- Clinical Data announced positive Phase 3 trial results for its antidepressant drug Vilazodone, validating its efficacy.
- Forest Laboratories announced negative Phase 3 results for its antidepressant Levomilnacipran, increasing the likelihood of a partnership between Forest and Clinical Data.
- The analyst maintains a Buy rating and $28 price target for Clinical Data, believing FDA approval and a partnership are likely, which could boost the stock price.
Paper fingerprinting using alpha-masked image matchingTuan Q. Pham
The document summarizes research from Canon Information Systems Research Australia on identifying paper fingerprints (PFP) for authentication purposes. It discusses using alpha-masked image matching and inpainting to make PFP matching more robust to changes in documents, such as printing. Experiments show alpha-masked correlation and normalized correlation are most effective at matching PFPs, even when a significant portion of the image is changed or masked. The researchers conclude PFP matching could be further improved by scanning documents at multiple orientations to separate diffuse and specular reflections.
This document discusses methods for finding the zeros of polynomial functions. It introduces the Fundamental Theorem of Algebra and Linear Factorization Theorem, which state that any polynomial function of degree n will have n zeros, but do not explain how to find them. The document then describes the Rational Zero Test for finding rational zeros and explains how to find all rational, real, and all zeros. It also notes that if a number is a zero, its complex conjugate will also be a zero. Examples are provided to illustrate these concepts.
This document is the introduction section of a Grade 10 mathematics learner's module developed by the Department of Education of the Philippines. It was created through a collaborative process involving educators from schools, colleges, universities, and the Department of Education. The material is intended to support the K-12 Basic Education Program and ensure students meet expected standards. It contains 8 modules covering various mathematics topics. The introduction describes the development and review process and outlines the topics to be covered in each module.
This document is a teacher's guide for teaching Grade 10 mathematics in the Philippines. It provides guidelines for teachers on how to effectively teach modules on permutations and combinations, as well as probability of compound events, using the provided learner's material. The teacher's guide includes learning outcomes, planning for assessment, sample teaching activities and solutions, summative tests, and references.
The document discusses a mathematics textbook for Grade 10 that was collaboratively developed by educators from various educational institutions in the Philippines. It provides instructions for teachers and other stakeholders to provide feedback and recommendations to the Department of Education. The document also outlines the copyright details and permissions regarding the content in the textbook.
Here are the answers to the pre-assessment questions:
1. B
2. A
3. B
4. D
5. B
6. C
7. C
8. A
9. B
10. C
11. B
12. A
13. B
14. B
For the mini-research question, here is a suggested outline:
Conduct a mini-research or survey among your classmates to determine the following:
1. Number of students interested to join the FUN RUN activity
2. Possible date preference for the activity
3. Suggested registration fee and minimum pledges
4. Prizes for top 3 runners
This document provides an introduction to and overview of a learning module on sequences. It outlines two main lessons that will be covered:
1) Arithmetic Sequences - including finding the nth term, next terms, means, and sums of terms
2) Geometric and Other Sequences - including finding the nth term, means, and sums of terms for geometric sequences as well as exploring other types of sequences like harmonic and Fibonacci sequences.
The module will help students learn about different types of sequences, how to analyze and calculate their properties, and apply these concepts to solve real-world problems. A pre-assessment is also included to gauge students' prior knowledge on topics related to sequences.
The presentation discussed Protalix's plant cell-expressed, chemically modified human alpha-galactosidase for the treatment of Fabry disease, called PRX-102. Fabry disease is caused by a deficiency of the enzyme alpha-galactosidase A, leading to accumulation of Gb3 substrate and increased risks of stroke, cardiomyopathy, and renal issues. Currently available treatments have short half-lives. PRX-102 aims to be a "bio-better" enzyme by using chemical modification via covalent cross-linking of the subunits to create a stable dimer, which may provide advantages like improved stability, longer half-life, and enhanced uptake in target organs, potentially leading to better clinical efficacy than
Paper fingerprinting using alpha-masked image matchingTuan Q. Pham
The document summarizes research from Canon Information Systems Research Australia on identifying paper fingerprints (PFP) for authentication purposes. It discusses using alpha-masked image matching and inpainting to make PFP matching more robust to changes in documents, such as printing. Experiments show alpha-masked correlation and normalized correlation are most effective at matching PFPs, even when a significant portion of the image is changed or masked. The researchers conclude PFP matching could be further improved by scanning documents at multiple orientations to separate diffuse and specular reflections.
