Market Newsdesk

LONDON and SAN FRANCISCO, March 26, 2021 (GLOBE NEWSWIRE) — GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the submission of an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 patients enrolled in the trial, demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy. Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA.

Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. New in vitro data from pseudotyped virus assays published online in bioRxiv in March 2021 support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants. Based on additional soon to be published preclinical data, VIR-7831 also appears to maintain activity against the California variant.

GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible. 

About COMET-ICE 
The multi-center, double-blind, placebo-controlled COMET-ICE trial investigated VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease. The Phase 2 lead-in portion of the trial, which served as the first-in-human assessment, evaluated the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in 21 non-hospitalized adults enrolled across the United States. In October 2020, based on a positive evaluation of safety and tolerability data of VIR-7831 from the lead-in part of the trial by an Independent Data Monitoring Committee, the trial began enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 portion of the trial.

In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrollment due to evidence of profound efficacy but is continuing to follow study participants for 24 weeks. Additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.

The Phase 3 portion of the trial assessed the safety and efficacy of a single IV infusion of VIR-7831 (500 mg) or placebo in non-hospitalized participants globally. The interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization.

About the VIR-7831 Clinical Development Program

In addition to the COMET-ICE trial, the full COMET clinical development program for VIR-7831 includes:

• COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes.
• COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19.
• COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.

VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of Eli Lilly’s bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19. Additionally, VIR-7831, along with VIR-7832 will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any other regulatory authority. 

About VIR-7831 / GSK4182136

VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About VIR-7832 / GSK4182137

VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor’s Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

About the Vir and GSK Collaboration 
In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

GSK Commitment to Tackling COVID-19 
GSK’s response to COVID-19 has been one of the broadest in the industry, with three potential treatments in addition to our vaccine candidates in development.

GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, a collaboration with Sanofi on an adjuvanted, protein-based vaccine candidate is now in Phase 2. An earlier stage collaboration with SK Bioscience is also ongoing. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people.

GSK is also working with mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac’s first generation COVID-19 vaccine.

GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are seeking Emergency Use Authorization in the US and authorizations in other countries. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of availability of preclinical and clinical data, clinical development program updates, and data disclosures related to VIR-7831, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus, Vir’s collaboration with GSK, and statements related to regulatory authorizations and approvals, including Vir’s plans to submit a BLA to the FDA and continue discussions with the EMA and other global regulators. Many factors may cause differences between current expectations and actual results, including challenges in obtaining regulatory approval, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

GSK Cautionary Statement Regarding Forward-Looking Statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company’s Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

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Vir Biotechnology Contacts:
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[email protected]
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VANCOUVER, British Columbia, March 26, 2021 (GLOBE NEWSWIRE) — Skyharbour Resources Ltd. (TSX-V:SYH) (OTCQB:SYHBF) (Frankfurt: SC1P) (the “Company or Skyharbour”) announces that Orano Canada Inc. (“Orano”) has completed the first earn-in option of a 51% (fifty-one percent) interest in the Preston Uranium Project (“Project”), located in the western Athabasca Basin, Saskatchewan, Canada. Orano previously held an option to acquire the interest through an option agreement entered into with Skyharbour and Dixie Gold Inc. (“Dixie Gold”).

Project Location – Western Athabasca Basin, Saskatchewan, Canada:

https://skyharbourltd.com/_resources/maps/SYH-Patterson-Lake.pdf

Orano has fulfilled their first earn-in option interest in the project by completing CAD $2.8 million in staged exploration expenditures and making a total of CAD $200,000 in cash payments over the previous three years, divided evenly between Skyharbour and Dixie Gold. Orano has spent a total of CAD $4.8 million on the Project to date.

Following acquisition of the interest, Orano has formed a joint venture with Skyharbour and Dixie Gold for the future advancement and development of the Project. Orano now holds a 51% (fifty-one percent) interest in the joint venture, with the remaining interest split evenly between Skyharbour and Dixie Gold with each company retaining a 24.5% (twenty-four and a half percent) interest in the joint venture.

About Preston:

In March 2017, Skyharbour signed an option agreement with Orano (formerly AREVA Resources Inc.) that provided Orano an earn-in option to acquire a majority working interest in the 49,653 hectare Preston Uranium Project (see also news release dated December 15, 2016). Under the option agreement, Orano could contribute cash and exploration program consideration totaling up to CAD $8,000,000 in exchange for up to 70% of the applicable project area over six years.

