Equifax Appoints Lena Bourgeois as Automotive General Manager

PR Newswire

ATLANTA, Nov. 17, 2020 /PRNewswire/ — Equifax (NYSE: EFX) has named Lena Bourgeois as automotive general manager, responsible for driving customer value and accelerating company growth in the automotive market. Bourgeois brings a strong background in data and information technology systems to the position, critical as automotive dealers and lenders embrace a digital automotive experience and navigate a challenging economic environment.

“Lena has successfully led our Equifax automotive Enterprise Alliances for the last four years, working to grow our partner network and augment our robust portfolio of auto services and solutions,” said Joy Wilder Lybeer, United States Information Solutions (USIS) Chief Revenue Officer and Senior Vice President of Global Partnerships at Equifax. “We are committed to helping automotive dealers and lenders navigate today’s COVID-19 economy. Under Lena’s leadership, the Equifax automotive business is well positioned to help OEM, dealer and finance partners obtain the smarter insights they need to not only take action today, but to plan for a successful future.”

Bourgeois has held senior management positions within Equifax for nearly a decade. Prior to joining the Equifax Automotive team, she served as vice president of consumer markets for the Equifax IXI Network, where she led business development in the automotive, communications, insurance, restaurant, retail and travel/leisure industries. Bourgeois also held senior sales and business development roles with Nielsen and Claritas.

“Today’s automotive industry is as much about data, analytics and technology as it is about innovative vehicle designs,” said Bourgeois. “Equifax has positioned itself at the center of the digital automotive experience. I am truly excited about leading a team of dedicated automotive professionals committed to providing the best solutions for our customers and partners looking for a customer journey built on trust, satisfaction and growth.”

Bourgeois holds a bachelor’s degree in International Business and Marketing from Jönköping International Business School. She received a master’s degree in International Business from McGill University.

ABOUT EQUIFAX INC.

At Equifax (NYSE: EFX), we believe knowledge drives progress. As a global data, analytics, and technology company, we play an essential role in the global economy by helping financial institutions, companies, employees, and government agencies make critical decisions with greater confidence. Our unique blend of differentiated data, analytics, and cloud technology drives insights to power decisions to move people forward. Headquartered in Atlanta and supported by more than 11,000 employees worldwide, Equifax operates or has investments in 25 countries in North America, Central and South America, Europe, and the Asia Pacific region. For more information, visit Equifax.com

 

FOR MORE INFORMATION

Kate Walker for Equifax USIS
[email protected]

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SOURCE Equifax Inc.

Praxis Precision Medicines Provides Update On PRAX-114 IND Submission For The Treatment Of Major Depressive Disorder

– Praxis expects to initiate Phase 2/3 clinical trial for PRAX-114 in MDD in 1H21 –

CAMBRIDGE, Mass., Nov. 17, 2020 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance, today announced that it has received comments from the U.S. Food and Drug Administration (FDA) on the full clinical hold of its Investigational New Drug (IND) submission for PRAX-114 for the treatment of major depressive disorder (MDD).

The IND for PRAX-114 was placed on clinical hold by the FDA pending the resolution of certain non-clinical pharmacology and toxicology matters. In its comment letter, the FDA proposed that the Company conduct further toxicological investigation of the effect of PRAX-114 and its metabolites on fertility, reproduction, and embryofetal development to support the planned trial. The Company believes that the results of its ongoing standard fertility and reproductive studies, expected to be completed in the first quarter of 2021, together with the available toxicology package will satisfy the FDA request. The FDA also requested updates to the Investigator’s Brochure and to the requirements for contraception in the protocol.

The Company now expects to initiate the randomized, placebo-controlled Phase 2/3 clinical trial for PRAX-114 in MDD in the first half of 2021. The Company is in dialogue with the FDA and intends to explore potential options to accelerate the initiation of the Phase 2/3 clinical trial.

About Praxis

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Praxis is applying insights into the genetic mutations that drive excitation-inhibition imbalance in diseases to select biological targets for severe pediatric epilepsies and more broadly for prevalent psychiatric diseases and neurologic disorders. Praxis has established a broad portfolio, including five disclosed programs across multiple central nervous system disorders including, depression, epilepsy, movement disorders and pain syndromes, with three clinical-stage product candidates.

Cautionary Statement 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 the Company’s expectations regarding the timing in which it will receive additional communications regarding the clinical hold on its IND submission for PRAX-114 from the FDA. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “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 timing and outcome of the Company’s planned interactions with regulatory authorities, including resolution of the current PRAX-114 clinical hold; the timing and anticipated results of our current preclinical studies and future clinical trials, strategy and future operations; the impact of COVID-19 on countries or regions in which we have operations or do business; the delay of any current preclinical studies or future clinical trials or the development of Praxis’ drug candidates; the risk that the results of current preclinical studies may not be predictive of future results in connection with future clinical trials; Praxis’ ability to successfully demonstrate the safety and efficacy of its drug candidates; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Praxis’ final prospectus related to its initial public offering, dated October 20, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Praxis’ subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Praxis’ views only as of today and should not be relied upon as representing its views as of any subsequent date. Praxis explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

 



Investor Contact:
Alex Kane
[email protected]
617-300-8481

Media Contact:
Ian Stone
[email protected]
619-849-5388

NASA Unveils New Research Progress for Human Mission to the Moon With Supercomputer Powered by Hewlett Packard Enterprise

NASA Unveils New Research Progress for Human Mission to the Moon With Supercomputer Powered by Hewlett Packard Enterprise

NASA’s Aitken supercomputer provides powerful modeling and simulation capabilities to support critical research for a safe and successful spaceflight for the next return-to-moon by 2024

SAN JOSE, Calif.–(BUSINESS WIRE)–Hewlett Packard Enterprise (HPE) today announced that NASA highlighted new research progress to support the next human landing on the moon by performing complex simulations on NASA’s Aitken supercomputer, which is powered by HPE. New research, which includes understanding the booster separation event and launch environment at Kennedy Space Center during lift-off, will help NASA’s engineers prepare for a safe and successful spaceflight as part of NASA’s Artemis mission set to launch in 2024.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201117005344/en/

NASA’s Modular Supercomputing Facility, where its Aitken supercomputer is housed, at NASA’s Ames Research Center in Mountain View, California. Image credit: NASA Ames Research Center

NASA’s Modular Supercomputing Facility, where its Aitken supercomputer is housed, at NASA’s Ames Research Center in Mountain View, California. Image credit: NASA Ames Research Center

HPE also announced today that it expanded NASA’s Aitken supercomputer with HPE Apollo systems that are purpose-built for compute-intensive modeling and simulation needs. The expansion of computational power, which will be operational in January 2021, supports NASA’s ongoing research involving computational fluid dynamics (CFD) that are critical to understanding aerodynamic events.

“At HPE, we are inspired by breakthroughs in scientific research that leverage our high-performance computing technologies. The researchers and engineers at NASA’s Ames Research Center continue to push boundaries to advance space flight,” said Bill Mannel, vice president and general manager, HPC, at HPE. “We are honored to continue collaborating with NASA and play a role in a historical moment by further expanding NASA’s Aitken supercomputer with HPE Apollo systems to accelerate time-to-insight and safely land the first woman and the next man on the moon.”

NASA’s Aitken Supercomputer Increases Computational Power and Drives Efficiency

NASA’s Modular Supercomputing Facility, where its Aitken supercomputer is housed, at NASA’s Ames Research Center in Mountain View, California

NASA’s Aitken supercomputer was built by HPE in August 2019 to support NASA missions, including research for the Artemis program, a mission to land the first woman and next man on the lunar South Pole region by 2024.

