Q1 2020: Progressing Slowly but Steady

Tuesday, May 19, 2020

electroCore (ECOR)

Q1 2020: Progressing Slowly but Steady

electrocore Inc is a commercial-stage bioelectronic medicine company with a platform for non-invasive vagus nerve stimulation therapy initially focused on neurology and rheumatology. Its product gammaCore is FDA-cleared for the acute treatment of pain associated with migraine and episodic cluster headache in adults.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Expanding the market potential of gammaCore. In the quarter, electroCore received the 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand gammaCore therapy use for the prevention of migraine in adult patients. The company is also evaluating gammaCore for the treatment of Covid-19 symptoms including difficulty in breathing and cytokine storm. These indications represent a large commercial opportunity for the Company.

    Q1 2020 financial update. The company reported $0.7338 mm (+9%) net sales in Q1 2020 compared to $0.675 mm in the previous quarter. The company experienced 19% sequential growth in paid months of therapy, rising to 2,611 in the first quarter of 2020 from 2,195 in the fourth quarter of 2019. The gain in adoption of…



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Q1 2020: Continue Progressing on Validation of C1 Platform

Tuesday, May 19, 2020

Dyadic International Inc. (DYAI)

Q1 2020: Continue Progressing on Validation of C1 Platform

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the industrially proven hyper productive engineered fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1.
The C1 microorganism, which enables the development and large scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Dyadic has a rich partnership portfolio. Dyadic has established multiple research collaborations assessing C1 technology to improve manufacturing of biologics in human and animal health. The proprietary C1 platform can potentially express various biologic products including Fc-fusion proteins, monoclonal antibodies, Fabs, bi or tri-specifics, gene therapy, vaccines, and others. The company is also evaluating C1 to produce vaccines and antibodies against coronavirus.

    C1’s has the potential to be a superior biomanufacturing technology. We believe these partnerships increase the probability of success of the C1 platform in biologic manufacturing. In our opinion, the demonstration of improved cost effectiveness and high yield production from any of the research collaborations or…



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Onconova Therapeutics Inc. (ONTX) – Q1 2020 Earnings: 2020 Could Be Transformational for Onconova

Friday, May 15, 2020

Onconova Therapeutics Inc. (ONTX)

Q1 2020 Earnings: 2020 Could Be Transformational for Onconova

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    INSPIRE topline data is set to readout in H2 2020. In Q1 2020, Onconova completed patient enrollment in pivotal Phase 3 INSPIRE trial evaluating rigosertib in 2nd-line high-risk myelodysplastic syndrome (HR-MDS) patients. The company plans to present topline data at a major conference (more likely ASH) in H2 2020.

    Pipeline diversification in 2020. Besides the INSPIRE study, the company is on track to diversify its pipeline with additional programs including an investigator-initiated study of rigosertib plus nivolumab in Stage IV KRAS mutated lung adenocarcinoma and a randomized Phase 2/3 study of the combination of oral rigosertib plus azacytidine in 1st line HR-MDS patients (anticipated in 2020). Also, IND submission of ON123300 (CDK 4/6 + ARK5 inhibitor) program is anticipated Q4 2020. We believe these programs will generate value and…




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Helix Biopharma (HBPCF)(HBP:CA) – Phase I Results at ASCO Bode Well for Lead Drug’s Prospects

Friday, May 15, 2020

Helix Biopharma (HBPCF)(HBP:CA)

Phase I Results at ASCO Bode Well for Lead Drug’s Prospects

As of April 24, 2020, Noble Capital Markets research on Helix Biopharma is published under ticker symbols (HBPCF and HBP:CA). The price target is in USD and based on ticker symbol HBPCF. Research reports dated prior to April 24, 2020 may not follow these guidelines and could account for a variance in the price target.
Helix BioPharma Corp is a Canada-based clinical-stage biopharmaceutical company focused on cancer drug development. It develops therapies in the field of immuno-oncology based on its proprietary technology mainly in the areas of cancer prevention and treatment. The company has Tumor Defense Breakers (L-DOS47), and Tumor Attackers (CAR-T) product candidates in the pipeline.

