Full Press Release Details
I-Mab Reports Financial Results for the Six Months Ended June 30 and Provides Corporate Update
Positive preliminary clinical trial results for lemzoparlimab (TJC4) demonstrate a differentiated drug profile in safety and
pharmacokinetics in cancer patients
Joined the global effort against COVID-19 with plonmarlimab (TJM2) study which represents the
first double-blind, placebo-controlled study evaluating anti-GM-CSF antibody in severe COVID-19 patients
significant pipeline updates in H2 2020 including China registrational trial with CD38 antibody felzartamab (TJ202) as third-line monotherapy for multiple myeloma; the Company also expects IND approval for eftansomatropin (TJ101), a unique long
acting growth hormone in the fourth quarter of 2020 and to initiate phase 3 study subsequently
The Company to host conference call
and webcast on August 31 at 8:00 a.m. ET
SHANGHAI, China and GAITHERSBURG, Md., August 31, 2020 /PRNewswire/ I-Mab (the
Company ) (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced financial results for the six months ended June 30, 2020 and
provided an overview of recent highlights and upcoming milestones.
I-Mab continues to advance our robust pipeline, create value through
innovation, and is well positioned to become a fully integrated global biopharmaceutical company. The differentiation of our innovative assets has become validated as the clinical trials progress, as exemplified by our positive preliminary clinical
results for lemzoparlimab, said Dr. Jingwu Zang, Founder, Honorary Chairman and Director of I-Mab. Looking ahead, we remain excited and confident in our science and increasing capabilities to deliver the promised corporate and
pipeline development milestones and create value for patients as well as for our shareholders.
The Company expects multiple data readouts across a
progressing pipeline in the coming months. These include the clinical results of phase 1 clinical trial in the U.S. and China for lemzoparlimab, initial data from uliledlimab (TJD5), the differentiated CD73 antibody, Part 2 clinical update from
plonmarlimab in patients with cytokine release syndrome associated with severe COVID-19, as well as phase 2 results from olamkicept (TJ301) in patients with ulcerative colitis. Felzartamab (TJ202), the Company s in-licensed CD38 antibody, is
being evaluated in two parallel registrational studies in China for the treatment of multiple myeloma and is on track for subject enrollment.
In addition, the Company s recent appointment of Chief Commercial Officer Ivan Yifei Zhu marks the
Company s commitment to building commercial capability and executing our commercialization plans for upcoming product launches. The remarkable progress in pipeline and corporate development demonstrated during this period significantly
strengthens the Company s position to achieve longer-term growth into 2021 and beyond.
Recent Highlights and Upcoming Milestones
Internally Discovered Global Pipeline
Fast to Market China Portfolio
Commercialization Capability
First Half 2020 Financial
As of June 30, 2020,
the Company had cash, cash equivalents, restricted cash and short-term investments of RMB1.6 billion (US$221.1 million), compared with RMB1.2 billion as of December 31, 2019.
Total net revenues for the six months ended
June 30, 2020 were nil, compared with RMB15.0 million for the six months ended June 30, 2019.
Research & Development Expenses
Research and development expenses for the six months ended June 30, 2020 were RMB442.3 million (US$62.6 million), compared with RMB265.1 million
for the six months ended June 30, 2019. The increase was primarily due to increases in CRO service fees to advance the Company s pipelines, higher share-based compensation, and higher employee salary and benefits expenses due to increased
research and development headcount.
Administrative Expenses
Administrative expenses for the six months ended June 30, 2020 were RMB171.4 million (US$24.3 million), compared with RMB574.6 million for the six months
ended June 30, 2019. The decrease was primarily due to reduced share-based compensation expenses of RMB268.9 million (US$38.1 million).
Net loss for the six months ended June 30, 2020 was RMB582.9 million (US$82.5 million), compared with RMB857.3 million for the six months ended
June 30, 2019. Net loss per share attributable to ordinary shareholders for the six months ended June 30, 2020 was RMB4.78 (US$0.68), compared with RMB119.34 for the six months ended June 30, 2019.
Non-GAAP adjusted net loss, which
excludes share-based compensation expenses, for the six months ended June 30, 2020 was RMB353.1 million (US$50.0 million), compared with RMB491.0 million for the six months ended June 30, 2019. Non-GAAP adjusted net loss per share
attributable to ordinary shareholders for the six months ended June 30, 2020 was RMB2.90 (US$0.41), compared with RMB68.34 for the six months ended June 30, 2019.
Conference Call and Webcast Information
host a live conference call and webcast on August 31, 2020 at 8:00 a.m. ET. Participants must register in advance of the conference call. Details are as follows:
| Registration Link: | http://apac.directeventreg.com/registration/event/8959387 | |
| Conference ID: | 8959387 |
Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be
used to join the conference call.
