Harte Hanks Promotes Brian Linscott to Chief Executive Officer


Harte Hanks Promotes Brian Linscott to Chief Executive Officer

 

Linscott’s Two-year Plus Company Senior Executive Role Ensures Continuity of Experienced Leadership

 

AUSTIN, Texas
June 23, 2021 /PRNewswire/ — 
Harte Hanks, Inc. (OTCQX: HRTH), an industry leader 
in Marketing Services and Execution, Customer Care, Fulfillment and Logistics Services, today announced that its Board of Directors has promoted Chief Operating Officer Brian Linscott to the position of CEO, succeeding Andrew Benett, effective immediately.

Mr. Benett is stepping down from his role as Chief Executive Officer to pursue other opportunities after positioning 
Harte Hanks for ongoing success.  Mr. Linscott and  Mr. Benett have agreed to work together to ensure a smooth transition at the Company.

Jack Griffin, Chairman of the Board of 
Harte Hanks, stated, ” Mr. Benett and  Mr. Linscott have worked closely together over the past 18 months and this transition ensures continuity of seasoned leadership at Harte Hanks. Brian’s success at 
Harte Hanks and his two plus decades of experience in operations, growth strategies, acquisitions, and finance, as well as leading teams in the development of new client opportunities positions Brian perfectly to lead Harte Hanks as our new CEO in our next phase of profitable growth.”

Mr. Linscott added, “We have worked to structure Harte Hanks for growth and profitability as our clients get back to business. I am honored to lead 
Harte Hanks’ outstanding team at this exciting time as we enter the next phases of this post-pandemic world.”

Brian has an accomplished track record for improving financial and operational results. Before joining 
Harte Hanks in late 2019, his prior positions include CFO of 
Sun Times Media, LLC, a media company that included the Chicago Sun-Times, Managing Director of Huron Consulting Group, and a Partner at 
BR Advisors, where he led operational improvements, developed new partnerships and drove topline growth for media clients and other companies.

Mr. Griffin continued, “I want to thank Andrew for his hard work and dedication in leading the Company through the challenges of restructuring our organization during the COVID-19 pandemic as well as maintaining the confidence and loyalty of our clients.”  

“I am proud of the progress we have achieved at 
Harte Hanks, and it has been a pleasure building and leading such a strong team,” said  Andrew Benett. “Brian is an accomplished corporate executive, and I am confident that he has the skills to lead execution at 
Harte Hanks going forward.”

About Harte Hanks 

Harte Hanks is a global marketing services firm specializing in customer lifecycle management.  
Harte Hanks effectively connects our clients with their customers in powerful ways. We are experts in defining, executing and optimizing the customer journey by offering end-to-end BPO marketing services including lead generation, data analytics, and multi-channel customer engagement solutions (digital, social, and mobile), as well as contact center, fulfillment and logistics services. From visionary thinking to tactical execution, Harte Hanks delivers smarter customer interactions for some of the world’s leading brands. Harte Hanks has approximately 2,500 employees located in North America, Asia-Pacific and Europe.

Cautionary Note Regarding Forward-Looking Statements:

