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I-Mab (IMAB) 2025 Conference June 05, 2025 03:45 PM ET Speaker0 Great. I think we can get started. Good afternoon, everyone. Thank you for attending Jefferies Healthcare Conference. My name is Yifan Shi from Jefferies Biotech Research Team. Today, we are very pleased to have Doctor. Sheng Fu, CEO of IMAP, and Doctor. Philip Dennis, CMO of IMAP, in for this session. Welcome. Speaker1 Thank you. Speaker0 So, to get start, so for those who may be less familiar with your story, could you please provide a high l ...

Core Points - I-Mab, a U.S.-based global biotech company, focuses on developing precision immuno-oncology agents for cancer treatment [1][2] - The management team of I-Mab will participate in the Jefferies Global Healthcare Conference from June 3-5, 2025, discussing clinical progress on its lead program, givastomig [1][2] - New data on givastomig has been accepted for a Mini Oral presentation at the ESMO Gastrointestinal Cancers Congress 2025, scheduled for July 2, 2025, in Barcelona, Spain [2] Company Information - I-Mab is headquartered in Rockville, Maryland, and has operations in Short Hills, New Jersey [2] - The company is publicly traded on NASDAQ under the ticker IMAB [1][2] - For more information, I-Mab's website and social media channels are available [2]

Core Insights - I-Mab has reported strong progress in its lead program, givastomig, aimed at treating gastric cancers, with patient enrollment in Phase 1b dose expansion cohorts completed ahead of schedule [2][3] - The company has a robust cash position of $168.6 million as of March 31, 2025, which is expected to fund ongoing studies and development initiatives into 2027 [6][8] - The anticipated milestones for givastomig include data presentations at the ESMO GI Congress in July 2025 and further updates in 2026 [3][4] Financial Performance - For Q1 2025, research and development expenses decreased to $0.8 million from $6.1 million in Q1 2024, primarily due to reimbursements and lower costs [10] - Administrative expenses increased to $4.5 million in Q1 2025 from $2.4 million in Q1 2024, influenced by changes in employee share-based compensation [11] - The net loss from continuing operations was $(3.2) million for Q1 2025, a significant reduction from $(9.4) million in Q1 2024, with net loss per share improving from $(0.05) to $(0.02) [15][17] Pipeline and Development - Givastomig is a bispecific antibody targeting CLDN18.2-positive tumor cells, currently in Phase 1b trials for first-line metastatic gastric cancers [18][20] - The ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy, with enrollment in the first dose expansion cohort completed ahead of schedule [20][21] - The company is also developing uliledlimab and ragistomig in collaboration with partners, with updates expected in 2026 [4][8]

Core Insights - I-Mab announced that an abstract for a combination study of givastomig, nivolumab, and chemotherapy has been accepted for a mini-oral presentation at the ESMO Gastrointestinal Cancers Congress 2025, scheduled for July 2-5 in Barcelona, Spain [1][2] Company Overview - I-Mab is a U.S.-based global biotech company focused on developing precision immuno-oncology agents for cancer treatment, with operations in Rockville, Maryland, and Short Hills, New Jersey [6] Product Information - Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2-positive tumor cells, designed to activate T cells through the 4-1BB signaling pathway in the tumor microenvironment [3] - Givastomig is being developed for first-line metastatic gastric cancers and has shown promising anti-tumor activity in Phase 1 trials, minimizing common toxicities associated with other 4-1BB agents [3] Clinical Study Details - The Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy for the treatment of gastric cancer in the first-line setting, with dose escalation completed and enrollment in the first dose expansion cohort finished ahead of schedule [4] - The study builds on positive Phase 1 monotherapy data, indicating strong potential for further development [4] Partnership Information - Givastomig is being jointly developed through a global partnership with ABL Bio, with I-Mab as the lead party sharing worldwide rights, excluding Greater China and South Korea, equally with ABL Bio [5]

