Molecular Insight Pharmaceuticals (MIPI) 8-K Regulation FD Disclosure

Molecular Insight Pharmaceuticals, Inc.

Convertible Preferred Offering

Investor Presentation

December 3, 2009

Exhibit 99.1

2

Disclaimer and Safe Harbor

Disclaimer

This document is based on information provided by Molecular Insight Pharmaceuticals, Inc. (the “Company”) and other sources that the Company

believes are reliable and includes additional and updated disclosure where available.  CRT Investment Banking LLC, as Placement Agent, is not making

any representation or warranty that the information in this document is accurate or complete and is not responsible for this information.  The Placement

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promise or representation by the Placement Agent or the Company as to the past or the future.

You should not construe the contents of this document as investment, legal or tax advice.  You should consult your counsel, accountant and other

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The

Company

is

not

making

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to

you

regarding

the

legality

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an

investment

in

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appropriate

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Neither

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Company nor the Placement Agent does or can guarantee that purchase of the securities will result in any economic gain and may result in the loss of

an investor’s entire investment.

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decision

regarding

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you

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Company

and

the

terms of this offering, including, without limitation, the merits and risks involved.

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subsequent to the date hereof.

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This presentation

contains

“forward-looking

statements”

within

the

meaning

of

the

“safe

harbor”

provisions

of

the

Private

Securities

Litigation

Reform

Act

of 1995.  Such forward looking statements include, but are not limited to, the available patient population for our products; our partnering opportunities

and capabilities; our ability to obtain covenant relief on our bonds; and our continued clinical trial progress, among others.  The words "may," "would,"

"will," "expect,"

"estimate,"

"anticipate,"

"plan,”

“believe,"

"intend,“

“target,”

“strategy,”

“potential”

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involve risks and uncertainties, many of which are beyond our ability to control.  These forward-looking statements are subject to a number of risks and

uncertainties that

may

cause

actual

results

to

differ

materially

from

those

described

in

the

forward-looking

statements.

These

risks

include

changes

in

laws and

regulations

effecting

radiopharmaceuticals,

our

ability

to

raise

capital

to

fund

ongoing

development

and

operations,

completing

our

manufacturing capability, the price and availability of raw materials for manufacturing, timing and results of product development and certification of our

product, unanticipated costs and delays in product development and manufacturing, our ability to hire and retain key management and technical

personnel, interest of channel partners, competitive factors, and our ability to manage growth, as well as the risks and other factors set forth in our

periodic filings with the U.S. Securities and Exchange Commission (including our Form 10-K for the year ended December 31, 2008 and our other

periodic reports as filed from time to time).

3

Company Overview

Publicly traded, clinical-stage biopharmaceutical company (NasdaqGM: MIPI)

Portfolio of five clinical stage drugs, all with significant potential product value

Focused

on

the

discovery

and

development

of

targeted

therapeutic

radiopharmaceuticals

and molecular imaging agents for use in oncology

Experienced scientific and regulatory management team, world class scientific and clinical

advisory boards

Patents

32 issued; 25 pending in US

(1)

163 issued; 94 pending outside US

(1)

Headquartered in Cambridge, MA

(1)

Including in-licensed.

4

Investment Highlights

Pioneer in the emerging field of molecular medicine

Five

clinical-stage

candidates

addressing

seven

indications

with

significant

unmet

patient

needs with no visible potentially competing products in development

Significant

near-term

partnering

opportunities

in

oncology

and

cardiology;

one

completed partnership (Onalta), one in late stage negotiations, and one targeted for out

licensing (Zemiva)

Clinical

risk

for

certain

products

reduced

through

established

history

of

use

outside

the

United States

Ultratrace™

is a proprietary radiolabeling

technology

Key clinical and corporate milestones within two years

Highly

experienced

management

team

with

history

of

success

and

value

creation

Near

term

value

drivers

have

the

potential

to

provide

significant

lift

in

equity

value

Partnerships with pharma

companies validate the science / market opportunity

Elimination

of

default

risk

on

the

Notes

via

this

fund

raise

and

anticipated

covenant

relief by bondholders suggests significant near term equity value recovery

5

Investment Highlights (continued)

Commitment

of

Cerberus

and

other

existing

investors

to

participate

in

current

fund

raise provides validation of products and strategy

Business

development

opportunities

are

anticipated

to

supply

a

significant

portion

of

the

needed cash for further advancement of the confirmation of the science and targeted drugs

Product

value

strategy

can

be

broken

into

three

categories:

Azedra

value is expected to more than “defease”

the total accreted bond value

Zemiva

value

may

fund

other

development

via

the

off

licensing

of

the

only

cardio

product

Trofex

is

expected

to

provide

significant

upside

equity

value

as

both

an

imaging

and

therapeutic product

Others (Onalta

and Solazed) are bonus points

6

Broad and Diverse Pipeline

Product

Candidate

Indication

Current Phase

Status

Pre

PI

PII

PIII

Azedra™

Treatment of neuroendocrine

tumors using tumor’s

norepinephrine uptake

mechanism

•

Molecule commercialized outside the US

•

Pivotal trial –

Phase II

•

Orphan Drug status

•

Fast Track designation

Onalta™

Treatment of carcinoid

tumors using receptor-based

radiotherapeutic

•

Orphan Drug status

•

Sub-licensed to BioMedica in certain

non-US territories

Trofex™

Detection and monitoring of

prostate cancer via binding

to prostate-specific

membrane antigen (PSMA)

•

Completed proof of concept –

Phase I

Solazed™

Treatment of metastatic

melanoma based on

melanin-binding small

molecule

•

Orphan Drug status

•

Initiated proof of concept

131

I-MIP-

1375

Prostate therapeutic

•

In discovery

99m

Tc-

Octreotide

Neuroendocrine cancer

diagnostic

•

In discovery

Zemiva™

Detection and management

of cardiac ischemia by

imaging metabolic changes

in the heart

•

Molecule commercialized outside the US

•

Phase III discussions ongoing with FDA

•

Targeted for out-licensing

Pheochromocytoma

Neuroblastoma

7

Clinical Development Timeline

2009

2010

2011

2012

2013

H1

H2

H1

H2

H1

H2

H1

H2

H1

H2

Azedra

Neuro

Azedra

Pheo

Trofex

Onalta

Solazed

Zemiva

IBN201 Pivotal Phase II Trial

Phase III Confirmatory Trial

Submit NDA

NDA Approval

IB12b Pivotal Phase II Trial

Phase III Confirmatory Trial

Submit NDA

NDA Approval

Phase I Clinical and

Nonclinical Studies

EU Phase III Confirmatory Trial

Submit

MAA

MAA

Approval

Phase I Dosimetry Study

(NIH Funded)

Phase III FDA Agreement

8

Proven Management Team

Executive

Experience

Daniel Peters

President

and

CEO

Chairman

of

the

Board

of

Phidias

AB

and

also

serves

on

the

board

of

MDRNA,

Inc.