The significant potential of the Project has been highlighted by recent discoveries in the area by NexGen Energy Ltd. (Arrow), Fission Uranium Corp. (Triple R) and a joint venture consisting of Cameco Corporation, Orano and Purepoint Uranium Group Inc. (Spitfire). Exploration at the Project has consisted of ground gravity, airborne and ground electromagnetics, radon, soil, silt, biogeochem, lake sediment, and geological mapping surveys, as well as exploratory drill programs. Over a dozen high-priority drill target areas associated with multiple prospective exploration corridors have been successfully delineated through these methodical, multiphased exploration initiatives, which have culminated in an extensive, proprietary geological database for the project area.

Qualified Person:

The technical information in this news release has been prepared in accordance with the Canadian regulatory requirements set out in National Instrument 43-101 and reviewed and approved by Richard Kusmirski, P.Geo., M.Sc., Skyharbour’s Head Technical Advisor and a Director, as well as a Qualified Person.

About Orano Canada Inc.:

Headquartered in Saskatoon, Saskatchewan, Orano Canada Inc. is a leading supplier of uranium, accounting for the processing of 18 million pounds produced in Canada in 2019. Orano Canada has been exploring for uranium, mining and producing uranium concentrate in Canada for more than 55 years. The company operates the McClean Lake uranium mill and holds a significant interest in the Cigar Lake, McArthur River and Key Lake operations. The company employs over 450 people in Saskatchewan, including about 320 at the McClean Lake operation where over 46% of employees are self-declared Indigenous. As a sustainable uranium producer, Orano Canada is committed to safety, environmental protection and contributing to the prosperity and well-being of neighbouring communities.

Orano Canada Inc. is a subsidiary of the multinational Orano Group offering products and services with high added value throughout the entire nuclear fuel cycle, from raw materials to waste treatment. Its activities, from mining to dismantling, as well as in conversion, enrichment, recycling, logistics and engineering, contribute to the production of low carbon electricity. Orano Group and its 16,000 employees bring to bear their expertise and their mastery of cutting-edge technology, as well as their permanent search for innovation and unwavering dedication to safety, to serve their customers worldwide.

About Skyharbour Resources Ltd.:

Skyharbour holds an extensive portfolio of uranium exploration projects in Canada’s Athabasca Basin and is well positioned to benefit from improving uranium market fundamentals with six drill-ready projects covering over 240,000 hectares of land. Skyharbour has acquired from Denison Mines, a large strategic shareholder of the Company, a 100% interest in the Moore Uranium Project which is located 15 kilometres east of Denison’s Wheeler River Project and 39 kilometres south of Cameco’s McArthur River uranium mine. Moore is an advanced stage uranium exploration property with high grade uranium mineralization at the Maverick Zone that returned drill results of up to 6.0% U₃O₈ over 5.9 metres including 20.8% U₃O₈ over 1.5 metres at a vertical depth of 265 metres. The Company has plans for upcoming drill programs at the project.

Skyharbour has now entered into a joint venture partnership with industry-leader Orano Canada Inc. and has a joint venture partnership with Azincourt Energy. Orano recently earned-in 51% of the Preston Project and Azincourt recently earned-in 70% of the East Preston Project through exploration expenditures, cash payments and Azincourt share issuance. Preston and East Preston are large, geologically prospective properties proximal to Fission Uranium’s Triple R deposit as well as NexGen Energy’s Arrow deposit.

The Company owns a 100% interest in the South Falcon Uranium Project on the eastern perimeter of the Basin which contains a NI 43-101 inferred resource totaling 7.0 million pounds of U₃O₈ at 0.03% and 5.3 million pounds of ThO₂ at 0.023%. Furthermore, Skyharbour has recently signed a Definitive Agreement with ASX-listed Valor Resources on the Hooke Lake (previously North Falcon Point) Uranium Project whereby Valor can earn-in 80% of the project through $3,500,000 in total exploration expenditures, $475,000 in total cash payments over three years and an initial share issuance.

Skyharbour’s goal is to maximize shareholder value through new mineral discoveries, committed long-term partnerships, and the advancement of exploration projects in geopolitically favourable jurisdictions.

Skyharbour’s Uranium Project Map in the Athabasca Basin:


http://skyharbourltd.com/_resources/maps/SYH-Athabasca-Map.jpg

To find out more about Skyharbour Resources Ltd. (TSX-V: SYH) visit the Company’s website at www.skyharbourltd.com.

SKYHARBOUR RESOURCES LTD.

“Jordan Trimble”

Jordan Trimble
President and CEO

For further information contact myself or:
Spencer Coulter
Corporate Development and Communications
Skyharbour Resources Ltd.
Telephone: 604-687-3376
Toll Free: 800-567-8181
Facsimile: 604-687-3119
Email: [email protected]

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

This release includes certain statements that may be deemed to be “forward-looking statements”. All statements in this release, other than statements of historical facts, that address events or developments that management of the Company expects, are forward-looking statements. Although management believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results or developments may differ materially from those in the forward-looking statements. The Company undertakes no obligation to update these forward-looking statements if management’s beliefs, estimates or opinions, or other factors, should change. Factors that could cause actual results to differ materially from those in forward-looking statements, include market prices, exploration and development successes, continued availability of capital and financing, and general economic, market or business conditions. Please see the public filings of the Company at www.sedar.com for further information.

