Wednesday, February 16, 2022

Item 9 Labs (INLB)
1Q22 Results In-line with Expectations

Item 9 Labs Corp. (OTCQX: INLB) is a vertically integrated cannabis operator and dispensary franchisor delivering premium products from its large-scale cultivation and production facilities in the United States. The award-winning Item 9 Labs brand specializes in best-in-class products and user experience across several cannabis categories. The company also offers a unique dispensary franchise model through the national Unity Rd. retail brand. Easing barriers to entry, the franchise provides an opportunity for both new and existing dispensary owners to leverage the knowledge, resources, and ongoing support needed to thrive in their state compliantly and successfully. Item 9 Labs brings the best industry practices to markets nationwide through distinctive retail experience, cultivation capabilities, and product innovation. The veteran management team combines a diverse skill set with deep experience in the cannabis sector, franchising, and the capital markets to lead a new generation of public cannabis companies that provide transparency, consistency, and well-being. Headquartered in Arizona, the company is currently expanding its operations space by 650,000+ square feet on its 50-acre site, one of the largest properties in Arizona zoned to grow and cultivate flower. For additional information, visit item9labscorp.com.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

1Q22 Results. For the quarter ended December 31st, Item 9 reported revenue of $6.2 million, an increase of $3.1 million, or 103.5%, compared with $3.0 million in 1Q21. Net loss was $3.3 million, or $0.04 per share. We had projected revenue of $6.2 million and a net loss of $3.8 million, or $0.04 per share. Adjusted EBITDA for the quarter was a loss of $1.2 million.


Moving Forward.  As the Company released FY21 results less than a month ago, there isn’t a lot of new activity to report. The Nevada facility is 95% complete and should receive its Temporary Certificate of Occupancy in 2Q22. The Arizona expansion should be up and running during the summer. Recall, this will increase plant material output by 250-300%, reducing the need for outsourced product by …

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

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Wednesday, February 16, 2022

Baudax Bio (BXRX)
Adjusting price target for stock split and updated funding expectations

Baudax Bio is a biopharmaceutical company focused on developing therapies for post-operative pain, peri-operative pain, and anesthesia. The company currently has one approved therapy in ANJESO for post-operative pain. Proprietary ANJESO (meloxicam) injection is the first and only once-daily IV analgesic. The company also has a pipeline of early-stage candidates with two novel neuromuscular blocking agents (NMBAs), a proprietary related reversal agent to their NMBAs, and Dex-IN, an intranasal formulation of dexmedetomidine (Dex) that has sedative, analgesic, and anti-anxiety properties.

Gregory Aurand, Senior Research Analyst, Noble Capital Markets, Inc.

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

Board approved a 1:35 reverse split. A shareholder meeting held February 9th approved an amendment granting the Board of Directors authority to effect a reverse split. Last night the Board approved and filed a 1 for 35 reverse split, effective February 16, 2022. This split will help BXRX regain Nasdaq compliance.


New CDC proposal encourages non-opioid therapies.  Last updated in 2016, the CDC has opened a public comment 60-day period for updated guidelines. The updated guidelines remove hard limitations on opioid dosage but, given opioid side effects and addiction problems, continue to recommend non-opioid therapies, like ANJESO, whenever possible to treat chronic and acute pain …

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

*Analyst certification and important disclosures included in the full report. 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 Biotech Announces Clinical Trial with Mayo Clinic to Study PDS0101 in Early Stage Pre-Metastatic- HPV-Associated Head and Neck Cancer

Research, News, and Market Data on PDS Biotech

 

The study evaluates PDS0101 with and without KEYTRUDA^® prior to surgery for HPV-associated oropharyngeal cancer

FLORHAM PARK, N.J., Feb. 15, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced the initiation of an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the checkpoint inhibitor, KEYTRUDA^®, in patients with HPV-associated oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence. The trial is being led by Drs. David Routman, Katharine Price, Kathryn Van Abel, and Ashish Chintakuntlawar of Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck cancers.

HPV(+)OPSCC is now the most common type of head and neck cancer and has been increasing significantly in recent years.  Oropharyngeal cancer is a disease in which cancer cells form in the tonsil tissues of the back (base of tongue) and side (palatine tonsils) of the throat. According to the National Cancer Institute, smoking or being infected with the human papillomavirus (HPV), especially HPV16, can increase the risk of oropharyngeal cancer. The American Cancer Society estimates there are over 54,000 new cases of oral and oropharyngeal cancer and over 11,000 related deaths in the United States, annually.

“We are excited to have a team of doctors at Mayo Clinic conducting a trial to study our novel Versamune^®-based T cell immunotherapy platform and lead asset, PDS0101 in earlier-stage disease,” commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “This upcoming trial not only broadens our addressable patient population of those affected by the increasing incidence of HPV(+)OPSCC, but also allows us to better understand the activity of PDS0101 alone or in combination with KEYTRUDA^® in earlier stages of disease.”