Cosme Ordonez, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Helix Biopharma presents data at ASCO 2020. Helix BioPharma yesterday announced results from a recently completed Phase I dose escalation clinical trial on the use of L-DOS47, in combination with pemetrexed and carboplatin, for the treatment of a type of lung cancer. The results were published by American Society of Clinical Oncology (ASCO).

    Lead drug L-DOS47 shows clinical benefit. Of the twelve patients evaluable for efficacy, 5 patients (42%) had a partial response to treatment, 4 patients (33%) showed stable disease and three patients (25%) had progressive disease. In the trial, the objective response rate was 42% and…



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NOTE: investment decisions should not be based upon the content of
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Q1 2020 Earnings: 2020 Could Be Transformational for Onconova

Friday, May 15, 2020

Onconova Therapeutics Inc. (ONTX)

Q1 2020 Earnings: 2020 Could Be Transformational for Onconova

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    INSPIRE topline data is set to readout in H2 2020. In Q1 2020, Onconova completed patient enrollment in pivotal Phase 3 INSPIRE trial evaluating rigosertib in 2nd-line high-risk myelodysplastic syndrome (HR-MDS) patients. The company plans to present topline data at a major conference (more likely ASH) in H2 2020.

    Pipeline diversification in 2020. Besides the INSPIRE study, the company is on track to diversify its pipeline with additional programs including an investigator-initiated study of rigosertib plus nivolumab in Stage IV KRAS mutated lung adenocarcinoma and a randomized Phase 2/3 study of the combination of oral rigosertib plus azacytidine in 1st line HR-MDS patients (anticipated in 2020). Also, IND submission of ON123300 (CDK 4/6 + ARK5 inhibitor) program is anticipated Q4 2020. We believe these programs will generate value and…




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NOTE: investment decisions should not be based upon the content of
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Phase I Results at ASCO Bode Well for Lead Drug’s Prospects

Friday, May 15, 2020

Helix Biopharma (HBPCF)(HBP:CA)

Phase I Results at ASCO Bode Well for Lead Drug’s Prospects

As of April 24, 2020, Noble Capital Markets research on Helix Biopharma is published under ticker symbols (HBPCF and HBP:CA). The price target is in USD and based on ticker symbol HBPCF. Research reports dated prior to April 24, 2020 may not follow these guidelines and could account for a variance in the price target.
Helix BioPharma Corp is a Canada-based clinical-stage biopharmaceutical company focused on cancer drug development. It develops therapies in the field of immuno-oncology based on its proprietary technology mainly in the areas of cancer prevention and treatment. The company has Tumor Defense Breakers (L-DOS47), and Tumor Attackers (CAR-T) product candidates in the pipeline.

Cosme Ordonez, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Helix Biopharma presents data at ASCO 2020. Helix BioPharma yesterday announced results from a recently completed Phase I dose escalation clinical trial on the use of L-DOS47, in combination with pemetrexed and carboplatin, for the treatment of a type of lung cancer. The results were published by American Society of Clinical Oncology (ASCO).

    Lead drug L-DOS47 shows clinical benefit. Of the twelve patients evaluable for efficacy, 5 patients (42%) had a partial response to treatment, 4 patients (33%) showed stable disease and three patients (25%) had progressive disease. In the trial, the objective response rate was 42% and…



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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

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NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision.
 

PDS Biotechnology Corp (PDSB) – Q1 Highlighted by Foray into Infectious Diseases Area

Thursday, May 14, 2020

PDS Biotechnology Corp (PDSB)

Q1 Highlighted by Foray into Infectious Diseases Area

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

Cosme Ordonez, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Q1/F2020 Financial Results in line with our expectations.PDS Biotechnology yesterday announced financial results for Q1/F2020. The Company reported a net loss of $4.0 mm, or $0.39 per basic share and fully diluted share. In our view, the highlight of the quarter was the expansion of the Company’s product pipeline into infectious diseases. Now, PDS has Versamune vaccine programs in cancer, tuberculosis, influenza and COVID-19.

