Category: Health

Monday, July 8, 2019

Dyadic International (DYAI)

VTT to Continue Validation of C1 Platform in Bioproduction.

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 full report for price target, fundamental analysis and rating. 

• Extension of Research Agreement with VTT. Dyadic has extended its research and development contract with VTT Technical Research Centre through June 2022. VTT is a Finland-based, state owned non-profit company, which provides research and innovation services. Dyadic and VTT continuing long history of collaboration to improve production of target proteins and establish glyco-engineering for C1 platform.  
• Terms of the Agreement. The terms of the agreement include a total payment of €2.52(EUR) million throughout the 36 months of contract period. The agreement also grants… 

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CAR-T Medicines for The Treatment of Cancer, Part 2

(click here
for part one)

(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)

Chimeric Antigen Receptor T cell therapy (CAR-T) is a gene therapy designed to harness the potency of antibodies and T-lymphocytes into one single medicine for the treatment of cancer. CAR-T therapy could be viewed as a “living anti-cancer drug” as the medicine itself consists of a living cell, which is genetically engineered as a pharmaceutical “chimera” to find and destroy cancer cells. The term chimera describes a monstrous being from Greek mythology composed from different animal parts. It appears in literature as a creature with two heads: a lion’s and a goat’s (see Figure 1 below). Like the creature from Greek mythology, a CAR-T medicine also has two heads: antibody binding domain and T-cell receptor (TCR) signaling domain.

Figure 1: According to Greek mythology, a Chimera was a hybrid with
parts from different animals. It consisted of a lion with a goat’s head and a
tail ending in snakes’ heads. In the Homer’s Iliad, a chimera is described as a
“fearsome beast snorting out the breath of terrible flame of bright fire”.

Source
– Chimera, Greek Mythology, www.mythortruth.com

In
science, the term chimera is often used to describe hybrids from different
species, such as a virus with DNA sequences from different species, or a CAR-T
drug construct consisting of an antibody fused to a T lymphocyte, combining the
medical potency of an anti-cancer antibody with the cancer killing properties
of a T lymphocyte. (read Part 1 of the CAR-T
article series here)

Wednesday, June 19, 2019

TherapeuticsMD (TXMD)

What Investors are Missing

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.

• The stock slides. TXMD shares are down 15% since the company held its analyst day on June 10, 2019. We believe that the shares overreacted to management’s weak revenue outlook which anticipates 87% revenue growth for the full year 2019 (21% below consensus revenue expectations). We estimate that revenues will show an accelerated growth in subsequent years, up 180% in 2020, up 346% in 2021 and up 108% in 2022.
• The bigger picture. We believe that there are encouraging revenue attributes; 1) the company’s product, Imvexxy, had solid upward Q1 revenue trajectory, surpassing…

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

Tuesday, June 11, 2019

electroCore (ECOR)

Choppy Waters for electroCore

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.

• CEO Frank Amato Departs. Yesterday, electroCore announced another departure from the leadership team since the annual shareholder meeting held on June 7, 2019. Frank R. Amato is leaving the company after serving as a Chief Executive Officer since 2016. He will continue to serve as the CEO and board member until a new CEO is recruited. This position is expected to be filled before September 30, 2019.
• Restructuring Continues.We expect the company to pursue additional steps to reshape the leadership team following two departures within the past week. Besides Frank’s departure… 

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

CAR-T and the Possibility of Cancer Treatment, Part 1

style=”margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: Calibri, sans-serif;”>click her for part two of this article series

(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)

Chimeric Antigen
Receptor T cell therapy (CAR-T) is a gene therapy designed to harness the
potency of antibodies and T-lymphocytes into one single medicine for the
treatment of cancer. CAR-T therapy could be viewed as a “living anti-cancer
drug” as the medicine itself consists of a living cell, which is genetically
engineered to find and destroy cancer cells. Dr. Carl H. June pioneered this
technology at the University of Pennsylvania, where the first tests were
conducted in cancer patients in 2010. Seven years later, the U.S. Food &
Drug Administration (FDA) approved this novel gene therapy for the treatment of
patients suffering from “B-cell precursor acute lymphoblastic leukemia” (ALL),
a type of blood cancer known to be the most common malignant growth in
children.

