Corporate Overview JUNE 2015 Private and Confidential ImmuMed ImmuMed Inc.© 2010-2015 Confidential...

Corporate Overview

JUNE 2015

Private and Confidential

ImmuMed

ImmuMed Inc.© 2010-2015 Confidential

A Therapeutic Antibody Company

3

ImmuMed Profile

Private therapeutic antibody company

Mission: To utilize our proprietary therapeutic antibody platform and build a leading organ transplantation business and transform the field by expanding recipient eligibility and enabling universal organ donor transplants

Established Lead product: Anti-Lymphocyte Globulin (ALG)– Historical use in 52,000 in organ transplant recipients at over

281 transplant centers across the U.S., Canada and parts of Europe

– Primary indication: Induction Therapy (Prevention of Acute Rejection)

– Published scientific record of efficacy and safety, support from KOLs in transplant

Antibody Platform and Pipeline Portfolio targeting antibody markets > $3B


4

Investment Thesis – ROI vs R&D process mitigates risk

Initial transplant antibody market size estimated at $470M W/W- 85% of revenue earned from Induction Therapy **

Opportunity to revive proven product used in over 52,000 patients

– Task: update mfg. and reproduce historical tox data to satisfy FDA IND requirement

$30M investment to market-rollout first product

– $10M to kick-off Ph III and potential IPO

Projected $250M+ in revenue within 5 years

Competitor with $79M in revenue sold for $600M in 2003 (8X multiple)

Additional revenue from pipeline development funded by product sales


** Induction Therapy is a drug protocol employing the administration of therapeutic antibodies to prevent rejection immediately following organ transplantation


5

Market Value Proposition

Growing organ transplantation industry– Increasing demand for organ transplants (W/W)

– Global Shortage of Donor Organs (growing waiting lists)

– Increasing Use of High-Risk Donor Organs (must use polyclonal antibody)

Fragmented market without a clear leader– Multiple products are sold into the field on a fragmented basis

Clear unmet transplantation medical need– No product enables universal organ donation

– No polyclonal antibody currently licensed for induction therapy

– No product addresses sensitized recipients

– Key anti-rejection products are marginally effective or sold “off-label”

ImmuMed well positioned for:– Market expansion by enabling universal organ transplants

– Capture the sales of current products now being used off-label

– Consolidation of existing products and businesses

– Market leadership to Establish Induction Therapy as Standard of CareImmuMed Inc.© 2010-2015 Confidential

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Monoclonal Antibodies (Low Risk Recipients) 5% US Revenue Share

– Single antigenic site with high specificity – Two (Simulect,® Zenapax®) approved to prevent rejection – One (OKT3) approved to treat acute rejection

Polyclonal Antibodies (High Risk Recipients) - Multiple antigenic sites – cytotoxic activity

– None approved for prevention of rejection

– Two approved (Thymoglobulin® , Atgam®) to treat acute rejection

– Treatment of Acute Rejection by antibodies – occurs in 4% of transplants

– Antibody revenues (Induction Therapy) now driven by Off-Label Use

– See IALG advantages vs. Thymoglobulin

– More efficient production at higher margins

– Absence of 10% microaggregates less safety concerns

Competitive Landscape for Induction Therapy

Antibody-based Immunosuppressive Drugs


95% US Revenue Share95% US Revenue Share

7

2012 Global Antibody Sales

Approved Polyclonal & Monoclonal Antibodies

Product Name

Type of Product

Manufacturer

Indication

$$ Sales ($Million

s)

% Change vs. PY

Thymoglobulin®

(Rabbit)Polyclon

al Genzyme Rx AR $320 12.0 %

Simulect®(Murine)

Monoclonal Novartis

Induction $110 4.5 %

rATG *(Rabbit)

Polyclonal Fresenius Rx AR $ 40 8.0 %

* Not sold in U.S.

Source: Evaluate Pharma 2013


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Technology Background

• Therapeutic antibody technology acquired from U. Minnesota 1996

• $66M R&D investment already done

• Lead product: ImmuMed Anti-Lymphocyte Globulin (“IALG”) • Primary indication: prevent rejection after solid organ transplantation

• 52,000 patient administrations (Compassionate Use) at least 281 transplant centers across the U.S., Canada and parts of Europe

• Lack of sufficient data reporting on compassionate use caused FDA clinical hold

• University refused commercial drug production• FDA issue with original inventor resolved

• Multiple pipeline products from common plasma inventory • Precondition donor tissue for bone marrow and stem cell transplants• Aplastic anemia• Autoimmune diseases• Lymphomas (FAB2 form)

• Qualified strategic partners identified• CMO: Cangene and/or Therapure BioPharmaceutical• CSO: Bio-Reliance and Apptec• CSO: Lake Immunogenics• CRO: Cato Research; Kendle; CTI


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Pipeline

Common Manufacturing Platform

Program Indication R&D PC Phase I Phase II Phase III

Biological Antibodies

ALG Solid Organ Transplantation

IATG-BMT Bone Marrow Transplantation

H. anti HIV Adjuvant Therapy in HIV and AIDS

Recombinant AntibodiesFab2 Infectious Diseases

ISI Mab Cancer Immunotherapy

Additional Opportunities

PRODUCT PIPELINE **


** Of products in its portfolio, ImmuMed has prioritized the sequence in which to develop acquired compounds based on the current stage of clinical development listed below.

