Garmin Honored with Consecutive On-Time Delivery Awards from Airbus Helicopters

Garmin Honored with Consecutive On-Time Delivery Awards from Airbus Helicopters

OLATHE, Kan.–(BUSINESS WIRE)–
Garmin® International Inc., a unit of Garmin Ltd. (NASDAQ: GRMN), today announced it has received a 2020 On-Time Delivery Award from Airbus Helicopters, Inc. for its efficient performance related to product delivery. Garmin avionics are available as standard on select Airbus Helicopters, including the H125, H130, H135 and H145.

Each year, Airbus Helicopters, Inc. recognizes suppliers who stand out in performance, competitiveness and reliability. This is the second year in a row Garmin has won the On-Time Delivery Award for commitment and timeliness in delivering avionics to fulfill Airbus Helicopters Inc. production lines and customer orders.

“We are once again very proud to be recognized by Airbus with this prestigious award for our commitment to serve them and our mutual customers with the on-time delivery of our products,” said Carl Wolf, Garmin vice president aviation sales and marketing. “To again receive this award is truly humbling and ultimately would not be possible without the dedication of our entire Garmin team, in addition to the gratifying strategic relationship with Airbus Helicopters.”

Garmin avionics are available as standard on the Airbus H125, including the G500H TXi flight display, GTN 650 touchscreen navigator, GNC 255 nav/comm, GMA 350c audio panel and the GTX 335R remote-mount ADS-B Out transponder. The GTN 750, GNC 255 and GTX 335R are also available as standard on the H130, while the H135/H145 feature the GTN 750 and Flight Stream 510 as standard equipment.

This marks the third consecutive year Garmin has received an award from Airbus Helicopters, Inc. In 2018, Garmin was also recognized by Airbus Helicopters, Inc. as the Supplier of Excellence for its unmatched responsiveness and competitiveness in its support of the UH-72A Lakota helicopter program, and for its overall support at the Airbus Helicopters Inc. final assembly and completion center in Columbus, Miss.

Garmin’s aviation business segment is a leading provider of solutions to OEM, aftermarket, military and government customers. Garmin’s portfolio includes navigation, communication, flight control, hazard avoidance, an expansive suite of ADS-B solutions and other products and services that are known for innovation, reliability, and value. For more information, visit Garmin’s virtual pressroom at garmin.com/newsroom, contact the Media Relations department at 913-397-8200, or follow us at facebook.com/garminaviation, twitter.com/garminaviation, instagram.com/garminaviation or youtube.com/garminaviation.

About Garmin International, Inc. Garmin International, Inc. is a subsidiary of Garmin Ltd. (Nasdaq: GRMN). Garmin Ltd. is incorporated in Switzerland, and its principal subsidiaries are located in the United States, Taiwan and the United Kingdom. Garmin is a registered trademark of Garmin Ltd. or its subsidiaries and GTN, GTX, and GMA are trademarks of Garmin Ltd. or its subsidiaries.

All other brands, product names, company names, trademarks and service marks are the properties of their respective owners. All rights reserved.

Notice on Forward-Looking Statements:

This release includes forward-looking statements regarding Garmin Ltd. and its business. Such statements are based on management’s current expectations. The forward-looking events and circumstances discussed in this release may not occur and actual results could differ materially as a result of known and unknown risk factors and uncertainties affecting Garmin, including, but not limited to, the risk factors listed in the Annual Report on Form 10-K for the year ended December 28, 2019, filed by Garmin with the Securities and Exchange Commission (Commission file number 0-31983). A copy of such Form 10-K is available at https://www.garmin.com/en-US/company/investors/earnings/. No forward-looking statement can be guaranteed. Forward-looking statements speak only as of the date on which they are made and Garmin undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

Conor McDougall

913-397-8200

[email protected]

KEYWORDS: United States North America Kansas

INDUSTRY KEYWORDS: Satellite Software Hardware Technology Air Aerospace Transport Manufacturing

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BrightView Holdings, Inc. Announces First Quarter Fiscal 2021 Earnings Release Date, Conference Call and Webcast

BrightView Holdings, Inc. Announces First Quarter Fiscal 2021 Earnings Release Date, Conference Call and Webcast

BLUE BELL, Pa.–(BUSINESS WIRE)–
BrightView Holdings, Inc. (NYSE: BV) announced today that it will hold its first quarter fiscal 2021 earnings conference call Thursday, February 4, 2021 at 10 a.m. EST. A press release detailing the Company’s first quarter fiscal 2021 results will be issued prior to the call. The information to join the earnings conference call is below:

Conference telephone number:

U.S. Participant Dial-in:

   

(877) 273-7124

International Participant Dial-in:

   

(647) 689-5396

Conference ID:

   

4778096

This call will be recorded:

U.S. Replay:

 

 

(800) 585-8367

International Replay:

 

 

(416) 621-4642

Replay Available:

 

 

Until 11:59 p.m. on February 11, 2021

Conference ID:

 

 

4778096

BrightView President and Chief Executive Officer Andrew Masterman, together with Executive Vice President and Chief Financial Officer John Feenan, will host the conference call and webcast. The news release, earnings presentation and live webcast of the conference will also be accessible on the company’s investor website or here.

About BrightView

BrightView is the largest provider of commercial landscaping services in the United States. Through its team of approximately 20,000 employees, BrightView provides services ranging from landscape maintenance and enhancements to tree care and landscape development for thousands of customers’ properties, including corporate and commercial properties, HOAs, public parks, hotels and resorts, hospitals and other healthcare facilities, educational institutions, restaurants and retail, and golf courses, among others. BrightView is the Official Field Consultant to Major League Baseball.

Investor Relations Contact

John E. Shave, Vice President of Investor Relations

(484) 567-7148

[email protected]

News Media Contact

Fred Jacobs, Vice President of Communications and Public Affairs

(484) 567-7244

[email protected]

KEYWORDS: United States North America Pennsylvania

INDUSTRY KEYWORDS: Other Construction & Property Commercial Building & Real Estate Construction & Property Landscape

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Applied DNA Promotes Judith Murrah to Chief Operating Officer

Applied DNA Promotes Judith Murrah to Chief Operating Officer

STONY BROOK, N.Y.–(BUSINESS WIRE)–Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced the promotion of Chief Information Officer Judith Murrah to the role of Chief Operating Officer effective immediately. The promotion formalizes Ms. Murrah’s expanding range of responsibilities that includes the development of key customer and partner relationships, QA oversight, and operations management. Ms. Murrah has been instrumental in the undertaking of capacity expansions for pooled COVID-19 surveillance testing at the Company’s wholly-owned subsidiary, Applied DNA Clinical Laboratories, LLC, and for the ongoing implementation of Current Good Manufacturing Practices (“cGMP”) at LineaRx, a majority-owned subsidiary of the Company. The Company believes that the implementation of cGMP at LineaRx is necessary to respond to opportunities in nucleic acid-based therapeutics – drugs and biologics – via the Company’s large-scale, PCR-based LinearDNA™ platform.

Ms. Murrah joined Applied DNA in 2013 as Chief Information Officer and has served as the Company’s Secretary since 2017. Prior to joining the Company, she held leadership positions in the technology industry, including as Senior Director of Information Technology at Motorola Solutions, and as Vice President for roles within global account sales, corporate and marketing communications, and information technology at Symbol Technologies before its acquisition by Motorola Solutions. Ms. Murrah holds an MBA from Harvard Business School and a B.S. in Industrial Engineering from the University of Rhode Island. She is an author of 14 U.S. patents.

“This promotion reflects the confidence of our Board in Judy’s leadership ability,” said Dr. James A. Hayward, president, CEO, and chairman, Applied DNA. “As Chief Information Officer, she demonstrated exceptional judgment and led with energy and a deep commitment to our core values to drive execution across all of our business groups. We believe her execution on our COVID-19 testing strategy has us well positioned for continued client base expansion. We look forward to her continued contributions to our growth as Chief Operating Officer.”

Ms. Murrah is active in Long Island’s business and academic community. She has co-founded and volunteers with non-profits engaging students in science, technology, engineering, and math disciplines. She serves on the boards of the Middle Country (N.Y.) Library Foundation, the Tesla Science Center at Wardenclyffe, and Stony Brook University’s Center for Corporate Education. Ms. Murrah received the inaugural 2001 Diamond Award for Long Island Women Leaders in Technology and was named to the 2005 and 2006 list of Top 50 Women of Long Island.