DENVER, March 26, 2021 (GLOBE NEWSWIRE) — Assure Holdings Corp. (the “Company” or “Assure”) (TSXV: IOM; OTCQB: ARHH), a provider of intraoperative neuromonitoring services (“IONM”), reported financial results for the fourth quarter and full year ended December 31, 2020.

Fourth Quarter 2020 Financial Summary vs. Fourth Quarter 2019

• Total revenue was $6.0 million versus $(4.7) million. In the fourth quarter 2020, $3.1 million of revenue was derived from hospitals and management fees, a $1.4 million increase from the year-earlier quarter. The fourth quarter of 2019 included a $10.3 million reserve relating to a private health insurance company and its affiliates in Louisiana, Texas and Michigan.
• Cost of revenue was $2.9 million vs $0.5 million due to the reversal of accrued billing fees related to the reserve adjustments taken in the fourth quarter of 2019, and to the Company building an internal revenue cycle management department in 2020.
• Managed cases increased 36% to a quarterly record of 3,057 versus 2,242.
• Equity method of investment in Provider Entities (“PEs”) was $0.3 million compared to $0.1 million.
• Net loss of $(0.5) million compared to net loss of $(6.7) million.
• Net loss per diluted share was $(0.01) compared to net loss of $(0.19) per diluted share.
• Adjusted EBITDA was $0.8 million versus $(8.2) million.
• The Company collected a quarterly record $6.5 million compared to $2.4 million for a combination of technical IONM services and cash collected from PEs for professional IONM services.
• The Company collected a record $3.7 million versus $1.3 million for IONM revenue that it retains 100%.

In fourth quarter and full-year 2020, the Company realized gains of $1.2 million associated with forgiveness for the SBA loan relating to the CARES Act.

Full Year 2020 Financial Summary vs. Full Year 2019

• Total revenue was $3.5 million versus $17.7 million.
• Managed cases increased 54% to an annual record of 9,914 versus 6,414.
• Equity method of investment in Provider Entities was ($1.2) million compared to $1.3 million.
• General and administrative expenses were $9.6 million compared to $8.4 million reflecting the building out of Assure’s management team and professional fees related to the Company’s financial transactions, S-1 filing and acquisitions.
• Net loss of $(15.0) million compared to net income of $2.7 million.
• Net loss per diluted share was $(0.41) compared to net income of $0.06 per diluted share.
• Adjusted EBITDA was $(14.4) million versus $5.7 million.
• The Company collected an annual record $23.9 million compared to $15.9 million for a combination of technical IONM services and cash collected from PEs for professional IONM services.
• The Company collected a record $13.8 million versus $8.0 million for IONM revenue that it retains 100%.
• In the second quarter of 2020 Assure pre-emptively recorded reserves of approximately $15 million to further reduce accrual rate and revenue per procedure expectations to more accurately reflect what the Company expects to collect based on current data.

Management Commentary

“Against a challenging 2020 environment, we made key investments in infrastructure, talent, and innovation to unlock our ability to fulfill the Company’s long-term strategy,” said John A. Farlinger, Assure’s executive chairman and CEO. “We made significant progress executing against our three key corporate objectives: improving the performance of Assure’s billing and collections function, development of an in-network revenue stream and scaling our platform through both organic growth and M&A. The Company reported record total collections that increased 50% from the prior year. More than 20% of Assure’s overall commercial insurance volume is now in-network, either directly or indirectly with payors, helping to reduce risk, minimize complexity, protect our liquidity and accelerate the timing of payments. Finally, we substantially expanded our scale in 2020, reporting a 54% increase in procedures during the year. This growth was achieved both by organically winning new business within our existing operational footprint, expanding into two new states and successfully integrating the acquisition of Neuro-Pro which continues to deliver as we expected.”

“The Company has taken numerous proactive steps to improve its financial flexibility. This included closing a $10.5 million institutional investor private placement, obtaining an expanded credit facility, securing an SBA loan under the CARES Act that was subsequently forgiven and raising funds in non-brokered convertible debenture offerings. We also brought revenue cycle management in-house after the legacy 3^rd party vendor was terminated as a result of poor performance. The Company’s revamped collections process generated a record $23.9 million compared to $15.9 in 2019.”