NASA’s Aitken is housed in the first of 12 computer modules in the Modular Supercomputing Facility (MSF), jointly developed by NASA and HPE, to drive greater efficiency and significantly reduce electricity and water use. As a result, NASA’s Aitken supercomputer, during its first year of operation, consumed only 16% of the energy needed for cooling, saving over $100K in costs and 1.4 million kilowatt-hours. It also reduced water usage, used to cool the supercomputer, by 91%, saving over one million gallons of water per day.

The supercomputer will expand with HPE Apollo systems using 2nd Gen AMD EPYC processors to provide advanced compute power to support ongoing research.

NASA’s Aitken Supercomputer Advances Research Progress for Return-to-Moon Mission

NASA’s Aitken supercomputer has already helped researchers make progress for the Artemis mission in the following areas:

Develop an Aerodynamic Database for Possible Events during the Artemis Booster Separation

NASA’s engineers need to understand possible events that could occur during booster separation from the core of the Artemis rocket during liftoff, which is critical to the safety of the crew and success of the mission. NASA considers the possibilities that the two solid rocket boosters (SRBs), developed for the mission, will strike the core center or each other during the separation event.

To simulate and model all variables during separation events during the Artemis mission, NASA has developed a database of aerodynamic data to showcase possible positioning of the boosters during separation. By applying computational fluid dynamics (CFD) tools using NASA’s Aitken supercomputer and accounting for 22 different engine rocket plumes, which are moving hot exhaust gases, researchers were able to develop a database of 13 independent variables to model all possible in-flight events during booster separation. The project can be viewed here.

The expansion to NASA’s Aitken supercomputer will enable even more detailed and comprehensive databases to improve accuracy in analysis for a safer flight.

Understanding the Launch Environment at the Kennedy Space Center

The Artemis mission is set to launch at the Kennedy Space Center in Merritt Island, Florida. NASA’s researchers need to understand the effects of ignition overpressure (IOP) and duct overpressure (DOP) waves that are caused by the rapid expansion of gas from the rocket nozzle during launch.

NASA’s Launch, Ascent, and Vehicle Aerodynamics (LAVA) team has been using NASA’s Aitken supercomputer to apply computational fluid dynamics (CFD) to simulate these waves and how they interact with the launch vehicle to examine any potential dangers to the mission.

The ongoing analysis helps NASA’s engineers make advancements to the design of the launch environment. With the expanded Aitken supercomputer, researchers will gain additional compute power to further improve time-to-solution for the launch pad redesign to accommodate the Space Launch System. The project can be viewed here.

To learn more about NASA’s research progress and view simulations, please visit https://www.nas.nasa.gov/SC20/home.html

To learn more about HPE’s supercomputing solutions, please visit: https://www.hpe.com/us/en/compute/hpc/supercomputing.html

About Hewlett Packard Enterprise

Hewlett Packard Enterprise is the global edge-to-cloud platform-as-a-service company that helps organizations accelerate outcomes by unlocking value from all of their data, everywhere. Built on decades of reimagining the future and innovating to advance the way we live and work, HPE delivers unique, open and intelligent technology solutions, with a consistent experience across all clouds and edges, to help customers develop new business models, engage in new ways, and increase operational performance. For more information, visit: www.hpe.com.

  1. NASA’s research progress using its Aitken supercomputer is based on the first deployment of the HPE SGI 8600

AMD, the AMD Arrow logo, EPYC and combinations thereof are trademarks of Advanced Micro Devices, Inc

Editorial contact

[email protected]

Nahren Khizeran, HPE

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Science Software Research Hardware Data Management Technology Aerospace Manufacturing

MEDIA:

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The Launch Complex 39B at Kennedy Space Center (KSC) shows a simulation of exhaust gas flow from the Space Launch System (SLS) during launch. Image credit: NASA Ames Research Center
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NASA’s Modular Supercomputing Facility, where its Aitken supercomputer is housed, at NASA’s Ames Research Center in Mountain View, California. Image credit: NASA Ames Research Center
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Artemis-II vehicle view with simulating boosters that are 75 feet downstream of their stowed position. Image credit: NASA Ames Research Center

Skanska builds new infrastructure at Los Angeles International Airport, California, USA, for USD 335 M, about SEK 2.9 billion

PR Newswire

ÖSTERSUND, Sweden, Nov. 17, 2020 /PRNewswire/ — Skanska has signed a contract with Los Angeles World Airports (LAWA) to serve as the design-builder for the airport authority’s Roadways, Utilities and Enabling (RUE) project. The contract is worth USD 335 M, about SEK 2.9 billion, which will be included in the US order bookings for the fourth quarter of 2020.

The RUE project supports the next phase of high-priority enabling work for LAWA’s Landside Access Modernization Program (LAMP), which aims to relieve congestion for people traveling to and from the third busiest airport in the world and second busiest in the U.S. This enabling work is critical for advancing LAMP projects including the Automated People Mover (APM), Consolidated Rent-A-Car (ConRAC) facility and Intermodal Transportation Facility (ITF)-West.   

Construction begins in Q4 2020 with completion expected in Q4 2025. Arup is the lead designer.

Skanska is one of the leading construction and development companies in USA, specializing in building construction, civil infrastructure and developing commercial properties in select U.S. markets. Skanska USA had sales of SEK 74 billion and about 7,900 employees in its operations in 2019.

For further information please contact:

Yena Williams, Communications Director, Skanska USA, tel +1 213-514-2918

Olof Rundgren, Media Relations Manager, Skanska AB, tel +46 (0)10 448 67 94

Direct line for media, tel +46 (0)10 448 88 99

This and previous releases can also be found at

www.skanska.com
.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/skanska/r/skanska-builds-new-infrastructure-at-los-angeles-international-airport–california–usa–for-usd-335,c3238119

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20201117 US infrastructure airport LA

 

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SOURCE Skanska

Mogo Expands Into Global B2B Fintech Market with Acquisition of Digital Payments Technology Company Carta Worldwide

Mogo Expands Into Global B2B Fintech Market with Acquisition of Digital Payments Technology Company Carta Worldwide

Transformational deal combines leading Canadian fintech with over 1 million members with next-gen payments technology platform that processed over $4.0 billion in transaction volume in 2019

Adds B2B payments platform addressing the $2.5 trillion global payments market1, with over 85% of Carta revenue generated from International markets outside of Canada

All-stock transaction with no shares distributed to Carta shareholders until the earlier of Mogo’s 10-day vwap on the TSX reaching $7.45 or December 2021

All figures in Canadian $

VANCOUVER, British Columbia–(BUSINESS WIRE)–Mogo Inc. (TSX:MOGO) (NASDAQ:MOGO) (“Mogo” or the “Company”), a financial technology company focused on empowering consumers with innovative digital financial solutions that help them get in control of their financial health, today announced it has reached a definitive agreement (the “Agreement”) to acquire Carta Solutions Holding Corporation, also known as Carta Worldwide (“Carta”), a leader in providing next-gen digital payments solutions, in an all-stock transaction by way of a plan of arrangement (the “Transaction”). The combination creates one of Canada’s largest vertically integrated fintech companies and significantly expands the Company’s addressable market by entering into the $2.5 trillion global digital payments market.

