Nascent Biotech Inc. · OTC:NBIO
Nascent Biotech — Investor Presentation (September 2016)
25 slides from Nascent Biotech's investor presentation, September 2016
Slide 1: Clinical Stage Human Antibody Investor Presentation
CLI NI CAL STAGE HUM AN ANTI BODY Investor Presentation September, 2016 Confidential | Nascent Biotech, Inc. (OTC: NBIO)
Slide 2: Safe Harbor for Forward-Looking Statements
Safe Harbor for Forward-Looking Statements This presentation contains "forward-looking statements" as that term is defined in Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this presentation which
Slide 3: Investment Highlights
Investment Highlights • Lead compound’s target, ectodomain vimentin, is a novel target on “unmet-need” cancers – Initial focus on brain – Received orphan drug designations for gliomas and pancreatic cancer • Key preclinical development completed – Found to be “Biologically Active” in human trials at
Slide 4: Seasoned Management Team
Seasoned Management Team • Sean Carrick – CEO, President and Director – Over 25 years of success building and leading medical device, pharma and biotech companies in large, mid-cap and venture backed stages including Pfizer, Praecis, Conmed and Maquet. • Brandon Price, PhD. – Senior Vice President o
Slide 5: Highly Accomplished Advisory Board
Highly Accomplished Advisory Board • Mark Glassy, PhD. – Founder, Chair, Scientific Advisory Board - Over 30 years’ experience in antibody development and commercialization. Prepared and directed several FDA-approved clinical trials utilizing human monoclonal antibodies to fight cancer. • Santosh Ke
Slide 6: Monoclonal Antibodies are the future of pharmaceuticals
Monoclonal Antibodies are the future of pharmaceuticals • Monoclonal antibodies (mAbs) are exquisitely specific, extremely sensitive, and result in effective immunotherapies • mAbs can be used to effectively treat diseases previously considered difficult or untreatable (e.g., autoimmune and certain
Slide 7: Pritumumab
Pritumumab • Fully human monoclonal antibody (mAb) – Naturally occurring proteins that bind with exquisite specificity to molecular structures on the surface of target cells. • Recognizes a unique, highly-conserved, antigen expressed on the surface of cancer cells • $48M US equivalent previously inv
Slide 8: Novel Target - Ectodomain Vimentin (EDV)
Novel Target - Ectodomain Vimentin (EDV) Normal Cell Cancer Cell • Vimentin is a Type III intermediate • EDV is a variant of Vimentin that is filament protein expressed on the outside surface of a • It is part of the internal structure of variety of tumor cell types … normal cells • But not on surfa
Slide 9: Pritumumab Attacks Cancers of Epithelial Origin – Difficult to Treat
Pritumumab Attacks Cancers of Epithelial* Origin – Difficult to Treat Millions (2012**) 1. Lung 1.83 2. Breast 1.68 3. Colon 1.36 4. Prostate 1.11 5. Stomach 0.95 6. Liver 0.79 7. Cervix 0.53 8. Esophagus 0.46 9. Bladder 0.43 Top 9 cancers are epithelial and account for Pancreas, approximately 9M ne
Slide 10: Brain Cancer is Initial Target Market
Brain Cancer is Initial Target Market • With current therapeutic strategies (surgery, TEMODAR®), 1 & 5 yr survival rates are 60% & 35% for all brain cancers (36% & 5% for glioblastomas) – SEER Registry Data (June 2016) • Brain metastases occur will occur in 20-40% of all cancer patients – estimated
Slide 11: Pritumumab kills human tumor cells and localizes to tumor in brain
Pritumumab kills Pritumumab localizes human tumor cells to tumor in brain (animal model) In Vitro ADCC Assay (ME -180 Cells) Blood Vessels Pritumumab 20 18 Pritumumab Healthy 16 Mouse Brains % specific 51Cr release 14 12 10 8 Tumor 6 No mAb 4 2 0 0 10 20 40 80 (human study) Effector/target ratio 3 h
Slide 12: MRI evidence of tumor shrinkage; serum anti-idiotype antibodies
Serum anti-idiotype MRI evidence of tumor antibodies correlates shrinkage with tumor shrinkage Glassy & Hagiwara, Human Antibodies 18 (2009) 127-137 Anti-idiotype antibody concentration (μg/mL) 1,800 -80% 160 1,600 140 120 -38% 100 CR • 61 year old male 80 -44% • Astrocytoma of right parietal lobe 0
Slide 13: Overview of Human Clinical Trials in Japan
