Group 1 - Corbus Pharmaceuticals Holdings Inc. is a clinical-stage company focused on oncology and obesity, with a commitment to innovative scientific approaches to serious illnesses [2] - The company will present a corporate overview at the 2026 Annual J.P. Morgan Healthcare Conference scheduled for January 12-15, 2026, in San Francisco, CA [1] - Corbus' pipeline includes CRB-701, a next-generation antibody drug conjugate targeting Nectin-4 on cancer cells; CRB-601, an anti-integrin monoclonal antibody blocking TGFβ activation; and CRB-913, a CB1 inverse agonist for obesity treatment [2]

Core Insights - Several small-cap biotech and healthcare companies experienced notable gains in after-hours trading, driven by recent corporate updates and clinical milestones Company Updates - Inspira Technologies Oxy B.H.N. Ltd. (IINN) rose 5.88% to $1.08 following a recent definitive agreement for a registered direct offering of its ordinary shares and a Standby Equity Purchase Agreement with YA II PN, Ltd. [2] - Galectin Therapeutics Inc. (GALT) increased by 1.79% to close at $6.27, despite no new corporate developments reported [3] - MediciNova, Inc. (MNOV) advanced 4.83% to $1.52 after successfully completing patient enrollment in its Phase 2 OXTOX study, evaluating MN-166 for chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients [4] - Marker Therapeutics, Inc. (MRKR) gained 5.56% to $1.33 without any new company-specific announcements [5] - Sharps Technology, Inc. (STSS) climbed nearly 4% to $2.09, also without fresh updates [6] - DiaMedica Therapeutics Inc. (DMAC) rose 2.89% to $8.55 after a productive pre-IND meeting with the FDA regarding its planned study of DM199 in preeclampsia [6] - Corbus Pharmaceuticals Holdings, Inc. (CRBP) edged higher by 1.36% to $8.21, following the completion of its Phase 1a study of CRB-913 and initiation of the Phase 1b CANYON-1 trial [7] - ProMIS Neurosciences, Inc. (PMN) added 0.83% to $8.49, recovering slightly after a decline earlier in the day, with the completion of enrollment of 144 patients in its PRECISE-AD Phase 1b clinical trial for Alzheimer's disease [8]

PresentationGood morning, and welcome to the Corbus Pharmaceuticals Investor Webinar. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be available on the Corbus website following the conclusion of the event. I will now turn the call over to Yuval Cohen, Chief Executive Officer and Director of Corbus Pharmaceuticals. Please go ahead, Yuval.Yuval CohenCEO & Director Thank you, Wilson. Good morning, everyone, and thank you for joining us on this call, this webinar, to disc ...

Corbus Pharmaceuticals Holdings (NasdaqCM:CRBP) Update Summary Company Overview - **Company**: Corbus Pharmaceuticals Holdings - **Event**: Investor Webinar held on December 11, 2025 Key Points Industry and Product Focus - The discussion centers around the development of **CRB-913**, a novel **CB1 inverse agonist** aimed at treating obesity and weight-related medical complications [1][2][5] - Comparison is made with **Monlunabant**, another CB1 inverse agonist, highlighting differences in brain exclusion and safety profiles [5][6][11] Clinical Study Insights - **Study Design**: The **Single Ascending Dose (SAD)** and **Multiple Ascending Dose (MAD)** studies involved healthy volunteers and participants with obesity, focusing on safety and pharmacokinetics (PK) [6][7][8] - **Dosing**: CRB-913 was administered at doses up to **600 mg**, significantly higher than effective doses of Monlunabant [7] - **Safety Profile**: CRB-913 exhibited a favorable safety profile with minimal gastrointestinal (GI) adverse events, contrasting sharply with Monlunabant, which had a high incidence of GI issues [9][10][11] Efficacy and Weight Loss Results - Participants in the obesity cohort (average BMI of **36**) experienced weight loss of **2.9%** over **14 days**, with no weight loss in the placebo group [13][52] - Weight loss was not associated with GI adverse events, indicating a unique mechanism of action for CRB-913 [22][39] - The drug demonstrated a long half-life, contributing to sustained weight loss effects beyond the dosing period [45][46] Neuropsychiatric Safety - CRB-913 showed no significant neuropsychiatric adverse events, with validated questionnaires indicating no cases of suicidality or depression among participants [11][12][25] - Mild anxiety was reported in a few cases, but these did not trigger any significant concerns [26][27] Future Directions - Corbus Pharmaceuticals plans to initiate **CANYON-1**, a Phase 1b study focusing on safety and tolerability, with a titration approach to dosing [19][20] - The company aims to learn from Monlunabant's experiences to improve patient outcomes and safety [19][20] Market Context and Need - There is a recognized need for diverse treatment options in obesity management, as many patients do not respond adequately to existing therapies, particularly GLP-1 agonists [33][34][35] - The potential for combination therapies targeting different pathways in obesity treatment is emphasized [34][35] Conclusion - The data presented indicates that CRB-913 has a promising profile as a treatment for obesity, with early indications of efficacy and a favorable safety profile compared to existing therapies [22][39][56] - Further studies are necessary to confirm these findings and establish the drug's role in clinical practice [56][58]

