Helix Biopharma Corp. · TSX:HBP
Helix Biopharma — Investor Presentation (August 2025)
32 slides from Helix Biopharma's investor presentation, August 2025
Slide 1: Shaping a near future where hard-to-treat cancers are vincible
HELIX biopharma Shaping a near future where today’s hard-to-treat cancers are vincible. As featured in: (US Audiences Only) PUBLIC Company Presentation, August 2025
Slide 2: Investment Highlights
INVESTMENT HIGHLIGHTS Helix BioPharma is on a mission to level the playing field against cancer’s biggest, most urgent challenges. INNOVATING FROM STRENGTH FOCUSED, AMBITIOUS PLAN AHEAD Assets with great potential and a head start Relocation to the US and NASDAQ listing Management team with a track
Slide 3: Our Pipeline
OUR PIPELINE Diverse, clinical-stage pipeline of candidates with great potential and a head start, honed into first- and best-in-class oncology medicines. PRODUCT / TYPE DISCOVERY PRECLINICAL PHASE IA/B PATENT LIFE L-DOS47 2036 Tumor microenvironment Non-Small Cell Lung Cancer (NSCLC) + extensions T
Slide 4: Lead Indications
LEAD INDICATIONS Prevalent and hard-to-treat cancers made vincible by novel therapies that rise to the challenge. HOW WE WANT TO MOVE THE NEEDLE LEAD INDICATIONS, GLOBAL INCIDENCE (MILLIONS) Lung cancer 2.5M ADD ≥30% EFFICACY to immune checkpoint inhibitors (CPIs) standard of care Breast cancer 2.3M
Slide 5: Investment & Return
INVESTMENT & RETURN USD 80M to achieve major project milestones and value inflection points for L-DOS47 and LEUMUNA as priority projects. USE OF PROCEEDS OVER THE NEXT 24 MONTHS THE WHOLE IS GREATER THAN THE SUM OF ITS PARTS CORPORATE CEACAM6 PLATFORM Grow world-class Phase IB + Phase II team random
Slide 6: Our Core Leadership & Scientific Team
OUR CORE Thomas Mehrling, MD, PhD Veronika Kandziora Rohit Babbar, CPA, CA Davide Guggi, PhD LEADERSHIP Chief Executive Officer Chief Operating Officer Chief Financial Officer Chief Technology Officer & SCIENTIFIC TEAM Jonathan Davis, PhD Brenda Lee, PhD Kim Gaspar, Jessica Kourniaktis, DPhil Direct
Slide 7: CEACAM6 Platform
CEACAM6 PLATFORM Bio-conjugates that score with precision against prevalent, hard-to-treat cancers over-expressing CEACAM6. 7
Slide 8: CEACAM6 Bio-Conjugate Target
BIO-CONJUGATE TARGET CEACAM6 Overexpressed in major cancers CEACAMs (carcinoembryonic antigen-related cell CEACAM6 is significantly low in healthy tissue. adhesion molecules) are a family of 12 cell adhesion proteins found on cell surfaces. CEACAM5 and CEACAM6 are over-expressed on Associated with p
Slide 9: Tumor Defence Breaker L-DOS47
PRODUCT 1, CEACAM6 PLATFORM TUMOR DEFENCE Camelid nanobodies BREAKER™ High binding affinity to CEACAM6. L-DOS47 Urease Catalyzes urea breakdown into ammonia and CO₂, neutralizing A clinical-stage AEC that neutralizes the the pH of the TME. acidic tumor microenvironment (TME) of prevalent, hard-to-tr
Slide 10: Mechanism of Action
MECHANISM OF ACTION L-DOS47 neutralizes tumor acidity, taking the brakes off anti-tumor immunity and delivering a game- changing assist to cancer immunotherapies. See MoA video. 10
Slide 11: A Force Multiplier for Anti-PD-1 Antibodies
A FORCE MULTIPLIER FOR ANTI-PD-1 ANTIBODIES Pembrolizumab + L-DOS47 synergistically and significantly reduces tumor growth, volume and weight compared to pembrolizumab alone in 28 days in pancreatic cancer mouse models. -70% greater tumor volume reduction -50% greater tumor weight reduction with L-D
