GenSpera Inc. (GNSZ)

G-202 Phase Ia MTD Clinical Trial Successfully Completed
Phase Ib Now Enrolling in Up To 18 Patients
Phase II Prostate Cancer Trial Planned for Q3
G-202 Unaffected by Changing Competitive Landscape

Download Full 24-Page Report with Important Disclosures: GNSZ Update 05-17-12

1.) G-202 Phase Ia MTD Trial Completed – Phase Ib Now Enrolling: On March 29^th, GenSpera announced the completion of the Phase Ia dose-escalation trial of G-202 and has now commenced enrollment of the Phase Ib trial in up to 18 patients to further refine the dosing regimen and determine a recommended dose for Phase II clinical studies. Specifically, 28 patients were treated in the Phase Ia at doses ranging from 1.2 mg/m²/dose (~2 mg/dose) up to 88 mg/m²/dose (~150 mg/dose). The drug exposure in patients receiving the higher doses of G-202 falls within the range associated with anti-tumor efficacy in animal models. Although the study was not designed to determine the anti-tumor effects of the drug, signs of potential positive effects were observed. GenSpera also stated that they expect to initiate a Phase II study in castrate-resistant, chemotherapy-naïve prostate cancer patients within the next few months. Data from the Phase Ib trial, expected in early 2013, should give additional insight into the efficacy of G-202 in humans. (see G-202 Phase Ia & Ib Human Clinical Trials). GenSpera is also planning on commencing a Phase II trial of G-202 in castrate-resistant chemotherapy-naive prostate cancer patients in the U.S. with additional sites in the U.K. in Q3 2012.

2.) G-202 Still Needed Despite Recent Advances in Prostate Cancer: Although several drugs have recently been approved in prostate cancer such as JEVTANA^®, ZYTIGA™ and PROVENGE^® they have different mechanisms-of-action to GenSpera’s G-202. Eventually, all patients will become refractory to these anti-androgen and chemotherapies while PROVENGE cellular therapy only extended survival by approximately 4.5 months. The new drugs under development also use mechanisms of action that inhibit androgen production or binding to receptors on the cancer cell surfaces such as Medivation’s MDV3100 (an androgen receptor signaling inhibitor) demonstrating a survival benefit of 4.8 months without the use of steroid co-administration (as seen with drugs like ZYTIGA™). However, MDV3100′s anti-cancer effect is still dependent on interrupting androgen signaling. Eventually patients will become resistant to the treatment and the disease will progress. In contrast, G-202 kills independently of androgen pathways and in theory could represent a curative option for advanced prostate cancer patients. (see Competition)

3.) Unique Mechanism of Action (MOA): GenSpera’s drug candidates are based on chemical derivatives of a plant cytotoxin, called thapsigargin, which is a potent inhibitor of the intracellular sarcoplasmic/endoplasmic reticulum calcium ATPase (SERCA) pump. The inhibition of the transport protein causes intracellular Ca2+ (calcium) to rise significantly and trigger apoptosis (cell death). For example, G-202 is a prodrug where the active cytotoxin, 12ADT, is masked by a peptide complex until it binds to and is cleaved by the targeted Prostate-Specific Membrane Antigen (PSMA) thus triggering apoptosis. (see Thapsigargin and Prodrug Delivery of 12ADT). Investors should note a video of GenSpera’s platform technology can be seen at: http://www.genspera.com/investors_mainvideo.html 

4.) Attractive Space for M&A: We note that Cougar Biotechnology, a former bulletin board company formed by a reverse-merger in 2006 was acquired by Johnson & Johnson (NYSE:JNJ) in 2009 for $970M in cash based on Phase II data for their prostate cancer drug (ZYTIGA™) which ultimately received FDA approval in April 2011. While partnerships and acquisitions are highly unpredictable, we believe GenSpera could eventually be an attractive candidate as early as Phase II completion should they show strong clinical results.

5.) Capital Raise Expected: Although GenSpera believes they have sufficient cash through March 2013, we expect the company to raise additional funds in preparation for their planned Phase II clinical trials in multiple indications and we have included our estimates in the financial model.

