electroCore Provides Business Update and Select Third Quarter 2021 Financial Guidance

 

• Third quarter 2021 revenue expected to be approximately $1.5 million
  
• Net cash used to fund operations in the third quarter 2021 of approximately $3.5 million

ROCKAWAY, NJ, 
Oct. 12, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today provided an operating and business update as well as select unaudited preliminary financial guidance for the third quarter of 2021.

“We are pleased to announce preliminary third quarter results, which continued to show sequential growth in our revenue generating channels.,” stated  Dan Goldberger, Chief Executive Officer of electroCore. “Revenue for the quarter ended 
September 30, 2021, is expected to be approximately 
$1.5 million. Our headache markets in the US and 
UK were impacted somewhat by the pandemic and we look forward to accelerating revenue in the future.”

Government Channels: During the third quarter of 2021, the company expects to recognize revenue of approximately 
$946,000 pursuant to the 
Department of Veterans Affairs (“VA”) and 
Department of Defense (“DoD”) originating prescriptions, compared to 
$779,000 during the second quarter of 2021 and 
$646,000 third quarter of 2020. 96 
VA and 
DoD military treatment facilities have purchased gammaCore products through 
September 30, 2021, as compared to 85 through the second quarter 2021 and 67 through the third quarter of 2020. 

Outside of the U.S.: During the third quarter of 2021, electroCore expects to recognize revenue of approximately 
$371,000 outside of 
the United States through direct channels, as compared to 
$369,000 during the second quarter of 2021 and 
$278,000 during the third quarter of 2020. These figures do not include new global stocking distributors which contributed revenues from 
Australia, 
Canada, and 
Qatar.

The company continued to expand its distributor relationships internationally, entering into an agreement with 
Kromax South Asia Ptd Ltd. to serve as the exclusive distributor of the gammaCore Sapphire^TM non-invasive vagus nerve stimulator (nVNS) in 
Malaysia, 
Singapore, and 
Indonesia.

Commercial: The company continues to make targeted investments in its Commercial channel. In 
January 2021, CMS published its Level II Healthcare Common Procedure Coding System, commonly known as HCPCS, including a unique code “K1020” for “Non-invasive vagus nerve stimulator,” which went into effect on 
April 1, 2021. During the third quarter, the company received a favorable coverage determination from a second regional payor and continues to work on obtaining additional positive medical benefit coverage decisions.

The company continues to develop cash pay business models for commercial patients with high deductible benefit plans or whose insurance does not yet cover nVNS therapy. More than 40 physicians’ offices in the US are currently offering the cash pay alternative contributing approximately 
$75,000 of revenue in the quarter ended 
September 30, 2021.

Financial Guidance: electroCore today announced the following preliminary unaudited financial guidance for the third quarter of 2021:

Third Quarter Revenue: electroCore anticipates that third quarter 2021 revenue will be approximately 
$1.5 million. This represents a 15% increase over second quarter 2021 revenue of 
$1.3 million and 36% growth over third quarter 2020 revenue of 
$1.1 million.

September 30, 2021 Cash: The company ended the third quarter of 2021 with approximately 
$39.0 million of cash, cash equivalents and marketable securities, compared to 
$23.7million as of the end of the second quarter 2021. Net cash used from operations in the third quarter was approximately 
$3.5 million. During the third quarter, the company raised net proceeds of approximately 
$18.8 million through a public offering of its common stock.

Mr. Goldberger commented further, “We continue to be enthusiastic about the prospects of the business.  We have a strong balance sheet which will support our continued efforts to educate and improve physician and patient awareness, which we believe will ultimately lead to the successful adoption of gammaCore globally.” 

The company intends to provide a detailed operational and financial update during its third quarter 2021 earnings call in 
November 2021.

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^TM
gammaCore^TM (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. 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

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

The 
U.S. FDA has cleared the gammaCore Sapphire CV (nVNS) device under an emergency use authorization for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved pharmacologic therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using noninvasive vagus nerve stimulation (nVNS) on either side of the patient’s neck.
gammaCore Sapphire CV has been authorized only for the duration of the statement that circumstances exist that warrant authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbbb-3(b)(1), until the authorization is terminated or revoked.