“Our 2020 results were negatively impacted by a number of anticipated factors. The major contributor was our lower accrual per case rate which we adjusted in the second quarter of 2020 to reflect issues associated with the collection of 2018 claims and IONM industry-wide downward market pressure in the average payment per procedure from commercial insurance companies. Of note, while the year-over-year decline in accrual per case was substantial, the sequential degradation in the third and fourth quarters of 2020 was minimal. We are now updating our revenue accrual rates on a quarterly basis and do not anticipate a significant decline from current accrual rates in 2021. The issue we experienced in 2020 reflects the lingering effects of poor performance from the legacy 3rd party billing provider that was terminated in the autumn of 2019. Assure re-billed all outstanding 2018 claims in 2020 and anticipates ultimately recovering a meaningful share of these receivables. Another factor was the previously disclosed impact of reserving claims from a private health insurance company that to-date has failed to reimburse Assure. The final contributor was the steep COVID-19-related decline in elective procedures we experienced in March and April which lingered in certain markets through the end of the year.”

“The fourth quarter saw the Company deliver on a number of milestones including: a quarterly record for both collections and number of procedures, reporting a positive EBITDA, a second consecutive quarter of stable revenue accrual rates, filing of Assure’s Form S-1 and closing an institutional investor private placement.”  

“Further, Assure has already made important advancements against our key corporate objectives in 2021. We intend to capitalize on growth opportunities including increasing scale by organically expanding into new states and pursuing strategic acquisitions. This includes an agreement to acquire Sentry Neuromonitoring, a Joint Commission accredited IONM provider with operations in Texas, Kansas and Missouri which performed more than 5,500 IONM procedures in 2020. Assure, through its wholly owned subsidiary, also expanded into telemedicine by launching professional neurology services. This will allow us to control quality of service in all aspects of our IONM offering which is a key consideration for payors as we negotiate new in-network agreements, strengthens our offering as we position to sell directly to hospitals, creates additional margin in our existing operations, and generates organic growth and acquisition targets. In addition, we believe our professional neurology services will act as a platform the Company can build from to offer additional and adjacent services around neurology. Assure is taking steps to support what we believe will be a year of profitable growth and sharply increasing case volume by securing a second draw SBA loan associated with the CARES Act. In addition, Assure’s Form S-1 was declared effective, and we are preparing for a potential uplisting to a major U.S. exchange.”

Assure will be filing its year-end financial statements with SEDAR and the SEC at www.sedar.com, www.sec.gov and the Company website.

Chief Financial Officer Succession

Trent Carman has decided to retire from his position as chief financial officer (“cfo”) of the Company. John Price, Assure’s vice president of finance, will succeed Carman as cfo. Carman will remain with the Company as an advisor through 2021.

“I want to thank Trent for his leadership and his many contributions to Assure through this period of unprecedented change and transformative growth. He has played an important role helping the Company deliver on our corporate objectives while building a strong finance team with deep expertise,” said Farlinger. “I want to wish Trent all the best as he enters the next chapter of his life.”

“I am proud of the significant progress we have made to drive our growth strategy over the past three years,” said Carman. “I believe Assure is operating from a position of strength, with a long runway of profitable growth ahead. John Price is a key member of our management team, and I am confident that his experience and strong leadership capabilities will help to ensure that Assure continues to drive improved operating performance and disciplined execution.”

“I have great confidence in John Price, a seasoned financial executive, stepping into this role,” said Farlinger. “I look forward to working closely with him in his new role to further fuel Assure success by delivering profitable revenue growth and strong cash collections while investing in key strategic initiatives to ensure we continue to differentiate Assure’s position in the IONM industry.”

Price has over 25 years of experience in accounting, financial planning and analysis, and business process improvement. He is also highly experienced in capital raise and debt financing, M&A, accounting operations, compliance, and system implementations. Price’s prior positions include serving as chief accountant of National Beverage, chief financial officer at Alliance MMA and MusclePharm and in various accounting and finance roles in high growth technology companies in the Silicon Valley. Price spent the first seven years of his career at Ernst & Young. He earned a Bachelor of Science in Accounting from Pennsylvania State University.

Operational Guidance

In 2020, Assure managed 9,914 cases, and at the end of that year, had worked with 141 surgeons across 77 hospitals and medical facilities, supported by 59 technologists. Comparatively, in 2019, the Company managed 6,414 cases, and at the end of that year worked with 98 surgeons at 53 hospitals and medical facilities, supported by 50 technologists.

The Company forecasts total procedures for full-year 2021 to exceed 14,000, a record number representing an increase of more than 40% compared with 2020. This projection is based on organic growth only and does not incorporate any impact from M&A activity. The guidance reflects the impact to-date of COVID-19, but not a substantial future disruption relating to the pandemic.