Versamune is a versatile vaccine platform technology.The Company is developing a platform technology known as Versamune, which consists of lipid nanoparticles designed to deliver disease-specific antigens to stimulate a potent immune response consisting of both humoral (antibodies) and cellular immunity. Versamune has potential applications for the treatment of cancer and…



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NOTE: investment decisions should not be based upon the content of
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Q1 Highlighted by Foray into Infectious Diseases Area

Thursday, May 14, 2020

PDS Biotechnology Corp (PDSB)

Q1 Highlighted by Foray into Infectious Diseases Area

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

Cosme Ordonez, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Q1/F2020 Financial Results in line with our expectations.PDS Biotechnology yesterday announced financial results for Q1/F2020. The Company reported a net loss of $4.0 mm, or $0.39 per basic share and fully diluted share. In our view, the highlight of the quarter was the expansion of the Company’s product pipeline into infectious diseases. Now, PDS has Versamune vaccine programs in cancer, tuberculosis, influenza and COVID-19.

Versamune is a versatile vaccine platform technology.The Company is developing a platform technology known as Versamune, which consists of lipid nanoparticles designed to deliver disease-specific antigens to stimulate a potent immune response consisting of both humoral (antibodies) and cellular immunity. Versamune has potential applications for the treatment of cancer and…



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NOTE: investment decisions should not be based upon the content of
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Ceapro (CRPOF)(CZO:CA) – Pursuing Novel Nutraceutical and Biopharmaceutical Markets

Tuesday, May 12, 2020

Ceapro (CRPOF)(CZO:CA)

Research Initiation-Pursuing Novel Nutraceutical and Biopharmaceutical Markets

Ceapro, Inc. is a publicly-held (TSX-V: CZO, OTCQX: CRPOF) Canadian biotechnology company developing and commercializing “active ingredients” for the healthcare and cosmetic industries. Ceapro’s active ingredients are primarily derived from oats and other renewable plant resources. The Company utilizes its proprietary plant extraction-based manufacturing process to supply active ingredients based on “oat beta glucan and avenanthramides”. Ceapro has patented a technology known as “Pressurized Gas eXpanded (PGX) technology”, which has superior features when compared to conventional drying and purification technologies. Using PGX technology, Ceapro generates novel biopolymers and biocomposites with micro/nanoparticles.

Cosme Ordonez, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Initiating Coverage. We are initiating research coverage on Ceapro, Inc.

    Revenue Generating Biotechnology Company. Ceapro is a commercial stage Canadian biotechnology company selling active ingredients for the personal care, cosmetic and healthcare industries. In F2019, the Company generated total revenue of $12.9 mm (11% growth) and CFO of $0.9 mm. Ceapro’s active ingredients are used by household name brands in the personal care markets including Johnson & Johnson’s Aveeno line of products, Neutrogena, and Lubriderm.

    Transition to become a Biopharmaceutical Company. While continuing to grow its active ingredients base business, Ceapro’s management plans to leverage its proprietary PGX manufacturing technology to develop novel products based on oat beta glucan and avenanthramides to pursuit nutraceutical, cosmeceutical and


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NOTE: investment decisions should not be based upon the content of
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Pursuing Novel Nutraceutical and Biopharmaceutical Markets

Tuesday, May 12, 2020

Ceapro (CRPOF)(CZO:CA)

Research Initiation-Pursuing Novel Nutraceutical and Biopharmaceutical Markets

Ceapro, Inc. is a publicly-held (TSX-V: CZO, OTCQX: CRPOF) Canadian biotechnology company developing and commercializing “active ingredients” for the healthcare and cosmetic industries. Ceapro’s active ingredients are primarily derived from oats and other renewable plant resources. The Company utilizes its proprietary plant extraction-based manufacturing process to supply active ingredients based on “oat beta glucan and avenanthramides”. Ceapro has patented a technology known as “Pressurized Gas eXpanded (PGX) technology”, which has superior features when compared to conventional drying and purification technologies. Using PGX technology, Ceapro generates novel biopolymers and biocomposites with micro/nanoparticles.

Cosme Ordonez, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Initiating Coverage. We are initiating research coverage on Ceapro, Inc.

