1 / 20

Investor Presentation

Biozep is a pioneering biopharmaceutical company focusing on developing safe and effective drugs for chronic eye diseases. Using therapeutic lipids designed to target disease causes, not just symptoms, Biozep aims to revolutionize eye disease treatment. Their lead compound, BIZ-101, has shown promising results in inhibiting inflammatory responses and protecting retinal cells from oxidative stress, offering potential treatments for conditions like AMD and dry eye disease.

dannysanchez
Download Presentation

Investor Presentation

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Investor Presentation Nov 2018

  2. ABOUT US Early stage biotechnology company with a focus on the treatment of eye diseases with huge unmet needs Our Mission Our mission is to develop safe, effective and affordable drugs for patients with chronic eye diseases with an unmet medical need by utilizing novel therapeutic lipids designed to target the cause of the disease and not just the symptoms.  Our Vision Our vision is to be recognized as a science-based and innovative biopharmaceutical company that develops and delivers vision saving drug therapy to patients worldwide.

  3. THERAPEUTIC LIPIDS Therapeutic Lipids - A Novel Concept in Ophthalmology • Biozep has in depth knowledge about natural bioactive lipids, their regulatory role in metabolism and their impact on essential functions in the cells. • Biozep uses this knowledge to create novel therapeutic lipids for treatment of eye diseases and we have generated a portfolio of therapeutic lipids which are potent and selective activators of receptors central in energy metabolism and inflammatory processes. • Our first generation of therapeutic lipids, the BIZ-100 series, are selective modulators of the nuclear receptors peroxisome proliferator activated receptors a and g (PPAR receptors). • Our second generation of therapeutic lipids, the BIZ-200 series, are selective agonists of G-coupled protein receptors (GPCRs). • Our objective within the next 2-3 years is to show efficacy of some of these therapeutic lipids in an animal model with an ocular surface disease and show that the product is safe both in animals and humans.

  4. OUR TECHNOLOGY Two series of therapeutic lipids – BIZ-100 series and BIZ-200 series, both with applications in treating diseases of the eyes and other parts of the body BIZ-201 BIZ 101 GPCR PPAR α/γ Neovascular Eye Diseases Inflammatory Eye Diseases Cardiovascular diseases Eye diseases Neuro- degenerative diseases Focus area Future opportunity AMD Uveitis BIZ 200 series activate GPCR receptors Diabetic Retinopathy Dry Eye Retinopathy of Prematurity BIZ 100 series activate PPAR α/γ receptors

  5. LEAD PRODUCT “BioZurface” – our first product for treatment of eye diseases of the surface of the eye • Our first generation therapeutic lipids, the BIZ-100 series, would form the basis of our first product for use in treatment of diseases of the surface of the eye such as dry eye disease (DED). • “BioZurface” will have to be applied 1-2 times per day and will have significant effect on both symptoms and signs of DED after 1-2 weeks. • After approval for use in clinical trials, “BioZurface” can be tested for a wide variety of eye diseases of the surface of the eye, which represents a huge upside of the Biozep approach as it fully leverages the previous pre-clinical work.

  6. OUR SECOND PRODUCT “BioZight” – our product for treatment of sight threatening diseases of the back of the eye • Our therapeutic lipids also form the basis of our first product for use in treatment of diseases of the back of the eye (AMD). • The route of administration will need to be decided based on bioavailability data.

  7. OUR LEAD COMPOUND BIZ-101 is the lead compound of the BIZ-100 series A broad range of in vitro data supports the potential role of BIZ-101 for the treatment of chronic inflammatory and degenerative eye diseases. • Potent PPAR agonist at nM concentrations • Increase energy metabolism • Protect ARPE-19 cells from cell death during oxidative stress • Reduce mtDNA damage in a neuroblastoma cell line during oxidative stress • Potent inhibitor of the NF-kB pathway

  8. INITIAL RESULTS I The transcription factor NF-kB is a master regulator for inflammatory responses. In chronic inflammatory diseases NF-kB is upregulated and the NF-kB pathway is regarded as a therapeutic target for chronic inflammatory diseases. BIZ-101 FA effectively inhibits NF-kB in cell assays and is more than 10 times as potent as natural PUFAs in the same assay. • The inhibitory effect of BIZ-101 on the NF-kB pathway is dose dependent. • The NF-kB pathway can be completely inhibited at high concentration which is not the case with dexamethasone.

  9. INITIAL RESULTS II In degenerative diseases of the eye oxidative stress eventually leads to cell death and patients lose their vision. Biozep has shown that BIZ-101 protects retinal pigment epithelial cells from cell death during conditions of oxidative stress. Conc. of tBHP ARPE19 is a spontaneously immortalized cell line of human retinal pigment epithelium. Pretreatment with BIZ-101 protects the ARPE-19 cell line at concentration of t-butylhydroperoxide of 0.01 & 0.03 Mm.

