I-Mab Provides Mid-Year 2023 Financial Results, Business and Corporate Updates
- Encouraging early results for uliledlimab and givastomig presented at ASCO 2023 and ESMO 2023 respectively
- Phase 3 study shows eftansomatropin alfa met primary endpoint and plans BLA filing in 2024
- Strong cash position of RMB3.0 billion (US$414.6 million) as of June 30, 2023
- New stock repurchase program authorized for up to US$40 million
- Net revenues decreased compared to the same period in 2022
- Higher unrealized exchange losses and equity in loss of affiliates
- Significant progress made year-to-date on key clinical assets:
‐ Uliledlimab (CD73 antibody): Encouraging early results were presented at ASCO 2023
‐ Givastomig (Claudin 18.2 x 4-1BB bispecific antibody): Topline Phase 1 data with promising early efficacy signals, including patients with low levels of Claudin 18.2 tumor expression. Data to be presented at ESMO 2023 - Eftansomatropin alfa (long-acting recombinant human growth hormone): Phase 3 pivotal study evaluating weekly injection of eftansomatropin alfa met the primary endpoint of annualized height velocity at week 52 and demonstrated non-inferiority to Norditropin®, administered by daily injection. A BLA filing is being planned for 2024
- Strong cash position of
RMB3.0 billion (US ) as of June 30, 2023, to support execution of the Company's strategic plan$414.6 million - The Board of Directors authorized a new stock repurchase program of up to
US to enhance long-term shareholder value$40 million - Conference call planned for August 17, 2023 at 8:00 a.m. EST
I-Mab has made significant progress in advancing its pipeline of innovative assets over the last eight months.
"2023 is off to a great start with promising early results from our two lead oncology programs, uliledlimab, and givastomig, coupled with new, positive Phase 3 eftansomatropin alfa results, thanks to the diligent efforts of our employees. As we move forward, we plan to focus on three strategic pillars: prioritizing two promising clinical assets in oncology to advance in the US, maintaining our strong balance sheet, and focusing on establishing a new operating model to become a US-based global biotech company," said Raj Kannan, Chief Executive Officer of I-Mab.
H1 2023 Key Clinical Program Highlights
Uliledlimab (CD73 mAb): Encouraging clinical and translational data presented at ASCO 2023
Uliledlimab is a highly differentiated CD73 antibody which can completely inhibit CD73 enzymatic activity without causing the aberrant pharmacological property known as the "hook effect." Results from an ongoing Phase 2 study of uliledlimab in combination with toripalimab, a PD-1 inhibitor, showed a favorable safety profile and an encouraging objective response rate (ORR) of
Next steps: The clinical program is currently focused on non-small cell lung cancer (NSCLC) and ovarian cancer. Enrollment in the Phase 2 study of uliledlimab with toripalimab for patients with ovarian cancer is ongoing in
Givastomig (Claudin 18.2 x 4-1BB bispecific Ab): Phase 1 trial data and publication highlight potential for a differentiated program
Encouraging initial Phase 1 results: Givastomig was designed as a bispecific antibody to target Claudin 18.2-positive tumor cells and stimulate pro-immune 4-1BB signaling. Phase 1 dose escalation has reached the highest planned dose level. Most treatment-related adverse events have been low-grade. In this study, encouraging findings of monotherapy efficacy were observed, including in tumors with lower levels of Claudin 18.2 expression, in patients with previously treated cancer that has relapsed or progressed after prior standard treatments.
Preclinical data on this program were published in the July 2023 issue of the Journal of Immunotherapy of Cancer, and the Phase 1 monotherapy dose escalation data were selected for presentation at the European Society of Medical Oncology (ESMO) in October 2023. An expansion cohort of patients with Claudin 18.2 positive gastric, gastroesophageal junction (GEJ), and esophageal cancer whose disease has progressed after previous treatment is enrolling, and interim results are expected in H1 2024.