Previously served as President and CEO of Medical Diagnostics for GE Healthcare

Successfully

integrated

Amersham

Health

into

GE

Healthcare

Former

Chief

Operating

Officer

of

Amersham

Health

John W. Babich, PhD

Co-Founder,

CSO,

Executive

VP,

and

President

of

R&D

Former Assistant Professor of Radiology at Harvard Medical School and Staff

Radiopharmaceutical Chemist at Massachusetts General Hospital

Former Principal Scientist and Head of the Radiopharmaceuticals at the Institute of

Cancer Research in England

BS degree in Pharmaceutical Sciences from St. John’s University; MS from University

of Southern California; PhD from the University of London

Charles Abdalian

CFO,

and

Senior

VP

of

Finance

Over 30 years of experience in executive financial management; has been

responsible

for

building

value

at

early-

to

mid-stage

biopharmaceutical

companies

Former Chief Financial Officer at Coley Pharmaceutical Group, Inc.

Successfully negotiated and completed sale of Coley to Pfizer

Former Audit Partner at Coopers & Lybrand (PWC)

Norman LaFrance, MD

CMO,

and

Senior

VP

More than 20 years of experience with molecular imaging and therapeutic companies

Widely published and experienced in imaging and therapeutic medical research

Board-certified

in

Internal

Medicine

and

Nuclear

Medicine

and

a

Fellow

in

the

American College of Physicians and the American College of Nuclear Physicians

Masters and BS in Nuclear Engineering and Science from Rensselaer Polytechnic

Institute; MD from the University of Arizona

9

Board of Directors

Board Member

Experience

Joseph M. Limber

Chairman of the Board

Current President and Chief Executive Officer of Prometheus Laboratories

John W. Babich, PhD

David R. Epstein

President and Chief Executive Officer of Novartis Oncology and former Chief

Operating Officer of Novartis Pharmaceuticals Corporation

Daniel Frank

Managing Director at Cerberus Capital Management

Scott Gottlieb, MD

Yvonne Greenstreet, MD

Senior Vice President and Chief of Strategy, R&D at GlaxoSmithKline

Daniel L. Peters

President and Chief Executive Officer of Molecular Insight Pharmaceuticals

David M. Stack

Executive Partner of MPM Capital and Managing Partner of Stack Pharmaceutical

Lionel Sterling

Founder and Partner of Equity Resources

Executive Vice President, Chief Scientific Officer and President of Research 

Former Deputy Commissioner for Medical and Scientific Affairs at the FDA

10

Scientific Advisory Board

Board Member

Experience

William C. Eckelman, PhD

Chairman

Former Chief of Positron Emission Tomography (PET) Department, National

Institutes of Health (NIH) 

Ronald Van Heertum, MD

Professor of Radiology, Acting Chairman of Radiology, Director of the Division of

Nuclear Medicine and PET, Columbia University College of Physicians &

Surgeons

Duncan Hunter, PhD

Professor and Associate Dean of Science, University of Western Ontario

Rob Mairs, PhD

Head of Pediatric Oncology, Cancer Research UK Beatson Laboratories,

University of Glasgow

Martin Pomper, MD

Professor of Radiology, Pharmacology, Molecular Sciences and Oncology, Johns

Hopkins University

John Thornback, PhD

Chairman, Sestria Limited

John F. Valliant, PhD

Associate Professor of Chemistry, McMaster University

Jon A Zubieta, PhD

Distinguished Professor of Chemistry, Syracuse University

11

MIPI’s Transformational Molecular Imaging Products

Enables early detection, appropriate staging and monitoring

of disease

Low radiation dose

Sensitivity to detect disease when anatomy is still normal

Specificity allows disease to be characterized and identified

Whole body scanning and 3-D imaging easily performed

Large installed base of imaging equipment exists at

accredited hospitals

Trofex, Zemiva &

99m

Tc-Octreotide

12

A New Generation of Targeted Oncology Therapeutics

Specific

targeting

delivery

of

systemic

radiotherapy

–

spares

normal tissue

Potentially effective anti-cancer treatment

Minimal side effects compared to chemotherapy

Potential to improve safety and efficacy of cancer therapy

Palliation and combination therapy possible

Azedra,

Onalta,

Solazed

&

131

I-MIP-1375

13

Business Strategy

Establish a market leading oncology-focused specialty pharmaceutical company committed

to the discovery, development and commercialization of both targeted radio-therapeutic

compounds and targeted molecular imaging radiopharmaceuticals

Primary

areas

of

focus

include

neuroendocrine

tumors,

prostate

cancer

and

metastatic

melanoma

Pursue near term and significant partnering opportunities where appropriate

Azedra:

standalone development and commercialization with a potential partner

Trofex:

therapeutic

standalone

development

and

commercialization

with

a

potential

partner

Zemiva:

out licensing to a cardio oriented nuclear medicine partner

Onalta:

additional partnering opportunities in regions not covered by BioMedica

transaction

Solazed:

potential

partnering

at

latter

stage

14

Leadership in Oncologic Radiopharmaceuticals

Targeted radiotherapy is an increasingly important contributor in cancer treatment

Rational care

Proven means to effect tumor remission

Logical option in delivering treatment efficacy

Imaging is critical in the diagnosis and management of most cancer; it is expected to be

increasingly deployed to determine treatment options reflecting new technologies with

greater discrimination

MIP has deployed extensive resources to advance targeted radioimaging and

radiotherapeutics, and is a leader in the field

The market for radiotherapeutics is expected to grow substantially over the next 10 years,

reflecting targeted products with more defined therapeutic efficacy

15

Enhanced Imaging Technology

Enhanced imaging, directed at clinically relevant targets, will increasingly impact cancer

treatment selection and monitoring

Essentially non-invasive method to

determine tumor size and location

Visualize pathology-associated

physiological, cellular, and molecular

processes in active tumor disease

Quantify clinically relevant variables

Blood flow, oxygen consumption,

glucose metabolism, proliferation,

hypoxia, apoptosis, etc.

