Gravity Analytica

I-Mab Reports Third Quarter 2024 Results

IMAB 11.14.2024

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Drug:TJ004309 uliledlimab

Drug:TJ033721 / ABL111 givastomig

Drug:TJ-L14B / ABL503 ragistomig

Diseases:first-line metastatic non-small cell lung cancer (mNSCLC)

Diseases:metastatic gastric cancer

Diseases:advanced and/or PD-L1 positive solid tumors

Date of Upcoming Event:2024-09-01

Name of Upcoming Event:European Society for Medical Oncology (ESMO) 2024

Date of Upcoming Event:2024-11-09

Name of Upcoming Event:Society for Immunotherapy of Cancer (SITC) 2024

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Givastomig data presented at ESMO 2024 and SITC 2024 highlights encouraging monotherapy data
On track to dose first patient in randomized Phase 2 study of uliledlimab in first-line mNSCLC in 1H 2025
Appointed Dr.Sean Fuas permanent CEO effectiveNovember 1, 2024
Estimated cash runway into 2027, based on$184.4 millionin cash and cash equivalents, and short-term investments as ofSeptember 30, 2024

ROCKVILLE, Md.,Nov. 14, 2024/PRNewswire/ --I-Mab(NASDAQ: IMAB) (the "Company"), aU.S.-based, global biotech company, exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer, today announced financial results for the three and nine months endedSeptember 30, 2024, and highlighted recent pipeline progress and business updates.

"I-Mabis making excellent progress in advancing the development of our pipeline projects, supported by our strong cash balance, streamlined operating model, and a focused in-licensing strategy," saidDr.Sean Fu, CEO and Board MemberofI-Mab. "In addition, Phase 1 data presented this year for uliledlimab, givastomig, and ragistomig at four international medical conferences highlight the strength of our early data sets for each program. These results have provided us with a strong foundation for advancing each molecule into expanded clinical trials, including Phase 2 studies, in the next year."

Pipeline Overview and Potential Upcoming Milestones:

Uliledlimab (CD73 antibody): Initiating a randomized Phase 2 combination study in 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.I-Mabowns worldwide rights to uliledlimab outside ofGreater China.

Pharmacokinetic/pharmacodynamic ("PK/PD") Phase 1 data presented at the 2024World Conference on Lung Cancer("WCLC 2024") in September showed that uliledlimab achieved full target engagement with a positive correlation between the overall response rate ("ORR") in patients with mNSCLC and uliledlimab exposure.

The Company is on track to dose the first patient in the randomized Phase 2 study in patients with first-line mNSCLC testing multiple doses of uliledlimab in combination with pembrolizumab plus chemotherapy versus standard of care in 1H 2025.

Givastomig (Claudin 18.2 x 4-1BB bispecific antibody):Ongoing Phase 1b escalation and expansion study in combination with nivolumab plus chemotherapy in first-line metastatic gastric cancer

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 ("CLDN 18.2")-positive tumor cells that conditionally activates T cells via 4-1BB in the tumor microenvironment, with potential CLDN 18.2 specificity even in tumors with low levels of CLDN 18.2 expression. The program is being jointly developed with ABL Bio.

Topline Phase 1 monotherapy dose escalation and dose expansion data presented at theEuropean Society for Medical Oncology ("ESMO2024") inSeptember 2024showed promising objective responses in patients with gastric cancers expressing CLDN 18.2 across low and high levels and defined the optimal monotherapy dose range (8-12 mg/kg). The study showed an ORR of 16.3% (7/43), including seven partial responses ("PR") at doses between 5 mg/kg and 18 mg/kg, with five of the seven patients (71%) having received prior checkpoint inhibitor therapy. Stable disease ("SD") was reported in 14 patients, with a disease control rate ("DCR") of 48.8% (21/43 patients). The safety profile was favorable, with mainly grade 1 or 2 treatment-related adverse events ("TRAEs") and no observations of dose-limiting toxicities ("DLTs") or identification of a maximum tolerated dose ("MTD").

I-Mabpresented a poster highlighting Phase 1 pharmacokinetic modeling data for optimizing dose estimation of givastomig at theSociety for Immunotherapy of Cancer("SITC 2024") onNovember 9, 2024, based on three clinical studies and additional nonclinical data. The studies demonstrated a dose-response relationship for givastomig and supported 8-12 mg/kg administered every two weeks ("Q2W") as the optimal monotherapy dose range for gastric cancer patients.

Topline data from the on-going Phase 1b study evaluating givastomig in combination with nivolumab plus chemotherapy are expected in 2H 2025 in patients with treatment-naïve CLDN 18.2-positive metastatic gastric cancer. The primary endpoint is safety, with secondary endpoints including tumor response, PK/PD, and survival.

