Full Press Release Details
I-Mab Provides Mid-Year 2023 Financial Results,
Business and Corporate Updates
(US) and SHANGHAI, China, August 17, 2023 - I-Mab (Nasdaq: IMAB) (the "Company"), 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, today
announced its financial results for the six months ended June 30, 2023, and provided key business updates.
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
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 China. In the US, I-Mab plans to submit an IND for uliledlimab in combination with chemotherapy
and checkpoint inhibitors in newly diagnosed patients with advanced NSCLC in H1 2024.
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
na ve gastric, GEJ, and esophageal cancer in the US, Japan, and China in H1 2024.
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 South Korea. The program is also being
developed in collaboration with ABL Bio.
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 [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 China in 2024.
Commercial partnership with Jumpcan for product
launch and commercialization of eftansomatropin alfa in China is ongoing.
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 China
The development of lemzoparlimab, focused on China,
has the potential to be the first-in-class CD47 antibody for hematologic malignancies in this market. The Phase 3 program is evaluating
lemzoparlimab in combination with azacytidine (AZA) as first-line treatment for patients with newly diagnosed higher-risk
myelodysplastic syndrome (MDS). Enrollment in the Phase 3 trial was initiated in April 2023. The Company will continue to
review Phase 2 clinical follow-up data in the higher risk-MDS study and analyze details from other trials evaluating other CD47-targeting
agents as they are released, to inform the Company's decisions on the future steps for the program.
Corporate Development
As of June 30, 2023, the Company had cash,
cash equivalents, restricted cash, and short-term investments of RMB3.0 billion (US$414.6 million), compared with RMB3.5 billion (US$489.0
million) as of December 31, 2022.
Total net revenues for the six months ended June 30,
2023 were RMB19.7 million (US$2.7 million), compared with RMB51.9 million (US$7.2 million) for the comparable period in 2022. Revenues
consisted of revenues recognized in connection with the strategic collaboration with AbbVie and revenues generated from the supply of
investigational products to AbbVie Inc (Abbvie) and Human Immunology Biosciences, Inc. for the six months ended June 30, 2022
and 2023, respectively.
Research & Development Expenses
Research and development expenses for the six months ended June 30,
2023 were RMB446.4 million (US$61.6 million), compared with RMB452.6 million (US$62.4 million) for the comparable period in 2022. The
decrease was primarily due to the reduced payroll and share-based compensation expenses, partially offset by a slight increase in Chemistry,
Manufacturing, and Controls service fees. Share-based compensation expense was RMB46.8 million (US$6.5 million) for the six months ended
June 30, 2023, compared with RMB77.6 million (US$10.7 million) for the comparable period in 2022.
Administrative Expenses
Administrative expenses for the six months ended
June 30, 2023 were RMB245.0 million (US$33.8 million), compared with RMB392.5 million (US$54.1 million) for the comparable period
in 2022. The decrease was primarily due to lower payroll expenses and share-based compensation expenses for management personnel and reduced
expenses for professional services. Share-based compensation expense was RMB88.0 million (US$12.1 million) for the six months ended June 30,
2023, compared with RMB119.3 million (US$16.5 million) for the comparable period in 2022.
Net other expenses for the six months ended June 30,
2023 were RMB71.7 million (US$9.9 million), compared with RMB51.9 million (US$7.2 million) for the comparable period in 2022. The increase