Our press release and related earnings conference call contain “forward-looking statements” within the meaning of 
U.S. federal securities laws. All such statements are qualified by this cautionary note, provided pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Statements other than historical facts are forward-looking and may be identified by words such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “seeks,” “could,” “intends,” or words of similar meaning.  These forward-looking statements are based on current information, expectations and estimates and involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements.  In that event, our business, financial condition, results of operations or liquidity could be materially adversely affected and investors in our securities could lose part or all of their investments.  These risks, uncertainties, assumptions and other factors include: (a) local, national and international economic and business conditions, including (i) the outbreak of diseases, such as the COVID-19 coronavirus, which has curtailed travel to and from certain countries and geographic regions, disrupted business operations resulting from travel restrictions and reduced consumer spending, and uncertainty regarding the duration of the virus’ impact, (ii) market conditions that may adversely impact marketing expenditures and (iii) the impact of economic environments and competitive pressures on the financial condition, marketing expenditures and activities of our clients and prospects; (b) the demand for our products and services by clients and prospective clients, including (i) the willingness of existing clients to maintain or increase their spending on products and services that are or remain profitable for us, and (ii) our ability to predict changes in client needs and preferences; (c) economic and other business factors that impact the industry verticals we serve, including competition and consolidation of current and prospective clients, vendors and partners in these verticals; (d) our ability to manage and timely adjust our facilities, capacity, workforce and cost structure to effectively serve our clients; (e) our ability to improve our processes and to provide new products and services in a timely and cost-effective manner though development, license, partnership or acquisition; (f) our ability to protect our facilities against security breaches and other interruptions and to protect sensitive personal information of our clients and their customers; (g) our ability to respond to increasing concern, regulation and legal action over consumer privacy issues, including changing requirements for collection, processing and use of information; (h) the impact of privacy and other regulations, including restrictions on unsolicited marketing communications and other consumer protection laws; (i) fluctuations in fuel prices, paper prices, postal rates and postal delivery schedules; (j) the number of shares, if any, that we may repurchase in connection with our repurchase program; (k) unanticipated developments regarding litigation or other contingent liabilities; (l) our ability to complete anticipated divestitures and reorganizations, including cost-saving initiatives; (m) our ability to realize the expected tax refunds; and (n) other factors discussed from time to time in our filings with the 
Securities and Exchange Commission, including under “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended 
December 31, 2020 which was filed on 
March 24, 2021. The forward-looking statements in this press release are made only as of the date hereof, and we undertake no obligation to update publicly any forward-looking statement, even if new information becomes available or other events occur in the future.

Contact: For more information, visit 
Harte Hanks at www.hartehanks.com, call 800-456-9748, or email us at pr@hartehanks.com and/ or sbe@abmac.com.

SOURCE: 
Harte Hanks

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


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 gammaCoreTM

gammaCoreTM (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

Virtual Roadshow with Helius Medical Technologies (HSDT) Interim CEO, CFO/COO, and Medical Advisor


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.

Release – Genprex Announces Initiation of its Phase 1 2 Acclaim-1 Clinical Trial for REQORSA Immunogene Therapy


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

 

AUSTIN, Texas — (June 23, 2021) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the U.S. Food and Drug Administration (FDA) has reviewed and confirmed all comments have been addressed regarding the Company’s clinical trial protocol for the Acclaim-1 clinical trial, an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA™ Immunogene Therapy, in combination with AstraZeneca’s Tagrisso® in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso. In January 2020, Genprex received FDA Fast Track Designation for the Acclaim-1 patient population.

In addition, the Company has engaged its first clinical site for Acclaim-1, and Genprex is continuing to work with a number of other important cancer research centers and academic institutions to select optimal study sites.

“This feedback from the FDA on our Acclaim-1 clinical trial and the engagement of our first clinical site are key milestones for Genprex,” said Rodney Varner, President and Chief Executive Officer of Genprex. “We are now looking forward to opening patient enrollment in this important study of this cutting-edge investigational gene therapy to evaluate the role it can play in the fight against lung cancer, the leading cause of cancer deaths worldwide.”

The Company expects the Phase 1 portion of the Acclaim-1 trial to enroll up to 18 patients at three clinical sites and for the Phase 2 portion to enroll approximately 74 patients (a 1:1 ratio of REQORSA and Tagrisso combination therapy versus Tagrisso monotherapy) at up to 15 clinical sites. The first part of the Phase 1/2 clinical trial will be a dose escalation study. The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization after first progression on Tagrisso, to first event (second progression) or death. An interim analysis will be performed at 51 events.

Genprex recently announced the Centralized Institutional Review Board (IRB) approval for the Acclaim-1 clinical trial in NSCLC. Additional information about the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform for cancer. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is then administered intravenously, where it is then taken up by tumor cells that express proteins that are deficient. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso.

For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on TwitterFacebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes;  Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships including the scale up of the manufacture of its product candidates; and Genprex’s intellectual property and licenses.

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.

(877) 774-GNPX (4679)

Investor Relations

GNPX Investor Relations

(877) 774-GNPX (4679) ext. #2

investors@genprex.com

Media Contact

Genprex Media Relations

Kalyn Dabbs

(877) 774-GNPX (4679) ext. #3

media@genprex.com

Genprex Announces Initiation of its Phase 1/2 Acclaim-1 Clinical Trial for REQORSA™ Immunogene Therapy in Combination with Tagrisso®


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

 

AUSTIN, Texas — (June 23, 2021) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the U.S. Food and Drug Administration (FDA) has reviewed and confirmed all comments have been addressed regarding the Company’s clinical trial protocol for the Acclaim-1 clinical trial, an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA™ Immunogene Therapy, in combination with AstraZeneca’s Tagrisso® in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso. In January 2020, Genprex received FDA Fast Track Designation for the Acclaim-1 patient population.

