I-Mab Reports 1H 2024 Financial Results, Pipeline Progress, and Business Updates
- Completed divestiture of
China operations - Uliledlimab IND clearance paves the way for
U.S. combination studies in first-line mNSCLC (CD73 antibody) - Clinical collaboration and supply agreement with
Bristol Myers Squibb strengthens givastomig first-line gastric cancer combination studies (CLDN18.2 X 4-1BB bispecific) - Ragistomig presentation at ASCO 2024 highlights encouraging early data (PD-L1 X 4-1BB bispecific)
- Well-positioned for pipeline advancement with
$207.5 million in cash and cash equivalents, and short-term investments as ofJune 30, 2024 , and cash runway expected into 2027 -
I-Mab August 28 th, at8:00 AM ET
"
Pipeline Overview and Potential Upcoming Milestones:
Uliledlimab (CD73 antibody)
Phase 2 combination studies, focused on first-line metastatic non-small cell lung cancer ("mNSCLC")
Uliledlimab (TJ004309) is an antibody designed to target CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. Blocking CD73 allows anti-tumor immunity to proceed without the presence of an adenosine-induced "immunological fog".
A previous single-arm Phase 2 study evaluating the combination of uliledlimab with toripalimab (results were presented at the ASCO Annual Meeting 2023) in patients with mNSCLC and showed that treatment with uliledlimab produced an overall response rate ("ORR") of 63% in patients with high CD73 expression and PD-L1 TPS≥1%.
Uliledlimab is also being evaluated in an ongoing, randomized Phase 2 study conducted by
To extend development in first-line mNSCLC,
Givastomig (Claudin 18.2 x 4-1BB bispecific antibody)
Ongoing Phase 1b dose expansion and combination studies, focused on first-line metastatic gastric cancer
Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2-positive tumor cells that conditionally activates T cells via 4-1BB in the tumor microenvironment where Claudin 18.2 is expressed. This program is being jointly developed through a global partnership with ABL Bio, in which
Phase 1 monotherapy data presented at the
As part of the ongoing Phase 1b trial, the Company entered into a clinical collaboration and supply agreement with
Updated clinical data from the dose expansion portion of the Phase 1 monotherapy study of givastomig will be presented at the
Ragistomig (PD-L1 x 4-1BB bispecific antibody)
Ongoing Phase 1 dose escalation and dose expansion in advanced solid tumors
Ragistomig (TJ-L14B / ABL503) is a bispecific antibody designed to provide anti-PD-L1 activity and 4-1BB-driven T cell activation in one molecule. The combination of an Fc-silent antibody with conditional 4-1BB engagement is intended to produce safety benefits, including the potential for lower hepatotoxicity compared to traditional 4-1BB agonists. This program is being jointly developed through a global partnership with ABL Bio, in which ABL Bio is the lead party and shares worldwide rights, excluding
Early observations reported by
- Top-line Phase 1 dose escalation and dose expansion results demonstrated an ORR of 26.9% (7/26), including six partial responses (PR) and one complete response (CR), and a clinical benefit ratio (CBR) of 69.2% (18/26) at doses of 3 mg/kg and 5 mg/kg.
