Monday, June 28, 2021

Cocrystal Pharma Inc. (COCP)
Cocrystal Announces CC-42334 To Start Clinical Studies in Influenza

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.

The Product Pipeline Advances Cocrystal announced that it has completed studies to file an IND for CC-42344, its PB2 inhibitor for the treatment of seasonal and pandemic influenza A.  The first Phase 1 study is planned for 3Q21.


CC-42334 Has A Unique Mechanism Of Action CC-42334 was developed using Cocrystal’s proprietary anti-viral technology, targeting an enzyme early in the process of producing the next viral generation.  This differs from other anti-influenza approaches that are based on stimulating an immune response or blocking viral surface proteins …

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. 

NIH Image Gallery (Flickr)

Research on How Cells Recover from Threats May Lead to New Insights Into Alzheimer’s and ALS

 

The Big Idea

Our bodies contain a special protein tag that plays a role in how cells recover from specific threats to their survival, according to new research I co-authored. Understanding how this process works may be key to future treatments for neurodegenerative diseases, such as Alzheimer’s disease and some forms of dementia.

Cells regularly encounter potentially harmful changes in their environment, such as fluctuating temperature or exposure to UV light or toxins. To ensure survival, cells have evolved complex ways to adapt to these stressful changes. These mechanisms range from temporary changes in metabolism to wholesale shutdown of critical biological processes that might otherwise be permanently damaged.

For example, many cellular stresses temporarily shut down protein production while messenger RNAs, which carry part of the DNA code through the cell, become sequestered in dense structures known as stress granules. When the stress passes, the stress granules are disassembled and cells emerge from this defensive state to resume normal activities.

But until now, molecular biologists like me didn’t understand exactly how this mechanism worked.

In a pair of peer-reviewed studies published in the journal Science on June 25, 2021, my colleagues and I working in J. Paul Taylor’s cell and molecular biology lab explain how a protein known as ubiquitin is responsible for getting cells back up and running once the coast is clear.

In the first study, I discovered that different types of stress lead to specific proteins in cells getting tagged with ubiquitin in distinct ways. I exposed cells to either heat stress or a toxic chemical, then blocked the ubiquitin-tagging process after seemingly identical stress granules formed. To my surprise, blocking ubiquitin tagging only prevented stress granule disassembly for heat shock. Importantly, I also found that cells were unable to restart key biological processes like protein production and transport when these stress granules remained present, even after a return to normal temperatures.

In the second study, my colleague Youngdae Gwon looked closer into this process. He discovered that heat stress triggers ubiquitin tagging of a key protein that allows an enzyme to disassemble stress granules. This enzyme grabs onto the ubiquitin tag and uses it as a handle to pull the structure apart.

 

 

Why It Matters

Researchers have linked stress granule biology and the stress response process in general to several neurodegenerative diseases, including Alzheimer’s disease, ALS or Lou Gehrig’s disease, and some forms of dementia.

For example, mutations in the same protein, which we found to be necessary to dissemble stress granules, can cause inherited neurodegenerative diseases. Understanding how stress granules are regulated is critical to getting a better grasp on how these diseases work and potentially finding new treatments for them.

 

What Still Isn’t Known

Although we identified several key factors in the role ubiquitin plays in the disassembly of stress granules, many molecular details of this process remain unknown. To gain further insight, scientists will need to identify which enzymes are responsible for putting the ubiquitin tag on proteins during stress in the first place. Additionally, it will be important to understand how mutations that lead to neurodegenerative diseases might also affect the stress recovery process.

What Other Research is Being Done

Researchers are investigating various aspects of stress granule biology and its links to neurodegenerative disease. Some are working to recreate stress granules in a test tube to explore questions not easily answered by working in cells. And others are looking inside live neurons, mice and fruit flies to understand how disease mutations affect stress recovery in living cells and creatures.

 

This article was republished with permission from The Conversation, a news
site dedicated to sharing ideas from academic experts.  It was written by
and represents the research-based opinions of Brian Andrew Maxwell Scientist
in Cell Biology, St. Jude Children’s Research Hospital Graduate School of
Biomedical Sciences.

 

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NIH Image Gallery (Flickr)

Research on How Cells Recover from Threats May Lead to New Insights Into Alzheimer’s and ALS

 

The Big Idea

Our bodies contain a special protein tag that plays a role in how cells recover from specific threats to their survival, according to new research I co-authored. Understanding how this process works may be key to future treatments for neurodegenerative diseases, such as Alzheimer’s disease and some forms of dementia.

Cells regularly encounter potentially harmful changes in their environment, such as fluctuating temperature or exposure to UV light or toxins. To ensure survival, cells have evolved complex ways to adapt to these stressful changes. These mechanisms range from temporary changes in metabolism to wholesale shutdown of critical biological processes that might otherwise be permanently damaged.