Ms. Murrah stated, “Applied DNA’s cutting-edge biotechnology platform and markets drive opportunity with a business pace and operational and intellectual demand that has proven to be a rewarding period in my career. I look forward to continuing to lead and support our innovative, dedicated team into new opportunities.”

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.

Applied DNA is a member of the Russell Microcap® Index.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, the possibility that the assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 17, 2020, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

Investor contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, [email protected]
Web:www.adnas.com

Twitter: @APDN

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Health Infectious Diseases Genetics Clinical Trials Pharmaceutical Biotechnology

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Home Capital Announces TSX Approval of Normal Course Issuer Bid

Home Capital Announces TSX Approval of Normal Course Issuer Bid

TORONTO–(BUSINESS WIRE)–
Home Capital Group Inc. (TSX: HCG) (“Home Capital”) announced today that the Toronto Stock Exchange (“TSX”) has approved the previously announced renewal of its Normal Course Issuer Bid. Under the terms of the Normal Course Issuer Bid, Home Capital may purchase for cancellation up to 4,367,617 of its common shares (the “Common Shares”), representing approximately 10% of its public float as of January 11, 2021, calculated in accordance with TSX rules. The average daily trading volume of Home Capital’s Common Shares from July 1, 2020 to December 31, 2020 was 183,210 Common Shares. Daily purchases under the new bid will be limited to 45,802 Common Shares, other than block purchase exceptions. As of January 11, 2021, Home Capital had 52,187,634 Common Shares issued and outstanding. The purchases may commence on January 22, 2021, and will terminate on January 21, 2022, or on such earlier date as Home Capital may complete its purchases pursuant to the Notice of Intention submitted to the TSX. The purchases made by Home Capital will be effected through the facilities of TSX, other designated exchanges and/or alternative trading systems, and in accordance with the rules of TSX. The price that Home Capital will pay for any Common Shares will be the market price of such Common Shares at the time of acquisition or such other price as may be permitted. Home Capital will make no purchases of Common Shares other than open-market purchases.

Home Capital believes that, from time to time, the market price of its Common Shares does not fully reflect the value of its business and its future business prospects. As a result, Home Capital believes that the purchase of its outstanding Common Shares may represent an appropriate and desirable use of its available funds. Common Shares purchased under the Normal Course Issuer Bid will be cancelled or used in connection with Home Capital’s equity settled incentive plans. Pursuant to its previous Normal Course Issuer Bid, Home Capital received approval from the TSX to purchase up to 5,266,187 Common Shares for the period of January 22, 2020 to January 21, 2021. Under the previous Normal Course Issuer Bid, Home Capital purchased 1,373,227 Common Shares as of January 14, 2021 at a weighted average price of C$27.15 through the facilities of the TSX, other designated exchanges and alternative trading systems. As previously announced, Home Capital suspended purchases under its prior Normal Course Issuer Bid in March 2020 due to the onset of the COVID-19 pandemic and resumed purchases thereunder at the end of December 2020. Aggregate purchases under the renewed Normal Course Issuer Bid are not currently expected to exceed C$50 million, inclusive of any amounts purchased under the prior Normal Course Issuer Bid from December 30, 2020 to January 21, 2021.

Home Capital will enter into an automatic purchase plan with a broker in respect of the renewed Normal Course Issuer Bid. From time to time, when Home Capital does not possess material non-public information about itself or its securities, it may direct its broker to allow for the purchase of Common Shares at times when Home Capital ordinarily would not be active in the market due to its own internal trading blackout periods, insider trading rules or otherwise. The automatic purchase plan to be entered into with Home Capital’s broker will be adopted in accordance with applicable Canadian securities laws.

Caution Regarding Forward-Looking Statements

This press release contains forward-looking information within the meaning of applicable Canadian securities legislation, including relating to potential future purchases by Home Capital of its Common Shares pursuant to its Normal Course Issuer Bid. Please refer to Home Capital’s 2019 Annual Report, available on Home Capital’s website at www.homecapital.com, and on the Canadian Securities Administrators’ website at www.sedar.com, for Home Capital’s Caution Regarding Forward-looking Statements.

About Home Capital and Home Trust

Home Capital Group Inc. is a public company, traded on the Toronto Stock Exchange (HCG), operating through its principal subsidiary, Home Trust Company. Home Trust is a federally regulated trust company offering residential and non-residential mortgage lending, securitization of residential mortgage products, consumer lending and credit card services. In addition, Home Trust offers deposits via brokers and financial planners, and through a direct-to-consumer brand, Oaken Financial. Home Trust also conducts business through its wholly owned subsidiary, Home Bank. Licensed to conduct business across Canada, we have offices in Ontario, Alberta, British Columbia, Nova Scotia, Quebec and Manitoba.

Jill MacRae

Director, Investor Relations

416-933-4991

[email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: REIT Finance Banking Professional Services Construction & Property

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Castle Biosciences to Present Data on DecisionDx®-Melanoma, DecisionDx® DiffDx™-Melanoma at 18th Annual Winter Clinical Dermatology Conference

Castle Biosciences to Present Data on DecisionDx®-Melanoma, DecisionDx® DiffDx™-Melanoma at 18th Annual Winter Clinical Dermatology Conference

FRIENDSWOOD, Texas–(BUSINESS WIRE)–
Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced poster presentations with data on two of its skin cancer gene expression profile tests at the 18th Annual Winter Clinical Dermatology Conference, taking place virtually from Jan. 15 – 24, 2021.

President and chief executive officer, Derek Maetzold, will also participate in the meeting’s “2021 View for Dermatology Industry Panel,” scheduled to take place on Saturday, Jan. 23, from 2:10 p.m. – 2:50 p.m. Eastern time.

Poster information is as follows:

DecisionDx®-Melanoma:

The virtual poster is entitled, “Identifying predictors of sentinel lymph node metastasis in cutaneous melanoma patients using molecular and clinicopathologic high-risk features.”

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors.

Study methods and findings:

  • For 3,093 patients with T1-T4 cutaneous melanoma, authors used decision tree analysis to determine which molecular and clinicopathologic features best stratify SLN positivity risk.

    • DecisionDx-Melanoma was the most important factor in distinguishing between high and low SLN-positivity rates (p<0.001).

DecisionDx® DiffDx™-Melanoma:

The virtual poster is entitled, “Performance of a 35-gene expression profile test in suspicious pigmented lesions of the head and neck.”

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions.

“Melanomas of the head or neck need special consideration with respect to staging and treatment decisions, as many have inconclusive diagnoses upon presentation based on the histological and pathological factors normally used,” said study author, Sarah I. Estrada, M.D., FCAP, laboratory director of Affiliated Dermatology. “We welcome the use of a gene expression profile test to help refine melanoma diagnoses of cases of indeterminate status. The study results demonstrate that DecisionDx DiffDx-Melanoma maintains its performance in this delicate sub-population of potential melanoma cases, and the utilization of this objective tool in clinical practice has the potential to improve subsequent management decisions.”

Study methods and findings:

  • As melanoma of the head and neck often require special consideration with respect to staging and treatment decisions, early and accurate detection is especially critical for these lesions. This study evaluated DecisionDx DiffDx-Melanoma’s accuracy in classifying pigmented lesions on the head and neck.
  • DecisionDx DiffDx-Melanoma was used to independently assess 105 lesions located on the head and neck in adults age 18 and up.
  • DecisionDx DiffDx-Melanoma classified these lesions as benign (n=54, 51.4%), malignant (n=48, 45.7%), and intermediate-risk (n=3, 2.9%) with accuracy metrics of 98.0% sensitivity, 100% specificity, 100% PPV and 98.2% NPV.
  • The test’s performance in the head and neck lesion population is similar to its performance in pigmented lesions in the rest of the body in the overall adult population.
  • DecisionDx DiffDx-Melanoma demonstrated its ability to be an effective tool for refining melanoma diagnoses on the head and neck and therefore improving downstream management decisions, as indicated by its high sensitivity and specificity in this study.

About DecisionDx-Melanoma

DecisionDx®-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through September 30, 2020, DecisionDx-Melanoma has been ordered more than 64,560 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx DiffDx-Melanoma

DecisionDx® DiffDx™-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.