Molecular Imaging

Broadly expands capabilities of

conventional anatomical imaging to

include staging of disease

Enables earlier cancer detection

Facilitates individualized treatment

Allows for effective monitoring of

therapeutic response

Directs therapeutic intervention by

tumor mass and location(s) and

tumor-receptor targets imaged

Cancer Treatment

16

Treatment Options Available to Oncologists

Treatment Alternatives

Limitations

Targets rapidly proliferating tumors

Systemic administration enables treatment of primary and metastatic lesions

Neo-adjuvant/adjuvant therapy options broaden efficacy

Targeted therapy increases efficacy and/or reduced toxicity

Severe side effects

Immunosuppression

Organ toxicity

Secondary neoplasia

Treats many solid tumors and diffuse leukemia and lymphomas

Improved safety with tighter beam focus, CT-scanning and MRI tumor

localization has delivered improved safety and efficacy

Frequently adjunctive to other treatment options

Acute and long term radiation side

effects

May achieve complete disease resolution alone or in combination with

chemo/radiation

Palliative de-bulking of late-stage/aggressive/invasive solid tumors

Prevention by removing lesions that are pre-malignant or encapsulated

Surgical complications

Potential for tumor reseeding

Can only treat solid tumors

Limited to accessible tumor sites

Less invasive and less toxic than conventional therapy

Targets specific cancers with reduced side effects

Utilizes immune system to target cancer cells

Anaphylactic reactions

Potential for other side effects

Multiple and increasingly diverse treatment options are available to oncologists, each with

unique modes of intervention, outcomes benefit, and use limitations

Targeted radiotherapy (“TRT”) representing an important new treatment option

17

Targeted Radiotherapeutics Provide Unique Benefits

As a single agent, radiotherapeutics have:

Cured cancer: I-131 in thyroid cancer

Effected complete remission: I-131-MIBG in neuroblastoma

And are:

Utilized as first-line treatment

Effective in consolidation therapy

Effective for palliation

Targeted

Radiotherapy

Demonstrated benefit in solid

tumors where no alternative

treatment options are available

High energy induced

destruction of cancer cells

independent of pathway activity

Treats disseminated

diseases with exquisite

targeting accomplished with

targeting molecules

Ability to non-surgically

debulk large tumor masses

(decompression)

18

Targeted Radiotherapy Debulking of Tumors

Advantages

Non-invasive

Reaches physically inaccessible

locations

Performed under direct

visualization

Instantaneous response

Minimally invasive procedure

Spares healthy tissue

Reduces blood loss

Short recuperative time

Non-invasive

Reaches inaccessible locations

Spares healthy tissue

Short recovery period

Disadvantages

Severe side effects

Unacceptable impact on patient

QoL

Limited utility

Painful

Potential for infection

Potential for long recovery time

Limited accessibility

Potential for infection

Contraindicated due to limited

accessibility

Longer response time than

surgery or ablation

Not universally applicable

Chemotherapeutic

Debulking

Surgical

Debulking

RF / Laser

Ablation

Targeted

Radiotherapy

Debulking

Product Overview

Leadership in Oncologic Radiopharmaceuticals

20

Ultratrace™

Delivers Unique Ultrapure Radiotherapeutics

Cancer cell

Cancer cell

Ultratrace™

maximizes

delivery

of

radioactivity to the tumor

Optimal tumor uptake means improved

efficacy

Low amount of drug administered

significantly reduces risk of

pharmacological or toxicity

Ultratrace™

Technology

Sub-optimal chemistry results in excess

of non-radioactive molecules

Non-radioactive molecules compete for

“chair”

on tumor cell

Low number of radioactive molecules on

tumor reduces therapeutic efficacy

Extraneous non-radioactive molecules

have the potential of producing serious

pharmacological or toxic side effects

Current Methods

21

Azedra –

Neuroendocrine Cancers

Tumor Sites for Azedra Indications

Overview

Radiotherapeutic product for the

treatment of metastatic neuroendocrine

tumors, specifically pheochromocytoma,

carcinoid and neuroblastoma

Description

I-131-Metaiodobenzylguanidine (“MIBG”)

Mechanism

of Action

Azedra binds to MIBG receptors, which

are commonly expressed on

neuroendocrine tumors

Therapy is targeted since beta particles

only travel a short distance from drug-

bound receptor

Expected

Performance

Provides treatment for patients that are

not amenable to treatment with surgery

or conventional chemotherapy

Product

Status

Orphan Drug status and a Fast Track

designation from the US FDA

Pivotal trial –

Phase II

Molecule commercialized both inside and

outside the US for diagnostic imaging

Currently available in the US on a

compassionate-use basis through

Draximage but contains cold

contaminants and is not approved by the

FDA

Adrenal Glands

(Pheochromocytoma

and Neuroblastoma)

Gastro-

Intestinal Tract

(Carcinoid)

Posterior

22

Azedra

–

Mechanism of Action

Developed at the University of Michigan to

image the adrenal medulla

MIBG is a substrate for the norepinephrine

transporter also known as Uptake-1, which

is found in some normal tissues and over-

expressed in a range of neuroendocrine

tumors

Norepinephrine

uptake

is

responsible

for

MI

BG

uptake

in

neuroendocrine

tumors

The success of targeted radionuclide

therapy is directly related to:

The ability to deliver sufficient number of

radioactive molecules to the tumor

Maintaining an acceptable radiation

dose to normal tissues

MIBG Uptake Mechanism

23

Azedra –

Proven Efficacy

Efficacy of I-131-MIBG  has been demonstrated in children with

neuroblastoma and in adults with pheochromocytoma and

carcinoid

J Clinical Oncology 2007

•

35% RR, improved survival

Annals of New York Academy of Science 1073: 465–490

(2006)