Thus far, anti-cancer
antibodies have been one of the most successful drug classes for the treatment
of cancer patients. Antibody drugs such as Roche’s Avastin, Herceptin and Rituxan have prolonged survival of many
cancer patients. Another class of medicines, known as T-infiltrating
lymphocytes (TILs), has been shown to be effective as an anti-cancer treatment.
Given the relative success of both therapeutic strategies, the question is, how
do you combine both treatments into one potent anti-cancer drug?

CAR-T represents
the solution to this riddle. CAR-T consists of two main components: 1) the
tumor associated antigen (TAA) domain of an anti-cancer antibody (scFV) linked through
a spacer/transmembrane region to 2) the cytoplasmic domain of the receptor of a
cancer-killing T lymphocyte. The new anti-cancer drug, CAR-T, is a genetically
engineered T-lymphocyte expressing a chimeric T cell receptor on its surface
(Figure 1). This chimera consists of the binding domain of the antibody
(external domain protruding from the cell surface), fused to the signaling portion
CD3 of the T cell receptor (internal domain facing the cellular cytoplasm).

Figure 1 – Structure of a CAR-T construct. The left panel depicts a
CAR-T medicine (first generation), whereas the right panel depicts the natural
T cell receptor, TCR. In the CAR-T construct (left panel), the binding domain
(light blue/purple) of an anti-cancer antibody (scFV) replaces the alpha/beta
chain portion (green/red) of the natural TCR (right panel). The transmembrane
and cytoplasmic components of CAR-T and TCR, including CD3 domain, are depicted
in blue.

 

Source – Oncotarget 2015,
8(52)90521-90531 ?

To generate a
CAR-T drug, five main steps are required (Figure 2):

1. blood from the patient is extracted
2. T-lymphocytes are purified from extracted
   blood, and subsequently genetically modified to express the CAR chimeric
   receptor
3. CAR-T cells are grown in vitro (ex vivo)
4. Once CAR-T cells are grown to reach a
   therapeutic dose, they are injected back into the patient
5. Injected CAR-T cells are engineered to find
   and kill cancer cells

Source – The University of Texas
Southwestern Medical Center

Wednesday June 5, 2019

electroCore (ECOR)

Continuing Execution of the Redeployment Plan

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.

Founder and Chief Science and Strategy Officer departs. electroCore announced another event as part of the redeployment plan that emerged on May 29. Founder Joseph P. Enrico, who served as the Company’s Chief Science and Strategy Officer,  agreed to leave the company, effective as of June 8, 2019. He co-founded the company in 2005 and served in multiple roles including Chief Executive Officer (CEO) prior taking his current role in 2016. He remains as a Board Director and holds 2.2% equity stake in the company.

Chief Medical Officer to take over the strategy role. Management stated plans to continue with the current leadership team. Tony Fiorino, M.D. Ph.D. will continue to serve as Chief…

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

Friday, May 31, 2019

electroCore (ECOR)

Can the Reduced Cash Burn Calm Ragged Nerves?

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.

• Concern around the high cash burn is lowered. electroCore implemented a cost reduction and deployment plan reducing the cash burn to $2.3 million from $4 million per month, effective by June 2019. We view extension of the cash runaway as a positive road map for the company, but we believe the stock will remain under pressure until the company shows a solid revenue ramp-up.
• Basis of the cost reduction plan. The cost reduction was endowed by i) reducing work force to 55 positions from 91 – eliminating sales, medical affairs personnel, ii) abolishing cash compensation of board servicing by independent directors, iii) voluntary acceptance of stock compensation in lieu of cash compensation by Chief Executive Officer Francis Amato and iv) postponing current clinical operations – to be determined following the company’s board meeting on June.

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