For example, many cellular stresses temporarily shut down protein production while messenger RNAs, which carry part of the DNA code through the cell, become sequestered in dense structures known as stress granules. When the stress passes, the stress granules are disassembled and cells emerge from this defensive state to resume normal activities.

But until now, molecular biologists like me didn’t understand exactly how this mechanism worked.

In a pair of peer-reviewed studies published in the journal Science on June 25, 2021, my colleagues and I working in J. Paul Taylor’s cell and molecular biology lab explain how a protein known as ubiquitin is responsible for getting cells back up and running once the coast is clear.

In the first study, I discovered that different types of stress lead to specific proteins in cells getting tagged with ubiquitin in distinct ways. I exposed cells to either heat stress or a toxic chemical, then blocked the ubiquitin-tagging process after seemingly identical stress granules formed. To my surprise, blocking ubiquitin tagging only prevented stress granule disassembly for heat shock. Importantly, I also found that cells were unable to restart key biological processes like protein production and transport when these stress granules remained present, even after a return to normal temperatures.

In the second study, my colleague Youngdae Gwon looked closer into this process. He discovered that heat stress triggers ubiquitin tagging of a key protein that allows an enzyme to disassemble stress granules. This enzyme grabs onto the ubiquitin tag and uses it as a handle to pull the structure apart.

 

 

Why It Matters

Researchers have linked stress granule biology and the stress response process in general to several neurodegenerative diseases, including Alzheimer’s disease, ALS or Lou Gehrig’s disease, and some forms of dementia.

For example, mutations in the same protein, which we found to be necessary to dissemble stress granules, can cause inherited neurodegenerative diseases. Understanding how stress granules are regulated is critical to getting a better grasp on how these diseases work and potentially finding new treatments for them.

 

What Still Isn’t Known

Although we identified several key factors in the role ubiquitin plays in the disassembly of stress granules, many molecular details of this process remain unknown. To gain further insight, scientists will need to identify which enzymes are responsible for putting the ubiquitin tag on proteins during stress in the first place. Additionally, it will be important to understand how mutations that lead to neurodegenerative diseases might also affect the stress recovery process.

What Other Research is Being Done

Researchers are investigating various aspects of stress granule biology and its links to neurodegenerative disease. Some are working to recreate stress granules in a test tube to explore questions not easily answered by working in cells. And others are looking inside live neurons, mice and fruit flies to understand how disease mutations affect stress recovery in living cells and creatures.

 

This article was republished with permission from The Conversation, a news
site dedicated to sharing ideas from academic experts.  It was written by
and represents the research-based opinions of Brian Andrew Maxwell Scientist
in Cell Biology, St. Jude Children’s Research Hospital Graduate School of
Biomedical Sciences.

 

Suggested Content:

Longeveron C-Suite Interview at World Stem Cell Summit (June 2021)	Caladrius C-Suite Interview at World Stem Cell Summit (June 2021)

Celularity C-Suite Interview at World Stem Cell Summit (June 2021)	Gid Bio C-Suite Interview at World Stem Cell Summit (June 2021)

 

 

 

Stay up to date. Follow us:

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Cocrystal Pharma Completes IND-enabling Studies with CC-42344 for the Treatment of Seasonal and Pandemic Influenza A, Plans to initiate a Phase 1 Trial in the Third Quarter

 

BOTHELL, Wash., June 23, 2021 — 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 influenza viruses, coronaviruses, hepatitis C viruses and noroviruses, announces the completion of IND-enabling studies with its potent, broad-spectrum PB2 inhibitor CC-42344 for the treatment of seasonal and pandemic influenza A and plans to initiate Phase 1 clinical development of CC-42344 in the third quarter of 2021.

“We are highly encouraged by the potential of CC-42344 to treat seasonal and pandemic influenza, both of which are major global health concerns,” said Sam Lee, Ph.D., Cocrystal’s President and interim co-CEO. “We recently completed a 14-day GLP toxicology study, which was the final pre-IND enabling step prior to advancing this potent inhibitor into a first-in-human study.

“There is a pressing need for new antivirals to treat influenza, as currently approved antiviral therapeutics are prone to viral resistance,” added Dr. Lee. “CC-42344 stops the first step of viral replication by binding to a highly conserved PB2 site of the influenza polymerase complex that is essential to replication. This uniquely positions CC-42344 to be an effective therapeutic against all significant A strains of the influenza virus, including avian pandemic strains as well as strains that are resistant to Tamiflu^® (oseltamivir) and Xofluza^® (baloxavir marboxil).”

