Market Newsdesk

Press release

Synairgen plc

(‘Synairgen’ or the ‘Company’)

Synairgen announces completion of recruitment into its Phase II Home-Based COVID-19 study of inhaled interferon beta

– Establishing proof of concept for home administration  

Southampton, UK – 20 January 2021: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, is pleased to announce that recruitment of 120 COVID-19 patients into its Phase II trial evaluating inhaled formulation of interferon-beta-1a (SNG001) conducted in the home setting has now been completed. Results from the trial are expected in Q2 2021.

The COVID-19 Phase II Study (SG016)

Synairgen’s two-part, placebo-controlled trial evaluating SNG001 as a treatment for COVID-19 infection involved dosing of (i) 101 patients in the hospital setting, the positive results from which were published in The Lancet Respiratory Medicine in November 2020¹, and (ii) 120 ‘at risk’ patients in the home setting, recruitment for which completed yesterday.

Innovative Virtual Trial Design for Home-Based Study

The study targeted patients with a positive SARS-CoV-2 test result aged over 65, and those over the age of 50 with ‘high risk’ medical conditions. The trial was designed to make it easy and safe for trial participants and researchers to conduct the study; all ­supplies were delivered directly to the patient’s door by a courier, and all trial assessments were conducted remotely by study doctors and nurses via video call. The study has confirmed the feasibility of rapid roll-out of antiviral treatment in the context of a pandemic, where there is a need to limit the movement of people to minimise risks to patients, the public and healthcare providers.

The trial was conducted in collaboration with the NIHR Southampton Clinical Trials Unit and TranScrip Partners.

Richard Marsden, CEO of Synairgen, commented:
“We are pleased to have completed recruitment of 120 ‘at risk’ patients into this innovative placebo-controlled trial whereby all trial ‘visits’ were conducted by video call. The trial is both a test of the drug, and a test of how technology can be utilised to deliver and manage the administration of an inhaled broad-spectrum antiviral to vulnerable patients in the context of a pandemic, reducing the need to transport infected patients, and eliminating virus exposure to healthcare workers. We believe this methodology and treatments such as SNG001 could be invaluable alongside vaccines, now and in the future, to fight highly pathogenic viruses such as SARS-CoV-2. We are extremely grateful to the team of healthcare workers, pharmacists and logistics providers who have worked tirelessly to deliver this trial which is a further example of great British science, attracting interest from academia and governments around the world.”

Professor Nick Francis, Professor of General Practice at the University of Southampton, commented: 
“We are delighted to announce completion of recruitment into the SG016 Home trial. This is a remarkable trial evaluating a novel therapeutic delivered in the home setting to people with COVID-19 who are at risk of developing complications. We have shown that inhaled therapies can be safely delivered at home, without the need for the patients, nurses or doctors to travel. Following the promising results from the SG016 Hospital Study, we are excited to see whether we can detect important benefits from early use of inhaled interferon beta (SNG001) for COVID-19 in the home environment, in terms of resolution of symptoms, preventing hospitalisation, and reducing the burden of Long-COVID.”

Professor Gareth Griffiths, Professor of Clinical Trials and Director of the NIHR Southampton Clinical Trials Unit, said:
“We were delighted to have supported Synairgen in running the home-setting arm of the SG016 trial, and to use our expertise in conducting clinical trials in a community setting. The innovative trial design meant that patients with COVID-19 were able to take part in the study from their own homes, with full support provided by the trial team, and finding evidence for treatments in this setting is a vital step forward in our fight against diseases such as COVID-19.”

In addition to The Lancet Respiratory Medicine publication, there is a growing body of evidence to support use of interferon beta in the context of COVID-19 infection as evidenced in the recent publication in Nature Genetics, following research carried out by the University of Southampton and published here.

References

1. The Lancet Respiratory Medicine: “Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial”. Monk, P D PhD, et al., 12 November 2020, accessible here.
2. Nature Genetics: “A novel ACE2 isoform is expressed in human respiratory epithelia and is upregulated in response to interferons and RNA respiratory virus infection”. 11 January 2021, accessible
   
   
   here
   
   
   .

Information within this announcement is deemed by the Company to constitute inside information under the Market Abuse Regulation (EU) No. 596/2014

For further enquiries, please contact:

Synairgen plc

Richard Marsden, Chief Executive Officer
John Ward, Finance Director
Tel: + 44 (0) 23 8051 2800

finnCap (NOMAD and Joint Broker)

Geoff Nash, Kate Bannatyne, Charlie Beeson (Corporate Finance)
Alice Lane, Manasa Patil (ECM)
Tel: + 44 (0) 20 7220 0500

Numis Securities Limited (Joint Broker)

James Black, Freddie Barnfield, Duncan Monteith
Tel: +44 (0) 20 7260 1000

Consilium Strategic Communications (Financial Media and Investor

Relations)

Mary-Jane Elliott, Sue Stuart, Olivia Manser, Carina Jurs
[email protected]
Tel: +44 (0) 20 3709 5700

Notes for Editors

About Synairgen

Synairgen is a clinical-stage respiratory drug discovery and development company founded by University of Southampton Professors Sir Stephen Holgate, Donna Davies and Ratko Djukanovic. Synairgen is currently fully focused on progressing its inhaled interferon beta broad spectrum antiviral drug as an effective treatment for people suffering with COVID-19 infection. 

Synairgen’s differentiating human biology BioBank platform and world-renowned international academic KOL network has broader applicability for lung viral defence in other respiratory disorders including asthma and COPD. Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com

SNG001 (inhaled Interferon beta) applicability to COVID-19

Interferon beta (‘IFN-beta’) is a naturally-occurring protein, which orchestrates the body’s antiviral responses. It is used widely in the treatment of multiple sclerosis and is a safe and well tolerated drug. There is growing evidence that deficiency in IFN-beta production by the lung could explain the enhanced susceptibility in ‘at-risk’ patient groups to developing severe lower respiratory tract (lung) disease during respiratory viral infections. Furthermore, viruses, including coronaviruses such as SARS-CoV-2, have evolved mechanisms which suppress endogenous IFN-beta production, helping the virus to evade the innate immune system. The addition of exogenous IFN-beta before or during viral infection of lung cells in vitro either prevents or greatly reduces viral replication, potentially reducing the severity of infection and accelerating recovery. Synairgen’s SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulisation. It is pH neutral, and is free of mannitol, arginine and human serum albumin, making it suitable for inhaled delivery direct to the site of action. Phase I and II trial data have shown that SNG001 activates lung antiviral defences as measured in sputum cells, and that SNG001 has been well tolerated in approximately 280 asthma/COPD/COVID-19 patients to-date.