6.) Maintaining Rating of Strong Speculative Buy and $4.00 Target: GenSpera has been successfully progressing “under the radar” for some time now and we believe the company will soon begin attracting wider investor attention. GenSpera’s G-202 with its unique mechanism of action in prostate cancer and other tumor types along with the strong preclinical data and intellectual property provides an intriguing opportunity for savvy investors wanting to get ahead of the curve. Our Strong Speculative Buy rating and 12-18 month Price Target of $4.00 is based on a 35x multiple on projected 2017 earnings and discounted 55% to adjust for risk with a 10% acquisition premium for Phase II results.

Download Full 24-Page Report with Important Disclosures: GNSZ Update 05-17-12

G-202 Phase Ia Dose-Escalation Trial in 28 Patients Completed
Phase Ib Commencing in up to 18 Patients – Phase II Prostate Cancer Planned
G-202 Unaffected by Changing Competitive Landscape

Download Full 5-Page Note with Important Disclosures: Morning Note 03-29-12 GNSZ

GenSpera announced the completion of the Phase Ia dose-escalation trial of G-202 and will now commence the Phase Ib trial in up to 18 patients to further refine the dosing regimen and determine a recommended dose for Phase II clinical studies.

Specifically, 28 patients were treated in the Phase Ia at doses ranging from 1.2 mg/m²/dose (~2 mg/dose) up to 88 mg/m²/dose (~150 mg/dose). The drug exposure in patients receiving the higher doses of G-202 falls within the range associated with anti-tumor efficacy in animal models. Although the study was not designed to determine the anti-tumor effects of the drug, signs of potential positive effects were observed. GenSpera also stated that they expect to initiate a Phase II study in castrate-resistant, chemotherapy-naïve prostate cancer patients within the next few months.

GenSpera has been successfully progressing “under the radar” for some time now and we believe the company will soon begin attracting wider investor attention. GenSpera’s G-202 with its unique mechanism of action in prostate cancer and other tumor types along with the strong preclinical data and intellectual property provides an intriguing opportunity for savvy investors wanting to get ahead of the curve. Our Strong Speculative Buy rating and 12-18 month Price Target of $4.00 is based on a 35x multiple on projected 2017 earnings and discounted 55% to adjust for risk with a 10% acquisition premium for Phase II results.

Investors should also note that G-202 Still Needed Despite Recent Advances in Prostate Cancer. Although several drugs have recently been approved in prostate cancer such as JEVTANA^®, ZYTIGA™ and PROVENGE^® they have different mechanisms-of-action to GenSpera’s G-202. Eventually, all patients will become refractory to these anti-androgen and chemotherapies while PROVENGE cellular therapy only extended survival by approximately 4.5 months. The new drugs under development also use mechanisms of action that inhibit androgen production or binding to receptors on the cancer cell surfaces such as Medivation’s MDV3100 (an androgen receptor signaling inhibitor) demonstrating a survival benefit of 4.8 months without the use of steroid co-administration (as seen with drugs like ZYTIGA™). However, MDV3100’s anti-cancer effect is still dependent on interrupting androgen signaling. Eventually patients will become resistant to the treatment and the disease will progress. In contrast, G-202 kills independently of androgen pathways and in theory could represent a curative option for advanced prostate cancer patients.

Download Full 5-Page Note with Important Disclosures: Morning Note 03-29-12 GNSZ

G-202 Phase Ia MTD Clinical Trial to Complete Soon
Phase Ib Expected to Commence for Prostate Cancer in Q2
G-202 Unaffected by Changing Competitive Landscape

Download Full 24-Page Report with Important Disclosures: GNSZ Update 03-22-12

1.) G-202 Phase Ia MTD Trial Completing Soon – Phase Ib to Commence in Q2: We anticipate GenSpera will soon complete the G-202 Phase Ia dose escalation trial in 30 patients with solid tumors and reach the required Maximum Tolerated Dose (MTD). We further expect GenSpera to immediately begin the Phase Ib clinical trial using the maximum tolerated dose in an additional 18 patients with advanced prostate cancer using the Phase Ia trial design. Data from this trial, expected in early 2013, should give additional insight into the efficacy of G-202 in humans (see G-202 Phase Ia & Ib Human Clinical Trials). GenSpera is also planning on commencing a Phase II trial of G-202 in castrate-resistant chemotherapy-naive prostate cancer patients in the U.S. with additional sites in the U.K.