Ragistomig (PD-L1 x 4-1BB bispecific antibody):Ongoing Phase 1 dose escalation and dose expansion in advanced and/or PD-L1 positive, solid tumors

Ragistomig (TJ-L14B / ABL503) is a bispecific, Fc-silent antibody designed to provide anti-PD-L1 activity and conditional 4-1BB-driven T-cell activation in one molecule. The program is being jointly developed with ABL Bio.

In October, the United States Patent and Trademark Office ("USPTO") issued a composition of matter patent for ragistomig, providing coverage through February2039 beforeconsideration of any potential patent term extensions.

Additional dose schedules are being explored to maximize the therapeutic index in advanced and/or PD-L1-positive solid tumors.

Significant Strategic Progress and Corporate Development

Appointment ofDr. Sean(Xi-Yong)Fu, PhD, MBA, as Chief Executive Officer:Dr. Fu was appointed as the Company's permanent Chief Executive Officer ("CEO") effectiveNovember 1, 2024.Dr. Fuhas served as the Company's Interim CEO sinceJuly 15, 2024.Dr. Fuwill continue to serve as a member of the I-Mab Board of Directors.Dr. Fuhas over 20 years of experience in the life sciences industry, leading and developing clinical-stage assets.
Sanofi S.A.("Sanofi") / TJ Biopharma ("TJ Bio") agreement for uliledlimab:OnSeptember 25, 2024, Sanofi and TJ Bio entered into a collaboration agreement to develop and commercialize uliledlimab inGreater China. The agreement includes an initial payment and near-term milestone payments totaling approximately €32 million, with the potential to receive up to €213 million in success-based milestone payments plus tiered royalties based on sales, with upside from potential expanded indications.I-Mabholds worldwide rights, excludingGreater China.
Settlement of remaining repurchase obligations:I-Mabsettled the remaining RMB equivalent of approximately$15 millionin redemption obligations related to the divestiture of itsChinaoperations inmid-September 2024. As previously disclosed, in connection with the divestiture ofI-Mab'sChinaoperations, certain non-participating shareholders of TJ Bio commenced arbitration againstI-Mab Biopharma Hong Kong Limited. As reported in the Company's 1H 2024 business update, the RMB equivalent of$17.3 millionrelated to the ongoing arbitration with certain non-participating shareholders was settled from funds previously placed into escrow, which was accounted for in prepayments and other current assets.I-Mab'sownership in TJ Bio post-settlement of the repurchase obligations is approximately 15%. As a result of the settlement of the redemption obligations, the corresponding put right liability was fully extinguished.

Third Quarter 2024 Financial Results

Cash Position

As ofSeptember 30, 2024, the Company had cash and cash equivalents, and short-term investments of$184.4 million, compared to$311.0 millionas ofDecember 31, 2023. There was$10.8 millionof cash classified as discontinued operations as ofDecember 31, 2023. The Company expects its existing cash and cash related balances to be sufficient to fund its current operating plan into 2027.

Shares Outstanding

As ofSeptember 30, 2024, the Company had 187,452,500 ordinary shares issued and outstanding, representing the equivalent of 81,501,087 ADSs, assuming the conversion of all ordinary shares into ADSs.

Research & Development Expenses

Research and development ("R&D") expenses were$4.5 millionand$15.7 millionfor the three and nine months endedSeptember 30, 2024, respectively, compared to$5.1 millionand$13.3 millionfor the three and nine months endedSeptember 30, 2023, respectively. R&D costs for the three months endedSeptember 30, 2024, were $0.6 million lower than the comparable period in 2023, primarily due to streamlined clinical pipeline activities. R&D costs for the nine months endedSeptember 30, 2024, were$2.4 millionhigher than the comparable period in 2023, driven by higher clinical trial costs associated with the preparation of enrollment for the uliledlimab Phase 2 combination study and increased spend on the givastomig Phase 1b dose expansion study. These higher costs were partially offset by decreased share-based compensation expense.

Administrative Expenses

Administrative expenses were$7.9 millionand$22.3 millionfor the three and nine months endedSeptember 30, 2024, respectively, compared to$5.9 millionand$19.9 millionfor the three and nine months endedSeptember 30, 2023, respectively. The increase of$2.0 millionand$2.4 millionfor the three and nine months endedSeptember 30, 2024, respectively, were primarily driven by legal costs associated with the litigation against Inhibrx, Inc., partially offset by lower share-based compensation expense.

