VBL Therapeutics to Report Third Quarter 2020 Financial Results on November 16

TEL AVIV, Israel, Nov. 02, 2020 (GLOBE NEWSWIRE) — VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced that it will host a conference call and live audio webcast on Monday, November 16, 2020 at 8:30am Eastern Time to report third quarter ended September 30, 2020 financial results and to provide a corporate update.

About VBL
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for areas of unmet need in cancer and immune/inflammatory indications. VBL has developed three platform technologies: a gene-therapy based technology for targeting newly formed blood vessels with focus on cancer, an antibody-based technology targeting MOSPD2 for anti-inflammatory and immuno-oncology applications, and the Lecinoxoids, a family of small-molecules for immune-related indications. VBL’s lead oncology product candidate, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. It is conveniently administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in a VBL-sponsored “all comers” Phase 1 trial as well as in three VBL-sponsored tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a VBL-sponsored Phase 3 potential registration trial for platinum-resistant ovarian cancer.

INVESTOR CONTACT:
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979

 

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Another 133 Positive Test Results In New Hampshire: Update

CONCORD, NH — The State Joint Information Center reported Sunday that another 133 people have tested positive for COVID-19 in New Hampshire, including 21 children.

The new positive test results were found after 7,122 polymerase chain reaction specimens were collected on Saturday with Friday’s count increased by about 1,500 with 575 tests pending for a positivity rate of 1.4 percent.

The median time period for test results is about two days, according to the state.

Forty of the new patients live in Rockingham County, 16 reside in Hillsborough County outside of Manchester and Nashua, 12 live in Merrimack County, and four live in Nashua.

Investigations on 10 more people remain underway.

Most of the new cases were female.

Thirty-eight people remain hospitalized and only one had no identified risk factors.

More than 23 percent of the state’s residents have been tested for COVID-19 with more than 622,000 tests implemented.

About 4,450 people are under public health monitoring in New Hampshire.

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Stop The Spread Of COVID-19

The COVID-19 virus is spread through respiratory droplets, usually through coughing and sneezing, and exposure to others who are sick or might be showing symptoms.

Health officials emphasize residents should follow these recommendations:

  • Avoid any domestic and international travel, especially on public transportation such as buses, trains, and airplanes.

  • Practice social distancing. Stay at least 6 feet from other people, including distancing while in waiting areas or lines.

  • When you can’t practice 6 feet of social distancing, wear a face covering.

  • Anyone who is told to self-quarantine and stay at home due to exposure to a person with confirmed or suspected case of COVID-19 needs to stay home and not go out into public places.

  • If you are 60 years or older or have chronic and underlying health conditions, you need to stay home and not go out.

  • Avoid gatherings of 10 people or more.

  • Employers should work from home as much as possible.

  • There is increasing evidence that the virus can survive for hours or possibly days on surfaces. People should clean frequently touched surfaces, including door handles, grocery carts and grocery basket handles, etc.

Take the same precautions as you would if you were sick:

  • Stay home and avoid public places.

  • Wear a face covering.

  • Cover mouth and nose when coughing and sneezing.

  • Wash hands frequently.

  • Disinfect frequently touched surfaces.

More information from the New Hampshire Department of Health and Human Services about coronavirus can be found here on the department’s website.

Got a news tip? Send it to [email protected] View videos on Tony Schinella’s YouTube channel.

This article originally appeared on the Concord Patch

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New Hampshire Reports Record High Positive COVID-19 Test Results

CONCORD, NH — Gov. Chris Sununu, R-NH, issued a weekend statement Saturday after state health officials reported the highest single day of new COVID-19 positive test results — 205, including 31 children.

The new test results were reported after 7,927 specimens were collected Friday and prior days of tests were updated slightly from previous reports. A little more than 1,100 test results are pending for a polymerase chain reaction test positivity rate of 1.6 percent.