2.) G-202 Still Needed Despite Recent Advances in Prostate Cancer: Although several drugs have recently been approved in prostate cancer such as JEVTANA®, ZYTIGA™ and PROVENGE^® they have different mechanisms-of-action to GenSpera’s G-202. Eventually, all patients will become refractory to these anti-androgen and chemotherapies while PROVENGE cellular therapy only extended survival by approximately 4.5 months. The new drugs under development also use mechanisms of action that inhibit androgen production or binding to receptors on the cancer cell surfaces such as Medivation’s MDV3100 (an androgen receptor signaling inhibitor) demonstrating a survival benefit of 4.8 months without the use of steroid co-administration (as seen with drugs like ZYTIGA™). However, MDV3100’s anti-cancer effect is still dependent on interrupting androgen signaling. Eventually patients will become resistant to the treatment and the disease will progress. In contrast, G-202 kills independently of androgen pathways and in theory could represent a curative option for advanced prostate cancer patients. (see Competition)

3.) Unique Mechanism of Action (MOA): GenSpera’s drug candidates are based on chemical derivatives of a plant cytotoxin, called thapsigargin, which is a potent inhibitor of the intracellular sarcoplasmic/endoplasmic reticulum calcium ATPase (SERCA) pump. The inhibition of the transport protein causes intracellular Ca2+ (calcium) to rise significantly and trigger apoptosis (cell death). For example, G-202 is a prodrug where the active cytotoxin, 12ADT, is masked by a peptide complex until it binds to and is cleaved by the targeted Prostate-Specific Membrane Antigen (PSMA) thus triggering apoptosis. (see Thapsigargin and Prodrug Delivery of 12ADT). Investors should note a video of GenSpera’s platform technology can be seen at: http://www.genspera.com/investors_mainvideo.html

4.) Attractive Space for M&A: We note that Cougar Biotechnology, a former bulletin board company formed by a reverse-merger in 2006 was acquired by Johnson & Johnson (NYSE:JNJ) in 2009 for $970M in cash based on Phase II data for their prostate cancer drug (ZYTIGA™) which ultimately received FDA approval in April 2011. While partnerships and acquisitions are highly unpredictable, we believe GenSpera could eventually be an attractive candidate as early as Phase II completion should they show strong clinical results.

5.) Capital Raise Expected: Although GenSpera believes they have sufficient cash through March 2013, we expect the company to raise additional funds in preparation for their planned Phase II clinical trials in multiple indications and we have included our estimates in the financial model.

6.) Maintaining Rating of Strong Speculative Buy and $4.00 Target: GenSpera has been successfully progressing “under the radar” for some time now and we believe the company will soon begin attracting wider investor attention. GenSpera’s G-202 with its unique mechanism of action in prostate cancer and other tumor types along with the strong preclinical data and intellectual property provides an intriguing opportunity for savvy investors wanting to get ahead of the curve. Our Strong Speculative Buy rating and 12-18 month Price Target of $4.00 is based on a 35x multiple on projected 2017 earnings and discounted 55% to adjust for risk with a 10% acquisition premium for Phase II results.

Download Full 24-Page Report with Important Disclosures: GNSZ Update 03-22-12

G-202 Phase I Human Trial Data Expected Q2 2012
G-202 Unaffected by Changing Competitive Landscape
Chemo-Naive Prostate Cancer Phase II Begins Q2’12 

Download Full 26-Page Report with Important Disclosures: GNSZ Update 11-21-11

1.) G-202 Phase I Human Clinical Trial Data Expected Q2 2012: As of September 30, 2011, 22 patients had been treated with G-202 in the ongoing Phase I human clinical trial for solid tumors. The trial is anticipated to complete enrollment of up to 30 patients in Q1 2012 with top-line data expected in Q2 2012.