•

35% RR

Cancer 2004;101:1987–93. 2004

•

Improved survival; dose response

Current trials in Europe combining MIBG with topotecan

Multiple tumors are seen

throughout the abdomen

and skeleton

24

Clinical Literature Supports Azedra Development

Study Name

High-Dose 131I-MBIG Therapy

for Patients with Malignant

Pheochromocytoma

Phase II Study on Response

to 131I-MBIG Therapy

Refractory Neuroblastoma

131I-MBIG Double Infusion

With Autologous Stem-Cell

Rescue for Neuroblastoma

Phase I Study

Patients

N=12

N=148 Rx 18mCi/kg

N=16 Rx 12mCi/kg

N=21 Rx ranges from 22 to

50mCi/kg

Authors

Rose B, Matthay KK, Price D,

Huberty J, Klencke B, Norton JA,

Fitzgerald PA

Matthay KK, Yanik G,

Messina J, Quach A,

Huberty J, Chen S, Veatch

J, Goldsby, Brophy P, Kersu

L, Hawkins R, Maris J

Matthay KK, Quach A,

Huberty J, Franc B, Hawkins

R, Jackson H, Groshen S,

Shusterman S, Yanik G,

Veatch J, Brophy P,

Villablanca J, Maris J

Research

Centers

Department of Medicine,

UC San Francisco

Department of Pediatrics,

UC San Francisco

Department of Pediatrics,

UC San Francisco

Journal

Cancer

(July 15, 2003)

Journal of Clinical Oncology

(March 20, 2007)

Journal of Clinical Oncology

(January 26, 2009)

Conclusion

“High-dose 131I-MIBG may lead

to long-term survival in patients

with malignant

pheochromocytoma”

“The high response rate and

low nonhematologic toxicity

with 131-I-MIBG suggest

incorporation of this agent

into initial multimodal 

therapy of neuroblastoma”

“The lack of toxicity with this

approach allowed dramatic

dose intensification of 131-I-

MIBG, with minimal toxicity

and promising activity”

25

Azedra

–

Targeted Therapeutic for Neuroendocrine

Tumors

Utilizes

the

Company’s

patented

Ultratrace™

technology

to

target

the

neuroendocrine

cancers:

neuroblastoma

(children),

pheochromocytoma

(adults)

and carcinoid

Demonstrated excellent tumor targeting in initial clinical trials

Demonstrated enhanced tumor kill in preclinical models of human disease

Largely avoids cardiovascular side effects of other MIBG preparations

Fast Track designation and Orphan Drug status granted for two indications

Neuroblastoma

and Pheochromocytoma

•

Serious life-threatening diseases

•

No known effective treatments

•

Annual incidents: 20,000

refractory

patients

of

100,000

patient

base

(1)

(1)

Campbell Alliance market research, December 2009.

26

Azedra –

Points of Differentiation

Ultratrace technology = Improved product purity

Greater tumor uptake

Reduced pharmacological toxicity/side effects

There are no known effective treatments for relapsed refractory neuroblastoma or

pheochromocytoma

“Cold carrier”

MIBG (I-131-metaiodobenzylguanidine) does not have FDA approval, and

is unlikely to pose a commercial threat

Options for patients with advanced neuroendocrine tumors refractory to surgery:

Chemotherapy

•

Causes serious side effects with minimal benefit

Experimental protocols

27

Azedra

–

Development Status

Pheochromocytoma

(“pheo”) / Paragangaloima

(“para”)

Fast Track and Orphan Drug status

Phase 1 dosimetry

study (IB-11) completed

Phase 2a dose escalation study (IB-12) completed

Phase 2 therapeutic trial (IB-12b) begun June 2009

Neuroblastoma

(“neuro”)

P2a MTD study (IB-13/NANT-1-2007) underway with NANT

consortium

P2b  (IB-N-201) targeted begin 4Q09 / 1Q10 depending on

IRB processes

28

Azedra

–

IB-12 Study Overview (Adult Pheo

/ Para)

Study Overview

Process

Phase I Dose-Escalation (“IB-12”)

Identify the maximum tolerated dose (“MTD”) of

Ultratrace

iobenguane

I 131

Evaluate the safety and efficacy of Azedra

in

patients with malignant pheo

Duke University Medical Center, New York

Presbyterian Hospital, Rhode Island Hospital

Dose

escalation

began

at

6

mCi/kg

and

proceeded

according to the 3+3 trial design with dose increases at

1 mCi/kg increments

Patients were dosed by weight up to 75 kg

Long term follow-up is ongoing

Safety and Toxicity

Dose-limiting Toxicities (“DLTs”)

Febrile

neutropenia

(temperature

38.5°C

and

ANC

<1000/µL)

Grade 3 thrombocytopenia with active bleeding

Grade 4 hematologic toxicity > 1 week duration

Grade 3-4 non-hematologic toxicity

Patient Population

Study Type

6.0

mCi/kg

(n=3)

7.0

mCi/kg

(n=6)

8.0

mCi/kg

(n=6)

9.0

mCi/kg

(n=6)

Total

Average Age

Mean

Range

52

36 –

72

54

30 –

72

48

39 –

55

48

34 –

65

50

30 –

72

Gender

Male %

Female %

0%

100%

83%

17%

67%

33%

67%

33%

62%

38%

Weight in kg

Mean

Range

62.3

56 –

70

68.9

42 –

84

97.6

60 –

126

91.3

78 –

103

82.6

42 –

126

Race

Black %

White %

Other %

33%

67%

0%

0%

83%

17%

17%

67%

17%

17%

83%

0%

14%

76%

10%

Dose (mCi)

Mean

Range

375

333 –

423

463

325 –

536

572

473 –

609

661

633 –

696

538

325 –

696

29

Azedra

–

IB-12 Study Results (Adult Pheo

/ Para)

Overview of Results

Best response per RECIST was partial response (“PR”)

for 3 patients (14%), stable disease for 14 (67%),

progressive disease for 2 (10%), and not evaluable for

2 (10%)

All

3

PRs

were

documented

at

3

months

and

continued through 12 months

Mean

serum

chromogranin

A

and

vanillylmandelic

acid

levels were decreased from baseline at 3, 6 and 9

months

Furthermore, 5 of 15 (33%) patients taking anti-

hypertensives

at

time

of

therapy

reduced

or

discontinued use following treatment

Posterior Bone Scans

12 Months

Post-Azedra

Baseline

18 Months

Post-Azedra

Best Change in Sum of Longest Diameters of Target Lesions

(1)

16%

7%

(4%)

(4%)

(5%)

(7%)

(9%)

(18%)

(23%)

(24%)

(26%)

(28%)

(31%)

(33%)

(39%)

(51%)

(64%)

(100%)

(75%)

(50%)

(25%)

0%

25%

A

B

C

D

E

Patient

F

G

H

I

J

K

L

M

N

O

P

Q

(1)

Change from baseline displayed in this figure is each patient’s largest decrease from baseline or smallest increase if no decrease,

as viewed from Reviewer 1 of 2 Reviewers.

