Transition Therapeutics, Inc.

FT. MYERS, FL / ACCESSWIRE / November 4, 2021 / NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of cancer-focused genetic testing services and global oncology contract research services, announced today an upcoming leadership team transition. William Bonello will be named Chief Financial Officer as of January 1, 2022. Mr. Bonello currently serves as President of our Informatics Division. He has led the division since its inception in 2020, building the team out to over 60 people today and presiding over impressive early growth. Prior to that role, Mr. Bonello served as Chief Strategy and Corporate Development Officer helping to formulate the company's growth strategy, and previously also served as Director of Investor Relations. Prior to joining NeoGenomics, Mr. Bonello worked as a healthcare equity analyst covering diagnostic services and product stocks at Craig-Hallum and at a variety of other investment banking firms and was also Senior Vice President for Investor Relations at LabCorp. Mr. Bonello received his B.A. degree from Carleton College and his MBA from the Kellogg School of Management at Northwestern University. Kathryn McKenzie will be named Chief Sustainability and Risk Officer as of January 1, 2022. Ms. McKenzie currently serves as our Chief Financial Officer and has led the company through multiple acquisitions, financing events, and navigated the company through the financial challenges associated with the COVID-19 global pandemic. Prior to that role, Ms. McKenzie served as Vice President of Finance and Chief Accounting Officer. Before joining NeoGenomics, Ms. McKenzie served in various roles at Chico's FAS, including Assistant Controller and Director of Financial Reporting and Treasury, and at Ernst and Young LLP. Ms. McKenzie is a Certified Public Accountant and holds a Master's of Science in Accountancy from the University of North Carolina Wilmington. "We are very excited to announce new appointments for two of our talented executives that positions the company for further success. We are delighted to name Bill as Chief Financial Officer and believe that his extensive capital markets and financial analysis background will be invaluable as we continue to execute on our ambitious growth strategy. We are also pleased to have Kathryn now serve in the newly created role of Chief Sustainability and Risk Officer with oversight of our Environmental, Social, and Governance initiatives as well as risk management activities," said Mark Mallon, Chief Executive Officer of NeoGenomics. About NeoGenomics, Inc. NeoGenomics, Inc. specializes in cancer genetics testing and information services, providing one of the most comprehensive oncology-focused testing menus in the world for physicians to help them diagnose and treat cancer. The Company's Pharma Services Division serves pharmaceutical clients in clinical trials and drug development. NeoGenomics is committed to connecting patients with life altering therapies and trials. We believe that, together, with our partners, we can help patients with cancer today and the next person diagnosed tomorrow. In carrying out these commitments, NeoGenomics adheres to all relevant data protection laws, provides transparency and choice to patients regarding the handling and use of their data through our Notice of Privacy Practices, and has invested in leading technologies to ensure the data we maintain is secured at all times. Headquartered in Fort Myers, FL, NeoGenomics operates CAP accredited and CLIA certified laboratories in Fort Myers and Tampa, Florida; Aliso Viejo, Carlsbad and San Diego, California; Research Triangle Park, North Carolina; Houston, Texas; Atlanta, Georgia; Nashville, Tennessee; and CAP accredited laboratories in Cambridge, United Kingdom; Rolle, Switzerland; and Singapore. NeoGenomics serves the needs of pathologists, oncologists, academic centers, hospital systems, pharmaceutical firms, integrated service delivery networks, and managed care organizations throughout the United States, and pharmaceutical firms in Europe and Asia. Forward-Looking Statements Certain information contained in this press release constitutes forward-looking statements for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project," "plan," "potential" and other words of similar meaning. These forward-looking statements address various matters including management transitions in 2022. These forward looking statements involve a number of risks and uncertainties that could cause actual future results to differ materially from those anticipated in the forward-looking statements as the result of the Company's ability to continue gaining new customers, respond to the effects of the COVID-19 outbreak, offer new types of tests, integrate its acquisitions and otherwise implement its business plan, as well as additional factors discussed under the heading "Risk Factors" and elsewhere in the Company's Annual Report on Form 10-K filed with the SEC on February 25, 2021, as such information has been updated in subsequent SEC filings. . As a result, this press release should be read in conjunction with the Company's periodic filings with the SEC. NeoGenomics routinely posts information that may be important to investors in the "Investor Relations" section of its website at . The Company encourages investors and potential investors to consult the NeoGenomics website regularly for important information about NeoGenomics. Forward-looking statements speak only as of the date such statements are made (unless another date is indicated) and should not be relied upon as of any subsequent date. While the Company may elect to update forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. NeoGenomics, Inc. Doug Brown Chief Strategy and Corporate Development Officer T: 239.768.0600 x2539 M: 704.236.2064 doug.brown@neogenomics.com Charlie Eidson Director, Investor Relations and Corporate Development T: 239.768.0600 x2726 M: 952.221.8816 charlie.eidson@neogenomics.com SOURCE: NeoGenomics, Inc. View source version on accesswire.com:

MIAMI, Feb. 18, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three months ended December 31, 2020. Business Highlights BioReference Laboratories’ volume in the fourth quarter of 2020 increased 170% compared to 2019. COVID-19 PCR testing volume increased 24% over the third quarter of 2020. During the fourth quarter of 2020, BioReference Laboratories (BRL) processed approximately 4.3 million COVID-19 PCR tests and currently has the capacity to process more than 100,000 PCR tests per day. In addition, BRL performed approximately 220,000 COVID-19 serology tests to measure SARS-CoV-2 antibody levels and currently has significant additional capacity. BRL continues to provide innovative solutions to the COVID-19 testing needs of physicians, health systems, long-term care facilities, governments, schools, employers, professional sports teams, entertainment venues, and the general public through relationships with Rite-Aid and CVS. In January 2021, BRL announced COVID-19 testing agreements for players and officials, as well as team and league staff for the 2020-2021 seasons for the National Basketball Association (NBA) and National Hockey League. BRL is also supporting the COVID-19 testing needs of the Winter X Games in Aspen, U.S. Soccer's Women's and Men's National Teams and the NBA G League in Orlando. BRL introduced Scarlet Health™ to expand digital health access. In January 2021, BRL launched Scarlet Health, an in-home, fully integrated digital platform providing access to on-demand diagnostic services. Backed by BRL’s national presence and infrastructure, with laboratory facilities and professionals across the country, Scarlet Health delivers an innovative, flexible, mobile alternative to traditional patient service centers or other draw locations when phlebotomy and other specimen collection services are needed. In January 2021, BRL launched Scarlet Health, an in-home, fully integrated digital platform providing access to on-demand diagnostic services. Backed by BRL’s national presence and infrastructure, with laboratory facilities and professionals across the country, Scarlet Health delivers an innovative, flexible, mobile alternative to traditional patient service centers or other draw locations when phlebotomy and other specimen collection services are needed. GeneDx added repeat expansion analysis genetic tests. GeneDx launched several new genetic tests, including repeat expansion analysis for spinocerebellar ataxia, Friedreich ataxia and other forms of hereditary ataxias. With these additions, GeneDx has created a comprehensive and affordable offering that covers the vast majority of genes involved with pediatric-onset and adult-onset ataxias. GeneDx launched several new genetic tests, including repeat expansion analysis for spinocerebellar ataxia, Friedreich ataxia and other forms of hereditary ataxias. With these additions, GeneDx has created a comprehensive and affordable offering that covers the vast majority of genes involved with pediatric-onset and adult-onset ataxias. Regulatory submission from OPKO’s commercial partner, Pfizer, accepted in the U.S. and filed in Japan for somatrogon to treat pediatric patients with growth hormone deficiency. The U.S. Food and Drug Administration (FDA) accepted for filing the initial Biologics License Application for somatrogon, a long-acting human growth hormone intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency. The target Prescription Drug User Fee Act action date for decision by the FDA is October 2021. In addition, a New Drug Application was submitted to the Ministry of Health, Labour, and Welfare in Japan for somatrogon. Pfizer remains on schedule with respect to its regulatory submission for marketing approval of somatrogon in Europe in the first quarter of this year. The U.S. Food and Drug Administration (FDA) accepted for filing the initial Biologics License Application for somatrogon, a long-acting human growth hormone intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency. The target Prescription Drug User Fee Act action date for decision by the FDA is October 2021. In addition, a New Drug Application was submitted to the Ministry of Health, Labour, and Welfare in Japan for somatrogon. Pfizer remains on schedule with respect to its regulatory submission for marketing approval of somatrogon in Europe in the first quarter of this year. RAYALDEE has received marketing authorizations in 11 European countries. Vifor Fresenius Medical Care Renal Pharma, OPKO’s commercial partner for RAYALDEE in Europe, has received marketing authorizations for RAYALDEE for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency in 11 European countries, adding Spain, Portugal, Italy and Switzerland to previously announced approvals in the United Kingdom, Germany, Sweden, Norway, Ireland, Denmark and the Netherlands. Market launch of RAYALDEE in authorized countries is expected later this year. Fourth Quarter Financial Results Net income for the fourth quarter of 2020 was $32.3 million, or $0.05 per diluted share, compared with a net loss of $112.4 million, or $0.18 per share, for the comparable period of 2019. Consolidated revenues for the fourth quarter of 2020 were $494.6 million compared with $224.3 million for