The study treatment will be administered before patients proceed to transoral robotic surgery (TORS) with curative intent. Treatment in this setting is referred to as neoadjuvant treatment. PDS0101 has been shown to induce killer T-cells that target and kill HPV-positive cancers, either alone or in combination with checkpoint inhibitors in preclinical studies, and in combination in clinical studies of patients with advanced recurrent/metastatic HPV-associated cancers.  This study will explore whether PDS0101 with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic regression, and decreases in circulating tumor DNA (ctDNA).

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms.

Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them.  The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate, and ovarian cancers.  

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

PDS Biotech Announces Clinical Trial with Mayo Clinic to Study PDS0101 in Early Stage Pre-Metastatic- HPV-Associated Head and Neck Cancer

Research, News, and Market Data on PDS Biotech

 

The study evaluates PDS0101 with and without KEYTRUDA^® prior to surgery for HPV-associated oropharyngeal cancer

FLORHAM PARK, N.J., Feb. 15, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced the initiation of an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the checkpoint inhibitor, KEYTRUDA^®, in patients with HPV-associated oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence. The trial is being led by Drs. David Routman, Katharine Price, Kathryn Van Abel, and Ashish Chintakuntlawar of Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck cancers.

HPV(+)OPSCC is now the most common type of head and neck cancer and has been increasing significantly in recent years.  Oropharyngeal cancer is a disease in which cancer cells form in the tonsil tissues of the back (base of tongue) and side (palatine tonsils) of the throat. According to the National Cancer Institute, smoking or being infected with the human papillomavirus (HPV), especially HPV16, can increase the risk of oropharyngeal cancer. The American Cancer Society estimates there are over 54,000 new cases of oral and oropharyngeal cancer and over 11,000 related deaths in the United States, annually.

“We are excited to have a team of doctors at Mayo Clinic conducting a trial to study our novel Versamune^®-based T cell immunotherapy platform and lead asset, PDS0101 in earlier-stage disease,” commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “This upcoming trial not only broadens our addressable patient population of those affected by the increasing incidence of HPV(+)OPSCC, but also allows us to better understand the activity of PDS0101 alone or in combination with KEYTRUDA^® in earlier stages of disease.”

The study treatment will be administered before patients proceed to transoral robotic surgery (TORS) with curative intent. Treatment in this setting is referred to as neoadjuvant treatment. PDS0101 has been shown to induce killer T-cells that target and kill HPV-positive cancers, either alone or in combination with checkpoint inhibitors in preclinical studies, and in combination in clinical studies of patients with advanced recurrent/metastatic HPV-associated cancers.  This study will explore whether PDS0101 with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic regression, and decreases in circulating tumor DNA (ctDNA).

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms.

Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them.  The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate, and ovarian cancers.  

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

Tuesday, February 15, 2022

Axcella Therapeutics (AXLA)
AXA1125 Receives Fast Track Designation For NASH Indication

Axcella Health Inc. is a clinical-stage biotechnology company focused on treating complex diseases and improvinge health using endogenous metabolic modulator, or EMM, compositions. Its product candidates are comprised of multiple EMMs that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. The company’s pipeline includes two lead therapeutic candidates:, AXA1665 for the reduction in risk of recurrent overt hepatic encephalopathy (OHE) , and AXA1125 for the treatment of non-alcoholic steatohepatitis (NASH).

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

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

Fast Track Designation Is A Strong Positive.  Axcella announced that the FDA has granted Fast Track Designation for AXA1125 in its non-alcoholic steatohepatitis (NASH) with fibrosis indication. AXA1125 is a formulation of amino acids in development to resolve NASH by controlling metabolic, inflammatory, and fibrotic pathways. AXA 1125 is currently in the Phase 2b EMMPACT clinical trial for the NASH indication.


Fast Track Designation Signifies Recognition Of Potential Impact.  AXA1125 was granted Fast Track Designation after the FDA reviewed clinical data from the previous studies. This designation is intended to assist development and shorten time to market by allowing the company to have more frequent communications about clinical plans and requirements. It can also allow for rolling submission and …

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

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Data Presented at 2022 International Stroke Congress Suggests Role for Non-invasive Vagus Nerve Stimulation (nVNS) for Treatment of Acute Stroke

News and Market Data on electroCore

 

Clinical Trial (n=69) suggests safety and feasibility of nVNS for the acute treatment of stroke.

Relative Ischemic Lesion Growth Decreased by 65.9% with nVNS vs. Sham Treatment.

ROCKAWAY, N.J., 
Feb. 09, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced top line data from three abstracts being presented at the American Heart Associations’ 2022 
International Stroke Conference (
February 9-11, 2022, 
New Orleans) on the possible role of nVNS in the acute treatment of stroke.