CRB-913 was safe and well-tolerated across all doses studiedDaily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative for all participantsA placebo-adjusted mean weight loss of 2.9% was observed at Day 14 in a dedicated cohort of people with obesity (n=12)A 12-week dose-finding study in people with obesity initiated with completion expected in summer 2026Company to host conference call and live webcast today at 8:00 am ET NORWOOD, Mass., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmace ...

Core Insights - After-hours trading in the U.S. saw significant gains in small-cap and micro-cap biotech stocks, driven by a mix of catalyst-driven moves and sentiment-based rebounds following the Fed's rate cut Group 1: Notable After-Hours Gainers - Agape ATP Corp. (ATPC) surged 29.41% after hours to $0.088, despite no specific news, reflecting a broader risk-on sentiment in micro-cap stocks [1] - Corbus Pharmaceuticals Holdings, Inc. (CRBP) rose 12.76% after hours to $11.57, driven by anticipation of a key clinical update on its Phase 1a study of CRB-913 [2] - Anebulo Pharmaceuticals, Inc. (ANEB) increased 8.37% after hours to $2.33, aligning with the overall positive sentiment in small-cap biotech [3] - Cue Biopharma, Inc. (CUE) gained 13.12% after hours to $0.54, with no new developments, indicating a macro-driven recovery in biotech [4] - Curis, Inc. (CRIS) saw a 7.68% increase after hours to $1.3999, following positive clinical data presented at the ASH Annual Meeting [5] - Skye Bioscience, Inc. (SKYE) rose 7.02% after hours to $1.22, benefiting from the overall biotech market lift [6] - Cerus Corporation (CERS) increased 3.17% after hours to $1.95, continuing its upward trend after announcing a purchasing agreement with Blood Centers of America [7]

Core Insights - Corbus Pharmaceuticals Holdings Inc. plans to release results of its Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) study of CRB-913 on December 11, 2025, before market open [1] - A conference call and live webcast will be held on the same day at 8:00 am ET to discuss the Phase 1a data [1] About CRB-913 - CRB-913 is an oral small molecule inverse agonist of the G-protein Coupled Receptor (GPCR) cannabinoid type-1 (CB1), designed for weight loss with reduced brain penetration [3] - Preclinical models indicate that CRB-913 is 15-fold less brain-penetrant than monlunabant and has a 50 times lower brain:plasma ratio than rimonabant [3] About Corbus - Corbus Pharmaceuticals is focused on oncology and obesity, aiming to address serious illnesses through innovative scientific approaches [4] - The company's pipeline includes CRB-701, an antibody drug conjugate targeting Nectin-4 on cancer cells, and CRB-601, an anti-integrin monoclonal antibody blocking TGFβ activation on cancer cells [4]