This document discusses methods for finding the zeros of polynomial functions. It introduces the Fundamental Theorem of Algebra and Linear Factorization Theorem, which state that any polynomial function of degree n will have n zeros, but do not explain how to find them. The document then describes the Rational Zero Test for finding rational zeros and explains how to find all rational, real, and all zeros. It also notes that if a number is a zero, its complex conjugate will also be a zero. Examples are provided to illustrate these concepts.
This document is the introduction section of a Grade 10 mathematics learner's module developed by the Department of Education of the Philippines. It was created through a collaborative process involving educators from schools, colleges, universities, and the Department of Education. The material is intended to support the K-12 Basic Education Program and ensure students meet expected standards. It contains 8 modules covering various mathematics topics. The introduction describes the development and review process and outlines the topics to be covered in each module.
This document is a teacher's guide for teaching Grade 10 mathematics in the Philippines. It provides guidelines for teachers on how to effectively teach modules on permutations and combinations, as well as probability of compound events, using the provided learner's material. The teacher's guide includes learning outcomes, planning for assessment, sample teaching activities and solutions, summative tests, and references.
The document discusses a mathematics textbook for Grade 10 that was collaboratively developed by educators from various educational institutions in the Philippines. It provides instructions for teachers and other stakeholders to provide feedback and recommendations to the Department of Education. The document also outlines the copyright details and permissions regarding the content in the textbook.
Here are the answers to the pre-assessment questions:
1. B
2. A
3. B
4. D
5. B
6. C
7. C
8. A
9. B
10. C
11. B
12. A
13. B
14. B
For the mini-research question, here is a suggested outline:
Conduct a mini-research or survey among your classmates to determine the following:
1. Number of students interested to join the FUN RUN activity
2. Possible date preference for the activity
3. Suggested registration fee and minimum pledges
4. Prizes for top 3 runners
This document provides an introduction to and overview of a learning module on sequences. It outlines two main lessons that will be covered:
1) Arithmetic Sequences - including finding the nth term, next terms, means, and sums of terms
2) Geometric and Other Sequences - including finding the nth term, means, and sums of terms for geometric sequences as well as exploring other types of sequences like harmonic and Fibonacci sequences.
The module will help students learn about different types of sequences, how to analyze and calculate their properties, and apply these concepts to solve real-world problems. A pre-assessment is also included to gauge students' prior knowledge on topics related to sequences.
The presentation discussed Protalix's plant cell-expressed, chemically modified human alpha-galactosidase for the treatment of Fabry disease, called PRX-102. Fabry disease is caused by a deficiency of the enzyme alpha-galactosidase A, leading to accumulation of Gb3 substrate and increased risks of stroke, cardiomyopathy, and renal issues. Currently available treatments have short half-lives. PRX-102 aims to be a "bio-better" enzyme by using chemical modification via covalent cross-linking of the subunits to create a stable dimer, which may provide advantages like improved stability, longer half-life, and enhanced uptake in target organs, potentially leading to better clinical efficacy than
This phase 2b study compares the efficacy and safety of aldoxorubicin versus doxorubicin as first-line treatment for patients with advanced soft tissue sarcomas. As of June 2013, 107 patients had been randomized to receive either 350 mg/m2 of aldoxorubicin or 75 mg/m2 of doxorubicin every 3 weeks for up to 6 cycles. Preliminary results found that a higher percentage of patients receiving aldoxorubicin were still active in the study, received at least 4 or 6 cycles of treatment, and had a greater number of tumor responses and stable disease compared to doxorubicin. The major grade 3-4 adverse event for both treatments was neutropenia
1) The Phase III randomized trial compared tivozanib to sorafenib as initial targeted therapy for patients with advanced renal cell carcinoma (RCC).
2) The trial found that tivozanib demonstrated superior progression-free survival compared to sorafenib, with median progression-free survival of 11.9 months for tivozanib versus 9.1 months for sorafenib.
3) Subgroup analyses found similar progression-free survival benefits with tivozanib compared to sorafenib across patient subgroups, including treatment-naïve patients for metastatic RCC.
Vintafolide showed promising results in a phase 2 study for treating non-small cell lung cancer (NSCLC). It met its primary endpoint of clinical benefit and was well tolerated. Patients with 100% folate receptor positive tumors had significantly improved progression-free survival of 7.2 months compared to 1.7 months for patients with 10-90% folate receptor positive tumors. Overall survival was also significantly improved at 10.9 months for fully folate receptor positive patients compared to 3.4 months for partially positive patients. These results suggest vintafolide has positive activity as a single agent, especially for fully folate receptor positive NSCLC patients who have failed multiple prior therapies.
