toCBC Group , she was an Executive Board Director and SVP of Fosun International and led Fosun's insurance business globally. She was also on the board ofFosun Pharma and Fosun United Health Insurance . Prior to joining Fosun,Ms. Kang was a Senior Client Partner atKorn/Ferry (KF) International . She successfully developed the Life Sciences practice for KF in mainlandChina , providing executive search and leadership assessment and human resources consulting to both multinational and local Chinese clients. Prior to that,Ms. Kang was a management consultant atMcKinsey & Company , also focusing on the healthcare practice inChina . Concurrently, Ms. Mengjiao Jiang, managing director atCBC Group , has resigned from the I-Mab Board due toCBC Group's internal transition of her roles and responsibilities.I-Mab held a corporate R&D event inApril 2021 , focusing on cutting-edge sector insights from industry experts and the latest progress of pipelines from management.I-Mab expanded the expertise of its board with the appointment of international gastrointestinal oncology expert Dr.Andrew Zhu to itsScientific Advisory Board , and Dr.Ruyi He and ProfessorRong Shao toI-Mab's Board of Directors.I-Mab was ranked among the top companies by the leading global financial publication Institutional Investor in both the "Honored Companies" and "Best CFO" categories, according to its 2021 All-Asia Executive Team survey.I-Mab was honored with the T+ Excellent Employer award based on an assessment of best practices in areas such as technological leadership, organization and talent, and commitment to creating a diversified workplace.I-Mab was ranked as "2021 Top 50 Enterprises ofTechnology Power " by Frost&Sullivan and LeadLeo.I-Mab donatedRMB 1 million toHenan Charity General Federation for the rescue and reconstruction of flood-hit regions inHenan Province .
First-Half 2021 Financial Results
Cash Position
As of
Net Revenues
Total net revenues for the six months ended
Research & Development Expenses
Research and development expenses for the six months ended
Administrative Expenses
Administrative expenses for the six months ended
Net Loss
Net loss for the six months ended
Non-GAAP Net Loss
Non-GAAP adjusted net loss, which excludes share-based compensation expenses, for the six months ended
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://zoom.us/j/96267698618?pwd=S3p1NzZqdzdtQnZmS2lEbUpkeGk5Zz09 |
Meeting ID: |
962 6769 8618 |
Password: |
781902 |
English Session
Meeting URL: |
https://zoom.us/j/99563840425?pwd=VTNTbUNFOHJhY1ptZFpkbU93WDBKUT09 |
Meeting ID: |
995 6384 0425 |
Password: |
819127 |
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:
Jielun Zhu, Chief Financial Officer
E-mail: jielun.zhu@i-mabbiopharma.com
Office line: +86 21 6057 8000
E-mail: Gigi.Feng@i-mabbiopharma.com
Office line: +86 21 6057 5709
Investor Inquiries:
E-mail: emilie@thepiacentegroup.com
Office line: + 86 21 6039 8363
Consolidated Balance Sheets (All amounts in thousands, except for share and per share data, unless otherwise noted) |
|||||
As of |
As of |
||||
2020 |
2021 |
||||
RMB |
RMB |
US$ |
|||
Assets |
|||||
Current assets |
|||||
Cash and cash equivalents |
4,758,778 |
4,341,960 |
672,484 |
||
Restricted cash |
- |
8,095 |
1,254 |
||
Accounts receivable |
130,498 |
- |
- |
||
Contract assets |
227,391 |
242,905 |
37,621 |
||
Short-term investments |
31,530 |
422,345 |
65,413 |
||
Prepayments and other receivables |
195,467 |
200,422 |
31,040 |
||
Total current assets |
5,343,664 |
5,215,727 |
807,812 |
||
Property, equipment and software |
25,272 |
22,316 |
3,456 |
||
Operating lease right-of-use assets |
14,997 |
43,181 |
6,688 |
||
Intangible assets |
120,444 |
120,055 |
18,594 |
||
|
162,574 |
162,574 |
25,180 |
||
Investment accounted for using the equity method |
664,832 |
578,030 |
89,525 |
||
Other non-current assets |
2,010 |
6,131 |
950 |
||
Total assets |
6,333,793 |
6,148,014 |
952,205 |
||
Liabilities and shareholders' equity |
|||||
Current liabilities |
|||||
Accruals and other payables |
