corporate overview june 2015 private and confidential immumed immumed inc.© 2010-2015 confidential...
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Corporate Overview
JUNE 2015
Private and Confidential
ImmuMed
ImmuMed Inc.© 2010-2015 Confidential
A Therapeutic Antibody Company
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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
ImmuMed Inc.© 2010-2015 Confidential
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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
ImmuMed Inc.© 2010-2015 Confidential
** Induction Therapy is a drug protocol employing the administration of therapeutic antibodies to prevent rejection immediately following organ transplantation
** Induction Therapy is a drug protocol employing the administration of therapeutic antibodies to prevent rejection immediately following organ transplantation
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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
ImmuMed Inc.© 2010-2015 Confidential
95% US Revenue Share95% US Revenue Share
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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
ImmuMed Inc.© 2010-2015 Confidential
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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
ImmuMed Inc.© 2010-2015 Confidential
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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 **
ImmuMed Inc.© 2010-2015 Confidential
** 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)
ImmuMed Inc.© 2010-2015 Confidential
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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
ImmuMed Inc.© 2010-2015 Confidential
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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 **
ImmuMed Inc.© 2010-2015 Confidential
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
ImmuMed Inc.© 2010-2015 Confidential
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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)
ImmuMed Inc.© 2010-2015 Confidential
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%
ImmuMed Inc.© 2010-2015 Confidential
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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)
ImmuMed Inc.© 2010-2015 Confidential
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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
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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
ImmuMed Inc.© 2010-2015 Confidential
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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
ImmuMed Inc.© 2010-2015 Confidential
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
ImmuMed Inc.© 2010-2015 Confidential
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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
ImmuMed Inc.© 2010-2015 Confidential
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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
ImmuMed Inc.© 2010-2015 Confidential
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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
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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
ImmuMed Inc.© 2010-2015 Confidential
** Induction Therapy is a drug protocol employing the administration of therapeutic antibodies to prevent rejection immediately following organ transplantation
** Induction Therapy is a drug protocol employing the administration of therapeutic antibodies to prevent rejection immediately following organ transplantation