Carta’s modern issuing platform is the engine behind innovative fintech companies and products around the globe, powering over 100 card programs and providing vital processing technology to industry leaders including TransferWise, Sodexo, Payfare, and others. Founded in 2007, Carta’s management team has decades of payments and technology industry experience. Carta is currently operating in Europe, Asia and Canada and recently expanded into the U.S. market. Carta, which has 70 employees, generated approximately $8.5 million of revenue in 2019, over 85% of which was from international markets outside of Canada.

Management Commentary

“Carta has created award-winning digital transaction processing technologies for the fast-growing market for next-generation payments programs, and we’re thrilled to add them to the Mogo platform,” said David Feller, Mogo’s Founder and CEO. “By using Carta’s payment processing engine, we expect to enhance Mogo’s digital wallet capabilities which includes the development of our upcoming peer-to-peer payment solution, and – when combined with our digital front-end capabilities – we see great opportunity to power the next generation of platforms globally.”

Peter Kaju, CEO of Carta, commented: “We’re excited to be combining with one of the pioneers in fintech and a leader in Canada. We see tremendous opportunity to accelerate the growth of our respective businesses by combining resources and capabilities.”

Greg Feller, President and CFO of Mogo, added: “This transformational transaction further enhances Mogo’s position as one of Canada’s leading fintech companies, accelerates the growth of our subscription & transaction-based revenue, and expands Mogo’s TAM into the $2.5 trillion global payments business. With the sale earlier this year of our consumer instalment loan portfolio, along with the recent launch of our MogoSpend account, referral partnerships and upcoming launch of our P2P payments platform, the Carta transaction further positions Mogo for accelerating revenue growth in 2021. In addition, as we continue to expand our platform and leadership position, we expect to evaluate additional technology and product acquisition opportunities going forward.”

Strategic Rationale & Transaction Highlights

  • Accelerates Mogo’s transformation to a broader digital wallet and payments technology business: Following the completion of the transaction, Mogo will integrate Carta’s transaction processing technology with its current MogoSpend product (which comes with a Mogo Visa* Platinum Prepaid Card). Mogo will also leverage Carta’s technology and capabilities to launch its previously announced mobile peer-to-peer payment solution (targeted for H1 2021).
  • Provides Carta with the ability to cross-sell Mogo’s front-end digital platform to provide enhanced value to customers: Adding Mogo’s mobile-first digital platform and app to Carta’s digital transaction processing platform, creates a powerful, vertically integrated offering for Carta’s fintech, bank and corporate clients that are issuing innovative payment solutions.
  • Increased revenue scale, diversification, and entry into the global B2B fintech market: The acquisition of Carta adds scale and diversification to Mogo’s high-margin subscription and services revenue and provides entry to the B2B fintech market. In 2019, Carta generated approximately $8.5 million of payments & transaction revenue from corporate customers. In 2019, both Mogo and Carta were named among Canada’s Top 50 FinTech Companies by the Digital Finance Institute.
  • Global reach and increased addressable market: Together, the companies will have a presence in over 40 countries and target a$2.5 trillion addressable market. More than 85% of Carta’s revenue comes from outside Canada. including Europe and Asia, along with its recent expansion into the massive U.S. payments market.
  • Highly supportive management teams and aligned shareholder base: Carta’s senior management, board members, and key outside shareholders, representing more than 60% of each class of Carta’s outstanding securities, have entered into voting and support agreements. On closing, Chris Payne, Carta’s lead director, is expected to join Mogo’s board of directors and Carta’s executive team will continue to run the operations as part of Mogo. The executive team and shareholders of Carta are highly aligned and incentivized to drive shareholder value, with 100% of the consideration going into a limited partnership and no shares will begin to be distributed to Carta shareholders, including management, before the earlier of (i) 10-day volume-weighted average price of common share of Mogo (“Mogo Shares”) on the TSX being equal to $7.45 per share or higher or (ii) December 2021 (refer to ‘Terms of the Transaction’).

Terms of the Transaction

Under the terms of the Agreement, Mogo will acquire 100% of the outstanding shares of Carta in exchange for the issuance of 10 million common shares (“Mogo Shares”), which is equal to a purchase price of $24.2 million based on the closing price of the Mogo Shares on the TSX on November 16, 2020. These shares will go into a limited partnership that will not begin to be distributed to current Carta shareholders, including management, until the earlier of the 10-day volume-weighted average price of Mogo Shares on the Toronto Stock Exchange being equal to (i) $7.45 per share or higher or (ii) December 2021. On a Pro Forma basis, Carta shareholders will own approximately 18% of Mogo’s fully diluted shares.

The proposed Transaction will be completed pursuant to a plan of arrangement under the Canada Business Corporations Act, which will require court approval and the approval of not less than 2/3 of the holders of each class of Carta securities. Pursuant to the requirements of the TSX, the Transaction will need to be approved by 50% of the votes cast by Mogo shareholders at a special meeting of shareholders, which is expected to be held in January 2021. An information circular detailing the terms and conditions of the Transaction will be filed with regulatory authorities and mailed to the shareholders of Mogo in accordance with applicable securities laws. The Transaction will also be subject to regulatory approvals, in addition to other customary closing conditions, and is expected to close in the first quarter of 2021. The Arrangement Agreement includes customary deal-protection provisions, including non-solicitation of alternative transactions and break fees payable by Mogo and Carta, respectively, under certain circumstances.

Mogo’s Board of Directors have determined that the proposed transaction is in the best interest of the shareholders and have unanimously approved the Transaction. Mogo’s Board of Directors recommends that their shareholders vote in favor of the proposed transaction.

* Trademark of Visa International Service Association and used under licence by Peoples Trust Company. Mogo Visa Platinum Prepaid Card is issued by Peoples Trust Company pursuant to licence by Visa Int. and is subject to Terms and Conditions, visit mogo.ca for full details. Your MogoCard balance is not insured by the Canada Deposit Insurance Corporation (CDIC). MogoSpend is only available to MogoMembers with an activated MogoCard. MogoCard means the Mogo Visa Platinum Prepaid Card.

1McKinsey & Company, Global Banking Practice, “The 2020 McKinsey Global Payments Report”. October 2020.

About Mogo

Mogo — a financial technology company — offers a finance app that empowers consumers with simple solutions to help them get in control of their financial health and be more mindful of the impact they have on society and the planet. We all know it’s time to do things differently. It’s time for a new way to manage our money, one that’s inclusive and sustainable. One that takes into account our financial health, the planet’s health and the health of our society. At Mogo, users can sign up for a free account in only three minutes and begin to learn the 4 habits of financial health and get convenient access to products that can help them achieve their financial goals and have a positive impact on the planet including a digital spending account with Mogo Visa* Platinum Prepaid Card featuring automatic carbon offsetting, free monthly credit score monitoring, ID fraud protection and personal loans. Members can also easily buy and sell bitcoin 24/7 through the Mogo app, as well as participate in Mogo’s new bitcoin rewards program. The Mogo platform has been purpose-built to deliver a best-in-class digital experience, with best-in-class products all through one account. With more than one million members and a marketing partnership with Canada’s largest news media company, Mogo continues to execute on its vision to gamify financial health and become the go-to financial app for the next generation of Canadians. To learn more, please visit mogo.ca or download the mobile app (iOS or Android).