“The situation here in New Hampshire remains very serious, the data shows that community transmission is increasing, and we expect cases to rise,” Sununu said. “We must all remain vigilant in our daily lives. As we enter these winter months, it will be more important than ever to wear your mask, practice social distancing, and maintain proper hand hygiene.”

Nearly a quarter of the new test results, 50, came from Rockingham County with 27 living in Hillsborough County outside of Manchester and Nashua, 19 residing in Nashua, and 13 living in Merrimack.

State officials are still investigating the residency of eight cases.

Fifty-three percent of the new positive test results were female.

The state reported that 42 people are currently hospitalizations while only one of the new cases has no identified risk factors.

Accumulatively, 11,084 people have contracted COVID-19 in New Hampshire with 1,338 currently infected and 9,263, 84 percent, having recovered from the virus.

The State Joint Information Center also announced the 483rd death in the New Hampshire — a woman who was 80 years of age or older and lived in a long-term care setting in Hillsborough County.

More than 345,000 people have been tested for the coronavirus with nearly 617,00 PCR tests being administered by the state and 4,400 people under public health monitoring.

More Possible Restaurant Exposures

Both state and Nashua health officials issued alerts during the past 24 hours about possible restaurant exposure to the public.

Nashua Public Health is investigating potential community exposure related to a person with a confirmed COVID-19 diagnosis at the Texas Roadhouse on 580 Amherst St. The potential community exposure occurred in the bar area between 3 and 10 p.m. on Oct. 22, and 11 a.m. to close on Oct. 23.

“The health and safety of our staff and customers is our top priority,” Eric Martin, the restaurant’s director of food safety. “We have been following CDC guidelines for cleaning and disinfecting our facility. We follow all reopening guidance for food service establishments from the state.”

Public health is investigating the situation and notifying any known close contacts directly but if you were at the restaurant during those dates, you should self-quarantine, monitor for symptoms — sore throat, congestion, runny nose, headache, muscle ache, fatigue, new loss of taste or smell, fever, cough, shortness of breath, nausea, vomiting, or diarrhea, and get tested.

State health officials said contact tracers were investigating another possible community exposure in Merrill’s Tavern and Stagecoach Grille at the Atkinson Resort & Country Club between 11 a.m. and 11:30

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Rhythm Pharmaceuticals Announces Publication of Results from Phase 3 Clinical Trials of Setmelanotide in The Lancet Diabetes & Endocrinology

Largest studies in POMC and LEPR deficiency obesities demonstrate that treatment with setmelanotide reduced body weight and hunger

BOSTON, Oct. 30, 2020 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, announced today that results from two pivotal Phase 3 studies evaluating setmelanotide in proopiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity were published in The Lancet Diabetes & Endocrinology. As previously reported, data from the studies demonstrate that treatment with setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, led to statistically significant and clinically meaningful reductions of weight and hunger.

“Results from Rhythm’s pivotal Phase 3 studies, which are the largest studies to date in POMC and LEPR deficiency obesities, provide evidence regarding the safety and efficacy of setmelanotide and we believe they validate its potential long-term use as a novel treatment for severe obesity and hyperphagia,” said co-author Peter Kühnen, M.D., Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin, Germany. “It is important to recognize the signs of these rare genetic disorders because we may soon have a targeted treatment option available for the first time for obesity disorders caused by impairments of the MC4R pathway.”

Rhythm initially reported positive topline data from the Phase 3 studies in August 2019 and subsequently presented updated data in a late-breaking research forum during the 37th Annual Meeting of The Obesity Society at ObesityWeek® 2019.

Eight of 10 participants with POMC deficiency obesity (80%; P<0.0001 compared with historical data) and five of 11 participants with LEPR deficiency obesity (45%; P=0.0001 compared with historical data) achieved at least 10 percent weight loss at approximately one year. The mean percent change in “most hunger” score in participants aged 12 years and older was -27.1 percent (n=7; P=0.0005) in POMC deficiency obesity and -43.7 percent (n=7; P<0.0001) in LEPR deficiency obesity. Consistent with prior clinical experience, setmelanotide was generally well-tolerated in both trials. The most common adverse events were injection site reaction, skin hyperpigmentation, and nausea.