More information can be found at:
Letter of authorization: https://www.fda.gov/media/139967/download
Fact sheet for healthcare workers: https://www.fda.gov/media/139968/download
Patient information sheet: https://www.fda.gov/media/139969/download
Instructions for use of gammaCore: https://www.fda.gov/media/139970/download

Forward-Looking Statements
This press release 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 expectations for revenue and cash used in operations during the third quarter of 2021, its expectations for future performance, as well as electroCore’s business prospects and clinical and product development plans for 2021 and beyond, its pipeline or potential markets for its technologies, additional indications for gammaCore, the timing, outcome and impact of regulatory, clinical and commercial developments (including human trials for the study of headache, PTH, mTBI, Parkinson’s diseases and sleep deprivation stress and the business, operating or financial impact of such studies), further international expansion, and statements about anticipated distribution arrangements, government and payor funding arrangements (including those relating to 
Canada, 
Western Europe, 
Qatar, 
Taiwan, and 
China) 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™, 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 CockrellCG Capital
404-736-3838
ecor@cg.capital

or

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

	Image Credit: Tima Miroshnichenko (Pexels)

Weighing Cancer Cells to Personalize Drug Choices

 

Anne Trafton |  MIT News Office

“With this disease, you don’t have much time to make adjustments. So, if you take an ineffective drug for six months, that’s pretty significant,” Ligon says. “This kind of assay could help to speed up the learning process for each individual patient and help with decision-making.”

Researchers at MIT and Dana-Farber Cancer Institute have developed a new way to determine whether individual patients will respond to a specific cancer drug or not. This kind of test could help doctors to choose alternative therapies for patients who don’t respond to the therapies normally used to treat their cancer.

The new technique, which involves removing tumor cells from patients, treating the cells with a drug, and then measuring changes in the cells’ mass, could be applied to a wide variety of cancers and drug treatments, says Scott Manalis, the David H. Koch Professor of Engineering in the departments of Biological Engineering and Mechanical Engineering, and a member of the Koch Institute for Integrative Cancer Research.

“Essentially all of the clinically used cancer drugs either directly or indirectly stop the growth of cancer cells,” Manalis says. “That’s why we think measuring mass could offer a universal readout of the effects of a lot of different types of drug mechanisms.”

The new study, which focused on glioblastoma, an aggressive form of brain cancer, is part of a collaboration between the Koch Institute and Dana-Farber Precision Medicine programs to find new biomarkers and diagnostic tests for cancer.

Manalis and Keith Ligon, director of the Center for Patient Derived Models at Dana-Farber and an associate professor at Harvard Medical School, are the senior authors of the study, which appears today in Cell Reports. The lead authors of the paper are Max Stockslager SM ’17, PhD ’20 and Dana-Farber research technician Seth Malinowski.

 

Measuring Cancer Cells

Glioblastoma, which is diagnosed in about 13,000 Americans per year, is incurable, but radiation and drug treatment can help to prolong patients’ expected lifespan. Most do not survive longer than one to two years.

“With this disease, you don’t have much time to make adjustments. So, if you take an ineffective drug for six months, that’s pretty significant,” Ligon says. “This kind of assay could help to speed up the learning process for each individual patient and help with decision-making.”

Patients diagnosed with glioblastoma are usually given a chemotherapy drug called temozolomide (TMZ). However, this drug only helps about 50 percent of patients.

Currently doctors can use a genetic marker — methylation of a gene called MGMT — to predict whether patients will respond to TMZ treatment. Patients who have this marker usually respond better to the drug. However, the marker doesn’t offer reliable predictions for all patients because of other genetic factors. For patients who don’t respond to TMZ, there are a handful of alternative drugs available, Ligon says, or patients can choose to participate in a clinical trial.

In recent years, Manalis and Ligon have been working on a new approach to predicting patient responses, which is based on measuring how tumor cells respond to treatment, rather than genomic signatures. This approach is known as functional precision medicine.