The nVNS research presented at the 
International Stroke Conference 2022 includes:

Non-invasive Vagus Nerve Stimulation for The Acute Treatment of Ischemic or Hemorrhagic Stroke (TR-VENUS)

In this randomized, sham controlled, multi-center study conducted at nine academic centers in 
Turkey, the intent-to-treat (ITT) population included 69 subjects (61 ischemic stroke and eight intracerebral hemorrhage) distributed into three treatment arms: sham (n=25), standard-dose nVNS (7 stimulations over one hour; n=19), and high-dose nVNS (7 stimulations in hour 1 and hour 5; n=25). Every subject in the ITT population received all prespecified treatment stimulations per protocol and 97% of all randomized subjects in the study received their first stimulation less than 6 hours from stroke onset. The study met its primary objective with the composite primary safety endpoint being consistent across the three treatment arms indicating that nVNS was able to be administered safely in this acute stroke population. The study also met all secondary safety and feasibility endpoints. Relative infarct growth, measured by diffusion weighted imaging, in the high dose nVNS group (63.3%) was lower than in the sham group (185.8%; p=0.05) against baseline. Dr. Murat Arasava, one of the primary investigators of the TR-VENUS study and Professor of Neurology at the 
Hacettepe University in 
Ankara, Turkey commented, “We are pleased to have successfully completed this first trial of nVNS as a possible treatment for acute stroke and believe our data suggests that nVNS may be safe and feasible in both ischemic and hemorrhagic stroke. The efficacy signal suggested by the reduction in relative infarct growth rate in the ischemic population, which needs to be confirmed in larger studies, clearly provides the basis for additional research to further define the role for nVNS for the acute treatment of stroke.”

Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke (NOVIS)

NOVIS is a prospective randomized clinical trial with blinded outcome assessment being conducted at the 
Leiden University Medical Center (Leiden, 
The Netherlands). 150 patients with ischemic stroke are being randomly allocated (1:1) to nVNS for five days in addition to standard treatment versus standard treatment alone. The primary endpoint is the final infarct volume on day five assessed with MRI. This study features a greater number of stimulations over five days than TR-VENUS, and advanced imaging endpoints including measurement of the penumbra, that should provide additional insight and clarity surrounding the role of nVNS for the acute treatment of ischemic stroke. Dr.  Anne van der Meij, from the 
Leiden University Medical Center, is presenting the poster at the 
International Stroke Conference and commented, “Our study is now more than 50% enrolled and our efficacy endpoints may provide greater definition, and possibly confirmation, of the efficacy of nVNS for the acute treatment of ischemic stroke.”

Effect Of Non-invasive Vagus Nerve Stimulation in Hemorrhagic Brain Injury and Permanent Ischemic Stroke in Rats

Dr.  Ilknur Ay of the 
Massachusetts General Hospital and 
Harvard Medical School presented the results of a pre-clinical study conducted in her lab at the 
Athinoula A. Martinos Center for Biomedical Imaging that supports prior evidence that nVNS may have therapeutic potential in ischemic stroke. The lack of adverse events in two different validated models of Intracerebral Hemorrhage in rats shown in this study suggests that nVNS could be safely administered as early as an ambulatory setting before the stroke etiology (ischemic vs. hemorrhagic) has been determined.

Stroke is ranked as the second leading cause of death worldwide with an annual mortality rate of about 5.5 million. The burden of stroke lies not only in its high mortality rate, but in the high morbidity rate as well with up to 50% of stroke survivors being chronically disabled. Stroke is a disease of immense public health importance with serious economic and social consequences. The public health burden of stroke is set to rise over future decades because of demographic transitions of populations across the world. According to the 
American Heart Association by 2030, 3.88% of the US population >18 years of age is projected to have had a stroke. Between 2012 and 2030, real (2010$) total direct annual stroke-related medical costs are expected to increase from 
$71.55 billion to 
$184.13 billion. Real indirect annual costs (attributable to lost productivity) are projected to rise from 
$33.65 billion to 
$56.54 billion over the same period. Overall, total annual costs of stroke are projected to increase to 
$240.67 billion by 2030, an increase of 129%.

Eric Liebler, Senior Vice President of Neurology for electroCore, commented, “We congratulate all of the investigators, patients and sites that have first in human study suggesting a role for nVNS in treatment of acute stroke. If effective, nVNS would represent a breakthrough treatment that could be safely deployed much earlier, more safely and more easily than current stroke treatments. As time to treatment is considered one of the most critical factors in the acute treatment of stroke, the ability to treat as early as in an ambulatory setting, before the type of stroke (ischemic or hemorrhagic) is confirmed by imaging, would represent a significant advance in the treatment of stroke. We look forward to the anticipated full publication of the TR-VENUS study in a peer reviewed journal later this year and the completion of the NOVIS study in 2023.”