“The planned Phase 1 study with CC-42344 will be conducted in Australia, which offers favorable regulatory policies and a clinical trial environment that aligns with our strategy for quickly and cost-efficiently moving into clinical development,” said James Martin, Cocrystal’s CFO and interim co-CEO. “The Australian regulatory agency allows for a streamlined path for early-stage study initiation and the Australian government offers generous incentives for clinical studies performed in that country. Importantly, clinical studies conducted in Australia have a reputation for generating high-quality data. In preparing to initiate this study, we have already established a subsidiary in Australia and have selected a contract research organization.”

According to the World Health Organization (WHO) estimates, approximately 1 billion people are infected with seasonal influenza annually, resulting in 3 million to 5 million cases of severe illness and 250,000 to 500,000 deaths worldwide. Approved influenza therapies have limited efficacy due to drug resistance and viral mutation.

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 viruses 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 our strategy with respect to the clinical development of CC-42344, including the planned initiation of influenza A Phase 1 study in Australia in the third quarter of 2021, and the potential of CC-42344 to treat seasonal and pandemic influenza. 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 Australian and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our influenza A program, the ability of the contract research organization to recruit patients into clinical trials, the results of future preclinical and clinical studies, and general risks arising from clinical trials. 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.

electroCore, Inc. Announces Exclusive Distribution Agreement with Kromax For Taiwan and China

 

ROCKAWAY, NJ, 
June 23, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced it has entered into an agreement with Kromax International Corporation to serve as the exclusive distributor of the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) in 
Taiwan and 
China.

“Kromax International Corp. is dedicated to transforming healthcare quality by introducing state-of-art medical solutions that improve the health of patients,” commented  Tim Hwang, 
Kromax Group Vice Chairman. “We have been deeply involved in the field of pain management and neuromodulation in the 
Taiwan, 
China, and 
South Asia markets for many years and are honored to cooperate with electroCore by representing their solution in these markets, providing benefits to patients in our region suffering from migraines.”

“We are delighted to partner with Kromax to introduce gammaCore into 
Taiwan and China,” stated Iain Strickland, electroCore’s Vice President of Global Sales and Strategy. “Kromax and electroCore share the common goal of utilizing proven healthcare innovations to improve the health and lives of their patients. We look forward to collaborating with the team at Kromax to help support the adoption of gammaCore in the region.”

The initial term of the agreement is three years, and it contains customary terms and conditions. Regulatory clearances are required before sales and revenue can occur, and the timing for any such potential clearances is uncertain at this time.

        
About Kromax

Founded in 1987, Kromax provides services covering the semiconductor, LCD, LED, solar and biotech industries in the 
Greater China area. Their business philosophy focuses on providing comprehensive services to the customer, starting from the early stages of research and marketing and also touching sales, production, distribution, installation, and warranty support. Their mission is to continually enhance the ability of our customers to compete in the international marketplace by bringing them the latest, most advanced technology.

For more information, visit www.kromax.com/en-US/AboutKromax.aspx

About electroCore, Inc.

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

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 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 pacemaker, hearing aid implant, or 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:
  • 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 of age)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

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

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; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in 
Taiwan, 
China, and other new markets 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 CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

Genprex Announces Initiation of its Phase 1/2 Acclaim-1 Clinical Trial for REQORSA™ Immunogene Therapy in Combination with Tagrisso® to Treat Non-Small Cell Lung Cancer Following FDA Review

 

Helius Medical Technologies Interim CEO Dane Andreeff, CFO/COO Joyce LaViscount, and Medical Advisor Jonathan Sackier make a formal corporate presentation. Afterwards, they are joined by Noble Capital Markets Senior Research Analyst Joe Gomes for a Q & A session featuring questions asked by the live audience throughout the event. Research, News, and Advanced Market Data on HSDT Information on upcoming live virtual roadshows About Helius Medical Technologies, Inc. Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.

Genprex Announces Initiation of its Phase 1/2 Acclaim-1 Clinical Trial for REQORSA™ Immunogene Therapy in Combination with Tagrisso® to Treat Non-Small Cell Lung Cancer Following FDA Review

 

electroCore, Inc. Announces Exclusive Distribution Agreement with Kromax For Taiwan and China

 

ROCKAWAY, NJ, 
June 23, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced it has entered into an agreement with Kromax International Corporation to serve as the exclusive distributor of the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) in 
Taiwan and 
China.

“Kromax International Corp. is dedicated to transforming healthcare quality by introducing state-of-art medical solutions that improve the health of patients,” commented  Tim Hwang, 
Kromax Group Vice Chairman. “We have been deeply involved in the field of pain management and neuromodulation in the 
Taiwan, 
China, and 
South Asia markets for many years and are honored to cooperate with electroCore by representing their solution in these markets, providing benefits to patients in our region suffering from migraines.”