“These results are significant because, as we know from natural history data, individuals living with POMC or LEPR deficiency obesity consistently experience substantial weight gain each year beginning in early childhood, and we would not expect any of these patients to be able to achieve 10 percent weight loss over the course of a year without continued treatment,” said co-author Karine Clément, professor of nutrition at Pitié-Salpêtrière hospital and Sorbonne University in Paris. “These data and the significant unmet need to address the obesity and hyperphagia caused by rare genetic disorders of obesity underscore the importance of testing for genetic variants that may impair MC4R activation and lead to severe obesity.”

In May 2020, Rhythm announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application (NDA) for setmelanotide for the treatment of POMC deficiency obesity and LEPR deficiency obesity, granted Priority Review of the NDA and assigned a Prescription Drug

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Study: 30% of nursing facilities in COVID-19 ‘hot spots’ wait 3 days or more for test results

Oct. 30 (UPI) — Nearly one-third of skilled nursing facilities situated in COVID-19 hot spots across the United States still are waiting three days or more for virus test results for staff and residents as of the end of September, according to a report published Friday by JAMA Internal Medicine.

Nationally, just under 40% of all of these facilities — which including residential and rehabilitation centers staffed with nurses, physical and occupational therapists, speech pathologists and audiologists — indicated that it took three days or more to receive COVID-19 test results for residents and staff, the data showed.

The findings were as of Sept. 27, or more than two months after Medicare began to distribute rapid, point-of-care tests to generate results in one day or less to these facilities, the researchers said.

While the number of facilities receiving test results in a day or less doubled in some areas during September, researchers say the progress is not sufficient enough.

“Rapid testing turnaround is critical to prevent outbreaks in nursing homes — and elsewhere — but only a tiny fraction of homes have access to turnaround that is less than one day,” study co-author Dr. Michael L. Barnett told UPI.

“With slower turnaround, staff with COVID-19 and no symptoms will circulate in a facility and spread infection before the positive test comes back,” said Barnett, assistant professor of health policy and management at Harvard T. H. Chan School of Public Health.

Nursing homes and assisted-living facilities across the country were hit hard by the COVID-19 pandemic, particularly in the spring, accounting for 40% of all virus-related deaths nationally, according to the Kaiser Family Foundation.

As a result, the U.S. Centers for Medicare and Medicaid Services began to distribute “rapid” virus testing kits to these facilities in July. The tests could be administered on-site and provide results in one day or less, agency officials said.

The agency requires facilities located in areas with low rates — less than 5% — of COVID-19 transmission to test residents and staff members monthly.

However, those based in hot spots — with up to 10% or more of virus transmission — should be testing staff and residents at least twice weekly, according to officials.

For this analysis, Barnett and his colleagues analyzed data from 15,065 — or 98% — of the skilled nursing facilities included in the Medicare COVID-19 Nursing Home Database. The database is a federally mandated weekly assessment of all Medicare-certified facilities, to examine facility-reported test result turnaround time.

As of Sept. 27, 14% of all facilities nationally said they received COVID-19 test results for staff members in one day or less, up from 6.2% three weeks earlier, the data showed.

By that same date, 10% of facilities reported getting test results for residents in one day or less, an increase from 5% earlier in the month.

In “hot spot counties” — with high rates of community spread of the virus — the number of facilities that reported test turnaround of one day or

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SF stops Google-affiliated testing after results take 10 days

San Francisco has stopped partnering with Google-affiliated Verily at its community COVID-19 test sites after the the state of California announced $55 million in contracts with the firm in March.

San Francisco’s first Verily testing site was set up in the Tenderloin in partnership with the San Francisco Department of Public Health and Glide Memorial Church. The pop-up was initially located next to Glide and later St. Mary’s Cathedral.