In July 2020, Synairgen announced the results of its Phase II double-blind, placebo-controlled study of 101 randomised COVID-19 hospitalised patients, which showed that SNG001 given for 14 days was associated with greater odds of improvement versus placebo on the WHO Ordinal Scale for Clinical Improvement and more rapid recovery to the point where patients were no longer limited in their activity, with a greater proportion of patients recovering during the 28-day study period.

The results were published in The Lancet Respiratory Medicine: “Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial”. Monk, P D PhD, et al., 12 November 2020, accessible here.

About Southampton Clinical Trials Unit

The Southampton Clinical Trials Unit (CTU) is a National Institute for Health Research (NIHR) supported CTU with expertise in the design, conduct and analysis of interventional clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. (www.southampton.ac.uk/ctu/index.page) 

ROCKVILLE, Md. and CHESTERBROOK, Pa., Jan. 20, 2021 (GLOBE NEWSWIRE) — Cerecor Inc. (“Cerecor”; NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, announced today the exercise by the underwriters of their option to purchase an additional 1,648,812 shares of Cerecor’s common stock, $0.001 par value (the “Common Stock”) at a price to the public of $2.60 per share, increasing the total offered through the previously announced underwritten public offering to 13,971,819 of Common Stock and 1,676,923 of prefunded warrants. The gross proceeds to Cerecor from this exercise were approximately $4.3 million, resulting in approximately $40.7 million total gross proceeds from the offering. Cerecor intends to use the proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses.

The securities described above were offered by Cerecor pursuant to an effective shelf registration statement on Form S-3 (File No. 333-233978), previously filed with the U.S. Securities and Exchange Commission (the “SEC”) on September 27, 2019 and declared effective on October 24, 2019, and the accompanying prospectus contained therein. The offering of securities was made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus relating to and describing the terms of the offering has been filed with the SEC. Copies of the final prospectus relating to the offering may be obtained on the SEC’s website at http://www.sec.gov or by contacting Jefferies LLC at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by e-mail at [email protected] or by calling (877) 547-6340.

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

About Cerecor

Cerecor is a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases. The company is advancing its clinical-stage pipeline of innovative therapies that address unmet patient needs within rare and orphan diseases. The company’s rare disease pipeline includes CERC-801, CERC-802 and CERC-803, which are in development for congenital disorders of glycosylation and CERC-006, an oral mTORc1/c2 inhibitor in development for the treatment of complex lymphatic malformations. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. CERC-002 targets the cytokine LIGHT (TNFSF14) and is in clinical development for treatment of severe pediatric-onset Crohn’s disease, and COVID-19 acute respiratory distress syndrome. CERC-007 targets the cytokine IL-18 and is in clinical development for the treatment of Still’s disease (adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM). CERC-006, 801, 802 and 803 have all received Orphan Drug Designation and Rare Pediatric Disease Designation, which makes all four eligible for a priority review voucher upon FDA approval.

For more information about Cerecor, please visit www.cerecor.com.

Forward-Looking Statements

This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Cerecor’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Cerecor’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; and other statements that are not historical. These statements are based upon the current beliefs and expectations of Cerecor’s management but are subject to significant risks and uncertainties, including: drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic; regulatory risks; Cerecor’s cash position and the need for it to raise additional capital; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic; and those other risks detailed in Cerecor’s filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Cerecor expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Cerecor’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For media and investor inquiries

James Harrell
Investor Relations
Chief Commercial Officer
Cerecor Inc.
[email protected]
623.439.2220 office

TORONTO, Jan. 20, 2021 (GLOBE NEWSWIRE) — MCI Medical Clinics Inc., a subsidiary of MCI Onehealth Technologies Inc. (“MCI Onehealth”) (TSX: DRDR) – a clinician-led healthcare technology company focused on increasing access and quality of healthcare – has begun conducting rapid pre-flight COVID-19 testing for Chartright pilots, flight staff, and passengers out of the charter terminal at Toronto Pearson International Airport, as coordinated through MCI’s Occupational Health group.

The rapid-testing on-site program began Tuesday January 19 and will continue for flight crew and passengers entering the United States. An additional mobile-testing program will be launched at the end of January. For this program, a mobile model with MCI registered nurses will visit the passenger’s home or workplace within 72 hours of their flight to collect for a lab analyzed COVID PCR test. Alternatively, the day-of-flight option at the Chartright terminal is a rapid result antigen test for which results are provided within 15 minutes.

The CDC will be requiring proof of a negative result for travellers entering the U.S. In accordance with this program, Chartright will offer its passengers two service options: one for those who wish to test in advance and one for those testing on the day of their flight.

Dr. Alexander Dobranowski, MD, CEO of MCI Onehealth says, “We are excited by Chartright’s diligent testing efforts and dedication to protecting the safety of its staff, passengers, and the community at large. We are proud to contribute to this, and look forward to the rollout of our operating model that can be used by other corporations seeking rapid testing services for their employees and customers in 2021.”

About MCI Onehealth:

MCI Onehealth is a healthcare technology company focused on empowering patients and doctors with advanced technologies to increase access, improve quality, and reduce healthcare costs. As part of the healthcare community for over 30 years, MCI Onehealth operates one of Canada’s leading primary care networks with 25 clinics, serves over 850,000 patients annually and had over 200,000 telehealth visits last year. MCI Onehealth additionally offers an expanding suite of occupational health service offerings that support a growing list of over 250 corporate customers. Led by a proven management team of doctors and experienced executives, MCI remains focused on executing a strategy centered around acquiring technology and health services that complement the company’s current roadmap. For more information, visit mcionehealth.com

For MCI Occupational Health enquiries please contact:

Genevieve Sadak PT
[email protected]
+1 (416) 779-5246

For media enquiries please contact:

Genna Alexopoulos
[email protected]  
+1 (647) 671-4279

–EDP1815 was well tolerated, and showed clinically meaningful and consistent changes in all measured
 physician-reported outcomes –

–Improvements in patient-reported outcomes in DLQI and POEM, including itch–

–EASI50 benchmark reached in 44% of patients treated with EDP1815 compared to 0% in placebo group at day 70–

–Phase 2 atopic dermatitis trial initiation in 3Q 2021–

–Management to host conference call at 8:30 a.m. ET today with Dr. Benjamin Ehst–

CAMBRIDGE, Mass., Jan. 20, 2021 (GLOBE NEWSWIRE) — Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, today announced new positive confirmatory data following completion of the mild and moderate atopic dermatitis cohort in its Phase 1b clinical trial. The Company previously reported interim data in 23 evaluable patients. These new results now include patient-reported outcomes, as well as all of the physician-reported outcomes for all 24 patients in the cohort. The primary endpoint of the Phase 1b trial was safety and tolerability. EDP1815 was well tolerated in this study with no treatment-related adverse events of moderate or severe intensity, and no serious adverse events.