5 understanding some basic trial designs in sarcomas (inclusive a placebo one...James Hilbert
The document summarizes three clinical trial designs:
1) A phase 3 trial compared doxorubicin alone versus doxorubicin plus ifosfamide as first-line chemotherapy for advanced soft tissue sarcoma. It found the combination improved response rates and progression-free survival but not overall survival, and was more toxic.
2) A phase 3 placebo-controlled trial of pazopanib versus placebo in patients with soft tissue sarcoma whose disease progressed on prior chemotherapy.
3) A phase 3 placebo-controlled trial of regorafenib in patients with gastrointestinal stromal tumor progressing on prior treatments including imatinib and sunitinib, with a cross-over design allowing patients
Transforming time for prostate cancer therapiesJames Hilbert
This document provides an overview of prostate cancer treatments and competitive landscape. Prostate cancer is the most commonly diagnosed cancer in men. Current standard of care includes local therapy for early stage, androgen deprivation therapy for advanced or recurrent disease, chemotherapy (e.g. Taxotere) for metastatic castration-resistant prostate cancer (mCRPC), and newer agents like Provenge, Zytiga, and Jevtana for mCRPC. The pipeline includes promising agents from Dendreon, Medivation, and OncoGenex that could change treatment paradigms and improve outcomes for mCRPC patients.
Vandetanib plus docetaxel versus docetaxel alone as second-line treatment for advanced NSCLC was evaluated in a randomized phase 3 trial (ZODIAC). The trial found:
1) Addition of vandetanib to docetaxel significantly improved progression-free survival compared to placebo plus docetaxel, with median PFS of 4.0 vs 3.2 months.
2) A similar PFS benefit was seen in the prespecified analysis of women.
3) Adverse events including rash, neutropenia, and febrile neutropenia were more common with vandetanib plus docetaxel.
CDX-011 is an antibody-drug conjugate targeting GPNMB, which is expressed in 40-75% of breast cancers and promotes metastasis. Preliminary results from the randomized Phase 2b EMERGE study show very encouraging activity of CDX-011 in triple-negative breast cancer patients and those with high GPNMB expression who have failed approved therapies. The EMERGE study randomized GPNMB-expressing advanced breast cancer patients to receive either CDX-011 or standard therapy to examine if anti-cancer activity depends on level of GPNMB expression. Over 99% of 338 screened patients were considered eligible based on ≥5% GPNMB expression.
This document summarizes a phase 1/2 clinical trial evaluating the safety, tolerability, and efficacy of enzyme replacement therapy (ERT) with recombinant human GALNS (BMN 110) in subjects with Mucopolysaccharidosis IVA (Morquio syndrome). The open-label, dose-escalation study enrolled 20 subjects aged 5-18 years who received weekly infusions of BMN 110 at doses of 0.1 mg/kg, 1.0 mg/kg, or 2.0 mg/kg for 12 weeks each. Key findings included improvements in measures of endurance like the 6-minute walk test and 3-minute stair climb, as well as decreases in urine keratan sulfate levels
The combos study an expert interview with william sJames Hilbert
The document summarizes the COMBOS study which evaluated the effects of adding prescription omega-3 ethyl esters (Lovaza) to stable statin therapy in patients with persistent hypertriglyceridemia. The study found that Lovaza plus simvastatin led to greater reductions in non-HDL cholesterol and other lipid parameters compared to simvastatin alone. Non-HDL cholesterol is a measure of total cholesterol carried by LDL, VLDL, and their remnants, and is a better predictor of cardiovascular risk than LDL alone, especially in patients with high triglycerides.