Overview of Human Clinical Trials in Japan Clinical studies, involving 249 patients, were conducted at dozens of Japanese hospitals from 1988 to 2002 – data published in 6 peer- reviewed journals 126 Evaluated for Safety • Based upon protocol compliance - a neuro- 74 of 126 oncology panel selected 1
Slide 14: Japanese Trials - Patients Were Evaluated for Safety
Japanese Trials - 126 Patients Were Evaluated for Safety Study Dose # of mg/dose, route, Admin. Primary Site Study Subjects Phase Freq. Cases # cases Period # of Sites Period 1 mg, IV, 3 1/wk 8 1 mg, IT, 2 Kobe Univ. 3/90 2 mg, IV, 3 School of I Gliomas 4 wks to Medicine 1 mg, IV, 7 2/91 2/wk 9 8 1
Slide 15: Tumor Size Change Data Suggest a Clinical Response at Low Doses
Tumor Size Change Data Suggest a Clinical Response Even at Extremely Low Doses Objective Response Criteria Tumor Reduction (Vol %) # Patients Complete Remission -100% 3 Partial Remission -51% to -99% 8 Stable Disease +25% to -50% 37 Progressive Disease >+25% 26 74 Total Clinical trial doses were 100
Slide 16: Independent Analysis of Japanese Data
Independent* Analysis of Japanese Data Pritumumab Historical Median Median Kaplan-Meier Survival Time Survival Time (months) (months) Caveat: It is extremely difficult to compare across studies given differences in tumor types, different Malignant evaluation criteria, types of treatments, performed
Slide 17: Takeaway on Japanese Clinical Data
Takeaway on Japanese Clinical Data “The Japanese data showed that Pritumumab was well tolerated and had clear objective biological activity with shrinkage of tumors at low doses. Confirmatory trials need to be performed at substantially higher dose levels.” -Dr. Santosh Kesari , Chair, Department of
Slide 18: Significant Milestones Achieved Since 2014
Significant Milestones Achieved Since 2014 • Successfully re-engineered the Pritumumab antibody into Chinese hamster ovary (CHO) cells • Created and fully characterized a Master Cell Bank (MCB) • Produced over 400 grams of clinical-grade Pritumumab – employing the GPEx® cell culture system at remark
Slide 19: Licensed Pritumumab to Zhejiang Hisun Pharmaceutical
June 2016 Licensed P ritum um ab to Zhejiang Hisun P harm aceutical, a m ajor Chinese com pany • $16 million in milestone payments and significant 20-year royalty stream. • $3 million initial payment received. Non-dilutive funding creates significant positive shareholder equity • Enables NBIO to sub
Slide 20: 2016 and Q1 2017 Goals
2016 and Q1 2017 Goals… • Complete fill/finish of bulk drug substance • Finalize toxicology reports • Complete IND and submit to the FDA (Q1 2017) • Initiate Phase I/II human clinical studies in the US for glioblastoma indication (including brain metastases) – Pritumumab dosages in the clinical stud
Slide 21: Clinical Timeline & Milestones
Clinical Timeline & Milestones Complete IND Phase I/II trial – gliomas Prepare 2nd IND Phase I/II trial - TBD 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Follow-Up 1st Glioma Submit Patents First Clinical Results Patient 2nd IND From Glioma Trial Submit Pancreatic CA Glioma IND 1st Patient Orphan Drug
Slide 22: Financial Highlights and Capitalization Table
Financial Highlights and Capitalization Table September 30, 2016 (Unaudited) Cash $ 376,814 Prepaid 145,500 R&D Materials 827,964 Total Assets 1,350,278 Accounts Payable and accrued liabilities 116,151 Current Liabilities 22,793 Total Liabilities 138,944 Stockholders Equity $ 1,211,334 Common Shares
Slide 23: Key Takeaways
Key Takeaways • Pritumumab’s target, Ectodomain vimentin, is a novel, conserved target on “unmet-need” cancers – Completed trials support additional testing at higher doses in a well-controlled trial • Major risks with program have been minimized – Technical • Drug has been manufactured at clinical
Slide 24: Survival Analysis – Malignant Astrocytoma
Survival Analysis – Malignant Astrocytoma (1 vs 2 doses per week – 1 mg/dose) 1 mg (0.014 mg/kg) per week N = 13 93 weeks N = 34 2 mg (0.028 mg/kg) per week 61 weeks P = 0.5675 Confidential | Nascent Biotech, Inc. (OTC: NBIO) 24
Slide 25: Survival Analysis – Glioblastoma
Survival Analysis – Glioblastoma (1 vs 2 doses per week – 1 mg/dose) 1 mg (0.014 mg/kg) per week N = 11 23 weeks N = 42 2 mg (0.028 mg/kg) per week 34 weeks P = 0.0836 Confidential | Nascent Biotech, Inc. (OTC: NBIO) 25
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