GEMCEDA™
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Helix BioPharma Corp. Announces Filing of Interim Financial Statements as of and for the Three-Month Period Ended October 31, 2025
Thenewswire· 2025-12-15 22:30
Toronto, Ontario – TheNewswire - 15 December, 2025 – Helix BioPharma Corp. (TSX: “HBP”, OTC PINK: “HBPCD”, FRANKFURT: “HBP0”) (“Helix” or the “Company”), a clinical-stage oncology company shaping a near future where today’s hard-to-treat cancers are vincible, announces the filing of the Company’s unaudited interim financial statements as of and for the three month period ended October 31, 2025 (the “Financial Statements”), the management’s discussion and analysis (“MD&A”), and the certifications of the Ch ...
Helix BioPharma Corp. Announces Fiscal 2025 Year-End Results
Thenewswire· 2025-10-29 16:45
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].
Helix BioPharma Responds to Market Activity
Thenewswire· 2025-10-06 15:35
Toronto, Ontario – TheNewswire - 6 October 2025 – Helix BioPharma Corp. (TSX: “HBP”, OTC: “HBPCF”, FRANKFURT: “HBP0”) (“Helix” or the “Company”), a clinical-stage oncology company shaping a near future where today’s hard-to-treat cancers are vincible, wishes to confirm that it is not aware of any material, undisclosed information related to the Company that would account for the recent increase in the market price and level of trading volume of its ordinary shares. About Helix BioPharmaHelix BioPharma is ...
Helix BioPharma Concludes Review, Will Not Proceed with Proposed Equity Draw-Down Subscription Facility with GEM
Thenewswire· 2025-09-05 20:15
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].
Helix Biopharma Corp. Announces Closing of Private Placement, in Preparation for Institutional Investment and NASDAQ Uplisting
Thenewswire· 2025-08-22 22:00
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].
Helix Biopharma Corp. Announces Publication in Frontiers in Oncology on the Effects of L-DOS47 as Monotherapy in NSCLC
Thenewswire· 2025-08-13 15:10
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]