A webcast replay will be archived on the Company s website for one year after the conclusion of the call at
A telephone replay will be available approximately two hours after the conclusion of the call. To access the replay, please
call +1-855-452-5696 (U.S.), +61-2-8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 8959387.
I-Mab (Nasdaq: IMAB) is a dynamic, global
biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company s mission is to bring
transformational medicines to patients around the world through innovation. I-Mab s innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company s Fast-to-PoC (Proof-of-Concept) and
Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge
R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com
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 loss as a non-GAAP
financial measure. Adjusted net loss represents net loss before share-based compensation. The Company s management believes that adjusted net loss facilitates better understanding of operating results and provide 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 is that adjusted net 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 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 are made at a rate of RMB7.0651 to US$1.00, the rate in effect as of June 30, 2020 published by the Federal Reserve Board.
Safe Harbor Statement
This press release contains
statements that may constitute forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology
such as will, expects, anticipates, aims, future, intends, plans, believes, estimates, likely to and similar statements.
Statements that are not historical facts, including statements about I-Mab s beliefs, plans and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. Further information regarding
these and other risks is included in I-Mab s filings with the SEC. All information provided in this press release is as of the date of this press release, and I-Mab does not undertake any obligation to update any forward-looking statement,
except as required under applicable law.
For more information, please contact:
E-mail: jielun.zhu@i-mabbiopharma.com
Office line: +86 21 6057
Gigi Feng, Vice President and Global Head of Corporate Communications
E-mail: Gigi.Feng@i-mabbiopharma.com
Inc. (Americas and Europe)
Office line: +1 212 213 0006
Piacente Group, Inc. (Asia)
Office line: + 86 21 6039 8363
Consolidated Balance Sheets
(All amounts in thousands, except for share and per share data, unless otherwise noted)
| As of December 31, | As of June 30, | |||||||||||
| 2019 | 2020 | |||||||||||
| RMB | RMB | US$ | ||||||||||
| Assets | ||||||||||||
| Current assets | ||||||||||||
| Cash and cash equivalents | 1,137,473 | 1,560,031 | 220,808 | |||||||||
| Restricted cash | 55,810 | |||||||||||
| Short-term investments | 32,000 | 1,926 | 273 | |||||||||
| Prepayments and other receivables | 136,036 | 131,130 | 18,560 | |||||||||
| Total current assets | 1,361,319 | 1,693,087 | 239,641 | |||||||||
| Property, equipment and software | 30,069 | 26,625 | 3,769 | |||||||||
| Operating lease right-of-use assets | 16,435 | 17,592 | 2,490 | |||||||||
| Intangible assets | 148,844 | 148,844 | 21,068 | |||||||||
| Goodwill | 162,574 | 162,574 | 23,011 | |||||||||
| Other non-current assets | 18,331 | |||||||||||
| Total assets | 1,737,572 | 2,048,722 | 289,979 | |||||||||
| Liabilities, mezzanine equity and shareholders equity (deficit) | ||||||||||||
| Current liabilities | ||||||||||||
| Short-term borrowings | 50,000 | |||||||||||
| Accruals and other payables | 273,553 | 243,068 | 34,404 | |||||||||
| Operating lease liabilities, current | 6,807 | 8,202 | 1,161 | |||||||||
| Ordinary shares to be issued to Everest | 258,119 | |||||||||||
| Total current liabilities | 588,479 | 251,270 | 35,565 | |||||||||
| Convertible promissory notes | 68,199 | 69,138 | 9,787 | |||||||||
| Operating lease liabilities, non-current | 7,492 | 7,254 | 1,027 | |||||||||
| Deferred subsidy income | 3,920 | 7,760 | 1,098 | |||||||||
| Other non-current liabilities | 9,424 | 1,334 | ||||||||||
| Total liabilities | 668,090 | 344,846 | 48,811 | |||||||||
| Mezzanine equity | ||||||||||||
| Series A convertible preferred shares (US$0.0001 par value, 30,227,056 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of June 30, 2020) | 687,482 | |||||||||||