Treatment with EDP1815 resulted in clinically meaningful improvement in the Dermatology Life Quality Index (DLQI) and Patient-Oriented Eczema Measure (POEM). These patient-reported outcomes capture the important impact of the disease on patients, including the domains of itch and sleep, both of which saw improvements in patients receiving EDP1815 on the study. All five measures of itch within the Pruritus-Numerical Rating Scale (Pruritus-NRS), SCORing Atopic Dermatitis (SCORAD), POEM, and DLQI showed greater improvements in the treated group at day 56 compared with placebo.

The full results also reinforce the positive interim data released on December 9, 2020. Additional physician- reported outcomes of Investigator’s Global Assessment (IGA) and SCORAD were consistent with the previously reported Eczema Area and Severity Index (EASI) and IGA times Body Surface Area (IGAxBSA) measures. Table 1 shows the treatment difference between patients receiving EDP1815 and placebo as measured by percentage change of these well-established efficacy endpoints at day 56.

Table 1

The data showed consistent improvements in percentage change from baseline compared to placebo for all three clinical scores: EASI, IGA*BSA, and SCORAD. In addition, 7 out of 16 (44%) patients treated with EDP1815 achieved an outcome of a 50% improvement from baseline in EASI score (EASI50) by day 70, compared with 0% in the placebo group, showing sustained improvement in those patients responding to EDP1815.

“The data shared today reinforce and extend the previously released results, demonstrating that EDP1815 treatment was well tolerated and resulted in clinically meaningful improvements in measures of atopic dermatitis,” said Douglas Maslin, M.Phil, M.B. B.Chir, Dermatology and Pharmacology Physician at Addenbrooke’s Hospital and Immunology Clinical Lead of Evelo. “These data show for the first time that treatment with EDP1815 resulted in improvements in patient-reported outcomes on patient experiences such as itch and sleep disturbance, as well as the improvements in all of the physician-reported scores of EASI, SCORAD, IGA, and IGA*BSA. We are planning to initiate a Phase 2 dose-ranging study in the third quarter of this year to evaluate the potential of this novel therapeutic candidate to benefit millions of people worldwide who are living with mild and moderate atopic dermatitis. Together with the previous results in psoriasis, EDP1815 continues to demonstrate the potential to be a safe, effective, well tolerated, oral, broad-spectrum anti-inflammatory therapy.”

About the EDP1815 Phase 1b Clinical Trial

EDP1815-101 is a double-blind, placebo-controlled Phase 1b trial designed to evaluate the safety and tolerability of EDP1815 in healthy volunteers and patients with psoriasis or atopic dermatitis. The atopic dermatitis cohort enrolled 24 patients with mild and moderate atopic dermatitis, randomized 2:1 to receive oral administration of the enteric capsule formulation of EDP1815 or placebo once daily, for 56 days, with follow-up off treatment at day 70. Patients were not allowed to use active topical treatments and were not required to use emollients. The primary endpoint was safety and tolerability. Secondary endpoints included a range of established markers of atopic dermatitis.

About EDP1815

EDP1815 is an investigational oral medicine being developed for the treatment of inflammatory diseases. It is a non-live pharmaceutical preparation of a strain of Prevotella histicola, selected for its potential to provide systemic pharmacological effects after oral administration with gut-restricted distribution. Being non-live, it has not been observed to colonize the gut or modify the microbiome. Preclinically, EDP1815 had anti-inflammatory effects in models that cover multiple pathways of inflammation, Th1, Th2, and Th17. Clinical results from four independent cohorts provide evidence supporting EDP1815’s potential to address Th1, Th2 and Th17-mediated inflammation.

In the psoriasis cohorts of the Phase 1b clinical trial, EPD1815 was also observed to limit the systemic production of multiple inflammatory cytokines, including IL-6, IL-8, TNF, and IL-1, which are well-established mediators of potentially harmful effects in patients with inflammatory diseases. Preclinical and clinical data to date showed that EDP1815 achieved this anti-inflammatory activity without inducing immunosuppression. EDP1815 has been observed to be well-tolerated in clinical studies to-date.

About Atopic Dermatitis

Atopic dermatitis, also known as eczema, is a common chronic inflammatory skin disease that affects both children and adults, with a prevalence of up to 3-6% in adults worldwide. It typically presents as a red, intensely itchy rash that may cause lifelong symptoms. Due to the chronic nature and frequency of relapses, atopic dermatitis is associated with a substantial physical and psychosocial burden on patients and their families. It can also occur alongside other atopic diseases including food allergy, asthma, and allergic rhinitis, as these conditions are all associated with an imbalance towards a Th2 inflammatory response – an immune pathway on which EDP1815 has been shown to have potent pre-clinical, and now also clinical, activity.

Patients with atopic dermatitis are often treated with topical medications, which are inconvenient and burdensome in application, leading to poor adherence and reduced efficacy in a real-world setting. Beyond topicals, patients have limited treatment options, especially patients with mild and moderate disease, who represent 80-90% of atopic dermatitis patients worldwide. This group of patients typically do not have access to high-cost, injectable antibody therapies or may be uncomfortable with the toxicity concerns and monitoring requirements of systemic immunosuppressants. There is a large need across the spectrum of disease severity, and especially for these midline, pre-biologic patients, for a safe and well-tolerated oral medicine that resolves the systemic inflammation that drives atopic dermatitis.

Conference Call
Evelo will host a conference call and webcast today at 8:30 a.m. ET with Dr. Benjamin Ehst, M.D., Ph.D., Board-certified Dermatologist, Investigator and Clinical Associate Professor with the Oregon Medical Research Center, to discuss these clinical results and the unmet need in atopic dermatitis. A live webcast containing slides for the event will be available under “News and Events” in the Investors section of Evelo’s website at http://ir.evelobio.com. To ask a question during today’s call, please dial (866) 795-3242 (domestic) or (409) 937-8909 (international) and refer to conference ID 9528164. The archived webcast will be available on Evelo’s website approximately two hours after the completion of the event and will be available for 30 days following the call.

About Evelo Biosciences
Evelo Biosciences is a clinical stage biotechnology company developing orally delivered medicines that act on SINTAX™, the small intestinal axis, and to have systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems. The company’s first product candidates are pharmaceutical preparations of single strains of microbes selected for defined pharmacological properties.