Based upon these encouraging signals, dose escalation is expected to begin in combination with standard chemotherapy and immunotherapy regimens for patients with treatment naïve gastric, GEJ, and esophageal cancer in the US,
The program is being developed in collaboration with ABL Bio.
TJ-L14B/ABL503 (PD-L1 x 4-1BB bispecific antibody): Phase 1 Dose Expansion initiated in H1 2023
TJ-L14B/ABL503 was designed to treat PD-(L)1 antibody-resistant tumors. The antibody acts by inducing conditional activation of 4-1BB when it binds to its target, PD-L1. A Phase 1 dose-escalation study is underway in patients with progressive, locally advanced or metastatic solid tumors who are relapsed or refractory following prior lines of treatment. A preliminary efficacy signal has been observed, and a maximally tolerated dose (MTD) has not yet been reached. The dose expansion portion of the Phase 1 study is underway in the US and
New Data: Eftansomatropin alfa (long-acting recombinant human growth hormone)
I-Mab today announced positive topline results from its multi-center, randomized, open-label, active-controlled pivotal phase 3 study (CTJ101PGHD301) evaluating the efficacy and safety of eftansomatropin alfa in children with growth hormone deficiency.
The study met its primary endpoint of annualized height velocity (AHV) at week 52 and demonstrated that eftansomatropin alfa was non-inferior to Norditropin®. Eftansomatropin alfa was given by weekly injection vs. Norditropin® given by daily injection. The mean AHV was 10.76 (cm/year) for eftansomatropin alfa vs. 10.28 (cm/year) for Norditropin®, with a difference of 0.47 [
Commercial partnership with Jumpcan for product launch and commercialization of eftansomatropin alfa in
Felzartamab (CD38 antibody): Phase 3 Multiple Myeloma Results Expected in 2024
Felzartamab is in development for the treatment of multiple myeloma (MM). Clinical studies have been conducted in second- and third-line treatment settings. The randomized, open-label, parallel-controlled Phase 3 study of felzartamab in combination with lenalidomide and dexamethasone as a second-line treatment for MM with progression-free survival (PFS) as the primary endpoint is ongoing with a projected read-out in 2024, followed by planned BLA submission.
Lemzoparlimab (CD47 antibody): Phase 3 trial underway in
The development of lemzoparlimab, focused on
Corporate Development
- 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 of American depository shares ("ADSs") or ordinary shares in aggregate over the next 12 months. The timing and dollar amount of share repurchase transactions will be subject to the applicable$40 million U.S. Securities and Exchange Commission rule requirements. The Company's Board of Directors will review the implementation of share repurchases periodically and may authorize adjustment of its terms and size. - Proprietary position for uliledlimab fortified with Tracon and KG Bio resolutions.
‐ The positive outcome in arbitration relating to the collaboration agreement with Tracon Pharmaceuticals, Inc. (Tracon) confirms that Tracon has no rights to share any future economics with I-Mab for uliledlimab.
‐ In June 2023, the Company terminated the first negotiation agreement with Kalbe Genexine Biologics (KG Bio), pursuant to which KG Bio no longer has a right of first negotiation for the exclusive right to commercialize uliledlimab inSoutheast Asia and other territories.
First-Half 2023 Financial Results
Cash Position
As of June 30, 2023, the Company had cash, cash equivalents, restricted cash, and short-term investments of
Net Revenues
Total net revenues for the six months ended June 30, 2023 were
Research & Development Expenses
Research and development expenses for the six months ended June 30, 2023 were
Administrative Expenses
Administrative expenses for the six months ended June 30, 2023 were
Other Expenses, Net
Net other expenses for the six months ended June 30, 2023 were
Equity in Loss of Affiliates
Equity in loss of affiliates for the six months ended June 30, 2023 was
Net Loss
Net loss for the six months ended June 30, 2023 was
Non-GAAP Net Loss
Non-GAAP adjusted net loss, which excludes share-based compensation expenses, for the six months ended June 30, 2023 was
Conference Call Information
Investors and analysts are invited to join the conference call at 8:00 a.m. EST on August 17, 2023 via Zoom:
https://i-mabbiopharma.zoom.us/j/87349766033?pwd=bFhVejFDS1dHeWw3eklaeW1JcFhpUT09
Meeting ID: 873 4976 6033
Password: 194422
Note that call participants can register in advance via the above link to streamline the login process.