** Of products in its portfolio, ImmuMed has prioritized the sequence in which to develop acquired compounds based on the current stage of clinical development listed below.

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Pipeline Target Markets

• Lead product: ImmuMed Anti-Lymphocyte Globulin (“IALG”) • $470MM potential market oppty. based on existing drugs

• Target markets for follow on pipeline products (derivatives of common plasma inventory = truncated development pathway)• Graft versus Host disease in Bone Marrow Transplant

($80MM)

• Aplastic Anemia ($175MM)

• Reduced viral loads in CMV and HIV infected patients ($750MM)

• B-cell lymphoma ($30MM)

• B-Cell Mediated Auto-Immune Diseases ($125MM)

• IVIG ($1.4B)


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How Does IALG Work?

- Adjuvant Immunosuppressive Drug

- Mechanism of Action

- Degraded by Liver

Adjuvant = administration as add-on to background immunosuppressive regimens to improve outcomes

Cytotoxic to lymphocytes (including those causing acute organ rejection )

Decreases: Recognition of Foreign Antigen Incidence of Acute Rejection Incidenceof Post-op dialysis events

• Anti-IALG antibodies occasionally measured


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Clinical Development Summary

Published Scientific Studies

Human Studies

Sample Size Major Findings

Phase I (1) Pharmacokinetics(N = 104)

Depletion Circulating lymphocytes

Phase II (2)

Dose response in humans

a) Skin grafts (N = 102)

b) Renal grafts (N = 47)

Increased graft survival was dose related

Phase III (3)Study drug v. PlaceboRenal grafts (N = 160)

Therapeutic Benefit improved renal graft

survival at 1 & 3 years** No Safety Issues **


1) Buchman TE., et al; Transplantation. 55(5):1190‑3, 1993 May.2) Simmons RL. Moberg AW., et al: Surgery. 68(1):62‑8, 1970 Jul.3) Condie RM, et al, Transplantation proceeding 1985; XVII(1): 1304-

1311.

1) Buchman TE., et al; Transplantation. 55(5):1190‑3, 1993 May.2) Simmons RL. Moberg AW., et al: Surgery. 68(1):62‑8, 1970 Jul.3) Condie RM, et al, Transplantation proceeding 1985; XVII(1): 1304-

1311.

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Post-Transplant Event ALG (n=81) Albumin (n=79)P-Value

Graft Survival: 3 years 45/81 (56%) 18/79 (23%) p<0.015

Graft Survival: 1 year 48/81 (59%) 37/79 (47%) p = 0.02

First rejection episode (median) 28 days 11 days p<0.0001

Fever 24.7% 15.2% NSChills 13.6% 6.3% NSHematuria 11.1% 13.9% NSNausea 7.4% 2.5% NSInfections

49.4% 55.7% NS

ALG versus Placebo (Phase III study)

Multicenter Efficacy Study for Induction Therapy

Efficacy

Safety

Phase III Trial Efficacy: Enhanced Graft Survival


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IALG vs. Rabbit Antithymocyte Globulin

[Comparative Efficacy for Induction Immunosuppression] Univ Hospital of Cincinnati Cincinnati,

OH + 4 other hospitals ALG(n=48)

95.8+2.9 95.8+2.9

87.5+4.884.6+5.4

50 (24)

1.87+.131.72+.07

% Patient Survival 6 months 12 months

% Graft Survival 6 months 12 months

% Patients with Rejection12 months

Serum Creatinine (mean) 6 months 12 months

rATG (n=50)

98+1.98 96+2.77

83.9+5.2 81.7+5.5

60 (30)

1.90+1.61.91+.22

p value

NSNS

NSNS

NS

NSNS

Comparative Performance Equine vs. Rabbit


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Renal Transplant Patients

(1) ALG data derived from all of the Case Report Forms submitted by transplant centers utilizing ALG in response to a letter request from the University of Minnesota pursuant to the clinical hold imposed by FDA. They represent data from all of the renal transplant patients from December 28, 1988 to August 12, 1992.

(2) Data from FDA’s summary basis of approval.