Impact of COVID-19

The adverse impact of the global pandemic on people and businesses has been extensive and far-reaching. Beginning in March and accelerating in April 2020, Assure saw a decline of more than 70% in its number of procedures performed; however, the Company’s overall weekly case volumes in May through December 2020 exceeded average weekly case rates in January and February 2020. Nevertheless, continued COVID-19 cases in the United States caused intermittent disruptions to linger in certain markets during the remainder of 2020. Assure is continuing to carefully monitor the impact of COVID-19 in all states within its operational footprint. The Company anticipates that the majority of the procedures that were postponed in 2020 will be rescheduled for a later date.

Subsequent Event: Assure Enters Into Agreement to Purchase Sentry Neuromonitoring and Receives United States Small Business Administration Second Draw Loan Under CARES Act

In February 2021, Assure signed a Term Sheet to acquire (the “Acquisition”) Sentry Neuromonitoring, LLC (“Sentry”), one of the largest IONM service providers in Texas, for a purchase price of $3,500,000. The purchase price to be paid is $1,225,000 in cash and $2,275,000 in Assure common stock, subject to escrow, TSX Venture Exchange and other requirements. Under the Term Sheet, Assure will acquire Sentry’s contracts, employees, business relationships and assets including accounts receivable, and assume up to $250,000 of its debt. Although key terms and conditions have been negotiated and agreed to, the Acquisition remains subject to a number of conditions.

In March 2021, Assure received a $1.7 million second draw loan provided under the United States Small Business Administration Paycheck Protection Program pursuant to the Coronavirus Aid, Relief, and Economic Security Act. Assure anticipates that all or a portion of the loan will be forgiven as the Company expects to maintain its employment and compensation within designated parameters.

Conference Call

The Company will hold a conference call today, March 26, 2021, at 12:00 p.m. Eastern time to discuss its fourth quarter and full year 2020 results.

Date: Friday, March 26, 2021
Time: 12:00 p.m. Eastern time (10:00 a.m. Mountain time)
Toll-free dial-in number: 1-877-407-0792
International dial-in number: 1-201-689-8263
Conference ID: 13717700

Please call the conference telephone number 5-10 minutes prior to the start time. An operator will register your name and organization.

The conference call will be broadcast live and available for replay here.

A replay of the conference call will be available after 3:00 p.m. Eastern time on the same day through April 9, 2021.

Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 13717700

Non-GAAP Measures

This press release includes certain measures which have not been prepared in accordance with Generally Accepted Accounting Principals (“GAAP”) such as Adjusted EBITDA, case volume, cases and managed cases. The non-GAAP measures presented are unlikely to be comparable to similar measures presented by other issuers. References to Adjusted EBITDA are to net income/(loss) excluding interest, taxes, depreciation and amortization, share-based compensation, gain on payroll protection program loan and gain on extinguishment of acquisition debt. Reference to case volume, cases and managed cases are to procedures monitored by the Company. None of the foregoing non-GAAP measures is an earnings measure recognized by GAAP and do not have a standardized meaning prescribed by GAAP. Management believes that Adjusted EBITDA, case volume, managed cases and cases are appropriate measures in evaluating the Company’s performance. Readers are cautioned that Adjusted EBITDA, managed cases, case volume and cases should not be construed as alternatives to net income (as determined under GAAP), as indicators of financial performance or to cash flow from operating activities (as determined under GAAP) or as measures of liquidity and cash flow.

About Assure Holdings

Assure Holdings Corp. is a Colorado-based company that works with neurosurgeons and orthopedic spine surgeons to provide a turnkey suite of services that support intraoperative neuromonitoring activities during invasive surgeries. Assure employs its own staff of technologists and uses its own state-of-the-art monitoring equipment, handles 100% of intraoperative neuromonitoring scheduling and setup, and bills for all technical services provided. Assure Neuromonitoring is recognized as providing the highest level of patient care in the industry and has earned The Joint Commission’s Gold Seal of Approval®. For more information, visit the Company’s website at www.assureneuromonitoring.com.

