Keynote Address, The Creation GenSpera and new Anti

January 5, 2018 | Author: Anonymous | Category: Science, Health Science, Cytology
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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.

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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.

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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 •

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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

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– – –

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

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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

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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

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GenSpera Valuations and Financings

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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

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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

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Location of GenSpera Investors

3 4

1 25

3 1

1

2 28

2 1

1 60

4 2 1 2

4 4

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Locations of GenSpera Team

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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

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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.

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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

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