Significant Strategic Progress and Corporate Development
- The agreement to divest assets and business operations in
China was completed onApril 2, 2024 . The Company transferred 100% of the outstanding equity interest inI-Mab Biopharma Co., Ltd ("I-Mab Shanghai") toI-Mab Biopharma (Hangzhou) Co., Ltd (now known as "Tianjing Biopharma" or "TJ Biopharma"), on a cash-free and debt-free basis, for an aggregate consideration of the RMB equivalent of up to$80 million , contingent on TJ Biopharma's achievement of certain future regulatory and sales-based milestone events. Concurrently, in exchange for the transfer of equity interest of TJ Biopharma, repurchase obligations owed byI-Mab Biopharma Hong Kong Limited ("I-Mab Hong Kong") in the amount of approximately$183 million were extinguished. In addition, the Company participated in a Series C fundraising of TJ Biopharma for an equity investment of$19 million . - As previously disclosed, certain non-participating shareholders of TJ Biopharma commenced arbitration against I-Mab Hong Kong, and as a result, the RMB equivalent of
$17.5 million was placed into court escrow for future redemption obligation settlements which were subsequently settled. The approximately$15 million of remaining redemption obligations to non-participating shareholders are expected to be settled inSeptember 2024 . As ofJune 30, 2024 , the fair value of the put right liabilities was$2.0 million and classified as a current liability and represents management's best estimate of the timing of redemption requests as of that date, compared with a$13.8 million and non-current liability as ofDecember 31, 2023 . The$11.8 million change in fair value was recorded as a non-cash item within other income (expenses), net. - The Company has been engaged in ongoing litigation related to
I-Mab's trade secret claims against Inhibrx, Inc. ("Inhibrx") and Dr.Brendan Eckelman for misappropriation whenDr. Eckelman served as an expert witness for Tracon Pharmaceuticals, Inc.I-Mab is seeking damages in the form of a reasonable royalty, along with exemplary damages for Inhibrx's andDr. Eckelman's willful and malicious misappropriation ofI-Mab's trade secrets. The trial is currently scheduled to commence at the end ofOctober 2024 . - The Audit Committee of the Company's Board of Directors approved the change in independent registered public accountants from
PricewaterhouseCoopers Zhong Tian LLP ("PwC China") toPricewaterhouseCoopers LLP ("PwC US") for the fiscal year endingDecember 31, 2024 .
First-Half 2024 Financial Results
Cash Position
As of
Share Buyback and Shares Outstanding
In
Net Revenues
The Company did not generate revenue during the three and six months ended
Research & Development Expenses
Research and development ("R&D") expenses were
Administrative Expenses
Administrative expenses were
Interest Income
Interest income was $1.9 million and
Other Income (Expenses), Net
Other income (expenses), net were
Equity in Loss of Affiliates
Prior to the
Net Loss from Continuing Operations
Net loss from continuing operations was
Discontinued Operations
On
Non-GAAP Net Loss from Continuing Operations
Non-GAAP adjusted net loss from continuing operations, which excludes share-based compensation expenses from continuing operations, was
Conference Call and Webcast Information
Investors and analysts are invited to join the conference call at 8:00 AM ET on August 28, 2024, via:
-
Domestic Dial -in: 1-877-407-0784 - International Dial-in: 1-201-689-8560
- Conference ID: 13747695
- Webcast: please click here
Note that Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event.
The Call me™ link will be made active 15 minutes prior to the scheduled start time.
A webcast of the call will also be available on the I-Mab website, on the Upcoming Events section of the Investor Relations page, available by clicking here. A replay of the call will be accessible under the Past Events section of the Investor Relations page and will be archived for 6 months.
About
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 loss and related per share measures is that adjusted net loss excludes share-based compensation expense that has been and may continue to be incurred in the future. In order to compensate for these limitations, management presents adjusted net loss together with GAAP results.
Exchange Rate Information
Effective
I-Mab Forward Looking Statements
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the
For more information, please contact:
I-Mab Contacts
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Senior Director, Investor Relations |
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Consolidated Balance Sheets |
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(All amounts in thousands, except for share data) |