Forward-Looking Statements

This news release may contain “forward-looking statements” within the meaning of applicable securities laws, including, but not limited to: the Company’s expansion and financing plans; the Company’s revenue and cash flow; the collection of outstanding amounts owed to the Company; comments with respect to strategies, expectations, planned operations and future actions of the Company; the maximization of the Company’s in-network revenue; plans to uplist to a major U.S. exchange; loans secured by the Company and the expected effects thereof; the rescheduling of postponed procedures; the Company’s accounting practices, including but not limited to the expected effects of the Company’s decision to write-down a sizable portion of its accounts receivable and to further reduce its accrual rate and revenue per procedure expectations; the impact of COVID-19; the total number of procedures for 2021; collections of accounts receivable including a meaningful share of the 2018 reserved receivables and the Acquisition and the expected effects thereof. Forward-looking statements may generally be identified by the use of the words “anticipates,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s revenue accrual rates may experience significant decline in 2021; the Company may not increase its scale and expand into new states in 2021; the Company’s ability to successfully expand; t the Company may not improve its revenue and cash flow; the Company’s ability to collect past due accounts receivable; the accuracy of the reservations made to receivables; the Company may not be able to maximize the Company’s in-network revenue and negotiate new in-network agreements the Company’s decision to write-down a sizable portion of its accounts receivable may not result in a more sustainable and profitable model; the Company may not see its case volume increase as a result of securing the SBA loan; the Company may not exceed 14,000 procedures performed in 2021; the cases postponed in 2020 may not be rescheduled for a later date; the TSX Venture exchange may not approve the Acquisition; the acquisition may not be completed; all or a portion of the $1.7 million Loan may not be forgiven; the Company may not maintain its employment and compensation framework within the parameters of the Coronavirus Aid, Relief, and Economic Security Act; the Company’s decision to further reduce its accrual rate and revenue per procedure expectations may not reduce its down-side risk; uncertainties related to market conditions and our ability to qualify for a listing on a major U.S. exchange; the uncertainty surrounding the spread of COVID-19 and the impact it will have on the Company’s operations and economic activity in general; and the risks and uncertainties discussed in our most recent annual and quarterly reports filed with the Canadian securities regulators and available on the Company’s profile on SEDAR at www.sedar.com and those included in the Company’s registration statement on Form S-1 filed with the United States Securities and Exchange Commission and available at www.sec/gov. Readers are cautioned not to place undue reliance on forward-looking statements. Except as required by law, Assure does not intend, and undertakes no obligation, to update any forward-looking statements to reflect, in particular, new information or future events.

Neither the 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.

Contact

Scott Kozak, Investor and Media Relations
Assure Holdings Corp.
1-720-287-3093
[email protected]

SCHEDULE A

ASSURE HOLDINGS CORP.
CONDENSED INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(in thousands of United States Dollars)
		December 31, 2020				December 31, 2019
ASSETS
Current assets
Cash		$	4,386			$	59
Accounts receivable, net			14,965				30,863
Income tax receivable			150				—
Other assets			284				168
Due from PEs			4,856				2,489
Due from related parties			334				128
Total current assets			24,975			$	33,707
Equity method investments			608				2,360
Property, plant and equipment, net			356				209
Operating lease right of use asset			124				196
Finance lease right of use asset			608				466
Intangibles, net			4,115				4,587
Goodwill			2,857				2,857
Total assets		$	33,643			$	44,382
LIABILITIES AND SHAREHOLDERS’ EQUITY
LIABILITIES
Current liabilities
Accounts payable and accrued liabilities		$	2,871			$	4,365
Current portion of debt			4,100				1,664
Current portion of lease liability			521				461
Current portion of acquisition debt			—				5,030
Other current liabilities			96				81
Total current liabilities			7,588				11,601
Lease liability, net of current portion			772				500
Debt, net of current portion			2,251				1,160
Acquisition debt, net of current portion			—				2,429
Provision for acquisition share issuance			540				540
Provision for fair value of stock options			16				66
Provision for performance share issuance			2,668				16,011
Deferred tax liability, net			599				2,010
Total liabilities			14,434				34,317
SHAREHOLDERS’ EQUITY
Common stock			56				35
Additional paid-in capital			30,841				6,682
Retained earnings (deficit)			(11,688	)			3,348
Total shareholders’ equity			19,209				10,065
Total liabilities and shareholders’ equity		$	33,643			$	44,382

