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I-Mab Provides Business and Corporate Updates and Reports Financial Results for the Six Months Ended

Key Takeaway: Provides Business and Corporate Updates and Reports Financial Results for the Six Months Ended June 30, 2022 will host conference calls and webcasts on August 30, 2022. A Mandarin session will be held at 7:00 a.m. ET and an English session will be held at 8:15 a.m. ET. Md. and

Full Press Release Details

Provides Business and Corporate Updates and Reports Financial Results for the Six Months Ended June 30, 2022
will host conference calls and webcasts on August 30, 2022. A Mandarin session will be held at 7:00 a.m. ET and an English session will
be held at 8:15 a.m. ET.
Md. and SHANGHAI, China, August 30, 2022 - I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical
company committed to the discovery, development, and commercialization of novel biologics, today announced financial results for the
six months ended June 30, 2022, and provided key business updates.
this reporting period, the Company has implemented a series of strategic initiatives that aim to re-position its overall business
priorities to focus on key value drivers while preserving a strong cash position estimated to be sufficient to support its key
business operations for more than three years.
the Company will continue to drive value by leveraging its global R&D competitive advantages in immuno-oncology, which has been demonstrated
in the Company's short history with such examples as lemzoparlimab, uliledlimab and TJ-CD4B. Today, our pipeline is not only innovative
but also advanced as certain key assets move towards BLA and near-term commercialization, including felzartamab and eftansomatropin alfa.
The Company's current business model relies on a two-pillar approach to realize the value of innovation. The first pillar is to
partner out the global rights of its innovative assets after global phase 1 or phase 2 clinical validation while retaining the rights
for clinical development, manufacturing, and commercialization in China. This is exemplified by the global partnership with AbbVie for
lemzoparlimab. The Company will continue to pursue more partnership opportunities for other global assets in its pipeline. The second
pillar is to rapidly develop the assets towards BLA and commercialization in China and then partner with large pharmaceutical companies
which have well-established sales forces and proven commercialization capabilities to market the products in China. This approach is
exemplified by the commercial partnership with Jumpcan for eftansomatropin alfa. The Company is seeking similar commercial partnerships
for other late-stage assets, including felzartamab. In addition to the broad strategic approach outlined above, the Company is committed
following a systematic review of its pipeline development and overall business, the Company has prioritized its resources to focus on
five key clinical stage assets with 10 ongoing and planned clinical trials. These prioritized programs represent the Company's
key value drivers as significant progress in these prioritized programs will not only accelerate the clinical development towards pivotal
or registrational studies (such as lemzoparlimab and uliledlimab) but also facilitate global business development deals. The Company
is currently pursuing potential global partnership deals for uliledlimab and TJ-CD4B.
the Company's current commercialization strategy aims to maximize the commercial value of its pre-BLA products through commercial
partnerships typically structured with upfront, regulatory, and sales milestone payments along with significant sales royalties. A commercial
partnership for eftansomatropin alfa was established with Jumpcan in 2021 and is progressing as planned. By doing so, the Company is
able to avoid investing significant resources to build its sales forces and instead allocate the resources to deliver the value-driver
milestones or catalysts. The Company is currently pursuing a similar commercial partnership for felzartamab.
the Company will continue to invest in the discovery and development of its next-generation pipeline assets. I-Mab's next-generation
innovative pipeline is strategically designed and driven by cutting-edge science and technology, with a focus on first-in-class and best-in-class
potential. Multiple novel assets focusing on innovative bi-specific antibodies and cytokine-based immune adjuvants are on track to advance
towards an IND enabling stage with a goal to achieve four to five INDs or Phase 1 study initiations around 2025.
through a strategy of re-positioning the pipeline to prioritize key assets with high probability of commercial success, the Company has
been making significant efforts to preserve its strong cash position. As of June 30, 2022, the Company had a total cash position, consisting
of cash, cash equivalents, and short-term investments, of US$586 million (RMB3.9 billion), which the Company estimates to be sufficient
to fund its key business operations for over three years.
we weather turbulent market conditions worldwide, we must prioritize our resources to focus on value-driving assets while continuing
to deliver on key milestones and strengthening the Company's fundamentals," said Dr. Jingwu Zang, Founder, Chairman, and
Acting CEO. "We have achieved seven critical clinical milestones year-to-date, including positive data readouts for lemzoparlimab,
uliledlimab and TJ-CD4B. In our pipeline development, we have also made significant progress on lemzoparlimab. Phase 2 data will be presented
in a proffered presentation at the upcoming European Society for Medical Oncology (ESMO) Congress in September, and we are on track to
initiate a registrational trial in China by the end of 2022. We expect to see additional data from the expanded phase 2 study of uliledlimab
in the fourth quarter of 2022."
Zang added, "Another key focus is the current registrational studies towards anticipated BLAs between now and 2024 and subsequent
commercialization for felzartamab and eftansomatropin alfa. We have a clear strategy to focus on creating value for our shareholders
while preserving a strong cash position to support our key business operations for over three years."