“The idea behind functional precision medicine is that, for cancer, you could take a patient’s tumor cells, give them the drugs that the patient might get, and predict what would happen, before giving them to the patient,” Ligon says.

Scientists are working on many different approaches to functional precision medicine, and one technique that Manalis and Ligon have been pursuing is measuring changes in cell mass that occur following drug treatment. The approach is based on a technology developed by Manalis’ lab for weighing single cells with extremely high accuracy by flowing them through vibrating microchannels.

Several years ago, Manalis, Ligon, and their colleagues demonstrated that they could use this technology to analyze how two types of cancer, glioblastoma and acute lymphoblastic leukemia, respond to treatment. This result was based on measuring individual cells multiple times after drug treatment, allowing the researchers to calculate how their growth rate changed over time following treatment. They showed that this statistic, which they called mass accumulation rate (MAR), was strongly predictive of whether the cells were susceptible to a given drug.

Using a high-throughput version of this system, which they developed in 2016, they could calculate an accurate MAR using just 100 cells per patient. However, a drawback to the MAR technique is that the cells must remain in the system for several hours, so they can be weighed over and over, in order to calculate the growth rate over time.

In their new study, the researchers decided to see if a simpler and significantly faster approach — measuring subtle changes in single-cell mass distributions between drug-treated and untreated cancer cells — would be able to predict patient survival. They performed a retrospective study with a set of live glioblastoma tumor cells from 69 patients, donated to the Ligon lab and the Dana-Farber Center for Patient Derived Models, and used them to grow spheroid tissue cultures. After separating the cells, the researchers treated them with TMZ and then measured their mass a few days later.

They found that by simply measuring the mass difference between cells before and after treatment, using as few as 2,000 cells per patient sample, they could accurately predict whether the patient had responded to TMZ or not.

 

Better Predictions

The researchers showed that their mass measurement was just as accurate as the MGMT methylation marker, but mass measurement has an added advantage in that it can work in patients for whom the genetic marker doesn’t reveal TMZ susceptibility. For many other types of cancer, there are no biomarkers that can be used to predict drug response.

“Most cancers do not have a genomic marker that can be used at all. What we argue is that this functional approach could work in other situations where you don’t have any option of a genomic marker,” Manalis says.

Because the test works by measuring changes in mass, it can be used to observe the effects of many different types of cancer drugs, regardless of their mechanism of action. TMZ works by arresting the cell cycle, which causes cells to become larger because they can no longer divide but they still increase their mass. Other cancer drugs work by interfering with cell metabolism or damaging their structure, which also affect cell mass.

 

 

The researchers’ long-term hope is that this approach could be used to test several different drugs on an individual patient’s cells, to predict which treatment would work best for that patient.

“Ideally we would test the drug the patient was most likely to get, but we would also test for things that would be the backup plan: first-, second-, and third-line therapies, or different combinations of drugs,” says Ligon, who also serves as chief of neuropathology at the Brigham and Women’s Hospital and a consultant in pathology at Boston Children’s Hospital.

Manalis and Ligon have co-founded a company called Travera, which has licensed this technology and is now gathering data from patient samples from several different types of cancer, in hopes of developing clinically validated lab tests that can be used to help patients.

The research was funded by the MIT Center for Precision Cancer Medicine, the DFCI Center for Patient Derived Models, the Cancer Systems Biology Consortium of the National Cancer Institute, and the Koch Institute Support (core) Grant from the National Cancer Institute.

 

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Thursday, October 07, 2021

Avivagen Inc. (VIVXF)(VIV:CA)
Management Call on AB Vista Distribution Agreement

Avivagen Inc is a Canadian based company operating in the healthcare sector. It develops science-based, natural health products for animals. It develops and commercializes products for livestock feeds to replace antibiotics for growth promotion and to help prevent disease by supporting the animal’s own health defenses. Its product range includes OxC-beta, Vivamune health chews, Oximunol chewable tablets, and Carotenoid Oxidation products.

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.