About I-Mab
I-Mab (Nasdaq: IMAB) is a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics for oncology. I-Mab's innovative pipeline is driven by internal R&D's Fast-to-Proof-of-Concept, Fast-to-Market development strategies, and through global partnerships. For more information, please visit https://www.i-mabbiopharma.com and follow us on LinkedIn, Twitter, and WeChat.
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 the translations of certain RMB amounts into
The translations of certain RMB amounts into
For more information, please contact:
Investors | Media |
Tyler Ehler | Gigi Feng |
Senior Director, Investor Relations | Chief Communications Officer |
I-MAB | ||||||||
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, | |||||||
2022 | 2023 | |||||||
RMB | US$ | RMB | US$ | |||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | 3,214,005 | 443,232 | 2,359,592 | 325,403 | ||||
Short-term restricted cash | 96,764 | 13,344 | 26,995 | 3,723 | ||||
Short-term investments | 235,429 | 32,467 | 585,913 | 80,801 | ||||
Prepayments and other receivables | 80,278 | 11,071 | 102,345 | 14,113 | ||||
Total current assets | 3,626,476 | 500,114 | 3,074,845 | 424,040 | ||||
Long-term restricted cash | - | - | 33,638 | 4,639 | ||||
Property, equipment and software | 60,841 | 8,390 | 52,583 | 7,252 | ||||
Operating lease right-of-use assets | 63,125 | 8,705 | 49,881 | 6,879 | ||||
Intangible assets | 118,888 | 16,395 | 118,499 | 16,342 | ||||
Goodwill | 162,574 | 22,420 | 162,574 | 22,420 | ||||
Investments accounted for using the | 30,850 | 4,254 | 11,411 | 1,574 | ||||
Other non-current assets | 10,911 | 1,505 | 8,264 | 1,140 | ||||
Total assets | 4,073,665 | 561,783 | 3,511,695 | 484,286 | ||||
Liabilities and shareholders' equity | ||||||||
Current liabilities | ||||||||
Short-term bank borrowings | 18,956 | 2,614 | 29,970 | 4,133 | ||||
Accruals and other payables | 706,572 | 97,440 | 595,221 | 82,085 | ||||
Operating lease liabilities, current | 23,961 | 3,304 | 27,322 | 3,768 | ||||
Contract liabilities, current | 8,677 | 1,197 | 10,560 | 1,456 | ||||
Total current liabilities | 758,166 | 104,555 | 663,073 | 91,442 | ||||
Put right liabilities | 88,687 | 12,230 | 64,787 | 8,935 | ||||
Contract liabilities, non-current | 267,878 | 36,942 | 267,644 | 36,910 | ||||
Operating lease liabilities, non-current | 32,069 | 4,423 | 20,406 | 2,814 | ||||
Other non-current liabilities | 16,963 | 2,339 | 49,002 | 6,758 | ||||
Total liabilities | 1,163,763 | 160,489 | 1,064,912 | 146,859 | ||||
Shareholders' equity | ||||||||
Ordinary shares ( | 132 | 18 | 133 | 18 | ||||
Treasury stock | (21,249) | (2,930) | (46,017) | (6,346) | ||||
Additional paid-in capital | 9,579,375 | 1,321,056 | 9,751,140 | 1,344,744 | ||||
Accumulated other comprehensive income | 213,794 | 29,484 | 376,473 | 51,918 | ||||
Accumulated deficit | (6,862,150) | (946,334) | (7,634,946) | (1,052,907) | ||||
Total shareholders' equity | 2,909,902 | 401,294 | 2,446,783 | 337,427 | ||||