30

Azedra –

IB12B Study Overview (Phase II Pheo / Para)

Study Overview

Study Population (target n = 58)

Phase 2 Pivotal Efficacy and Safety (“IB12B”)

Evaluate the efficacy of Azedra in patients with

malignant relapsed/refractory pheo / para

Evaluate the safety of Azedra in patients with

malignant relapsed/refractory pheo / para

Males and females of at least 12 years of age

Histologically confirmed para/pheo

Failed prior therapy and not eligible for chemotherapy

or other potential curative therapies

Stable antihypertensive regimen

At least one measurable lesion

Adequate renal and hepatic function

Adequate hematologic status

Study Conduct

Twelve US centers participating

Duke

Washington University

Cornell

Lousiana State University

Johns Hopkins

University of Pennsylvania

MD Anderson

University of Miami

Mt. Sinai

University of California (SF)

RI Hospital

University of Iowa

Study currently enrolling patients

Two open-label doses of Ultratrace Iobenguane I 131

(Azedra) three months apart

Follow-up:1 year for primary efficacy; 5 years for

survival

Key Endpoints

Reduction (at least 50%) in antihypertensive medication

for at least 6 months

Status of hypertension and changes in blood pressure

Proportion of patients with complete response (“CR”) or

partial response (“PR”) by RECIST criteria

Quality of life

Overall survival

Safety

31

Azedra –

IB-N201 Study Overview (Phase II Neuro)

Study Overview

Study Population (target n = 100)

Phase 2 Pivotal Efficacy and Safety (“IB-N201”)

Evaluate the efficacy of Azedra in patients with

relapsed/refractory high-risk neuroblastoma

Evaluate the safety of Azedra in patients with

relapsed/refractory high-risk neuroblastoma

Males and females of at least 12 years of age

Diagnosis of high-risk neuroblastoma that is

relapsed/refractory

At least one measurable, MIBG avid lesion

Adequate renal, hepatic, cardiac, lung, and thyroid

function

Adequate hematologic status and recovery from prior

chemotherapy, immunotherapy, and radiation therapy

Eligible for at least one 15 mCi/kg dose of Azedra per

dosimetry findings

Study Conduct

Eighteen US centers selected to participate

Two UK centers under consideration

Institutional review board/ethics committee reviews in

process

Two open-label doses of Ultratrace Iobenguane I 131

(Azedra) 2 -

3 months apart

Follow-up: 1 year for primary efficacy; 2 years for

survival

Key Endpoints

Proportion of patients with CR or PR by RECIST

criteria over the course of two efficacy assessments

Duration of response in patients with CR or PR

Change in use of pain medication

Quality of life

Overall survival

Safety

32

Trofex –

Revolutionary Prostate Cancer Diagnostic

Trofex Prostate Cancer Imaging

Overview

Radiotherapeutic for the imaging of

prostate cancer

Description

I-123 radiolabeled small molecule

Mechanism

of Action

Detection of metastatic disease in men

with elevated prostate specific antigen

(“PSA”), but no other obvious symptoms

to identify prostate cancer

Expected

Performance

Improves therapeutic treatment strategy

•

Identifies presence and extent of

localized, regional or distant

metastatic disease

•

Suggests pretreatment disease

burden

•

Monitors post treatment effects of

therapy

•

Potential therapeutic application

Product

Status

Completed proof of concept –

Phase I

Market

Opportunity

One out of every six U.S. men will

develop

prostate

cancer

(1)

US population: prevalence >2.2 million;

annual incidence >200,000; annual

deaths 30,000

(1)

Cancer Facts and Figures (2009)

33

Trofex –

Superior Imaging Technology

Bladder

Normal

Kidneys

Posterior Planar Image

SPECT / CT Fused Slices of 3D Image

Normal

Liver

Known Bone

Tumor Lesion

Unknown Soft

Tissue (Lymph

Node) Lesion

34

Trofex –

Points of Differentiation

Potential to change the prostate cancer imaging landscape

Current technologies lack both sensitivity and specificity for detecting metastatic disease

Small molecular size compounds have a definitive advantage

Achieve greater permeability into solid tumors, which leads to higher percent uptake per

gram of tumor tissue and a high percentage of specific binding

Likely to display improved blood clearance and tissue distribution in normal tissues as

compared with intact immunoglobulins, making lesion detection more conspicuous

Time: 4-5 days

Large molecule = poor tumor penetration

Prolonged blood levels = low contrast

Binds to intracellular

component of PSMA

Limited sensitivity and specificity

Unable to detect bone metastases

ProstaScint

®

*

Prostate Cancer Imaging In Relapsed and High Risk Patients

Time: 4 Hours

Trofex

Small molecule = good tumor penetration

Rapid tumor uptake = high contrast

Binds to extracellular component of PSMA

Detects soft tissue and bone metastases

Potential to accurately detect and stage

prostate cancer

* Currently available treatment

Source: Health Advances (2007 Market Research)

35

Trofex –

101 Study Overview (Prostate Cancer)

Study Objectives

Study Design

Randomized, single blind, cross-over study patients to

receive 123I-MIP-1072  &  123I-MIP-1095 10 mCi with

2 weeks between treatments

Whole body A/P and SPECT images acquired

several times post-injections

Blood samples for pharmacokinetics and

metabolism obtained several times post-injection

Urine collected for clearance and metabolism

several times post-injections

Safety parameters monitored for 2 weeks after

second administration

Examine the PK, organ dosimetry, metabolism and

safety of 123I-MIP-1072  &  123I-MIP-1095 in patients

with prior histological diagnosis of prostate cancer and

evidence of recurrent metastatic disease

Safety and Toxicity

Expanded acute toxicity rat study

No adverse effects observed at doses > 300X the

human equivalent dose

Cardiovascular effects in conscious dogs (arterial

pressure, heart rate and ECG)

No adverse effects observed at doses > 300 times

human equivalent dose

General pharmacology screen (NovaScreen™)

No effects observed at 1 µM

Patient Population

Charac-

teristic

Patient

Mean

Std.

Dev.