Other Income (Expenses), Net

Other income (expenses), net were$(10.5) millionand$(5.0) millionfor the three and nine months endedSeptember 30, 2024, respectively, compared to$2.4 millionand$(9.1) millionfor the three and nine months endedSeptember 30, 2023, respectively. The$12.9 millionincrease in other expenses for the three months endedSeptember 30, 2024, was primarily driven by the settlement of the TJ Bio repurchase obligations. The$4.1 milliondecrease in other expenses for the nine months endedSeptember 30, 2024, was primarily driven by a smaller impact from foreign exchange losses for the current period, partially offset by the settlement of the TJ Bio repurchase obligations.

Net Loss from Continuing Operations

Net loss from continuing operations was$(20.5) millionand$(38.9) millionfor the three and nine months endedSeptember 30, 2024, respectively, compared to$(8.2) millionand$(45.3) millionfor the three and nine months endedSeptember 30, 2023, respectively.

AboutI-Mab

I-Mab(NASDAQ: IMAB) is aU.S.-based, global biotech company, exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer.I-Mabhas established operations in theU.S.inRockville, Maryland, andShort Hills, New Jersey. For more information, please visithttps://www.i-mabbiopharma.comand follow us onLinkedInandX.

Exchange Rate Information

As part ofI-Mab'sstrategic transition to a US-based biotech, effectiveApril 2, 2024, the Company changed its reporting currency from RMB to USD. As indicated in its interim financial results, reported onAugust 28, 2024, the Company applied this change retrospectively to its historical results of operations and financial statements, as if the Company had always used theU.S.dollar as its reporting currency.

I-Mab Forward Looking Statements

This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of theU.S.Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will", "expects", "believes", "designed to", "anticipates", "future", "intends", "plans", "potential", "estimates", "confident", and similar terms or the negative thereof.I-Mabmay also make written or oral forward-looking statements in its periodic reports to theU.S. Securities and Exchange Commission(the "SEC"), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements aboutI-Mab'sbeliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company's pipeline and capital strategy; the projected advancement of the Company's portfolio and anticipated milestones and related timing; the market opportunity andI-Mab'spotential next steps (including the potential expansion, differentiation, or commercialization) for uliledlimab, givastomig and ragistomig; the Company's expectations regarding the impact of data from ongoing and future clinical trials; the Company's financial condition and results of operations; the Company's expectations regarding its cash runway; timing and progress of studies and trials (including with respect to patient enrollment); the availability of data and information from ongoing studies and trials; and the patent protection available for the Company's product candidates. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following:I-Mab'sability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval ofI-Mab'sdrug candidates;I-Mab'sability to achieve commercial success for its drug candidates, if approved;I-Mab'sability to obtain and maintain protection of intellectual property for its technology and drugs;I-Mab'sreliance on third parties to conduct drug development, manufacturing and other services; andI-Mab'slimited operating history andI-Mab'sability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the "Risk Factors" section inI-Mab'smost recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors inI-Mab'ssubsequent filings with theSEC. All forward-looking statements are based on information currently available toI-Mab.I-Mabundertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.

I-Mab Investor & Media Contacts

Tyler Ehler
Senior Director, Investor Relations
IR@imabbio.com

I-Mab
Consolidated Balance Sheets
(All amounts in thousands, except for share data)

	As ofSeptember 30,		As ofDecember 31,
	2024		2023

	*(Unaudited)*		*(Unaudited)*
Assets
Current assets
Cash and cash equivalents	$	79,327	$	290,799
Short-term investments		105,064		20,172
Prepayments and other current assets		3,820		714
Current assets of discontinued operations		—		17,428
Total current assets		188,211		329,113
Property, equipment and software		186		1,772
Operating lease right-of-use assets		3,505		3,768
Investments at fair value - available for sale securities		39,343		—
Other non-current assets		1,437		248
Non-current assets of discontinued operations		—		33,127
Total assets	$	232,682	$	368,028

Liabilities and shareholders' equity
Current liabilities
Accruals and other payables	$	11,018	$	7,895
Operating lease liabilities, current		753		624
Current liabilities of discontinued operations		—		49,484
Total current liabilities		11,771		58,003
Put right liabilities, non-current		—		13,819
Operating lease liabilities, non-current		3,028		3,253
Other non-current liabilities		—		105
Non-current liabilities of discontinued operations		—		50,851
Total liabilities	$	14,799	$	126,031

Shareholders' equity
Ordinary shares (US$0.0001par value, 800,000,000 shares authorizedas ofSeptember 30, 2024andDecember 31, 2023; 187,452,500 and185,613,662 shares issued and outstanding as ofSeptember 30,2024 andDecember 31, 2023, respectively)		19		19
Treasurystock		(6,225)		(8,001)
Additional paid-in capital		1,459,196		1,380,918
Accumulated other comprehensive income		41,869		42,013
Accumulated deficit		(1,276,976)		(1,172,952)
Total shareholders' equity		217,883		241,997
Total liabilities and shareholders' equity	$	232,682	$	368,028