MAP0004, an orally inhaled formulation of dihydroergotamine (DHE), was evaluated in a randomized, double-blind, placebo-controlled study for the acute treatment of migraine. 903 patients experiencing a migraine attack were randomized to receive either MAP0004 (0.63 mg emitted dose) or placebo via inhalation. The primary endpoints were pain relief and absence of photophobia, phonophobia, and nausea at 2 hours. MAP0004 was superior to placebo for all primary endpoints. A greater percentage of patients treated with MAP0004 experienced pain relief, absence of photophobia, absence of phonophobia, and absence of nausea compared to those receiving placebo. MAP0004 was well tolerated with no serious
This document discusses novel molecular therapies for hepatocarcinoma (HCC). It summarizes that sorafenib is the current standard of care therapy for advanced HCC based on two phase III trials showing improved median overall survival. However, sorafenib resistance can develop. The document reviews several other targeted agents that have shown some activity for HCC including bevacizumab, erlotinib, and sunitinib. Ongoing clinical trials are exploring combinations of sorafenib with other agents or replacing sorafenib. Biomarkers associated with response and resistance to therapies like sunitinib are also discussed.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The document discusses updates on second-line treatment of metastatic non-small cell lung cancer from the World Conference on Lung Cancer. It summarizes findings from studies comparing weekly versus 3-weekly docetaxel administration and pemetrexed versus docetaxel. Current guidelines recommend second-line cytotoxic chemotherapy or EGFR inhibitors for disseminated metastatic disease and radiation therapy for localized symptoms.
Docetaxel Versus Docetaxel/Cisplatin in NSCLCJames Hilbert
This study compared docetaxel alone versus docetaxel plus cisplatin as frontline treatment for advanced non-small cell lung cancer. 302 patients were randomly assigned to receive either docetaxel alone (146 patients) or the docetaxel/cisplatin combination (156 patients). The overall response rate was significantly higher for the combination at 36% versus 18% for docetaxel alone. However, median survival time, time to disease progression, and 1-year survival rates were similar between the two groups. Toxicity was higher with the combination therapy. Both regimens showed similar effectiveness in terms of survival, though the combination resulted in a higher response rate and more toxicity.
Second or third additional chemotherapy drug for non-small cell lung cancer i...James Hilbert
This Cochrane review evaluated 65 randomized controlled trials with over 13,000 patients to determine the clinical benefit of adding additional chemotherapy drugs to treatment regimens for advanced non-small cell lung cancer. The review found that adding a second drug to a single-agent chemotherapy regimen improved tumor response rates and one-year survival rates. Adding a third drug to a two-drug chemotherapy regimen increased tumor response rates but did not improve one-year survival rates and was associated with higher toxicity.
Soligenix is initiating coverage with a Buy rating for their lead product orBec®, an oral therapy for GI GvHD currently in a Phase 3 trial. Prior trials show efficacy for orBec® with a localized corticosteroid and the Phase 3 trial further lowers clinical risk. The treatment of acute GI GvHD is an unmet medical need and orBec® has the potential to generate $150-300 million in revenue. Soligenix is also developing therapeutics for radiation injury and vaccines for biodefense through additional platforms.
- Wedbush Securities provides an update on Cleveland BioLabs, Inc. (CBLI) and reiterates an OUTPERFORM rating and $10/share price target.
- CBLI is still anticipated to receive a $50+ million government contract award from BARDA now expected in July/August for development of CBLB502, though the announcement has been delayed.
- CBLI has a low $11 million annual cash burn and no fundamental reasons for its recent stock price decline. The BARDA contract delay does not jeopardize the company or CBLB502 program.
- CBLI expects to submit a BLA for CBLB502 in H1 2012 and anticipates FDA approval by H2 2012, positioning the company
Pluristem Therapeutics is developing placental stem cells (PLX) for the treatment of peripheral arterial disease. The company's proprietary 3-D bioreactor technology appears to produce therapeutic stem cells that release multiple angiogenic factors in response to local disease. Research by an independent group confirmed the potential benefit of 3-D culturing versus traditional 2-D technologies. Pluristem reported encouraging results from an open-label study and is finalizing pivotal studies with regulators, which are anticipated to commence by year-end. The analyst initiates coverage with an Outperform rating and $5 price target.
This phase 2b study compares the efficacy and safety of aldoxorubicin versus doxorubicin as first-line treatment for patients with advanced soft tissue sarcomas. As of June 2013, 107 patients had been randomized to receive either 350 mg/m2 of aldoxorubicin or 75 mg/m2 of doxorubicin every 3 weeks for up to 6 cycles. Preliminary results found that a higher percentage of patients receiving aldoxorubicin were still active in the study, received at least 4 or 6 cycles of treatment, and had a greater number of tumor responses and stable disease compared to doxorubicin. The major grade 3-4 adverse event for both treatments was neutropenia
1) The Phase III randomized trial compared tivozanib to sorafenib as initial targeted therapy for patients with advanced renal cell carcinoma (RCC).
