I-Mab Provides Mid-Year 2023 Financial Results, Business and Corporate Updates
- 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$414.6 million ) as ofJune 30, 2023 , to support execution of the Company's strategic plan - The Board of Directors authorized a new stock repurchase program of up to
US$40 million to enhance long-term shareholder value - Conference call planned for
August 17, 2023 at 8:00 a.m. EST
"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
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 31% (21/67) in the overall population regardless of CD73 and PD-L1 expression. In this study, without concomitant chemotherapy, in patients whose tumors expressed higher levels of CD73 and had a PD-L1 tumor proportion score (TPS) of >1%, the observed ORR was 63% (10/16).
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
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)
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 [95% CI -0.06,1.00] and non-inferiority p-value <0.0001. Eftansomatropin alfa was well tolerated and no drug discontinuation was reported due to treatment related adverse events. The safety profile of eftansomatropin alfa was comparable to Norditropin®. The Company is planning to file a BLA submission in
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 toUS$40 million 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 applicableU.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 withI-Mab for uliledlimab.
‐ InJune 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
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
Other Expenses, Net
Net other expenses for the six months ended
Equity in Loss of Affiliates
Equity in loss of affiliates 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 Information
Investors and analysts are invited to join the conference call at 8:00 a.m. EST on
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 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 |
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Senior Director, Investor Relations |
Chief Communications Officer |
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Consolidated Balance Sheets |
||||||||
(All amounts in thousands, except for share and per share data, unless otherwise noted) |
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As of |
As of |
|||||||
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 |
||||
|
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 |
||||
|
(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 |
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Consolidated Statements of Comprehensive Loss |
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(All amounts in thousands, except for share and per share data, unless otherwise noted) |
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For the six months ended |
|||||||
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 |
(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 |
(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 |
(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 |
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Net loss per share attributable to ordinary |
|||||||
—Basic and diluted |
(5.54) |
(0.76) |
(4.04) |
(0.56) |
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Net loss per ADS attributable to ordinary |
|||||||
—Basic and diluted |
(12.74) |
(1.76) |
(9.29) |
(1.28) |
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Notes: |
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(1) Includes share-based compensation expense of |
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(2) Includes share-based compensation expense of |
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(3) Includes share-based compensation expense of |
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(4) Each ten ADSs represents twenty-three ordinary shares. |
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Reconciliation of GAAP and Non-GAAP Results |
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For the six months ended |
||||||||
2022 |
2023 |
|||||||
RMB |
US$ |
RMB |
US$ |
|||||
GAAP net loss attributable to |
(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) |
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Non-GAAP adjusted loss per ADS |
||||||||
—Basic and diluted |
(10.33) |
(1.42) |
(7.61) |
(1.05) |
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