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Shareholder Meeting March 2 nd , 2018

Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

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Page 1: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Shareholder MeetingMarch 2nd, 2018

Page 2: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Mr. Rajin Ahuja

Chairman

Biomarck Pharmaceuticals, LTD

Welcome & Introduction

Page 3: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Biomarck Pharmaceuticals

Shareholder MeetingMarch 2, 2018

NC Biotechnology Center, Durham, NC

Agenda

Welcome and Introduction Mr. Rajin Ahuja

Board Introductions Mr. Rajin Ahuja

Board Voting Mr. Rajin Ahuja

Pre-Clinical Drug Discovery Professor Ken Adler

Clinical Development Update Dr. Brian Dickson

NSCLC

ARDS

Pediatric Cancer – expanded access Dr. Brian Dickson

Financials Mr. Mike Enright

Strategic M&A Considerations Dr. Brian Dickson

Questions and Close Dr. Brian Dickson

Page 4: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Board IntroductionsMr. Rajin Ahuja Chairman

Mr. Thomas Roberg Vice Chairman

Dr. Brian Dickson

Dr. Ashish Bhatia

Dr. Laura Calamos Nasir

Dr. Walker Long

Mr. Kennedy O’Herron

Mr. Craig Collard

Page 5: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Professor Kenneth Adler

N.C. State University

Pre Clinical Discovery Update

Page 6: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

BIO-11006 and SYNERGY WITH CHEMOTHERAPEUTIC

AGENTS

Page 7: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

syn·er·gyˈsinərjē/noun

noun: synergy; plural noun: synergies; noun: synergism; plural noun: synergisms1.the interaction or cooperation of two or more organizations, substances, or other agents to produce a combined effect greater than the sum of their separate effects.

Page 8: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

BIO-11006 SHOWS SYNERGY WITH CISPLATIN IN MOUSE MODELS OF NON SMALL CELL LUNG

CANCER

Page 9: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Average Number of Macroscopic Metastatic Tumor Nodules in Lungs

Left lu

ng

Right lung

Left lu

ng

Right lung

Left lu

ng

Right lung

Left lu

ng

Right lung

Left lu

ng

Right lung

Left lu

ng

Right lung

Left lu

ng

Right lung

Left lu

ng

Right lung

0

1

2

3

4

5

BIO-11006 (25µM)

BIO-11006 (50µM)

BIO-11006 (100µM)

BIO-11006 (25µM) + Cisplatin

BIO-11006 (50µM) + Cisplatin

BIO-11006 (100µM) + Cisplatin

Cisplatin

Vehicle Control

a

bc d,e

f,g

h,i

j

Avg.

no. o

f met

asta

tic tu

mor

nodu

les

Page 10: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Vehicle Contro

l

BIO-11006 (2

5µM)

BIO-11006 (5

0µM)

BIO-11006 (1

00µM)

BIO-11006 (2

5µM) +

Cisplatin

BIO-11006 (5

0µM) +

Cisplatin

BIO-11006 (1

00µM) +

Cisplatin

Cisplatin

0

1

2

3

4

Groups

a

b

cd,e

f,g

h,i

j

Avg.

no. o

f met

asta

tic tu

mor

nodu

les

Average Number of Macroscopic Metastatic Tumor Nodules in Distal

Organs (Diaphragm, Sternum, Ribs & Mediastinum)

Page 11: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Aerosolized BI0-11006 : Mouse Orthotopic Lung CancerPrimary Tumor Size

(peptide treatment started on Day 26, experiment finished on Day 42)

* P < 0.05** P < 0.01

Vs untreated 42 days

Prim

ary

tum

or si

ze (m

m)

U n trea t 2

5 da y s

U n trea t 4

2 da y s

B io-1

1 0 0 6 On ly

B io-1

1 0 0 6 + C

isp lt i

n

0

1

2

3

4

**

*

Page 12: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

TRIPLE NEGATIVE BREAST CANCER

COMBINATION OF MANS + PACLITAXEL (TAXOL) SHRINKS BREAST TUMORS IN MOUSE MODEL

• WORK PERFORMED IN COLLABORATION WITH COLLEAGUES AT UC DAVIS IN CALIFORNIA

Page 13: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Tumors generated by orthotopic injection of MDA-MB-468 cells into the fat pad of mouse breast. Drugs were given every three days. Tumors were measured every 3 days up to Day 21, when tumors were removed and weighed. The combination of MANS + Paclitaxel blocked tumor growth in these mice.