More information about the test and disease can be found at www.CastleTestInfo.com.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a commercial-stage dermatologic cancer company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma, DecisionDx®-CMSeq), cutaneous squamous cell carcinoma (DecisionDx®-SCC), suspicious pigmented lesions (DecisionDx® DiffDx™-Melanoma) and uveal melanoma (DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq). For more information about Castle’s gene expression profile tests, visit www.CastleTestInfo.com. Castle also has active research and development programs for tests in other dermatologic diseases with high clinical need. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix, Arizona. For more information, visit www.CastleBiosciences.com.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq and are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning the ability of DecisionDx DiffDx-Melanoma to characterize difficult to diagnose melanocytic lesions and accurately differentiate between benign and malignant pigmented lesions in order to add diagnostic clarity and confidence for dermatopathologists and help dermatologists better understand the clinical implications for more informed patient care, the ability of DecisionDx-Melanoma test results to help identify patients with low probability of sentinel lymph node positivity, and statements concerning each of their impact to influence treatment plans and optimize or improve treatment decisions. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business, the timing and amount of revenue we are able to recognize in a given fiscal period, unexpected delays in planned launch of our pipeline products, the level and availability of reimbursement for our products, our ability to manage our anticipated growth and the risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

Investor and Media Contact:

Camilla Zuckero

832-835-5158

[email protected]

KEYWORDS: Texas Arizona United States North America

INDUSTRY KEYWORDS: Oncology Health Genetics General Health Clinical Trials Pharmaceutical Biotechnology

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First Majestic Produces 5.5M Silver Eqv. Oz in Q4 2020 (3.5M Silver Oz and 26K Gold Oz); Provides 2021 Outlook and Conference Call Details

VANCOUVER, British Columbia, Jan. 20, 2021 (GLOBE NEWSWIRE) — First Majestic Silver Corp. (“First Majestic” or the “Company”) is pleased to announce the Company’s fourth quarter and full year 2020 production results, as well as production and cost guidance for 2021. The Company’s fourth quarter and full year 2020 financial results are scheduled to be released on February 18, 2021.

Q4 2020 HIGHLIGHTS

  • Total production reached 5.5 million silver equivalent ounces, representing a 5% increase over the prior quarter.
  • Silver production reached 3.5 million ounces, representing a 9% increase over the prior quarter and the Company’s second highest quarterly silver production.
  • Gold production reached 26,343 ounces, representing a 2% increase from the prior quarter.
  • San Dimas produced 1.9 million ounces of silver and 19,980 ounces of gold, representing an increase of 16% and 9%, respectively, from the prior quarter and the highest quarterly silver production since acquiring the mine in May 2018.
  • La Encantada produced 1.1 million silver ounces, representing a 12% increase from the prior quarter and the highest quarterly production since Q2 2013.
  • At the end of the fourth quarter, 25 exploration drill rigs were active across the Company’s mines and projects consisting of 12 rigs at San Dimas, seven rigs at Santa Elena, four rigs at La Encantada and two rigs at La Parrilla.

FY 2020 HIGHLIGHTS

  • Silver production of 11.6 million ounces achieved the top-end of the Company’s revised guidance range of producing between 11.0 to 11.7 million ounces of silver. Strong silver production from La Encantada and San Dimas in the second half of 2020 helped to offset some of the production losses resulting from the national COVID-19 shutdowns which occurred in the second quarter of 2020.
  • Gold production in 2020 reached 100,081 ounces and slightly below the Company’s guidance range of producing between 106,000 to 112,000 ounces. The slight miss was primarily due to lower production rates at Santa Elena and lower gold grades at San Dimas in the second half of 2020.
  • La Encantada produced 3.5 million silver ounces, representing a 14% increase from the prior year and beating the Company’s revised production guidance of between 3.1 to 3.3 million silver ounces. In addition, La Encantada recorded its highest annual silver production since 2014.
  • Achieved record consolidated average silver recoveries of 88%, the highest in the Company’s 18-year history due to the continued success with fine grinding technologies and mill modifications.
  • La Encantada achieved average silver recoveries of 78% in 2020 marking its highest annual recovery rate in the Company’s history.
  • Completed 2,292 metres of underground development at the Ermitaño project near Santa Elena in advance of production ramp up scheduled for early 2022.
  • Construction of the liquid natural gas (“LNG”) facility at Santa Elena was approximately 90% complete at year end and remains on schedule to begin commissioning in February 2021 with initial power delivery expected in Q2 2021.
  • Completed 156,244 metres of exploration drilling in 2020.
  • Ended the year with record cash and cash equivalents balance of US$238.6 million.

First Majestic posted another strong year in 2020 despite the many challenges brought on by the COVID-19 pandemic and Mexico’s two-month national shutdown,” said Keith Neumeyer, President & CEO. “Nevertheless, our team quickly adapted to the new normal and outperformed in the second half of the year. During the fourth quarter, silver production at La Encantada and San Dimas again exceeded our expectations. At La Encantada, silver production hit a six year high due to continued improvements in recoveries and underground production from the caving areas. San Dimas had a strong close to 2020 by producing 3.5 million silver equivalent ounces in the fourth quarter and the highest quarterly silver production while under our ownership.”

Mr. Neumeyer continues, “In 2021, we expect an increase of up to 20% in consolidated silver production across the three operating mines. In addition, our investment in underground development at the Ermitaño project near Santa Elena will kick into high gear in order to prepare the area for production ramp up in early 2022. Along with a few other projects currently being advanced, we now have a clear path to achieving our goal of producing 30 million silver equivalent ounces by 2023.”       

FY2020 Mine by Mine Production Table:

Mine Ore
Processed
Tonnes
per Day
Ag Grade
(g/t)
Au Grade
(g/t)
Ag
Recovery
Au
Recovery
Ag Oz
Produced
Au Oz
Produced
Equivalent
Ag Ounces
San Dimas 713,064 1,954 297 3.24 94 % 96 % 6,399,667 71,598 12,670,526
Santa Elena 640,276 1,754 88 1.43 93 % 96 % 1,692,761 28,242 4,181,708
La Encantada 860,613 2,358 162 0.01 78 % 90 % 3,505,953 241 3,526,776
Total 2,213,953 6,066 184 1.46 88 % 96 % 11,598,380 100,081 20,379,010
*Certain amounts shown may not add exactly to the total amount due to rounding differences.
*The following prices were used in the calculation of silver equivalent ounces: Silver: $20.55 per ounce; Gold: $1,770 per ounce.



Production Details Table:

Q4 Q3 Q/Q   FY FY Y/Y
2020 2020 Change Consolidated Production Results 2020 2019 Change
625,332 655,920 -5 % Ore processed/tonnes milled 2,213,953 2,831,999 -22 %
5,477,492 5,201,085 5 % Total production – Silver equivalent ounces 20,379,010 25,554,288 -20 %
3,452,959 3,158,866 9 % Silver ounces produced 11,598,380 13,241,118 -12 %
26,343 25,771 2 % Gold ounces produced 100,081 134,580 -26 %

QUARTERLY REVIEW

Total ore processed during the quarter at the Company’s mines amounted to 625,332 tonnes, representing a 5% decrease compared to the previous quarter. The decrease in tonnes processed was primarily due to lower production at Santa Elena’s Main Vein partially offset by higher production rates at San Dimas.

Consolidated silver and gold grades in the quarter averaged 194 g/t and 1.37 g/t, respectively, compared to 170 g/t and 1.27 g/t, respectively, in the previous quarter. The increase in consolidated grades were primarily due to the increased tonnage of higher grade material at San Dimas and La Encantada.   

Consolidated silver and gold recoveries were fairly consistent averaging 89% and 96%, respectively, during the quarter. La Encantada continues to achieve higher recoveries as a result of improved blending procedures of stockpiles and processing ore with low manganese content.

Quarterly Mine by Mine Production Table:

Mine Ore
Processed
Tonnes
per Day
Ag Grade
(g/t)
Au Grade
(g/t)
Ag
Recovery
Au
Recovery
Ag Oz
Produced
Au Oz
Produced
Equivalent
Ag Ounces
San Dimas 208,648 2,268 309 3.10 94 % 96 % 1,941,286 19,980 3,477,062
Santa Elena 168,276 1,829 83 1.22 93 % 96 % 418,153 6,294 901,630
La Encantada 248,408 2,700 172 0.01 80 % 90 % 1,093,521 69 1,098,800
Total 625,332 6,797 194 1.37 89 % 96 % 3,452,959 26,343 5,477,492
*Certain amounts shown may not add exactly to the total amount due to rounding differences.
*The following prices were used in the calculation of silver equivalent ounces: Silver: $24.39 per ounce; Gold: $1,874 per ounce.