the comparable period of 2019. Diagnostics: Revenue from services in the fourth quarter of 2020 increased to $457.9 million from $177.9 million in the prior-year period, due to COVID-19 testing volume, partially offset by lower clinical test volume reflecting the negative impact of the pandemic and by reduced clinical and genomic test reimbursement. Total costs and expenses were $388.0 million in the fourth quarter of 2020 compared with $223.4 million in the fourth quarter of 2019, resulting in operating income of $69.9 million compared with an operating loss of $45.4 million in the 2019 period. The increase in operating income of $115.3 million reflects increased volumes as a result of COVID-19 testing and a non-cash impairment charge of $38.7 included in the 2019 period for goodwill and intangible assets related to the acquisition of Claros. Revenue from services in the fourth quarter of 2020 increased to $457.9 million from $177.9 million in the prior-year period, due to COVID-19 testing volume, partially offset by lower clinical test volume reflecting the negative impact of the pandemic and by reduced clinical and genomic test reimbursement. Total costs and expenses were $388.0 million in the fourth quarter of 2020 compared with $223.4 million in the fourth quarter of 2019, resulting in operating income of $69.9 million compared with an operating loss of $45.4 million in the 2019 period. The increase in operating income of $115.3 million reflects increased volumes as a result of COVID-19 testing and a non-cash impairment charge of $38.7 included in the 2019 period for goodwill and intangible assets related to the acquisition of Claros. Pharmaceuticals: Revenue from products in the fourth quarter of 2020 was $30.8 million compared with $32.0 million in the fourth quarter of 2019, primarily attributable to a decline in sales of Rayaldee, which were negatively impacted by challenges in onboarding new patients due to the intensified COVID-19 pandemic, offset by an increase in sales from OPKO Chile. Total prescriptions of Rayaldee for the fourth quarter of 2020 decreased to approximately 15,000, compared with approximately 17,900 for the fourth quarter of 2019. Revenue from the transfer of intellectual property was $5.9 million in the fourth quarter of 2020 compared with $14.4 million in the fourth quarter of 2019, reflecting a decrease in the amortization of payments received from Pfizer with respect to somatrogon. Total costs and expenses were $45.7 million in the fourth quarter of 2020 compared with $103.2 million in the prior-year period, which included a non-cash impairment charge of $53.1 million for goodwill and intangible assets related to the acquisitions of CURNA and Transition Therapeutics. The operating loss was $9.0 million in the fourth quarter of 2020 compared with $56.8 million in the fourth quarter of 2019. Revenue from products in the fourth quarter of 2020 was $30.8 million compared with $32.0 million in the fourth quarter of 2019, primarily attributable to a decline in sales of Rayaldee, which were negatively impacted by challenges in onboarding new patients due to the intensified COVID-19 pandemic, offset by an increase in sales from OPKO Chile. Total prescriptions of Rayaldee for the fourth quarter of 2020 decreased to approximately 15,000, compared with approximately 17,900 for the fourth quarter of 2019. Revenue from the transfer of intellectual property was $5.9 million in the fourth quarter of 2020 compared with $14.4 million in the fourth quarter of 2019, reflecting a decrease in the amortization of payments received from Pfizer with respect to somatrogon. Total costs and expenses were $45.7 million in the fourth quarter of 2020 compared with $103.2 million in the prior-year period, which included a non-cash impairment charge of $53.1 million for goodwill and intangible assets related to the acquisitions of CURNA and Transition Therapeutics. The operating loss was $9.0 million in the fourth quarter of 2020 compared with $56.8 million in the fourth quarter of 2019. Cash and equivalents: Cash, cash equivalents and marketable securities were $72.2 million as of December 31, 2020. In addition, the Company has availability under its present line of credit with JP Morgan of $57.6 million and an unutilized $100 million credit facility that provides access to incremental capital on a non-dilutive basis. CONFERENCE CALL & WEBCAST INFORMATION OPKO’s senior management will provide a business update, discuss fourth quarter financial results and answer questions during a conference call and live audio webcast at 4:30 p.m. Eastern time today, February 18, 2021. Participants are requested to pre-register for the conference call using the link here, or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 8597848. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call. To access the live call via webcast, please click on the link OPKO 4Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast. For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 4Q20 Results Conference Call. A telephone replay will be available beginning approximately two hours after the completion of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 8597848. About OPKO Health OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit . Cautionary Statement Regarding Forward Looking Statements This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, expectations about COVID-19 testing, the demand for testing, our capacity for testing, the impact of COVID-19 on all of our businesses, positively and negatively, our ability to expand our capacity should there be additional demand, the availability