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Ocugen On Track to Submit Emergency Use Authorization Application to U.S. FDA for its COVID-19 Vaccine Candidate COVAXIN

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Ocugen On Track to Submit Emergency Use Authorization Application to U.S. FDA for its COVID-19 Vaccine Candidate, COVAXIN™

 

  • Active discussions with FDA related to COVAXIN initiated late last year
  • Master file submitted to FDA on March 26, 2021; awaiting feedback from FDA

MALVERN, Pa., May 26, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today confirmed its plan to submit its Emergency Use Authorization (EUA) application for COVAXIN to the U.S. Food & Drug Administration (FDA) in June.

“Since we have been in discussions with the FDA since late last year, we do not believe that the FDA’s recently revised guidance regarding EUAs raises any concerns about our ability to submit the EUA for COVAXIN as planned, which is currently in process and which we expect to submit to the FDA in June. We believe that the FDA’s new guidance confirms that Ocugen continues to meet all criteria for submission of an EUA. Once the EUA application has been submitted, Ocugen intends to commence pre-biologics license application (BLA) discussions with the FDA,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“FDA’s guidance refers specifically to vaccines based on the spike protein. COVAXIN is a unique yet traditional vaccine using an inactivated version of the whole virus with a novel adjuvant that provides a broadly protective immune response beyond the spike protein, offering potential effectiveness against multiple existing and emerging variants and reducing the possibility of mutant virus escape,” said Dr. Bruce Forrest, Acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen.

About COVAXIN

COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied. Based on a traditional vaccine platform that has a long-established safety profile, COVAXIN continues to show strong results in all the studies conducted to date including a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations, in second interim results of Bharat Biotech’s Phase 3 clinical trial.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to published safety data from separate studies for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8?C.

COVAXIN studies show potential effectiveness against three key variants of SARS-CoV-2. Scientists at the Indian Council of Medical Research (ICMR)-National Institute of Virology, using an in-vitro plaque reduction neutralization assay, have found that COVAXIN-vaccinated sera effectively neutralized the Brazil variant of SARS-CoV-2, B.1.128.2, the UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data referred to in this press release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
[email protected]

Media Contact:
LaVoieHealthScience
Lisa DeScenza
[email protected]
+1 9783955970 

Great Lakes Announces Participation in the Noble Capital Markets Virtual Road Show

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Great Lakes Announces Participation in the Noble Capital Markets Virtual Road Show

 

HOUSTON, May 26, 2021 (GLOBE NEWSWIRE) — Great Lakes Dredge & Dock Corporation (“Great Lakes”) (NASDAQ: GLDD), the largest provider of dredging services in the United States announced their participation in Noble Capital Markets Virtual Road Show Series, presented by Channelchek, scheduled for June 2, 2021.

The virtual road show will feature a corporate presentation from Great Lakes Dredge & Dock Corporation’s President and Chief Executive Officer Lasse Petterson and Chief Financial Officer Mark Marinko, followed by a Q&A session proctored by Noble Senior Research Analyst Poe Fratt, featuring questions submitted by the audience.

The live broadcast of the virtual road show is scheduled for Wednesday, June 2, 2021, at 1 PM EDT. Registration is free and open to all investors, at any level. Register Here. Noble’s research, as well as news and advanced market data on Great Lakes is available on Channelchek.

The Company

Great Lakes Dredge & Dock Corporation (“Great Lakes” or the “Company”) is the largest provider of dredging services in the United States. In addition, the Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprising over 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

Noble Capital Markets

Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 36 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports.
www.noblecapitalmarkets.com email: [email protected]

Channelchek

Channelchek (.com) is a comprehensive investor-centric portal – featuring more than 6,000 emerging growth companies – that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC/FINRA registered broker-dealer since 1984.
channelchek.vercel.app email: [email protected]

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking” statements as defined in Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”), the Private Securities Litigation Reform Act of 1995 (the “PSLRA”) or in releases made by the Securities and Exchange Commission (the “SEC”), all as may be amended from time to time. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of Great Lakes and its subsidiaries, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements that are not historical fact are forward-looking statements. These cautionary statements are being made pursuant to the Exchange Act and the PSLRA with the intention of obtaining the benefits of the “safe harbor” provisions of such laws. Great Lakes cautions investors that any forward-looking statements made by Great Lakes are not guarantees or indicative of future events.

Although Great Lakes believes that its plans, intentions and expectations reflected in this press release are reasonable, actual events could differ materially. The forward-looking statements contained in this press release are made only as of the date hereof and Great Lakes does not have or undertake any obligation to update or revise any forward-looking statements whether as a result of new information, subsequent events or otherwise, unless otherwise required by law.

For further information contact:
Tina Baginskis
Director, Investor Relations
630-574-3024

Casual Dining and Fast Serve to Benefit from Back-to-Work

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As People Make it Back to the Office, Restaurants See More Traffic

 

Restaurants Welcome Back to Work Traffic

The 2020 pandemic beat up many industries while causing others to rocket. Stock market investors endured sharp selloffs and, in many sectors, rapid recovery. Industries including hospitality and food were among the hardest hit as many restaurants saw their stocks crash during the Covid era. While some restaurants did what they could with either complete lockdowns, or a substantially reduced dining room capacity, and a low customer appetite for dining in, their business was still well-off the normal pace.

To make matters more trying for restaurants, the businesses in their neighborhood had employees working remotely — grocery store sales were up; lunchtime restaurant traffic was limited.  According to Sentieo, publicly traded restaurant chains saw an increase in the price of only 4% in all of 2020 as compared to an 18% total return on the S&P 500.

