Helix Biopharma Corp. · TSX:HBP
Helix Biopharma — Investor Presentation (September 2025)
33 slides from Helix Biopharma's investor presentation, September 2025
Slide 1: Helix Biopharma Company Presentation, September 2025
HELIX biopharma Shaping a near future where today’s hard-to-treat cancers are vincible. As featured in: (US Audiences Only) PUBLIC Company Presentation, September 2025
Slide 2: Patient testimonial on L-DOS47
“I am a stage 4 lung cancer patient and have been on L-DOS47 [with chemotherapy] since June of 2017. To date my tumor has shrunk by 99%! Early on in my diagnosis I was told I had maybe four months to live. I am now in remission, and looking forward to many years with my grandchildren.“ Patient email
Slide 3: 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 4: 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 5: 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 6: 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 7: 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 8: CEACAM6 Platform
CEACAM6 PLATFORM Bio-conjugates that score with precision against prevalent, hard-to-treat cancers over-expressing CEACAM6. 8
Slide 9: 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 10: 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 11: 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. 11
Slide 12: 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 13: 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 14: 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 15: 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 16: 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 17: LEUMUNA
LEUMUNA An oral immune checkpoint modulator to bring long-term remission within reach of patients relapsing with leukemia. 17
Slide 18: 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 19: 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. 19
Slide 20: 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 21: 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 22: 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 23: GEMCEDA
GEMCEDA A pioneering oral chemotherapy to enrich the spectrum of disease-limiting and life-enhancing outcomes for patients whose cancer has progressed. 23
Slide 24: 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 25: 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 26: 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 27: 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 28: The Bottom Line
THE BOTTOM LINE 28
Slide 29: 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 30: 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 31: Expert Collaborators' Opinions
EXPERT COLLABORATORS’ OPINIONS on Helix BioPharma’s most advanced assets. Professor Robert Gillies, Moffitt Cancer Center Vice-Chair Radiology, Director Professor Caius Radu, Departments of Molecular and Medical of Experimental Imaging Program & US Key Opinion Leader, on L-DOS47 Pharmacology and Sur
Slide 32: 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 33: 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
Helix BioPharma — Investor Presentation (September 2025) on 6ix