Mogo Cautionary Statement

This news release may contain “forward-looking statements” that relate to Mogo’s current expectations and views of future events. In some cases, these forward-looking statements can be identified by words or phrases such as “may”, “might”, “will”, “expect”, “anticipate”, “estimate”, “intend”, “plan”, “indicate”, “seek”, “believe”, “predict” or “likely”, or the negative of these terms, or other similar expressions intended to identify forward-looking statements. Mogo has based these forward-looking statements on its current expectations and projections about future events that it believes might affect its financial condition, results of operations, business strategy and financial needs. These forward-looking statements include, among other things, statements relating to completion of the Transaction, receipt of required shareholder and regulatory approvals for the Transaction, court approval of the Arrangement, the holding of the Mogo shareholder meeting and the mailing of the Mogo circular.

Forward-looking statements are based on certain assumptions and analyses made by Mogo in light of the experience and perception of historical trends, current conditions and expected future developments and other factors it believes are appropriate and are subject to risks and uncertainties. Although we believe that the assumptions underlying these statements are reasonable, they may prove to be incorrect, and we cannot assure that actual results will be consistent with these forward-looking statements. Given these risks, uncertainties and assumptions, any investors or users of this document should not place undue reliance on these forward-looking statements.

The forward-looking statements made in this news release relate only to events or information as of the date of this news release and are expressly qualified in their entirety by this cautionary statement. Except as required by law, we do not assume any obligation to update or revise any of these forward-looking statements to reflect events or circumstances after the date of this news release, including the occurrence of unanticipated events. An investor should read this news release with the understanding that our actual future results may be materially different from what we expect.

Craig Armitage

Investor Relations

[email protected]

(416) 347-8954

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Professional Services Environment Technology Other Technology Software Finance Banking

MEDIA:

Todos Medical Announces Clinical Validation and National CLIA Certification for MOTO+PARA Mobile High Complexity Labs

NEW YORK, NY, TAMPA, FL and BATON ROUGE, LA, Nov. 17, 2020 (GLOBE NEWSWIRE) — via NewMediaWire Todos Medical (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening and diagnosis, and developing blood tests for the early detection of cancer and Alzheimer’s disease, today announced the completion of clinical validation and CLIA certification for MOTO+PARA’s mobile lab. The Company’s mobile CLIA lab partner, Integrated Health LLC, has fully validated the clinical performance of the proprietary COVID-19 RT-PCR laboratory testing process performed in MOTO+PARA’s Mobile High Complexity Labs built to biosafety level 3 (BSL3), and has received the approval needed to begin offering COVID-19 screening and analysis as a service to clients anywhere in the United States. Rapid antigen and antibody testing also have been validated and are now ready to be deployed. MOTO+PARA is prepared to accept contracts from prospective clients immediately.

“We are thrilled to begin testing anywhere in the United States and worldwide with our first-of-their-kind mobile labs,” said Eric Canonico, CEO of MOTOPARA Foundation. “With the recent surge of COVID-19 cases, the upcoming holidays predicted to further drive case counts, and the need to pair COVID-19 testing with other tests and emerging vaccination programs, our highly scalable mobile lab solutions are exactly what is needed to address the challenges COVID-19 has placed on existing testing infrastructure. MOTO+PARA is prepared to deploy rapid antigen and antibody tests in addition to diagnostic testing with our onsite RT-PCRs, which can turn results around in as little as 4 hours.”

“We are confident that the validations we have completed and the systems we have implemented will enable high scalability for our mobile labs,” said Jeff Faucheaux, CEO of Integrated Health. “Being able to bring these all-encompassing COVID-19 testing solutions directly to the people will improve the end-to-end testing experience for the patient. This allows us to significantly reduce turnaround times for PCR testing and improve the value of each test we provide because the results will be available more quickly than with traditional lab methodologies.”

“The strategy of deploying all available testing solutions in the nation’s first high complexity mobile labs allows us to assist MOTO+PARA in designing COVID-19 surveillance programs that will meet the diverse needs of different constituents who need access to testing for a myriad of use cases that have emerged since the pandemic began,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Whether it is making highly sensitive PCR testing available to government entities with turnaround times fast enough to dramatically reduce infection risk, screening fans before entering a stadium for sporting events, or supporting disaster relief efforts to ensure emergency responders are working in a COVID-free environment, we believe these mobile labs are the solution to many of the nation’s testing challenges. This distribution channel will also allow us to rapidly commercialize emerging novel COVID-19 lab-based testing and monitoring technologies we expect to come to market in the months ahead. “

For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid19.com

For testing and PPE inquiries, please email [email protected] .

About MOTOPARA Foundation, Inc.

MOTOPARA Foundation, Inc. dba MOTOPARA Foundation™, MOTOPARA™ and MOTO+PARA™ is based in Tampa, Florida, USA, as a not-for-profit corporation incorporated in 2010 as a 501(c)(3), non-profit Private Operating Foundation (POF) under the U.S. Internal Revenue Code. MOTOPARA Foundation serves as an non-governmental organization (NGO) dedicated to the research, development, education and implementation of mobility logistics for Global Disaster First Response™, and healthy sustainable lives connected with sciences, technology, engineering, arts and math, and the professions encompassing such sustainable and renewable resources both domestically and internationally.

MOTO+PARA™ is a neutral nonpartisan NGO providing an elite, asset-based logistics and mobility solution for search and rescue (SAR), reconnaissance (RECON), disaster response and humanitarian relief. It assists fellow NGOs, government agencies and foreign nations in rapid response and secure transport of personnel, supplies, and victims of urgent emergencies and disasters. MOTO+PARA employs full-time Veteran Special Operations Operators and Veterans of Special Operations Support and Logistics Operations who perform mission critical responses utilizing the extensive training and experience gained from their Military service. MOTO+PARA responds by air, sea, and land to get to “ground zero” of a crisis anywhere in the world, using equipment to clear paths and push through to disaster sites while also providing coordinated communications support, power, water, and protection.

MOTO+PARA’s COVID-19 Response is part of its Biological Protective Services & Response Division, which can serve countries around the world with its Mobile High Complexity Laboratories built to BSL-3 specifications, developed jointly with Integrated Health LLC.

www.motopara.org

About Integrated Health LLC

Integrated Health LLC, based in Baton Rouge, Louisiana, USA, is a health management solutions company with a mobile medical laboratory division that is the first CLIA-certified high complexity mobile laboratory built to BSL-3 specification in the western hemisphere. Integrated Health specializes in ensuring all communities have access to testing and laboratory services, whether urban, rural or extreme remote locations domestically and internationally. Integrated Health’s goal is to become the most innovative and biologically diverse company in the world, and offers an extensive array of testing to meet any community’s diagnostics testing needs.

www.integrated-health.com

About Todos Medical Ltd.

Headquartered in Rehovot, Israel, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company’s state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer’s influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos’ two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe. Todos recently entered into an exclusive option agreement to acquire U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista’s proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the third quarter of 2020.

Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer’s disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer’s disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.

Additionally, Todos has entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The agreements cover multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory in the United States. Todos has formed strategic partnerships with Integrated Health LLC, and MOTOPARA Foundation to deploy mobile COVID-19 testing and lab analysis in the United States.

For more information, please visit https://www.todosmedical.com/.

Forward-looking Statements

Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.

Todos Investor Contact:

Kim Sutton Golodetz

LHA Investor Relations

Senior Vice President

(212) 838-3777

[email protected]

Todos Corporate Contact:

Priyanka Misra

Todos Medical

(917) 983-4229 ext. 103

[email protected]

Media Contact:

Paula Angel-Jones

MOTOPARA Foundation

(813) 956-2458

[email protected]

Attachment



Zoomd Reports Q3 2020 Results: Quarterly revenue growth of 12% year-over-year and up 17% quarter-over-quarter while reaching the first development milestone in releasing its self-serve SaaS product

PR Newswire

VANCOUVER, British Columbia, Nov. 17, 2020 /PRNewswire/ — Zoomd Technologies Ltd. (TSXV: ZOMD) (OTC: ZMDTF) (https://www.zoomd.com) and its wholly-owned subsidiary Zoomd Ltd. (collectively, “Zoomd” or the “Company“), the marketing tech (MarTech) user-acquisition and engagement platform, today reported financial results for the threeand nine months ended September 30, 2020. The interim financial statements and interim MD&A are available on SEDAR under the Company’s profile.