In 2021, things look much better for restaurants. As many states, counties, and towns began to ease the previous restrictions and capacity limits, restaurant stocks began to climb back up. By some measures, restaurant stocks already have a year-on-year increase of 51.7%. Clearly, we’re getting past the turning point of the post-Covid era. Can we expect more growth in the sector?

 

“We’re absolutely seeing an increase in lunchtime traffic as well as maintaining delivery and to-go
business. We’re working on all cylinders right now.” – Andy Wiederhorn, CEO, FAT Brands

 

People are Doing What they Couldn’t do Before

Now at the tail-end of the Covid 19 era, authorities in the U.S. and many countries have begun to ease restrictions. People now do things they previously could not. For instance, they can now take their families to dinner, explore theme parks and spend in ways they were prevented from during the lockdown.

Earlier this year, investors began moving into recreational stocks like Disney (DIS). The result, between January 27 and March 8, DIS saw a 24% increase in market value before retreating. Full-service restaurants saw a similar spike as investors anticipated full dining rooms. People who had been restricting themselves to their homes now were expected to do things they were not.

Andy Wiederhorn, CEO of FAT Brands (FAT), responded to a listener question last week on lunchtime traffic. He was the guest at a Channelchek sponsored Virtual Roadshow.  Wiederhorn responded, “some restaurants are at 120% of sales pre-covid.”  Fat Brands is a restaurant franchising company that owns  the Fatburger, Johnny Rockets, Buffalo’s Cafe, Buffalo’s Express, Hurricane Grill & Wings, Yalla Mediterranean, Ponderosa, Bonanza, and Elevation Burger brands. As it relates to traffic, Mr. Wiederhorn added, “sales over the past month are reaching all-time highs with some of the brands.” He responded more directly, “ We’re absolutely seeing an increase in lunchtime traffic as well as maintaining delivery and to-go business. We’re working on all cylinders right now.”

 

Recreational Dining vs. Regular Dining Out

Employers and government workers worldwide are starting to call back their staff members. This is coming as many governments and business organizations look to resume full onsite operations by late June. This is welcome by most. According to a study by Morning Consult, 65% of remote workers are ready to return to their offices to start resume working as they did before.

This adds to the good news for restaurants that relied in large part on local businesses adding to their lunchtime customers. It takes the remote workers who were preparing lunch in their kitchen and places them back in the running to a fast service restaurant.

Throughout the COVID 19 crisis, fast food and partial service food outlets struggled to survive. Some of them were already set up for take-outs. However, there have already been large spikes in companies that cater to workers stopping in for lunch. For instance, Mac Donald’s stock is up by 11%, just as the entire market surges around the same percentage. We expect that with a massive return to work as we hope soon, the dining rooms of these restaurants will see more large crowds. This will, in turn, boost their revenues massively and improve the market in general.

 

Suggested Reading:

Space as a Lucrative Investment Space

FAT Brands Virtual Roadshow replay (May 2021)



Cannabis Customers Served by the “Ice Cream Truck” Delivery Model

Toilet Paper Sales Unravel as People are Flush with Paper Goods

 

Sources:

https://morningconsult.com/return-to-work/

https://channelchek.vercel.app/channelcast-detail/228

 

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Virtual Roadshow with FAT Brands (FAT) CEO Andy Wiederhorn

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Great Lakes Dredge & Dock CFO Mark Marinko makes a formal corporate presentation. Afterwards, he is joined by Noble Capital Markets Senior Research Analyst Poe Fratt for a Q & A session featuring questions asked by the live audience throughout the event.

Research, News, and Advanced Market Data on FAT


Information on upcoming live virtual roadshows

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) 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.

Copper Facing an Onslaught of Demand

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Ford’s Announcement is Another Reason for Copper Investors to Smile

 

Ford Motor is gaining on Tesla in the hearts of EV and ESG investors. The company gave both fans and investors in the growth of electric vehicle technology, along with those supporting green energy acceptance, a reason to cheer this week. The iconic company, known for its contribution to manufacturing technology one hundred years ago (1928), which made automobiles available to average families, may again make history by ushering in an era where electric Mustangs, Explorers, and even Broncos are within the price range of the American middle class.  An announcement by Ford on May 26 committed the company to spend $30 billion on electric vehicle manufacturing by 2025 and for 40 percent of its global fleet to be all-electric by 2030.

The EV movement had already shifted into high gear before the announcement. And, with the strongest economies of the world now aligned in supporting carbon reduction policies, ie: electrification, a revolution has begun. As with other dramatic historical shifts in technology, investing in the components or industries that produce the goods to make the components is an ordinarily lower risk than betting on any one car company (final product).

 

Copper Components

EV growth has brought a focus on demand for the elements used to produce batteries, such as lithium and cobalt. The focus should also be on how the onslaught of demand for copper will be filled.  There are many competing tech revolutions increasing the demand for the metal. New needs for copper are coming from the growth of solar and wind energy, along with EVs and EV charging stations. As it relates to just cars, here’s how just one car changes demand. An average gasoline-powered car uses about 44lbs of copper, mainly as wiring. A hybrid car uses about 88lbs, and a fully electric car uses roughly 176lbs of the metal. As part of the increased demand, add about 45lbs for each charging point.

