Category: Health

Friday, May 24, 2019

Trovagene Inc. (TROV)

What a Preclinical Agreement Means

TrovaGene Inc is a US-based life science company which focuses on the development and commercialization of a proprietary molecular genetic detection technology for use in pharmaceutical development, clinical research and medical testing across a variety of clinical disciplines, including oncology and virology. 

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

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

• Early Stage Development Agreement with Nektar Therapeutics. Trovagene announced a research and development agreement
  with Nektar Therapeutics (NKTR, Not Covered) to assess Onvansertib in
  combination with Onzeald (etirinotecan pegol) in preclinical colorectal cancer
  model.
• The basis of the agreement. The preclinical work includes two different colorectal cancer
  models; BRAF-mutant and KRAS-mutant. Management stated that Nektar is
  re…

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Friday, May 17, 2019

electroCore (ECOR)

Has the stock overreacted?

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 full report for price target, fundamental analysis and rating.

• Current stock price doesn’t reflect the value of
  gammaCore. Following and investor call on May 14th, ECOR stock lost over 40% of its value. While we recognize the slower than anticipated revenue ramp and prolonged timelines for additional payer agreements, we would like to emphasize gammaCore’s potential in the multi-billion-dollar migraine market.
• Revenues should ramp up. The company currently has agreements established with three large payers (CVS Caremark, Highmark and Federal Supply Schedule). As the managem… 

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Thursday, May 16, 2019

electroCore (ECOR)

Will Revenue Ramp up in the Next Quarters?

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 full report for price target, fundamental analysis and rating.

• First quarter 2019 results are
  below expectations. The company reported $0.4 million of revenue (+11%), 2,200 prescribing physicians (+22%) and consistent prescriptions in this quarter relative to the previous quarter. In the quarter, electroCore expanded coverage of reimbursement with payers (CVS Caremark, Highmark and federal supply schedule (FSS)), however this has not yet impacted revenue growth.
• Acceleration is anticipated in the next
  quarters. We are assessing the company’s progress and scrutinizing the market uptake of gammaCore in the next quarters of 2019. On the call, management stated that the modest revenue ramp is dri… 

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making any investment decision. 

Wednesday, May 15, 2019

ProMIS Neurosciences (PMN:CA)

Progress in Q1 Bodes Well For Partnership Opportunities.

ProMIS Neurosciences, Inc., a development stage biotech company, discovers and develops precision medicine therapeutics for the treatment of neurodegenerative diseases, primarily Alzheimer’s disease (AD) and amyotrophic lateral sclerosis (ALS).     
  

Cosme Ordoñez, M.D., Ph. D. , Life Sciences Analyst, Noble Capital Markets, Inc.

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

• Antibody drug
  candidates identified. In Q1/2019, ProMIS Neurosciences identified several antibody drug candidates for the treatment of Parkinson’s disease. These antibodies target toxic forms of alpha synuclein, which play a critical role on the development and progression of this illness.
• Parkinson’s program update. The progress made in Parkinson’s program was presented at “The 14^th International Conference on Alzheimer’s & Parkinson’s Diseases” held in Lisbon, Portugal, from March 26-31, 2019. ProMIS was able to showcase results demonstrating the selectivity of anti-alpha synuclein antibodies, which selectively bind to tox…
  
  

  
  
  

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Friday, May 10, 2019

Dyadic International (DYAI)

Putting Recent Developments Into Perspective.

Dyadic International Inc. is a biotechnology company developing a proprietary C1 expression platform to express and manufacture biologic products. The C1 technology is part of a fungi expression system, which utilizes inexpensive substrates yielding a high level of production. Dyadic is currently improving and optimizing the production of biological products in a C1 expression system. 

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

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

• Positioned in a rapidly growing market. The biologics market remains one of the most rapidly growing segments of the pharmaceutical industry, expected to grow to $1.2 billion in sales in 2022. Dyadic has expanded its collaboration and licensing portfolio to assess C1’s potential to manufacture vaccines, gene therapy, monoclonal antibodies and others in human disease and in animal health.  
• More deals appear likely. Following two recently announced licensing agreements for its C1 technology, management indicated on an investor call that more licensing agreements and research collaborations are likely. These agreements will potentially generate re… 

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Friday, May 10, 2019

Trovagene Inc. (TROV)

Data Rich Year Ahead.

TrovaGene Inc is a US-based life science company which focuses on the development and commercialization of a proprietary molecular genetic detection technology for use in pharmaceutical development, clinical research and medical testing across a variety of clinical disciplines, including oncology and virology. 

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

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

• Demonstrated Clinical Activity in
  AML. Trovagene is making progress in a Phase 1b/2 study of onvansertib in combination with standard-of-care chemotherapy in acute myeloid leukemia (AML). The company’s most recent presentation at the American Association for Cancer Research (AACR) demonstrated an 89% disease control rate (DCR) including one complete response (CR), and one incomplete blood recovery (iCR) in 12 AML patients. 
• Progressing in Other Indications. The company continues advancement in other indications, including i) Phase 2 study in metastatic castration-Resistant Prostate Cancer (mCRPC); second arm is set to be initiated with reduced dosing sche… 

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The Importance of CDKs (Cyclin-dependent kinases)

(Note: companies that could be impacted by the content of this article are listed at the base of the story (desktop version). This article uses third-party references to provide a bullish, bearish and balanced point of view; sources listed in the “Balanced” section) 

Cell proliferation is a tightly regulated
process by the cell cycle machinery in normal tissues, while dysregulated
cellular proliferation and aberrant proliferation is a hallmark of cancer. Cyclin-dependent
kinases (CDKs) are critical regulatory enzymes that drive cell cycle
transitions, control cell division and proliferation. Many of the key concepts
of CDK biology were discovered over 20 years ago through the study of yeast.
In 2001, Doctor Leland H. Hartwell, R. Timothy
Hunt and Paul M. Nurse were awarded the Nobel Prize
for their discoveries of “key regulators
of the cell cycle”.