At the San Dimas Silver/Gold Mine:

  • San Dimas recorded its highest quarterly silver production under First Majestic’s ownership during the fourth quarter. The operation produced 1,941,286 ounces of silver and 19,980 ounces of gold representing an increase of 16% and 9%, respectively, compared to the prior quarter for a total production of 3,477,062 silver equivalent ounces.
  • The mill processed a total of 208,648 tonnes with average silver and gold grades of 309 g/t and 3.10 g/t, respectively.
  • Silver and gold recoveries during the quarter averaged 94% and 96%, respectively.
  • The Central Block and Sinaloa Graben areas contributed approximately 72% and 24%, respectively, of the total production during the quarter. In addition, the Tayoltita and El Cristo areas contributed approximately 4% of total production in the quarter.
  • A total of 12 drill rigs, consisting of three surface rigs and nine underground rigs, were active at the end of the quarter.
  • The Company is expecting to release an updated NI 43-101 Technical Report on San Dimas by the end of the first quarter of 2021.

At the Santa Elena Silver/Gold Mine:

  • During the quarter, Santa Elena produced 418,153 ounces of silver and 6,294 ounces of gold representing a decrease of 17% and 15%, respectively, compared to the prior quarter for a total production of 901,630 silver equivalent ounces.
  • The mill processed a total of 168,276 tonnes, consisting of 105,591 tonnes of underground ore and 62,685 tonnes from the above ground heap leach pad. The decrease in tonnes was primarily due to having limited contractor and equipment availability during the quarter. The Company expects mine and plant production to return to normal operating rates by the second quarter of 2021 following improvements in underground ore haulage and increased production at the Main, Alejandra Bajo and America veins.
  • Silver and gold grades from underground ore averaged 113 g/t and 1.58 g/t, respectively, while silver and gold grades from the above ground heap leach pad averaged 33 g/t and 0.61 g/t, respectively.
  • Silver and gold recoveries averaged 93% and 96%, respectively, during the quarter. The Company continues to advance the SAG mill circuit conversion at Santa Elena and anticipates the mill to be commissioned in the third quarter of 2021. Lower operating costs are expected to be achieved once the mill is fully commissioned due to having lower power requirements compared to a standard ball mill as well as a reduction in chemical reagents and steel balls.
  • The LNG generators were successfully installed at Santa Elena’s new LNG power facility during the quarter and the project was approximately 90% complete at year end. Electromechanical activities such as the installation of the natural gas pipelines, cooling system, instrumentation and controls, plant safety infrastructure and connection of the main electric cables continued throughout the quarter. Dry-testing and commissioning activities are scheduled to start in February. The power generation plant is expected to be fully operational in the second quarter after completing the commissioning and ramp-up period.
  • At the Ermitaño project near Santa Elena, the Company completed approximately 923 metres of underground development during the quarter. The underground ventilation circuit, which ties together the West and East ramps, was completed at the end of November. On surface, the construction of the transmission power line and housing for the temporary diesel generators were completed. The diesel generators were delivered to site in early January and are currently undergoing installation.      
  • A total of seven drill rigs, consisting of five surface rigs and two underground rigs, were active at the end of the quarter.
  • The Company is expecting to release an updated NI 43-101 Technical Report on Santa Elena by the end of the first quarter of 2021.

At the La Encantada Silver Mine:

  • During the quarter, La Encantada processed 248,408 tonnes of ore and produced 1,093,521 ounces of silver, or approximately 12% above the previous quarter and the highest quarterly production since Q2 2013.
  • Silver grades and recoveries during the quarter averaged 172 g/t and 80%, respectively.
  • Strong production from the San Javier and La Prieta caving areas contributed approximately 81% of the total silver production during the quarter. Caving production benefited from higher than expected grades and tonnage during the quarter.
  • The mill modernization project designed to improve processing efficiencies had some installation delays throughout 2020 due to the impacts caused by the COVID-19 pandemic. As a result, the project is expected to continue into 2021 with the installation of new scrubbers for the foundry, main gear replacement and new impellers for two thickener tanks, filter press upgrades and improvements to the electrical control room.
  • A total of four drill rigs, consisting of one surface rig and three underground rigs, were active at the end of the quarter.
  • The Company is expecting to release an updated NI 43-101 Technical Report on La Encantada by the end of the first quarter of 2021.

2021 GUIDANCE

The Company expects 2021 production from its three operating mines to range between 12.5 to 13.9 million ounces of silver and 100,000 to 112,000 ounces of gold for total production (with gold credits converted to silver ounces) of between 20.6 to 22.9 million silver equivalent ounces. Based on the midpoint of the guidance range the Company expects a 14% increase in silver production and a 7% increase in total production when compared to 2020. The increases are primarily due to higher throughputs and silver grades at San Dimas and having a full year of production following Mexico’s two month national shutdown in 2020, offset by a lower silver to gold ratio which impacts the calculation of conversion to silver equivalent ounces.

A mine-by-mine breakdown of the 2021 production guidance is included in the table below. Effective 2021, the Company is adjusting its cost guidance and future reporting to reflect cash costs and all-in sustaining cost per ounce (“AISC”) on a per silver equivalent payable ounces compared to previous disclosure of only silver payable ounces. For 2021, the Company is using an 80:1 silver to gold ratio compared to a 100:1 silver to gold ratio in its revised 2020 guidance. Metal price and foreign currency assumptions for calculating equivalents are silver: $22.50/oz, gold: $1,800/oz, MXN:USD 20:1.

Mine Silver Oz (M)  Gold Oz (k) Silver Eqv Oz (M) Cash Costs per
AgEq Oz ($)
AISC per

AgEq Oz ($)
San Dimas 7.1 – 8.0 72 – 80 12.9 – 14.4 7.94 – 8.43 11.36 – 12.23
Santa Elena 2.0 – 2.2 29 – 32 4.3 – 4.8 12.93 – 13.71 16.49 – 17.68
La Encantada 3.4 – 3.7 3.4 – 3.7 11.20 – 11.89 13.72 – 14.70
Totals: 12.5 – 13.9 100 112 20.6 – 22.9 $9.52 $10.10 $14.81 $15.99

* Certain amounts shown may not add exactly to the total amount due to rounding differences.
* Cash Costs and AISC are non-GAAP measures. Consolidated AISC includes Corporate General & Administrative cost estimates and non-cash costs of $1.74 to $1.94 per payable silver equivalent ounce.    The Company calculates consolidated AISC in the manner set out in the table below.

The Company is projecting its 2021 AISC to be within a range of $14.81 to $15.99 on a per consolidated payable silver equivalent ounce basis. Excluding non-cash items, the Company anticipates its 2021 AISC to be within a range of $14.17 to $15.29 per payable silver equivalent ounce. An itemized AISC cost table is provided below:

All-In Sustaining Cost Calculation

(1)
FY 2021
($ /AgEq oz)
Total Cash Costs per Payable Silver Equivalent Ounce (2) 9.52 – 10.10
General and Administrative Costs 1.10 – 1.23
Sustaining Development Costs 1.37 – 1.53
Sustaining Property, Plant and Equipment Costs 1.04 – 1.16
Sustaining Exploration Costs 0.02 – 0.03
Workers Participation Costs 0.74 – 0.82
Lease Payments 0.37 – 0.42
Share-based Payments (non-cash) 0.52 – 0.58
Accretion of Reclamation Costs (non-cash) 0.12 – 0.13
All-In Sustaining Costs: $14.81 – $15.99
All-In Sustaining Costs: (excluding non-cash items) $14.17 – $15.29
  1. AISC is a non-GAAP measure and is calculated based on the Company’s consolidated operating performance. Other mining companies may calculate AISC differently as a result of differences in underlying accounting principles, the definition of “sustaining costs” and the distinction between sustaining and expansionary capital costs.
  2. Total cash cost per payable silver equivalent ounce includes estimated royalties and 0.5% mining environmental fee of $0.11 per payable silver equivalent ounce.


Ermitaño Development and Construction Remain Key Focus in 2021

Since its initial discovery in 2016, the high-grade Ermitaño project has been a major priority exploration project for the Company. Located only four kilometres east of the existing Santa Elena milling facility, the project has the potential to add significant mine life to the Santa Elena operation.