In all, 5 times more copper than a conventional gas-powered car is needed. Copper has the best conductivity of any non-precious metal and is being called upon to electrify the green renewable energy revolution

 

How to Get Copper Exposure with Stocks

When the price of copper rises, copper mining companies benefit from production without increasing their costs. This makes buying miners a strategy worth considering. Yesterday Noble Capital Markets released a research note on Chakana Copper Corp. (CHKKF) and (PERU:CA). The report includes the latest company results, the analyst’s views, and price targets. Also available on Channelchek related to CHKKF is the average daily volume of shares traded which is important to gauge liquidity.  Up to the minute, data can also be found on Channelchek for other copper mining companies.  The domestic miner Nevada Copper Corp. (NEVDF) is a U.S.-based mining company currently trading at $0.21 which is in the lower quartile of its 52-week trading range. Western Copper & Gold Corp (WRN) is a Canada-based exploration-stage company. Its engaged in the acquisition, exploration, and future development of resource properties. WRN is currently trading near the top of its 52-week range at $2.61.

Other copper mining candidates can be found at Channelchek.com under the “Company Data” section.

 

Take-Away

There’s a revolution going on with a move toward putting more electric cars on the road. Although Tesla tends to grab the spotlight, there are many other new car companies that are involved.  Meanwhile, traditional auto manufacturers all have goals to increase their EV offerings. Coupled with what is going on in wind and solar, which also increases demand for copper, investors may want to look toward investing in what now appears inevitable.

 

Your Personal Data is the Currency of the Digital Age

Repurposing Power Plants for Crypto Mining



Chakana Copper C-Suite Interview

Palladium One Mining C-Suite Interview

 

Sources:

https://tradingeconomics.com/commodity/copper

https://www.barrons.com/articles/ford-motor-stock-ev-spending-investor-day-51622041264

Release – Great Lakes Announces Participation in the Noble Capital Markets Virtual Road Show

Posted on by Admin


Great Lakes Announces Participation in the Noble Capital Markets Virtual Road Show

 

HOUSTON, May 26, 2021 (GLOBE NEWSWIRE) — Great Lakes Dredge & Dock Corporation (“Great Lakes”) (NASDAQ: GLDD), the largest provider of dredging services in the United States announced their participation in Noble Capital Markets Virtual Road Show Series, presented by Channelchek, scheduled for June 2, 2021.

The virtual road show will feature a corporate presentation from Great Lakes Dredge & Dock Corporation’s President and Chief Executive Officer Lasse Petterson and Chief Financial Officer Mark Marinko, followed by a Q&A session proctored by Noble Senior Research Analyst Poe Fratt, featuring questions submitted by the audience.

The live broadcast of the virtual road show is scheduled for Wednesday, June 2, 2021, at 1 PM EDT. Registration is free and open to all investors, at any level. Register Here. Noble’s research, as well as news and advanced market data on Great Lakes is available on Channelchek.

The Company

Great Lakes Dredge & Dock Corporation (“Great Lakes” or the “Company”) is the largest provider of dredging services in the United States. In addition, the Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprising over 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

Noble Capital Markets

Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 36 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports.
www.noblecapitalmarkets.com email: [email protected]

Channelchek

Channelchek (.com) is a comprehensive investor-centric portal – featuring more than 6,000 emerging growth companies – that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC/FINRA registered broker-dealer since 1984.
www.channelchek.com email: [email protected]

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking” statements as defined in Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”), the Private Securities Litigation Reform Act of 1995 (the “PSLRA”) or in releases made by the Securities and Exchange Commission (the “SEC”), all as may be amended from time to time. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of Great Lakes and its subsidiaries, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements that are not historical fact are forward-looking statements. These cautionary statements are being made pursuant to the Exchange Act and the PSLRA with the intention of obtaining the benefits of the “safe harbor” provisions of such laws. Great Lakes cautions investors that any forward-looking statements made by Great Lakes are not guarantees or indicative of future events.

Although Great Lakes believes that its plans, intentions and expectations reflected in this press release are reasonable, actual events could differ materially. The forward-looking statements contained in this press release are made only as of the date hereof and Great Lakes does not have or undertake any obligation to update or revise any forward-looking statements whether as a result of new information, subsequent events or otherwise, unless otherwise required by law.

For further information contact:
Tina Baginskis
Director, Investor Relations
630-574-3024

Release – Ocugen On Track to Submit Emergency Use Authorization Application to U.S. FDA for its COVID-19 Vaccine Candidate COVAXIN

Posted on by Admin


Ocugen On Track to Submit Emergency Use Authorization Application to U.S. FDA for its COVID-19 Vaccine Candidate, COVAXIN™

 

  • Active discussions with FDA related to COVAXIN initiated late last year
  • Master file submitted to FDA on March 26, 2021; awaiting feedback from FDA

MALVERN, Pa., May 26, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today confirmed its plan to submit its Emergency Use Authorization (EUA) application for COVAXIN to the U.S. Food & Drug Administration (FDA) in June.

“Since we have been in discussions with the FDA since late last year, we do not believe that the FDA’s recently revised guidance regarding EUAs raises any concerns about our ability to submit the EUA for COVAXIN as planned, which is currently in process and which we expect to submit to the FDA in June. We believe that the FDA’s new guidance confirms that Ocugen continues to meet all criteria for submission of an EUA. Once the EUA application has been submitted, Ocugen intends to commence pre-biologics license application (BLA) discussions with the FDA,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“FDA’s guidance refers specifically to vaccines based on the spike protein. COVAXIN is a unique yet traditional vaccine using an inactivated version of the whole virus with a novel adjuvant that provides a broadly protective immune response beyond the spike protein, offering potential effectiveness against multiple existing and emerging variants and reducing the possibility of mutant virus escape,” said Dr. Bruce Forrest, Acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen.