In addition, the Company has engaged its first clinical site for Acclaim-1, and Genprex is continuing to work with a number of other important cancer research centers and academic institutions to select optimal study sites.

“This feedback from the FDA on our Acclaim-1 clinical trial and the engagement of our first clinical site are key milestones for Genprex,” said Rodney Varner, President and Chief Executive Officer of Genprex. “We are now looking forward to opening patient enrollment in this important study of this cutting-edge investigational gene therapy to evaluate the role it can play in the fight against lung cancer, the leading cause of cancer deaths worldwide.”

The Company expects the Phase 1 portion of the Acclaim-1 trial to enroll up to 18 patients at three clinical sites and for the Phase 2 portion to enroll approximately 74 patients (a 1:1 ratio of REQORSA and Tagrisso combination therapy versus Tagrisso monotherapy) at up to 15 clinical sites. The first part of the Phase 1/2 clinical trial will be a dose escalation study. The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization after first progression on Tagrisso, to first event (second progression) or death. An interim analysis will be performed at 51 events.

Genprex recently announced the Centralized Institutional Review Board (IRB) approval for the Acclaim-1 clinical trial in NSCLC. Additional information about the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform for cancer. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is then administered intravenously, where it is then taken up by tumor cells that express proteins that are deficient. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso.

For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on TwitterFacebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes;  Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships including the scale up of the manufacture of its product candidates; and Genprex’s intellectual property and licenses.

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.

(877) 774-GNPX (4679)

Investor Relations

GNPX Investor Relations

(877) 774-GNPX (4679) ext. #2

investors@genprex.com

Media Contact

Genprex Media Relations

Kalyn Dabbs

(877) 774-GNPX (4679) ext. #3

media@genprex.com

C-Suite Interview with CoreCivic (CXW) President & CEO Damon Hininger


Noble Capital Markets Senior Research Analyst Joe Gomes sits down with CoreCivic President & CEO Damon Hininger for this exclusive interview.

Research, News, and Advanced Market Data on CXW


View all C-Suite Interviews

About CoreCivic

CoreCivic is a diversified government solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. CoreCivic provides a broad range of solutions to government partners that serve the public good through corrections and detention management, a network of residential reentry centers to help address America’s recidivism crisis, and government real estate solutions. CoreCivic is the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believes it is the largest private owner of real estate used by government agencies in the U.S. CoreCivic has been a flexible and dependable partner for government for more than 35 years. CoreCivic’s employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good.

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


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 gammaCoreTM

gammaCoreTM (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


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.

Investment Opportunities in Hydrogen



Unhyped Hydrogen Investments

 

Hydrogen finally seems on the road to fulfilling its “promise” of becoming a large contributor to the renewable energy mosaic. The interest in hydrogen energy was reignited last year with the push toward zero carbon emissions. Some other drivers of this elevated interest are increased government support and public interest in clean energy options. Hydrogen has been spoken about since the ’70s gas crisis as being the “answer.” It appears as though when it comes to lower emissions, power storage, and abundance, hydrogen is a prime candidate to be part of the answer.

There are many applications for hydrogen and hydrogen fuel cells, and as with most renewable energy solutions, there is some level of “baggage” that comes with each. We’ll discuss the baggage alongside the applications and provide the names of investable companies operating in and with the potential to benefit from the growth of hydrogen as a power source.

 

Powerful Applications for H

Processing Chemicals – Hydrogen’s primary use today is as a catalyst or agent in chemical and industrial processes. Among the chemical processes is the production of methanol and ammonia. The ammonia produced is used directly or indirectly as fertilizer. Hydrogen is also used to refine oil and as part of a process to remove impurities from crude oil. In steel production, it can be used to replace the traditional fuel (cokes) in a blast furnace. These processes are all currently being used and largely executed by what is called “dirty” or “grey” hydrogen.

 Automotive Fuel Cell– At the turn of the Millenium, hydrogen was going to be the clean-energy answer.   President George W. Bush even brought it up in his 2003 State of the Union address, saying, “the first car driven by a child born today could be powered by hydrogen and pollution-free.