Agreement. As we had anticipated, Avivagen has entered into a distribution agreement focused on the U.S., Brazil, and Thailand markets. The 8-year agreement is with AB Vista. We expect the agreement to expand the adoption and use of OxC-beta in a number of high-value feed production markets worldwide. The AB Vista agreement should bring additional credibility for OxC-beta across the feed additive industry.


Who Is AB Vista? AB Vista is a a global animal nutrition technology company supplying feed additives, nutrition expertise and analytical services to animal feed and protein producers.  The Company is one of the top distributors of feed enzymes worldwide, with a large technical sales force. We believe AB Vista will be able to leverage its existing relationships and distribution partnerships for …

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. 

MedX Health President of Dermatology Services Mike Druhan delivers a formal corporate overview, followed by a Q & A session moderated by Noble Capital Markets Senior Healthcare Services & Medical Devices Analyst Gregory Aurand. Return to the Investor Forum Event Page MedX, headquartered in Ontario, Canada, is a leading medical device and software company focused on skin health with its SIAscopy® on DermSecure® telemedicine platform, utilizing its SIAscopy® technology. SIAscopy® is also imbedded in its products SIAMETRICS®, SIMSYS®, and MoleMate®, which MedX manufactures in its ISO 13485 certified facility. SIAMETRICS®, SIMSYS®, and MoleMate® include hand-held devices that use patented technology utilizing light and its remittance to view up to 2 mm beneath suspicious moles and lesions in a pain free, non-invasive manner, with its software then creating real-time images for physicians and dermatologists to evaluate all types of moles or lesions within seconds. These products are cleared by Health Canada, the U.S. Food and Drug Administration, the Therapeutic Goods Administration and Conformité Européenne for use in Canada, the US, Australia, New Zealand, the European Union, Brazil and Turkey. Visit https://medxhealth.com. News & Advanced Market Data on MDXHF

ProMIS Neurosciences Announces Special Shareholder Meeting

 

TORONTO, Ontario and CAMBRIDGE, Mass. – October 7, 2021 – ProMIS Neurosciences Inc. (TSX: PMN) (OTCQB: ARFXF) (the “Company”), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, is pleased to announce that it will hold a special general meeting of shareholders (the “Special Meeting”) on December 1, 2021. The Company has set October 18, 2021, as the record date for the Special Meeting.

The purpose of the Special Meeting is to ask shareholders to grant the Board of Directors (the “Board”) the authority, exercisable in the Board’s discretion, to consolidate (or reverse split) the Company’s issued and outstanding common shares in furtherance of a potential listing of the Company’s shares on a stock exchange in the United States.  The full particulars of the special business will be set out in the management information circular for the Special Meeting, which will be mailed to shareholders and filed on SEDAR after the record date. 

“With the recent closing of our successful financing, our lead program PMN310 is presently on track to complete all of the work necessary to file an IND in the second half of 2022 as well as initiate Phase 1 clinical trials soon thereafter,” stated Eugene Williams, the Company’s Executive Chairman.   “We believe a listing on a stock exchange in the United States, which should provide greater liquidity for our shareholders, should also provide greater access to capital to help expedite the development of our potential therapies and the process of obtaining clinical validation of such potential therapies.”

At the Special Meeting, the shareholders will be specifically asked to consider, and if deemed advisable, pass a special resolution authorizing the Board to determine, at its discretion, to file articles of amendment to consolidate the common shares of the Company at a consolidation ratio within the range to be specified in the proxy materials.  Subject to shareholder approval, the Board intends to proceed with a share consolidation in furtherance of a listing of the Company’s shares on a stock exchange in the United States but there can be no assurances that any such listing will occur following shareholder approval, a share consolidation or otherwise.  Further, there is no assurance that the Company will meet the quantitative or qualitative requirements to list on a stock exchange in the United States.  Finally, notwithstanding approval of the resolution by shareholders, the Board will retain the discretion to elect not to proceed with the share consolidation.

Any authority proposed to be granted to the Board to consolidate the shares is conditional upon the prior approval of the Toronto Stock Exchange.