Evelo currently has four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.

For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements concerning the timing and results of any clinical trials or readouts for EDP1815, our development plans, and the promise and potential impact of any of our therapies.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; our unproven approach to therapeutic intervention; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our reliance on third parties and collaborators to expand our microbial library, conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; our lack of experience in manufacturing, selling, marketing, and distributing our product candidates; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; our management and principal stockholders have the ability to control or significantly influence our business; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us.

These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contact

Jessica Cotrone, 978-760-5622
[email protected]

New Chief Operating Officer, Chief Technology Officer and Chief Marketing Officer to support Company’s mission to democratize medical imaging globally

Nanox.ARC deployments are expected to begin in the second half of 2021, subject to regulatory clearance

NEVE ILAN, Israel, Jan. 20, 2021 (GLOBE NEWSWIRE) — NANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company, announced today three senior level additions to the leadership team to further support the Company’s long-term growth objectives. The Company announced that Jim Dara has joined as Chief Operating Officer, Ofir Koren as Chief Technology Officer and Tamar Aharon as Chief Marketing Officer. Nanox’s current Chief Technology Officer, Yoel Raab, is returning to his former position as special technology advisor to the Company.   

“I am very pleased to welcome Jim, Ofir and Tamar to the Nanox team, and believe that they round out what I view as a world class team firmly capable of executing on our mission to democratize medical imaging,” stated Ran Poliakine, Founder and Chief Executive Officer of Nanox. “We ended 2020 on a very high note with the successful demonstration of our Nanox.ARC at the RSNA meeting in December, and we are now forging ahead with our plan to begin deployments in the back half of this year while advancing along the U.S. regulatory path. This year is perhaps our most important yet, and I believe the addition of Jim, Ofir and Tamar, with their diverse backgrounds and experiences, position us for long-term success. I look forward to working with them and the rest of the Nanox team to make our vision a reality.”

James Dara, Chief Operating Officer, adds significant experience launching emerging technologies into Fortune 500 companies across diverse geographies. He most recently served as President of myCharge, a developer of portable charging solutions, where he created cross-functional organizations to support product launches, particularly in the U.S. Prior to that, he served at Vice President of Business Development at Powermat Technologies Ltd., and, before that, as interim Chief Executive Officer of Wellsense Technologies Ltd. At Wellsense, Mr. Dara worked with the medical community to focus test beta products and then specify for production design and user interface for a novel patient/resident pressure sensing and monitoring system. Earlier in his career, he served as Chief Sales Officer and General Manager of North America for Braintech Inc. and, before that, Sales Manager/Engineer at ITW Shakerproof Group. Mr. Dara earned a B.S. in Mechanical Engineering from Michigan State University and a Master of Science in Finance, Magna Cum Laude, from Walsh University.

Ofir Koren, Chief Technology Officer, has decades of experience leading research and development organizations in high technology industries. He most recently served as General Site Manager-Israel, Vice President of Research and Development and Regulatory Affairs at ReWalk Robotics, a developer of exoskeleton solutions for stroke and spinal cord injury rehabilitation, since 2013. Prior to that, he served as a consultant to the company. Before ReWalk Robotics, Mr. Koren was Site Manager and Vice President of Research and Development at RuggedCOM, where he led a team of over 50 people developing and manufacturing cellular systems for the smart power grid market. Earlier in his career, he held research and development focused positions at Alvarion and other technology companies. Mr. Koren earned a degree in practical engineering from the Ort Practical Engineering College. He also earned a B.Sc. in Electrical Engineering from Tel Aviv University, and an MBA from Heriot-Watt University. He also completed the Technion Senior Management Program at the Technion Institute.   

Tamar Aharon Cohen, Chief Marketing Officer, brings to the Nanox team extensive experience in leading and managing business strategy, including marketing, sales and service systems in global corporations. She joins Nanox from Tempo Beverages, LTD, where she held numerous positions of increasing responsibility since 2010. In 2017, she became Chief Executive Officer of Tempo Beverages Cyprus LTD. Prior to that, she served as Marketing Manager at L’Oréal Israel. Ms. Aharon Cohen received a Bachelor of Management, a Bachelor of Law and an Executive MBA, all from Tel Aviv University.

About Nanox:

Nanox, founded by the serial entrepreneur Ran Poliakine, is an Israeli corporation that is developing a commercial-grade digital X-ray source designed to be used in real-world medical imaging applications. Nanox believes that its novel technology could significantly reduce the costs of medical imaging systems and plans to seek collaborations with world-leading healthcare organizations and companies to provide affordable, early detection imaging service for all. For more information, please visit www.nanox.vision.

Forward-Looking Statements:

This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of Nanox’s research and development, manufacturing and commercialization activities with respect to its X-ray source technology and the Nanox.Arc. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information Nanox has when those statements are made or management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises could cause a disruption of the development, deployment or regulatory clearance of the Nanox System and adversely impact our business; Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its X-ray source technology and the Nanox.Arc from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.Arc; the market acceptance of the Nanox.Arc and the proposed pay-per-scan business model; Nanox’s expectations regarding collaborations with third-parties and their potential benefits; and Nanox’s ability to conduct business globally, among others. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in Nanox’s expectations.

Contacts:

Investors

Itzhak Maayan
Nanox Imaging
IR@nanox.vision

Bob Yedid
LifeSci Advisors
646-597-6989
[email protected]

Media

Alona Stein
ReBlonde for Nanox
[email protected]

NEW YORK, Jan. 20, 2021 (GLOBE NEWSWIRE) — Built In today announced that Biz2Credit was honored in its 2021 Best Places To Work Awards. Specifically, Biz2Credit earned a place on Built In’s ‘NYC Best Midsize Companies to Work For’ list. The annual awards include companies of all sizes, from startups to the enterprise, nationally and in the eight largest tech markets.

“Biz2Credit is thrilled to be among the honorees for Built In’s ‘NYC Best Midsize Companies to Work For’ list for 2021,” said Biz2Credit CEO Rohit Arora, one of the nation’s leading experts in FinTech and small business finance. “Being in the company of other great midsized companies in New York City is very gratifying.”

Built In determines winners for Best Places to Work based on an algorithm, using company data about compensation, benefits, and cultural programs. To reflect the attributes candidates are searching for on Built In today, this year’s program weighted criteria more heavily, like remote opportunities and programs for diversity, equity, and inclusion.