101

201

202

203

301

302

303

Age

66

53

67

76

70

79

86

71

10.7

Height

(cm)

174

175

161

176

173

178

168

172

5.8

Weight

(kg)

99

93

62

71

77

112

95

87

17.6

Race

BK

WH

BK

WH

BK

WH

WH

NA

NA

PSA

(µg/L)

4.6

30.7

517

85.3

15.9

87.6

104.8

140.2

187.9

36

Trofex

–

101 Study Results

Tumor Uptake (Decay Corrected)

Tumor to Background Ratios

Planar Imaging

SPECT Imaging

Tumor Uptake (Not Decay Corrected)

37

Trofex

–

101 Study Conclusion

Both 123I-MIP 1072 & 123I-MIP 1095 detect suspected tumors between 1 & 4 hr post-

injection

Both

compounds

have

similar

tumor

uptake

and

adequate

T/B

ratios

on

a

per

tumor

basis

123I-MIP

1072

clears

the

circulation

more

rapidly

and

is

excreted

renally

while

123I-MIP

1095 does not clear as readily over the time period studied

123I-MIP 1072 is excreted intact while some metabolism was observed with 123I-MIP 1095

Human dosimetry

supports a 123I diagnostic dose of 10-15 mCi

Extrapolation to 131I therapy demonstrates that the kidney will be the dose-limiting organ

(assumes adequate thyroid blockade) at administered doses for 131I-MIP 1072 of 539 mCi

and for 131I-MIP 1095 of 162 mCi

38

Onalta

–

Metastatic Carcinoid

and Pancreatic Tumors

Pancreas

(Pancreatic

Neuroendocrine

Tumors)

Posterior

Tumor Sites for Onalta

Indications

Gastro-

Intestinal Tract

(Carcinoid)

Overview

Radiotherapeutic

for the treatment of

metastatic carcinoid

and pancreatic

tumors in patients whose symptoms are

not controlled by conventional therapy

Description

Yttrium-90 somatostatin

487

Radioisotope Y-90 is carried by

somatostatin

analog

Mechanism

of Action

Somatostatin

analog binds to

somatostatin

receptors SST2 and SST5

expressed on neuroendocrine

tumors

Therapy is targeted since beta particles

only travel a short distance from drug-

bound receptor

Expected

Performance

Provides treatment for patients that are

refractory to somatostatin

therapy

Allows targeted radionuclide therapy at

tumor sites expressing somatostatin

receptors

Product

Status

Orphan Drug designation in EU

Completed three Phase I and three

Phase II clinical trials in the U.S.

EMEA has approved MIPI’s

Phase 3

protocol design

39

Onalta

–

Development History

Time

Event

Q2 1997

Originating IND filed with the US FDA

3 Phase 1 trials (n = 66), 3 Phase 2 trials (n = 278) completed

2005

FDA grants Orphan Drug status for the treatment of somatostatin

receptor-

positive neuroendocrine

gastroenteropancreatic

tumors

Q1 2007

Molecular Insight in-licenses Onalta

program from Novartis

Q4 2007

Bachem

grants sub-license from Molecular Insight to produce and distribute

DOTATOC peptide

Q2 2008

Molecular Insight supports a physician-sponsored Phase I study in children

with refractory somatostatin

receptor positive tumors at University of Iowa

•

Submits protocols to Sloan Kettering to complete dosimetry

studies

Q1 / Q2

2008

Scientific

Advice

Meetings

with

MHRA

(UK)

and

BfArM

to

formalize

regulatory

endpoints in Phase 3 registration studies in the EU

Q4 2008

EMEA

grants

Orphan

Drug

status

for

the

treatment

of

somatostatin

receptor-

positive

neuroendocrine

gastroenteropancreatic

tumors

40

Onalta –

Points of Differentiation

Targeted radiotherapeutic with minimal pharmacological side effects

Chemotherapy with single or combination cytotoxic agents has produced little benefit

Currently, patients with an endocrine-active tumor that cannot be treated by surgery are

given drugs to decrease hormone production; however, symptom control often disappears

in 6 to 18 months

Competitive Landscape

Class of Compound

Products in Development

Level of Threat

Anti-angiogenic compounds

•

Avastin

Low

Multi-Kinase inhibitor

•

Sunitinib

•

Sorafenib

Low

mTOR Inhibitor

•

Everolimus (RAD-001)

Low

Radiotherapy

•

Lutate

Medium

Cold SST analogue

•

SOM-230

Low

41

Onalta –

Opportunities in the EU

Currently being utilized as a first-line or second-line treatment for refractory, somatostatin-

positive patients in the EU

Current patient population is unsatisfied and seeking new options

Metastatic

pancreatic

neuroendocrine

tumors

(PNET)

affect

~7,500

patients;

~700

currently

on radiolabeled therapy

Availability

of

a

commercial

radiolabeled

product

is

anticipated

to

expand

addressable

PNET population to ~2,100

Metastatic carcinoid tumors affect ~85,000 patients; ~6,500 currently on radiolabeled

therapy

Availability of

a

commercial

radiolabeled

therapy

is

anticipated

to

expand

addressable

carcinoid patient population to ~26,300

42

Onalta –

Sub-Licensing Agreement

Overview

Sub-licensed Onalta in June 2009 to BioMedica Life Sciences, S.A., for distribution in

certain countries in Europe, Middle East, North Africa, Russia and Turkey

-

BioMedica receives exclusive sub-license to intellectual property rights and know-

how

-

Onalta has Orphan Drug designation in EU

-

EMEA accepted MIPI’s Phase III protocol design and plan for EU development

MIPI retains all rights to all other markets, including the U.S., Japan, and Asia

BioMedica

Responsibilities

Conduct clinical studies

Market, distribute and commercialize Onalta

Secure all regulatory approvals

Will purchase from MIPI (for 5 years with a 5-year renewal option):

-

Finished product (including compassionate use)

-

Clinical trial supplies exclusively

Sub-licensing

Terms

Receives $4.4 million initial payment and is eligible for additional regulatory milestone

payments

Total pre-commercial milestones worth >$10 million (regulatory and upfront

payments, net of license payments)

MIPI eligible to receive milestone and tiered royalties on Onalta sales

43

Onalta –

Clinical Program Overview

Summary

Clinical Studies Performed

338 patients treated with 90Y-edotreotide

Administered

doses

ranged

from

1.8

–

32.6

GBq

Mean cumulative dose 13.8 GBq

Adverse effects minimized by:

Individualized dosing based upon dosimetry

Concomitant amino acid infusion

Monitoring renal function

Clinical Benefits

Study Type

Phase

Agent

# of

Subjects

Disease

PK & Safety

1

Y-86

24

Somatostatin-Receptor

Positive Malignant Tumors

PK & Safety

1

Y-86

42

Somatostatin-Receptor

Positive Malignant Tumors

Safety &

Efficacy

1

Y-90

60

(1)

Refractory Somatostatin

Receptor-Positive Tumors

Safety &

Efficacy

2

Y-90

168

Advanced Metastatic

Cancers

Safety &

Efficacy

2

Y-90

20

Pancreatic Endocrine

Tumors

Safety &

Efficacy

2

Y-90

90

Symptomatic Malignant

Carcinoid Tumors

(1) All patients enrolled in Study B151 previously participated in Studies 0101 or B102 ..