ALG(1) Atgam(2) OKT3(2)

Thymoglobulin(

2)

Simulect(2

)

Safety Database 8,059 1,587 63 82 193

Incidence of Death

0.5% 28.0% 4.7% 7.3% 4.6%

IALG: Favorable Sample Size and AE/SAE Rates


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Sales and Market valuation of Thymoglobulin have soared due to:

Off-label use

Absence of competitors

Proven Polyclonal Market (Thymoglobulin)


1980Pasteur Merioux (France)Product: Lymphoglobuline in EU

1993Sangstat (California)Licensed Lymphoglobuline, N.A.Renames: Thymoglobulin

1993Q3 – Sangstat IPO@ $7.50 per sharePiper lead, H&Q, others

1997

1998Q4 – SangstatAcquires ThymoglobulinFrom Pasteur Merioux:

2003Q3 – GenzymeAcquires Sangstat

$31M

$600M

Q1 – Sangstat Secondary Offering@ $30 share, 2.6 M sharesH&Q lead, others

HistoryHistory

2008$198M17.8%

18.7%

18.5%

Sales

2005$128M

2004$108M

2003$91M

2006$156M

21.9%

2007$168M11.5%

2009$232M

2010$250M

17.2%

7.1%

2012$320 M

** Sales to 2010 derived from 10Q filings; since Sanofi purchase current sales (2012) independent estimate

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IALG Thymoglobulin

ImmuMed Sanofi

IALG Competitive Advantages

Gross Margins Fraction of MALGHigh

Market Factors

T-Cell OnlyAntigen TypeT-CellB-Cell

Safety & Efficacy

Efficiency1 Horse = 140 liters 2,800 Rabbits = 140 liters

Mfg. VolumesLarge Plasma Inventory Low Inventory Potential

Production

Powder-Freeze DriedPhysical StateLiquid Solution Always

Micro-aggregates 10%<1%

Purity 90%99%


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Proprietary + Data + New Patent Claims = Unique Phase 3 Product

IALG ADVANTAGEIALG ADVANTAGE

Method of ImmunizationMethod of Lot Formulation

Newly Formulated Plasma Purification

Process

Essential to Not DestroyingBiologic Activity

New Patent

Essential to Developing

Biologic Activity

Proprietary Patentable

Strong Intellectual Property

Immunogens T-cells

B-cell (available

only for IALG)


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US Trial Potentials Label

NIT to Standard of Care Induction Label

NIT to Simulect or Zenapax Induction Label

Superiority to Simulect or Zenapax Induction Label

NIT to Atgam or Thymoglobulin Rejection Treatment

Differential Dosing (high/low IALG dose) Induction Label

Non-US Trial Potentials

Study drug vs. Placebo; Induction Protocol

Superiority to Simulect or Zenapax

NIT to Simulect or Zenapax; Induction Protocol

Pivotal Trial Options Available

Multiple Registration Plans Available for IALG

Current Status:No Approved Polyclonal Standard of Care for Induction


20

Marketing approval for a large molecule biologic based on standardized method of manufacturing correlated with safety and therapeutic benefit data discovered pursuant to a pivotal clinical trial.

Based on Pre-IND Meetings, ImmuMed required to:

• Finalize manufacturing method (finished by vendor)

• Manufacture commercial size lots (sufficient for 2,400 patients)

• Repeat toxicity study (required for new manufacturing process)

• Submit new IND for IALG pivotal clinical trial (drafted)

• Complete nested dosing and pivotal trial

• File BLA using new acquired data

FDA Pathway / Regulatory Milestones


21

0.027.3

83.9

246.8

19.3

97.2

470.0533.0

587.6647.8

1992 2003 2012 2014 2016 2018

Year

0.0

100.0

200.0

300.0

400.0

500.0

600.0

700.0

Mill

ion

s U

SD

IALG Revenue Model

IALG Pro Forma vs. Expected Global Market(5% Projected Growth)

Pro Forma


GlobalGlobal

FundingFunding

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Complete Market Approvals for IALG - Induction Therapy Indication

- Ph IV study for chronic rejection (3 and 5 year end-points)

- Expand life-cycle for desensitization therapy

Early Market Exposure and Revenues- Secondary Retransplant Market in US – (≈ 2,000 / year)

- “Named-Patient” sales – EU and rest of world (ROW)

– Emergency drug release authorization (Canada)

Product Launches First on-label product in induction therapy(≈ 36 months)

Capture “Off-Label sales; gain market share from monoclonals

First product for desensitization (if studied)

Consolidate products/market as single industry leader

Business Objectives


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Business Model

Begin As Near Virtual Company during pre-revenue period

Build Infrastructure, R & D With Cash Flow Expand Acquired Portfolio; In-License or Acquire New Technologies

Build the ImmuMedCompany

RestartIALG

Production

FDAPhase III

INDIALG

#1Sales

StrategicAlliances

forDistribution

R&DOutsourcingCo-Develop

IPO

Acquired

Merge

OUTSOURCE

Material

Prod

Testing

Trials

Execution:

Vision:

Minimal Infrastructure, Rely On Outsourcing Avoid Amassing Overhead In Search of Products

Commercialize Established Polyclonal Antibodies First

Focus On Achieving Early Cash Flow Projected 12 to 15 Months

No Early R & D Expense


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Reduced Regulatory & Development Risk – Multiple, well-defined FDA pathways (5 previous antibody

products)– No R & D required absence of surprises, efficacy understood– 52,000 patient history to supplement new safety data– Efficacy and superiority established– Data points (safety, dose, efficacy) to be replicated, not new– Manufacturing method establish/approved for another product

type– Proven Mfg. partners with experience in existing products

Attractive Commercial Opportunities– Growing transplant market– Product history demonstrates high medical approval– Acceptance of safety and efficacy profile– Multiple products derived from the same manufacturing platform– High manufacturing COG margins– Transplant market is mature, yet highly focused– Only few dozen leading US transplant centers potentiates “80:20”

market scenario.

Mitigation of Investment Risk


25

Executive Mgt.

Martin Driscoll, Chairman of the Board of Directors - Presently CEO and Director of Asmacure Ltee, a venture-backed clinical-stage biopharmaceutical company. Previous CEO of Javelin Pharmaceuticals (acquired by Hospira, Inc. in 2010). Over 31 years’ experience in bio pharmaceutical industry with responsibility in commercial, business development, and general management at Schering-Plough, ViroPharma, and Reliant Pharmaceuticals.

Allen Moberg, MD., Acting CEO/Director/CMO - Founder of ImmuMed, Inc.. Received his MD degree in 1964 and thereafter was educated in general and transplantation surgery at the University of Minnesota. Was responsible for development and patenting of medical devices for organ preservation and cofounder of IALG Program with other colleagues in the University of Minnesota’s Department of Surgery. Served as initial Program Director responsible for IALG’s production, Phase I and Phase II clinical testing, coa-uthored IND. Recent focus on organizing effort to return IALG to the marketplace, including raw material production and manufacturing and regulatory affairs.

Thomas Burton, CFO/Director - Cofounder of ImmuMed. From 1960 to 1990, was President and CEO of Waters Instruments, Inc., a diversified publicly traded company [ZRBA-NASDAQ] manufacturing and marketing medical and electronic devices. Served by appointment by the Governor of Minnesota on the Public Utilities Commission. Recently consulting with principal investigators developing new products in the medical field.

ImmuMed Inc.© 2010-2015. Confidential

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Advisors

Peter Levitch - Special expertise in clinical study design, implementation and compliance, good manufacturing practices and regulatory affairs. 25 years as consultant to more than 200 biotech, pharmaceutical and medical device companies, participating in at least 260 IND’s and FDA approval of many biotechnology derived products. Previous Manager of Clinical Research at Eaton Laboratories and Director of Clinical Research and Regulatory Affairs at Ortho Diagnostics, where, acting as Responsible Head to CBER (working to assure compliance for Ortho’s 60 licensed products) and as Official Correspondent to CMDRH.

Thomas Stagnaro – Over 35 years’ experience in medical and biotechnology fields. Presently President, CEO and Founder of Americas Biotech Distributor, LLC., distributing US biotech products into Latin America. Previously President and CEO of Agile Therapeutics, Inc. Prior to Agile, pharmaceutical consultant to Rock Hill Ventures/Hillman Medical Ventures, and President and CEO of 3-Dimensional Pharmaceuticals, Inc. Former Senior Executive Vice President at NABI, responsible for sales and marketing, generating sales in excess of $250 million and served as in the research and development for human polyclonal antibody products and vaccines. At NABI, managed the “In-licensing” of a late-stage product, and successfully brought the product through CBER and launched in US. Prior to NABI, was President and CEO of Univax Biologics, Inc., (acquired by NABI in 1995 for $150 million).

John St. Cyr, II, MD, Ph.D. - Director of Research. Surgical education at University of Minnesota, cardiovascular-thoracic training at University of Colorado Health Sciences, specializing in adult and pediatric Cardiovascular surgery, and transplantation. History in research, dedicated to myocardial preservation. ImmuMed Inc.© 2010-2015 Confidential

27

Investment Thesis – ROI vs R&D process mitigates risk

Initial transplant antibody market size estimated at $470M W/W- 85% of revenue earned from Induction Therapy **

Opportunity to revive proven product used in over 52,000 patients

– Task: update mfg. and reproduce historical tox data to satisfy FDA IND requirement

$30M investment to market-rollout first product

– $10M to kick-off Ph III and potential IPO

Projected $250M+ in revenue within 5 years

Competitor with $79M in revenue sold for $600M in 2003 (8X multiple)

Additional revenue from pipeline development funded by product sales




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