Page 14: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

MOA:SYNERGY WITH CHEMOTHERAPY

• CANCER CELLS DIVIDE MORE RAPIDLY THAN NORMAL CELLS

• CELL CYCLE: DIVIDING CELLS ARE IN A PHASE CALLED G2/M

• PLATINUM-BASED CHEMOTHERAPY (eg. CISPLATIN) PREFERENTIALLY KILLS FAST GROWING CELLS; eg. CELLS IN G2/M

• BIO-11006 KEEPS CANCER CELLS IN G2/M PHASE. THIS IS CALLED G2/M “CELL CYCLE ARREST”. THUS, IT WORKS TOGETHER WITH CISPLATIN, CARBOPLATIN, TAXOL, ETC. TO KILL CANCER CELLS AND SHRINK TUMORS

Page 15: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

ActinCDK2pTyr15 (MARKER OF G1/S ARREST)

Histone H3 pser10 (MARKER OF G2/M ARREST)

MARCKS

siRNA

CTL

Bio-

1100

6

BIO-11006 or MARCKS siRNA induce G2/M cell cycle arrest in cancer cells

G1/S arrested

G2/M arrested

Loading control

Page 16: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

• Platinum-based chemotherapy causes cell cycle arrest in G2 phase and accumulation of cancer cells in G2/M phase, ultimately leading to apoptosis (Cell Death).

Page 17: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Cell replication occurs in a series of phases, called the cell cycle. The cell cycle phases are: resting (G0; nothing is happening), G1 (or gap 1; a growth phase), S (synthesis; the replication of DNA occurs), G2 (gap 2; another growth phase), and M (mitosis; the actual division from 1 cell into 2).

Rapidly dividing cells are more likely to be in G2/M phase. The more rapidly cells are replicating, the more time they spend in G2/M phase.

METHOD OF ACTION (MOA) OF SYNERGY BETWEEN BIO-11006 AND CHEMOTHERAPEUTIC AGENTS

CELL CYCLE

Page 18: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

MOA OF SYNERGY BETWEEN BIO-11006 AND CHEMOTHERAPEUTIC AGENTS

• CANCER CELLS DIVIDE MORE RAPIDLY THAN NORMAL CELLS

• RAPIDLY DIVIDING CELLS ARE IN G2/M PHASE MORE THAN NORMAL

• PLATINUM-BASED CHEMOTHERAPY (eg. CISPLATIN) PREFERENTIALLY KILLS FAST GROWING CELLS (eg. CELLS IN G2/M)

• BIO-11006 KEEPS CANCER CELLS IN G2/M PHASE. THIS IS CALLED G2/M “CELL CYCLE ARREST”. THUS, IT WORKS TOGETHER WITH CISPLATIN, CARBOPLATIN, TAXOL, ETC. TO KILL CANCER CELLS AND SHRINK TUMORS

Page 19: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

CELL CYCLE

Page 20: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Dr. Brian Dickson

Chief Executive Officer

Biomarck Pharmaceuticals, LTD

Clinical Development Update

Page 21: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Clinical Development Update

ARDS

Opportunity• Unmet Need• Other Studies

Study Progress• UNC, Vanderbilt, University of Chicago• Duke, University of Pennsylvania• Enrollment• AE• Timing

Page 22: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Clinical Development Update

NSCLCOpportunity

• Unmet Need• Immunotherapeutics• Interaction – Potentiation

- Reduce AE

Study Progress• Regulatory• Drug Import• CRO / Cliantha• Enrollment• AE• Timing

Page 23: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Pediatric Cancer

(Expanded Access)

• Individual• Diffuse Intrinsic Pontine Glioma (DIPG)• Intranasal (BBB)

• Study• Sarcoma• Lung Secondary Tumors• Miami Children’s Hospital• Supplies Available• Controlled Study

Page 24: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

• 19 year old male with synovial sarcoma and extensive lung metastases• No response to all approved treatments• Given BIO-11006 for 2 months – no effect• Severe pain, unable to walk, severely out of breath• One month life expectancy, DNR issued• Given Trabectedin as palliative therapy, 3 days after BIO-11006• Dramatic improvement (not reported before with Trabectedin alone)• Now walking, no pain or shortness of breath • CT scan confirmed significant reduction in lung metastases• Studies planned to explore if BIO-11006 potentiates chemotherapy (Taxol,

Cisplatin, Trabectedin)

Pediatric SarcomaSynergy between BIO-11006 and Trabectedin?

Page 25: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Strategic M&A Considerations

Reviewing All/Best Options for Shareholders

Any Action Will Require a Vote• Co-Development• Licensing• Merger/Acquisition

Bio International• Boston, MA – June 2018• Presentation• One on One Meetings• >10,000 Attendees

Press Releases• ARDS 11/2017• NSCLC 01/2018

Page 26: Shareholder Meeting March 2nd, 2018 - BioMarck€¦ · Shareholder Meeting March 2, 2018 NC Biotechnology Center, Durham, NC Agenda Welcome and Introduction Mr. RajinAhuja Board Introductions

Questions

Close