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

For more information, please visit gammaCore.com

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of 
U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential use of nVNS for the acute treatment of stroke and hemorrhagic brain injury, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
jackie.dorsky@electrocore.com

  Phil & Pam Gladwell (Flickr)

FDA Oncology Director Expresses Concerns Over Applicability of Chinese Data

 

The Food and Drug Administration (FDA) will soon begin reviewing two dozen applications for cancer drugs. The trial data is based, in many cases, entirely on tests from mainland China. The U.S. regulator has begun expressing concerns about the quality of studies conducted in China and whether the results should even apply to patients in the U.S.

 

Background

Eli Lilly (LLY) has applied for a license to roll out a lung-cancer immunotherapy developed in China and sell it at a lower price than similar drugs now in the U.S. The application is for a drug called Sintilab, which is a PD-1 monoclonal antibody checkpoint inhibitor for non-small cell lung cancer. The FDA has concerns over the validity of test results. This could threaten the plan to bring the treatment to market later this year. How the FDA concerns translate into actions will become clearer after February 10^th when they begin reviewing the data from Lilly’s Chinese partner, Innovent Biologics Inc. Lilly’s application is just the first of many applications to be considered by the agency, the decision is expected by late March.

The shift in thinking could stall or threaten applications from many large drugmakers, including Eli Lilly and Novartis, who stand to gain billions of dollars in sales from being the conduit for these medicines. It could also heighten trade tensions between the two countries.

 

“The elephant in the room is obviously, what is the quality of the data that is coming from these foreign countries?” Dr. Richard Pazdur, FDA

 

FDA Considerations

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, has been quoted in academic and medical literature about his new concerns regarding “me-too” drugs coming from China and the fundamental challenges they pose to the agency’s drug approval criteria. This includes whether results, provided primarily from test subjects in China, are applicable to Americans, and the validity of the data. Pazdur has said, “We have nothing against drugs being developed in China. Our issue is, are those results generalizable to the U.S. population?”

Clinical trials, especially extensive, late-stage studies that regulators review to decide whether to approve a new drug, are among the highest research and development expenses. Industry executives are watching to see if the newer mindset leads to delays or outright FDA rejections of increased efforts to bring a pipeline of treatments to American patients from abroad. Perhaps measures and additional assessments of benefits and safety profiles on different populations will be needed in the future. Dr. Pazdur has expressed when drugs are tested only or primarily in one country such as China, it is difficult to assess whether the drug would have the same benefits and safety profile in the U.S. population. Dr. Pazdur also said he was concerned the Chinese studies used outdated study designs, which don’t directly establish whether the China-developed drug works, as well as similar drugs, approved in the U.S.

There are also concerns that go beyond the applicability of the data. Dr. Pazdur has also shown concern about the integrity of data generated by drug studies in China. According to the British Medical Journal, an analysis by Chinese regulators in 2016 found that about 80% of domestic drug applications reviewed at that time, contained fabricated, flawed, or insufficient data in the studies – in some cases, there were discrepancies between original study data and what was submitted to regulators.

 

Take-Away

A growing trend of large drugmakers partnering with testing labs in China as part of an application for U.S. FDA approval may be faced with an FDA, that had once been friendly to the idea, but now has openly changed its tone. The new thinking seems to be, that there may be differences in medical care and populations that affect how a drug performs.

This could impact two dozen applications before the FDA. A final agency decision on whether to clear the Lilly/Innovent treatment is expected by the end of March.

Paul Hoffman

Managing Editor, Channelchek

 

Suggested Reading

Understanding the FDA Medical Device Approval Pathways Helps Investors

Immunotherapy to Treat Cancer May Involve Placing Cancer Cells in the Body

Therapeutic Research Advanced by Stem Cell Science

Imugene (IUGNF) – Three Innovative Platforms That Could Change Cancer Treatment

 

Source

https://www.fda.gov/media/156021/download

https://www.statnews.com/2022/02/04/fda-richard-pazdur-cancer-drug-eli-lilly-china/

https://endpts.com/appearing-to-walk-back-fdas-openness-to-foreign-trials-pazdur-suggests-eli-lillys-pd-1-will-face-tough-road-ahead/

https://cancerletter.com/conversation-with-the-cancer-letter/20220204_1/

https://www.wsj.com/articles/fda-raises-concerns-about-china-developed-drugs-11644408180?mod=Searchresults_pos1&page=1

https://www.nejm.org/doi/full/10.1056/NEJMp2116863

 

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Data Presented at 2022 International Stroke Congress Suggests Role for Non-invasive Vagus Nerve Stimulation (nVNS) for Treatment of Acute Stroke

News and Market Data on electroCore

 

Clinical Trial (n=69) suggests safety and feasibility of nVNS for the acute treatment of stroke.