“These companies raise the bar for cultural excellence and the ability to adapt to meet changing needs of employees,” says Sheridan Orr, Chief Marketing Officer, Built In. “The 2021 winners show a commitment not just to creating meaningful cultures but to delivering talent needs as they change in a dynamic landscape. We’re thrilled to extend our congratulations to the winners.”

Tech professionals rely on Built In’s Best Places to Work lists to discover employers that align with their preferences, passions, and values. Since its inception three years ago, the award has expanded in reach, from online views of tens of thousands to just under 1 million views today.

Built In, a revolution in tech recruitment, serves more than 1,800 innovative companies of all sizes, from startups to the enterprise, delivering content and digital recruitment solutions that work. The platform amplifies companies’ brands as national, local, or remote employers of choice, as well as leaders in DEI. Monthly, 2.5 million tech professionals rely on Built In to stay up on trends, grow in their roles and discover companies with missions they want to join. The platform publishes stories about companies’ tech, culture, and people. This activates sought-after professionals to apply to customers’ open roles.

Built In’s esteemed Best Places to Work awards, now in its third year, honor companies across numerous categories: 100 Best Places to Work, 50 Best Small Places to Work, 100 Best Midsize Places to Work, 50 Companies with the Best Benefits and 50 Best Paying Companies. Two new national categories reflect what candidates are searching for, including 100 Best Large Companies to Work For and 50 Best Remote-First Places to Work. Built In ranks companies algorithmically based on compensation information, benefits, and culture programs. This year, based on data showing tech professionals’ needs, the Best Places to Work algorithm added weight to companies’ commitment to DEI and remote culture. Rank is determined by combining a company’s score in each of these categories.

About Biz2Credit

Founded in 2007, Biz2Credit has arranged more than $3 billion in small business financing. The company is expanding its industry-leading technology in custom digital platform solutions for banks and other financial institutions, investors, and service providers. Visit www.biz2credit.com or Twitter @Biz2Credit, Facebook, and LinkedIn.

Media Contact: John Mooney, (908) 720-6057, [email protected]. 

KNOXVILLE, TN, Jan. 20, 2021 (GLOBE NEWSWIRE) — Provectus (OTCQB: PVCT) today announced that H. Lee Moffitt Cancer Center (Moffitt) has released a manuscript preprint describing how investigational autolytic cancer immunotherapy PV-10, an injectable formulation of Provectus’ proprietary small molecule rose bengal disodium (RBD), in combination with gemcitabine may enhance the chemotherapy’s efficacy against pancreatic tumors. Chemotherapy regimens that include gemcitabine are the standard of care for the treatment of pancreatic cancer.

The manuscript, entitled “Intralesional injection of Rose Bengal augments the efficacy of gemcitabine chemotherapy against pancreatic tumors,” is available at the following link: https://assets.researchsquare.com/files/rs-140621/v1/cb1df721-b58b-4f5d-9ba6-1b8b2880391d.pdf.

Moffitt co-authors/researchers Patrick Innamarato, Jennifer Morse, Amy Mackay, Sarah Asby, Matthew Beatty, Jamie Blauvelt, Scott Kidd, John Mullinax, Amod Sarnaik, and Shari Pilon-Thomas showed that:

• The injection of PV-10 into mouse pancreatic tumors caused lesion-specific ablation,
   
• The combination of PV-10 and systemic administration of gemcitabine caused lesion-specific ablation and delayed the growth of untreated distal tumors,
   
• The combination was markedly more successful in immunogenic tumors that express the neoantigen ovalbumin, suggesting PV-10 and gemcitabine enhanced the immune clearance of tumors, and
   
• The regression of tumors in mice that received PV-10 in combination with gemcitabine was associated with the depletion of myeloid-derived suppressor cells (MDSCs) and increases in damage associated molecular patterns (DAMPs) high-mobility group box 1 (HMGB1), S100A8, and interleukin-1α.

HMGB1, S100A8, and interleukin-1α are dual-function alarmins that have key intracellular and extracellular functions¹ (alarmins are a subgroup of the larger set of DAMPs). PV-10 treatment-mediated DAMP-release has been demonstrated in three different tumor types: melanoma, colon cancer, and now pancreatic cancer.

Intralesional (IL) PV-10 treatment alone or in combination with gemcitabine was capable of inducing the complete regression of injected pancreatic tumors, while gemcitabine monotherapy failed to induce complete regressions. This suggested that increased pancreatic tumor burden, which diminished gemcitabine efficacy, was overcome when PV-10 was combined with gemcitabine.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors said, “Moffitt’s preclinical data, which show PV-10 improves chemotherapy’s efficacy against pancreatic cancer, are consistent not only with preclinical data showing synergistic activity of PV-10 and either chemotherapy or radiation against relapsed and refractory neuroblastoma, but with clinical data that demonstrate PV-10 enhances the efficacy of immune checkpoint blockade in checkpoint-naïve and checkpoint-refractory metastatic melanoma and metastatic uveal melanoma, and of radiotherapy in in-transit and metastatic melanoma.”

Mr. Rodrigues added, “A strategic aim of Provectus’ drug development program is to show that PV-10 can be a universal contributor in a variety of different cancer combination therapies. Improving the efficacy of standard-of-care chemotherapy against pancreatic cancer is just one example of how Provectus and PV-10 can help make the biotechnology social contract a reality.”

About PV-10

Intralesional (aka intratumoral) administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death within hours of tumor injection, and induce tumor-specific reactivity in circulating T cells within days.^2,3,4 This IL PV-10-induced functional T cell response may be enhanced and boosted in combination with CB.⁵ In CB-refractory advanced cutaneous melanoma, IL PV-10 may restore disease-specific T cell function, which may also be prognostic of clinical response. IL PV-10 has been administered to over 450 patients with cancers of the skin and of the liver. It is administered under visual, tactile or ultrasound guidance to superficial malignancies, and under CT or ultrasound guidance to tumors of the liver.

About Rose Bengal Disodium

RBD is 4,5,6,7-tetrachloro-2′,4′,5′,7′-tetraiodofluorescein disodium, a halogenated xanthene and Provectus’ proprietary lead molecule. Provectus’ current Good Manufacturing Practices (cGMP) RBD is a proprietary pharmaceutical-grade drug substance produced by the Company’s quality-by-design (QbD) manufacturing process to exacting regulatory standards that avoids the formation of uncontrolled impurities currently present in commercial-grade rose bengal. Provectus’ RBD and cGMP RBD manufacturing process are protected by composition of matter and manufacturing patents as well as trade secrets.

An IL formulation (i.e., by direct injection) of cGMP RBD drug substance, cGMP PV-10, is being developed as an autolytic immunotherapy drug product for solid tumor cancers.