“We stopped utilizing the Verily asset in August when the turnaround time for testing results were 10-plus days,” the city said in a statement. “Upon resolution of the results reporting, we reached out to the state to deploy the asset to a new site but California Department of Public Health decided that the testing asset was needed elsewhere, a county that had higher infection rates. It was deemed at that point that San Francisco already had high testing rate and low infection rate and the asset was needed elsewhere.”

Pop-up testing led by the Department of Public Health and the genetic-testing company Color now operates in the Tenderloin twice a week in coordination with Glide.


Verily, the life sciences arm of Google’s parent company Alphabet, is one of many vendors the state has contracted with to provide testing. The state’s contract with the company based in South San Francisco was much hailed by state officials, as it offered a platform that screens potential patients and connects them with testing. The intention was to use the platform to bring testing to those neighborhoods most impacted by the virus or those with hard-to-reach populations.

In an April 29 press briefing, Gov. Gavin Newsom said the company was “focusing on expanding their testing with a socioeconomic lens to diverse communities, not just in rural California but inner city California.”

Trump even touted Verily, announcing on March 13 that Google was building a site to help Americans locate COVID-19 testing, misleading people to believe the Northern California effort was geared to the entire country.

While Verily was meant to help reach underserved communities in San Francisco, Kenneth Kim, clinical director of Glide, told Kaiser Health News that the platform presented many hurdles for the homeless population it was meant to serve. Verily requires users to have a Google account and Kim said many homeless residents getting tested had the accounts but they couldn’t remember passwords.

Alameda County also partnered with Verily to open two testing sites. The first one closed by May, and the second, at an Oakland Church, closed in August, according to Kaiser Health News. A June letter to California Secretary of Health and Human Services Dr. Mark Ghaly from Oakland Mayor Libby Schaaf and other members of the county’s COVID-19 Racial Disparities Task Force noted many of the problems with the platform, including the inability for users to make an appointment over the phone and the requirement to have a Google account.

Kathleen Parkes told Kaiser Health News Gmail accounts are required to register with Verily’s platform because Google’s authentication procedures safeguard

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Two COVID-19 Outpatient Antibody Drugs Show Encouraging Results

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

Two COVID-19 antibody treatments, one developed by Regeneron and the other by Eli Lilly, show promise in the outpatient setting in results released on Wednesday.

Regeneron, in a randomized, double-blind trial, is assessing the effect of adding its investigational antibody cocktail REGN-COV2 to usual standard of care in comparison with adding placebo to standard of care. A descriptive analysis from the first 275 patients was previously reported. The data described Wednesday, which involve an additional 524 patients, show that the trial met all of the first nine endpoints.

Regeneron announced prospective results from its phase 2/3 trial showing REGN-COV2 significantly reduced viral load and patient medical visits, which included hospitalizations, visits to an emergency department, visits for urgent care, and/or physician office/telemedicine visits.

Interest in the cocktail spiked after President Donald Trump extolled its benefits after it was used in his own COVID-19 treatment earlier this month.

Trump received the highest dose of the drug, 8 g, but, according to a Regeneron news release announcing the latest findings, “results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 grams).”

The company described further results of the industry-funded study in the release: “On the primary endpoint, the average daily change in viral load through day 7 (mean time-weighted average change from baseline) in patients with high viral load (defined as greater than107 copies/mL) was a 0.68 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p<0.0001). There was a 1.08 log greater reduction with REGN-COV2 treatment by day 5, which corresponds to REGN-COV2 patients having, on average, a greater than 10-fold reduction in viral load, compared to placebo.”

The treatment appears to be most effective in patients most at risk, whether because of high viral load, ineffective baseline antibody immune response, or preexisting conditions, according to the researchers.

According to the press release, these results have not been peer reviewed but have been submitted to the US Food and Drug Administration, which is reviewing a potential emergency use authorization for the treatment in high-risk adults with mild to moderate COVID-19.