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As of |
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As of |
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||
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2024 |
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2023 |
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||
|
|
|
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|
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||
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(Unaudited) |
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(Unaudited) |
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Assets |
|
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Current assets |
|
|
|
|
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|
||
Cash and cash equivalents |
|
$ |
151,961 |
|
|
$ |
290,799 |
|
Short-term investments |
|
|
55,525 |
|
|
|
20,172 |
|
Prepayments and other current assets |
|
|
22,991 |
|
|
|
714 |
|
Current assets of discontinued operations |
|
|
— |
|
|
|
17,428 |
|
Total current assets |
|
|
230,477 |
|
|
|
329,113 |
|
Property, equipment and software |
|
|
204 |
|
|
|
1,772 |
|
Operating lease right-of-use assets |
|
|
3,682 |
|
|
|
3,768 |
|
Investments accounted for using the cost method |
|
|
19,000 |
|
|
|
— |
|
Other non-current assets |
|
|
464 |
|
|
|
248 |
|
Non-current assets of discontinued operations |
|
|
— |
|
|
|
33,127 |
|
Total assets |
|
$ |
253,827 |
|
|
$ |
368,028 |
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Liabilities and shareholders' equity |
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Current liabilities |
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||
Accruals and other payables |
|
$ |
11,259 |
|
|
$ |
8,555 |
|
Operating lease liabilities, current |
|
|
737 |
|
|
|
624 |
|
Put right liabilities, current |
|
|
1,976 |
|
|
|
— |
|
Current liabilities of discontinued operations |
|
|
— |
|
|
|
48,824 |
|
Total current liabilities |
|
|
13,972 |
|
|
|
58,003 |
|
Put right liabilities, non-current |
|
|
— |
|
|
|
13,819 |
|
Operating lease liabilities, non-current |
|
|
3,222 |
|
|
|
3,253 |
|
Other non-current liabilities |
|
|
— |
|
|
|
105 |
|
Non-current liabilities of discontinued operations |
|
|
— |
|
|
|
50,851 |
|
Total liabilities |
|
$ |
17,194 |
|
|
$ |
126,031 |
|
|
|
|
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Shareholders' equity |
|
|
|
|
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|
||
Ordinary shares ( |
|
|
19 |
|
|
|
19 |
|
|
|
|
(6,369) |
|
|
|
(8,001) |
|
Additional paid-in capital |
|
|
1,459,005 |
|
|
|
1,380,918 |
|
Accumulated other comprehensive income |
|
|
40,448 |
|
|
|
42,013 |
|
Accumulated deficit |
|
|
(1,256,470) |
|
|
|
(1,172,952) |
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Total shareholders' equity |
|
|
236,633 |
|
|
|
241,997 |
|
Total liabilities and shareholders' equity |
|
$ |
253,827 |
|
|
$ |
368,028 |
|
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Consolidated Statements of Comprehensive Loss |
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(All amounts in thousands, except for share and per share data) |
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Three Months Ended |
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Six Months Ended |
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|
2024 |
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2023 |
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|
2024 |
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|
2023 |
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||||
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|
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|
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||||
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(Unaudited) |
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(Unaudited) |
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Revenues |
|
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|
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|
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||||
Licensing and collaboration revenue |
|
$ |
— |
|
|
$ |
159 |
|
|
$ |
— |
|
|
$ |
312 |
|
Total revenues |
|
|
— |
|
|
|
159 |
|
|
|
— |
|
|
|
312 |
|
Expenses |
|
|
|
|
|
|
|
|
|
|
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|
||||
Research and development expenses (Note 1) |
|
|
(3,137) |
|
|
|
(4,289) |
|
|
|
(10,789) |
|
|
|
(9,021) |
|
Administrative expenses (Note 2) |
|
|
(11,871) |
|
|
|
(7,920) |
|
|
|
(14,312) |
|
|
|
(14,034) |
|
Loss from operations |
|
|
(15,008) |
|
|
|
(12,050) |
|
|
|
(25,101) |
|
|
|