The unfilled expectations around hydrogen to power transportation have their reasons.  From a practical standpoint using a driver’s perspective, the shift would seem easy.  Fuelling a car with liquid H takes a similar amount of time as refilling with gas or diesel; the driving range would also be about the same. One issue preventing widespread use is the infrastructure for hydrogen refueling is not in place. And, as we have seen with electric vehicles, one can’t sell alternative “fuel” cars without the ability to fuel them along the road. On the other hand, building fuel stations isn’t economically feasible until there are customers. The solution to this chicken/egg question has yet to avail itself.

Heavy-Duty Transport– This category is comprised mainly of trains and boats. Hydrogen is a high-density energy source that can provide the appropriate power for heavy goods vehicles. It can provide power where we now implement diesel. Hydrogen is quick to refuel, which reduces downtime in these applications.

Forklifts– Fuel cells are already widely used in forklift fleets. One big advantage of hydrogen-powered fuel cells is it saves time compared to battery-powered machines. The benefits are particularly strong in a three-shift, round-the-clock operation. Fuel cells powered by hydrogen are also without carbon monoxide, which is preferable indoors. Large warehouses operated by Amazon and Walmart use hydrogen-powered forklift fleets.

Power Plants– Stationary Power plants are also using hydrogen fuel cells. They can be used as primary and backup power. The power is reliable and can support on-grid or off-grid power generation. These stationary fuel cells are able to connect directly to the gas infrastructure.

 

Grey Hydrogen vs. Green Hydrogen, What’s the Difference?

Hydrogen is as clean as the production method. Most hydrogen currently produced is called “dirty” or “grey” hydrogen. This means it was produced from natural gas and emits greenhouse gas. Grey hydrogen is produced using a process that isn’t the super clean hydrogen envisioned 20 or more years ago. That hydrogen, the one that emits no greenhouse gases, is referred to as “green” hydrogen. The difference provides a challenge and investment opportunities for this emerging field.  There is a lot of grey hydrogen used today that can be replaced by green hydrogen. It is estimated more than 95% of hydrogen production in 2019 was grey. Converting one to the other isn’t without cost, but it is then truly green.

Hydrogen can be produced using another method that is somewhat cleaner than grey. It uses natural gas and is called steam reforming. With steam reforming, it’s possible to capture 80% to 90% of the CO2 produced in the process. This CO2 is then used in other processes. You’ll hear hydrogen separated in this way called “blue” hydrogen. An alternative natural gas technique that doesn’t generate CO2 creates “turquoise” hydrogen.

 

Investments In Hydrogen

 There are many companies worldwide in this space.  The largest companies are hydrogen producers, which mainly use the method of steam reforming. Smaller niche companies focus on specific aspects of hydrogen. These can be sub-categorized into electrolyzer producers and fuel cell producers. Some companies will combine the two providing a fully integrated hydrogen producer.

There is a movement toward green hydrogen for most involved. This movement includes joint ventures, sometimes the small helping the big. Linde (LIN), for example, has a joint venture with ITM Power (OTCPK:ITMPF). ITM Linde Electrolysis provides industrial-scale turnkey solutions for green hydrogen production.

 

Electrolyzers

Electrolyzers are one way to invest in green hydrogen. There is a lot of wind, and solar-produced energy coming onto the power grid. One problem with this is the unstable production associated with these methods. By transforming this energy into green hydrogen, it can replace the current supply of grey hydrogen. electrolyzers may be the best way to invest in hydrogen.

Electrolyzers use a system that, with the use of electricity, breakdown water (H2O) into hydrogen and oxygen in a process known as electrolysis. McPhy Energy SA (OTC:MPHYF) is a designer, manufacturer, and integrator of hydrogen equipment. Its product range features two main categories: Electrolyzers (hydrogen production equipment) of all capacities and hydrogen refueling stations (refueling/distribution equipment) for hydrogen-powered mobility. Another company, Nel Hydrogen (NLLSY) covers the entire chain from hydrogen production to the manufacturing of hydrogen fueling stations, providing all fuel cell electric vehicles with fast fueling similar to conventional vehicles. The company’s segments include Fueling and Electrolyzer. ITM Power PLC (ITMPF) designs and manufactures integrated hydrogen energy systems for energy storage and clean fuel production.

The above companies are European with valuations that may cause concern in other industries. They are listed because they are pure-plays on green hydrogen and electrolysis.