2.) G-202 Still Needed Despite Recent Advances in Prostate Cancer: Although several drugs have recently been approved in prostate cancer such as JEVTANA®, ZYTIGA™ and PROVENGE® they have different mechanisms-of-action to GenSpera’s G-202. Eventually, all patients will become refractory to these anti-androgen and chemotherapies while PROVENGE cellular therapy only extended survival by approximately 4.5 months. There are also several new drugs under development however they also use mechanisms of action that inhibit androgen production or androgen binding to receptors on the cancer cell surfaces. For example, on November 3, 2011, Medivation’s Phase III trial for MDV3100 (and androgen receptor signaling inhibitor) demonstrated a survival benefit of 4.8 months (18.4mo vs. 13.6mo placebo) without the use of steroid co-administration as seen with drugs like ZYTIGA™. While we view this as a positive development for the treatment of patients with advanced prostate cancer, Medivation’s MDV3100’s anti-cancer effect is still dependant on interrupting androgen signaling. Eventually patients will become resistant to the treatment and the disease will progress. In contrast, G-202 kills independently of androgen pathways and in theory could represent a curative option for advanced prostate cancer patients. (see Competition)

3.) Additional Prostate Cancer Clinical Trials to Begin: GenSpera is currently planning to enroll two separate prostate cancer clinical trials following the completion of the Phase I all solid tumor trial. Beginning in Q1 2012, up to 18 additional patients will be evaluated in a Phase Ib study in a broader patient population consisting primarily of prostate cancer patients who have previously failed treatment with chemotherapeutic agents. The patients in the Phase Ib trial will be treated at the Maximum Tolerated Dose (MTD) as determined by the Phase I study. Starting in Q2 2012, GenSpera is planning on commencing enrollment in a Phase II trial of G-202 for the treatment of castrate-resistant chemotherapy-naive prostate cancer patients in the US with additional sites in the UK.

4.) Unique Mechanism of Action (MOA): GenSpera’s drug candidates are based on chemical derivatives of a plant cytotoxin, called thapsigargin, which is a potent inhibitor of the intracellular sarcoplasmic/endoplasmic reticulum calcium ATPase (SERCA) pump. The inhibition of the transport protein causes intracellular Ca2+ (calcium) to rise significantly and trigger apoptosis (cell death). For example, G-202 is a prodrug where the active cytotoxin, 12ADT, is masked by a peptide complex until it binds to and is cleaved by the targeted Prostate-Specific Membrane Antigen (PSMA) thus triggering apoptosis. (see Thapsigargin and Prodrug Delivery of 12ADT). Investors should note a video of GenSpera’s platform technology can be seen at: http://www.genspera.com/investors_mainvideo.html

5.) G-202 Expected to Avoid Pricing Pressures for Prostate Cancer Therapies: The slow adoption of Dendreon’s PROVENGE® cellular therapy, which carries a $93,000 price tag for treatment, has brought attention to treatment costs in the prostate cancer space. Investors should note that our model uses a modest $40,000 treatment cost for G-202, which is lower than other advanced prostate cancer treatment options such as ZYTIGA™ costing about $50,000.

6.) Strong Preclinical Data and IP: We note that preclinical testing of three different human prostate cancer cell line xenographs in nude mice (inactive immune system) showed material degrees of tumor inhibition, regression and resolution. (see G-202 Preclinical Results) GenSpera also has a strong portfolio of patents and patent applications covering 12ADT and other derivates of thapsigargin, peptide “masking/targeting” sequences and their prodrug conjugates. The patents are owned by GenSpera with no royalties or milestone payments due to any third party. (see Intellectual Property)

7.) Attractive Space for M&A: We note that Cougar Biotechnology, a former bulletin board company formed by a reverse-merger in 2006 was acquired by Johnson & Johnson (NYSE:JNJ) in 2009 for $970M in cash for their prostate cancer drug (ZYTIGA™) which recently received FDA approval in April 2011. While partnerships and acquisitions are highly unpredictable, we believe GenSpera could eventually be an attractive candidate should they show strong clinical results.

8.) Maintaining Rating of Strong Speculative Buy and $4.00 Target: GenSpera has been successfully progressing “under the radar” for some time now and we believe the company will soon begin attracting wider investor attention. GenSpera’s G-202 with its unique mechanism of action in prostate cancer and other tumor types along with the strong preclinical data and intellectual property provides an intriguing opportunity for savvy investors wanting to get ahead of the curve. Our Strong Speculative Buy rating and 12-18 month Price Target of $4.00 is based on a 35x multiple on projected 2017 earnings and discounted 55% to adjust for risk.