Group 1 - I-Mab Sponsored ADR (IMAB) has experienced significant selling pressure, resulting in a 20.3% decline over the past four weeks, but analysts anticipate better earnings than previously predicted [1] - The stock is currently in oversold territory, indicated by an RSI reading of 29.66, suggesting that the heavy selling may be exhausting itself and a rebound could occur [5] - There has been a strong consensus among sell-side analysts to raise earnings estimates for IMAB, leading to a 37.3% increase in the consensus EPS estimate over the last 30 days, which typically correlates with price appreciation [7] Group 2 - IMAB holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a potential turnaround in the near term [8]

Group 1 - I-Mab Sponsored ADR (IMAB) has experienced significant selling pressure, resulting in a 19.7% decline over the past four weeks, but analysts anticipate better earnings than previously predicted [1] - The stock is currently in oversold territory, indicated by an RSI reading of 29.26, suggesting that the heavy selling may be exhausting itself [5] - There has been a 37.3% increase in the consensus EPS estimate for IMAB over the last 30 days due to a strong agreement among sell-side analysts, which typically correlates with price appreciation [7] Group 2 - IMAB holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a potential turnaround [8]

Financial Performance - I-Mab reported a net loss of $(22.2) million for the year ended December 31, 2024, a significant decrease from $(207.7) million in 2023, with net loss per share improving from $(1.09) to $(0.12) [21] - Total revenues for the year ended December 31, 2024, were $0, compared to $632 million in 2023, indicating a significant decline [30] - The net loss from continuing operations for 2024 was $49.70 million, an improvement from a loss of $82.22 million in 2023 [30] - The company reported a net loss of $22.23 million for 2024, compared to a net loss of $207.73 million in 2023, reflecting a substantial reduction in losses [30] - Total comprehensive loss for 2024 was $28.62 million, significantly lower than the $202.12 million reported in 2023 [30] Cash and Investments - The company had cash, cash equivalents, and short-term investments totaling $173.4 million as of December 31, 2024, providing a runway into 2027 for ongoing clinical studies [11] - Cash and cash equivalents at the end of 2024 were $68.26 million, down from $310.67 million at the end of 2023 [39] - Net cash used in operating activities from continuing operations was $52.67 million in 2024, compared to $72.70 million in 2023, indicating improved cash flow management [36] Expenses - Research and development expenses increased to $21.8 million in 2024 from $21.4 million in 2023, primarily due to higher spending on the lead program, givastomig [13] - Administrative expenses rose to $29.7 million in 2024, up from $28.2 million in 2023, largely due to increased legal expenses related to trade secret disputes [14] - Research and development expenses increased slightly to $21.77 million in 2024 from $21.45 million in 2023, while administrative expenses rose to $29.66 million from $28.16 million [30] - The company incurred share-based compensation expenses of $1.95 million in 2024, a decrease from $10.24 million in 2023 [36] Asset Transactions - I-Mab completed the divestiture of its Greater China assets, recognizing a gain of $34.4 million from the transaction [19] - The company recorded a gain of $34.36 million on the sale of discontinued operations in 2024, contrasting with a loss of $125.51 million in 2023 [30] Clinical Development - Givastomig, a bispecific antibody targeting CLDN18.2, is being developed for first-line metastatic gastric cancers, with promising Phase 1 trial results indicating strong tumor-binding properties [4] - The first dose expansion cohort for givastomig's Phase 1b study was completed ahead of schedule, with ongoing momentum in the second cohort [5] - The company expects topline dose escalation data from the givastomig Phase 1b trial in the second half of 2025 [10] - The company anticipates continued development of its pipeline, focusing on givastomig and uliledlimab, with potential milestones expected in 2025 and 2026 [3] Share Information - As of December 31, 2024, I-Mab had 187,452,495 ordinary shares outstanding, equivalent to 81,501,085 ADSs [12] - The weighted-average number of ordinary shares used in calculating net loss per share was 186,728,372 for 2024, compared to 191,423,850 for 2023 [30]