SunHydrogen (OTCPK:
HYSR) could become an alternative to electrolyzer companies. SunHydrogen is working on an innovative hydrogen generator. The generator uses solar energy to split water into hydrogen and oxygen directly. The technology is still in the design and test stage.

 

Fuel Cell Companies

Fuel cells are necessary to convert hydrogen into electricity. They can be used in transportation or stationary power systems. Fuel cells can also be powered by other fuels such as natural gas. Most companies are focusing on fuel cells powered with hydrogen or flexible fuel cells. Ballard Power Systems (Nasdaq:BLDP) designs, develops, manufactures, sells, and services fuel cell products for a variety of applications, focusing on motive power (material handling and buses) and stationary power (backup power, supplemental power, and distributed generation). Fuel Cell Energy ((Nasdaq:FCEL) designs manufactures, sells, installs, operates, and services fuel-cell products, which efficiently convert chemical energy in fuels into electricity through a series of chemical reactions. It serves various industries such as wastewater treatment, commercial and hospitality, data centers and communications, education and healthcare, and others. Plug Power (Nasdaq:PLUG) just announced their plans to build a plant to create green hydrogen. The plant will produce 15 tons per day of liquid green hydrogen, produced using 100% renewable energy and intended to fuel transportation applications, including material handling and fuel cell electric vehicle fleets. Plug Power is investing $84 million in the facility, which is expected to create at least 24 jobs in the local community starting in 2022. Plug is an innovator of green hydrogen and fuel cell technology.

 

Conclusion

Wind, solar, nuclear, and other Renewables are getting investors’ attention. Hydrogen has been spoken about for decades, but like electric vehicles, technology had to catch up with the desire to benefit from the potential. Globally, a move toward renewables is being supported by the major economies, closing the gap on the needed technology is now happening and ramp speed.

 

Suggested Reading:

How Does the Gates Buffett Natrium Reactor Works?

Is the Future of Nuclear, Small Modular Reactors?



What Companies are Involved in Spaceflight?

The Future of Electric Vehicles

 

Sources:

https://www.fchea.org/stationary

https://safety4sea.com/seven-energy-and-maritime-companies-collaborate-on-hydrogen/

https://www.iea.org/data-and-statistics/data-products

https://www.iea.org/fuels-and-technologies/hydrogen

 

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Virtual Roadshow with Great Bear Resources (GTBAF)(GBR.V) CEO Chris Taylor


Great Bear Resources CEO Chris Taylor makes a formal corporate presentation. Afterwards, he is joined by Noble Capital Markets Senior Research Analyst Mark Reichman for a Q & A session featuring questions asked by the live audience throughout the event.

Research, News, and Advanced Market Data on GTBAF


Information on upcoming live virtual roadshows

About Great Bear Resources:

Great Bear Resources Ltd. is a well-financed gold exploration company managed by a team with a track record of success in mineral exploration. Great Bear is focused in the prolific Red Lake gold district in northwest Ontario, where the company controls over 200 km2 of highly prospective tenure across 4 projects, all 100% owned: The flagship Dixie Project, the Pakwash Property, the Sobel Property, and the Red Lake North Property, all of which are accessible year-round through existing roads.

QuickChek – June 22, 2021



FAT Brands Inc. Announces Closing of Public Offering of Series B Cumulative Preferred Stock and Full Exercise of Underwriter’s Overallotment Option

FAT Brands Inc. announced the closing of its previously announced underwritten public offering of 460,000 shares of 8.25% Series B Cumulative Preferred Stock

Research, News & Market Data on FAT Brands

Watch recent presentation from FAT Brands



Capstone Announces Closing Of $11.5 Million Bought Deal Offering Of Common Stock

Capstone Green Energy announced the closing of its previously announced public offering of 2,190,477 shares of its common stock

Research, News & Market Data on Capstone

Watch recent presentation from Capstone Green Energy



Gold Royalty Corp. to acquire Ely Gold Royalties

See today’s research report on Ely Gold Royalties from Mark Reichman, Senior Research Analyst of Natural Resources at Noble Capital Markets

Research, News & Market Data on Ely Gold Royalties

Watch recent presentation from NobleCon17



Comstock Acquires Renewable Process Solutions

Comstock Mining announced the acquisition of 100% of the equity of Renewable Process Solutions, Inc., an advanced process engineering and renewable technology development company

Join today’s Virtual Road Show with Comstock CEO Corrado DeGasperis live at 1pm EDT. Registration is free and open to all investors, at any level.