Relative Ischemic Lesion Growth Decreased by 65.9% with nVNS vs. Sham Treatment.

ROCKAWAY, N.J., 
Feb. 09, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced top line data from three abstracts being presented at the American Heart Associations’ 2022 
International Stroke Conference (
February 9-11, 2022, 
New Orleans) on the possible role of nVNS in the acute treatment of stroke.

The nVNS research presented at the 
International Stroke Conference 2022 includes:

Non-invasive Vagus Nerve Stimulation for The Acute Treatment of Ischemic or Hemorrhagic Stroke (TR-VENUS)

In this randomized, sham controlled, multi-center study conducted at nine academic centers in 
Turkey, the intent-to-treat (ITT) population included 69 subjects (61 ischemic stroke and eight intracerebral hemorrhage) distributed into three treatment arms: sham (n=25), standard-dose nVNS (7 stimulations over one hour; n=19), and high-dose nVNS (7 stimulations in hour 1 and hour 5; n=25). Every subject in the ITT population received all prespecified treatment stimulations per protocol and 97% of all randomized subjects in the study received their first stimulation less than 6 hours from stroke onset. The study met its primary objective with the composite primary safety endpoint being consistent across the three treatment arms indicating that nVNS was able to be administered safely in this acute stroke population. The study also met all secondary safety and feasibility endpoints. Relative infarct growth, measured by diffusion weighted imaging, in the high dose nVNS group (63.3%) was lower than in the sham group (185.8%; p=0.05) against baseline. Dr. Murat Arasava, one of the primary investigators of the TR-VENUS study and Professor of Neurology at the 
Hacettepe University in 
Ankara, Turkey commented, “We are pleased to have successfully completed this first trial of nVNS as a possible treatment for acute stroke and believe our data suggests that nVNS may be safe and feasible in both ischemic and hemorrhagic stroke. The efficacy signal suggested by the reduction in relative infarct growth rate in the ischemic population, which needs to be confirmed in larger studies, clearly provides the basis for additional research to further define the role for nVNS for the acute treatment of stroke.”

Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke (NOVIS)

NOVIS is a prospective randomized clinical trial with blinded outcome assessment being conducted at the 
Leiden University Medical Center (Leiden, 
The Netherlands). 150 patients with ischemic stroke are being randomly allocated (1:1) to nVNS for five days in addition to standard treatment versus standard treatment alone. The primary endpoint is the final infarct volume on day five assessed with MRI. This study features a greater number of stimulations over five days than TR-VENUS, and advanced imaging endpoints including measurement of the penumbra, that should provide additional insight and clarity surrounding the role of nVNS for the acute treatment of ischemic stroke. Dr.  Anne van der Meij, from the 
Leiden University Medical Center, is presenting the poster at the 
International Stroke Conference and commented, “Our study is now more than 50% enrolled and our efficacy endpoints may provide greater definition, and possibly confirmation, of the efficacy of nVNS for the acute treatment of ischemic stroke.”

Effect Of Non-invasive Vagus Nerve Stimulation in Hemorrhagic Brain Injury and Permanent Ischemic Stroke in Rats

Dr.  Ilknur Ay of the 
Massachusetts General Hospital and 
Harvard Medical School presented the results of a pre-clinical study conducted in her lab at the 
Athinoula A. Martinos Center for Biomedical Imaging that supports prior evidence that nVNS may have therapeutic potential in ischemic stroke. The lack of adverse events in two different validated models of Intracerebral Hemorrhage in rats shown in this study suggests that nVNS could be safely administered as early as an ambulatory setting before the stroke etiology (ischemic vs. hemorrhagic) has been determined.

Stroke is ranked as the second leading cause of death worldwide with an annual mortality rate of about 5.5 million. The burden of stroke lies not only in its high mortality rate, but in the high morbidity rate as well with up to 50% of stroke survivors being chronically disabled. Stroke is a disease of immense public health importance with serious economic and social consequences. The public health burden of stroke is set to rise over future decades because of demographic transitions of populations across the world. According to the 
American Heart Association by 2030, 3.88% of the US population >18 years of age is projected to have had a stroke. Between 2012 and 2030, real (2010$) total direct annual stroke-related medical costs are expected to increase from 
$71.55 billion to 
$184.13 billion. Real indirect annual costs (attributable to lost productivity) are projected to rise from 
$33.65 billion to 
$56.54 billion over the same period. Overall, total annual costs of stroke are projected to increase to 
$240.67 billion by 2030, an increase of 129%.

Eric Liebler, Senior Vice President of Neurology for electroCore, commented, “We congratulate all of the investigators, patients and sites that have first in human study suggesting a role for nVNS in treatment of acute stroke. If effective, nVNS would represent a breakthrough treatment that could be safely deployed much earlier, more safely and more easily than current stroke treatments. As time to treatment is considered one of the most critical factors in the acute treatment of stroke, the ability to treat as early as in an ambulatory setting, before the type of stroke (ischemic or hemorrhagic) is confirmed by imaging, would represent a significant advance in the treatment of stroke. We look forward to the anticipated full publication of the TR-VENUS study in a peer reviewed journal later this year and the completion of the NOVIS study in 2023.”