About ProMIS Neurosciences 

ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery engine is based on the use of two complementary techniques. The Company applies its thermodynamic, computational discovery platform—ProMI and Collective Coordinates—to predict novel targets, known as Disease Specific Epitopes, on the molecular surface of misfolded proteins. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and PD. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

For further information about ProMIS Neurosciences, please consult the Company’s website at: www.promisneurosciences.com  

For Investor Relations please contact: 

Alpine Equity Advisors Nicholas Rigopulos, President nick@alpineequityadv.com Tel. 617 901-0785 

 

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release.  

This news release contains certain “forward-looking statements” within the meaning of such statements under applicable securities law. Forward-looking statements are frequently characterized by words such as “anticipates”, “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed”, “positioned” and other similar words, or statements that certain events or conditions “may” or “will” occur including, but not limited to, statements related to the intent of the Company to pursue a potential listing of its common shares on a stock exchange in the United States and the potential benefits to the Company and its shareholders related to such a listing, the Company conducting a share consolidation in furtherance of a potential listing of its common shares on a stock exchange in the United States and the potential timing for the filing of an IND and the commencement of clinical trials related to the Company’s lead program PMN310. Readers are cautioned that forward-looking statements are based on certain assumptions and are subject to known and unknown risks and uncertainties (both general and specific) that contribute to the possibility that the future events or circumstances contemplated by such forward-looking information will not occur.  Such risks and uncertainties with respect to the forward-looking statements contained in this news release include, but are not limited to, the Company obtaining shareholder and Toronto Stock Exchange approval for a consolidation of its common shares, the Company’s ability to generally meet the quantitative and qualitative requirements to list its common shares on a stock exchange in the United States, the trading volumes in the Company’s common shares increasing as a result of a listing on a stock exchange in the United States, the Company’s ability to access capital improving as a result of a listing on a stock exchange in the United States, and the Company obtaining the necessary regulatory approvals and satisfying the other requirements to file an IND and commence its clinical trials related to its lead program PMN310 soon thereafter.  Readers should also refer to the risk factors set forth in the Company’s continuous disclosure documents available at SEDAR (www.sedar.com). There can be no assurance that the plans, intentions or expectations upon which forward-looking statements are based will be realized. Actual results may differ, and the difference may be material and adverse to the Company and its shareholders.  Therefore, readers should not place undue reliance upon such forward-looking statements.  The Company does not intend, and does not assume any obligation, to update these forward-looking statements in order to reflect events or circumstances that may arise after the date of this news release except as required by applicable law or regulatory requirements. 

Baudax Bio President and CEO Gerri Henwood delivers a formal corporate overview, followed by a Q & A session moderated by Noble Capital Markets Senior Healthcare Services & Medical Devices Analyst Gregory Aurand. Return to the Investor Forum Event Page Baudax Bio is a pharmaceutical company focused on commercializing and developing innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs. For more information, please visit www.baudaxbio.com. News & Advanced Market Data on BXRX

BioElectronics VP of Product Development Sree Koneru delivers a formal corporate overview, followed by a Q & A session moderated by Noble Capital Markets Senior Healthcare Services & Medical Devices Analyst Gregory Aurand. Return to the Investor Forum Event Page Headquartered in Frederick, Maryland, and founded in 2000, BioElectronics Corporation is the leading company in the field on non-invasive electroceutical medical devices. BioElectronics is the maker of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Therapy for postoperative pain and chronic wound care. News & Advanced Market Data on BIEL

Heron Therapeutics CEO Barry Quart & President John Poyhonen deliver a formal corporate overview, followed by a Q & A session moderated by Noble Capital Markets Senior Healthcare Services & Medical Devices Analyst Gregory Aurand. Return to the Investor Forum Event Page Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com. News & Advanced Market Data on HRTX

electroCore CEO Daniel Goldberger delivers a formal corporate overview, followed by a Q & A session moderated by Noble Capital Markets Senior Healthcare Services & Medical Devices Analyst Gregory Aurand. Return to the Investor Forum Event Page 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 and the acute treatment of migraine and episodic cluster headache. News & Advanced Market Data on ECOR

New Developments in Pain Management – a NobleCon Online Investor Event
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ProMIS Neurosciences Announces Special Shareholder Meeting

 

TORONTO, Ontario and CAMBRIDGE, Mass. – October 7, 2021 – ProMIS Neurosciences Inc. (TSX: PMN) (OTCQB: ARFXF) (the “Company”), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, is pleased to announce that it will hold a special general meeting of shareholders (the “Special Meeting”) on December 1, 2021. The Company has set October 18, 2021, as the record date for the Special Meeting.