Since 2016, the Company has completed approximately 72,270 metres of diamond drilling on the property to define the current Indicated Resource of 4.7 million ounces of silver and 311,000 ounces of gold, or 30.4 million silver equivalent ounces grading an average 449 AgEq g/t (70 g/t silver and 4.59 g/t gold). In addition, Inferred Resources totaling 7.0 million ounces of silver and 370,000 ounces of gold, or 37.5 million silver equivalent ounces grading an average 312 AgEq g/t (58 g/t silver and 3.08 g/t gold) have been defined. The Company is planning to release a Preliminary Economic Assessment (“PEA”) for Ermitaño with an effective cut-off date of June 30, 2020 and an updated Resource statement, with an effective cut-off date of December 31, 2020, by the end of the first quarter of 2021. Furthermore, the Company is currently conducting hydrogeological and geotechnical drilling which will be used as key study work for an upcoming Pre-Feasibility Study (“PFS”) on the project. The PFS is expected to be released in the second half of 2021 and will define initial Reserves, production rates, costs and estimated life of mine for the Ermitaño project.

In 2021, the Company has budgeted a total of $42.1 million to be invested at Ermitaño and expects to begin initial test block mining by mid-2021 to assess the geotechnical conditions, subject to delineation drilling results, and extract approximately 30,000 to 60,000 tonnes of material to be used for industrial metallurgical testing. Investment in development will prepare Ermitaño for initial limited mine production in the second half of 2021 followed by additional stope preparation and ramp up activities in early 2022. Procurement for the underground mining fleet is expected to occur in the first half of 2021. In addition, blending and batching test work is expected to be completed by mid-year to determine the ideal processing procedure to apply at the Santa Elena processing plant.    


Investing for Future Growth

In 2021, the Company plans to invest a total of $168.4 million on capital expenditures consisting of $55.7 million for sustaining investments and $112.7 million for expansionary projects (including $42.1 million on the Ermitaño project). This represents a 28% increase compared to the revised 2020 capital budget and is aligned with the Company’s future growth strategy of investments in fine grinding technology, processing plant modernizations and to prepare the Ermitaño project for production in early 2022.

The 2021 annual budget includes total capital investments of $75.9 million to be spent on underground development; $49.8 million towards property, plant and equipment; $27.6 million in exploration; and $15.1 million towards corporate processing innovation projects. Management may revise the guidance and budget during the year to reflect actual and anticipated changes in metal prices or to the business.

The Company plans to increase underground development in 2021 to approximately 47,000 metres compared to 38,504 metres completed in 2020. The 2021 development program consists of approximately 27,800 metres at San Dimas; 8,800 metres at Santa Elena; 4,600 metres at La Encantada; and 5,800 metres at the Ermitaño project near Santa Elena. This year-over-year increase is primarily due to the return to normal operating levels following the two-month national shutdown in the second quarter of 2020 as well as higher development rates at Santa Elena following haulage contractor challenges caused by the COVID-19 pandemic. In addition, higher development rates are planned at the Ermitaño project in order to prepare the mine for initial production in early 2022.

The Company also plans to increase exploration drilling in 2021 to approximately 184,150 metres compared to 156,244 metres completed in 2020. The 2021 drilling program will consist of approximately 104,000 metres  at San Dimas with infill and step out holes focusing on near mine and brownfield targets in the West, Central, and Tayoltita blocks; 37,600 metres at Santa Elena with near mine, brownfield and greenfield holes continuing to test the Main, America and Alejandra veins and new targets north and south of the mine area; 14,550 metres at La Encantada with infill and step out holes testing the potential of several near mine and brownfield targets; 13,900 metres at the Ermitaño project intended to increase resource confidence and add new mineral resources; and 7,600 metres at Del Toro and 6,500 metres at La Parrilla intended to test new brownfield and greenfield targets identified through generative exploration in 2020.

Mr. Ramon Mendoza Reyes, Vice President Technical Services for First Majestic, is a “Qualified Person” as such term is defined under National Instrument 43-101 and has reviewed and approved the technical information disclosed in this news release.


Conference Call

The Company will be holding a conference call and webcast today, January 20, 2021 at 8:00 am PT (11:00 am ET) to discuss the quarterly production results as well as its 2021 production, cost and capital guidance. To participate in the conference call, please dial the following:

  Toll Free Canada & USA: 1-800-319-4610
  Outside of Canada & USA: 1-604-638-5340
  Toll Free Germany: 0800 180 1954
  Toll Free UK: 0808 101 2791

Participants should dial in 10 minutes prior to the conference.

Click on “January 20, 2021 Webcast Link” on the First Majestic homepage as a simultaneous audio webcast of the conference call will be posted at www.firstmajestic.com.

The conference call will be recorded and you can listen to an archive of the conference by calling:

  Canada & USA Toll Free: 1-800-319-6413
  Outside Canada & USA: 1-604-638-9010
  Access Code: 5906 followed by the # sign

The replay will be available approximately one hour after the conference and will available for seven days following the conference. The replay will also be available on the Company’s website for one month.

ABOUT THE COMPANY

First Majestic is a publicly traded mining company focused on silver production in Mexico and is aggressively pursuing the development of its existing mineral property assets. The Company presently owns and operates the San Dimas Silver/Gold Mine, the Santa Elena Silver/Gold Mine and the La Encantada Silver Mine. Production from these mines are projected to be between 12.5 to 13.9 million silver ounces or 20.6 to 22.9 million silver equivalent ounces in 2021.

FOR FURTHER INFORMATION contact [email protected], visit our website at www.firstmajestic.com or call our toll free number 1.866.529.2807.

FIRST MAJESTIC SILVER CORP.
“signed”
Keith Neumeyer, President & CEO

Cautionary Note Regarding Forward Looking Statements

This press release contains “forward‐looking information” and “forward-looking statements” under applicable Canadian and U.S. securities laws (collectively, “forward‐looking statements”). These statements relate to future events or the Company’s future performance, business prospects or opportunities that are based on forecasts of future results, estimates of amounts not yet determinable and assumptions of management made in light of management’s experience and perception of historical trends, current conditions and expected future developments. Forward-looking statements include, but are not limited to, statements with respect to: the Company’s business strategy; future planning processes; commercial mining operations; cash flow; budgets; capital expenditures; the timing and amount of estimated future production; recovery rates; mine plans and mine life; the future price of silver and other metals; costs; costs and timing of the development of new deposits; capital projects and exploration activities and the possible results thereof; completion of technical reports and the timing of release. Assumptions may prove to be incorrect and actual results may differ materially from those anticipated. Consequently, guidance cannot be guaranteed. As such, investors are cautioned not to place undue reliance upon guidance and forward-looking statements as there can be no assurance that the plans, assumptions or expectations upon which they are placed will occur. All statements other than statements of historical fact may be forward‐looking statements. Statements concerning proven and probable mineral reserves and mineral resource estimates may also be deemed to constitute forward‐looking statements to the extent that they involve estimates of the mineralization that will be encountered as and if the property is developed, and in the case of measured and indicated mineral resources or proven and probable mineral reserves, such statements reflect the conclusion based on certain assumptions that the mineral deposit can be economically exploited. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives or future events or performance (often, but not always, using words or phrases such as “seek”, “anticipate”, “plan”, “continue”, “estimate”, “expect”, “may”, “will”, “project”, “predict”, “forecast”, “potential”, “target”, “intend”, “could”, “might”, “should”, “believe” and similar expressions) are not statements of historical fact and may be “forward‐looking statements”.

Actual results may vary from forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results to materially differ from those expressed or implied by such forward-looking statements, including but not limited to: the duration and effects of the coronavirus and COVID-19, and any other pandemics or public health crises on our operations and workforce, and the effects on global economies and society, actual results of exploration activities; conclusions of economic evaluations; changes in project parameters as plans continue to be refined; commodity prices; variations in ore reserves, grade or recovery rates; actual performance of plant, equipment or processes relative to specifications and expectations; accidents; fluctuations in costs; labour relations; availability and performance of contractors; relations with local communities; changes in national or local governments; changes in applicable legislation or application thereof; delays in obtaining approvals or financing or in the completion of development or construction activities; exchange rate fluctuations; requirements for additional capital; government regulation; environmental risks; reclamation expenses; outcomes of pending litigation including appeals of judgments; resolutions of claims and arbitration proceedings; negotiations and regulatory proceedings; limitations on insurance coverage as well as those factors discussed in the section entitled “Description of the Business – Risk Factors” in the Company’s most recent Annual Information Form, available on www.sedar.com, and Form 40-F on file with the United States Securities and Exchange Commission in Washington, D.C.  Although First Majestic has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended.