IL PV-10 is also undergoing preclinical study for relapsed and refractory pediatric solid tumor cancers, such as neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma.^6,7

A topical formulation of cGMP RBD drug substance, PH-10^®, is being developed as a clinical-stage immuno-dermatology drug product for inflammatory dermatoses, such as atopic dermatitis and psoriasis. RBD can modulate multiple interleukin and interferon pathways and key cytokine disease drivers.⁸

Oral formulations of cGMP RBD are undergoing preclinical study for relapsed and refractory pediatric blood cancers, such as acute lymphocytic leukemia and acute myelomonocytic leukemia.^9,10

Oral formulations of cGMP RBD are also undergoing preclinical study as prophylactic and therapeutic treatments for high-risk adult solid tumor cancers, such as head and neck, breast, pancreatic, liver, and colorectal cancers.

Different formulations of cGMP RBD are also undergoing preclinical study as potential treatments for multi-drug resistant (MDR) bacteria, such as Gram-negative bacteria.

Topical formulations of cGMP RBD are also undergoing preclinical study as potential treatments for diseases of the eye, such as infectious keratitis

Tumor Cell Lysosomes as the Seminal Cancer Drug Target

Lysosomes are the central organelles for intracellular degradation of biological materials, and nearly all types of eukaryotic cells have them. Discovered by Christian de Duve, MD in 1955, lysosomes are linked to several biological processes, including cell death and immune response. In 1959, de Duve described them as ‘suicide bags’ because their rupture causes cell death and tissue autolysis. He was awarded the Nobel Prize in 1974 for discovering and characterizing lysosomes, which are also linked to each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Building on the Discovery, Exploration, and Characterization of Lysosomes

Cancer cells, particularly advanced cancer cells, are very dependent on effective lysosomal functioning.¹¹ Cancer progression and metastasis are associated with lysosomal compartment changes^12,13, which are closely correlated (among other things) with invasive growth, angiogenesis, and drug resistance¹⁴.

RBD selectively accumulates in the lysosomes of cancer cells upon contact, disrupting the lysosomes and causing the cells to die. Provectus^2,15, external collaborators⁶, and other researchers^16,17,18 have independently shown that RBD triggers each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Cancer Cell Autolytic Death via RBD: RBD-induced autolytic cell death, or death by self-digestion, in Hepa1-6 murine hepatocellular carcinoma (HCC) cells can be viewed in this Provectus video of the process (ethidium homodimer 1 [ED-1] stains DNA, but is excluded from intact nuclei; lysosensor green [LSG] stains intact lysosomes; the video is provided in 30-second frames, with a duration of approximately one hour). Exposure to RBD triggers the disruption of lysosomes, followed by nucleus failure and autolytic cell death. Identical responses have been shown by the Company in HTB-133 human breast carcinoma (which can be viewed in this Provectus video of the process, with a duration of approximately two hours) and H69Ar human multidrug-resistant small cell lung carcinoma. Cancer cell autolytic cell death was reproduced by research collaborators in neuroblastoma cells to show that lysosomes are disrupted upon exposure to RBD.⁶

Tumor Autolytic Death via RBD: RBD causes acute autolytic destruction of injected tumors (via autolytic cell death), mediating the release of danger-associated molecular pattern molecules (DAMPs) and tumor antigens; release of these signaling factors may initiate an immunologic cascade where local response by the innate immune system may facilitate systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. Mediated immune signaling pathways may include an effect on STING, which plays an important role in innate immunity.¹⁰

Orphan Drug Designations (ODDs)

ODD status has been granted to RBD by the U.S. Food and Drug Administration for metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

Intellectual Property (IP)

Provectus’ IP includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the process by which cGMP RBD and related halogenated xanthenes are produced, avoiding the formation of previously unknown impurities that exist in commercial-grade rose bengal in uncontrolled amounts. The requirement to control these impurities is in accordance with International Council on Harmonisation (ICH) guidelines for the manufacturing of an injectable pharmaceutical. US patent numbers are 8,530,675, 9,273,022, and 9,422,260, with expirations ranging from 2030 to 2031.

The Company’s IP also includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the combination of RBD and CB (e.g., anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents) for the treatment of a range of solid tumor cancers. US patent numbers are 9,107,887, 9,808,524, 9,839,688, and 10,471,144, with expirations ranging from 2032 to 2035; US patent application numbers include 20200138942.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on an entirely- and wholly-owned family of small molecules called halogenated xanthenes. Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company’s website at www.provectusbio.com.

References

1.  Bertheloot et al. HMGB1, IL-1α, IL-33 and S100 proteins: dual-function alarmins. Cellular & Molecular Immunology 14(1):43-64, 2017.

2.  Wachter et al. Functional Imaging of Photosensitizers using Multiphoton Microscopy. Proceedings of SPIE 4620, 143, 2002.

3.  Liu et al. Intralesional rose bengal in melanoma elicits tumor immunity via activation of dendritic cells by the release of high mobility group box 1. Oncotarget 7, 37893, 2016.

4.  Qin et al. Colon cancer cell treatment with rose bengal generates a protective immune response via immunogenic cell death. Cell Death and Disease 8, e2584, 2017.

5.  Liu et al. T cell mediated immunity after combination therapy with intralesional PV-10 and blockade of the PD-1/PD-L1 pathway in a murine melanoma model. PLoS One 13, e0196033, 2018.

6.  Swift et al. Potent in vitro and xenograft antitumor activity of a novel agent, PV-10, against relapsed and refractory neuroblastoma. OncoTargets and Therapy 12, 1293, 2019.

7.  Swift et al. In vitro and xenograft anti-tumor activity, target modulation and drug synergy studies of PV-10 against refractory pediatric solid tumors. 2018 ASCO Annual Meeting, J Clin Oncol 36, 2018 (suppl; abstr 10557).

8.  Krueger et al. Immune Modulation by Topical PH-10 Aqueous Hydrogel (Rose Bengal Disodium) in Psoriasis Lesions. Psoriasis Gene to Clinic, 8^th International Congress, Br J Dermatol 177.

9.  Swift et al. In Vitro Activity and Target Modulation of PV-10 Against Relapsed and Refractory Pediatric Leukemia. 2018 ASH Annual Meeting, Blood 132, 2018 (suppl; abstr 5207).

10.  Thakur et al. Association of heat shock proteins as chaperone for STING: A potential link in a key immune activation mechanism revealed by the novel anti-cancer agent PV-10. 2020 AACR VAM II, (abstr 5393).

