bantam pharmaceutical jan_17

Bantam Pharmaceutical Developing Novel Therapeutics for the Treatment of KRAS Dependent Cancers

www.bantampharma.com

BOS HQ

2015 FOUNDED

CHEMICAL BIOLOGY

PLATFORMTO DETERMINE BTM-10xx MOA

200+ YEARS

DRUG DISCOVERY AND DEVELOPMENT EXPERIENCE

Leadership Team and Advisory Board:

MERCK, NOVARTIS, MILLENIUM, TRANS-TECH, HARVARD, AZ, GSK

$10M CASH RAISED TO DATE

Seeking $5M – $10M from Investors and Partners to Support Pivotal PoC Clinical Trials

Value Proposition and Executive Summary

2

DIFFERENTIATED MOA: G0/G1 CELL CYCLE ARREST

POTENTIALCOMBINATIONS

WITH TARGETED AND I/O THERAPIES

$4B CRCMARKET OPPORTUNITY

BTM-10xx

PoC IN VIVO

STRATIFIEDPIVOTAL PoC CRC CLINICAL

TRIALS STRATEGY

PIPELINE

IND FILING

Colorectal – NSCLC – Pancreatic Myeloma - Lymphoma

BTM-10xx:PRE-CLINICAL

Q4, 2018 ANTICIPATED

POTENTIAL INDICATIONS

$9B TOTAL

ADDRESABLE MARKET OPPORTUNITY

Bantam Pharmaceutical - History

Founded late 2015

Based on research from McGill and Harvard Medical Schools

Developing novel therapeutics for the treatment of KRAS dependent cancers

Scientific Founders

– Mike Luther, PhD

– Matt Kostura, PhD

– Jedd Levine, MD

Seasoned Investors:

– W. James Tozer Jr.

– Lionel Goldfrank

– Victor Keen

Management Team and Advisory Boards with large and start-up Bio-Pharma experience

Bantam Pharmaceutical, LLC 3

4

Mike Luther,

PhD, MBAPresident and CEO

Jedd Levine,

MD, MBAChief Medical Officer

Matt Kostura,

PhDChief Scientific Officer

Vibha Oza,

Ph.D.Chief Operating Officer

Alan Cooper,

PhDChemistry Head

Experienced Leadership Team with Extensive Development Experience

5

Briggs Morrison,

MD, PhDChair

Mike Patane,

PhDScientific Advisor

Rainer Fuchs;

PhDScientific Advisor

Nahum Sonenberg

Ph.D.Scientific Advisor

Pamela Cohen,

MDScientific Advisor

Distinguished Advisory Board

Cost-Effective Path to Near-Term IND and Clinical Development


CHEMISTRY PHARMACOLOGYCOMPUTATIONAL

SCIENCES

Large Market Opportunity with Unmet Patient Needs


Sources: 1) RnR Market Research, 2) GBI Research, 3) GlobalData

$3.9B KRAS CRC Market, 2016

$4.82B

$3.94B(45%)

Colorectal Cancer Market, 2016

Total CRC Market KRAS CRC Market

$3.94B(44%)

$1.92B(22%)

$1.27B(14%)

$1.78B(20%)

Total Addressable KRAS Mutant Cancer Market, 2016

Colorectal adenocarcinoma Lung adenocarcinoma

Pancreatic adenocarcinoma Multiple Myeloma and Lymphoma

$9.1B Total Addressable Market, 2016

- CRC is the 2nd most lethal cancer in the US- KRAS is a frequent “driver” mutation in three of the four most lethal cancers- No current therapies available which effectively target mutated KRAS signaling

CONVENTIONAL CYTOTOXIC THERAPIES– 5FU, Capecitabine, Oxaliplatin, Irinotecan, Trifluridine/Tipiracil and

Combinations

TARGETED THERAPIES– EGFR antibodies Cetuximab (Lilly), Panitumumab (Amgen)

– Multi-Kinase Inhibitor Regorafenib (Bayer)

– Anti-angiogenic agents Bevacizumab (Genentech), Ramicirumab(Lilly), Aflibercept (Sanofi)

SELECTED ONGOING TRIALS IN CRC


Company Drug MOA/Target

Array Encorafenib/Binimetinib BRAF mutation/ MEK

Baxalta Imalumab/BAX69 Oxidized MIF

4SC Resminostat HDAC

XBiotech Xilinx IL-1α

Bayer Regorafenib Multi-Kinase

Bayer Atezolizumab/Cobimetinib PD-L1/MEK

Differentiated Opportunity for Targeting KRAS Mutated Colorectal Cancers

KRAS Mutations Impact Critical Cancer Hallmarks

KRAS is one of the most frequently mutated oncogenes in human cancer

Key consequences of KRAS mutations:

– Increased cancer cell proliferation/cell cycle progression

– Suppression of apoptosis

– Altered cancer cell metabolism

– Changes in tumor microenvironment

A drug that modulates KRAS signaling will have substantial clinical benefit and value for a broad spectrum of cancer patients


Cox, Adrienne D., Stephen W. Fesik, Alec C. Kimmelman, Ji Luo, and Channing J. Der. “Drugging the UndruggableRAS: Mission Possible?” Nature Reviews Drug Discovery 13, no. 11 (October 17, 2014): 828–51.