The Company believes that the expectations reflected in these forward‐looking statements are reasonable, but no assurance can be given that these expectations will prove to be correct and such forward‐looking statements included herein should not be unduly relied upon. These statements speak only as of the date hereof. The Company does not intend, and does not assume any obligation, to update these forward-looking statements, except as required by applicable laws. 



Onex to Announce Fourth-Quarter and Full-Year 2020 Results on February 26, 2021

All amounts
in U.S. dollars 
unless otherwise stated 

TORONTO, Jan. 20, 2021 (GLOBE NEWSWIRE) — Onex Corporation (TSX: ONEX) will release its results for the fourth quarter and full year ended December 31, 2020 on February 26, 2021. A live broadcast of Onex’ webcast to discuss the results will begin at 11:00 a.m. ET on February 26, 2021.

A link to the live webcast and the 90-day on-line replay will be available at www.onex.com/events-and-presentations.

About Onex
Founded in 1984, Onex invests and manages capital on behalf of its shareholders, institutional investors and high net worth clients from around the world.  Onex’ platforms include: Onex Partners, private equity funds focused on larger opportunities in North America and Europe; ONCAP, private equity funds focused on middle market and smaller opportunities in North America; Onex Credit, which manages primarily non-investment grade debt through collateralized loan obligations, senior loan strategies and other private credit strategies; and Gluskin Sheff’s wealth management services including its actively managed public equity and public credit funds.  In total, as of September 30, 2020, Onex has approximately $36.6 billion of assets under management, of which approximately $6.7 billion is its own shareholder capital.  With offices in Toronto, New York, New Jersey and London, Onex and its experienced management teams are collectively the largest investors across Onex’ platforms.

The Onex Partners and ONCAP businesses have assets of $36 billion, generate annual revenues of $22 billion and employ approximately 149,000 people worldwide.  Onex shares trade on the Toronto Stock Exchange under the stock symbol ONEX.  For more information on Onex, visit its website at www.onex.com.  Onex’ security filings can also be accessed at www.sedar.com.

For further information:

Jill Homenuk
Managing Director, Shareholder Relations and Communications
Tel: +1 416.362.7711



Oncorus Announces Publication of Preclinical Data Demonstrating Potent Systemic Antitumor Activity of its Clinical Stage Oncolytic Herpes Simplex Viral Immunotherapy Product Candidate ONCR-177

— Preclinical findings show that ONCR-177’s systemic antitumor immunity is driven by its 
five complementary immunomodulatory transgene payloads and retention of γ
34.5 —

Complete and durable tumor regression and protective antitumor memory observed in multiple syngeneic tumor models —

Preclinical safety data and preliminary readout from the ongoing Phase 1 study support Oncorus’ proprietary safety strategies —

CAMBRIDGE, Mass. , Jan. 20, 2021 (GLOBE NEWSWIRE) — Oncorus, Inc. (Nasdaq: ONCR), a clinical stage biopharmaceutical company developing next-generation, systemically active viral immunotherapies to transform outcomes for cancer patients, announced today the recent publication of preclinical data supporting the clinical development of its lead oncolytic Herpes Simplex Virus (oHSV) clinical candidate, ONCR-177. In the paper, entitled, “ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity” (Haines, et al., 2020), published online in the journal Cancer Immunology Research, ONCR-177 demonstrated potent and durable antitumor activity in multiple immune-competent tumor models. The preclinical findings demonstrate that the activity of ONCR-177, an intratumorally administered viral immunotherapy engineered for systemic activity currently in a Phase 1 study, is driven by Oncorus’ unique combination of five complementary immunomodulatory transgene payloads in addition to its retention of γ34.5. A herpes simplex virus 1 (HSV-1) gene, γ34.5 allows the virus to replicate in the presence of host antiviral immune responses. ONCR-177’s safety strategies and their ability to enhance oHSV tolerability without impeding potency were previously characterized in a paper published by Oncorus in September 2020 in Molecular Therapy on ONCR-159, the unarmed version of ONCR-177, (Kennedy et al., 2020) titled, “Design of an Interferon-Resistant Oncolytic HSV-1 Incorporating Redundant Safety Modalities for Improved Tolerability.”

“We are pleased to share these encouraging preclinical findings, which supported our advancement of ONCR-177 into clinical development last year. These data give important insight into how our proprietary engineering of ONCR-177 may enable systemic activity without compromising safety, and position us to advance our mission to realize the full potential of this therapeutic class for cancer patients,” said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer at Oncorus. “We believe viral immunotherapies as a class are a proven modality and represent the most promising approach in development today to activate multiple arms of the immune system and improve outcomes for cancer patients.”

Oncorus is conducting a Phase 1 study to evaluate the safety and tolerability of ONCR-177 as well as to evaluate preliminary antitumor activity in patients with solid tumors (NCT04348916) as a monotherapy and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) via a clinical trial collaboration and supply agreement signed with Merck in July 2020. Oncorus expects to report initial interim data from the monotherapy dose escalation part of this trial in the second half of 2021 with addition data readouts through the second half of 2022.

Christophe Quéva, Ph.D., Oncorus’ Chief Scientific Officer and Senior Vice President, Research, commented, “We have designed our proprietary oHSV Platform to safely maximize the impact of viral immunotherapies to foster the development of a potent systemic antitumor activity. With our Phase 1 study of ONCR-177 now well underway, we look forward to the potential of these preclinical findings translating into improving patient outcomes.”

In addition to ONCR-177, Oncorus plans to nominate a second intratumorally administered oHSV clinical candidate to specifically target cancers of the central nervous system, including glioblastoma multiforme, in the second half of 2021 (ONCR-GBM). In the first half of 2021, Oncorus plans to nominate intravenously administered Synthetic Coxsackievirus A21 and Synthetic Seneca Valley Virus clinical candidates from its Synthetic Virus Platform for difficult-to-inject tumors such as those of the lung.

Preclinical Data Highlights

Highlights from Oncorus’ preclinical data described in these papers include:

  • The murine version of ONCR-177 (mONCR-171) demonstrated durable complete tumor regressions and abscopal activity in four syngeneic tumor models: A20, MC38, CT26 and B16F10N1.
  • Durable survival was achieved in both A20 and CT26 models versus the unarmed version of ONCR-177 (i.e., ONCR-159), specifically demonstrating the impact that ONCR-177’s arming strategy has in driving systemic activity in these in vivo models of cancer. Re-challenge experiments in long term responders to mONCR-171 demonstrated that tumor antigen-specific protective memory responses were achieved.
  • The retention of a gene coding for γ34.5 demonstrated more robust replication in the presence of interferon-γ versus viruses that do not contain this gene. Of note, ONCR-159, which also retains γ34.5 expression, demonstrated statistically significant improvement in an in vivo bi-lateral CT26 model of survival.
  • The addition of systemic anti-PD-1 augmented the activity of mONCR-171, particularly for un-injected tumors, suggesting that utilizing systemic anti-PD-1 immunotherapy may augment the systemic antitumor effect of ONCR-177.
  • Directional viral promoters, CAG and MND, were shown to elicit strong transgene expression in injected tumors. Furthermore, the addition of the five complementary immunomodulatory transgenes and other modifications in ONCR-177 remain potently oncolytic in vitro in cancer cell lines. The oncolytic activity of ONCR-177 is on par with what has been reported for talimogene laherparepvec (IMLYGIC®), which is commonly referred to as “T-VEC”.1
  • In vivo biodistribution analyses suggest that viral DNA and transgene expression were relegated primarily to the injected tumor. As previously disclosed, no dose limiting toxicities were observed in the first four patients dosed with ONCR-177 suggesting that the safety strategies incorporated into ONCR-177 are working as intended.

About ONCR-177

ONCR-177, Oncorus’ lead viral immunotherapy candidate, is designed to mount a multidimensional attack on cancer. It induces immunogenic cancer cell death and ignites innate and adaptive immunity to drive a lasting and systemic anti-tumor response.

Five Complementary Immunomodulatory Transgene Payloads to Recruit Multiple Arms of Immune System

ONCR-177 is armed with five complementary transgenes with strong clinical and preclinical validation, IL-12, FLT3LG, CCL4, anti-PD-1 and anti-CLTA-4, which were selected by Oncorus to comprehensively drive the Cancer-Immunity Cycle2 at multiple nodes:

  • IL-12 is known to activate and expand CD8, CD4 TH1 and natural killer (NK) cells.
  • FLT3LG is well understood to expand antigen cross-presenting classical dendritic cells, and CCL4 is known facilitate dendritic and CD8 T cell recruitment.
  • ONCR-177’s local expression of agonists to PD-1 (via a proprietary PD-1 nanobody) and CTLA-4 (using the ipilimumab sequence) is intended to counteract compensatory upregulation of key immune checkpoints.