 

Zoomd Logo

 

“Weare excited to return to revenue growth, as some sectors return and increased their marketing budgets” said Ofer Eitan, Zoomd’s CEO, adding “Furthermore, webeen successful in attracting new clients in sectors such as E-commerce and FinTech who havebenefitted from the COVID-19 pandemic. Based on our most recent results, we believe that the markets are in the midst of a recovery from the disruptions caused by the COVID-19 pandemic. The rebound is scaling with our existing customers is testament to the strong return on investment we provide them.

Mr. Eitan further noted that “We remain on track with regards to the release of our Self-serve SaaS product during Q4 2020, and a full-scale launch expected during 2021. We remain excited about the product given its high margin and scalability potential. In October, we released the first version of our Self-Serve SaaS product and are progressing towards second milestone on the product roadmap, betarelease to collect customer feedback, during Q1 2021. As such, during the third quarter we pushed and increased even more our investment in R&D, however we expect R&D expenses to decrease to normalized levels in 2021.”

Mr. Eitan concluded by stating that “We are more excited than ever about Zoomd’s growth prospects going forward. We continue to have high customer retention levels and in recent months, have accelerated new customer growth. We believe that our ability to reach and service customers will expand exponentially as we roll out our Self-Serve SaaS product. From a financial standpoint we remain strong, with no debt and a robust balance sheet.”



THIRD QUARTER 2020 HIGHLIGHTS (ALL FIGURES ARE IN US$)

  • Total revenue for the three months ended September 30, 2020 was $6.6 million compared to $5.9 million for the same period in 2019, an increase of 12%. The increase in revenues was primarily attributed to the increase in activity of existing customers and the Company penetrating into verticals that have benefitted from the COVID-19 pandemic, such as E-commerce and FinTech.
    As a result of the foregoing, quarter-over-quarter revenue growth was at 17%.
  • Cost of sales and services for the three months ended September 30, 2020 was $4.6 million, representing an increase of approximately 15% compared to the same period in 2019. The increase was primarily attributed to the increase in revenues.
  • Gross profit margin (revenue less cost of sales and services) of 31% compared to 32% for the same period in 2019. The decrease in gross margin was primarily attributable to increase in the sale of services that have lower margins relative to the other products and services offered by the Company. 
  • Net loss for the three months ended September 30, 2020 was $1.5 million compared to net loss of $2.7 million for the three months ended September 30, 2019. The decrease in net loss was primarily attributed to the expenses incurred during 2019 related to mark-to-market adjustment of convertible debt securities that took place immediately prior to the closing of the qualifying transaction.
  • Adjusted EBITDAof $(850) thousand for the three months ended September 30, 2020 compared to Adjusted EBITDA of $(380) thousand for the same period in 2019. The increase in the operating losses for the three months ended September 30, 2020 was primarily attributed to the Company’s growth plan causing an increase in research & development expenses due to the Company’s stages of developing the Company’s new Self-serve SaaS platform.
  • As of September 30, 2020, the Company’s cash and cash equivalents amounted to $3 million compared to $5.9 million for the same period in 2019.
  • As of September 30, 2020, the Company had working capital of $1.7 million, compared to approximately $5.8 million as of September 30, 2019.

Non-IFRS Measures

This press release refers to “Adjusted EBITDA” which is a non-GAAP and non-IFRS financial measure that does not have a standardized meaning prescribed by GAAP or IFRS. The Company’s presentation of this financial measure may not be comparable to similarly titled measures used by other companies. This financial measure is intended to provide additional information to investors concerning the Company’s estimated results. Adjusted EBITDA is defined as earnings before interest, tax, depreciation and amortization and share-based compensation and is a measure of a company’s operating performance. Essentially, it is a way to evaluate a company’s performance without having to factor in financing decisions, accounting decisions or tax environments. The following table (all in $US thousands) shows the Company’s Non-IFRS measure (Adjusted EBITDA) reconciled to operating profit for the indicated periods:



Three months ended



September 30,
2020




September 30,
2019


Operating loss

(1,488)

(1,059)

Adjustments:

Depreciation and amortization

613

574

Cost of share-based payments

25

105

Total adjustments

638

679


Adjusted EBITDA


(850)


(380)

Management uses this non-IFRS measure as a key metric in the evaluation of the Company’s performance and the consolidated financial results. The Company believes Adjusted EBITDA is useful to investors in their assessment of the operating performance and the valuation of the Company. However, non-IFRS financial measures are not prepared in accordance with GAAP or IFRS, and the information is not necessarily comparable to other companies and should be considered as a supplement to, not a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP or IFRS.

About Zoomd:

Zoomd (TSXV: ZOMD, OTC: ZMDTF), founded in 2012 and began trading on the TSX Venture Exchange in September 2019, offers a site search engine to publishers, and a mobile app user-acquisition platform, integrated with a majority of global digital media, to advertisers. The platform unifies more than 600 media sources into one unified dashboard. Offering advertisers, a user acquisition control center for managing all new customer acquisition campaigns using a single platform. By unifying all these media sources onto a single platform, Zoomd saves advertisers significant resources that would otherwise be spent consolidating data sources, thereby maximizing data collection and data insights while minimizing the resources spent on the exercise. Further, Zoomd is a performance-based platform that allows advertisers to advertise to the relevant target audiences using a key performance indicator-algorithm that is focused on achieving the advertisers’ goals and targets.


Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release.

Disclaimer IN REGARD TO Forward-looking statements

This news release includes certain “forward-looking statements” under applicable Canadian securities legislation. Forward-looking statements include, but are not limited to, statements with respect to Zoomd’s future financial situation, the impact and length of time of the COVID-19 pandemic on global advertising budgets and Zoomd’s revenue, the actions or inactions of its current and perspective customers regarding their advertising budgets, its ability to meet its strategic targets on the development roadmap and the overall success of the development roadmap. Forward-looking statements are necessarily based upon several estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties (including the impacts of the COVID-19 pandemic), the extent and duration of which are uncertain at this time on Zoomd’s business and general economic and business conditions and markets. There can be no assurance that any of the forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether because of new information, future events or otherwise, except as required by law.

The reader should not place undue importance on forward-looking information and should not rely upon this information as of any other date. All forward-looking information contained in this press release is expressly qualified in its entirety by this cautionary statement.

For further information please contact:

Company Media Contacts:
Amit Bohensky
Chairman
Zoomd
[email protected] 
Website: www.zoomd.com

Investor relations:
Lytham Partners, LLC
Ben Shamsian
New York | Phoenix
[email protected]

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SOURCE Zoomd Technologies Ltd.

Rigel Finalizes the Study Design of its Ongoing Phase 3 Clinical Trial of Fostamatinib in Warm Autoimmune Hemolytic Anemia

FDA agrees to the proposed primary efficacy endpoint and additional secondary endpoints

PR Newswire

SOUTH SAN FRANCISCO, Calif., Nov. 17, 2020 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the final design of its FORWARD study, a pivotal Phase 3 clinical trial of fostamatinib disodium hexahydrate (fostamatinib) in warm autoimmune hemolytic anemia (AIHA). The FDA agreed to Rigel’s proposed durable response measure for the primary efficacy endpoint as well as the inclusion of additional secondary endpoints.  

The Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study of approximately 90 patients with primary or secondary warm AIHA who have failed at least one prior treatment. The primary efficacy endpoint for the trial is a durable response defined as a hemoglobin level ≥ 10 g/dl with an increase from baseline of ≥ 2 g/dl on three consecutive available visits during the 24-week treatment period, with the response not being attributed to rescue therapy. This endpoint allows for missed visits due to the COVID-19 pandemic without impacting a durable outcome. As of November 5, the trial had enrolled 57 of the 90 patients targeted for enrollment and currently has over 90 clinical trial sites established across 22 countries.

“Our conversations with the FDA have enabled us to finalize the primary efficacy endpoint for the only ongoing Phase 3 trial in warm AIHA, a condition for which there is no approved therapy,” said Raul Rodriguez, Rigel’s president and CEO. “We are over 60% of our enrollment target despite the headwinds drug development is facing due to COVID-19. We believe this progress is a result of the geographic diversity of our clinical sites, the ability of fostamatinib to be given orally, and the FDA’s clinical trial guidance during the pandemic.”

Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE® (fostamatinib disodium hexahydrate) tablets, which is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. The FDA has granted TAVALISSE Orphan Drug designation for the treatment of patients with warm AIHA.


About AIHA


Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body’s own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. Warm AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.


About TAVALISSE


Indication

TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information

Warnings and Precautions

  • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
  • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
  • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
  • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
  • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

Drug Interactions

  • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
  • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
  • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
  • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

Adverse Reactions

  • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
  • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

Please see www.TAVALISSE.com for full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.


About Rigel (www.rigel.com)


Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company’s first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib).  

Fostamatinib1 is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (AIHA); a NIH/NHLBI-Sponsored Phase 2 trial for the treatment of hospitalized COVID-19 patients, in collaboration with Inova Health System; and a Phase 2 trial for the treatment of COVID-19 being conducted by Imperial College London. Additionally, we plan to launch a Phase 3 clinical trial of fostamatinib for the treatment of hospitalized COVID-19 patients in the fourth quarter of 2020.

Rigel’s other clinical programs include an ongoing Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program, and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo. 


1

The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority. 


Forward Looking Statements


This release contains forward-looking statements relating to, among other things, Rigel’s ability to complete enrollment in its phase 3 clinical trial as a treatment for AIHA and the trial design for such indication. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “potential,” “may,” “aim,” “believe,” “expects” and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of fostamatinib in the U.S. and Europe; risks that the FDA, European Medicines Agency (EMA) or other regulatory authorities may make adverse decisions regarding fostamatinib or any of Rigel’s product candidates; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; the availability of resources to develop and, if approved, commercialize fostamatinib or any other of Rigel’s product candidates; the progress of our and our collaborators’ product development programs, including clinical testing, and the timing of results thereof; our expectations with respect to regulatory submissions and approvals; our research and development expenses; protection of our intellectual property; market competition; as well as other risks detailed from time to time in Rigel’s reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020
. In addition, the ongoing COVID-19 pandemic may result in further delays in Rigel’s studies and trials, or impact Rigel’s sales and ability to obtain supply of fostamatinib.
 
Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

Rigel IR Contact: David Burke
Phone: 650.624.1232
Email: [email protected]

 

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SOURCE Rigel Pharmaceuticals, Inc.

BrainStorm Announces Topline Results from NurOwn® Phase 3 ALS Study

Clinical trial did not meet statistical significance in primary efficacy endpoint

NurOwn® showed a clinically meaningful treatment response compared to placebo in a pre-specified subgroup

CSF biomarker analyses confirmed NurOwn resulted in a statistically significant increase of neurotrophic factors and reduction in neurodegenerative and neuroinflammatory biomarkers

Company management to host conference call and live webcast today at 8:30 AM ET

PR Newswire

NEW YORK, Nov. 17, 2020 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today topline results from the Company’s randomized, double-blind placebo-controlled Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for Amyotrophic lateral sclerosis (ALS). Results from the trial showed that NurOwn® was generally well tolerated in this population of rapidly progressing ALS patients. While showing a numerical improvement in the treated group compared to placebo across the primary and key secondary efficacy endpoints, the trial did not reach statistically significant results.

BrainStorm_Logo

The Phase 3 clinical trial’s primary efficacy endpoint, a responder analysis evaluating the proportion of participants who experienced a 1.25 points per month improvement in the post-treatment Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) slope, was powered on assumed treatment response rates of 35% on NurOwn versus 15% on Placebo. These estimates were based on available historical clinical trial data and the NurOwn Phase 2 data. The primary endpoint was achieved in 34.7% of NurOwn participants versus 27.7% for Placebo (p=0.453).  Therefore, the trial met the expected 35% NurOwn treatment group efficacy response assumption, however the high placebo response exceeded placebo responses observed in contemporary ALS trials.  The secondary efficacy endpoint measuring average change in ALSFRS-R total score from baseline to Week 28, was -5.52 with NurOwn versus -5.88 on Placebo, a difference of 0.36 (p= 0.693).

In an important, pre-specified subgroup with early disease based on ALSFRS-R baseline score ³ 35, NurOwn demonstrated a clinically meaningful treatment response across the primary and key secondary endpoints and remained consistent with our pre-trial, data-derived assumptions.  In this subgroup, there were 34.6% responders who met the primary endpoint definition on NurOwn and 15.6% on Placebo (p=0.288), and the average change from baseline to week 28 in ALSFRS-R total score was -1.77 on NurOwn and -3.78 on Placebo (p=0.198), an improvement of 2.01 ALSFRS-R points favoring NurOwn.

Cerebrospinal fluid (CSF) biomarker analyses confirmed that treatment with NurOwn resulted in a statistically significant increase of neurotrophic factors and reduction in neurodegenerative and neuroinflammatory biomarkers that was not observed in the placebo treatment group. We also carried out pre-specified statistical modeling designed to predict clinical response with high sensitivity and specificity based on ALS biomarkers and ALS Function and confirmed that NurOwn treatment outcomes could be predicted by baseline ALS function as well as key CSF neurodegenerative and neuroinflammatory biomarkers.

Dr. Merit Cudkowicz, one of the Principal Investigators of this trial and the Julianne Dorn Professor of Neurology at Harvard Medical School and the Director of the Healey Center for ALS and Chair of Neurology at Mass General Hospital said, “We found a clinically meaningful response to NurOwn in a pre-specified group of patients (greater than or equal to 35 ALSFRS-R at baseline). A change in pre- to post- treatment slope of 1.25 or more is substantial and clinically important. Given the heterogeneity of ALS, it is not surprising that measurement of treatment effect may be influenced by disease severity including the behavior of disease progression rates at the lower end of the scale. It is important to fully explore this finding. In addition, NurOwn was observed to have its clear intended biological effects with important changes in the pre-specified disease and drug related biomarkers.”

“This clinical trial included a more severely affected ALS population compared to other recent ALS clinical trials.  We identified a superior treatment response in a pre-specified subgroup of patients with less advanced disease. We are in active discussions with the FDA who have expressed their eagerness to review the data and have committed to prioritize review of this data.  The FDA will review the data to see if there is a path forward to support approval” said Chaim Lebovits, Chief Executive Officer of BrainStorm. “We would like to sincerely thank the patients, their families and caregivers, investigators and staff who participated in this study, as their dedication and hard work allowed for the study’s on-time completion despite the ongoing COVID-19 pandemic.  I also want to thank the California Institute for Regenerative Medicine (CIRM) for their enormous support to conduct this trial.” 