The purpose of the Special Meeting is to ask shareholders to grant the Board of Directors (the “Board”) the authority, exercisable in the Board’s discretion, to consolidate (or reverse split) the Company’s issued and outstanding common shares in furtherance of a potential listing of the Company’s shares on a stock exchange in the United States.  The full particulars of the special business will be set out in the management information circular for the Special Meeting, which will be mailed to shareholders and filed on SEDAR after the record date. 

“With the recent closing of our successful financing, our lead program PMN310 is presently on track to complete all of the work necessary to file an IND in the second half of 2022 as well as initiate Phase 1 clinical trials soon thereafter,” stated Eugene Williams, the Company’s Executive Chairman.   “We believe a listing on a stock exchange in the United States, which should provide greater liquidity for our shareholders, should also provide greater access to capital to help expedite the development of our potential therapies and the process of obtaining clinical validation of such potential therapies.”

At the Special Meeting, the shareholders will be specifically asked to consider, and if deemed advisable, pass a special resolution authorizing the Board to determine, at its discretion, to file articles of amendment to consolidate the common shares of the Company at a consolidation ratio within the range to be specified in the proxy materials.  Subject to shareholder approval, the Board intends to proceed with a share consolidation in furtherance of a listing of the Company’s shares on a stock exchange in the United States but there can be no assurances that any such listing will occur following shareholder approval, a share consolidation or otherwise.  Further, there is no assurance that the Company will meet the quantitative or qualitative requirements to list on a stock exchange in the United States.  Finally, notwithstanding approval of the resolution by shareholders, the Board will retain the discretion to elect not to proceed with the share consolidation.

Any authority proposed to be granted to the Board to consolidate the shares is conditional upon the prior approval of the Toronto Stock Exchange.

About ProMIS Neurosciences 

ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery engine is based on the use of two complementary techniques. The Company applies its thermodynamic, computational discovery platform—ProMI and Collective Coordinates—to predict novel targets, known as Disease Specific Epitopes, on the molecular surface of misfolded proteins. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and PD. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

For further information about ProMIS Neurosciences, please consult the Company’s website at: www.promisneurosciences.com  

For Investor Relations please contact: 

Alpine Equity Advisors Nicholas Rigopulos, President nick@alpineequityadv.com Tel. 617 901-0785 

 

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release.  

This news release contains certain “forward-looking statements” within the meaning of such statements under applicable securities law. Forward-looking statements are frequently characterized by words such as “anticipates”, “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed”, “positioned” and other similar words, or statements that certain events or conditions “may” or “will” occur including, but not limited to, statements related to the intent of the Company to pursue a potential listing of its common shares on a stock exchange in the United States and the potential benefits to the Company and its shareholders related to such a listing, the Company conducting a share consolidation in furtherance of a potential listing of its common shares on a stock exchange in the United States and the potential timing for the filing of an IND and the commencement of clinical trials related to the Company’s lead program PMN310. Readers are cautioned that forward-looking statements are based on certain assumptions and are subject to known and unknown risks and uncertainties (both general and specific) that contribute to the possibility that the future events or circumstances contemplated by such forward-looking information will not occur.  Such risks and uncertainties with respect to the forward-looking statements contained in this news release include, but are not limited to, the Company obtaining shareholder and Toronto Stock Exchange approval for a consolidation of its common shares, the Company’s ability to generally meet the quantitative and qualitative requirements to list its common shares on a stock exchange in the United States, the trading volumes in the Company’s common shares increasing as a result of a listing on a stock exchange in the United States, the Company’s ability to access capital improving as a result of a listing on a stock exchange in the United States, and the Company obtaining the necessary regulatory approvals and satisfying the other requirements to file an IND and commence its clinical trials related to its lead program PMN310 soon thereafter.  Readers should also refer to the risk factors set forth in the Company’s continuous disclosure documents available at SEDAR (www.sedar.com). There can be no assurance that the plans, intentions or expectations upon which forward-looking statements are based will be realized. Actual results may differ, and the difference may be material and adverse to the Company and its shareholders.  Therefore, readers should not place undue reliance upon such forward-looking statements.  The Company does not intend, and does not assume any obligation, to update these forward-looking statements in order to reflect events or circumstances that may arise after the date of this news release except as required by applicable law or regulatory requirements. 