Business Operations and Strategy - The company divested its Greater China assets and business operations in April 2024, transitioning to primarily operate through its U.S. subsidiary[31] - The company may face significant risks related to the transition of its business focus to the U.S. market[47] - The company has not received or been denied permissions from the PRC authorities regarding the listing and issuance of securities to foreign investors[32] - The company has divested its Greater China assets, significantly reducing the number of drug candidates in its pipeline[209] - Recent management changes include the appointment of Xi-Yong (Sean) Fu as interim CEO in July 2024 and permanent CEO in November 2024, which may impact business operations[211] Financial Performance and Funding - The company recorded net cash outflow from operating activities in the past and may need additional financing to fund operations[45] - The company has incurred net losses historically and may not achieve or maintain profitability in the future[45] - The company incurred net losses of $22.2 million, $207.7 million, and $371.1 million in 2024, 2023, and 2022, respectively, primarily due to research and development and administrative costs[50] - The company raised over $400 million in pre-IPO financing and received total net proceeds of approximately $105.3 million, $397.2 million, and $105.6 million from various funding activities[53] - The company used $52.7 million, $72.7 million, and $49.6 million in net cash for operations in the years ended December 31, 2024, 2023, and 2022, respectively[53] - The company has $173.4 million in cash, cash equivalents, and short-term investments, which is expected to meet working capital requirements into 2027[57] - The company may need to obtain additional financing to fund operations and may face dilution of interests for existing shareholders if additional capital is raised[58] - The company anticipates incurring significant commercialization expenses if regulatory approvals for drug candidates are obtained[56] Drug Development and Clinical Trials - The company is focused on developing precision immuno-oncology agents for cancer treatment, with all drug candidates currently in preclinical or clinical development[47] - The company plans to rely on third parties for the manufacturing process of its drug candidates, which poses risks if those parties fail to meet quality or quantity requirements[47] - The company has open INDs with the FDA for three drug candidates: givastomig, uliledlimab, and ragistomig[72] - None of the drug candidates have been approved for marketing in any jurisdiction, requiring additional preclinical and clinical development[72] - The company faces significant risks in clinical development, including potential failure at any stage of the process[72] - Delays in patient enrollment for clinical trials could significantly impact the development timeline and increase costs[78] - The regulatory approval process is time-consuming and may evolve, potentially delaying commercialization plans[90] - The company may incur additional costs or experience delays if clinical trials do not demonstrate safety and efficacy[83] - The company may not be able to identify or develop new drug candidates due to limited resources, impacting future growth[75] - Regulatory authorities may require more information or additional trials, which could delay or prevent approval[93] - Adverse events from drug candidates could lead to interruptions in clinical trials or changes in development plans[97] - Adverse events such as liver toxicities and cytokine release syndrome could lead to trial suspensions or terminations, impacting the company's reputation and financial condition[100] Regulatory and Compliance Risks - The company has identified a material weakness in internal control related to ineffective information technology general controls[46] - The company may face uncertainties regarding regulatory approvals for offshore offerings, which could materially affect its business and financial condition[61] - The company may be subject to ongoing regulatory obligations and penalties if it fails to comply with requirements post-approval[103] - Legislative changes, such as the Inflation Reduction Act, could increase difficulties and costs associated with obtaining marketing approvals and affect pricing strategies[124] - Legislative changes may impact marketing approvals and increase scrutiny on the FDA's approval process, potentially delaying or preventing marketing approval for drug candidates[126] - The company faces challenges in obtaining patent term extensions, increasing the risk of generic competition[94] - The company may face significant delays in obtaining reimbursement for approved drug candidates, impacting revenue generation[121] Intellectual Property and Competition - The company holds a patent portfolio consisting of 63 issued patents and 60 patent applications, primarily related to its drug candidates[153] - The patent examination process may require the company to narrow the scope of claims, potentially limiting patent protection[156] - The company may encounter difficulties in protecting its intellectual property rights in jurisdictions with less favorable legal systems, impacting its competitive position[161] - The company faces risks of patent abandonment due to non-compliance events, which could harm its competitive position and ability to commercialize drug candidates[166] - The company may need to obtain licenses from third parties if it fails in priority disputes, which could adversely impact its business if such licenses are not available on commercially reasonable terms[167] - Litigation regarding patent infringement is common in the biotechnology and pharmaceutical industries, and the company may face costly legal challenges from third parties[168] - The company cannot guarantee that its drug candidates do not infringe on third-party patents, which could lead to significant litigation costs and potential damages[172] - Changes in U.S. patent law could increase uncertainties and costs related to patent applications and enforcement, potentially diminishing the value of the company's patents[174] - The company’s patent rights could be challenged or invalidated, which may result in loss of patent protection for its drug candidates[178] - Enforcing intellectual property rights may lead to counterclaims that could be costly to defend and may require the company to pay substantial damages[179] - Intellectual property litigation could harm the company's reputation and negatively impact the market price of its American Depositary Shares (ADSs)[180] - The company may face difficulties in protecting trade secrets, which could harm its competitive position if proprietary information is disclosed[184] - The company may face claims regarding the use or disclosure of intellectual property from former employers of its employees, which could lead to litigation and substantial costs[185] - The growth of the company may depend on its ability to acquire and maintain licenses for third-party intellectual property rights, which is a competitive area with established companies having advantages[186] - The company relies on licenses from third parties for the development and commercialization of drug candidates, and may need additional licenses to advance its research[187] - If the company fails to comply with its licensing obligations, it could lose important rights and face monetary damages, adversely affecting its business[195] - The company may not be able to obtain additional licenses at reasonable costs, which could hinder its ability to develop and commercialize drug candidates[198] Operational Challenges - The company reduced its workforce by approximately 27% as part of a strategic reprioritization plan to focus on advancing its lead program, givastomig[67] - The company faces challenges in recruiting and retaining qualified personnel due to intense competition in the biopharmaceutical industry[211] - There is a risk of inaccurate or incomplete data affecting the development of drug candidates, which could harm the company's reputation and financial condition[214] - The company relies on third parties for data management in clinical programs, and any failure by these parties could compromise trial data and regulatory compliance[217] - Liability claims from clinical trials could result in significant costs and impact the company's financial condition[218] - The company maintains limited insurance coverage, which may not be sufficient to cover all potential claims, leading to substantial costs[220] - Disruptions in financial markets could affect the company's ability to raise capital on acceptable terms[221] - The company may engage in future acquisitions or partnerships, which could increase capital requirements and dilute investor value[229] - Compliance with anti-bribery laws is critical, as violations could lead to severe penalties and disrupt business operations[231]

