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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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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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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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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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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Monday, April 15, 2019

Dyadic International (DYAI)

The Importance Behind The Nasdaq Up-Listing.

Dyadic International Inc. is a biotechnology company developing a proprietary expression platform to manufacture of biologic products. The company is employing C1 technology, part of a fungi expression system, to produce variety of modalities of biologic products, including vaccines, oncolytic viruses, monoclonal and bispecific antibodies, as well as biosimilars. 

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

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

• Important Milestone Accomplishment. Dyadic has announced the up-listing of its common stock on The Nasdaq
  Capital Market Exchange under stock symbol “DYAI”. The company has
  maintained the stock price requirement, for Nasdaq, following its SEC filing on
  February 2019. Trading will commence as early as 
  April 17, 2019. We believe this
  is an important milestone for the company and its current and future investors. 
• Why is this important?  The company has accomplished key
  milestones as guided, including the SEC filing and the Nasdaq up-listing. The
  stock has gained +112% YTD 2019. We believe the biggest potential benefit from
  the up-listing is increased visibility and tran…
  

  
  
  
  
  

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Wednesday, April 3, 2019

Trovagene Inc. (TROV)

Updated early prostate cancer data demonstrates sustained PSA levels.

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. 

• AACR
  Presentation. The company had the second presentation from a Phase 2 study
  of onvansertib in combination with Zytiga/prednisone in patients with metastatic
  castration-resistant prostate cancer (mCRPC), at the American Association for
  Cancer Research (AACR) annual meeting today, following the update from the
  acute myeloid leukemia (AML) trial (refer to the note published on April 2nd,
  2019).
• Data Update in
  Prostate Cancer.  Onvansertib in combination with Zytiga/prednisone treatment
  achieved a reduction of prostate specific antigen (PSA) levels in 2 out of
  6 mCRPC patients. The previous data reported at
  the Genitourinary Cancers Symposium (ASCO-GU, on February) showed
  reduced PSA levels, however levels were relapsed. The company plans to
  comm… 

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Tuesday, April 2, 2019

Trovagene Inc. (TROV)

Improved and updated data from AML patients.

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.  

• AACR Data
  Presentation.  The company presented data from a Phase 1b clinical trial of
  onvansertib in patients with acute myeloid leukemia (AML) at the American
  Association for Cancer Research (AACR) annual meeting on April 1st, 2019. The
  anti-leukemic activity improved with an increased number of patients treated.
  The disease control rate (DCR) rose to 89% (17/19 patients) from previous
  reported rate of 83% (10/12 patients) at The American Society of
  Hematology (ASH) on December 2018.
• Digging Through Data. In addition to the improved DCR,  the overall response
  rate also increased; one patient with complete response (CR), one
  incomplete blood recovery (iCR), one morphologic leukemia-freestate (MLFS) and
  one partial response (PR) compar… 

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Can any other treatment beat anti-VEGF in macular edema?

(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)

Macular edema (ME) is an eye disease condition that causes the sudden or chronic decrease in visual acuity. The condition arises from fluid accumulation within the macula, an area in the center of the retina, leading to vascular instability and the breakdown of the blood-retinal barrier (BRB). Characterization of the diseases is made by the swelling and thickening of the macula distorting a person’s central vision, causing a decline in visual acuity and eventually could lead to blindness.

Major causes of macular edema include diabetes, branch and central retinal vein occlusion, choroidal neovascularization, posterior uveitis, postoperative inflammation and central serous chorioretinopathy.

Fluid accumulation results from an imbalance between processes governing fluid entry and exit, when inner or outer blood-retinal barriers are disrupted. ME can arise from various conditions:

1. 7 million subjects due to diabetes, called diabetic macular edema (DME)
2. 3 million subjects due to vein occlusion
3. 40% of visual impairment in patients with uveitis
4. 5% of individuals older than 60 years of age due to neovascular age-related macular degeneration (AMD) in industrialized countries

ME treatment is a rapidly growing market with an increasing elderly population, and people living with diabetes. The anti-vascular endothelial growth factor (VEGF) therapy has revolutionized the treatment landscape for ME providing benefit to patients, however 30-50% of patients don’t respond or develop resistance to anti-VEGF treatment and the opportunity still remains for the development of novel compounds.

Monday, April 1, 2019

TherapeuticsMD (TXMD)

.

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. TherapeuticsMD’s drug candidates that have completed clinical trials are designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis, and discomfort. 

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

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

…

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