Bio-Path Holdings, Inc. · OTC:BPTH
Bio-Path — Investor Presentation (January 2016)
20 slides from Bio-Path's investor presentation, Jan 13, 2016
Slide 1: A New Paradigm in Antisense Drug Delivery
“A New Paradigm in Antisense Drug Delivery” Corporate Presentation January 2016
Slide 2: Forward Looking Statements
This Presentation contains forward - looking statements with respect to business conducted by Bio - Path Holdings, Inc . By their nature, forward - looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future
Slide 3: Overview
Overview □ About Bio - Path Holdings □ Antisense and DNAbilize ™ Technology □ BP1001 (Liposomal Grb2) in the clinic □ Future plans and milestones □ Financial snapshot 3
Slide 4: About Bio-Path Holdings
□ Oncology focused pharmaceutical development company located in Houston, TX □ Established in 2008 with technology licensed from the University of Texas MD Anderson Cancer Center □ Listed on NASDAQ in March 2014 as BPTH □ Breakthrough science and cancer drugs ▪ DNAbilize ™ Technology is our propriet
Slide 5: Investment Highlights
» Solving the antisense drug delivery challenge with DNAbilize ™ Technology » World’s leading cancer institution, MD Anderson, is significant shareholder Broad Vision, Focused Strategy » Liposomal delivery technology distributes antisense drugs throughout the human body by simple intravenous infusio
Slide 6: Core Organization
Core Organization Peter Nielsen Co - Founder, President, Chief Executive Officer and Chief Financial Officer • Officer and D irector since founding Company in 2007 Ulrich Mueller, PhD Chief Operating Officer • P reviously Vice President at the Fred Hutchinson Cancer Research Center • Former Managing
Slide 7: Board of Directors
Jorge Cortes, M.D . Chairman • M.D . from la Facultad de Medicina , Universidad Nacional Autónoma de México • Jane and John Justin Distinguished Chair in Leukemia Research, Chief of the AML and CML sections , and Deputy Chair of the Department of Leukemia at The University of Texas MDACC • Has consu
Slide 8: DNAbilize Technology
DNAbilize ™ Technology □ P - ethoxy DNA incorporate into the neutral liposomes’ hydrophobic multi - lamellar structure in contrast to electrostatic interactions in cationic lipid delivery methods. □ Neutral liposomes avoid toxic effects of cationic liposomes on cell membranes by avoiding nonspecific
Slide 9: DNAbilize Antisense DNA: A Targeted Method for Treating Disease
DNAbilize ™ Antisense DNA: A Targeted Method for Treating Disease □ Antisense - molecules that interfere with the process of producing proteins inside cells (RNAi) » Does not use a toxic agent to kill cells, but instead blocks production of proteins » Advantage of specificity because it targets the
Slide 10: BP1001 in Clinical Testing
BP1001 in Clinical Testing □ Grb2 is a protein that bridges activated tyrosine kinases to the Ras signaling pathway □ Phase I clinical trial: » First 6 cohorts completed » P reliminary results show drug has been well tolerated in patients with AML, CML, and MDS with no signs of toxicity and signs of
Slide 11: Summary of Phase I Monotherapy and Ib Combination Therapy Results for BP1001
□ AML, CML, ALL & MDS Patients Refractory or Resistant to Current Therapies □ Dose escalating, treatment cycle 8 doses over 4 weeks Results through cohort 6 ( 90 mg/m 2 ) » Patients averaged 6 prior therapies » 15 of 20 evaluable patients’ blasts demonstrated anti - leukemia activity » 8 patients st
Slide 12: Response to Treatment for Patients 002 and 006
□ Patient 002 : 32 year - old, Hispanic male with myeloid blast crisis of CML □ Prior therapies consist of: ― Gleevec ― Dasatinib ― Nilotinib ― DCC - 2036 ― Cytarabine/Fludarabine/ ― Dasatinib/Gemtuzumab ― PHA - 739358 ― Clofarabine/Dasatinib □ Patient taken off therapy, CNS disease was assumed (not
Slide 13: % Decrease of Target Grb2 Protein and pErk Protein
% Decrease of Target Grb2 Protein and pErk protein » Grb2 levels decreased 50% in 11 of 13 samples by end of treatment (EOT) » pErk levels decreased an average of 52% in 7 of 13 samples by EOT. NS 1 = no sample collected 2 Fewer cells used in analysis because sample had less cells
Slide 14: Results of Phase II Cohort Combination LDAC + BP1001 Therapy
Results of Phase II Cohort 7 Combination LDAC + BP1001 Therapy □ S afety evaluation of combination l ow - dose cytarabine (LDAC) with BP1001 in refractory and relapsed patients □ Three (3) evaluable patients were treated twice a week for 4 weeks with 60 mg/m 2 of BP1001 and LDAC □ Total of 8 doses i
Slide 15: Percent Blasts in Bone Marrow for Phase II Cohort 7
Percent Blasts in Bone Marrow for Patients in Safety Study Phase II Cohort 7 15 Baseline Nadir Off-Tx 035 AML 17 2 yes 1 037 AML 25 25 yes 1 038 AML 23 2 ongoing 4 Peripheral or bone marrow (BM) Blast % Cycles Completed Patients Diagnosis
Slide 16: Plans For Phase II Clinical Trials of BP1001
Plans For Phase II Clinical Trials of BP1001 □ The proposed clinical program is to evaluate BP1001 in AML in a Phase II clinical trial in combination with frontline therapy □ Currently completing the safety segment of the Phase II (Phase Ib) trial evaluating 2 cohorts at 2 dose levels, 3 patients pe
Slide 17: Recent Accomplishments
Recent Accomplishments □ Phase I monotherapy clinical trial completed through six cohorts with very promising results » 34 patients enrolled » Well tolerated drug with no toxicity » 18 evaluable patients with circulating blasts, 83% had a response » 8 of 21 evaluable patients stabilized for addition
Slide 18: Upcoming Milestones
Upcoming Milestones □ Completion of safety segment of Phase II (Phase Ib) clinical trial □ Continued pre - clinical evaluation of BP1001 for inflammatory and triple negative breast cancer and if successful, rapid deployment into a Phase I clinical trial □ Exciting new drug candidates coming from our
Slide 19: Clinical Pipeline
Clinical Pipeline * BP1001 for AML has received orphan drug designation from the U.S. FDA * 19
Slide 20: Financial Snapshot
Ticker: NASDAQ: BPTH Shares: 89.8M shares outstanding Sept 30, 2015 Market Cap: approximately $130 MM Capital Raised: $30.6 MM Cash: $9.9 MM as of Sept 30, 2015 Burn rate: approximately $1,000,000 per quarter excluding the clinical trial costs Financing: $25 million ATM program in place Financial Sn
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