About COVAXIN

COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied. Based on a traditional vaccine platform that has a long-established safety profile, COVAXIN continues to show strong results in all the studies conducted to date including a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations, in second interim results of Bharat Biotech’s Phase 3 clinical trial.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to published safety data from separate studies for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8?C.

COVAXIN studies show potential effectiveness against three key variants of SARS-CoV-2. Scientists at the Indian Council of Medical Research (ICMR)-National Institute of Virology, using an in-vitro plaque reduction neutralization assay, have found that COVAXIN-vaccinated sera effectively neutralized the Brazil variant of SARS-CoV-2, B.1.128.2, the UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data referred to in this press release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
[email protected]

Media Contact:
LaVoieHealthScience
Lisa DeScenza
[email protected]
+1 9783955970 

Release – PDS Biotechnology Establishes Partnership With Head and Neck Cancer Alliance

Posted on by Admin

 


PDS Biotechnology Establishes Partnership With Head and Neck Cancer Alliance

 

Strategic partnership offers both organizations a way to share information about emerging treatment options with clinicians and patients battling HPV-attributed head and neck cancer

FLORHAM PARK, N.J., May 27, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a novel therapy for HPV-associated cancer based on the Company’s proprietary Versamune® T-cell activating technology, and the Head and Neck Cancer Alliance (HNCA) today announced a partnership. This collaboration seeks to raise awareness of new and developing treatment options, including available clinical trials, for patients with HPV-attributed head and neck cancer diagnoses.

Unlike many other cancers, the incidence of head and neck cancer is increasing in the United States, primarily due to rates of infection with human papillomavirus (HPV). Because head and neck cancer is often diagnosed at later stages, treatment is often more difficult and more invasive. PDS Biotech is working to change the landscape of HPV-attributed head and neck cancer treatment with their lead candidate, PDS0101, which uses Versamune® to activate the immune system to recognize HPV-associated cancer cells and respond by inducing T-cells to attack and destroy them.

Partnerships such as the one between PDS Biotech and HNCA are becoming more common in the patient advocacy and biotechnology spaces. By combining their efforts, partners can more efficiently spread the word about emerging treatments, clinical trials, and additional options for patients who may not have responded to traditional therapies.

“Raising awareness of treatment options for patients and their families who are dealing with head and neck cancer that has returned or spread is critical,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “Treatment options for these patients can be limited and the search often expands to include investigational therapies being studied in clinical research. We’re excited to partner with the HNCA to raise awareness of these options for patients and physicians.”

“There are exciting things happening in clinical research for head and neck cancer therapies,” said Amanda Hollinger, Executive Director of HNCA. “Partnering with companies like PDS Biotech who are leading the way forward and working together to raise awareness of new and developing treatment options brings hope to patients, survivors, and families of those battling cancer, as well as offering new avenues of treatment for clinicians.”

Head and neck cancer refers to cancers that arise in the mouth, voice box, throat, sinuses, nasal cavity, or salivary glands. Worldwide in 2021, there will be more than 650,000 new cases of oral, head and neck cancer diagnosed and approximately 330,000 deaths from these cancers. Over the last few decades, there has been a 225% increase in HPV-attributed head and neck cancer diagnoses. In 2018, head and neck cancer surpassed cervical cancer as the most common HPV-attributed cancer in the United States.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers.  In partnership with Merck and Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

About Head and Neck Cancer Alliance
HNCA’s mission is to advance prevention, detection, treatment and rehabilitation of oral, head and neck cancer through public awareness, research, advocacy and survivorship. As the one-stop center for patients, survivors, and family members seeking information about head and neck cancer, HNCA provides support to head and neck cancer patients throughout the year and works in partnership with healthcare, corporate, and community partners to raise awareness of ongoing research in head and neck oncology and educate the public in the disease process, treatment and prevention of oral, head and neck cancers. Led by a Board of Directors with expertise in head and neck surgery, research, and survivorship, HNCA develops strategic priorities to tackle the challenges facing those impacted by this disease.

Forward Looking Statements

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

PDS Biotech Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

Release – ProMIS Neurosciences appoints renowned scientist, Dr. David Wishart as Chief Physics Officer

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ProMIS Neurosciences appoints renowned scientist, Dr. David Wishart as Chief Physics Officer

 

TORONTO, Ontario and CAMBRIDGE, Mass.—May 27, 2021—ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced the appointment of  Dr. David Wishart, Distinguished University Professor in the Departments of Biological Sciences and Computing Science at the University of Alberta, as Chief Physics Officer at ProMIS. Dr. Wishart has been  one of the world’s most highly cited scientists for each of the past seven years and brings more than three decades in protein folding and misfolding research to ProMIS, creating industry-leading depth in this area of therapeutic development for neurodegenerative and other diseases. 

“Over the past half year as a member of the ProMIS scientific advisory board (SAB) I have participated in the ProMIS weekly R&D meetings and have come to appreciate the outstanding quality of the ProMIS scientific program and team led by Dr. Neil Cashman. With my appointment as Chief Physics Officer I now look forward to offering my experience and expertise in the field of protein misfolding to the ProMIS team, and in particular to continued expansion of the ProMIS technology platform which is uniquely capable of identifying the sequence and shape (conformation) of novel binding targets on misfolded proteins implicated in the development of neurodegenerative diseases such as Alzheimer’s, Parkinson’s and ALS.”

“ProMIS has leveraged its industry leading technology platform to create a portfolio of antibody, intrabody and vaccine candidates that are highly selective for the misfolded protein aggregates driving pathogenesis,” stated Dr. Neil Cashman, ProMIS Chief Scientific Officer (CSO).  “As Chief Physics Officer, Dr. Wishart will play a pivotal role to further develop and expand the application of our proprietary platform to the biology of additional misfolded protein diseases.  I would also like to take this opportunity to sincerely thank Dr. Steven Plotkin for his outstanding prior service to the company as the ProMIS Chief Physics Officer since its inception.”