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

For more information, please visit gammaCore.com

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of 
U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential use of nVNS for the acute treatment of stroke and hemorrhagic brain injury, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
jackie.dorsky@electrocore.com

Tuesday, February 08, 2022

Cocrystal Pharma Inc. (COCP)
Drugs For COVID-19 Advance As The Pandemic Won’t Go Away

Cocrystal Pharma Inc is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, hepatitis C viruses, and noroviruses. The company employs structure-based technologies and Nobel Prize-winning expertise to create first-and best-in-class antiviral drugs. It is developing CC-31244, an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). CC-31244 is currently being evaluated in a Phase 2a study for the treatment of hepatitis C as part of a cocktail for ultra-short therapy of 4 to 6 weeks.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

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

Cocrystal Makes Progress Against SARS-CoV-2.  In November 2021, the SARS-CoV-2 Omicron variant was identified as a new, highly contagious strain. Although less virulent than other strains, its genetic variations allowed it to evade immune protection from current vaccines. Since then, variants have been identified with genetic sequences showing emergence after the Omicron strain. We believe this highlights the need for new drugs with different mechanisms of action and long-term efficacy.


Cocrystal Has Developed Drugs That Block Viral Reproduction.  Cocrystal has been developing drugs that block the RNA protease enzyme needed for viral replication. These are highly conserved proteins that do not vary between strains and can be effective against new variants. This contrasts with the current COVID-19 vaccines that stimulate an immune response against a viral surface marker which can …

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

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Neovasc Announces German Reimbursement Renewal and Commercial Progress

Research, News, and Market Data on Neovasc

 

VANCOUVER and MINNEAPOLIS – ( NewMediaWire ) – February 08, 2022 –  Neovasc, Inc. (Neovasc or the Company) ( NASDAQ , TSX : NVCN) today announced the German Institute for the Hospital Remuneration System (“InEK”) has awarded the Neovasc Reducer™ (“Reducer”), a CE-Marked medical device for the treatment of refractory angina, NUB Status 1 designation yet again for 2022. Additionally, the Company announced the 500th patient has been treated in Germany.

New examination and treatment methods (NUBs) are comprised of novel and innovative medicines, medical products and procedures that can be utilized by hospitals before reaching full reimbursement eligibility. The NUB process opens the path for negotiations between hospitals and health insurers for the reimbursement of new medical treatments in the German healthcare system. InEK is responsible for prioritizing new therapies in Germany through the NUB process.

Reducer has been granted Status 1 the highest priority designation available. The NUB decision is valid for one year and can be renewed annually. For 2022, 256 German hospitals applied for the Reducer NUB, and they can now negotiate full reimbursement coverage for the Reducer therapy.

“Our team has been focused on securing broad reimbursement coverage for Reducer so more patients can benefit from the therapy,” commented Fred Colen, Chief Executive Officer of Neovasc. “Obtaining NUB Status 1 for 2022 from the German reimbursement authorities is a vital component of our overall strategy. In the past several quarters, we have had significant reimbursement wins in Germany, France, the U.K., and the United States. These reimbursement expansions are a testament to the profound impact that the Reducer can have on patients.”

500th patient treated with the Reducer in Germany

The Cardiology team at Helios-Kliniken, Schwerin, Germany recently completed the 500th implant of the Reducer in Germany. The procedure marks another meaningful step as the Company continues to expand adoption of the procedure. Prof. Alexander Staudt, Director of Cardiology, and Dr. Philipp Hammer performed the procedure.

“We are extremely grateful to be able to offer this treatment for our patients with chronic refractory angina,” commented Prof. Staudt. “Prior to the availability of the Reducer, we struggled to treat these patients. Now, we have a reliable treatment option that offers them hope.”

About Reducer

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. Reducer is investigational in the United States in the COSIRA-II clinical trial. Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, affects millions of patients worldwide, who typically lead severely restricted lives because of their disabling symptoms. The Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is under clinical investigation in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com.

Contacts

Investors:
Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com

Media:
Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: Sean.Leous@westwicke.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the Company’s focus on securing broad reimbursement coverage for Reducer, the impact that the Reducer can have on patients, the growing incidence of refractory angina and the growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company considering its experience and its perception of historical trends, current conditions and expected future developments, market, and other conditions as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company’s actual results, performance, or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and nine months ended September 30, 2021 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Neovasc Announces German Reimbursement Renewal and Commercial Progress

Research, News, and Market Data on Neovasc

 

VANCOUVER and MINNEAPOLIS – ( NewMediaWire ) – February 08, 2022 –  Neovasc, Inc. (Neovasc or the Company) ( NASDAQ , TSX : NVCN) today announced the German Institute for the Hospital Remuneration System (“InEK”) has awarded the Neovasc Reducer™ (“Reducer”), a CE-Marked medical device for the treatment of refractory angina, NUB Status 1 designation yet again for 2022. Additionally, the Company announced the 500th patient has been treated in Germany.