11.  Piao et al. Targeting the lysosome in cancer. Annals of the New York Academy of Sciences. 2016; 1371(1): 45.

12.  Nishimura et al. Malignant Transformation Alters Intracellular Trafficking of Lysosomal Cathespin D in Human Breast Epithelial Cells. Pathology Oncology Research. 1998; 4(4): 283.

13.  Gocheva et al. Distinct roles for cysteine cathepsin genes in multistage tumorigenesis. Genes & Development. 2006; 20(5): 543.

14.  Fehrenbacher et al. Lysosomes as Targets for Cancer Therapy. Cancer Research. 2005; 65 (8): 2993.

15.  Wachter et al. Imaging Photosensitizer Distribution and Pharmacology using Multiphoton Microscopy. Proceedings of SPIE 4622, 112, 2002.

16.  Koevary. Selective toxicity of rose Bengal to ovarian cancer cells in vitro. International Journal of Physiology, Pathophysiology and Pharmacology 4(2), 99, 2012.

17.  Zamani et al. Rose Bengal suppresses gastric cancer cell proliferation via apoptosis and inhibits nitric oxide formation in macrophages. Journal of Immunotoxicology, 11(4), 367, 2014.

18.  Luciana et al. Rose Bengal Acetate photodynamic therapy-induced autophagy. Cancer Biology & Therapy, 10:10, 1048, 2010.

Trademarks

PV-10^® and PH-10^® are registered trademarks of Provectus, Knoxville, Tennessee, U.S.A.

FORWARD-LOOKING STATEMENTS:

The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.

The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.

Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.

Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the SEC, including those described in


Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019


and


Provectus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2020


.

###

Contact:

Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999

NEW YORK, Jan. 20, 2021 (GLOBE NEWSWIRE) — Vidaris is pleased to announce the promotion of Zachary Nord, PE as Principal. In his 10 years at Vidaris, Zach has added tremendous value through leading the Roofing and Waterproofing division as well as growing the South Florida office as Regional Director. Zach joins colleagues Jeffrey Somerlot, Stanford Chan, Dan Popadynec, Jennifer Sze, Michael Chen and Nathan Walker as leadership within the firm’s Building Envelope division.

In his new position, Zach will continue to guide the development of the firm’s envelope services in South Florida and ensure Vidaris remains focused upon our clients’ needs and surpassing their expectations.

“I am proud to recognize the professional accomplishments of Zach; since joining the firm in 2010, he has proven to be an effective and visionary leader,” said Marc Weissbach, CEO of Vidaris. “We are confident that his technical prowess and leadership experience will position him to help lead the next phase of the company’s growth and success.”

Vidaris President, Jeffrey Somerlot, said, “Zach represents excellent leadership within our team; he is respected by clients, peers, and colleagues alike. His promotion to Principal is well deserved – Zach has greatly contributed to our work through consulting excellence and creating valuable client relationships, notably so in Florida where he has led and grown our regional office there.” Jeff continued, saying, “His strengths lie in his ability to quickly understand clients’ operational and project aspirations and to organize and direct the resources necessary to complete projects successfully. His deep understanding of the application of Vidaris’ specialist skills in both the new and existing building sector is second to none.”

Zach’s expertise has been displayed on over 500 of the firm’s new construction and existing building restoration, historic preservation and repositioning projects. His portfolio includes One and Three World Trade Center, the 9/11 Memorial and Museum, 432 Park Avenue, JFK Airport’s Delta Terminal 4 Headhouse, ExxonMobil’s Houston campus, Paramount Miami WorldCenter, Tampa’s Water Street waterfront redevelopment, numerous forensic investigations and envelope-related insurance claims support due to natural disasters, as well as multiple dispute resolution and litigation support projects.

“I am honored to be chosen for this expanded leadership role,” Zach said. “We will continue to invest in the development of innovative and industry leading building envelope consulting for our industry. I look forward to continuing to work with the executive team and employees to serve our customers and drive growth.”

Zach has passionately engaged in building envelope design and engineering since his graduation from Drexel University with degrees in Architectural Engineering and Civil Engineering. A Professional Engineer in Florida and New York, his deep experience with engineered design, material fabrication and façade construction continue to be a strong and proven asset to the Vidaris mission.

About Vidaris
Vidaris is a leading TIC (testing, inspection and certification) consultancy focused on assurance services, building design, efficiency and dispute resolution in the construction, real estate, infrastructure and industrial fields, serving as an independent third‐party advisor for leading developers, property owners, industrial operators, utilities, architects and engineers. The Company’s multidisciplinary, highly technical, and integrated service offering includes three major segments: (i) Architectural Consulting, Testing, Inspection and Certification (« ATIC »); (ii) Dispute Resolution (« DR »); and (iii) Engineering Consulting, Testing, Inspection and Certification (« ETIC ») on both existing and new assets.

See www.vidaris.com for more information.

Michelle Maxwell
Vidaris, Inc.
+1 212 689 5389 Ext. 168
[email protected]

EL DORADO, Ark., Jan. 20, 2021 (GLOBE NEWSWIRE) — Murphy USA Inc. (NYSE: MUSA), a leading marketer of retail motor fuel products and convenience merchandise, today announced selected preliminary financial items for the three and twelve months ended December 31, 2020.

Selected preliminary fourth quarter and full-year 2020 financial items and key metrics are detailed below:

Net income for the fourth quarter of 2020 is expected to be approximately $61.0 million driven primarily by robust total fuel contribution of 19.8 cpg and other factors such as continued strength in merchandise margin contribution trends. Adjusted EBITDA for the quarter is expected to be $136.3 million and lead to overall full year Adjusted EBITDA of $722.7 million. As previously announced, the Company opened its 1,500th store in December and ended the year with 1,503 stores.

During the fourth quarter 2020, Murphy USA repurchased approximately 1.3 million common shares for $169.1 million at an average price of $128.17 per share. The Company had total common share repurchases for the year of 3.3 million shares for $399.6 million at an average price of $119.70 per share. The repurchase plan authorized by the Board of Directors and announced in July 2019 was completed in November 2020, and a new authorization of $500 million announced October 28, 2020 is now in effect, with $375.0 million remaining available for purchase through December 2023 as of year-end 2020.

“As we exit 2020, we are excited to embark upon a new chapter in our value creation strategy as outlined in our October 2020 Capital Allocation update, which included a higher rate of planned organic growth, continuing to return capital through share repurchases, a newly announced $0.25 per share quarterly dividend, and the potential for select M&A activity, including to accelerate development of food and beverage capabilities,” said President and CEO Andrew Clyde. “In December 2020, we took an important first step in executing the M&A element of our strategy, announcing the planned acquisition of QuickChek, and its distinctive brand and customer value proposition, for $645 million. The acquisition will transform existing organic growth plans in attractive markets and accelerate and de-risk the roll-out of Food and Beverage platforms across the network. We plan to update the market with our combined performance expectations for the two firms when we provide 2021 guidance, which we expect to announce in conjunction with our fourth quarter and full-year earnings release on February 3, 2021.”