“ProMIS’s unique capability is our unrivalled antibody discovery platform, and Dr. Wishart has already added immeasurably to that capability,” said Executive Chairman Eugene Williams.  “IBM’s quantum computing group predicted last year that within five years (i.e., by 2025) quantum computing will enable ‘developing novel biologic products based on protein folding predictions.’  ProMIS has already demonstrated that capability for years, in part by focusing on the narrower problem of predicting conformational epitopes exposed only on pathogenic, mis-folded proteins, but also by collaborating with extraordinarily talented scientists like Dr. Wishart and his team.”

About Dr. David Wishart

Dr. Wishart has been studying protein folding and misfolding for more than 30 years using a combination of computational and experimental approaches. These experimental approaches include NMR spectroscopy, circular dichroism, fluorescence spectroscopy, electron microscopy, protein engineering and molecular biology. The computational methods include molecular dynamics, agent-based modeling, bioinformatics and machine learning. Over the course of his career, Dr. Wishart has published more than 430 scientific papers, which have been cited more than 78,000 times, covering many areas of protein science including structural biology, protein metabolism and computational biochemistry. He has been with the University of Alberta since 1995 and is currently a Distinguished University Professor in the Departments of Biological Sciences and Computing Science. He also holds adjunct appointments with the Faculty of Pharmaceutical Sciences and the Department of Pathology and Laboratory Medicine.  

Dr. Wishart has been awarded research grants totaling more than $130 million from a number of funding agencies. He has also led or directed a number of core facilities and centers and currently co-directs The Metabolomics Innovation Centre (TMIC), Canada’s national metabolomics laboratory. Dr. Wishart held the Bristol-Myers Squibb Research Chair in Pharmaceutical Sciences from 1995-2005, received the Astra-Zeneca-CFPS Young Investigator Prize in 2001, was awarded a Lifetime Honorary Fellowship by the Metabolomics Society in 2014 and was elected as a Fellow of the Royal Society of Canada in 2017. 

About ProMIS Neurosciences

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

 

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

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For Investor Relations please contact:

Alpine Equity Advisors
Nicholas Rigopulos, President
[email protected]
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Release – Palladium One Drills Haukiaho Trend Intercepts 72 Meters

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Palladium One Drills Haukiaho Trend, Intercepts 72 Meters @ 1.8 g/t Palladium-Equivalent, Finland

 

May 26, 2021 – Toronto, Ontario – First drill results from the Company’s 2,000 meter drill program at Haukiaho, a zone approximately 20 kilometers south of the Company’s primary target area Kaukua South, have returned  significant widths and grades, including 72 meters at 1.8 g/t Palladium-equivalent “Pd_Eq”) (Hole LK21-071), on the Läntinen Koillismaa “LK”) PGE-Ni-Cu project in Finland, said Palladium One Mining Inc. “Palladium One” or the “Company”) (TSXV: PDM, FRA: 7N11, OTC: NKORF) today.

A total of 12 holes (1,943 metres) were drilled on the Haukiaho trend. This release contains the results from the first 7 holes of this program. The drilling was designed establish sufficient drill density to prepare a National Instrument 43-101 resource estimate at Haukiaho, which the Company anticipates completing in Q3 2021.

“Establishing a NI43-101 resource estimate at Haukiaho has been a priority for the Company given the robust historical data set available to the Company. Haukiaho was the original focus of the Phase I drill program in 2020, however, the discovery of Kaukua South led us towards first defining the potential of this new discovery and exploring the greater Kaukua area.  Despite this, Haukiaho was not forgotten and has remained an important part of our strategy to grow a multi-million ounce resource base. At 17 kilometers in length, the Haukiaho trend, currently represents the largest continuous patch of blue-sky potential on the LK property.” said Derrick Weyrauch, President and CEO.

Highlights

  • Drilling has returned significant widths and grades
  • Expanded higher grade areas within the known historic Haukiaho resource area
  • Expanded mineralization 100m to east of the historic resource
  • 72.2 meters grading 1.79 g/t Pd_Eq in hole LK21-071 starting 56m down hole, including 17.0 meters grading 2.23 g/t Pd_Eq
  • 15.7 meters grading 2.26 g/t Pd_Eq in hole LK21-069 including 3.6 meters grading 3.11 g/t Pd_Eq
  • 51.2 meters grading 1.07 g/t Pd_Eq in hole LK21-073 including 9.1 meters grading 2.10 g/t Pd_Eq
  • The historic Haukiaho resource is shallowly drilled, mostly above 200m in depth and therefore amendable to open pit mining

Haukiaho Historic Resource Estimate

In the 1980’s, Outokumpu  (a Finnish State-run mining company) prepared a resource estimate using very widely spaced holes along a portion of the Haukiaho trend, which estimated 7 million tonnes grading 0.38% Cu and 0.24% Ni, however importantly, no PGE assays were undertaken. The cut-off grade used was a 0.7% Copper_equivalent (defined as Cu% + 2 x Ni%).

Subsequently in 2013, Finore Mining Inc. completed a non-pit constrained NI43-101 historic resource estimate, over a much smaller strike length.  Using  a 0.1 g/t Pd cut-off, they estimated a resource of 1.13 million Pd_Eq ounces within 23.2 million tonnes grading 1.51 g/t Pd_Eq (0.31 g/t Pd, 0.12g/t Pt, 0.10 g/t Au, 0.21% Cu, and 0.14% Ni) (See news release August 12, 2019 and May 7, 2020).  This resource estimate encompassed widely spaced drilling with a focus on maximizing tonnage, not grade.