Slide 12: Clinically Safe and Effective with Chemo
CLINICALLY SAFE AND EFFECTIVE WITH CHEMO L-DOS47 in combination with Pemetrexed/Carboplatin delivers 75% overall clinical benefit in a Phase IB, open-label dose-escalation study in heavily pre-treated patients with Stage IV NSCLC. EFFICACY & SAFETY — Best % Change in Lesion Size from Baseline (patie
Slide 13: Timely & Close to the Finish Line
TIMELY & CLOSE TO THE FINISH LINE L-DOS47 STRENGTHS L-DOS47 OPPORTUNITIES L-DOS47 NEXT STEPS 2025 2026 2027 2028 2029 2030 First-in-class TME AEC Significant improvement in PFS Phase Ib completed Significant improvement in OS CMC clinical batch Results highly encouraging CPI market share expansion I
Slide 14: Leveraging Radio-Ligand Technology
CEACAM6 Product 2 PRODUCT 2, CEACAM6 PLATFORM CEACAM6-RL-ST (radio-ligand LEVERAGING RADIO- targeting CEACAM6-expressing solid tumors). LIGAND TECHNOLOGY Design Radio-Isotope Single chain camelid nanobody Alpha emitter, carefully with CEACAM6 high binding selected to maximise tumor affinity. penetra
Slide 15: The Promise of Our Discovery ADCs
CEACAM6 Products 3 & 4 Conjugation PRODUCTS 3 & 4, CEACAM6 PLATFORM CEACAM6-GIT (Gastro-intestinal) Newest linker system, THE PROMISE OF OUR CEACAM6-GYN (Gynaecological) ensuring systemic stability. DISCOVERY ADCs Carefully-designed ADCs capitalising on latest, state-of-the- art technology. Design P
Slide 16: LEUMUNA
LEUMUNA An oral immune checkpoint modulator to bring long-term remission within reach of patients relapsing with leukemia. 16
Slide 17: Lead Indication
IMMUNE CHECKPOINT MODULATOR, LEUMUNA LEAD INDICATION Allogeneic SCT is the only chance patients have Each failed SCT Costs USD 500,000. for a cure. More than 60,000 patients undergo allogeneic stem cell transplantation (SCT) each year, because it is the only treatment option for acute leukemia with
Slide 18: Immune Checkpoint Modulator, LEUMUNA
IMMUNE CHECKPOINT MODULATOR, LEUMUNA Activates transplanted immune system to fight A pre-IND, first-in-class oral immune checkpoint resurging leukemia modulator and inhibitor of PNP to initiate graft- versus-leukemia (GvL) effect in patients relapsing with leukemia after allogeneic SCT. 18
Slide 19: Evidence with LEUMUNA
EVIDENCE WITH LEUMUNA LEUMUNA significantly reduces risk of relapse mortality in preclinical minor-MHC mismatch B Cell Acute leukemia model. 1) Improvement in survival with LEUMUNA is due to T-cell OVERALL SURVIVAL 2) Risk of graft-versus-host disease (GVHD) mortality outweighed by COMPETING RISK AN
Slide 20: Historical Clinical Data
HISTORICAL CLINICAL DATA Predecessor compound, Ulodesine (BCX4208), developed in gout and psoriasis, and analogue, forodesine hydrochloride. BCX4208: OUTSTANDING SAFETY AND TOLERABILITY COMPLETE REMISSION ACHIEVED A 3-year old pediatric patient was cured of relapsed T-Cell Acute Demonstrated in Phas
Slide 21: LEUMUNA Facts & Prospects
LEUMUNA FACTS & PROSPECTS LEUMUNA STRENGTHS LEUMUNA OPPORTUNITIES LEUMUNA NEXT STEPS 2026 2027 2028 2029 2030 FDA Orphan status Potential 2+ yrs. OS or cure CoM Patent (exp. 2041) Poised to become SoC CMC clinical batch Supporting clinical evidence Breakthrough potential and accelerated approval IND