Operation Warp Speed, the Trump administration’s treatment and vaccine program, contracted in July with Regeneron for up to 300,000 doses of its antibody cocktail.

Lilly Treatment Shows Drop in Hospitalizations, Symptoms

Another treatment, also given in the outpatient setting, shows promise as well.

Patients recently diagnosed with mild to moderate COVID-19 who received Eli Lilly’s antibody treatment LY-CoV555 had fewer hospitalizations and symptoms compared with a group that received placebo, an interim analysis of a phase 2 trial indicates.

Peter Chen, MD, with the Department of Medicine, Women’s Guild Lung Institute at Cedars-Sinai Medical Center, Los Angeles, California, and colleagues found that the most profound effects were in the high-risk groups.

The interim findings of the BLAZE-1 study, which was funded by Eli Lilly, were published online October 28 in The

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Antibody drug tested in Cook County may be helpful to some COVID-19 patients, results show

A new antibody-based drug shows promise in treating outpatients who have mild to severe COVID-19, according to initial results of research conducted in part at Cook County Health and Northwestern University.

Patients given the drug were hospitalized or visited the emergency room less often than those given a placebo, Cook County Health officials said. The patients receiving the drug also showed improvement within two to six days, a shorter disease course that is not only good for patients but also may reduce the amount of time a person is infectious, helping protect other people.

The drug, manufactured by Eli Lilly and AbCellera Biologics Inc., was tested on 452 outpatients at 24 medical institutions across the country, including Cook County’s vast public health system and the Northwestern University Feinberg School of Medicine. Most of the 14 patients who took part at Cook County Health were Latino or Black, populations that have been hit especially hard by the disease.

The results of the continuing study, which is being run by Eli Lilly, were published Wednesday by the New England Journal of Medicine.

The drug, administered through a one-time infusion, includes the replicated antibodies of one of the first patients in the United States to survive COVID-19. It’s classified as a monoclonal antibody treatment, the same type of medication given to President Donald Trump after he was diagnosed with the disease and which he described as “a cure.”

The drug in the Eli Lilly trial was formulated using a single antibody. The drug Trump received was made by Regeneron and involves two antibodies.

Dr. Gregory Huhn, an infectious disease expert who led the arm of the Eli Lilly research conducted at Cook County Health, made it clear that the drug is a treatment, not a cure.

“Our hope has been that the antibody drug will reduce COVID symptoms quickly after diagnosis and help to eradicate the virus more quickly,” Huhn said. “While a vaccine is still necessary, this drug therapy has the potential to prevent bad clinical outcomes and complications of COVID-19.”

Scientists have surmised that monoclonal antibodies would be more effective earlier in the course of the disease, and that so far appears to be the case. Another recently released study found the Eli Lilly drug had no benefit for patients sick enough to be hospitalized — results that brought the research to a halt. Most of those patients also were treated with the antiviral drug remdesivir.

“There’s a more compelling argument to administer antibodies early on, before our own bodies generate their own immune response,” Huhn said.

The results released Wednesday found that 1.6% of outpatients given the Eli Lilly drug needed to be hospitalized or visit an emergency room, compared with 6.3% of patients who received a placebo. The drug worked by reducing the amount of virus in people’s bodies, the study determined.

The study’s findings also indicate better outcomes among high-risk patients — defined as patients 65 or older or morbidly obese patients who were at least

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Early results from DETECT study suggest fitness trackers can predict COVID-19 infections

IMAGE

IMAGE: The DETECT study uses a mobile app to collect smartwatch and activity tracker data from consenting participants, and also gathers their self-reported symptoms and diagnostic test results. Any adult living…
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Credit: Scripps Research

LA JOLLA, CA–Examining data from the first six weeks of their landmark DETECT study, a team of scientists from the Scripps Research Translational Institute sees encouraging signs that wearable fitness devices can improve public health efforts to control COVID-19.