The Haukiaho trend is 17 kilometers long and the historic 2013 Haukiaho resource prepared by Finore covers less than 2 kilometers of this trend.  This knowledge coupled with the historic work by Outokumpu point to the enormous potential to significantly add resources at Haukiaho with disciplined execution of exploration activities.

While similar to the Kaukua deposit (See new release, September 30, 2019), the Haukiahio trend is more copper-nickel rich.  At Kaukua, approximately ~1/3 of the in-situ value per tonne is copper-nickel, while at Haukiaho copper-nickel represent approximately ~2/3s of the in-situ value.

Figure 1. LK Project location map showing 43-101 compliant Kaukua deposit and historic Haukiaho resource along with 2020 IP grids (blue lines) and current 2021 IP grid areas (black boxes). Yellow lines represent Exploration Permits, red lines represent Exploration Reservations held by the Company.

Figure 2. Plan map of Haukiaho 2020 IP chargeability anomalies and Palladium One drill holes locations.

Figure 3. Plan map of the Haukiaho historic 2013 Finore resource estimate represented by the > 0.5g/t Pd_Eq resource shape with Palladium One drill holes.

Figure 4. Haukiaho Cross section showing holes LK21-071, Finore hole HAU11-005, and geological survey of Finland (GTK) holes R-390 and R-389.

Table 1: Palladium One Haukiaho drill results

Hole

From
(m)

To
(m)

Width
(m)

Pd_Eq
g/t*

Pd
g/t

Pt
g/t

Au
g/t

Cu
%

Ni
%

LK20-008

17.3

33.5

16.2

1.99

0.38

0.15

0.14

0.26

0.20

Inc.

20.3

23.3

3.0

2.55

0.48

0.19

0.22

0.33

0.25

LK20-009

161.5

168.1

6.6

2.34

0.47

0.20

0.13

0.26

0.25

LK20-010

118.7

202.0

83.3

1.27

0.24

0.09

0.05

0.12

0.16

Inc.

166.8

201.0

34.3

2.09

0.47

0.20

0.10

0.20

0.22

Inc.

167.8

173.0

5.3

3.08

0.66

0.25

0.20

0.38

0.30

Inc.

20.3

23.3

3.0

2.55

0.48

0.19

0.22

0.33

0.25

LK21-067

No Significant values (collared in footwall rocks)

LK21-068

81.5

122.0

40.6

0.65

0.05

0.02

0.02

0.04

0.11

Inc.

106.2

120.0

13.9

0.80

0.12

0.05

0.02

0.06

0.12

Inc.

106.2

112.7

6.6

0.91

0.13

0.05

0.03

0.09

0.13

LK21-069

48.5

64.1

15.7

2.26

0.47

0.18

0.18

0.27

0.22

Inc.

48.5

60.0

11.6

2.53

0.52

0.19

0.18

0.30

0.25

Inc.

48.5

52.0

3.6

3.11

0.60

0.22

0.23

0.37

0.32

LK21-070

103.5

131.0

27.5

0.65

0.01

0.00

0.02

0.04

0.12

Inc.

113.0

119.0

6.0

0.83

0.02

0.00

0.04

0.09

0.14

LK21-071

55.8

128.0

72.2

1.79

0.37

0.15

0.14

0.22

0.17

Inc.

72.0

77.0

5.0

2.33

0.53

0.21

0.18

0.27

0.22

Inc.

74.0

75.5

1.5

3.20

0.75

0.29

0.23

0.39

0.29

And

86.2

94.0

7.8

2.74

0.53

0.21

0.23

0.32

0.27

And

111.0

128.0

17.0

2.23

0.53

0.21

0.18

0.28

0.18

Inc.

112.5

118.0

5.5

2.84

0.64

0.25

0.23

0.36

0.25

LK21-072

No Significant values (ended before zone)

LK21-073

75.8

127.0

51.2

1.07

0.15

0.06

0.06

0.13

0.13

Inc.

90.0

113.1

23.1

1.51

0.25

0.10

0.10

0.21

0.16

Inc.

90.8

99.9

9.1

2.10

0.37

0.15

0.16

0.27

0.21

Inc.

98.0

99.0

1.0

3.21

0.61

0.27

0.29

0.47

0.28

LK21-074

Pending

LK21-075

Pending

LK21-076

Pending

LK21-077

Pending

LK21-078

Pending

* Reported widths are “drilled widths” not true widths.
**Italicised orange highlighted results are previously released results see news release September 15, 2020

*Palladium Equivalent
Palladium equivalent is calculated using US$1,100 per ounce for palladium, US$950 per ounce for platinum, US$1,300 per ounce for gold, US$6,614 per tonne for copper, and US$15,4332 per tonne for nickel. This calculation is consistent with the calculation in the Company’s September 2019 NI 43-101 Kaukua resource estimate. Additionally, US$1,100 per ounce for palladium is consistent with the UBS January 2021 long-term consensus price forecast even though the current price of palladium is approximately US$2,800 per ounce.

QA/QC
The Phase I drilling program was carried out under the supervision of Neil Pettigrew, M.Sc., P. Geo., Vice President of Exploration and a director of the Company.