of resources, including labor, equipment and supplies, to meet demand for testing and the potential impact on us should these resources be constrained, our product development efforts and the expected benefits of our products, whether our products in development will be commercialized, the possibility of further analyses of existing clinical data, the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities, whether regulatory authorities will be satisfied with the design of and results from our clinical studies, whether RAYALDEE prescriptions will increase, our ability to market and sell any of our products in development, GeneDx’s test offerings and the effectiveness and utility of its ataxias tests, BioReference's Scarlet Health mobile service, the availability of and demand for the service, whether the service and the integrated platform will function or perform as designed, the role and value of the service to patients and healthcare providers and whether the demand for at home health care will continue or increase as anticipated, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading “Risk Factors” in our other filings with the Securities and Exchange Commission, as well as the ongoing effects of the COVID-19 pandemic, the continuation and success of our relationship with Pfizer, Vifor and our other partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that somatrogon, RAYALDEE, and/or any of our compounds or diagnostic products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications proposed or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. Contacts: LHA Investor Relations Yvonne Briggs, 310-691-7100 ybriggs@lhai.com or Bruce Voss, 310-691-7100 bvoss@lhai.com OPKO Health, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (in millions) Unaudited OPKO Health, Inc. and Subsidiaries Condensed Consolidated Statements of Operations (in millions, except share and per share data) Unaudited

CALGARY, ALBERTA--(Marketwire - April 9, 2009) - Stem Cell Therapeutics Corp. ("SCT") (TSX VENTURE:SSS) today announced its financial results for the period ended December 31, 2008. Operating Highlights from 2008 and the period ending April 9, 2009: - Received 'May Proceed' notification from the FDA for its Phase IIb clinical stroke trial and IND in April 2008 - Enrolled first patient in the Canadian REGENESIS Phase IIb stroke trial, announced May 2008 - Completed animal efficacy study for Multiple Sclerosis - Completed traumatic brain injury animal study comparator - Received positive review from the Data Safety & Monitoring Board to continue progress of the REGENESIS Phase IIb clinical stroke trial, September 2008 - Received 'No Objection Letter' from Health Canada for a Traumatic Brain Injury Trial, September 2008 - Received Letter from Health Canada and Verbal Request from the FDA to place a clinical hold on the REGENESIS Phase IIb stroke trial in Canada; triggered by an unrelated German study, September 2008 - Announced final payment in common shares to Transition Therapeutics Inc. to complete the intellectual property acquisition of Stem Cell Therapeutics Inc., October 2008 - Appointed Mr. Barry Herring as Chief Financial Officer and VP, Finance, January 2009 - Presented positive final results for the BETAS Phase IIa clinical safety study in stroke in February 2009, including all U.S. and Canadian patient data 2009 Objectives - Receive FDA approval to proceed with REGENESIS or alternate strategy for the Phase IIb stroke trial; Q2 09 - Complete REGENESIS Phase IIb clinical stroke study; Q4 09 - Initiate and enrol patients in the U.S. IND approved Phase IIb clinical stroke study; H1 09 - Initiate and enrol patients in the Phase IIa clinical study for Traumatic Brain Injury; H2 09 - Initiate clinical Proof-of-Concept study for Multiple Sclerosis; H2 09 Dr. Alan Moore, President & CEO of SCT commented as follows: "Looking back at 2008, the Company faced both exciting and trying times, all of which are part of drug development. We are looking forward to 2009 as being a clinically productive year." Capital Position As of December 31, 2008, the working capital (current assets minus current liabilities) of the Company was $5,803,377 ($9,138,263 as of December 31, 2007). Outstanding securities as of December 31, 2007 totaled 132,802,497 common shares, 25,912,500 common share purchase warrants and 7,481,103 common share options. Financial Review The Company's loss for the year ended December 31, 2008 increased by $105,936 to $5,559,517 ($0.05 per common share) from the loss of $5,453,581 ($0.08 per common share) reported for the year ended December 31, 2007. The primary reason for the increase in loss was an increase in research and development and professional fees. The increase in these expenses was partially offset by the increase in foreign exchange gains, and interest income, as well as lower interest expense and general and administration expenses. About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX-V: SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient's own resident stem cells. The Company's programs aim to repair neurological function lost due to disease or injury. SCT's extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases such as traumatic brain injury, multiple sclerosis, Huntington's disease, Alzheimer's disease, and ALS. For further information on Stem Cell Therapeutics Corp., visit These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any state, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons unless an applicable exemption from U.S. registration requirements is available. Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.