ASSURE HOLDINGS CORP.
CONDENSED INTERIM CONSOLIDATED STATEMENT OF INCOME/(LOSS)
(in thousands of United States Dollars, except per share amounts)
		Three Months Ended December 31,								Years Ended December 31,
			2020				2019				2020				2019
		(unaudited)				(unaudited)
Revenue
Patient service fees, net		$	2,899			$	(6,328	)		$	(3,443	)		$	13,738
Hospital, management and other			3,065				1,669				6,967				3,987
Total revenue			5,964				(4,659	)			3,524				17,725
Cost of revenues			2,850				489				7,912				4,955
Gross (loss) margin			3,114				(5,148	)			(4,388	)			12,770
Operating expenses
General and administrative			3,739				3,337				9,592				8,427
Sales and marketing			408				369				1,209				1,435
Depreciation and amortization			245				205				1,014				537
Total operating expenses			4,392				3,911				11,815				10,399
Income/(loss) from operations			(1,278	)			(9,059	)			(16,203	)			2,371
Other income/(expenses)
Earnings/(loss) from equity method investments			255				113				(1,194	)			1,305
Gain on Payroll Protection Program loan			1,211				—				1,211				—
Gain on extinguishment of acquisition debt			188				—				188				—
Other income/(expense)			39				167				89				172
Accretion expense			(163	)			(74	)			(782	)			(74	)
Interest, net			(366	)			(89	)			(530	)			(252	)
Total other income/(expense)			1,164				117				(1,018	)			1,151
Income/(loss) before income taxes			(114	)			(8,942	)			(17,221	)			3,522
Income tax benefit (expense)			(385	)			2,216				2,185				(806	)
Net income/(loss)		$	(499	)		$	(6,726	)		$	(15,036	)		$	2,716
Basic income/(loss) per common share		$	(0.01	)		$	(0.19	)		$	(0.41	)		$	0.08
Diluted income/(loss) per common share		$	(0.01	)		$	(0.19	)		$	(0.41	)		$	0.06

ASSURE HOLDINGS CORP.
RECONCILIATION OF NON-GAAP ADJUSTED EBITDA TO NET LOSS
(in thousands of United States Dollars)
	Three Months Ended December 31,								Years Ended December 31,
		2020				2019				2020				2019
		(unaudited)				(unaudited)
Reported net income (loss)	$	(499	)		$	(6,726	)		$	(15,036	)		$	2,716
Interest, net		366				89				530				252
Accretion expense		163				74				782				74
Depreciation and amortization		245				205				1,014				537
Share based compensation		92				307				548				1,259
Income tax expense (benefit)		385				(2,216	)			(2,185	)			806
Provision for stock option fair value		—				27				(50	)			8
	$	752			$	(8,240	)		$	(14,397	)		$	5,652

ASSURE HOLDINGS CORP.
EARNINGS PER SHARE
(in thousands of United States Dollars, except per share amounts)
	Three Months Ended December 31,								Years Ended December 31,
		2020				2019				2020				2019
Net income (loss)	$	(499	)		$	(6,726	)		$	(15,036	)		$	2,716
Basic weighted average common shares outstanding		36,233,127				34,402,607				36,233,127				34,402,607
Basic earnings (loss) per common share	$	(0.01	)		$	(0.19	)		$	(0.41	)		$	0.08
Net income (loss)	$	(499	)		$	(6,726	)		$	(15,036	)		$	2,716
Basic weighted average common shares outstanding		36,233,127				34,402,607				36,233,127				34,402,607
Dilutive effect of stock options, warrants, and performance shares		—				—				—				7,510,000
Dilutive weighted average common shares outstanding		36,233,127				34,402,607				36,233,127				41,912,607
Diluted earnings (loss) per common share	$	(0.01	)		$	(0.19	)		$	(0.41	)		$	0.06

SAN FRANCISCO and TORONTO, March 26, 2021 (GLOBE NEWSWIRE) — Claritas Pharmaceuticals, Inc. (formerly Kalytera Therapeutics, Inc.) (TSX VENTURE: KLY and OTC: KALTF) (the “Company” or “Claritas“) today announced the addition of Perenlei Enkhbaatar, MD, PhD, FAHA as an independent member of the Company’s board of directors (the “Board of Directors”), effective immediately.

Dr. Enkhbaatar is an internationally renowned authority and leader on the biology and pathophysiology of nitric oxide and acute lung injury, and his appointment to the Board of Directors will further strengthen the Company position as a leader in the field of nitric oxide therapeutics.

Nitric oxide was named molecule of the year by Science magazine in 1992; over 130,000 peer reviewed articles have been published on the nitric oxide; and nitric oxide was the subject of a 1998 Nobel Prize in medicine.

“The addition of Dr. Enkhbaatar to the Company’s Board enhances and strengthens our focus on nitric oxide pharmaceuticals,” stated Robert Farrell, President and CEO. “We previously announced the addition of Dr. Salvatore Cuzzocrea to our Board. Both Dr. Enkhbaatar and Dr. Cuzzocrea are internationally renowned authorities and leaders on the biology and pathophysiology of nitric oxide. Drs. Enkhbaatar and Cuzzocrea will help guide the Company’s development of R-107, our proprietary nitric oxide-releasing compound that is being developed as a treatment for coronavirus, COVID-19, and other viral infections. Dr. Enkhbaatar will be a strong strategic resource for Claritas, and we look forward to the contributions he will make.”