Drill core samples were split using a rock saw by Company staff, with half retained in the core box and stored indoors in a secure facility, in Taivalkoski, Finland. The drill core samples were transported by courier from the Company’s core handling facility in Taivalkoski, Finland, to ALS Global “ALS”) laboratory in Outokumpu, Finland. ALS, is an accredited lab and are ISO compliant (ISO 9001:2008, ISO/IEC 17025:2005). PGE analysis was performed using a 30 grams fire assay with an ICP-MS or ICP-AES finish. Multi-element analyses, including copper and nickel were analysed by four acid digestion using 0.25 grams with an ICP-AES finish.

Certified standards, blanks and crushed duplicates are placed in the sample stream at a rate of one QA/QC sample per 10 core samples. Results are analyzed for acceptance at the time of import. All standards associated with the results in this press release were determined to be acceptable within the defined limits of the standard used.

Qualified Person
The technical information in this release has been reviewed and verified by Neil Pettigrew, M.Sc., P. Geo., Vice President of Exploration and a director of the Company and the Qualified Person as defined by National Instrument 43-101.

About Palladium One
Palladium One Mining Inc. is an exploration company targeting district scale, platinum-group-element (PGE)-copper nickel deposits in Finland and Canada. Its flagship project is the Läntinen Koillismaa or LK Project, a palladium dominant platinum group element-copper-nickel project in north-central Finland, ranked by the Fraser Institute as one of the world’s top countries for mineral exploration and development. Exploration at LK is focused on targeting disseminated sulfides along 38 kilometers of favorable basal contact and building on an established NI 43-101 open pit resource.

ON BEHALF OF THE BOARD
“Derrick Weyrauch”
President & CEO, Director

For further information contact: Derrick Weyrauch, President & CEO
Email: [email protected]

Neither the TSX Venture Exchange nor its Market Regulator (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This press release includes “forward-looking information” that is subject to a few assumptions, risks and uncertainties, many of which are beyond the control of the Company. Statements regarding listing of the Company’s common shares on the TSXV are subject to all of the risks and uncertainties normally incident to such events. Investors are cautioned that any such statements are not guarantees of future events and that actual events or developments may differ materially from those projected in the forward-looking statements. Such forward-looking statements represent management’s best judgment based on information currently available. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions and general business conditions. Such forward-looking information reflects the Company’s views with respect to future events and is subject to risks, uncertainties and assumptions, including those set out in the Company’s annual information form dated April 29, 2020 and filed under the Company’s profile on SEDAR at www.sedar.com. The Company does not undertake to update forward?looking statements or forward?looking information, except as required by law. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements.

Release – Ceapro Inc. Announces Completion of Patient Enrollment in Clinical Study Evaluating Beta Glucan as a Cholesterol-Lowering Agent

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Ceapro Inc. Announces Completion of Patient Enrollment in Clinical Study Evaluating Beta Glucan as a Cholesterol-Lowering Agent

 

– Clinical study evaluating the well-known health claims of beta glucan and its potentially beneficial approach for patients to lower plasma cholesterol –

– Study conducted in collaboration with the Montreal Heart Institute and led by MHI’s Montreal Health Innovations Coordinating Center (MHICC) –

– Topline data readout expected Q4 2021 –

EDMONTON, Alberta, May 26, 2021 (GLOBE NEWSWIRE) —  Ceapro Inc. (TSX-V: CZO) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced the completion of patient enrollment in its comparison study evaluating high-medium molecular weight beta glucan as a stand-alone or add-on therapy to statins (the “BetAvena study”) in subjects with hyperlipidemia.

The study is being conducted with the Montreal Heart Institute (MHI), led by Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Center and Principal Investigator for this clinical trial as part of a long-term collaboration.

“We are incredibly pleased with the flawless execution of this important clinical study, despite challenges posed by the COVID-19 pandemic. We are extremely grateful to Dr. Jean-Claude Tardif and his expert team at the Montreal Heart Institute and their dedication to getting this study across the finish line and providing the opportunity to assess and validate the well-known health benefits of beta glucan per the highest clinical practice standards. The amended protocol that we were granted for the study expanded our target addressable patient population, which provided both scientific and clinical value and aided in successfully completing patient enrollment. This is a major milestone for our Company as we expand as a biopharmaceutical company and we look forward to reporting topline data in the fourth quarter of this year,” stated Gilles Gagnon, M.Sc., MBA, President and CEO.

“With patient enrollment now complete, our team is focused on advancing this potential alternative treatment forward and bring the study to successful completion. Pending statistical review, the BetAvena study may represent a significant shift for the patient community hoping to achieve hyperlipidemia control with nutraceuticals such as Ceapro’s CP105F. We are impressed by the engagement of our clinical sites and our patients who had to compose with very difficult COVID circumstances,” added Dr. Tardif.

This multicenter, randomized, double-blind, parallel group, placebo-controlled study is conducted to determine the efficacy and safety of high-medium molecular weight beta glucan in subjects with hyperlipidemia (LDL-C level >130 mg/d L (3.37 mmol/L). The 18 to 24-month study enrolled approximately 264 subjects who cannot tolerate high doses of current treatments. The Company received approval from Health Canada in February 2020 to expand the inclusion criteria of the study to allow evaluation of enrolled subjects with confirmed pathophysiological condition of hyperlipidemia who voluntarily request to be treated with beta glucan only, without regular dosing of statins. Enrolled patients were randomized to receive either placebo, low, medium or high doses of beta glucan (500 mg tablet) as add-on therapy, or not, to atorvastatin 10 mg – 20 mg or an equivalent statin for a 12-week treatment period. The primary efficacy endpoint of the study is the change over 12 weeks in LDL-cholesterol.