Virpax Pharmaceuticals Chairman and CEO Anthony Mack delivers a formal corporate overview, followed by a Q & A session moderated by Noble Capital Markets Senior Healthcare Services & Medical Devices Analyst Gregory Aurand. Return to the Investor Forum Event Page Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval of its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage osteoarthritis pain. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular-Envelope Technology (MET) enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder (PTSD) under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax recently acquired global rights to VRP324, a product candidate for the nasal delivery of a cannabidiol (CBD) for the management of epilepsy in adults and children, a rare pediatric disease. For more information, please visit www.virpaxpharma.com. News & Advanced Market Data on VRPX

Cocrystal Pharma Receives Australian Regulatory Clearance to Initiate Phase 1 Study of CC-42344 for the Treatment of Pandemic and Seasonal Influenza

 

BOTHELL, Wash., Oct. 06, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of coronaviruses, influenza, hepatitis C viruses and noroviruses, announces receipt of clearance from an Australian Human Research Ethics Committee (HREC) to initiate a Phase 1 trial with its orally administered PB2 inhibitor CC-42344 for the treatment of pandemic and seasonal influenza A.

The Phase 1 randomized, double-blind, placebo-controlled study is expected to enroll 56 healthy volunteers at a single site in Australia. The study is designed to assess the safety, tolerability and pharmacokinetics of CC-42344.

CC-42344 binds to a highly conserved PB2 site of influenza polymerase complex and exhibits a novel mechanism of action that inhibits viral replication. In preclinical testing, CC-42344 demonstrated excellent antiviral activity against influenza A strains, including avian pandemic strains and Tamiflu^® and Xofluza^®-resistant strains, as well as favorable pharmacokinetic and drug-resistance profiles.

“The need for a novel, broad-spectrum, oral antiviral for pandemic and seasonal influenza A is clear as current approved influenza treatments are partially effective and are prone to viral resistance,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “We discovered CC-43244 using our proprietary structure-based drug discovery platform technologies. CC-43244 is specifically designed to be effective against pandemic and seasonal influenza A strains and emerging avian influenza viruses.”

“Our decision to conduct the Phase 1 trial in Australia was due to favorable regulatory policies and a clinical trial environment that aligns with our strategy for rapid, cost-efficient and high-quality clinical development,” added James Martin, Cocrystal’s CFO and co-interim CEO. “We are delighted to begin our first clinical study with CC-42344 as a treatment for this major global health concern.”

The World Health Organization (WHO) estimate there are approximately 1 billion cases of influenza annually worldwide, resulting in 3 million to 5 million cases of severe illness and 290,000 to 650,000 deaths. The Center for Disease Control (CDC) estimates that since 2010 influenza has resulted in 9 million to 45 million illnesses in the U.S. annually, resulting in 140,000 to 810,000 hospitalizations and 12,000 to 61,000 deaths.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C virus and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding conducting the Phase 1 study of CC-42344 in Australia and our strategy with respect to clinical development. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the impact of the COVID-19 pandemic on the national and global economy, on our collaboration partners, CROs, CMOs, and on our Company, including raw material and test animal shortages and other supply chain disruptions, the ability of our CROs to recruit volunteers for, and to proceed with, clinical trials, possible delays resulting from the lockdowns in Australia, potential delays related to the manufacturing of the drug for the study, the results of clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.