Summary of Corbus Pharmaceuticals Holdings FY Conference Call Company Overview - Corbus Pharmaceuticals Holdings is a drug development company based in Norwood, Massachusetts, with a focus on oncology and obesity [4][5] - The company has a small team of approximately 40 employees and emphasizes its preference for remaining small [4] Key Pipeline Developments ADC Program for Nectin-4 - The company is focusing on its ADC program for Nectin-4, with key milestones expected in the next 18 months [7] - Upcoming regulatory updates and data releases are planned for: - Q1: Regulatory update on pivotal study for Nectin-4 ADC monotherapy in second-line head and neck cancer [5] - Mid-year: Data on monotherapy for head and neck cancer, with a focus on durability [5] - Second half of the year: Data on monotherapy for cervical cancer and combination therapy with Keytruda in front-line head and neck cancer [5][6] CB1 Program for Obesity - The company is preparing to release SAD/MAD data imminently, with a significant study on obese non-diabetics planned for mid-year [6][19] - The phase 1 study design includes a classic SAD/MAD approach, with dosing up to hundreds of milligrams per day to assess safety and pharmacokinetics [19][20] Market Context and Competitive Landscape - The second-line treatment landscape for head and neck cancer is described as grim, with current therapies offering limited efficacy [7][8] - The company aims to differentiate its therapies based on safety profiles, particularly in terms of lower neuropathy and ocular toxicity compared to competitors like Padcev [16][17] Financial Position - Corbus Pharmaceuticals has extended its cash runway into 2028, providing a stable financial foundation for upcoming studies and developments [7] Strategic Focus - The company prioritizes investment in second-line monotherapy for head and neck cancer, followed by cervical cancer, with a wildcard focus on front-line combination therapy [30][32] - The potential for combination therapies with GLP-1 agonists is also being explored, with preclinical data showing promising results [28][29] Additional Insights - The company is cautious about expanding its focus beyond its current pipeline due to resource limitations, although it remains open to exploring other tumor types that express Nectin-4 [10][11] - The safety profile of CRB-701 is highlighted as a potential commercial advantage, particularly its low levels of peripheral neuropathy, which is a significant concern for patients [16][17] Conclusion - Corbus Pharmaceuticals is positioned to make significant advancements in its ADC and CB1 programs over the next year, with a clear focus on regulatory milestones and data releases that could shape its future in the oncology and obesity markets [5][6][30]

Summary of Corbus Pharmaceuticals Holdings Conference Call Company Overview - Corbus Pharmaceuticals is a small biotech company based in Norwood, Massachusetts, with approximately 40 employees - The company has a diverse pipeline with two main assets: a Nectin-4 ADC targeting solid tumors (head and neck and cervical cancers) and a small molecule oral CB1 inverse agonist targeting obesity [3][4] Oncology Asset Development - The Nectin-4 ADC is developed in partnership with CSPC, the third largest pharmaceutical company in China - The development programs for the ADC are independent, with separate data sets for U.S./European and Chinese sites [4][5] - Recent data presented at ISMO showed a 48% overall response rate (ORR) at 3.6 mg/kg and 33% at 2.7 mg/kg for head and neck and cervical cancers [7][10] Efficacy and Safety - The company is optimistic about the durability of responses, with data expected to mature by mid-next year [10][11] - Safety profile shows low rates of peripheral neuropathy, a significant advantage over competitors like Padcev, which has higher rates of this adverse effect [12][13] - Ocular toxicity remains a concern, with a noted 44% incidence in Padcev, while Corbus's ADC has a manageable profile [14][15] Market Opportunity - The second-line treatment space for head and neck cancer is currently limited, with an ORR of about 10% or lower, making Corbus's asset attractive [20][21] - The U.S. second-line therapy market for head and neck cancer is estimated at around 24,000 patients, potentially increasing to 36,000 due to improved survival rates from front-line therapies [21][22] Competitive Landscape - Other ADCs in the second-line space are limited, with Pfizer's attempts not progressing [22] - Corbus's Nectin-4 ADC is positioned well due to its unique safety profile, making it less likely for competitors to enter the same market segment [22][23] Obesity Asset Development - The CB1 inverse agonist is currently in SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) studies, with data expected before the end of the year [34][35] - The upcoming 90-day study in obese non-diabetic patients aims to assess safety and weight loss efficacy [35][36] - Historical data from Rimonabant suggests that CB1 inverse agonists can lead to significant weight loss, although the exact efficacy of Corbus's asset remains to be determined [36][38] Financial Position and Future Catalysts - Corbus has approximately $180 million in cash, which supports ongoing and upcoming studies [53] - Key data catalysts for the next year include results from the 701 program and the 90-day dose range finding study for the 913 asset [53][54] Conclusion - Corbus Pharmaceuticals is strategically positioned in the oncology and obesity markets with promising assets and a solid financial foundation, making it an interesting prospect for investors looking for opportunities in biotech [53][54]

