Core Insights - Helix BioPharma Corp. presented new data on its CEACAM6-directed antibody-drug conjugate (ADC) program at the 16th Annual World ADC London conference, highlighting its commitment to developing innovative cancer therapies [1][2] Group 1: Presentation Highlights - The presentation titled "Next-Generation ADCs: Unlocking the Potential of CEACAM6-Directed Targeted Therapies" was delivered by Dr. Jonathan Davis, showcasing Helix's leadership in ADC technology [2] - CEACAM6 was identified as a promising therapeutic target due to its high expression in various epithelial cancers, association with poor clinical outcomes, and limited presence in healthy tissues [3] - Data presented demonstrated the tumor-selective binding profile of Helix's proprietary anti-CEACAM6 VHH, supporting the development of next-generation ADCs that minimize off-target effects while delivering potent therapeutic payloads [3][4] Group 2: Company Pipeline and Innovations - Helix's lead candidate, Tumor Defense Breaker™ L-DOS47, is designed to enhance the sensitivity of CEACAM6-expressing tumors to therapy and has shown favorable safety and clinical activity in Phase I/II studies for non-small cell lung cancer (NSCLC) [6] - The company is also advancing two pre-IND candidates: LEUMUNA™, an oral immune checkpoint modulator for post-transplant leukemia relapse, and GEMCEDA™, a first-in-class oral gemcitabine prodrug with bioavailability comparable to intravenous administration [6]

Core Viewpoint - Helix BioPharma Corp. has extended its Research and Exclusive Option Agreement with metaShape Pharma AG for the compound LEUMUNA™ until December 31, 2028, allowing further research and development in metabolic diseases while maintaining a focus on oncology assets [1][4]. Group 1: Agreement Details - The original agreement was established in April 2023 between metaShape and Laevoroc Immunology AG, granting metaShape an exclusive research license and an option for a commercial license for LEUMUNA™ [2]. - The extension of the agreement provides additional time to advance research activities and supports the progression of the program toward clinical-stage development [4]. Group 2: Compound Development - MS 001, the compound under development, is designed as an orally administered co-therapy to GLP-1 receptor agonists, aimed at enhancing adipose tissue reduction and weight loss durability [2]. - Preclinical studies indicated that MS 001 increased levels of inosine and NAD+, which improved mitochondrial function and energy expenditure in adipose tissue, leading to better weight loss outcomes in mice [3]. Group 3: Company Perspectives - The CEO of metaShape expressed excitement about the progress of MS 001 and the developments in the program [5]. - Helix's CEO highlighted the quality of preclinical data around MS 001, particularly its effects on NAD+ biology and fat metabolism, indicating potential benefits across various disease settings [5]. Group 4: Company Backgrounds - MetaShape Pharma, founded in 2023, focuses on developing first-in-class metabolic therapies to address metabolic dysfunction [6]. - Helix BioPharma specializes in oncology, with a pipeline that includes Tumor Defense Breaker™ L-DOS47 and two pre-IND candidates: LEUMUNA™ and GEMCEDA™, aimed at treating hard-to-treat cancers [7].

Core Insights - Helix BioPharma Corp. has filed its unaudited interim financial statements for the three-month period ending October 31, 2025, along with management's discussion and analysis and certifications from the CEO and CFO [1] Company Overview - Helix BioPharma is focused on developing innovative solutions for difficult-to-treat cancers, with a pipeline led by Tumor Defense Breaker™ L-DOS47, an antibody-enzyme conjugate aimed at enhancing therapy sensitivity in CEACAM6-expressing tumors [2] - L-DOS47 has completed Phase Ib studies in non-small cell lung cancer (NSCLC) and shares its targeting foundation with the company's next-generation bi-specific antibody-drug conjugates currently in discovery [2] - The company is also advancing two pre-IND candidates: LEUMUNA™, an oral immune checkpoint modulator for post-transplant leukemia relapse, and GEMCEDA™, a first-in-class oral gemcitabine prodrug designed to expand treatment options for advanced cancers [2]

Core Viewpoint - Helix BioPharma Corp. reported a net loss of $5,205,000 for the fiscal year ended July 31, 2025, showing an improvement from a loss of $9,264,000 in the previous year, indicating progress in financial management and operational focus [2][13]. Financial Performance - The total comprehensive loss for the year was $5,205,000, translating to a loss of $0.09 per common share, compared to a loss of $0.21 per common share in the previous year [2][13]. - Research and Development expenses decreased by 40% to $3,558,000 from $5,977,000 in the previous year, attributed to the conclusion of a Phase Ib/II study and changes in stock-based compensation [8][9]. - Operating, general, and administration expenses also saw a significant reduction of 43%, totaling $1,839,000 compared to $3,262,000 in the prior year, primarily due to changes in service providers [10][11]. Clinical Development - The Phase Ib/II trial (LDOS006) for metastatic pancreatic adenocarcinoma was completed in October 2024, with ongoing data analysis and a Clinical Study Report expected in fall 2025 [3]. - A new Phase Ib/Randomized Phase II study (LDOS007) is in planning to assess L-DOS47 in combination with pembrolizumab for NSCLC, with positive feedback received from the FDA regarding the study design [4][6]. Corporate Development - The company decided to focus on developing L-DOS47 as a combination therapy for NSCLC, terminating collaborations with external research institutions that did not align with this focus [6]. - The company closed its laboratory in Edmonton, Canada, on October 31, 2024, and liquidated laboratory equipment while securing important documents and samples [6]. Capital and Liquidity - As of July 31, 2025, the company reported a working capital deficiency of $2,807,000 and an accumulated deficit of $215,876,000, indicating challenges in liquidity [13][18]. - The company closed a non-brokered private placement of 2,222,333 common shares at $0.75 per share, raising gross proceeds of $1,667,000 [7]. Research & Development Focus - The company’s pipeline includes L-DOS47, which targets CEACAM6-expressing tumors, and two pre-IND candidates: LEUMUNA™ and GEMCEDA™, aimed at addressing significant unmet medical needs in oncology [20].