The above information reflects the Company’s preliminary estimates, is based on the information available as of the date hereof and does not represent a comprehensive statement of our results of operations or financial condition as of or for the year ended December 31, 2020. Actual results may differ materially from the estimates described above as our quarterly financial statement preparation process is not yet complete and additional developments and adjustments may arise between now and the time the financial results for the fourth quarter and fiscal year 2020 are finalized.

These preliminary results should not be viewed as a substitute for our fourth quarter consolidated condensed financial statements prepared in accordance with GAAP as the Company anticipates filing a more detailed press release regarding its fourth quarter and fiscal year 2020 financial results on Form 8-K on February 3, 2021, with an accompanying investor conference call to follow on February 4, 2021.

Notes

¹Same store sales (SSS) metric includes aggregated individual store results for all stores open throughout both periods presented. For all periods presented, the store must have been open for the entire calendar year to be included in the comparison. Remodeled stores that remained open or were closed for just a very brief time (less than a month) during the period being compared remain in the same store sales calculation. If a store is replaced either at the same location (raze-and-rebuild) or relocated to a new location, it will be excluded from the calculation during the period it is out of service. Newly constructed sites do not enter the calculation until they are open for each full calendar year for the periods being compared (open by January 1, 2019 for the sites being compared in the 2020 versus 2019 comparison). When prior period same store sales volumes or sales are presented, they have not been revised for current year activity for raze-and-rebuilds and asset dispositions.

Supplemental Disclosure Regarding Non-GAAP Financial Information

The following table sets forth the Company’s estimates of EBITDA and Adjusted EBITDA for the three and twelve months ended December 31, 2020 and 2019. EBITDA means net income (loss) plus net interest expense, plus income tax expense, plus depreciation and amortization, and Adjusted EBITDA adds back (i) other non-cash items (e.g., impairment of properties and accretion of asset retirement obligations) and (ii) other items that management does not consider to be meaningful in assessing our operating performance (e.g., (income) from discontinued operations, net settlement proceeds, (gain) loss on sale of assets, loss on early debt extinguishment, transaction costs related to acquisitions, and other non-operating (income) expense). EBITDA and Adjusted EBITDA are not measures that are prepared in accordance with U.S. generally accepted accounting principles (GAAP).

We use Adjusted EBITDA in our operational and financial decision-making, believing that the measure is useful to eliminate certain items in order to focus on what we deem to be a more reliable indicator of ongoing operating performance and our ability to generate cash flow from operations. Adjusted EBITDA is also used by many of our investors, research analysts, investment bankers, and lenders to assess our operating performance. We believe that the presentation of Adjusted EBITDA provides useful information to investors because it allows understanding of a key measure that we evaluate internally when making operating and strategic decisions, preparing our annual plan, and evaluating our overall performance. However, non-GAAP measures are not a substitute for GAAP disclosures, and EBITDA and Adjusted EBITDA may be prepared differently by us than by other companies using similarly titled non-GAAP measures.

The reconciliation of net income to EBITDA and Adjusted EBITDA is as follows:

Earnings Call Information


The Company will host a conference call on February 4, 2021 at 10:00 a.m. Central time to discuss fourth quarter 2020 results. The conference call number is 1 (833) 968-2218 and the passcode number is 6049229. The earnings and investor related materials, including reconciliations of any non-GAAP financial measures to GAAP financial measures and any other applicable disclosures, will be available on that same day on the investor section of the Murphy USA website (http://ir.corporate.murphyusa.com). Approximately one hour after the conclusion of the conference, the webcast will be available for replay. Shortly thereafter, a transcript will be available.

Source: Murphy USA Inc. (NYSE: MUSA)

Forward-Looking Statements

Certain statements in this current report on Form 8-K contain or may suggest “forward-looking” information (as defined in the Private Securities Litigation Reform Act of 1995) that involve risk and uncertainties, including, but not limited to our M&A activity, anticipated store openings, fuel margins, merchandise margins, sales of RINs, trends in the Company’s operations, dividends and share repurchases. Such statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. Actual future results may differ materially from historical results or current expectations depending upon factors including, but not limited to: the Company’s ability to consummate the acquisition of QuickChek on the stated terms or at all; the Company’s ability to realize projected synergies from the acquisition of QuickChek and successfully expand our food and beverage offerings; the Company’s ability to finance the acquisition of QuickChek on acceptable terms; the Company’s ability to continue to maintain a good business relationship with Walmart; successful execution of our growth strategy, including our ability to realize the anticipated benefits from such growth initiatives, and the timely completion of construction associated with our newly planned stores which may be impacted by the financial health of third parties; the Company’s ability to effectively manage our inventory, disruptions in our supply chain and our ability to control costs; the impact of severe weather events, such as hurricanes, floods and earthquakes; the impact of a global health pandemic such as COVID-19, including the impact on the Company’s fuel volumes if the gradual recoveries experienced throughout 2020 stall or reverse as a result of any resurgence in COVID-19 infection rates and the government reaction in response thereof; the impact of any systems failures, cybersecurity and/or security breaches, including any security breach that results in theft, transfer or unauthorized disclosure of customer, employee or company information or our compliance with information security and privacy laws and regulations in the event of such an incident; successful execution of our information technology strategy; future tobacco or e-cigarette legislation and any other efforts that make purchasing tobacco products more costly or difficult could hurt our revenues and impact gross margins; changes to the Company’s capital allocation, including the timing, declaration, amount and payment of any future dividends or levels of the Company’s share repurchases, or management of operating cash; the market price of the Company’s stock stock prevailing from time to time, the nature of other investment opportunities presented to the Company from time to time, the Company’s cash flows from operations, and general economic conditions; compliance with debt covenants; availability and cost of credit; and changes in interest rates. Our SEC reports, including our most recent Annual Report on our Form 10-K and Quarterly Reports on Form 10-Q, contain other information on these and other factors that could affect our financial results and cause actual results to differ materially from any forward-looking information we may provide. The Company undertakes no obligation to update or revise any forward-looking statements to reflect subsequent events, new information or future circumstances.

Investor Contact:


Christian Pikul (870) 875-7683
Vice President, Investor Relations and Financial Planning and Analysis
[email protected]