Bio-Path Holdings, Inc. · OTC:BPTH
Bio-Path — Shareholder Meeting (December 2015)
20 slides from Bio-Path's shareholder meeting presentation, Dec 30, 2015
Slide 1: A New Paradigm in Drug Delivery: Annual Meeting Presentation, Highlights from 2015
“A New Paradigm in Drug Delivery” Annual Meeting Presentation Highlights from 2015
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: 2015 Overview
2015 Overview □ Core Organization » Scientific Advisory Board □ Corporate Development » PR and Marketing » New Patent » DNAbilize ™ □ BP1001 (Liposomal Grb2) in the clinic □ ASH 2015 □ Plans and milestones □ Financial snapshot 3
Slide 4: 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 Center Research Center • Former Managing
Slide 5: Scientific Advisory Board
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 6: Corporate Development
□ Brought on corporate marketing and branding Firm, 6 Degrees, to increase Bio - Path profile and outreach » Increase Bio - Path visibility in media » Develop partnerships with influential journalists » Strategic planning for conferences and investor presentations □ Development of drug product marke
Slide 7: 2015 Press Releases and News
□ Bio - Path Holdings’ Data from Phase I and Safety Segment of Phase II Clinical Trials in Blood Cancers Presented at 57th American Society of Hematology (ASH) Annual Meeting □ Bio - Path Holdings Reports Third Quarter 2015 Operational and Financial Results □ Bio - Path Holdings’ Data to be presente
Slide 8: Conference Program 2016
□ Biotech Showcase EDB Group - January □ The 18th Annual BIO CEO & Investor Conference – February □ 28 th Annual ROTH Conference - March □ TIDES - Oligonucleotides in Therapeutics conference - May □ BIO International Convention - June □ ASCO 2016 - June □ Rodman & Renshaw 18th Annual Healthcare Conf
Slide 9: New Trade Name and Patent
New Trade Name and Patent □ DNAbilize ™ Technology – a platform technology utilizing the P - ethoxy stabilized DNA backbone with neutral liposomal incorporation of antisense DNA □ New Composition of Matter and Process Patent filed for the manufacturing of DNAbilize ™ DNA 9
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 and Ib Clinical Trial 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 » O f 15 of 20 evaluable patients’ blasts demonstrated anti - leukemia activity » 8 patient
Slide 12: Response to Treatment for Select Patients
□ 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 □ T otal of 8 doses
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 ND 1 037 AML 25 25 ND 1 038 AML 23 2 ongoing 4 Peripheral or bone marrow (BM)* Blast % Cycles Completed Patients Diagnosis
Slide 16: Safety, Pharmacokinetics, and Efficacy of BP1001 in Refractory or Relapsed Leukemia
Safety , Pharmacokinetics, and Efficacy Of BP - 100 - 1 . 01 (Liposomal Grb - 2 Antisense Oligonucleotide) In Patients With Refractory Or Relapsed Acute Myeloid Leukemia (AML), Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia (ALL), and Myelodysplasti
Slide 17: 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 first in a Phase II clinical trial in combination with frontline therapy □ The current safety segment of the Phase II (Phase Ib) trial is evaluating 2 cohorts at 2 dose levels, 3 patients per co
Slide 18: Accomplishments 2015 and Future Development for 2016
Accomplishments 2015 and Future Development for 2016 □ Significant corporate development in 2015: » Phase II safety segment (Phase Ib ) dosing for the combination therapy for BP1001 near completion » IND package for BP1002 (Liposomal Bcl2) in preparation to begin a clinical trial » Promising new tar
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 $145 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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