The Company anticipates the statistical analysis to be completed this fall and subsequently submitted to Heath Canada. The Company expects to report topline data from the study in the fourth quarter of 2021.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions. For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: [email protected]

Issuer:
Gilles R. Gagnon, M.Sc., MBA
President & CEO
T: 780-421-4555

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release


Source: Ceapro Inc.

Release – Comtech Telecommunications Corp. Awarded 1.6 Million Contract for High-Power Solid-State Amplifiers

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Comtech Telecommunications Corp. Awarded $1.6 Million Contract for High-Power Solid-State Amplifiers

 

MELVILLE, N.Y.–(BUSINESS WIRE)–May 26, 2021– 
May 26, 2021— 
Comtech Telecommunications Corp. (NASDAQ: CMTL), a world leader in secure wireless communications technologies, announced today that during its third quarter of fiscal 2021, its 
New York-based subsidiary, 
Comtech PST Corp., which is part of Comtech’s Government Solutions segment, was awarded an additional 
$1.6 million contract for RF microwave solid-state amplifiers from a major domestic prime contractor, adding to an initial 
$1.7 million contract awarded earlier this fiscal year.

These very high-power solid-state amplifiers, which utilize the latest in solid-state GaN transistor technology, were developed in close cooperation with the prime contractor and are part of a complex RF microwave transmission system used by the 
U.S. Military.

“This additional order is another example of Comtech’s technical strength in delivering high-power solid-state transmitter solutions for military applications and the ongoing demand for our high-power solid-state amplifier products,” said  Fred Kornberg, Chairman of the Board and Chief Executive Officer of 
Comtech Telecommunications Corp.

Comtech PST Corp. (www.comtechpst.com) is a leading independent supplier of broadband, high-power, high performance RF microwave amplifiers and control components for use in a broad spectrum of applications including defense, medical, satellite communications systems and instrumentation.

Comtech Telecommunications Corp. is a leader in the global communications market headquartered in 
Melville, New York. With a passion for customer success, 
Comtech designs, produces and markets advanced secure wireless solutions to more than 1,000 customers in more than 100 countries. For more information, please visit www.comtechtel.com.

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results could differ materially from such forward-looking information. The Company’s 
Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such 
Securities and Exchange Commission filings.

Media Contact:
Michael D. Porcelain, President and Chief Operating Officer

Comtech Telecommunications Corp.
631-962-7000
[email protected]

Source: 
Comtech Telecommunications Corp.

Release – ProMIS Neurosciences initiates commercialization of COVID-19 serology assay

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ProMIS Neurosciences initiates commercialization of COVID-19 serology assay

 

Seasoned industry executive and entrepreneur, Owen Dempsey to lead the effort for ProMIS

TORONTO, Ontario and CAMBRIDGE, Massachusetts – May 25, 2021– ProMIS Neurosciences, Inc. (TSX: PMN); (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics selectively targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced that it has initiated commercialization of its COVID-19 serology assay and has appointed Owen Dempsey to lead the commercialization program.

Owen’s professional work for the past 25 years has been to build companies founded to discover and commercialize antibodies in applications including life science research, pharmaceutical drug discovery, clinical diagnostics and therapeutic treatment of cancer, AIDS and other serious illness.  He has led private, venture-backed as well as NASDAQ-listed companies and is a past board member of ALDA, the Analytical, Life Science & Diagnostics Association.

 “I am delighted to lead this opportunity on behalf of ProMIS Neurosciences”, stated Owen Dempsey. “Our serology assay commercialization efforts will be targeting the need for a highly accurate test to detect, quantify and characterize antibodies against the virus causing COVID-19, either as a consequence of contracting the viral disease or in response to vaccination. Our initial focus will be on commercialization to the medical and public health community, vaccine developers, pharmaceutical companies, governmental agencies and other organizations.”

This advanced serology test developed by ProMIS Neurosciences measures not only serum antibodies to SARS-CoV-2, the novel coronavirus causing COVID-19, but also their protective activity against infection.  The assay simultaneously assesses antibody levels in the blood of study participants and their neutralizing activity against the original strain of SARS-CoV-2 as well as emerging variants.  Additional variants can be added to the assay as they are identified.  The assay utilizes an advanced, high-throughput, sensitive and accurate surface plasmon resonance (SPR) technology as opposed to traditional ELISA (enzyme-linked immunosorbent assay) methods.  

In commercializing an advanced serology testing platform, we aim to meet the needs of the medical community and investigators in academia, industry and government working to assess response and durability of response to vaccines as well as to monitor and assess antibody response to emerging strains of the virus..  As reported in the scientific literature, our accurate and sensitive format is capable of measuring neutralizing antibodies that inhibit coronavirus RBD binding to the human ACE2 receptor. This provides a powerful surrogate measure of antibody immunity without the need for live virus or pseudovirus formats. This and similar collaborative efforts may help to guide the need for boosters or modified vaccines addressing emerging strains and will inform the medical community’s preparedness to meet similar public threats to global health in the years ahead. 

It is important to note, as stated above that the initial marketing and commercialization of the assay will be directed only to organizations such as vaccine manufacturers, pharmaceutical companies and government organizations at the national and state/provincial level. The assay is not currently available to private individual consumers or the general public.

About ProMIS Neurosciences, Inc.

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

 

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

 

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For Investor Relations please contact:

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Nicholas Rigopulos, President
[email protected]
Tel. 617 901-0785

 

 

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. Specifically, the Company’s effort to commercialize its COVID-19 serology assay may not succeed due to many known and unknown factors, including the emergence of competing products, lack of market acceptance for its test, the cost of production relative to the revenue generated, and/or changes in the need for COVID-19 serology tests. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.