  10. MARKET OPPORTUNITY BioZurface potentially addressable market exceeds $3.5bn in 2017 CAGR 4.5% • The dry eye disease segment is $3.5billion in 2017 with an expected CAGR of 4.5% between 2017 and 2030. • First line treatments normally include artificial tears (OTC/CE marked products) • With severe DED topical corticosteroids treatment may be required • Approved drugs for treating DED in US and Europe are Restasis, Xiidra and Ikervis.

  11. UNMET NEEDS - DED There is a huge unmet medical need in Dry Eye Disease therapy market BIZ 101: • Can treat both signs and symptoms • Has excellent tolerability and safety profile • Combines lubrication effect with therapeutic effects • May have faster onset of action compared to Cyclosporin • Has a novel mechanism of action Current therapies: • No cure for DED • Most treatments only provide symptom relief • Corticosteroids have significant side effects • Used in combination with OTC eye drops • Have prolonged onset of action (Restasis) • Have similar mechanism of action (Cyclosporin A based)

  12. COMPETITION There are only two approved product in the US market for the treatment of DED, however, there are many products in development On the Market In development • 1400 M USD in 2017 Allergan • $259M USD forecast for 2018 Takeda (Shire) • Registered 2018 Sun Pharma

  13. TARGET CUSTOMERS Our potential customers are pharmaceutical companies in the ophthalmic market Pharma Companies • Our target customers are pharmaceutical companies active in the field of ophthalmology. • For rare diseases, Biozep could sell products directly to specialists.

  14. BUSINESS MODEL Focus on preclinical and early clinical development and partner with pharmaceutical companies to bring product to market Drug Approval Sales and Marketing Drug Discovery Preclinical Development Clinical Trial Phases Biozep Partner • Focus on R&D projects in therapeutic areas with a high unmet medical need in the field of ophthalmology. • Establish strategic partnerships with pharmaceutical companies early in the development phase to speed up product development. • Business model based on income from upfront and milestone payments in addition to royalties based on product sale. • Partner strategy with pharma companies after completing phase 1. • Opportunity to sell directly to specialists for rare diseases.

  15. R&D ROADMAP Projected launch date for front and back of eye indications in 2026 and 2031 respectively Research 2019 Dry Eye Disease Preclinical GLP NDA filing 8 mos. April 2025 8 mos. Phase I 6 mos. Phase II 16 mos. Phase III 18 mos. Reg Approval 2017 2017 12 mos. IND filing/CTA Launch Jan - Mar Today Nov. 1st Dry AMD Dec 1st Aug 1st Aug – Nov 2nd Launch CMA approval & EU Launch IND filing/CTA Research 24 mos. Preclinical GLP 6 mos. Phase I Phase II 18 mos. Conditional Marketing Application (EU) 30 mos. 14 mos. Phase III 48 mos. 12 mos. Reg Approval

  16. FINANCIAL PROJECTIONS Rapid growth to profitability with very attractive margins • Biozep is operating with a lean expense structure. • In 2028, Royalty revenue will surpass expenses. • A $5-10Mio investment will bring the company to Phase I • Substantial milestone payments in the period 2024-28 • Attractive margins of over 80% short-term and over 90% long-term 2017 2017 Today • Revenues • Profit Analysis

  17. OUR TEAM Our team has many years of experience from pharmaceutical companies in addition to successful startup and international business experience • MSc (chemical engineering), PhD in organic chemistry • 20 years of experience in drug discovery and development. • Inventor of two active pharmaceutical ingredients in clinical development at Avexxin AS & North Sea Therapeutics. • Proven track record of developing PUFA base drug substances. • Many years of management experience. Erik Rosen Anne Kristin Holmeide (PhD.) Jan Alfheim AtleLohrmann Robert Keil Board Chairman Managing Director & Founder Board Member Board Member Board Member • CEO Oncoinvent AS • Business executive pharma/biotech • >30 years of experience bringing product to markets • Business Attorney with management experience  • >20 years of experience with capital raising processes and purchase and sale of businesses • CEO Keil consulting • Program Manager Creuna • Business executive experience • CEO and Founder Nortek • >30 years of experience from technology development • Broad international business experience

  18. IP POSITION Patent application covers novel compounds and use of lipid compounds in treatment of eye diseases • UK patent application was filed in November 2015 covering broad indications and active compounds. (App#GB1521085.9). • PCT patent filed 30. November 2016. • Positive international search report. • The national filing was in May 2018. • A second patent is in preparation covering a new class of molecules targeting a new receptor which is a validated target for chronic inflammatory diseases, and many eye diseases. • Biozep will patent specific formulations, specific indications, and novel compounds. 2017 2017 Today

  19. CONCLUSIONS Very attractive business opportunity • Biozep is becoming a market leader in therapeutic lipids. • Therapeutic lipids have a huge market potential both in ophthalmology and other disease areas. • Biozep has an existing product pipeline for font-on-the-eye and back-of-the-eye diseases with initial proof-of-concept data. • We are seeking a $5-10 million dollar investment to reach phase I of clinical trials at which point we are planning to find a pharmaceutical partner for co-development and commercialization. 2017 2017 Today

  20. RECENT OPTHALMOLOGY DEALS

More Related