There are currently >20 members of the CDK family. The cyclin D/cyclin-dependent kinases 4 and 6 (CDK4/6) are regulators of cell cycle and signal through cell cycle pathway involving p16, an endogenous suppressor of CDK4/6, cyclin D1, the regulatory subunit of CDK4/6, and retinoblastoma (Rb) protein, a tumor suppressor. Controlled phosphorylation and deactivation of the Rb protein by the CDK4/6 complex is crucial for the normal cell cycle progression. Unhindered activity of CDK4/6 pathway can result in alterations of cyclin-dependent kinases stimulating cell cycle pathway and cell proliferation in cancer cells. Selective CDK4/6 inhibitors “turn off” these kinases and dephosphorylation of Rb, resulting in a block of cell-cycle progression preventing the proliferation of cancer cells. 

Figure 1. Immune Mechanism in
Response to CDK4/6 Inhibitors

Source: AACR 2018

Wednesday, May 8, 2019

electroCore (ECOR)

Small Piece of Migraine Market Could be a Big Deal.

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 full report for price target, fundamental analysis and rating.

• Market Opportunity. Upon establishment of reimbursement coverage, we expect to see a ramp up in revenue and further adoption in the market in H219. We believe potential approval in prevention of migraine and acute migraine treatment in adolescents to be a potential value generator, and the migraine indication to be the dominant market for electroCore.
• Protraction in Commercialization. electroCore is engaging in multiple key aspects to foster commercialization by expanding the sales force, reimbursement coverage, as well as promotional and educational programs. We believe electroCor… 

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NOTE: investment decisions should not be based upon the content of
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making any investment decision. 

Wednesday, May 8, 2019

Dyadic International (DYAI)

What Does Another Licensing Agreement Mean?

Dyadic International Inc. is a biotechnology company developing a proprietary C1 expression platform to express and manufacture biologic products. The C1 technology is part of a fungi expression system, which utilizes inexpensive substrates yielding a high level of production. Dyadic is currently improving and optimizing the production of biological products in a C1 expression system.

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

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

• Second Sub-licensing Deal. Following a sub-licensing deal with Luina Bio announced on April 29, the company announced a second sub-licensing agreement with biotech company Alphazyme. Alphazyme produces molecular biology enzymes for the molecular tool industry including, custom DNA and RNA molecules, genomic medicines and genetic testing. Dyadic’s C1 technology platform meets Alphazyme’s requirements for high quality, low cost production of enzymes on an industrial scale.
• Terms of the Deal. Dyadic will be granted an equity stake in Alphazyme,
  and is entitled to receive milestone payments and royalties upon the
  commercialization of C1 expressed Alphaz…

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Tuesday, May 7, 2019

TherapeuticsMD (TXMD)

Will Revenue Trends From Imvexxy be Recognized?

TherapeuticsMD Inc is a major drug manufacturing with a focus on creating and commercializing products targeted exclusively for women. The company intends to commercialize advanced hormone therapy pharmaceutical products. 

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

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

• Solid Imvexxy
  Revenue Growth. Net revenue generated by Imvexxy reached $2.0 million in Q1 2019 (+122%) compared to $0.9 in the fourth quarter of 2018 with sustained growth in prescription and refill rates; approximately 31,200 prescriptions in April 2019 (47,500 prescriptions in Q4 2018). In our view, increasing market share of Imvexxy will be meaningful to eradicate skepticism on commercialization.
• Bijuva Launch to Follow
  with Annovera. Annovera is set to launch in Q3 2019, following Bijuva’s launch in April 2019. We continue to highlight the market and cost synergies of Bijuva and Imvexxy, and also no…

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NOTE: investment decisions should not be based upon the content of
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making any investment decision. 

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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. 

Monday, April 29, 2019

TherapeuticsMD (TXMD)

Can the Early Commercial Success Eradicate the Stock Overhang?

TherapeuticsMD Inc is a major drug manufacturing with a focus on creating and commercializing products targeted exclusively for women. The company intends to commercialize advanced hormone therapy pharmaceutical products. 

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

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

• Assumption of Coverage with Outperform Rating and $13 Price
  Target. We are assuming coverage of TherapeuticsMD with an Outperform rating and Price Target of $13, based on an NPV analysis of the
  pipeline. Three product approvals were granted by the FDA in 2018 providing a
  solid foundation for the company to become a significant player in the
  women’s health space.
• Strong Player in Women’s Health. Three product approvals granted in 2018 include; i) Imvexxy
  for patients with vulvovaginal atrophy (VVA), ii) Bijuva (estradiol and
  progesterone) to treat vasomot…
  

  
  
  
  
  

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NOTE: investment decisions should not be based upon the content of
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Friday, April 26, 2019

Genprex (GNPX)

Poised to Emerge as a Leader in Cancer Gene Therapy.

Genprex Inc is a US-based clinical stage gene therapy company. It is engaged in developing a new approach to treating cancer, based upon its novel proprietary technology platform, including initial product candidate, Oncoprex immunogene therapy.

Cosme Ordoñez, M.D., Ph. D. , Life Sciences Analyst, Noble Capital Markets, Inc.

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

• Coverage
  Initiation. We are initiating coverage of Genprex, Inc. with an
  Outperform Rating and a $5.00 target price.
• Unique Gene
  Therapy Technology. We believe that Genprex will emerge as a leader in the area
  of gene therapy for the treatment of cancer. The Company is developing a unique
  platform technology consisting on the use of lipid nano…
  

  
  
  
  
  

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NOTE: investment decisions should not be based upon the content of
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