“We are delighted to partner with Kromax to introduce gammaCore into 
Taiwan and China,” stated Iain Strickland, electroCore’s Vice President of Global Sales and Strategy. “Kromax and electroCore share the common goal of utilizing proven healthcare innovations to improve the health and lives of their patients. We look forward to collaborating with the team at Kromax to help support the adoption of gammaCore in the region.”

The initial term of the agreement is three years, and it contains customary terms and conditions. Regulatory clearances are required before sales and revenue can occur, and the timing for any such potential clearances is uncertain at this time.

        
About Kromax

Founded in 1987, Kromax provides services covering the semiconductor, LCD, LED, solar and biotech industries in the 
Greater China area. Their business philosophy focuses on providing comprehensive services to the customer, starting from the early stages of research and marketing and also touching sales, production, distribution, installation, and warranty support. Their mission is to continually enhance the ability of our customers to compete in the international marketplace by bringing them the latest, most advanced technology.

For more information, visit www.kromax.com/en-US/AboutKromax.aspx

About electroCore, Inc.

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

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 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 pacemaker, hearing aid implant, or 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:
  • 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 of age)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

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

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; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in 
Taiwan, 
China, and other new markets 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 CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

Cocrystal Pharma Completes IND-enabling Studies with CC-42344 for the Treatment of Seasonal and Pandemic Influenza A, Plans to initiate a Phase 1 Trial in the Third Quarter

 

BOTHELL, Wash., June 23, 2021 — 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 influenza viruses, coronaviruses, hepatitis C viruses and noroviruses, announces the completion of IND-enabling studies with its potent, broad-spectrum PB2 inhibitor CC-42344 for the treatment of seasonal and pandemic influenza A and plans to initiate Phase 1 clinical development of CC-42344 in the third quarter of 2021.

“We are highly encouraged by the potential of CC-42344 to treat seasonal and pandemic influenza, both of which are major global health concerns,” said Sam Lee, Ph.D., Cocrystal’s President and interim co-CEO. “We recently completed a 14-day GLP toxicology study, which was the final pre-IND enabling step prior to advancing this potent inhibitor into a first-in-human study.

“There is a pressing need for new antivirals to treat influenza, as currently approved antiviral therapeutics are prone to viral resistance,” added Dr. Lee. “CC-42344 stops the first step of viral replication by binding to a highly conserved PB2 site of the influenza polymerase complex that is essential to replication. This uniquely positions CC-42344 to be an effective therapeutic against all significant A strains of the influenza virus, including avian pandemic strains as well as strains that are resistant to Tamiflu^® (oseltamivir) and Xofluza^® (baloxavir marboxil).”

“The planned Phase 1 study with CC-42344 will be conducted in Australia, which offers favorable regulatory policies and a clinical trial environment that aligns with our strategy for quickly and cost-efficiently moving into clinical development,” said James Martin, Cocrystal’s CFO and interim co-CEO. “The Australian regulatory agency allows for a streamlined path for early-stage study initiation and the Australian government offers generous incentives for clinical studies performed in that country. Importantly, clinical studies conducted in Australia have a reputation for generating high-quality data. In preparing to initiate this study, we have already established a subsidiary in Australia and have selected a contract research organization.”

According to the World Health Organization (WHO) estimates, approximately 1 billion people are infected with seasonal influenza annually, resulting in 3 million to 5 million cases of severe illness and 250,000 to 500,000 deaths worldwide. Approved influenza therapies have limited efficacy due to drug resistance and viral mutation.

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 viruses 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 our strategy with respect to the clinical development of CC-42344, including the planned initiation of influenza A Phase 1 study in Australia in the third quarter of 2021, and the potential of CC-42344 to treat seasonal and pandemic influenza. 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 Australian and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our influenza A program, the ability of the contract research organization to recruit patients into clinical trials, the results of future preclinical and clinical studies, and general risks arising from clinical trials. 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.

Onconova Therapeutics Regains Compliance With Nasdaq Continued Listing Requirement

 

NEWTOWN, Pa., June 22, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a biopharmaceutical company focused on discovering and developing novel products for patients with cancer, announced that on June 17, 2021 it received a letter from The Nasdaq Stock Market LLC stating that the Company has regained compliance with the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2), as the Company’s common stock had a closing bid price of at least $1.00 per share for 18 consecutive business days, from May 21, 2021 to June 16, 2021.

About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1/2a investigator-initiated study targeting patients with KRAS+ non-small cell lung cancer with oral rigosertib in combination with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19.

For more information, please visit www.onconova.com.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the registered direct offering, its patents and clinical development plans including [patient enrollment timelines and] indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to maintain its Nasdaq listing, the timing of the Company’s annual stockholder meeting, market conditions and those and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:

Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:

Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com