New examination and treatment methods (NUBs) are comprised of novel and innovative medicines, medical products and procedures that can be utilized by hospitals before reaching full reimbursement eligibility. The NUB process opens the path for negotiations between hospitals and health insurers for the reimbursement of new medical treatments in the German healthcare system. InEK is responsible for prioritizing new therapies in Germany through the NUB process.

Reducer has been granted Status 1 the highest priority designation available. The NUB decision is valid for one year and can be renewed annually. For 2022, 256 German hospitals applied for the Reducer NUB, and they can now negotiate full reimbursement coverage for the Reducer therapy.

“Our team has been focused on securing broad reimbursement coverage for Reducer so more patients can benefit from the therapy,” commented Fred Colen, Chief Executive Officer of Neovasc. “Obtaining NUB Status 1 for 2022 from the German reimbursement authorities is a vital component of our overall strategy. In the past several quarters, we have had significant reimbursement wins in Germany, France, the U.K., and the United States. These reimbursement expansions are a testament to the profound impact that the Reducer can have on patients.”

500th patient treated with the Reducer in Germany

The Cardiology team at Helios-Kliniken, Schwerin, Germany recently completed the 500th implant of the Reducer in Germany. The procedure marks another meaningful step as the Company continues to expand adoption of the procedure. Prof. Alexander Staudt, Director of Cardiology, and Dr. Philipp Hammer performed the procedure.

“We are extremely grateful to be able to offer this treatment for our patients with chronic refractory angina,” commented Prof. Staudt. “Prior to the availability of the Reducer, we struggled to treat these patients. Now, we have a reliable treatment option that offers them hope.”

About Reducer

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. Reducer is investigational in the United States in the COSIRA-II clinical trial. Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, affects millions of patients worldwide, who typically lead severely restricted lives because of their disabling symptoms. The Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is under clinical investigation in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com.

Contacts

Investors:
Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com

Media:
Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: Sean.Leous@westwicke.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the Company’s focus on securing broad reimbursement coverage for Reducer, the impact that the Reducer can have on patients, the growing incidence of refractory angina and the growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company considering its experience and its perception of historical trends, current conditions and expected future developments, market, and other conditions as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company’s actual results, performance, or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and nine months ended September 30, 2021 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Tuesday, February 08, 2022

Cocrystal Pharma Inc. (COCP)
Drugs For COVID-19 Advance As The Pandemic Won’t Go Away

Cocrystal Pharma Inc is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, hepatitis C viruses, and noroviruses. The company employs structure-based technologies and Nobel Prize-winning expertise to create first-and best-in-class antiviral drugs. It is developing CC-31244, an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). CC-31244 is currently being evaluated in a Phase 2a study for the treatment of hepatitis C as part of a cocktail for ultra-short therapy of 4 to 6 weeks.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

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

Cocrystal Makes Progress Against SARS-CoV-2.  In November 2021, the SARS-CoV-2 Omicron variant was identified as a new, highly contagious strain. Although less virulent than other strains, its genetic variations allowed it to evade immune protection from current vaccines. Since then, variants have been identified with genetic sequences showing emergence after the Omicron strain. We believe this highlights the need for new drugs with different mechanisms of action and long-term efficacy.


Cocrystal Has Developed Drugs That Block Viral Reproduction.  Cocrystal has been developing drugs that block the RNA protease enzyme needed for viral replication. These are highly conserved proteins that do not vary between strains and can be effective against new variants. This contrasts with the current COVID-19 vaccines that stimulate an immune response against a viral surface marker which can …

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

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Record-Breaking Rapid DNA Sequencing Promises Timely Diagnosis for Thousands of Rare Disease Cases

 

For children suffering from rare diseases, it usually takes years to receive a diagnosis. This “diagnostic odyssey” is filled with multiple referrals and a barrage of tests, seeking to uncover the root cause behind mysterious and debilitating symptoms.

A new speed record in DNA sequencing may soon help families more quickly find answers to difficult and life-altering questions.

In just 7 hours, 18 minutes, a team of researchers at Stanford Medicine went from collecting a blood sample to offering a disease diagnosis. This unprecedented turnaround time is the result of ultra-rapid DNA sequencing technology paired with massive cloud storage and computing. This improved method of diagnosing diseases allows researchers to discover previously undocumented sources of genetic diseases, shining new light on the 6 billion letters in the human genome.