the corporate development front, business development remains a key strategic priority for the Company, and we continue to pursue potential
partnership opportunities. Looking ahead, we remain confident in achieving critical clinical and corporate milestones by year-end to
continue to create value for our stakeholders." Dr. Zang concluded.
Pipeline Development Highlights and Upcoming Milestones
Company's drug pipeline has a number of critical features: (1) The pipeline is innovative and globally competitive, comprised of
three generations of products with first-in-class and best-in-class potential. This is exemplified by the first generation of differentiated
drug assets, such as felzartamab and eftansomatropin alfa, which are in registrational trial or at a pre-BLA stage, as well as novel
monoclonal antibodies such as lemzoparlimab and uliledlimab, which are in phase 2 clinical trials or preparation for phase 3. The second
generation of even more innovative bi-specific antibody assets, including TJ-CD4B and TJ-L14B, are in phase 1 clinical trials, followed
by additional bi-specific antibody assets progressing towards an IND enabling stage. The new discovery initiatives for the third-generation
innovation are on the way for high-risk and high-value drug candidates enabled by transformative technologies. (2) The pipeline is focused
on immuno-oncology and biologics, leveraging its unique R&D and CMC strengths. (3) The pipeline is advanced with three assets are
either in phase 3 or registrational studies or planned for phase 3. The Company expects to achieve three potential BLA submissions or
market launches between 2023 and 2025.
chart below summarizes the development status of the Company's clinical stage pipeline (pre-clinical programs are not shown).
Five prioritized clinical assets:
(Phase 3 planned): The current focus is on the combination therapy of lemzoparlimab with azacytidine (AZA) for the treatment
of newly diagnosed myelodysplastic syndromes (MDS) with the goal of being first-to-market in China. The probability of success is supported
by collective safety data based on nearly 200 patients from multiple clinical trials and the positive efficacy data, especially from
the phase 2 study in patients with MDS. Active communications are ongoing with the China CDE and NMPA for the initiation of a registrational
trial by the end of 2022, depending upon the regulatory process and the preparation of the clinical sites around the country. In parallel,
two other studies, including solid tumor indications are ongoing.
development progress and update on global strategic partnership with AbbVie. Lemzoparlimab, a novel CD47 antibody developed by the
Company, is being investigated through a comprehensive clinical development plan for hematologic malignancies and solid tumors. The Company's
near-term priority is to initiate a phase 3 registrational trial in newly diagnosed higher-risk MDS patients by Q4 2022, potentially
making lemzoparlimab the first CD47 product in China. I-Mab is currently leading three clinical studies of lemzoparlimab, with about
200 patients treated across different indications. Safety Data. Overall, the safety data from multiple clinical trials
in the U.S. and China involving nearly 200 cancer patients have demonstrated a good safety profile of lemzoparlimab without the need
for a priming dose regimen. Efficacy Data. Lemzoparlimab has shown encouraging efficacy signals in different tumor indications
from multiple clinical trials. In particular, recent phase 2 data from lemzoparlimab combination therapy with AZA indicated that lemzoparlimab
exerted a comparable level of clinical efficacy with magrolimab in a similar therapeutic setting as described below.
3 clinical trial of lemzoparlimab in combination with AZA as a 1L treatment for MDS. An end-of-phase 2 (EOP2) meeting request was
submitted to China CDE and NMPA and discussion is ongoing with CDE to initiate a phase 3 clinical trial in patients with MDS by the end
1. Clinical efficacy of lemzoparlimab and AZA combination in MDS patients who received initial dose over six months
in combination with rituximab for non-Hodgkin's lymphoma (NHL): The dose expansion trial is ongoing to enroll more patients.
The preliminary data were reported at ASH 2021.
in combination with PD-1 therapy for solid tumors: Phase 2 clinical trial in combination with a PD-1 antibody (pembrolizumab
or toripalimab) are ongoing in patients with selected advanced solid tumors.
on AbbVie partnership: On August 15, 2022, the Company and AbbVie entered into an amendment to the original license and collaboration
agreement dated September 3, 2020 between the parties on CD47 antibody therapies (as amended, the "Agreement"). Both parties
will continue to collaborate on the global development of anti-CD47 antibody therapy under the Agreement. The Company will be eligible
to receive, and AbbVie will pay, up to US$1.295 billion in the development, regulatory and sales milestone payments, and the tiered royalties
at rates from mid-to-high single digit percentages on global net sales outside of Greater China for certain new anti-CD47 antibodies
currently in development, or the original milestone payments and tiered royalties previously disclosed in the Company's Form 20-F
for the fiscal year 2021 for other licensed products. The Company has the exclusive right to develop and commercialize all licensed products
under the Agreement in Greater China.
Company continues its commitment to lemzoparlimab development based on the accumulative safety data, without the need for a priming dosing
regimen, from nearly 200 cancer patients as well as the efficacy data, especially from a Phase 2 study of combination therapy of lemzoparlimab
and AZA in patients with higher risk MDS. The detailed data will be presented in a proffered paper at the European Society for Medical
Oncology (ESMO) Congress in September 2022. The Company is on track to initiate a Phase 3 clinical trial in patients with MDS in China
has discontinued the global Phase 1b study of lemzoparlimab combination therapy with AZA and venetoclax, in patients with MDS and AML.
This decision was not based on any specific or unexpected safety concerns.
Last updated: Aug 30, 2022