Helix Biopharma Corp. · TSX:HBP
Helix Biopharma — Investor Presentation (June 2025)
29 slides from Helix Biopharma's investor presentation, June 2025
Slide 1: Helix biopharma: Shaping a near future
HELIX biopharma Shaping a near future where today’s hard-to-treat cancers are vincible. As featured in: (US Audiences Only) June 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. 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 randomized study in $10M $40M NSCLC Business $25M >
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
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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: Product 1, CEACAM6 Platform: L-DOS47
PRODUCT 1, CEACAM6 PLATFORM TUMOR DEFENCE BREAKER™ L-DOS47 Aclinical-stage AEC that neutralizes the Camelid nanobodies High binding affinity to CEACAM6. Urease Catalyzes urea breakdown into ammonia and CO,, neutralizing the pH of the TME. acidic tumor microenvironment (TME) of prevalent, hard-to-tre
Slide 10: Mechanism of Action
MECHANISM OF ACTION ‘ “a A T Cells ALKALINE, Ve y / soy ry A ¥ TME acidity = acritical ; defence mechanism L-DOS47 — Immunotherapy ye ° againsti PY neutralizes tumor acidity, & chemotherapy. taking the brakes off anti-tumor NX immunity and delivering a game- nee changing assist to anti-cancer Cancer
Slide 11: Clinical Evidence with L-DOS47
CLINICAL EVIDENCE WITH L-DOS47 Study supporting L-DOS47 as combination therapy with checkpoint inhibitors / chemotherapy in NSCLC. Phase Ib, Open-Label Dose-Escalation Study in Stage IV NSCLC — L-DOS47 in combination with Pemetrexed + Carboplatin EFFICACY & SAFETY Best % Change in Lesion Size from B
Slide 12: 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 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 IND Co
Slide 13: 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 14: 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 15: LEUMUNA
LEUMUNA An oral immune checkpoint modulator to bring long-term remission within reach of patients relapsing with leukemia.
Slide 16: Lead Indication: Leukemia relapse after SCT
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 17: Immune Checkpoint Modulator, LEUMUNA
Activated T-Cells 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
Slide 18: 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 19: 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 20: LEUMUNA Facts & Prospects
LEUMUNA FACTS & PROSPECTS LEUMUNA STRENGTHS LEUMUNA OPPORTUNITIES LEUMUNA NEXT STEPS 2025 2026 2027 2028 2029 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 21: GEMCEDA
GEMCEDA A pioneering oral chemotherapy to enrich the spectrum of disease-limiting and life-enhancing outcomes for patients whose cancer has progressed.
Slide 22: 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 23: GEMCEDA mechanism: second liver passage
3 Second liver passage Cytidine-aminase inhibition prevents inactivation to uridine derivative for some time —_\—_ Cedazuridine 7 Gemcitabine GEMCEDA Apre-IND, first-in-class oral gemcitabine prodrug 2 AX combined with cedazuridine, with bioavailability First liver passage releases gemcitabine 14 Pr
Slide 24: 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 25: GEMCEDA Facts & Prospects
GEMCEDA FACTS & PROSPECTS GEMCEDA STRENGTHS GEMCEDA OPPORTUNITIES GEMCEDA NEXT STEPS 2025 2026 2027 2028 2029 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 Phase I
Slide 26: Upcoming Milestones
Q1 2025 Q2 2025 Q3 2025 Q4 2025 Q1 2026 Q2 2026 UPCOMING Private placement (CAD 3M) Complete asset acquisitions Drawdown from SSFA (10M) MILESTONES CMC clinical batch Phase Ib IND (NSCLC) Our ambitious plan over the next Discovery & patent filings Relocation to US & NASDAQ listing 18 months. FPI (NS
Slide 27: Expert Collaborators' Opinions
EXPERT COLLABORATORS’ OPINIONS on Helix BioPharma’s clinical-stage and pre-IND 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, Califor
Slide 28: 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 29: Helix biopharma contact
HELIX biopharma Shaping a near future where today’s hard-to-treat cancers are vincible. For investor relations, contact helix@argotpartners.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, CEO