More than 7,000 rare diseases affect 300 million people worldwide, 50% of whom are children. Of these diseases, 80% have a genetic component. The onset of some rare genetic diseases can be swift and debilitating. Spotting symptoms and identifying the root cause is a race against the clock for many families.

 

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and opinions of Joseph P. Laycock, Assistant Professor of Religious Studies, Texas, Kevin Doxzen Postdoctoral Fellow in Precision Medicine and Emerging Biotechnologies, Arizona State University.

 

I’m a biotechnology and policy scholar who works on improving access to innovative health care technologies. Whether it’s simple and affordable tests or sophisticated and expensive gene therapies, medical breakthroughs need to reach populations around the world. I believe that ultra-rapid DNA sequencing is key to casting a wider net and providing a faster turnaround for diagnosing rare diseases.

 

A New Guinness World Record

The Human Genome Project, the first successful attempt to sequence a complete or “whole” human genome, took 13 years, from 1990 to 2003, and cost $2.7 billion. In 2014, the field of whole genome sequencing passed another major milestone by hitting the $1,000 price point. Every year, the cost of sequencing continues to fall, driven by engineering and computational innovation.

In their quest for a world record, Stanford researchers reached for a DNA sequencing platform from the company Oxford Nanopore Technologies, which developed a device that reads genomes by pulling large strands of DNA through pores comparable in size and composition to the openings in biological cell membranes. As a DNA strand passes through the pore, the device reads subtle electrical changes unique to each DNA letter, thus detecting the DNA sequence.

 

Researchers at Stanford University set the record for sequencing a human genome – 5 hours, 2 minutes. Steve Fisch/courtesy of Stanford Medicine

 

Thousands of these pores are distributed across a device called a flow cell. The researchers sequenced a single patient’s genome across 48 flow cells simultaneously, allowing them to read the entire genome in a record time of 5 hours, 2 minutes.

The ultra-rapid DNA sequencing generated terabytes of data, which was moved to a cloud-based storage system. In the cloud, algorithms scanned the genome, looking for tiny variations – mutations – within the DNA sequence that could help explain the origin of a genetic disease.

 

Rewriting the Diagnostic Odyssey

If a disease’s origin is thought to reside in the genome, the standard medical way forward is to order a gene panel. This test sequences a list of predetermined genes for possible disease-causing mutations. Receiving test results usually takes two to three weeks but can take up to eight weeks, and can miss mutations in genes not on the list.

Shortening the sequencing and analysis process to seven hours and expanding the sequencing from a few genes to the entire genome could fundamentally alter the diagnostic odyssey. Ultra-rapid DNA sequencing has already made a difference in the lives of two children.

Matthew Junzman, a 13-year-old from Oregon, was rushed to Stanford Hospital and placed on life support. His heart was failing, and no one knew why. Doctors narrowed down the cause to two options: myocarditis, a reversible condition involving inflammation of the heart, or an untreatable genetic condition.

In the Stanford study, doctors performed an ultra-rapid DNA sequencing test, which quickly revealed that Matthew had a genetic condition. He was immediately placed on a transplant list and received a new heart three weeks later.

In the same study, a 3-month-old patient was admitted to the pediatric hospital suffering from seizures. Using the ultra-rapid DNA sequencing process, doctors quickly spotted a mutation in a gene that explained the seizures. Standard tests would have initially missed this diagnosis.

 

Disease Diagnosis is a Global Problem

Advances in health care technology typically have a high price tag when they first become available. Corporate competition, cheaper materials and new generations of technology can help drive down costs. But infrastructure, political and regulatory hurdles all contribute to limiting global access.

While Oxford Nanopore’s technology is cheaper than several alternative sequencing devices, costs of equipment and materials are still prohibitively expensive for labs in many countries. Similarly, less than 20% of low- and middle-income countries have modern data infrastructure. This removes the possibility of cloud computing in many places.

Researchers in Africa are working to ensure that African populations are represented in and benefit from advances in genomic research.

Bringing ultra-rapid DNA sequencing to these countries will involve investing in regional efforts to support genomic research. For example, the Human Heredity & Health in Africa Initiative invests in scientific infrastructure and workforce development to study health and disease for African populations. Providing groups like these with the equipment and software needed for ultra-rapid DNA sequencing will ensure that rare diseases that are more common in African populations will not go unexplored.

There are no approved treatments for 95% of rare diseases. The limited number of individuals affected by a given rare disease makes it difficult to study symptoms and design clinical trials. Creating data-sharing systems and crafting regulations will be vital to allow people to safely share their personal information between countries. The European Joint Program on Rare Diseases and the Global Alliance for Genomics & Health are making progress toward these goals, building bridges between rare disease communities around the world.

As ultra-rapid genome sequencing becomes a feature in hospitals across high-income countries, I believe it’s important to consider how the broader rare disease community will have access to these tools and benefit from the wave of new disease insight on the horizon.

 

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