γ34.5 Retention to Enable Resistance to Host Antiviral Immune Responses and Additional Innovations

ONCR-177 also retains a copy of γ34.5 to enable resistance to host antiviral interferon responses. γ34.5 is known to play a more central role in inhibition of antiviral response than US11.3 Furthermore, ONCR-177 contains a gB:N/T mutation in a surface fusion protein shown to broaden tropism beyond Herpesvirus entry mediator (HVEM) and nectin-1 to include nectins-2, 3 and 4 and enhance infectivity.4 Lastly, ONCR-177 contains inactivating null mutations in ICP47 intended to improve antigen presentation.5

Orthogonal Safety Strategies to Enable Selective Attenuation and Retention of γ
34.5

Oncorus’ oHSV platform incorporates two complementary and proprietary approaches to limit viral replication in normal tissues. First, Oncorus’ microRNA attenuation strategy leverages the known differential expression of certain microRNA in tumors versus normal tissues to allow unencumbered viral replication in tumor cells, while preventing replication in healthy tissues. This microRNA attenuation strategy allows ONCR-177 to retain the ability to express the gene encoding for γ34.5, a feature unique among oHSV-based therapies such as T-VEC and others in development today. In addition, ONCR-177 also has engineered proprietary mutations into UL37 to eliminate the virus’ ability to transport, replicate and establish latency inside neurons.6

About Oncorus

At Oncorus, we are focused on driving innovation to deliver next-generation, systemically active viral immunotherapies to transform outcomes for cancer patients. We are advancing a portfolio of intratumorally and intravenously administered viral immunotherapies for multiple indications with significant unmet needs based on our oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform. Designed to deliver next-generation viral immunotherapy impact, our oHSV Platform improves upon key characteristics of this therapeutic class to enhance potency without sacrificing safety, including greater capacity to encode transgenes to drive systemic immunostimulatory activity, retention of full replication competency to enable high tumor-killing potency, and orthogonal safety strategies to restrict viral activity in tumor cells. Oncorus’ lead oHSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent, as well as low systemic exposure to the therapy, which we believe could potentially limit systemic toxicities. Please visit us at www.oncorus.com to learn more.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding:  expectations with respect to Oncorus’ ability to advance its clinical and preclinical pipelines, including statements regarding the clinical development of ONCR-177 and timing and anticipated data read-outs for the ongoing Phase 1 clinical trial; Oncorus’ expectations regarding upcoming milestones for its other potential product candidates, including the timing for nomination of clinical candidates from its two Synthetic Virus Platform development programs and its second oHSV Platform clinical candidate; and the therapeutic potential and clinical benefits of Oncorus’ existing and potential product candidates. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on Oncorus’ operations and the timing and anticipated results of its ongoing and planned preclinical studies and clinical trials; the risk that the preliminary results of preclinical studies or clinical trials may not be predictive of future results in connection with future clinical trials; Oncorus’ ability to successfully demonstrate the safety and efficacy of ONCR-177 and obtain regulatory approval and that Oncorus’ other preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; and Oncorus’ ability to obtain, maintain and protect its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Oncorus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the Securities and Exchange Commission on November 12, 2020, as well as discussions of potential risks, uncertainties, and other important factors in the other filings that Oncorus makes with the Securities and Exchange Commission from time to time. These documents are available under the “SEC filings” page of the Investors section of Oncorus’ website at http://investors.oncorus.com.

Any forward-looking statements represent Oncorus’ views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Oncorus explicitly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Contact:                                                       
Alan Lada                                
Solebury Trout                                 
617-221-8006                                
[email protected]    
Media Contact:                                
Liz Melone                             
[email protected]

___________________________________________________  

1 Moesta, et al, Cancer Research 2017
2 Chen and Mellman, Immunity 2013
3 Mulvey et al., J. Virol. 2004 and Peters et al., J. Virol. 2018
4 Uchida, J. Virol. 2010
5 Twumasi-Boateng, Nat. Rev. Cancer 2018
6 Richards et al., PLoSPathog. 2017 



Imara Announces the Appointment of Kenneth Attie, M.D. as Chief Medical Officer

Brings 30 years of medical research experience within the biopharmaceutical industry, including Acceleron Pharma and Genentech

BOSTON, Jan. 20, 2021 (GLOBE NEWSWIRE) — Imara Inc. (Nasdaq: IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin, today announced the appointment of Kenneth Attie, M.D. as Senior Vice President and Chief Medical Officer. Dr. Attie joins Imara with over 30 years of experience within academia and the biopharmaceutical industry, most recently at Acceleron Pharma, Inc. where he led global clinical development efforts that led to the recent FDA and EMA approvals of a new treatment for patients with rare anemias, including beta-thalassemia. 

“We are excited to have the benefit of Ken’s global medical experience as we continue to advance IMR-687 in multiple clinical studies worldwide,” said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. “Ken’s deep expertise in rare anemias and disorders of hemoglobin, combined with his established clinical management experience, will be a great addition to our leadership team.”

“I am excited to be part of the Imara team as we move closer toward our goal of providing novel and accessible treatments for patients suffering from hemoglobinopathies, including sickle cell disease and beta-thalassemia,” commented Dr. Attie. “I look forward to providing medical leadership as Imara continues to advance IMR-687 in its ongoing global Phase 2b trials in those indications, as well as in potential future indications amenable to PDE9 inhibition, such as heart failure with preserved ejection fracture.”

Prior to joining Imara, Dr. Attie served as Vice President of Medical Research at Acceleron Pharma for more than ten years. In this role, he managed clinical studies with several investigational drugs involving TGF-beta superfamily pathways in rare anemias, malignancies, and neuromuscular disorders, leading to regulatory approval of Reblozyl® for patients with transfusion-dependent beta-thalassemia and certain myelodysplastic syndromes. Before Acceleron, Dr. Attie held clinical development and medical affairs leadership roles of increasing responsibility at Altus Pharmaceuticals, Insmed, Inc. and Genentech, Inc. His work in the field of growth hormone and related growth factors contributed to the approval of therapies in numerous indications, including pediatric and adult GH deficiency, chronic renal insufficiency, Turner syndrome, idiopathic short stature and primary IGF-1 deficiency. Dr. Attie, a board-certified pediatric endocrinologist with over 55 publications in peer-reviewed journals, was a visiting professor at the State Institute for Diabetes and Endocrinology in Rio de Janeiro and an assistant clinical professor in the Department of Pediatric Endocrinology at the University of California, San Francisco. He received his education and medical training at the University of Michigan, Ann Arbor, New York University Medical Center, and University of California, San Francisco Medical Center.

About IMR-687

IMR-687 is a highly selective and potent small molecule inhibitor of PDE9. PDE9 selectively degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology. Lower levels of cGMP are found in people with SCD and beta-thalassemia and are associated with reduced blood flow, increased inflammation, greater cell adhesion and reduced nitric oxide mediated vasodilation.

Blocking PDE9 acts to increase cGMP levels, which is associated with reactivation of fetal hemoglobin (HbF), a natural hemoglobin produced during fetal development. Increased levels of HbF in RBCs have been demonstrated to improve symptomology and substantially lower disease burden in both patients with SCD and patients with beta-thalassemia.

About Imara

Imara Inc. is a clinical-stage biotechnology company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin. Imara is currently advancing IMR-687, a highly selective, potent small molecule inhibitor of PDE9 that is an oral, once-a-day, potentially disease-modifying treatment for sickle cell disease and beta-thalassemia. IMR-687 is being designed to have a multimodal mechanism of action that acts on red blood cells, white blood cells, adhesion mediators and other cell types. For more information, please visit www.imaratx.com.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the Company’s plans, strategies and prospects. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the “Risk Factors” section of the Company’s most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Contact:

Gina Nugent
Ten Bridge Communications
617-460-3579
gina@tenbridgecommunications.com

Investor Contact:

Michael Gray
617-835-4061 
[email protected]



Ocuphire Announces Publication of ORION-1 Phase 2 Results for Nyxol in Clinical Ophthalmology and Presentation at the January OIS Presbyopia Innovation Showcase

Durability of Nyxol’s Pupil Constricting Effects Using an Evening Dosing Regimen Informs Dosing Strategy for Phase 2 Trial in Presbyopia and Phase 3 Trial in NVD

Ocuphire Invited to Present at the Ophthalmology Innovation Summit (OIS) Presbyopia Innovation Showcase on January 28, 2021

FARMINGTON HILLS, Mich., Jan. 20, 2021 (GLOBE NEWSWIRE) — Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, announced today that results from its ORION-1 (NCT03960866) Phase 2 clinical trial evaluating the safety and efficacy of Nyxol® in glaucoma and presbyopia have been published in Clinical Ophthalmology, an international, peer-reviewed, open access journal covering all subspecialties within ophthalmology.