The DETECT study, launched on March 25, uses a mobile app to collect smartwatch and activity tracker data from consenting participants, and also gathers their self-reported symptoms and diagnostic test results. Any adult living in the United States is eligible to participate in the study by downloading the research app, MyDataHelps.

In a study that appears today in Nature Medicine, the Scripps Research team reports that wearable devices like Fitbit are capable of identifying cases of COVID-19 by evaluating changes in heart rate, sleep and activity levels, along with self-reported symptom data–and can identify cases with greater success than looking at symptoms alone.

“What’s exciting here is that we now have a validated digital signal for COVID-19. The next step is to use this to prevent emerging outbreaks from spreading,” says Eric Topol, MD, director and founder of the Scripps Research Translational Institute and executive vice president of Scripps Research. “Roughly 100 million Americans already have a wearable tracker or smartwatch and can help us; all we need is a tiny fraction of them–just 1 percent or 2 percent–to use the app.”

With data from the app, researchers can see when participants fall out of their normal range for sleep, activity level or resting heart rate; deviations from individual norms are a sign of viral illness or infection.

But how do they know if the illness causing those changes is COVID-19? To answer that question, the team reviewed data from those who reported developing symptoms and were tested for the novel coronavirus. Knowing the test results enabled them to pinpoint specific changes indicative of COVID-19 versus other illnesses.

“One of the greatest challenges in stopping COVID-19 from spreading is the ability to quickly identify, trace and isolate infected individuals,” says Giorgio Quer, PhD, director of artificial intelligence at Scripps Research Translational Institute and first author of the study. “Early identification of those who are pre-symptomatic or even asymptomatic would be especially valuable, as people may potentially be even more infectious during this period. That’s the ultimate goal.”

For the study, the team used health data from fitness wearables and other devices to identify–with roughly 80% prediction accuracy–whether a person who reported symptoms was likely to have COVID-19. This is a significant improvement from other models that only evaluated self-reported symptoms.

As of June 7, 30,529 individuals had enrolled in the study, with representation from every U.S. state. Of these, 3,811 reported symptoms, 54 tested positive for the coronavirus and 279 tested negative. More sleep and less activity than an individual’s normal levels were significant

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HEXO Corp to Release Fourth Quarter and Fiscal Year 2020 Financial Results and Host Investor Webcast

OTTAWA, Oct. 27, 2020 (GLOBE NEWSWIRE) — HEXO Corp (“HEXO” or the “Company”) (TSX: HEXO; NYSE: HEXO) plans to release its complete financial results for the quarter and fiscal year ended July 31, 2020, after market hours on Thursday, October 29, 2020, as well as host a webcast for investors and analysts beginning at 8:30 a.m. EDT on Friday October 30, 2020.

Webcast Details
Date: October 30, 2020
Time: 8:30 a.m. EDT
Webcast:  https://event.on24.com/wcc/r/2771524/47E7001045651D265D3F12D203F6F5A4

For previous quarterly results and recent press releases, see hexocorp.com.

About HEXO

HEXO Corp is an award-winning consumer packaged goods cannabis company that creates and distributes innovative products to serve the global cannabis market. The Company serves the Canadian adult-use markets under its HEXO Cannabis, Up Cannabis and Original Stash brands, and the medical market under HEXO medical cannabis. For more information please visit hexocorp.com.

Forward Looking Statements

This press release contains forward-looking information and forward-looking statements within the meaning of applicable securities laws (“forward-looking statements”). Forward-looking statements are based on certain expectations and assumptions and are subject to known and unknown risks and uncertainties and other factors that could cause actual events, results, performance and achievements to differ materially from those anticipated in these forward-looking statements. Forward-looking statements should not be read as guarantees of future performance or results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements as a result of new information or future events, or for any other reason.

Investor Relations:
[email protected]
www.hexocorp.com 

Media Relations:
(819) 317-0526
[email protected] 

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