Nitric oxide is part of the body’s natural defense system against viral infections. However, a viral infection can spread more rapidly than the body can produce nitric oxide to combat the infection. Claritas is developing R-107 to supplement the body’s natural production of nitric oxide. Following administration orally as a capsule, or nasally through use of a nasal spray, or by injection, R-107 releases nitric oxide systemically throughout the body.

The importance of R-107 for the treatment of, and possibly also the prevention of, COVID-19 cannot be overstated. Unlike vaccines, that may lose effectiveness as the virus mutates, nitric oxide-releasing R-107 is expected to be a universal therapy against all COVID-19 strains, including those that are vaccine-resistant.

Dr. Enkhbaatar currently serves as the Charles Robert Allen Professor and the Director of the Translational Intensive Care Unit in the Department of Anesthesiology at the University of Texas Galveston Medical Branch.

Following his medical training at the University of Saint Petersburg in Russia, Dr. Enkhbaatar served as a Senior Lieutenant physician in the Mongolian Army. He went on to receive his Ph.D. at Kumamoto University Graduate School of Medical Sciences in Japan. He then undertook his post-doctoral training in the Department of Anesthesiology, University of Texas Medical Branch in Galveston, Texas, under the mentorship of the late Professor Daniel Traber, the foremost authority over the last fifty years on the pathophysiology of acute lung injury. Upon Dr. Traber’s death, Dr. Enkhbaatar assumed the leadership of the research unit in Galveston and has further expanded its research prominence in the development of effective therapeutic approaches with special emphasis on tissue regeneration and stem cell biology.

For the past 25 years, Dr. Enkhbaatar has played a leading role in the elucidation of basic mechanisms of disease in acute lung injury and acute respiratory distress syndrome secondary to pneumonia, sepsis, toxic gas inhalation, and thermal injury associated with smoke inhalation. He has been at the forefront of pioneering therapeutic approaches to counter reactive oxidative and nitrosative stress. In recognition of these advances in the medical science of acute lung injury, Dr. Enkhbaatar has been awarded numerous federal grants, including funding from the National Institutes of Health, the American Heart Association, the Department of Defense, Shriners of North America, and the Office of Naval Research. His research advances have been presented at international conferences and in the publication of more than three hundred abstracts, one hundred and fifty-four original manuscripts in leading peer-reviewed journals, and twelve book chapters.

In recognition of his contributions to the field of cytokine storm induced acute lung injury, Dr. Enkhbaatar has been selected to serve on the Editorial Boards of leading journals in the fields of trauma and acute lung injury, including Critical Care Medicine, Shock, and Burn & Trauma, and has been invited to join numerous professional societies, including the Society of Critical Care Medicine, the American Burn Association, the Shock Society, the American Thoracic Society, the American Physiological Society, the American Heart Association, the Surgical Infection Society, and the Royal Society of Medicine.

Dr. Enkhbaatar brings expert knowledge of R-107 to Claritas, having carried out clinically relevant large animal studies showing its treatment benefit in experimental models of bacterial pneumonia, smoke inhalation and burn injury, and chlorine inhalational lung injury. As a world authority on the biological mechanisms of pulmonary damage in cytokine-storm induced acute lung injury, Dr. Enkhbaatar is ideally positioned to appreciate the underlying pathophysiology of COVID-19 disease and to guide potential therapeutic approaches based on the provision of nitric oxide via the clinical administration of R-107.

Professor Salvatore Cuzzocrea, a member of the Company’s Board of Directors, President of the University of Messina and former President of the European Shock Society, has read and approved the scientific disclosure in this news release. Professor Cuzzocrea has deep expertise regarding the medical use of nitric oxide and nitric oxide donors, and has published more than 600 papers on nitric oxide. He has conducted research and experiments with nitric oxide and nitric oxide donors since 1994, and worked closely as an advisor with the Salzman Group team that designed and invented R-107.

The Company is not making any express or implied claims that its product has the ability to eliminate, cure, or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

About Claritas Pharmaceuticals

Claritas Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing and commercializing therapies for patients with significant unmet medical needs. Claritas focuses on areas of unmet medical need, and leverages its expertise to find solutions that will improve health outcomes and dramatically improve people’s lives.

• Website Home: https://claritaspharma.com/
• News and Insights: https://claritaspharma.com/news/
• Investors: https://claritaspharma.com/investors

Cautionary Statements


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.

This press release may contain certain forward-looking information and statements (“forward-looking information”) within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives, and other statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the ris
k that future clinical studies may not proceed as expected or may produce unfavorable results. Claritas
undertakes no obligation to comment on analyses, expectations or statements made by third parties, its securities, or financial or operating results (as applicable). Although Claritas believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Claritas’ control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Claritas disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise. 

Contact Information

Robert Farrell
President, CEO
(888) 861-2008
[email protected]