2) The trial found that tivozanib demonstrated superior progression-free survival compared to sorafenib, with median progression-free survival of 11.9 months for tivozanib versus 9.1 months for sorafenib.
3) Subgroup analyses found similar progression-free survival benefits with tivozanib compared to sorafenib across patient subgroups, including treatment-naïve patients for metastatic RCC.
Vintafolide showed promising results in a phase 2 study for treating non-small cell lung cancer (NSCLC). It met its primary endpoint of clinical benefit and was well tolerated. Patients with 100% folate receptor positive tumors had significantly improved progression-free survival of 7.2 months compared to 1.7 months for patients with 10-90% folate receptor positive tumors. Overall survival was also significantly improved at 10.9 months for fully folate receptor positive patients compared to 3.4 months for partially positive patients. These results suggest vintafolide has positive activity as a single agent, especially for fully folate receptor positive NSCLC patients who have failed multiple prior therapies.
5 understanding some basic trial designs in sarcomas (inclusive a placebo one...James Hilbert
The document summarizes three clinical trial designs:
1) A phase 3 trial compared doxorubicin alone versus doxorubicin plus ifosfamide as first-line chemotherapy for advanced soft tissue sarcoma. It found the combination improved response rates and progression-free survival but not overall survival, and was more toxic.
2) A phase 3 placebo-controlled trial of pazopanib versus placebo in patients with soft tissue sarcoma whose disease progressed on prior chemotherapy.
3) A phase 3 placebo-controlled trial of regorafenib in patients with gastrointestinal stromal tumor progressing on prior treatments including imatinib and sunitinib, with a cross-over design allowing patients
Transforming time for prostate cancer therapiesJames Hilbert
This document provides an overview of prostate cancer treatments and competitive landscape. Prostate cancer is the most commonly diagnosed cancer in men. Current standard of care includes local therapy for early stage, androgen deprivation therapy for advanced or recurrent disease, chemotherapy (e.g. Taxotere) for metastatic castration-resistant prostate cancer (mCRPC), and newer agents like Provenge, Zytiga, and Jevtana for mCRPC. The pipeline includes promising agents from Dendreon, Medivation, and OncoGenex that could change treatment paradigms and improve outcomes for mCRPC patients.
Vandetanib plus docetaxel versus docetaxel alone as second-line treatment for advanced NSCLC was evaluated in a randomized phase 3 trial (ZODIAC). The trial found:
1) Addition of vandetanib to docetaxel significantly improved progression-free survival compared to placebo plus docetaxel, with median PFS of 4.0 vs 3.2 months.
2) A similar PFS benefit was seen in the prespecified analysis of women.
3) Adverse events including rash, neutropenia, and febrile neutropenia were more common with vandetanib plus docetaxel.
CDX-011 is an antibody-drug conjugate targeting GPNMB, which is expressed in 40-75% of breast cancers and promotes metastasis. Preliminary results from the randomized Phase 2b EMERGE study show very encouraging activity of CDX-011 in triple-negative breast cancer patients and those with high GPNMB expression who have failed approved therapies. The EMERGE study randomized GPNMB-expressing advanced breast cancer patients to receive either CDX-011 or standard therapy to examine if anti-cancer activity depends on level of GPNMB expression. Over 99% of 338 screened patients were considered eligible based on ≥5% GPNMB expression.
This document summarizes a phase 1/2 clinical trial evaluating the safety, tolerability, and efficacy of enzyme replacement therapy (ERT) with recombinant human GALNS (BMN 110) in subjects with Mucopolysaccharidosis IVA (Morquio syndrome). The open-label, dose-escalation study enrolled 20 subjects aged 5-18 years who received weekly infusions of BMN 110 at doses of 0.1 mg/kg, 1.0 mg/kg, or 2.0 mg/kg for 12 weeks each. Key findings included improvements in measures of endurance like the 6-minute walk test and 3-minute stair climb, as well as decreases in urine keratan sulfate levels
The combos study an expert interview with william sJames Hilbert
The document summarizes the COMBOS study which evaluated the effects of adding prescription omega-3 ethyl esters (Lovaza) to stable statin therapy in patients with persistent hypertriglyceridemia. The study found that Lovaza plus simvastatin led to greater reductions in non-HDL cholesterol and other lipid parameters compared to simvastatin alone. Non-HDL cholesterol is a measure of total cholesterol carried by LDL, VLDL, and their remnants, and is a better predictor of cardiovascular risk than LDL alone, especially in patients with high triglycerides.