Adverse Events

Most commonly observed adverse events are those

frequently found  in advanced cancer patients:

Nausea 74.9%

Fatigue 39.9%

Abdominal pain 21.9%

Dizziness 16.0%

Anorexia 13.9%

Vomiting 61.8%

Diarrhea 26.3%

Flushing 17.2%

Headache 15.7%

Majority (85%) of patients with refractory carcinoid

reported improvement in at least one symptom

Nearly half (49%) reported improvement in four or

more symptoms

Majority of patients (62%) with insulinoma achieved

normalization of insulin/glucose ratios

Half experienced decreased requirement for

somatostatin analog use

44

(1)  National Cancer Institute.

Solazed

–

Therapeutic for Malignant Metastatic Melanoma

Tumor Sites for Solazed

Indications

Overview

Targeted radiotherapeutic

for treatment

of malignant metastatic melanoma

Description

Ioflubenzamide

I 131

Mechanism

of Action

The drug selectively binds to melanin

that is found in high concentration in

melanoma cells and delivers a lethal

dose of radiation

Expected

Performance

Exhibits excellent dose response and

efficacy in a model of human melanoma

Exhibits favorable toxicity profile in

preclinical evaluations

Product

Status

Currently initiating Phase I clinical study

to confirm proof of concept in man

Market

Opportunity

The incidence of malignant melanoma

is the fastest growing of any cancer in

the US

(1)

Effective treatment still represents a

challenge to oncologists because

chemotherapeutic agents have limited

activity in the treatment of metastatic

melanoma

45

Solazed –

Points of Differentiation

Selective targeting of metastatic melanoma

Selective delivery of radiation to tumors

Highly effective in human models of melanoma

Minimal pharmacological toxicity of nonradioactive Solazed

46

Solazed –

Pre-Clinical Data

Time after initiation of treatment (days)

0

5

10

15

20

0

25

50

75

100

125

3 x dacarbazin

1 x Solazed

3 x Solazed +

3 x dacarbazin

saline

2 x Solazed

3 x Solazed

47

Zemiva –

Improved Cardiac Ischemia Imaging

Myocardium Metabolism

During Ischemic Event

Overview

Diagnostic product for the early

detection of ischemic myocardium via

SPECT imaging in conjunction with

early standard cardiac diagnostic data

Description

Iodofiltic acid I 123

Mechanism

of Action

Binds to fatty acid metabolizing tissue

rather than tissue undergoing glycolysis

Changes in fatty acid metabolism are

visualized for up to 30 hours following

the ischemic event

Expected

Performance

Utility in emergency department acute

setting

•

Improved sensitivity and specificity

Proven safe

•

More than 400,000 patients dosed

in Japan for over 10 years

•

Over 800 patients injected in MIP

clinical trials with no major drug

related adverse events

•

Single injection uses 1/10th

radiation dose vs. Cardiac CT

Product

Status

Molecule commercialized outside the

US

Phase III discussions ongoing with FDA

48

Zemiva –

Cardiac Ischemia

Detection and management of cardiac ischemia by imaging metabolic changes in the heart

in the emergency department acute setting

Cardiac tissue shifts from fatty-acid metabolism to glucose metabolism when ischemic

Healthy cardiac tissue accumulates Zemiva but ischemic tissue has significantly reduced

accumulation which appears as a defect on SPECT imaging

No additional stress event is necessary for imaging

Ischemic Heart

Insufficient oxygen supply (ischemia)

causes the heart to switch from fat to

carbohydrates as primary energy source

Non-Ischemic Heart

A healthy heart requires sufficient

oxygen supply to metabolize fat

49

Zemiva –

Imaging Capabilities

Angiogram

Zemiva SPECT Images

A large defect is observed with Zemiva in the lateral wall, consistent with the stenosis and the

potential culprit lesion seen in the left circumflex coronary artery in the angiogram

50

Zemiva –

Market Opportunity

3.5 Million Patients

Equivocal

Admitted for Observation

($6 billion in unnecessary

hospitalizations)

1.5 Million Patients

Ischemia Ruled Out

Discharged

(40,000 Missed

Heart Attacks)

1.0 Million Patients

Definitive Heart Attack

Admitted for

Intervention / Treatment

6 Million Patients Annually Admitted to Emergency Departments for Potential Heart Attacks

Cardiac

Ischemia / ACS

Life Saving

Non-Cardiac

Diagnosis

Cost Saving

Zemiva

Source: Advance Data From Vital & Health Statistics Number 386, June 2007, National Hospital Ambulatory Medical Care Survey: 2005

Emergency Dept. Summary by Eric Nawar, M.H.S.; Richard Niska, M.D., F.A.C.E.P.; and Jianmin Xu, M.S., Division of Health Care Statistics

51

Zemiva –

Points of Differentiation

Provides improved

visualization

that

leads

to

more

immediate

and

accurate

diagnosis

of

cardiac causes of chest pain compared to either rest sestamibi perfusion scans or stress

perfusion imaging tests

High negative predictive value (“NPV”) and sensitivity

Immediate readout available

Can detect ischemic event up to 30 hours after occurring

Zemiva imaging of FA metabolism may have advantages in the diagnosis of ACS compared

with existing techniques:

More rapid

and

sensitive

detection

of

ischemia

due

to

“Ischemic

Memory”

up

to

30

hours

after symptoms subside

Reduced radiation exposure

Eliminating need for stress

(1)  Source: Campbell Alliance Nov. 2009. Health Advances Nov.2005

Chest

X-Ray

Observation

Serial Enzymes

Admit to

Hospital

Serial

ECGs

Stress

Test

Perfusion

Imaging

Time: 86 Hours

Cost: $7,500

(1)