Research, News & Market Data on Comstock Mining

Watch recent presentation from Comstock Mining



Onconova Therapeutics Regains Compliance With Nasdaq Continued Listing Requirement

Onconova Therapeutics announced that the Company has regained compliance with the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2)

Research, News & Market Data on Onconova

Watch recent presentation from NobleCon17



Lineage’s OPC1 Cell Therapy for the Treatment of Spinal Cord Injury to Return to Clinical Testing

Lineage Cell Therapeutics provided an update on the clinical advancement of OPC1, its investigational allogeneic oligodendrocyte progenitor cell (OPC) transplant therapy

Research, News & Market Data on Lineage Cell Therapeutics

Watch recent presentation from NobleCon17

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Release – FAT Brands Inc. Announces Closing of Public Offering of Series B Cumulative Preferred Stock

 


FAT Brands Inc. Announces Closing of Public Offering of Series B Cumulative Preferred Stock and Full Exercise of Underwriter’s Overallotment Option

 

Beverly Hills, CA, June 22, 2021 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc. (NASDAQ: FAT, FATBP, FATBW), a leading global franchising company and parent company of iconic brands including Fatburger, Johnny Rockets, and seven other restaurant concepts, today announced the closing of its previously announced underwritten public offering of 460,000 shares of 8.25% Series B Cumulative Preferred Stock at a price to the public of $20.00 per share, which includes 60,000 shares issued and sold upon full exercise of the underwriter’s option to purchase additional shares.

The aggregate gross proceeds to the Company were $9,200,000, prior to deducting underwriting discounts and other offering expenses.

FAT Brands Inc. intends to use the net proceeds of the offering for general corporate purposes and possible future acquisitions and growth opportunities.

ThinkEquity, a division of Fordham Financial Management, Inc., acted as sole book-running manager for the offering. Digital Offering, LLC acted as a financial advisor for the offering.

This offering is being made pursuant to a registration statement on Form S-1 (No. 333-256344), as amended, previously filed with the U.S. Securities and Exchange Commission (the “SEC”) and declared effective on June 17, 2021. A final prospectus related to the proposed offering has been filed and made available on the SEC’s website. Electronic copies of the final prospectus may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, Telephone: (877) 436-3673, Email: prospectus@think-equity.com.

 The press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About FAT (Fresh. Authentic. Tasty.) Brands
FAT Brands Inc. (NASDAQ: FAT, FATBP, FATBW) (the Company) is a leading global franchising company that strategically acquires, markets and develops fast casual and casual dining restaurant concepts around the world. The Company currently owns nine restaurant brands: Fatburger, Johnny Rockets, Buffalo’s Cafe, Buffalo’s Express, Hurricane Grill & Wings, Elevation Burger, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises approximately 700 units worldwide. For more information, please visit www.fatbrands.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to significant business, economic and competitive risks, uncertainties and contingencies including, but not limited to, uncertainties surrounding the severity, duration and effects of the COVID-19 pandemic, many of which are difficult to predict and beyond our control, which could cause our actual results to differ materially from the results expressed or implied in such forward-looking statements. We refer you to the documents we file from time to time with the Securities and Exchange Commission, such as our reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these and other risks, uncertainties and contingencies. We undertake no obligation to update any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

Investor Relations:
ICR
Lynne Collier
IR-FATBrands@icrinc.com
646-430-2216

Media Relations:
JConnelly
Erin Mandzik
emandzik@jconnelly.com
862-246-9911

Lineage’s OPC1 Cell Therapy for the Treatment of Spinal Cord Injury to Return to Clinical Testing


Lineage’s OPC1 Cell Therapy for the Treatment of Spinal Cord Injury to Return to Clinical Testing

 

  • RMAT Interaction with FDA Held to Propose Clinical Testing of a Novel Delivery Device for OPC1
  • Safety Study Eligibility is Expected to Include Patients with Chronic Injury
  • Late-Stage Clinical Study Continues to be Planned for 2022