MAP0004, an orally inhaled formulation of dihydroergotamine (DHE), was evaluated in a randomized, double-blind, placebo-controlled study for the acute treatment of migraine. 903 patients experiencing a migraine attack were randomized to receive either MAP0004 (0.63 mg emitted dose) or placebo via inhalation. The primary endpoints were pain relief and absence of photophobia, phonophobia, and nausea at 2 hours. MAP0004 was superior to placebo for all primary endpoints. A greater percentage of patients treated with MAP0004 experienced pain relief, absence of photophobia, absence of phonophobia, and absence of nausea compared to those receiving placebo. MAP0004 was well tolerated with no serious
This document discusses novel molecular therapies for hepatocarcinoma (HCC). It summarizes that sorafenib is the current standard of care therapy for advanced HCC based on two phase III trials showing improved median overall survival. However, sorafenib resistance can develop. The document reviews several other targeted agents that have shown some activity for HCC including bevacizumab, erlotinib, and sunitinib. Ongoing clinical trials are exploring combinations of sorafenib with other agents or replacing sorafenib. Biomarkers associated with response and resistance to therapies like sunitinib are also discussed.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The document discusses updates on second-line treatment of metastatic non-small cell lung cancer from the World Conference on Lung Cancer. It summarizes findings from studies comparing weekly versus 3-weekly docetaxel administration and pemetrexed versus docetaxel. Current guidelines recommend second-line cytotoxic chemotherapy or EGFR inhibitors for disseminated metastatic disease and radiation therapy for localized symptoms.
Docetaxel Versus Docetaxel/Cisplatin in NSCLCJames Hilbert
This study compared docetaxel alone versus docetaxel plus cisplatin as frontline treatment for advanced non-small cell lung cancer. 302 patients were randomly assigned to receive either docetaxel alone (146 patients) or the docetaxel/cisplatin combination (156 patients). The overall response rate was significantly higher for the combination at 36% versus 18% for docetaxel alone. However, median survival time, time to disease progression, and 1-year survival rates were similar between the two groups. Toxicity was higher with the combination therapy. Both regimens showed similar effectiveness in terms of survival, though the combination resulted in a higher response rate and more toxicity.
Second or third additional chemotherapy drug for non-small cell lung cancer i...James Hilbert
This Cochrane review evaluated 65 randomized controlled trials with over 13,000 patients to determine the clinical benefit of adding additional chemotherapy drugs to treatment regimens for advanced non-small cell lung cancer. The review found that adding a second drug to a single-agent chemotherapy regimen improved tumor response rates and one-year survival rates. Adding a third drug to a two-drug chemotherapy regimen increased tumor response rates but did not improve one-year survival rates and was associated with higher toxicity.
Soligenix is initiating coverage with a Buy rating for their lead product orBec®, an oral therapy for GI GvHD currently in a Phase 3 trial. Prior trials show efficacy for orBec® with a localized corticosteroid and the Phase 3 trial further lowers clinical risk. The treatment of acute GI GvHD is an unmet medical need and orBec® has the potential to generate $150-300 million in revenue. Soligenix is also developing therapeutics for radiation injury and vaccines for biodefense through additional platforms.
- Wedbush Securities provides an update on Cleveland BioLabs, Inc. (CBLI) and reiterates an OUTPERFORM rating and $10/share price target.
- CBLI is still anticipated to receive a $50+ million government contract award from BARDA now expected in July/August for development of CBLB502, though the announcement has been delayed.
- CBLI has a low $11 million annual cash burn and no fundamental reasons for its recent stock price decline. The BARDA contract delay does not jeopardize the company or CBLB502 program.
- CBLI expects to submit a BLA for CBLB502 in H1 2012 and anticipates FDA approval by H2 2012, positioning the company
Pluristem Therapeutics is developing placental stem cells (PLX) for the treatment of peripheral arterial disease. The company's proprietary 3-D bioreactor technology appears to produce therapeutic stem cells that release multiple angiogenic factors in response to local disease. Research by an independent group confirmed the potential benefit of 3-D culturing versus traditional 2-D technologies. Pluristem reported encouraging results from an open-label study and is finalizing pivotal studies with regulators, which are anticipated to commence by year-end. The analyst initiates coverage with an Outperform rating and $5 price target.