Zemiva

Imaging

Time: <1 Hour

Cost: $1,750 –

2,250

(1)

Current

Standard

of Care

Zemiva

52

Intellectual Property Overview

Azedra:

The

Company

has

in-licensed

patents

and

a

pending

application

from

The

University

of

Western

Ontario

that

relate

to

the

precursor

material,

a

process

of

preparing

the

precursor

material,

and

the

Ultratrace™

technology

used

to

produce

Azedra™

These patents are set to expire in October 2018

•

The

pending

US

application

in

the

family

has

recently

received

a

Notice

of

Allowance

Trofex:

The

Company

owns

patent

applications

related

to

the

composition

and

methods

of

use

for

MIP

1072

and

MIP

1095

but

no

application

has

been

granted

Should

any

rights

be

granted

in

these

applications,

they

would

expire

in

November

2027

Onalta:

The

Company

entered

into

a

license

agreements

with

Novartis

Pharma

AG

and

Mallinckrodt for Onalta

The

patents

for

Onalta

will

expire

between

November

2009

and

September

2017

Solazed:

The

Company

acquired

Solazed™

from

Bayer

Schering

Pharma

through

an

exclusive, worldwide license

Patent

term

for

this

family

expire

between

March

2024

and

March

2025

Zemiva:

The

Company

owns

patents

directed

to

specific

stereoisomers

of

Zemiva™

and

the use of these stereoisomers

as imaging agents

All

patents

in

this

family

are

set

to

expire

in

November

2016

Key Milestones and Offering Discussion

54

Recent Molecular Insight Milestones

Event

Timing

Clinical

Advances Azedra

into pivotal Phase II therapeutic trial

3Q 2009

Receives EMEA approval to proceed with Phase III trial of Onalta

2Q 2009

Releases

positive

Phase

II

exploratory

trial

results

for

Zemiva

(1)

1Q 2009

Corporate

Licenses Onalta for development to BioMedica

3Q 2009

Appoints Charles Abdalian to CFO and VP of Finance

3Q 2009

Appoints Daniel Peters to CEO and President

2Q 2009

(1) Although key secondary endpoints, including clinical benefit, were met, the initial analysis of the Phase 2 clinical trial primary endpoint did

not meet predetermined performance thresholds. The reported results reflected the subsequent analysis of a subset of the sample

population with sufficient objective evidence for evaluation of the diagnosis of cardiac ischemia or myocardial infarction. These results and

exclusion criteria were determined to be the appropriate conclusion of the Phase 2 program. The Company is currently in discussions with

the FDA on the design of the Phase 3 trial.

55

Upcoming Molecular Insight Milestones

Event

Timing

Clinical

Begin

Phase

III

Confirmatory

Trial

for

Onalta

in

EU

1H 2010

Complete

Phase

I

Clinical

and

Nonclinical

Trofex

Studies

1H 2010

Initiate Azedra

pivotal Phase II study in neuroblastoma

1H 2010

Submit Azedra

NDA for neuroblastoma

2011

Begin

Phase

III

Confirmatory

Trial

for

Azedra

for

neuroblastoma

1H 2011

Complete

Phase

III

Confirmatory

Trial

for

Onalta

in

EU

2H 2011

Receive Azedra NDA for neuroblastoma

2H 2011 / 1H 2012

Corporate

Oncology licensing deal with partner

1Q 2010

Raise additional capital

1Q 2010

License

development

of

Zemiva

to

partner

2010

56

Ownership and Capitalization

Proceeds

from

offering

to

fund

Azedra

and

Trofex

clinical development and enhance

the Company’s liquidity position

Concurrently pursuing modifications to key

covenants to the Senior Secured Floating

Rate Bonds

Liquidity and strategic validation to be

further enhanced by potential partnering

opportunities

Source: Capital IQ.

Ownership as of 6/30/09

Top 10 Holders

# of Shares (MM)

% Out

Cerberus Capital Management, L.P.

3.7

14.8%

Barlow, David S.

2.7

10.7%

Savitr

Capital, LLC

2.1

8.4%

Poitras, James

1.3

5.2%

Clough Capital Partners, L.P.

0.8

3.2%

Barclays Global Investors UK Holdings

0.6

2.2%

Perennial Investors, LLC

0.5

1.9%

U Capital Group LP

0.5

1.8%

Dimensional Fund Advisors LP

0.4

1.6%

QVT Financial LP

0.4

1.4%

Total Top 10

12.9

51.3%

Total Other

12.3

48.7%

Total Shares

25.2

100.0%

Capitalization as of 11/20/09

(Amounts in millions, except per share data)

Share Price (11/20/09)

$4.23

Total Diluted Shares Outstanding

25.2

Equity Value

$106.6

Plus Debt (Face Value)

150.0

Plus: PIK Interest

28.7

Less: Cash and Cash Equivalents

(71.8)

Total Eneterprise

Value

$213.5

57

Investment Highlights

Pioneer in the emerging field of molecular medicine

Five

clinical-stage

candidates

addressing

seven

indications

with

significant

unmet

patient

needs with no visible potentially competing products in development

Significant

near-term

partnering

opportunities

in

oncology

and

cardiology;

one

completed partnership (Onalta), one in late stage negotiations, and one targeted for out

licensing (Zemiva)

Clinical

risk

for

certain

products

reduced

through

established

history

of

use

outside

the

United States

Ultratrace™

is a proprietary radiolabeling

technology

Key clinical and corporate milestones within two years

Highly

experienced

management

team

with

history

of

success

and

value

creation

Near

term

value

drivers

have

the

potential

to

provide

significant

lift

in

equity

value

Partnerships with pharma

companies validate the science / market opportunity

Elimination

of

default

risk

on

the

Notes

via

this

fund

raise

and

anticipated

covenant

relief by bondholders suggests significant near term equity value recovery

58

Investment Highlights (continued)

Commitment of Cerberus and other existing investors to participate in current fund

raise provides validation of products and strategy

Business

development

opportunities

are

anticipated

to

supply

a

significant

portion

of

the

needed cash for further advancement of the confirmation of the science and targeted drugs

Product value strategy can be broken into three categories:

Azedra

value is expected to more than “defease”

the total accreted bond value

Zemiva

value may fund other development via the off licensing of the only cardio product

Trofex

is

expected

to

provide

significant

upside

equity

value

as

both

an

imaging

and

therapeutic product

Others (Onalta

and Solazed) are bonus points