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 22, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided an update on the clinical advancement of OPC1, its investigational allogeneic oligodendrocyte progenitor cell (OPC) transplant therapy for the treatment of spinal cord injury (SCI). Following feedback received from an interaction held with the 
U.S. Food and Drug Administration (FDA) last week under the FDA’s Regenerative Medicine Advanced Therapy (RMAT) program, Lineage intends to submit an amendment to its Investigational New Drug application (IND) for OPC1 to support a Phase 1 clinical study to evaluate the safety and performance of Neurgain Technologies Inc.’s Parenchymal Spinal Delivery System (“Neurgain PSD system”) to deliver OPC1 cells to the spinal cord. In February, the Company entered into an exclusive option and license agreement with Neurgain to evaluate its novel PSD system in both preclinical and clinical settings. The IND amendment is expected to be submitted to the FDA in the fourth quarter of 2021. The data from the Phase 1 clinical study is intended to validate the Neurgain PSD system for use in a late-stage clinical study, expected to begin in 2022 following the completion of the Phase 1 study.

“It is a privilege to report that our novel OPC1 program will be returning to clinical testing earlier than anticipated. There currently are few opportunities for SCI patients to participate in clinical trials, so we are excited to re-engage with these patients and their advocacy community as part of our efforts to improve outcomes for individuals with this debilitating condition, for which there are no FDA-approved treatments,” stated  Brian M. Culley, Lineage’s CEO. “In the past 18 months, we have significantly increased the purity and production scale of the OPC1 cells utilized in a prior clinical study. This improved production process has been transferred to our in-house Current Good Manufacturing Practice (cGMP) suite and will support production of clinical study material for later-stage clinical work. In parallel, we are finalizing plans to test the safety of the Neurgain PSD system to deliver OPC1 in SCI patients. We believe this device can improve the ease and precision of delivering our cells to the spinal parenchyma. As an added benefit, based on feedback from the FDA, in addition to patients with subacute SCI, we anticipate that patients with chronic SCI also will be eligible for enrollment in this study. Gaining additional OPC1 safety and device performance data across a broader range of patients and injury types will be more informative to the program and support further product and device development. Our recent accomplishments in areas of production and delivery contributed real-world feasibility to the promising clinical results previously reported with this program, in which OPC1 demonstrated improvements to quality of life and motor function for certain SCI patients. Importantly, we are working to be in a position to initiate a late-stage clinical study in SCI next year.”

The Neurgain PSD system has been designed to allow for the administration of cells to the spinal cord without stopping the patient’s ventilator during the procedure. Elimination of the need to stop respiration during surgery is expected to reduce the complexity, risk, and variability of administering cells to the area of injury. The Neurgain PSD system has been designed to provide delivery of cells with accurate anatomical positioning and dosing, is more compact than existing devices and is attached directly to the patient during the procedure. This innovative delivery system is expected to provide a significant improvement in usability and provide more flexibility to the surgeon when compared to the methods and tools utilized to deliver OPC1 cells in the completed Phase 1/2a SCiStar study of OPC1 for the treatment of cervical SCI. 
Neurgain Technologies, Inc. is a medical device company that is developing technologies developed by neurosurgeons at the 
University of California San Diego.

Lineage plans to evaluate the safety and performance of the Neurgain PSD system to deliver OPC1 to the spinal cord in both the preclinical and clinical setting. If results of these studies are positive, Lineage may exercise its option to enter into a pre-negotiated license and commercialization agreement with Neurgain. Pursuant to that agreement, Lineage may integrate the Neurgain PSD system into a late-stage clinical trial and, if approved, commercial use of OPC1 for the treatment of patients with spinal cord injury. There currently are no FDA approved treatments for spinal cord injury.

About Spinal Cord Injuries
A spinal cord injury occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the 
U.S. The cost of a lifetime of care for a severe spinal cord injury can be as high as 
$5 million.

About OPC1
OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements in motor recovery in individuals with subacute spinal cord injuries. OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. While variability exists for the precise duration of each phase, subacute SCI generally refers to the phase that is three to six weeks post-injury and chronic SCI refers to the phase beginning after the subacute phase. The OPC1 program has been partially funded by a 
$14.3 million grant from the 

California Institute for Regenerative Medicine (CIRM)
. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation for its use in subacute cervical SCI and Orphan Drug designation from the FDA.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of subacute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to advancement of the clinical development of OPC1 to treat SCI, OPC1’s potential to improve quality of life and/or motor function for patients with SCI, the potential benefits of using the Neurgain PSD system to deliver OPC1 for the treatment of SCI, OPC1’s regulatory approval pathway, and Lineage’s potential exclusive license and commercialization agreement with Neurgain. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.