Core Insights - I-Mab has undergone a transformational year, establishing itself as a U.S.-based biotech company, divesting operations in China, and focusing on its lead program, givastomig, a novel therapy for gastric cancer [2][3] Financial Highlights - As of December 31, 2024, the company reported cash and cash equivalents of $173.4 million, providing a financial runway into 2027 for ongoing clinical studies [8][11] - Research and development expenses for the year were $21.8 million, slightly up from $21.4 million in 2023, primarily due to increased spending on givastomig [13] - Administrative expenses increased to $29.7 million from $28.2 million, largely due to higher professional services fees related to legal disputes [14] - The net loss from continuing operations was $(49.7) million for 2024, an improvement from $(82.2) million in 2023, with a net loss per share of $(0.27) compared to $(0.43) [18][21] Pipeline and Development Updates - Givastomig is a bispecific antibody targeting CLDN18.2-positive tumor cells, currently in Phase 1b trials for first-line metastatic gastric cancer, showing promising anti-tumor activity [4][5] - Enrollment in the first dose expansion cohort for givastomig was completed ahead of schedule, with continued momentum in the second cohort [5][8] - Upcoming milestones include topline dose escalation data expected in the second half of 2025 and topline results from the ongoing dose expansion study anticipated in the first half of 2026 [10][8] Strategic Changes - The company has redefined its strategy and strengthened its leadership team, with Sean Fu appointed as CEO [2][9] - The divestiture of Greater China assets was completed, resulting in a gain of $34.4 million for the year [20] Shareholder Information - As of December 31, 2024, the company had 187,452,495 ordinary shares outstanding, equivalent to 81,501,085 ADSs [12]