The paper, titled “Phentolamine Mesylate Ophthalmic Solution Provides Lasting Pupil Modulation and Improves Near Visual Acuity in Glaucoma Patients in a Randomized Phase 2b Clinical Trial”, reported the following key findings:

  • Use of Nyxol eye drops produced a statistically significant 20% mean reduction or approximately 1 mm in pupil diameter under daytime and nighttime lighting conditions that was sustained for over 30 hours post-dosing;
  • Over 60% of patients in the Nyxol treatment group demonstrated a statistically significant improvement of 1-line or greater in near visual acuity compared to 20% on placebo;
  • There was no statistical difference in eye redness compared to placebo upon examination the following morning after dosing the prior evening before bedtime; and
  • Nyxol eye drops demonstrated with daily evening dosing for 2 weeks a tolerable profile with no systemic effects and an intraocular pressure (IOP) lowering trend, especially for those with IOP baselines that were slightly higher than the normal range.

Highlights from this double-masked, randomized, placebo-controlled, multiple-dose, multi-center Phase 2b trial were first presented by Dr. Jay Pepose at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2020. The peer-reviewed journal publication can now be found at on Ocuphire’s website here.

“We are excited to announce the second peer-reviewed publication of clinical results from our second recent Phase 2 trial in our Nyxol program and would like to thank the authors, who include the five site investigators, our medical monitor at Oculos, and our team at Ocuphire for their contributions,” said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. “The findings of the ORION-1 trial and our comprehensive end of Phase 2 meeting with the FDA in May 2020 set the direction for us to also pursue Nyxol in presbyopia. We believe that 2021 could be a transformational year for Ocuphire with 4 late-stage trials planned with our Nyxol eye drops in front of the eye indications and APX3330 oral tablets for diabetic retinal disease, starting with the first Phase 3 data read-out expected at the end of first quarter 2021.”

The ORION-1 Phase 2 trial together with the MIRA-1 Phase 2 trial established Ocuphire’s strategy to focus on acute and chronic pupil modulation indications: night vision disturbances (NVD), reversal of mydriasis, and presbyopia. The observation from the trial of durable moderate miotic effects combined with many presbyopia patients experiencing a 1-line improvement in near visual acuity confirmed the potential overall benefits of a smaller pupil aperture for improvement in everyday vision. The results also reaffirmed the potential for Nyxol, a moderate miotic, to be combined with another moderate miotic with the goal to achieve “pinhole” diameter of 1.6 mm to 2.0 mm. This target diameter has been demonstrated by ophthalmic devices and pharmacological treatments to achieve the primary endpoint of 3-line near vision improvement in many patients. Accordingly, Ocuphire is planning to initiate VEGA-1, a Phase 2 randomized, double-masked, placebo-controlled trial investigating a combination of 1% Nyxol and low dose (0.4%) pilocarpine to treat presbyopia. Ocuphire believes that the addition of low-dose pilocarpine, a miotic that works through a different iris muscle and mechanism than Nyxol, may synergistically produce the “pinhole” effect on the pupil as well as reduce the side effects common with higher approved doses of pilocarpine. For more information about the VEGA-1 Phase 2 trial design, please visit www.clinicaltrials.gov (NCT04675151).

Ocuphire has been invited to present on its approach to treating presbyopia at the Ophthalmology Innovation Summit (OIS) Presbyopia Innovation Showcase on January 28, 2021. More information about the showcase can be found at https://ois.net/ois-presbyopia-innovation-showcase-2021.

For NVD, Ocuphire’s most advanced chronic ophthalmic indication, the same daily evening dosing regimen from ORION-1 for Nyxol is planned. Ocuphire recently initiated the LYNX-1 Phase 3 randomized, double-masked, placebo-controlled trial in 160 NVD patients. The primary endpoint in this registration trial is the percentage of subjects with at least 3 lines of improvement in mesopic, low-contrast, best-corrected distance visual acuity after 7 days. Secondary endpoints include pupil diameter reductions, other visual acuity measures (distance and near), and safety and tolerability. Additional information about the LYNX-1 Phase 3 trial can be found at www.clinicaltrials.gov (NCT04638660).

About Presbyopia

Presbyopia is an age-related condition with onset most common in people over 40 years old. As the eye ages, the lens becomes stiffer, which limits the eye’s ability to adjust its focus for reading or for other tasks that require clear vision at near distances. It is estimated that 120 million Americans have presbyopia and this number is expected to grow as the population above the age of 40 increases. Currently, there are no pharmacological therapies approved for presbyopia, but there is evidence that decreasing pupil diameter, especially to a size of 1.6 mm to 2.0 mm to create a “pinhole” effect, can improve near visual acuity by increasing the depth of focus.

About Night Vision Disturbances (NVD)

NVD, also known as dim light vision disturbances, is a condition in which peripheral imperfections (aberrations) of the cornea scatter light when the pupil dilates in dim light conditions. These imperfections can be naturally occurring, especially with age, or surgically induced from refractive procedures such as LASIK. Patients with NVD experience glare, halos, starbursts and decreased contrast sensitivity. About 38 million individuals in the US are believed to suffer from some level of NVD, with an estimated 16 million having moderate-to-severe NVD that may be directly addressable with a pupil management approach. The effects of NVD may be reduced or eliminated by moderately reducing pupil diameter to avoid some of the aberrations and their scattering effect, without impeding the ability to see at night. Four major patient subpopulations of NVD have been identified based on their underlying cause of aberrations: night myopia (naturally occurring), non-central cataracts, post-LASIK procedures, and post-IOL implantation. These conditions span an age range of late teenagers to those 80 years and older, with no approved pharmacologic therapies available for use.

About Ocuphire Pharma

Ocuphire is a publicly traded (NASDAQ: OCUP), clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders. Ocuphire’s pipeline currently includes two small-molecule product candidates targeting front and back of the eye indications. The company’s lead product candidate, Nyxol® Eye Drops, is a once-daily preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, and is being developed for several indications, including dim light or night vision disturbances (NVD), reversal of pharmacologically-induced mydriasis (RM), and presbyopia, and has been studied in 7 Phase 1 and 2 trials. Ocuphire’s second product candidate, APX3330, is an oral tablet designed to inhibit angiogenesis and inflammation pathways relevant to retinal and choroidal vascular diseases, such as diabetic retinopathy (DR) and diabetic macular edema (DME), and has been studied in 11 Phase 1 and 2 trials. Nyxol is entering Phase 3 clinical development for NVD and RM, and Phase 2 for presbyopia. APX3330 is entering Phase 2 clinical development for DR/DME. As part of its strategy, Ocuphire will continue to explore opportunities to acquire additional ophthalmic assets and to seek strategic partners for late-stage development, regulatory preparation and commercialization of drugs in key global markets. Please visit www.clinicaltrials.gov to learn more about Ocuphire’s completed Phase 2 clinical trials and ongoing Phase 3 registration trials (NCT04620213 and NCT04638660) and soon to recruit Phase 2 trials (NCT04675151 and NCT04692688). For more information, please visit www.ocuphire.com.


Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning Ocuphire’s product candidates, results of ongoing and future clinical trials, and commercialization and market opportunities. These forward-looking statements are based upon Ocuphire’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions and pre-clinical and clinical trials; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) changes in capital resource requirements; (v) risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vi) legislative, regulatory, political and economic developments, (vii) changes in market opportunities, and (viii) the effects of COVID-19 on clinical programs and business operations. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and may be filed by Ocuphire from time to time with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Ocuphire Contacts

Mina Sooch, President & CEO 
Ocuphire Pharma, Inc. 
[email protected]
www.ocuphire.com 

Corey Davis, Ph.D.
LifeSci Advisors
[email protected]