Financial Performance - For the three months ended September 30, 2025, the total operating expenses were approximately $24.4 million, an increase of 57% compared to $15.5 million for the same period in 2024[106] - The accumulated deficit as of September 30, 2025 was approximately $534.9 million, with net losses of approximately $23.3 million for the three months ended September 30, 2025, compared to $13.8 million for the same period in 2024[101] - Total operating expenses for the nine months ended September 30, 2025 were approximately $63.3 million, an increase of $27.2 million or 75% compared to $36.1 million for the same period in 2024[111] - Total other income, net for the nine months ended September 30, 2025 was approximately $5.4 million, a slight decrease of $0.1 million or 1% from $5.4 million recorded for the same period in 2024[115] Research and Development - Research and development expenses for the three months ended September 30, 2025 totaled approximately $20.9 million, reflecting a 93% increase from approximately $10.8 million in the same period of 2024[106] - Research and development expenses for the nine months ended September 30, 2025 totaled approximately $51.7 million, an increase of $28.3 million from approximately $23.4 million recorded for the same period in 2024, representing a 121% increase[111] - CRB-701's program-specific costs increased by $5.4 million due to higher clinical costs as more sites were activated and participants enrolled in the ongoing Phase 1/2 clinical trial[107] - CRB-601's program-specific costs increased by $3.6 million as a result of higher clinical and drug supply-related costs, with the first participant dosed in December 2024[107] - Total program-specific costs increased by $25.7 million for the nine months ended September 30, 2025, with CRB-701 costs rising by $12.5 million due to higher clinical and drug supply costs[112] - CRB-913 is currently in a Phase 1 study, with the first participant dosed in the first quarter of 2025, and data from this study is expected to be reported in the fourth quarter of 2025[97] - The company plans to engage with the FDA regarding the design of a registrational study for CRB-701, anticipating to commence this study by mid-2026[98] Capital and Financing - The company raised gross proceeds of approximately $75.0 million from a public offering completed on November 3, 2025, with net proceeds of approximately $70.2 million after deducting underwriting discounts and commissions[100] - The company expects to continue incurring significant operating losses and will need additional financing to support ongoing operations[102] - The company will need to raise significant additional capital to continue funding clinical trials for CRB-701, CRB-601, and CRB-913[122] Cash and Assets - At September 30, 2025, total current assets were approximately $107.6 million, with current liabilities of approximately $17.1 million, resulting in working capital of approximately $90.5 million[117] - The company expects its cash, cash equivalents, and investments of approximately $104.0 million at September 30, 2025, along with net proceeds of $73.8 million from stock sales, to be sufficient for operating and capital requirements for at least twelve months[121] Personnel and Administrative Expenses - Personnel-related costs increased by $2.7 million for the nine months ended September 30, 2025, primarily due to an increase in headcount[113] - General and administrative expenses for the nine months ended September 30, 2025 totaled approximately $11.7 million, a decrease of $1.0 million from approximately $12.7 million for the same period in 2024[114]