Title: ConjuChem Inc. is an early stage biotechnology company and its primary business purpose is the development and use of its novel in vivo bioconjugation technology to develop improved therapeutic drugs.
1- ConjuChem Inc. is an early stage biotechnology
company and its primary business purpose is the
development and use of its novel in vivo
bioconjugation technology to develop improved
therapeutic drugs. - The Company was incorporated in 1997. In
November 2000 it completed its initial public
offering of shares. - ConjuChem is located in Montreal, Canada and
employs 45 people, 90 of whom are in research
and development. - The management team is headed by CEO Jacques
Lapointe whose previous experience includes
positions such as President and Chief Executive
Officer of Glaxo Wellcome in both Canada and the
UK and President and Chief Operating Officer of
BioChem Pharma Inc.
2Current price 12.29 (02/17/04) 52 week range
0.3-12.88 Average volume 455,742 (3mo) Market
Cap 486.7 mm EPS -0.92 P/E
-13.13 Revenue (03) 1.0 mm Expenses (03)
23.0 mm Net Loss (03) 27.6 mm Cash 41.9
mm Burn Rate (mm/mo) 2.0 Months of cash
21 Long term debt 22.3mm
DACGLP-1 formulation problems
Announcement of year end results
DAC opioid trials fail-August DACTI trial
fails-August CEO resigns- September
Preliminary DACGLP-1 Phase I/II data ( Jaques
Lapointe appointed CEO)
Phase II begins enrolling
Final I/II DACGLP-1 data
3- Each DAC construct is a fully patentable new
chemical entity (NCE) that is composed of three
components - A drug component a peptide or small molecule
that is responsible for the biological activity - A connector permanently attached to the drug
component - A reactive chemistry group at the opposite end
of the connector responsible for the permanent
bonding of the construct to albumin - The DAC construct can be administered into the
patient by intravenous or subcutaneous injection.
The reactive chemistry portion of the DAC
construct will then covalently (permanently and
specifically) bond to a single known site on
albumin
4- SAFETY
- DAC bioconjugates are not primarily metabolized
in the liver and kidneys and therefore, cannot
damage these organs. DAC bioconjugates do not
readily cross the blood brain barrier, therefore
they cannot access the central nervous system. - LONGEVITY
- DAC bioconjugates can extend the half-life of
a peptide from minutes to days. This extended
duration of activity results from bonding the
peptide to the most abundant protein in serum,
albumin, in a process we call in vivo
bioconjugation.
5- Conjuchems patent portfolio 52 patents in several
countries covering - methods for producing drug conjugates
- use of cellular and serum proteins as drug
anchors and conjugates - affinity labelling libraries
- novel conjugates of opioids
- affinity markers for human serum albumin
- long lasting insulinotropic peptides
- Long lasting synthetic glucagon like peptide
- Long lasting fusion peptide inhibitors of viral
infection - The oldest of these patents (expiring in the year
2014) includes broad method claims on the use of
in vivo bioconjugation for all therapeutic
applications. Subsequent patent applications
relate to focused therapeutic indications and
specific drug conjugates
6- Lead product DACGLP-1
- -Glucagon-Like peptide-1(GRP-1) induces
pancreatic secretion of insulin for type II
diabetic patients - -Type II diabetes market expect to reach US20.5
billion by 2012 - - 10/2002 resolved formulation problems due to
degradation of product slowed phase I/II trials
now last 3 months - -Phase I/II results 6/2003- 4 trials at
different doses showed glucose control for up to
6 days post injection n140 - Side effect was nausea which was expected with
GLP- treatable with Reglan no nausea seen with
step up tx - Final Phase I/II- glucose normalization with all
patients for 7 days post injection no
immunogenicity - Phase II results expected Q2-2004- Our Binary
event- endpoint HbA1c levels
7- 2nd product DACGRF
- -Growth releasing hormone (GRH) stimulates Growth
Hormone (GH) which is deficient in many disease
(congential - deficiencies, AIDS-related lipodystrophy, COPD,
and slow recovery from injury) - Conjuchem currently has multiple constructs that
stimulate IGF-1 secretion in animal models for up
to 10 days - post-single injection
- -Phase I/II trials to commence Q2 2004
8- Products in research phase DACNP
- -Atrial Natriuretic Peptide( ANP) is a vasoactive
peptide that regulates blood pressure - Lead construct, CJC-1382HSA maintains
bioactivity after conjugation and has serum
half-life of 14.8 hours
Products in research phase GLP-2(Crohns
disease and other intestinal disorders),
Insulin PTH( Parathyroid Hormone)
hypocalecemia/osteoperosis Kringle V
(anti-angiogenic factor)- solid tumors
Two failed products DACOpioid DACTI (
thrombin inhibitor)
9NONE- Conjuchem is perfect for acquisition
10- Competitors/Competitive Technology
Exenatide (Eli Lily/Amylin) Phase III trials
showed decreased HgbA1c levels lowered, weight
loss, Immunogenicity issues, cash burner, over
priced?, multiple injections Albugon (Human
Genome Sciences) AlbuminGLP-1 fusion
peptide No clinical trials yet Symlin
(Amylin) - synthetic version of pancreatic
hormone amylin May dose titration trial showed
25 of patients couldnt tolerate high doses,
recent withdrawal of Swiss drug application due
to side effects, recent Morgan Stanley
upgrade ThGLP-1(Theratechnologies) Long acting
platform that modifies enzymatic cleavage site
targeting, GLP-1, GRF, PTH three phase II trials
data expected soon. Litaglutide (NN2211 Novo
Nordisk) Long acting GLP-1 analog with a amino
acid modification that allows fatty acid
attachment that facilitates albumin binding
(protein lipidation). Not that long acting and
may be marketed as twice-daily or once daily
formulation. Currently in Phase II. Also using
this technology for Insulin ZP10
(Aventis/Zealand Pharma) Exendin-4 analog phase
I/II results show 2x daily administration lowers
blood glucose levels. Longer acting version is
in early stage development DPP-IV (Di-peptyl
peptidase) inhibitors (Probiodrug, Novartis) Long
term effects still unclear phase I trials have
not begun
11- Summary
- Conjuchem is currently trading at 12.40/share.
The GLP-1 target is on track to achieve upcoming
phase II trial milestone, potential partnership
and the advancement of additional compounds into
clinical trials. - Issues
- -DACGLP-1 critical for company survival
- -multiple competitors positive/negative data
will affect stock price - -company is not profitable and partnering is
essential for survival - Upcoming Binary events
- -Phase II trial data- Q2/04
- - Potential for partnership /acquisition before
Phase II data - (Large firms with diabetic therapy development
but no current in-house GLP-1 development-
Pfizer, Glaxo, AstraZeneca) - - Phase I GRH trials to begin Q2/04
- - Nasdaq listing likely after phase II trial
data - We recommend buying 100 shares of Conjuchem with
the endpoint of Phase II trial data or
acquisition.
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