KRAS and BTM-10xx Connection: KRAS Mutated Cancers are Responsive to BTM-10xx


* p=.002

Cell line screening data. KRAS genotype identified in 74 solid tumor cell lines

Overall 21 of 74 (28.6%) of solid tumors with known KRAS genotype are responsive

to BTM-10xx

KRAS genotype responsive to BTM-10xx

WT - +/+ 12 of 60 (20%)

MUT +/- 7 of 8 (88%)

MUT -/- 2 of 6 (33%)

BTM-10xx Novel Mechanism of Action: Induces Cell Cycle Arrest at G0/G1


• BTM-10xx inhibits tumor cell growth with nanomolar potency

• No effects observed on normal cells

• Cell cycle arrest occurs in G0/G1

o Inhibition at G1 phase prevents processes associated with tumor growth, including cancer cell metabolism

o Potential combinations with other targeted cancer agents, including downstream cell cycle and immune checkpoint inhibitors

• Unique mechanism: not an inhibitor of CDKs or HDACs

Ce

ll G

row

th In

hib

itio

nC

ell

Cyc

le a

rre

st

BTM-10xx In Vitro and In Vivo Efficacy

Bantam Pharmaceutical, LLC12

BTM-10xx Inhibits Growth of KRAS Mutant Colorectal Tumor Xenografts In Vivo

• 88% TGI

• Good tolerability with no significant weight loss

• Good rodent and non-rodent PK Profile with >99% Oral Bioavailability

• EGFR antibody therapies associated with clinical benefit only in KRAS (and NRAS, BRAF) wild type patients

BTM-10xx Inhibits Growth in Multiple Cancer Cell Lines In Vitro

Induces growth arrest in solid tumors

No response in all normal human cell lines tested (e.g. fibroblasts, endothelial cell lines)

BTM-10xx

BTM-10xx Summary

▪ In vivo PoC in human KRAS mutant colorectal tumor xenografts

▪ Nanomolar in vitro cellular potency in KRAS mutated cancer cell lines

▪ Active across a spectrum of KRAS mutant cancers

▪ Excellent pharmacokinetics and oral bioavailability

▪ Well tolerated in vivo with no observed AEs at MTD

▪ KRAS status can be used as patient stratification marker

▪ Other potential indications, including DLBCL

▪ Novel Mechanism of Action:

▪ Inhibits restriction point of cell cycle leading to arrest in G0/G1

▪ Concomitant potent effects on cancer cell metabolism

▪ MoA is specific to cancer cells:

▪ No activity in normal human cells.

▪ No relationship to alternate targeted MoAs

▪ No biochemical activity on known targets observed to date

▪ e.g. CDKs, Kinases, HDACs, BDRs



▪ Patents published December, 2016 (WO2016196644A1)– Current patent covers Composition of Matter and Use Claims for Candidate

and Back-Ups

– US Provisional Patent Application (no. 62/169376) filed June 2015

– PCT Application (no. PCT/US/2016/035288) filed June 2016

– Market exclusivity likely through 2036

– 6 additional provisional patent applications filed

– Patent Strategy in place for downstream activities, including companion diagnostics

IP Summary


2016 2017 2018 2019 2020 2021

Candidate Selection

IND Phase I/IIPivotal Phase II

BTM-10xx

Bantam Pipeline

KRAS Mutant Solid Tumors

Expansion Phase: KRAS Mutant CRC

• Establish Phase 2 dose • PK and Tox• Validate PD markers for

target engagement• Demonstrate clinical

efficacy signals in KRAS CRC

Single agent BTM-3528 vs. combination with other agents in KRAS

mutant CRC (e.g. cetuximab)

• Demonstrate signals of clinical utility in relapsed/refractory KRAS selected cancers

• Early exploration of combination therapies in KRAS mutant CRC

Exploration of other potential indications and ROA (IV)

BOS HQ

2015 FOUNDED

CHEMICAL BIOLOGY

PLATFORMTO DETERMINE BTM-10xx MOA

200+ YEARS

DRUG DISCOVERY AND DEVELOPMENT EXPERIENCE

Leadership Team and Advisory Board:

MERCK, NOVARTIS, MILLENIUM, TRANS-TECH, HARVARD, AZ, GSK

$10M CASH RAISED TO DATE

Seeking $5M – $10M from Investors and Partners to Support Pivotal PoC Clinical Trials

Value Proposition and Executive Summary

16

DIFFERENTIATED MOA: G0/G1 CELL CYCLE ARREST

POTENTIALCOMBINATIONS

WITH TARGETED AND I/O THERAPIES

$4B CRC MARKET OPPORTUNITY

BTM-10xx

PoC IN VIVO

STRATIFIEDPIVOTAL PoC CRC CLINICAL

TRIALS STRATEGY

PIPELINE

IND FILING

Colorectal – NSCLC – Pancreatic Myeloma - Lymphoma

BTM-10xx:PRE-CLINICAL

Q4, 2018 ANTICIPATED

POTENTIAL INDICATIONS

$9B TOTAL

ADDRESABLE MARKET OPPORTUNITY

bantam pharmaceutical jan_17

Documents