Slide 22: GEMCEDA
GEMCEDA A pioneering oral chemotherapy to enrich the spectrum of disease-limiting and life-enhancing outcomes for patients whose cancer has progressed. 22
Slide 23: Oral Prodrug of a WHO Essential Medicine
GEMCEDA Rising global need Oral chemotherapy ORAL PRODRUG for chemotherapeutics, despite the arrival of novel cancer creates opportunities to turn resistant into sensitive tumors OF A WHO ESSENTIAL medicines.* (metronomic dosing).*** MEDICINE 25%** Our solution, GEMCEDA Gemcitabine is used to treat
Slide 24: GEMCEDA
3 Second liver passage Cytidine-aminase inhibition prevents inactivation to uridine derivative for some time Cedazuridine Gemcitabine GEMCEDA A pre-IND, first-in-class oral gemcitabine prodrug 2 Esterase & carboyxylase hydrolysis 1 combined with cedazuridine, with bioavailability First liver passage
Slide 25: Gemcitabine Oral Chemotherapy
High-grade Serous High vs low replication stress (RB1, CDKN2A Ovarian Cancer* loss, or surplus of CCNE1, KRAS, MYC). Combination with PARP or ATR inhibitor. GEMCITABINE ORAL Pancreatic Ductal Use GemciTest ®️ to predict gemcitabine CHEMOTHERAPY Adenocarcinoma response. Target indications with biomar
Slide 26: GEMCEDA Facts & Prospects
GEMCEDA FACTS & PROSPECTS GEMCEDA STRENGTHS GEMCEDA OPPORTUNITIES GEMCEDA NEXT STEPS 2026 2027 2028 2029 2030 First-in-class oral gemcitabine IV gem. treats 1/3 of cancers Oral bioavailability = IV Regulatory 505(b)2 pathway Tox & CMC clinical batch CoM Patent (exp. 2043) Maintenance therapy IND Est
Slide 27: The Bottom Line
THE BOTTOM LINE 27
Slide 28: Our Strategy
OUR STRATEGY Innovating from strength to shape a near future where hard-to-treat cancers are vincible. CANDIDATE L-DOS47 LEUMUNA™ GEMCEDA™ C6 RDCs & ADCs HARD-TO-TREAT Non-small cell lung Advanced solid Leukemia relapse Solid tumors CANCER cancer (NSCLC) tumors Synergistic efficacy with Backed by cl
Slide 29: Upcoming Milestones
Q3 2025 Q4 2025 Q1 2026 Q2 2026 Q3 2026 Q4 2026 UPCOMING Private placement (CAD 3M) FDA End-of-Phase I meeting MILESTONES Drawdown from SSFA (CAD 7M) Our ambitious plan on our priority FDA Meeting projects over the next 18 months. Relocation to US & NASDAQ listing Public Offering (USD 80M) Financial
Slide 30: Expert Collaborators' Opinions
EXPERT COLLABORATORS’ OPINIONS on Helix BioPharma’s most advanced assets. Dr. Robert Gillies, Director of Moffitt Cancer Imaging Professor Caius Radu, Departments of Molecular and Medical and Technology Center of Excellence, Florida, US on L-DOS47 Pharmacology and Surgery, UCLA, California, US on LE
Slide 31: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This presentation document contains certain forward-looking statements and information (collectively, “forward-looking statements”) within the meaning of applicable securities laws. Forward-looking statements are statements and information that are not historical facts but
Slide 32: Helix BioPharma contact
HELIX biopharma Shaping a near future where today’s hard-to-treat cancers are vincible. For investor relations, contact corporate@helixbiopharma.com HELIX BIOPHARMA CORP. Bay Adelaide Centre – North Tower 40 Temperance Street, Suite 2 Toronto, ON M5H 0B4 Tel: +1 857 208 7687 TSX: HBP Thomas Mehrling
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