Our Approach to Building a Company
January 2012
Safe Harbor Statement
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: Any
statements that are not historical facts are forward-looking statements that involve risks
and uncertainties that could cause actual results to differ materially from those in the
forward-looking statements, which may include, but are not limited to, factors related to
GenSpera’s anticipated growth strategies, future business development, ability to attract
and retain new clients, ability to develop new products, expand to other related industries
or markets in other geographical locations, and other information detailed from time to
time in the filings and future filings with the United States Securities and Exchange
Commission. Readers are advised that this information is intended for the use of
investment professionals. Anyone interested in obtaining information on GenSpera
should contact GenSpera, as set forth above, to receive GenSpera’s most recent financial
reports. This presentation was developed by GenSpera and is intended solely for
informational purposes and is not to be construed as an offer to sell or the solicitation of
an offer to buy the Company’s stock. This profile is based upon information available to
the public, as well as other information from sources which management believes to be
reliable, but is not guaranteed by the Company as being accurate nor does it purport to be
complete. Opinions expressed herein are those of management as of the date of
publication and are subject to change without notice.
2
GenSpera’s Breakthrough Technology
Traditional chemotherapy features:
• Targets cell division
• Typified by side effects, drug resistance
• Little effect on slow growing tumors or cancer stem cells
• Just doesn’t work well enough
Our “molecular grenade” features are a major breakthrough:
• Kills independent of cell division rate (kills slow-growing tumors and
stem cells)
• Targeted delivery specifically to tumors (minimize side effects,
maximize efficacy)
• No development of drug resistance
• Complete tumor regression observed in multiple preclinical animal
studies
3
How Our Molecular Grenades Work
Our active drug, with a targeting/masking agent attached,
i.e., the prodrug, is inactive in the blood stream – similar
to a grenade with an intact pin…
NORMAL CELL
…until it finds an “enzyme” (tumor marker),
which is found only at our “target site,” that
“pulls the pin on the grenade” off the
targeting/masking agent.
CANCER CELL
(or blood vessel
of tumors)
The active drug, no longer soluble,
“precipitates” directly into nearby cells
and kills them.
4
Thapsigargin – A Novel Cytotoxin
•
Isolated from seeds of Thapsia garganica
Isolated from seeds of Thapsia garganica
• 100 kg seeds yields ~1 kg of thapsigargin
• 100 kg seeds yields ~1 kg of thapsigargin
• Potent inhibitor of ER Ca2+ ATPase pump
• Potent inhibitor of ER Ca2+ ATPase pump
• Kills cancer cells independent of growth rate
• Kills cancer cells independently of growth rate
•
5
How We Make G-202
12ADT
Released
G-202
Delivered to Tumor
Peptide Attached
O
O
O
O
O
H
O
3
O
11
3
O
O
O
O
• Well-characterized and
studied
• Kills:
–
Slow- and fastgrowing cancer cells
–
Cancer stem cells
–
Established vascular
cells
11
–
–
–
3
O
O
O
O
• Renders 12ADT:
OR
8
1
OH
OH
• Peptide attached to 12ADT
O
H
O
OR
8
1
OH
OH
• Derived from
Mediterranean plant
(exclusive supply
agreements)
O
O
O
H
O
OR
8
1
O
12ADT
11
OH
OH
O
O
• Peptide removed by enzyme
PSMA at the target site
Inactive
Soluble
Targets tumor
• Intravenous application
• Patent-protected*
• Patent-protected*
* 9 patents & 4 patent applications; no milestone or royalty payments are owed
6
Achievements and Milestones
Recent achievements:
• Phase I program is ongoing at CTRC, Johns Hopkins and Univ
Wisconsin
• G-202 exposure in patients is at levels expected to show
efficacy
• Second cGMP clinical batch of G-202 is in use
Near-term milestones:
• Continued enrollment and dose-escalation in G-202 Phase I
• Initiate Phase Ib post-chemotherapy prostate cancer study
• Initiate Phase II castrate-resistant chemotherapy-naïve prostate
cancer study in US and UK
• Plan to start two other Phase II studies in 2012 and early 2013
7
Why start a company?
Without a stand alone company, this great technology likely won’t
be developed any other way.
• Perceived development issues
• Immature technology at the time
• Scientific prejudice
• Similar approaches at other companies had failed
8
Time and Costs for Drug Development
Drug
Discovery
Preclinical
Development
Phase I
Phase II
Phase III
3 – 15 yr
1 – 2 yr
1 – 2 yr
2 – 3 yr
3 – 5 yr
$30M-$
300M
(internal
costs)
$2M-$5M
$1M-$3M $20M-$100M
Market
~$250M
Drug development takes too much time, needs too much
money and has too much risk.
VCs no longer invest before Phase II.
But drugs with Phase II activity can be worth $1B!!!
Need a new model to attract investors.
9
GenSpera’s Initial Value Proposition
Investors want upside, timeliness and liquidity.
GenSpera offers:
• Reasonable entry price
• Possible 60-fold return on investment within 5-6 years
• Likelihood of steadily increasing valuations
• Liquidity via public listing on OTCBB
10
GenSpera Valuations and Financings
11
GenSpera Financing 2007
• Identified successful financing approach
• Recruited a team using stock awards
• Rewrote the business plan
• Identified investors (19 of 22 invested)
Lessons:
• Be flexible
• Listen and learn
• Build a great team
• Know your potential investors
• Don’t be greedy
• Communicate your vision
12
GenSpera Financing 2008
• Used investment banker to lead the round
• Went to raise $5M, only brought in $2.3M
• Expanded investor base to West Coast
Lessons:
• Tough to raise money in difficult markets
• Run your company as if money will always be scarce
• Plan and execute
13
GenSpera Financings 2009 – 2011
2009
• Almost all new investors were introduced by previous
investors
2010, 2011
• >90% of monies raised came from previous investors
Lessons:
• Investors are important team members
• Keep your investors engaged
• Plan and execute
14
Location of GenSpera Investors
3
4
1
25
3
1
1
2
28
2
1
1
60
4
2
1
2
4
4
15
Locations of GenSpera Team
16
Life as an Entrepreneur
• Takes real commitment and hard work
• Can be incredibly frustrating, especially at the beginning
• Requires flexibility and constant learning
• Can be incredibly rewarding
• Opportunity to create something with real impact
• Opportunity to work with fantastic people of varying backgrounds
and expertise
17
Advice for Entrepreneurs
• Personal integrity and honesty are your greatest assets.
• Communicate your vision.
• Build a great team.
• Listen carefully and have an open mind.
• Keep it simple. Stay organized. Stay focused.
• Read the fine print. Do diligence on your potential investors.
• Plan and execute.
• Respect the money.
18
Contact
Craig A. Dionne, PhD
President and CEO
[email protected]
GenSpera, Inc.
2511 N Loop 1604 W, Suite 204
San Antonio, TX 78258
www.genspera.com
Phone: (210) 479-8112
Fax: (210) 479-8113
19
Download

Keynote Address, The Creation GenSpera and new Anti