“The findings from this clinical trial demonstrated that NurOwn treatment was associated with a clinically meaningful treatment response and consistent biomarker effects in known ALS disease pathways and that the ability of the clinical trial to demonstrate treatment effects compared to placebo are influenced by baseline disease status, as revealed through ALS function and key biomarkers. We are committed to advancing discussions with the FDA to identify regulatory pathways that may support NurOwn in ALS,” commented Ralph Kern MD MHSc, President and CMO of Brainstorm. “In addition to planned scientific engagements, biosamples from this study will be shared through the NEALS biorepository to enable additional scientific discovery efforts. We want to thank our partners, I AM ALS, and ALSA, who kindly supported the biomarker study”.

“The consistency of effect observed across NurOwn treated patients, including within pre-specified subgroups, highlights an important treatment effect in a fatal disease with very limited treatment options. The placebo response observed in this trial is unprecedented and the ability to show treatment benefit in this context provides evidence of the clinical value of NurOwn. The robust changes in biomarkers of Neurodegeneration, including NfL and MCP-1, which allows identification of likely responders prior to treatment is encouraging”, said Stacy Lindborg PhD, EVP and Head of Global Clinical Research. “More detailed analyses will be shared at upcoming scientific conferences and in subsequent publications.  We are committed to learning as much as we can from this trial and to partner with the ALS community to progress our collective understanding of ALS, which in turn will help us to continue to bring forward new treatments for this unrelenting disease.”

Study Design

The Phase 3 NurOwn® trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of NurOwn® in 189 ALS patients. It was conducted at six centers of excellence: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford); California Pacific Medical Center (Prof. Robert Miller); Massachusetts General Hospital (Prof. Merit Cudkowicz, Dr. James Berry); University of Massachusetts Medical School (Prof. Robert Brown) and Mayo Clinic (Prof. Anthony Windebank, Dr. Nathan Staff). Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as patients with at least a 3 point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn® or placebo. Participants were followed for 28 weeks after treatment. The primary endpoints of the trial were safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks, where response was defined as participants with a ³ 1.25 points/month improvement in the post-treatment versus pre-treatment slope in ALSFRS-R at 28 weeks following the first treatment.  Secondary endpoints included the percentage of patients with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056.

Conference Call and Webcast Details

BrainStorm’s management team will host a call and webinar to discuss the Phase 3 data today at 8.30 AM EST. The call can be accessed by dialing the numbers below:

Participant Numbers:

Toll Free: 877-407-9205
International: 201-689-8054

Those interested in listening to the conference call live via the internet may do so by visiting the “Investors & Media” page of BrainStorm’s website at www.ir.brainstorm-cell.com and clicking on the conference call link.

Event Link:

Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/38723   

Webcast Replay Expiration:

Wednesday, November 17, 2021

There will also be a replay of the call which can be accessed by using the webcast link above or by dialing the numbers below. The replay will be available for 14 days.

Replay Number:

Toll Free: 877-481-4010
International: 919-882-2331
Replay Passcode: 38723

Teleconference Replay Expiration:

Tuesday, December 01, 2020

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed the Phase 3 pivotal trial in ALS

(NCT03280056); this trial investigated repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study was intended to support a filing for FDA approval of autologous MSC-NTF cells in ALS and discussion of potential regulatory pathways for approval are planned with the U.S. FDA. BrainStorm is also conducting an FDA-cleared Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

For more information, visit the company’s website at www.brainstorm-cell.com.

Safe-Harbor Statement 

Statements in this announcement other than historical data and information, including statements regarding the topline results from the NurOwn® Phase 3 ALS study and future clinical trial enrollment and data, constitute “forward-looking statements” and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.’s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as “may”, “should”, “would”, “could”, “will”, “expect”, “likely”, “believe”, “plan”, “estimate”, “predict”, “potential”, and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, the regulatory approval potential of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate, if approved, to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern; and other factors detailed in BrainStorm’s annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm’s forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management’s beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS 
Investor Relations:


Corey Davis, Ph.D.
LifeSci Advisors, LLC
Phone: +1-646-465-1138
[email protected]

Media:

Paul Tyahla

SmithSolve
Phone: + 1.973.713.3768
[email protected]

 

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SOURCE BrainStorm Cell Therapeutics Inc.

Palatin Technologies, Inc. Reports First Quarter Fiscal Year 2021 Results and Provides Business Update

– Regained North American Rights to Vyleesi® for HSDD with Palatin Receiving $12 Million from AMAG Plus $4.3 Million Due March 31, 2021

– Phase 2 Clinical Results of PL9643 for the Treatment of Dry Eye Disease on Track for December 2020

– $86.6 Million in Cash and Cash Equivalents as of September 30, 2020

– Conference Call Today at 11:00 AM ET

PR Newswire

CRANBURY, N.J., Nov. 17, 2020 /PRNewswire/ — Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, today announced results for its first quarter ended September 30, 2020.


First Quarter Ended September 30, 2020 Financial Highlights

  • Net loss for the quarter was $(3.9) million, or $(0.02) per share, compared to a net loss of $(4.5) million, or $(0.02) per share for the comparable quarter of 2019;
  • Vyleesi® gross sales for the period July 25 to September 30 amounted to $809,100. Recognized $(288,560) in Vyleesi product revenue, net of allowances and accruals;
  • Recognized no contract and license revenue for the quarter, compared to $97,379 for the comparable quarter of 2019;
  • Total operating expenses for the quarter were $3.7 million, including a $1.6 million gain on the license termination agreement, compared to $5.0 million for the comparable quarter of 2019;
  • As of September 30, 2020, the Company had $86.6 million in cash and cash equivalents and $5.0 million in accounts receivable, compared to $82.9 million in cash and cash equivalents and no accounts receivable as of June 30, 2020, with no outstanding debt.


Business Highlights and Updates

  • In July 2020, regained exclusive North American rights to market Vyleesi® (bremelanotide injection), the first and only on demand treatment for premenopausal women suffering from acquired, generalized, hypoactive sexual desire disorder (HSDD), a condition affecting one in ten premenopausal women;
  • Vyleesi commercial activities: solidified the distribution network and procedures, improved contact with prescribers and healthcare providers through virtual meetings, increased insurance reimbursement coverage, and initiated a highly-selective  digital marketing and telemedicine campaign to rebuild awareness and demand among pre-menopausal women with initial geo-targeting to top prescriber and digital locations;
  • Completed enrollment of a Phase 2 clinical study with PL9643 for the treatment of dry eye disease (DED). Data readout expected December 2020;
  • A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is targeted to start in the first half of calendar year 2021.

“We have made significant progress and improvement on Vyleesi commercial activities, specifically around insurance reimbursement and expanded coverage. This put us in the proper position as we initiated a targeted marketing digital campaign to raise condition and treatment awareness with premenopausal women,” stated Carl Spana, Ph.D., President and CEO of Palatin.

“Despite the challenges posed by the ongoing viral pandemic, we are on track for data readout next month on our PL9643 Phase 2 clinical study in subjects with dry eye disease. Most people living with dry eye disease suffer from episodic flare-ups. These flares can be caused by a multitude of triggers and frequently are not sufficiently addressed by current therapies.”



