On 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, reported its financial results for the six months ended June 30, 2023, and provided key business updates (Press release, I-Mab Biopharma, AUG 17, 2023, View Source [SID1234634472]).
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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 (Free ASCO Whitepaper) 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 (SITC) (Free SITC Whitepaper), and the Phase 1 monotherapy dose escalation data were selected for presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 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, 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 reported 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
· 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$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 applicable 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 in Southeast 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 RMB3.0 billion (US$414.6 million), compared with RMB3.5 billion (US$489.0 million) as of December 31, 2022.
Net Revenues
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.
Other Expenses, Net
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 was primarily caused by the higher unrealized exchange losses due to the significant fluctuation in the exchange rate of the Renminbi (RMB) against the U.S. dollars in 2023.
Equity in Loss of Affiliates
Equity in loss of affiliates for the six months ended June 30, 2023 was RMB59.6 million (US$8.2 million), compared with RMB181.0 million (US$25.0 million) for the comparable period in 2022. The loss was mainly recognized in relation to the Company’s affiliate, I-Mab Biopharma (Hangzhou) Co., Ltd.
Net Loss
Net loss for the six months ended June 30, 2023 was RMB772.8 million (US$106.6 million), compared with RMB1,046.9 million (US$144.4 million) in the comparable period in 2022. Net loss per share attributable to ordinary shareholders as of June 30, 2023 was RMB4.04 (US$0.56), compared with RMB5.54 (US$0.76) for the comparable period in 2022. Net loss per ADS attributable to ordinary shareholders as of June 30, 2023 was RMB9.29 (US$1.28), compared with RMB12.74 (US$1.76) for the comparable period in 2022. As of June 30, 2023, I-Mab has 190,033,689 shares outstanding.
Non-GAAP Net Loss
Non-GAAP adjusted net loss, which excludes share-based compensation expenses, for the six months ended June 30, 2023 was RMB634.2 million (US$87.5 million), compared with RMB848.0 million (US$116.9 million) for the comparable period in 2022. Non-GAAP adjusted net loss per share attributable to ordinary shareholders for the six months ended June 30, 2023 was RMB3.31 (US$0.46), compared with RMB4.49 (US$0.62) for the comparable period in 2022. Non-GAAP adjusted net loss per ADS attributable to ordinary shareholders for the six months ended June 30, 2023 was RMB7.61 (US$1.05), compared with RMB10.33 (US$1.42) for the comparable period in 2022.
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:
Meeting ID: 873 4976 6033
Password: 194422