(22,743) |
|
Interest income |
|
|
1,921 |
|
|
|
2,889 |
|
|
|
2,840 |
|
|
|
4,506 |
|
Other income (expenses), net |
|
|
6,277 |
|
|
|
(16,411) |
|
|
|
5,480 |
|
|
|
(11,481) |
|
Equity in loss of affiliates (Note 3) |
|
|
— |
|
|
|
(1,986) |
|
|
|
(1,038) |
|
|
|
(8,191) |
|
Loss from continuing operations before income tax expense |
|
|
(6,810) |
|
|
|
(27,558) |
|
|
|
(17,819) |
|
|
|
(37,909) |
|
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Loss from continuing operations |
|
$ |
(6,810) |
|
|
$ |
(27,558) |
|
|
$ |
(17,819) |
|
|
$ |
(37,909) |
|
|
|
|
|
|
|
|
|
|
|
|
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|
||||
Discontinued operations: |
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|
|
|
|
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|
|
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|
||||
Loss from operations of discontinued operations (Note 4) |
|
$ |
— |
|
|
$ |
(33,908) |
|
|
$ |
(6,779) |
|
|
$ |
(68,664) |
|
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Gain on sale of discontinued operations |
|
|
31,936 |
|
|
|
— |
|
|
|
31,936 |
|
|
|
— |
|
Income (loss) from discontinued operations |
|
$ |
31,936 |
|
|
$ |
(33,908) |
|
|
$ |
25,157 |
|
|
$ |
(68,664) |
|
|
|
|
|
|
|
|
|
|
|
|
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|
||||
Net income (loss) attributable to |
|
$ |
25,126 |
|
|
$ |
(61,466) |
|
|
$ |
7,338 |
|
|
$ |
(106,573) |
|
Net income (loss) attributable to ordinary shareholders |
|
$ |
25,126 |
|
|
$ |
(61,466) |
|
|
$ |
7,338 |
|
|
$ |
(106,573) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income (loss) attributable to |
|
$ |
25,126 |
|
|
$ |
(61,466) |
|
|
$ |
7,338 |
|
|
$ |
(106,573) |
|
Foreign currency translation adjustments net of tax |
|
|
(348) |
|
|
|
40,597 |
|
|
|
(1,565) |
|
|
|
22,434 |
|
Total comprehensive income (loss) attributable to |
|
$ |
24,778 |
|
|
$ |
(20,869) |
|
|
$ |
5,773 |
|
|
$ |
(84,139) |
|
|
|
|
|
|
|
|
|
|
|
|
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|
||||
Net loss from continuing operations per share attributable |
|
$ |
(0.04) |
|
|
$ |
(0.14) |
|
|
$ |
(0.10) |
|
|
$ |
(0.20) |
|
Net loss from continuing operations per ADS attributable |
|
$ |
(0.09) |
|
|
$ |
(0.33) |
|
|
$ |
(0.23) |
|
|
$ |
(0.46) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income (loss) from discontinued operations per share |
|
$ |
0.17 |
|
|
$ |
(0.18) |
|
|
$ |
0.14 |
|
|
$ |
(0.36) |
|
Net income (loss) from discontinued operations per ADS |
|
$ |
0.39 |
|
|
$ |
(0.41) |
|
|
$ |
0.32 |
|
|
$ |
(0.83) |
|
|
|
|
|
|
|
|
|
|
|
|
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|
||||
Net income (loss) attributable to ordinary shareholders |
|
$ |
0.13 |
|
|
$ |
(0.32) |
|
|
$ |
0.04 |
|
|
$ |
(0.56) |
|
Net income (loss) per ADS attributable to ordinary |
|
$ |
0.30 |
|
|
$ |
(0.74) |
|
|
$ |
0.09 |
|
|
$ |
(1.29) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average number of ordinary shares outstanding |
|
|
186,143,586 |
|
|
|
191,049,393 |
|
|
|
186,001,620 |
|
|
|
191,329,890 |
|
|
|
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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) Includes share-based compensation expense of |
|
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(5) Each 10 ADSs represents 23 ordinary shares. |
|
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|
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Reconciliation of GAAP and Non-GAAP Results |
|
|||||||||||||||
(All amounts in thousands, except for share and per share data) |
|
|||||||||||||||
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|
|||||||||||||||
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
(Unaudited) |
|
|
(Unaudited) |
|
||||||||||
GAAP net loss from continuing operations |
|
$ |
(6,810) |
|
|
$ |
(27,558) |
|
|
$ |
(17,819) |
|
|
$ |
(37,909) |
|
Add back: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Share-based compensation expense from continuing |
|
|
1,137 |
|
|
|
3,937 |
|
|
|
(3,741) |
|
|
|
7,100 |
|
Non-GAAP adjusted net loss from continuing operations |
|
$ |
(5,673) |
|
|
$ |
(23,621) |
|
|
$ |
(21,560) |
|
|
$ |
(30,809) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average number of ordinary shares used |
|
|
186,143,586 |
|
|
|
191,049,393 |
|
|
|
186,001,620 |
|
|
|
191,329,890 |
|
Non-GAAP adjusted loss from continuing operations per |
|
|
|
|
|
|
|
|
|
|
|
|
||||
—Basic and diluted |
|
$ |
(0.03) |
|
|
$ |
(0.12) |
|
|
$ |
(0.12) |
|
|
$ |
(0.16) |
|
Non-GAAP adjusted loss from continuing operations per |
|
|
|
|
|
|
|
|
|
|
|
|
||||
—Basic and diluted |
|
$ |
(0.07) |
|
|
$ |
(0.28) |
|
|
$ |
(0.28) |
|
|
$ |
(0.37) |
|
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