Programs Overview



Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi® (bremelanotide injection)

In July 2020, Palatin announced the mutual termination of its License Agreement with AMAG Pharmaceutical, Inc, for Vyleesi. Under the termination agreement, Palatin regained all North American development and commercialization rights for Vyleesi. AMAG made a $12.0 million payment to Palatin at closing and will make a $4.3 million payment to Palatin on March 31, 2021. Palatin assumed all Vyleesi manufacturing agreements, and AMAG transferred information, data, and assets related exclusively to Vyleesi, including existing inventory. AMAG is providing certain transitional services to Palatin for a period to ensure continued patient access to Vyleesi and regulatory compliance during the transition back to Palatin. Palatin is reimbursing AMAG for the agreed upon costs of the transition services.

Palatin is exploring its options to enhance the commercialization of Vyleesi, including discussions with potential collaboration partners that currently market female healthcare products. Palatin continues collaboration discussions for territories outside the currently licensed territories of China and Korea and anticipates executing multiple agreements through calendar year 2021.

The Company’s strategy implements an informed and highly targeted approach to marketing, focusing on telemedicine, social media, and digital advertising. The Company is committed to working with payers and healthcare professionals to ensure women with HSDD have continued and affordable access to Vyleesi. Vyleesi remains commercially available through specialty pharmacies Avella and BioPlus. Patients also can connect with a healthcare provider through telemedicine. Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com.

Vyleesi is the first FDA-approved product for the as-needed treatment for premenopausal women who experience distress or interpersonal difficulty due to low sexual desire. This treatment is available as a subcutaneous self-injection in a prefilled disposable autoinjector pen for use in anticipation of a sexual encounter.



Anti-Inflammatory / Autoimmune Programs

Enrollment in a Phase 2 clinical study with PL9643 for the treatment of dry eye disease was completed in August 2020. Data readout is targeted for December of 2020. If results from the Phase 2 study support advancing to Phase 3, the Company will initiate a Phase 3 efficacy study as early as mid-calendar year 2021.

A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is targeted to start in the first half of calendar year 2021, with data readout potentially in the first half of calendar year 2022.

The Company continues its assessment and development work related to the treatment of patients with diabetic retinopathy, with an investigational new drug (IND) filing targeted for mid-calendar year 2021. 

The Company currently anticipates filing an IND and commencing clinical trials with PL8177 for non-infectious uveitis, for which the FDA granted orphan drug designation, in the second half of calendar year 2021.

Palatin is advancing its COVID-19 development plan and is conducting all the required activities needed to file an IND and begin clinical studies with PL8177 as a treatment in COVID-19 patients. These activities will be completed in the fourth calendar quarter of 2020, allowing the Company to potentially file an IND with the FDA and initiate a clinical study of PL8177 for the treatment of COVID-19 patients early in the first calendar quarter of 2021.

The landscape for treating and conducting clinical studies in COVID-19 patients is rapidly evolving. This impacts the design, risk, and ability to conduct clinical studies in COVID-19 patients.  Considering the risk and uncertainty of conducting COVID-19 clinical studies, the start of a PL8177 clinical study is subject to receiving external funding and operational support. The Company is in the process of applying to government programs that provide such support.



Natriuretic Peptide Receptor (NPR) System Program

PL3994, an NPR-A agonist, will be evaluated in a Phase 2A clinical study in heart failure patients with preserved ejection fraction. The proposed study is a collaboration with two major academic medical centers and is supported by an American Heart Association grant. Patient enrollment in the study has commenced and the first patient was dosed in November 2020.



Genetic Obesity Program

Palatin’s melanocortin receptor 4 (MC4r) peptide PL8905 and orally active small molecule PL9610 are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designations, potential development, and licensing.


Conference Call / Webcast

Palatin will host a conference call and audio webcast on November 17, 2020 at 11:00 a.m. Eastern Time to discuss the quarter ended September 30, 2020 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-800-353-6461 (US/Canada) or 1-334-323-0501 (international), conference ID 3383273. The audio webcast and replay can be accessed by logging on to the “Investor/Webcasts” section of Palatin’s website at http://www.palatin.com. A telephone and audio webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 3383273. The webcast and telephone replay will be available through November 24, 2020.


About Palatin Technologies, Inc.

Palatin Technologies, Inc. is a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin’s website at www.Palatin.com.


Forward-looking Statements

Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, Palatin’s ongoing relationship with AMAG, market potential for product candidates, and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin’s actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin’s actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, Palatin’s ability to establish and maintain the capability for manufacturing, marketing and distribution of Vyleesi, sales of Vyleesi in the United States and elsewhere in the world, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin’s ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin’s products, and other factors discussed in Palatin’s periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.

Palatin Technologies® and Vyleesi® are registered trademarks of Palatin Technologies, Inc.

 


PALATIN TECHNOLOGIES, INC.


and Subsidiary


Consolidated Statements of Operations

(unaudited)


Three Months Ended September 30,


2020


2019

REVENUES

Product revenue, net

$                    (288,560)

$                              –

License and contract

97,379

(288,560)

97,379

OPERATING EXPENSES

    Cost of products sold

25,200

Research and development

2,923,851

3,127,489

Selling, general and administrative

2,331,606

1,832,442

Gain on license termination agreement

(1,623,795)

Total operating expenses

3,656,862

4,959,931

Loss from operations

(3,945,422)

(4,862,552)

OTHER INCOME (EXPENSE)

Investment income

12,135

370,654

Interest expense

(7,489)

(9,051)

Total other income, net

4,646

361,603

NET LOSS

$                 (3,940,776)

$                (4,500,949)

Basic and diluted net loss per common share

$                          (0.02)

$                         (0.02)

Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share

236,345,862

233,113,241

 


PALATIN TECHNOLOGIES, INC.


and Subsidiary


Consolidated Balance Sheets

(unaudited)


September 30, 2020


June 30, 2020


ASSETS

Current assets:

Cash and cash equivalents

$                  86,587,455

$      82,852,270

Accounts receivable

5,044,372

Inventories

5,792,595

Prepaid expenses and other current assets

2,360,001

738,216

Total current assets

99,784,423

83,590,486

Property and equipment, net

126,772

140,216

Right-of-use assets

1,190,410

1,266,132

Other assets

56,916

56,916

Total assets

$                101,158,521

$      85,053,750


LIABILITIES AND STOCKHOLDERS’ EQUITY 

Current liabilities:

Accounts payable 

$                       971,308

$           715,672

Accrued expenses

3,823,682

2,899,097

Short-term operating lease liabilities

282,275

312,784

Other current liabilities

7,575,000

Total current liabilities

12,652,265

3,927,553

Long-term operating lease liabilities

911,775

953,348

Other long-term liabilities

10,619,000

Total liabilities

24,183,040

4,880,901

Stockholders’ equity:

Preferred stock of $0.01 par value – authorized 10,000,000 shares; shares issued and outstanding designated as follows:

Series A Convertible: authorized 264,000 shares: issued and outstanding 4,030 shares as of September 30, 2020 and June 30, 2020

40

40

Common stock of $0.01 par value – authorized 300,000,000 shares:

issued and outstanding 229,855,417 shares as of September 30, 2020 and 229,258,400 shares as of June 30, 2020 

2,298,554

2,292,584

Additional paid-in capital

396,816,565

396,079,127

Accumulated deficit 

(322,139,678)

(318,198,902)

Total stockholders’ equity 

76,975,481

80,172,849

Total liabilities and stockholders’ equity

$                101,158,521

$      85,053,750

                        

 

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SOURCE Palatin Technologies, Inc.