560,558 |
536,164 |
83,041 |
||
Operating lease liabilities, current |
8,058 |
9,896 |
1,533 |
||
Deferred subsidy income |
7,509 |
4,560 |
706 |
||
Total current liabilities |
576,125 |
550,620 |
85,280 |
||
Put right liabilities |
116,006 |
100,254 |
15,527 |
||
Operating lease liabilities, non-current |
5,542 |
31,245 |
4,839 |
||
Other non-current liabilities |
8,975 |
6,200 |
960 |
||
Total liabilities |
706,648 |
688,319 |
106,606 |
||
Shareholders' equity |
|||||
Ordinary shares ( |
114 |
122 |
19 |
||
Additional paid-in capital |
7,701,116 |
8,683,716 |
1,344,936 |
||
Accumulated other comprehensive loss |
(50,793) |
(124,370) |
(19,262) |
||
Accumulated deficit |
(2,023,292) |
(3,099,773) |
(480,094) |
||
Total shareholders' equity |
5,627,145 |
5,459,695 |
845,599 |
||
Total liabilities and shareholders' equity |
6,333,793 |
6,148,014 |
952,205 |
||
Consolidated Statements of Comprehensive Loss (All amounts in thousands, except for share and per share data, unless otherwise noted) |
|||||
For the six months ended |
|||||
2020 |
2021 |
||||
RMB |
RMB |
US$ |
|||
Revenues |
|||||
Licensing and collaboration revenue |
- |
17,775 |
2,753 |
||
Expenses |
|||||
Research and development expenses (Note 1) |
(442,291) |
(592,993) |
(91,843) |
||
Administrative expenses (Note 2) |
(171,384) |
(451,500) |
(69,928) |
||
Loss from operations |
(613,675) |
(1,026,718) |
(159,018) |
||
Interest income |
18,955 |
9,409 |
1,457 |
||
Interest expense |
(957) |
- |
- |
||
Other income, net |
12,824 |
51,904 |
8,039 |
||
Equity in loss of an affiliate (Note 3) |
- |
(114,200) |
(17,687) |
||
Loss before income tax expense |
(582,853) |
(1,079,605) |
(167,209) |
||
Income tax benefit |
- |
3,124 |
484 |
||
Net loss attributable to |
(582,853) |
(1,076,481) |
(166,725) |
||
Net loss attributable to ordinary shareholders |
(582,853) |
(1,076,481) |
(166,725) |
||
Net loss attributable to |
(582,853) |
(1,076,481) |
(166,725) |
||
Foreign currency translation adjustments, net of nil tax |
34,726 |
(73,577) |
(11,396) |
||
Total comprehensive loss attributable to |
(548,127) |
(1,150,058) |
(178,121) |
||
Net loss attributable to ordinary shareholders |
(582,853) |
(1,076,481) |
(166,725) |
||
Weighted-average number of ordinary shares used in calculating net loss per share |
121,815,986 |
168,827,190 |
168,827,190 |
||
Weighted-average number of ordinary shares used in calculating net loss per share |
121,815,986 |
168,827,190 |
168,827,190 |
||
Net loss per share attributable to ordinary shareholders |
|||||
—Basic |
(4.78) |
(6.38) |
(0.99) |
||
—Diluted |
(4.78) |
(6.38) |
(0.99) |
||
Net loss per ADS attributable to ordinary shareholders (Note 4) |
|||||
—Basic |
(10.99) |
(14.67) |
(2.28) |
||
—Diluted |
(10.99) |
(14.67) |
(2.28) |
Note: |
(1) Includes share-based compensation expense of |
(2) Includes share-based compensation expense of |
(3) Includes share-based compensation expense of nil and |
(4) Each ten ADSs represents twenty-three ordinary shares. |
Reconciliation of GAAP and Non-GAAP Results |
||||||
For the six months ended |
||||||
2020 |
2021 |
|||||
RMB |
RMB |
US$ |
||||
GAAP net loss attributable to |
(582,853) |
(1,076,481) |
(166,725) |
|||
Add back: |
||||||
Share-based compensation expense |
229,795 |
347,061 |
53,753 |
|||
Non-GAAP adjusted net loss attributable to |
(353,058) |
(729,420) |
(112,972) |
|||
Non-GAAP adjusted loss attributable to ordinary shareholders |
(353,058) |
(729,420) |
(112,972) |
|||
Weighted-average number of ordinary shares used in |
121,815,986 |
168,827,190 |
168,827,190 |
|||
Weighted-average number of ordinary shares used in |
121,815,986 |
168,827,190 |
168,827,190 |
|||
Non-GAAP adjusted loss per share attributable to ordinary shareholders |
||||||
—Basic |
(2.90) |
(4.32) |
(0.67) |
|||
—Diluted |
(2.90) |
(4.32) |
(0.67) |
|||
Non-GAAP adjusted loss per ADS attributable to ordinary shareholders |
||||||
—Basic |
(6.67) |
(9.94) |
(1.54) |
|||
—Diluted |
(6.67) |
(9.94) |
(1.54) |
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