Core Viewpoint - Helix BioPharma Corp. is not aware of any undisclosed material information that could explain the recent increase in its share price and trading volume [1] Company Overview - Helix BioPharma is a clinical-stage oncology company focused on developing solutions for hard-to-treat cancers [2] - The company's leading product is Tumor Defense Breaker™ L-DOS47, an antibody-enzyme conjugate aimed at enhancing the effectiveness of therapies for CEACAM6-expressing tumors [2] - L-DOS47 has completed Phase Ib studies in non-small cell lung cancer (NSCLC) and shares its foundation with the company's next-generation bi-specific antibody-drug conjugates currently in discovery [2] - Helix is also advancing two pre-IND candidates: LEUMUNA™, an oral immune checkpoint modulator for post-transplant leukemia relapse, and GEMCEDA™, a first-in-class oral gemcitabine prodrug designed for advanced cancers [2] Stock Information - Helix BioPharma is listed on multiple exchanges: TSX (HBP), OTC PINK (HBPCD), and FWB (HBP0) [3]

Core Viewpoint - Helix BioPharma Corp. has decided not to proceed with the previously announced equity draw-down subscription facility with GEM Global Yield LLC SCS and GEM Yield Bahamas Limited due to a misalignment with its capital strategy and long-term shareholder value objectives [1][2]. Group 1: Financing Decision - The company entered into a non-binding term sheet with GEM on October 15, 2024, and received shareholder approval for the financing arrangement on March 26, 2025 [2]. - After evaluating market conditions and corporate objectives, Helix concluded that the GEM facility no longer aligns with its capital strategy [2]. - The letter of intent with GEM expired, and the company has chosen not to execute binding agreements or pursue financing with them [2]. Group 2: Future Financing Plans - Helix is actively engaging in discussions with financial partners to explore alternative financing structures that better align with its strategic direction [3]. - The company remains committed to securing the necessary capital to advance its clinical programs and achieve corporate objectives [3]. Group 3: Company Overview - Helix BioPharma is focused on developing innovative solutions for hard-to-treat cancers, with its pipeline led by Tumor Defense Breaker™ L-DOS47, which targets CEACAM6-expressing tumors [4]. - L-DOS47 has completed Phase Ib studies in non-small cell lung cancer (NSCLC) and is part of a broader strategy that includes next-generation bi-specific antibody-drug conjugates [4]. - The company is also advancing two pre-IND candidates: LEUMUNA™, an oral immune checkpoint modulator, and GEMCEDA™, a first-in-class oral gemcitabine prodrug [4].

Core Viewpoint - Helix BioPharma Corp. has successfully closed a non-brokered private placement of 2,222,333 common shares at a price of $0.75 per share, raising gross proceeds of $1,666,750, as part of its bridge financing strategy to secure larger institutional investments [1][2]. Group 1: Private Placement Details - The recent private placement follows a previous one of $3,000,000 announced on January 9, 2025, marking the second phase in Helix's financing strategy [2]. - The net proceeds from this private placement will be allocated towards near-term development activities and working capital [2]. - The offering is subject to final approval from the Toronto Stock Exchange, with a hold period of four months and one day expiring on December 23, 2025 [2]. Group 2: Company Overview - Helix BioPharma is focused on developing innovative solutions for hard-to-treat cancers, with its pipeline led by Tumor Defense Breaker™ L-DOS47, which is designed to enhance the effectiveness of existing cancer therapies [5]. - L-DOS47 has completed Phase Ib studies in non-small cell lung cancer (NSCLC) and shares its foundation with Helix's next-generation bi-specific antibody-drug conjugates currently in discovery [5]. - The company is also advancing two pre-IND candidates: LEUMUNA™, an oral immune checkpoint modulator, and GEMCEDA™, a first-in-class oral gemcitabine prodrug [5].

Core Insights - Helix BioPharma Corp. announced the publication of a peer-reviewed article on the safety of L-DOS47, an unconventional antibody-drug conjugate, in treating advanced non-small cell lung cancer (NSCLC) [1][2] Company Overview - Helix BioPharma is a clinical-stage oncology company focused on developing innovative treatments for hard-to-treat cancers, with L-DOS47 as its lead candidate [4] - The company is also advancing two pre-IND candidates: LEUMUNA™, an oral immune checkpoint modulator, and GEMCEDA™, a first-in-class oral gemcitabine prodrug [5] Clinical Study Findings - The Phase I/II study of L-DOS47 demonstrated good tolerability at doses up to 13.55 µg/kg, with a median progression-free survival (PFS) of 4.1 months in the highest dosing quartile [3] - No complete or partial responses were observed, but higher doses correlated with a statistically significant extension in PFS (P=0.0203) [3] - CEACAM6 was found to be highly expressed in nearly half of NSCLC cases, suggesting its potential as a biomarker for patient selection in future trials [3] Future Development Plans - Helix plans to advance L-DOS47 into a new clinical study in combination with the PD-1 inhibitor pembrolizumab, aiming to enhance the efficacy of immunotherapies by neutralizing tumor acidity [3] - The company has received positive feedback from the FDA regarding the planned Phase I/II study in combination with pembrolizumab [3]