    Revenue Generating Biotechnology Company. Ceapro is a commercial stage Canadian biotechnology company selling active ingredients for the personal care, cosmetic and healthcare industries. In F2019, the Company generated total revenue of $12.9 mm (11% growth) and CFO of $0.9 mm. Ceapro’s active ingredients are used by household name brands in the personal care markets including Johnson & Johnson’s Aveeno line of products, Neutrogena, and Lubriderm.

    Transition to become a Biopharmaceutical Company. While continuing to grow its active ingredients base business, Ceapro’s management plans to leverage its proprietary PGX manufacturing technology to develop novel products based on oat beta glucan and avenanthramides to pursuit nutraceutical, cosmeceutical and


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst
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NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision.
 

Trovagene (TROV) – New CEO, New Name, Still a Promising Cancer Drug

Friday, May 8, 2020

Trovagene (TROV)

New CEO, New Name, Still a Promising Cancer Drug

Trovagene, Inc. is a clinical stage biotechnology company focused on the development of new therapeutics for hematology and oncology. The company’s clinical programs of Onvansertib (PLK1 inhibitor) include Phase 1b/2 study in AML, Phase 1b/2 study in mCRPC and Phase 1b/2 trial in KRAS-mutant colorectal cancer.

Cosme Ordonez, MD, Ph.D., Senior Life Sciences Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Financial Results in line with expectations. Trovagene, Inc. yesterday released Q1/F2020 financial results. The Company reported a net loss of $(4.1) mm and total operating expenses of $4.2 mm compared to $(4.2) mm and $4.0 mm, respectively, in Q1/F2019. Net cash used in operations was $3.37 mm in Q1/F2020, compared to $3.36 mm in Q1/F2019. The Company finished the quarter with $9.3 mm in cash and cash equivalents. Overall, the results were in line with our expectations.

    New name is Cardiff Oncology, Inc. Trovagene announced a name change to Cardiff Oncology, Inc. The Company’s Nasdaq ticker symbol will change to CRDF, which will become effective at the open of the market on…



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New CEO, New Name, Still a Promising Cancer Drug

Friday, May 8, 2020

Trovagene (TROV)

New CEO, New Name, Still a Promising Cancer Drug

Trovagene, Inc. is a clinical stage biotechnology company focused on the development of new therapeutics for hematology and oncology. The company’s clinical programs of Onvansertib (PLK1 inhibitor) include Phase 1b/2 study in AML, Phase 1b/2 study in mCRPC and Phase 1b/2 trial in KRAS-mutant colorectal cancer.

Cosme Ordonez, MD, Ph.D., Senior Life Sciences Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Financial Results in line with expectations. Trovagene, Inc. yesterday released Q1/F2020 financial results. The Company reported a net loss of $(4.1) mm and total operating expenses of $4.2 mm compared to $(4.2) mm and $4.0 mm, respectively, in Q1/F2019. Net cash used in operations was $3.37 mm in Q1/F2020, compared to $3.36 mm in Q1/F2019. The Company finished the quarter with $9.3 mm in cash and cash equivalents. Overall, the results were in line with our expectations.

    New name is Cardiff Oncology, Inc. Trovagene announced a name change to Cardiff Oncology, Inc. The Company’s Nasdaq ticker symbol will change to CRDF, which will become effective at the open of the market on…



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TherapeuticsMD Inc. (TXMD) – Focusing on Annovera and Imvexxy Commercialization

Thursday, May 7, 2020

TherapeuticsMD Inc. (TXMD)

Focusing on Annovera and Imvexxy Commercialization

(current) TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. It manufactures and distributes branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD’ and BocaGreenMD’ brands. The company is currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. It is also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Q1 2020 earnings release. The company reported first-quarter earnings yesterday. Total revenues from marketed products reached $12.3 mm, EBITDA was ($50.7 mm) and EPS was ($0.21).

    Greater patient demand for Annovera. In Q1 2020, Annovera net sales were $2.3 million showing a reduction (from $5.8 million in Q4 2019), primarily attributed to lower wholesale orders by the distributors. Total prescriptions sold to patients doubled in Q1 2020. Prescription numbers represent a positive trajectory and greater patient demand. Large scale consumer campaign is now expected to…



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