Total liabilities and shareholders' equity | 4,073,665 | 561,783 | 3,511,695 | 484,286 | ||||
I-MAB | |||||||
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, | |||||||
2022 | 2023 | ||||||
RMB | US$ | RMB | US$ | ||||
Revenues | |||||||
Licensing and collaboration revenue | 23,756 | 3,276 | 8,825 | 1,217 | |||
Supply of investigational products | 28,102 | 3,875 | 10,830 | 1,494 | |||
Total revenues | 51,858 | 7,151 | 19,655 | 2,711 | |||
Cost of revenues | (27,237) | (3,756) | - | - | |||
Expenses | |||||||
Research and development expenses (Note 1) | (452,618) | (62,419) | (446,436) | (61,566) | |||
Administrative expenses (Note 2) | (392,460) | (54,123) | (244,991) | (33,786) | |||
Loss from operations | (820,457) | (113,147) | (671,772) | (92,641) | |||
Interest income | 6,566 | 905 | 30,514 | 4,208 | |||
Interest expense | - | - | (219) | (30) | |||
Other expenses, net | (51,944) | (7,163) | (71,701) | (9,888) | |||
Equity in loss of affiliates (Note 3) | (181,022) | (24,964) | (59,618) | (8,222) | |||
Loss before income tax expense | (1,046,857) | (144,369) | (772,796) | (106,573) | |||
Income tax expense | - | - | - | - | |||
Net loss attributable to I-MAB | (1,046,857) | (144,369) | (772,796) | (106,573) | |||
Net loss attributable to ordinary shareholders | (1,046,857) | (144,369) | (772,796) | (106,573) | |||
Net loss attributable to I-MAB | (1,046,857) | (144,369) | (772,796) | (106,573) | |||
Foreign currency translation adjustments, net of | 233,561 | 32,210 | 162,679 | 22,434 | |||
Total comprehensive loss attributable to I-MAB | (813,296) | (112,159) | (610,117) | (84,139) | |||
Net loss attributable to ordinary shareholders | (1,046,857) | (144,369) | (772,796) | (106,573) | |||
Weighted-average number of ordinary shares used in | 188,857,353 | 188,857,353 | 191,329,890 | 191,329,890 | |||
Net loss per share attributable to ordinary | |||||||
—Basic and diluted | (5.54) | (0.76) | (4.04) | (0.56) | |||
Net loss per ADS attributable to ordinary | |||||||
—Basic and diluted | (12.74) | (1.76) | (9.29) | (1.28) | |||
Notes: | |||||||
(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. |
I-MAB | ||||||||
Reconciliation of GAAP and Non-GAAP Results | ||||||||
For the six months ended June 30, | ||||||||
2022 | 2023 | |||||||
RMB | US$ | RMB | US$ | |||||
GAAP net loss attributable to I-MAB | (1,046,857) | (144,369) | (772,796) | (106,573) | ||||
Add back: | ||||||||
Share-based compensation expense | 198,867 | 27,424 | 138,553 | 19,108 | ||||
Non-GAAP adjusted net loss attributable | (847,990) | (116,945) | (634,243) | (87,465) | ||||
Non-GAAP adjusted loss attributable to | (847,990) | (116,945) | (634,243) | (87,465) | ||||
Weighted-average number of ordinary | 188,857,353 | 188,857,353 | 191,329,890 | 191,329,890 | ||||
Non-GAAP adjusted loss per share | ||||||||
—Basic and diluted | (4.49) | (0.62) | (3.31) | (0.46) | ||||
Non-GAAP adjusted loss per ADS | ||||||||
—Basic and diluted | (10.33) | (1.42) | (7.61) | (1.05) |
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SOURCE I-Mab