| Series B convertible preferred shares (US$0.0001 par value, 30,305,212 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of June 30, 2020) | 921,243 | |||||||||||
| Series C convertible preferred shares (US$0.0001 par value, 31,046,360 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of June 30, 2020) | 1,306,633 | |||||||||||
| Series C-1 convertible preferred shares (US$0.0001 par value, 3,857,143 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of June 30, 2020) | 188,819 | |||||||||||
| Total mezzanine equity | 3,104,177 |
Consolidated Balance Sheets
(All amounts in thousands, except for share and per share data, unless otherwise noted)
| As of December 31, | As of June 30, | |||||||||||
| 2019 | 2020 | |||||||||||
| RMB | RMB | US$ | ||||||||||
| Shareholders equity (deficit) | ||||||||||||
| Ordinary shares (US$0.0001 par value, 500,000,000 and 800,000,000 shares authorized as of December 31, 2019 and June 30, 2020, respectively; 8,363,719 and 133,006,644 shares issued and outstanding as of December 31, 2019 and June 30, 2020, respectively) | 6 | 92 | 13 | |||||||||
| Additional paid-in capital | 389,379 | 4,675,991 | 661,844 | |||||||||
| Accumulated other comprehensive income | 70,127 | 104,853 | 14,841 | |||||||||
| Accumulated deficit | (2,494,207 | ) | (3,077,060 | ) | (435,530 | ) | ||||||
| Total shareholders equity (deficit) | (2,034,695 | ) | 1,703,876 | 241,168 | ||||||||
| Total liabilities, mezzanine equity and shareholders equity (deficit) | 1,737,572 | 2,048,722 | 289,979 |
Consolidated Statements of Comprehensive Loss
(All amounts in thousands, except for share and per share data, unless otherwise noted)
| For the six months ended June 30, | ||||||||||||
| 2019 | 2020 | |||||||||||
| RMB | RMB | US$ | ||||||||||
| Revenues | ||||||||||||
| Licensing and collaboration revenue | 15,000 | |||||||||||
| Expenses | ||||||||||||
| Research and development expenses (Note 1) | (265,084 | ) | (442,291 | ) | (62,602 | ) | ||||||
| Administrative expenses (Note 2) | (574,584 | ) | (171,384 | ) | (24,258 | ) | ||||||
| Loss from operations | (824,668 | ) | (613,675 | ) | (86,860 | ) | ||||||
| Interest income | 12,818 | 18,955 | 2,683 | |||||||||
| Interest expense | (1,936 | ) | (957 | ) | (135 | ) | ||||||
| Other gains, net | 303 | 12,824 | 1,815 | |||||||||
| Fair value change of warrants | (43,854 | ) | ||||||||||
| Loss before income tax expense | (857,337 | ) | (582,853 | ) | (82,497 | ) | ||||||
| Income tax expense | ||||||||||||
| Net loss attributable to I-MAB | (857,337 | ) | (582,853 | ) | (82,497 | ) | ||||||
| Net loss attributable to ordinary shareholders | (857,337 | ) | (582,853 | ) | (82,497 | ) | ||||||
| Net loss attributable to I-MAB | (857,337 | ) | (582,853 | ) | (82,497 | ) | ||||||
| Foreign currency translation adjustments, net of nil tax | (4,972 | ) | 34,726 | 4,915 | ||||||||
| Total comprehensive loss attributable to I-MAB | (862,309 | ) | (548,127 | ) | (77,582 | ) | ||||||
| Net loss attributable to ordinary shareholders | (857,337 | ) | (582,853 | ) | (82,497 | ) | ||||||
| Weighted-average number of ordinary shares used in calculating net loss per share basic and diluted | 7,184,086 | 121,815,986 | 121,815,986 | |||||||||
| Net loss per share attributable to ordinary shareholders | ||||||||||||
| Basic | (119.34 | ) | (4.78 | ) | (0.68 | ) | ||||||
| Diluted | (119.34 | ) | (4.78 | ) | (0.68 | ) |
Reconciliation of GAAP and Non-GAAP Results
| For the six months ended June 30, | ||||||||||||
| 2019 | 2020 | |||||||||||
| RMB | RMB | US$ | ||||||||||
| GAAP net loss attributable to I-MAB | (857,337 | ) | (582,853 | ) | (82,497 | ) | ||||||
| Add back: | ||||||||||||
| Share-based compensation expense | 366,356 | 229,795 | 32,525 | |||||||||
| Non-GAAP adjusted net loss attributable to I-MAB | (490,981 | ) | (353,058 | ) | (49,972 | ) | ||||||
| Non-GAAP adjusted net loss attributable to ordinary shareholders | (490,981 | ) | (353,058 | ) | (49,972 | ) | ||||||
| Weighted-average number of ordinary shares used in calculating net loss per share basic and diluted | 7,184,086 | 121,815,986 | 121,815,986 | |||||||||
| Non-GAAP adjusted net loss per share attributable to ordinary shareholders | ||||||||||||
| Basic | (68.34 | ) | (2.90 | ) | (0.41 | ) | ||||||
| Diluted | (68.34 | ) | (2.90 | ) | (0.41 | ) |