Download Full 26-Page Report with Important Disclosures: GNSZ Update 11-21-11 

G-202 Phase I Human Trial Data Expected Q1 2012
Advanced Prostate Cancer Phase Ib Trial Begins Q4’11
Chemo-Naive Prostate Cancer Phase II Begins Q1’12

Download Full 25-Page Report with Important Disclossures: GNSZ Update 08-17-11

1.) G-202 Phase I Human Clinical Trial Enrollment to Complete Q4: As of June 30, 2011, 19 patients had been treated with G-202 in the ongoing Phase I human clinical trial for solid tumors. The study is anticipated to complete enrollment in Q4 2011 with data in Q1 2012.

2.) Additional Prostate Cancer Clinical Trials to Begin: GenSpera is currently planning to enroll two separate prostate cancer clinical trials following the completion of the Phase I all solid tumor trial. Beginning in Q4 2011, up to 18 additional patients will be evaluated in a Phase Ib study in a broader patient population consisting primarily of prostate cancer patients who have previously failed treatment with chemotherapeutic agents. Starting in Q1 2012, GenSpera is planning on commencing enrollment in a Phase II trial of G-202 for the treatment of castrate-resistant chemotherapy-naive prostate cancer patients in the US with additional sites in the UK.

3.) Advances Still Needed in Prostate Cancer: Although several drugs have recently been approved in prostate cancer such as JEVTANA ®, ZYTIGA™ and PROVENGE®, they have different mechanisms-of-action to GenSpera’s G-202. Eventually, all patients will become refractory to these anti-androgen and chemotherapies while PROVENGE cellular therapy only extended survival by approximately 4.5 months. There are also several new drugs under development however they also use mechanisms of action that inhibit androgen production or androgen binding to receptors on the cancer cell surfaces. (see Competition)

4.) Unique Mechanism of Action (MOA): GenSpera’s drug candidates are based on chemical derivatives of a plant cytotoxin, called thapsigargin, which is a potent inhibitor of the intracellular sarcoplasmic/endoplasmic reticulum calcium ATPase (SERCA) pump. The inhibition of the transport protein causes intracellular Ca2+ (calcium) to rise significantly and trigger apoptosis (cell death). For example, G-202 is a prodrug where the active cytotoxin, 12ADT, is masked by a peptide complex until it binds to and is cleaved by the targeted Prostate-Specific Membrane Antigen (PSMA) thus triggering apoptosis. (see Thapsigargin and Prodrug Delivery of 12ADT)

5.) Strong Preclinical Data and IP: We note that preclinical testing of three different human prostate cancer cell line xenographs in nude mice (inactive immune system) showed material degrees of tumor inhibition, regression and resolution. (see G-202 Preclinical Results) GenSpera also has a strong portfolio of patents and patent applications covering 12ADT and other derivates of thapsigargin, peptide “masking/targeting” sequences and their prodrug conjugates. The patents are owned by GenSpera with no royalties or milestone payments due to any third party. (see Intellectual Property)

6.) Attractive Space for M&A: We note that Cougar Biotechnology, a former bulletin board company formed by a reverse-merger in 2006 was acquired by Johnson & Johnson (NYSE:JNJ) in 2009 for $970M in cash for their prostate cancer drug (ZYTIGA™) which recently received FDA approval in April 2011. While partnerships and acquisitions are highly unpredictable, we believe GenSpera could eventually be an attractive candidate should they show strong clinical results.

7.) Maintaining Rating of Strong Speculative Buy and $4.00 Target: GenSpera has been successfully progressing “under the radar” for some time now and we believe the company will soon begin attracting wider investor attention. GenSpera’s G-202 with its unique mechanism of action in prostate cancer and other tumor types along with the strong preclinical data and intellectual property provides an intriguing opportunity for savvy investors wanting to get ahead of the curve. Our Strong Speculative Buy rating and 12-18 month Price Target of $4.00 is based on a 35x multiple on projected 2017 earnings and discounted 55% to adjust for risk.

Download Full 25-Page Report with Important Disclossures: GNSZ Update 08-17-11