1. Andrew Vaino, Ph.D. , (949) 720-7102
avaino@roth.com
Sales (800) 933-6830, Trading (800) 933-6820
FLASH NOTE | EQUITY RESEARCH | January 20, 2011
Biotechnology
Clinical Data, Inc. | CLDA - $15.60 - NASDAQ | Buy
Stock Data CLDA: Phase 3 Failure Of Forest
52 Week Low - High $10.87 - $22.39 Anti-Depressant Could Improve Partnership
Shares Out. (mil) 29.95
Mkt. Cap.(mil) $467.3 Odds
3-Mo. Avg. Vol. 201,492
12-Mo.Price Target $28.00 s Levomilnacipran no better than placebo in Phase 3 clinical study.
Cash (mil) $47.0 Forest Laboratories announced that a Phase 3 (362 patients) clinical study
Tot. Debt (mil) NA of Levomilnacipran (F2695 SR, single optical isomer version of Savella:
Est. 3Yr. EPS Growth NM approved to treat fibromyalgia) was not effective in treating depression.
The primary endpoint of this study was change in the MADRS scale (a
EPS ($)
marker of depression) after 8 weeks. Forest is conducting two other Phase
Yr Mar 2010 —2011E— —2012E— 3 studies of Levomilnacipran to treat depression, using the same primary
Curr Curr endpoint: results of these studies are expected later in 2011: these studies
1Q (0.67)A (0.51)A —
could be positive, but the negative result announced today does not
strongly support that hypothesis. Milnacipran, an optically impure version of
2Q (0.79)A (0.56)A —
Levomilnacipran, is approved to treat depression in Europe and Japan.
3Q (0.63)A (0.55)E —
4Q (1.44)A (0.65)E —
s Vilazodone showed efficacy in same measure. CLDA has a PDUFA
YEAR (3.57)A (2.26)E (0.69)E
date for its depression treatment, Vilazodone, on January 22. We note that
P/E NM NM NM
the Levomilnacipran Phase 3 study used the same endpoint that CLDA
2009 Annual: EPS excludes a $(0.40) impact from discontinued used in its Phase 3 clinical studies of Vilazodone. In two Phase 3
operations.
depression studies, Vilazodone demonstrated a statistically significant
Revenue ($ millions) benefit of ~3 points over placebo in the MADRS, a result that was
statistically significant (p < 0.01 in both studies). Our take is that this
Yr Mar 2010 —2011E— —2012E— provides further validation of Vilazodone's utility.
Curr Curr
1Q 3.7A 5.4A — s Other implications for CLDA. Composition of matter patents for Lexapro,
2Q 3.0A 3.4A — an anti-depressant sold by Forest, expire in March 2012 (presumably
3Q 3.1A 4.5E — Levomilnacipran was intended as a replacement). In 2010, Lexapro sales
4Q 3.2A 0.9E — were 58% of Forest's sales. Further, patents on Forest's Alzheimer's drug
YEAR 13.1A 14.3E 55.1E Namenda (which accounts for 29% of the company's sales) expired in
2010. Losing these revenue streams to generics could present an issue for
Forest. We have speculated previously that Forest, with a sales force
1 Year Price History/Ave. Daily Vol for CLDA
already in place to sell anti-depressants, would be an ideal partner for
24
21 Vilazodone. Today's result could make a partnership more likely.
18
15
12 s Overall take positive for CLDA. We continue to believe that odds of
9
6 approval for Vilazodone are 75%, and we believe that a partnership (with
Q1 Q2 Q3 Q1
FRX or another major pharmaceutical firm) could well emerge
2010 2011
post-approval.
Created by BlueMatrix [Intraday price: $14.96 (2:06 PM EST)]
Refer to important disclosure information and rating System Definition on pages 3 - 4 of this report. Regulation Analyst Certification ("Reg AC"): The
research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report
accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or
will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
Roth Capital Partners, LLC | 24 Corporate Plaza | Newport Beach CA 92660 | 949 720 5700 | Member FINRA/SIPC
2. Clinical Data, Inc. Flash Note - January 20, 2011
VALUATION
We maintain our BUY rating for Clinical Data inc, and our 12-month target price of $28/share. The price target
is based on a 20x multiple of our risk-adjusted estimated FY14 EPS of $2.46 (fully diluted) discounted at 20%
annually.
Factors that could impede CLDA shares from reaching our price target include delays or rejection of the
Vilazodone NDA filing, risk of further dilutive financing, and a general downturn in market conditions.