I-Mab
Consolidated Statements of Comprehensive Loss
(All amounts in thousands, except for share and per share data)

	Three Months EndedSeptember 30,				Nine Months EndedSeptember 30,
	2024		2023		2024		2023

	*(Unaudited)*				*(Unaudited)*
Revenues
Licensing and collaboration revenue	$	—	$	315	$	—	$	627
Total revenues		—		315		—		627
Expenses
Research and development expenses (Note 1)		(4,475)		(5,088)		(15,740)		(13,286)
Administrative expenses (Note 2)		(7,937)		(5,861)		(22,315)		(19,895)
Loss from operations		(12,412)		(10,634)		(38,055)		(32,554)
Interest income		2,449		2,483		5,289		6,989
Other income (expenses), net		(10,528)		2,379		(5,048)		(9,102)
Equity in loss of affiliates (Note 3)		—		(2,449)		(1,038)		(10,640)
Loss from continuing operations before income taxexpense		(20,491)		(8,221)		(38,852)		(45,307)
Income tax expense		—		—		—		—
Loss from continuing operations	$	(20,491)	$	(8,221)	$	(38,852)	$	(45,307)

Discontinued operations:
Loss from operations of discontinued operations(Note 4)	$	—	$	(25,035)	$	(6,898)	$	(94,522)
Income tax expense		—		—		—		—
Gain on sale of discontinued operations		—		—		32,582		—
Income (loss) from discontinued operations	$	—	$	(25,035)	$	25,684	$	(94,522)

Net loss attributable toI-Mab	$	(20,491)	$	(33,256)	$	(13,168)	$	(139,829)
Net loss attributable to ordinary shareholders	$	(20,491)	$	(33,256)	$	(13,168)	$	(139,829)

Net loss attributable toI-Mab	$	(20,491)	$	(33,256)	$	(13,168)	$	(139,829)
Foreign currency translation adjustments net of tax		1,071		(13,547)		(494)		8,887
Total comprehensive loss attributable toI-Mab	$	(19,420)	$	(46,803)	$	(13,662)	$	(130,942)

Net loss from continuing operations per shareattributable to ordinary shareholders—Basic and diluted	$	(0.11)	$	(0.04)	$	(0.21)	$	(0.24)
Net loss from continuing operations per ADSattributable to ordinary shareholders (Note 5)—Basic and diluted	$	(0.25)	$	(0.09)	$	(0.48)	$	(0.55)

Net income (loss) from discontinued operations pershare attributable to ordinary shareholders—Basic and diluted	$	-	$	(0.13)	$	0.14	$	(0.49)
Net income (loss) from discontinued operations perADS attributable to ordinary shareholders (Note 5)—Basic and diluted	$	-	$	(0.30)	$	0.32	$	(1.13)

Net loss attributable to ordinary shareholders—Basic and diluted	$	(0.11)	$	(0.17)	$	(0.07)	$	(0.73)
Net loss per ADS attributable to ordinaryshareholders (Note 5)—Basic and diluted	$	(0.25)	$	(0.39)	$	(0.16)	$	(1.68)

Weighted-average number of ordinary sharesoutstanding —Basic and diluted		187,440,440		192,922,665		186,485,241		191,306,670

Notes:

(1) Includes share-based compensation expense of$0.6 millionand$0.9 millionfor the three and nine months endedSeptember 30, 2024, respectively, compared to$0.6 millionand$2.3 millionfor the three and nine months endedSeptember 30, 2023, respectively.

(2) Includes share-based compensation expense of$(0.3) millionand($3.7) millionfor the three and nine months endedSeptember 30, 2024, respectively, compared to$1.5 millionand$6.2 millionfor the three and nine months endedSeptember 30, 2023, respectively. The period endedSeptember 30, 2024includes forfeitures as a result of the divestiture ofChinaoperations and organizational changes.

(3) Includes share-based compensation expense of$0.0 millionand($0.7) millionfor the three and nine months endedSeptember 30, 2024, respectively, compared to$0.1 millionand$0.7 millionfor the three and nine months endedSeptember 30, 2023, respectively. The period endedSeptember 30, 2024includes forfeitures as a result of the divestiture ofChinaoperations.

(4) Includes share-based compensation expense of$0.0 millionand($11.5) millionfor the three and nine months endedSeptember 30, 2024, respectively, compared to$2.7 millionand$14.8 millionfor the three and nine months endedSeptember 30, 2023, respectively. The period endedSeptember 30, 2024includes forfeitures as a result of the divestiture ofChinaoperations.

(5) Each 10 ADSs represents 23 ordinary shares.

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SOURCEI-Mab Biopharma

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