RISKS
Company specific risks for CLDA are listed below. An investment in Clinical Data inc. should be considered
speculative.
s Regulatory risk - CLDA filed an NDA for Vilazodone in 1Q10. Failure of this filing to gain acceptance by the
FDA could have a material adverse impact on company shares.
s Intellectual property risk - Patent protection for CLDA's tests appears less than bullet-proof, and there is a
chance competition could emerge for some tests.
s Demand risk - Viladozone will compete for market share against a number of currently available therapies
for depression. Failure to achieve estimated sales could have a material adverse impact on stock price. As
well, sales of CLDA's genetic tests could also disappoint, which would also materially effect stock price.
s Financing risk - CLDA will likely have to raise additional finds from investors prior to product launch. If the
company is unable to raise these funds on favorable terms this could have a material adverse impact on
share price.
COMPANY DESCRIPTION
Clinical Data, Inc. provides molecular and pharmacogenomics services, as well as clinical diagnostics for the
improvement of patient care worldwide. The PGxHealth division focuses on biomarkers and related test
development, validation, and commercialization activities designed to improve the efficacy and safety of drugs
for patients. It markets these genetic tests to providers, payers, and consumers. This division is also seeking
to develop and commercialize Vilazodone, a novel dual-serotonergic antidepressant compound being studied
for the treatment of depression along with a potential companion pharmacogenetic test. The Cogenics division
offers a range of genomics services for both research and regulated projects, including services to support
pharmacogenomics discovery and validation, and biomarker research and development. Its services include
sequencing, genotyping, gene expression, and bio-banking in both regulated and unregulated markets for
pharmaceutical, biotechnology, academic, agricultural, and government clients. The company was founded in
1969 and is headquartered in Newton, Massachusetts.
MENTIONED COMPANIES
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3. Clinical Data, Inc. Flash Note - January 20, 2011
Disclosures:
Within the last twelve months, ROTH has received compensation for investment banking services from Clinical Data, Inc.
ROTH makes a market in shares of Clinical Data, Inc. and as such, buys and sells from customers on a principal basis.
Within the last twelve months, ROTH has managed or co-managed a public offering for Clinical Data, Inc.
On September 28, 2010, ROTH changed its rating system in order to replace the Hold rating with Neutral.
Rating and Price Target History for: Clinical Data, Inc. (CLDA) as of 01-19-2011
09/30/08 08/11/09 01/21/10
I:B:$21 B:$24 B:$28
24
20
16
12
8
4
Q1 Q2 Q3 Q1 Q2 Q3 Q1 Q2 Q3 Q1
2008 2009 2010 2011
Created by BlueMatrix
Each box on the Rating and Price Target History chart above represents a date on which an analyst made a change to a
rating or price target, except for the first box, which may only represent the first note written during the past three years.
Distribution Ratings/IB Services shows the number of companies in each rating category from which Roth or an affiliate
received compensation for investment banking services in the past 12 month.
Distribution of IB Services Firmwide
IB Serv./Past 12 Mos.
as of 01/20/11
Rating Count Percent Count Percent
Buy [B] 202 72.1 43 21.3
Neutral [N] 72 25.7 4 5.6
Sell [S] 6 2.1 0 0
Not Rated [NR] 0 0.0 0 0
Our rating system attempts to incorporate industry, company and/or overall market risk and volatility. Consequently, at any
given point in time, our investment rating on a stock and its implied price movement may not correspond to the stated
12-month price target.
Ratings System Definitions - ROTH employs a rating system based on the following:
Buy: A security, which at the time the rating is instituted and or reiterated, indicates an expectation of a total return of at
least 10% over the next 12 months.
Neutral: A security, which at the time the rating is instituted and or reiterated, indicates an expectation of a total return
between negative 10% and 10% over the next 12 months.
Sell: A security, which at the time the rating is instituted and or reiterated, indicates an expectation that the price will decline
by more than 10% over the next 12 months.
Not Rated: A security which at the time the rating is instituted and or reiterated, indicates that we have no opinion or
expectations as to the price of the security over the next 12 months.
Not Covered (NC): ROTH does not publish research or have an opinion about the security.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business
Page 3 of 4
4. Clinical Data, Inc. Flash Note - January 20, 2011
relationships with the covered companies mentioned in this report in the next three months.The material, information and
facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from
sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used as
a complete analysis of the company, industry or security discussed in the report. Additional information is available upon
request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are
subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual
results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high
degree of risk and may not be suitable for all investors. No part of this report may be reproduced in any form without the
express written permission of ROTH. Copyright 2011. Member: FINRA/SIPC.
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