Chembio Diagnostics Receives ANVISA Approval for DPP SARS-CoV-2 Antigen Test System in Brazil

HAUPPAUGE, N.Y., Nov. 13, 2020 (GLOBE NEWSWIRE) — Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, today announced that its subsidiary Chembio Diagnostics Brazil Ltda. has received regulatory approval from Agência Nacional de Vigilância Sanitária (ANVISA) to market the DPP SARS-CoV-2 Antigen test system in Brazil.

The DPP SARS-CoV-2 Antigen test system is designed to detect SARS-CoV-2 antigens in only 20 minutes. The detection of specific SARS-CoV-2 viral antigens implies a current infection by the virus responsible for COVID-19 cases. The DPP SARS-CoV-2 Antigen test system consists of a DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader 1 or DPP Micro Reader 2 analyzer, and a minimally invasive nasal swab.

Clinical trial data demonstrates sensitivity of 96.0% at zero to six days from the onset of symptoms and specificity of 98.7% on symptomatic population as compared to PCR tests.

“We are grateful for the rapid review and approval of our DPP SARS-CoV-2 Antigen assay by ANVISA. The exceptional performance of this assay highlights again the value and flexibility of our DPP technology,” stated Javan Esfandiari, Chembio’s Vice President and Chief Science & Technology Officer. “We believe helping people understand their infection status has shown to be one of the most effective methods for controlling the spread of COVID-19. Enabling patients and providers to know this information at the point-of-care in 20 minutes can help further reduce the risk of virus transmission and improve patient outcomes. We are very proud to offer this test in Brazil and assist in efforts to manage the global pandemic.”

Chembio Diagnostics Brazil, formerly Orangelife Comercio e Industria Ltda., is Chembio’s Brazilian commercial subsidiary that Chembio acquired in November 2019. Offering leading point-of-care tests to Brazilian state, private, and pharmacy markets, Chembio Diagnostics Brazil also provides local support to the Company’s long-time partner Bio-Manguinhos.

“Combined with ANVISA’s prior Approval for Emergency Use of the DPP COVID-19 IgM/IgG assay, we are now able to offer the Brazilian healthcare system tests that detect active infections and provide antibody status that both run on the same Micro Reader analyzers. Our test systems are rapid, accurate, and ideal for decentralized testing which can help expand access to testing across communities,” stated Charles Caso, Chembio’s Vice President, Sales and Marketing. “We view Brazil as one of the most attractive infectious disease testing markets in the world, and we plan to expand the commercial team at Chembio Diagnostics Brazil to leverage our growing portfolio of approved tests in the country.”

About the DPP Rapid Test Platform

Chembio’s proprietary DPP technology platform provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples. Through advanced multiplexing, the DPP platform can detect up to eight, distinct test results from a single patient sample, delivering greater clinical value than other rapid tests. For certain applications, Chembio’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzer then reports accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still on-site. Objective results produced by the DPP Micro Reader reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests.

Chembio’s portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA). Additionally, DPP-based tests have received regulatory approvals from the World Health Organization, CE-Mark, Agência Nacional de Vigilância Sanitária (ANVISA), and other global organizations, where they aid in the detection and diagnosis of several other critical diseases and conditions.

All DPP tests are developed and manufactured in the United States and are the subject of a range of domestic and global patents and patents pending.

About Chembio Diagnostics

Chembio is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases, including COVID-19, sexually transmitted disease, and fever and tropical disease. Coupled with Chembio’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease. Chembio’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers. Learn more at www.chembio.com.

DPP is Chembio’s registered trademark. For convenience, this trademark appears in this release without ® symbols, but that practice does not mean that Chembio will not assert, to the fullest extent under applicable law, its rights to the trademark.

Contact:  
Philip Taylor
Gilmartin Group
(415) 937-5406
[email protected]



Eurofins Transplant Diagnostics Introduces TruGraf Liver At AASLD – The Liver Meeting

Novel Biomarker-Based Assay Confirms Immune Quiescence in Liver Transplant Patients

PR Newswire

MANSFIELD, Mass., Nov. 13, 2020 /PRNewswire/ — Transplant Genomics, Inc. (“TGI”) a member of Eurofins Transplant Diagnostics, is excited to introduce TruGraf Liver, the only non-invasive blood-based test to assist in lowering immunosuppression in liver transplant patients, at The Liver Meeting Digital Experience (“The Liver Meeting”). The Liver Meeting is the annual meeting of the American Association for the Study of Liver Diseases, being held online November 13-16, 2020.  In continuation of Eurofins Transplant’s commitment to improving organ transplant outcomes worldwide, TruGraf Liver follows TruGraf®, the only non-invasive kidney rejection test reimbursed by CMS for the surveillance of “silent” sub-clinical acute rejection in patients with stable renal function.

TruGraf Liver is the only non-invasive blood-based test to assist in lowering immunosuppression in transplant patients.

Immunosuppression is essential to prevent rejection following liver transplantation. However, due to the significant complications associated with the use of immunosuppression, clinicians routinely minimize immunosuppression in liver transplant recipients in an effort to address these complications. TruGraf Liver is the first and only blood-based test that offers biomarker guidance to aid physicians in minimizing immunosuppression in transplant recipients. Until now, immunosuppression minimization has largely been a “trial and error” process, with clinicians relying only on laboratory and clinical indicators of rejection, graft injury, and failure resulting from the effects of immune activation. TruGraf Liver can help clinicians confirm immune quiescence prior to, as well as following, immunosuppression reduction in patients with stable graft function, minimizing the risk of overt graft injury due to rejection.

Josh Levitsky, MD, MS (Professor of Medicine and Surgery in the Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois) detailed the development of TruGraf Liver in his April 2020 article in the American Journal of Transplantation (https://onlinelibrary.wiley.com/doi/full/10.1111/ajt.15953). This study is based on findings from an NIH-funded, multi-center longitudinal study (CTOT-14: NCT01672164) that has set the stage for the use of non-invasive biomarkers for serial monitoring of liver transplant recipients. He will present his study at The Liver Meeting on Sunday, November 15 at 1:00pm ET, in a satellite symposium titled “Biomarkers in Liver Transplantation: The Next Frontier.”

Transplant Genomics is currently selecting liver transplant centers for the TruGraf Liver Early Access Program, and is preparing documentation for submission to the Molecular Diagnostics Services (MolDX) program to determine reimbursement coverage from the Centers for Medicare and Medicaid Services. The Early Access Program will be followed by the TRULI (TruGraf Liver) Registry Study, which is expected to involve more than 30 liver transplant centers and enroll up to 1,000 patients.

Members of the American Association for the Study of Liver Diseases may register for The Liver Meeting 2020 to see Dr. Levitsky’s presentation at https://www.aasld.org/node/2046.

Hepatologists and other liver transplant care professionals may contact Transplant Genomics to learn more about TruGraf Liver at (844) 878-4723 or at [email protected].

For more information:

Branden Morris

Transplant Genomics, Inc.
e) [email protected]
p) 510-745-4707

About Transplant Genomics, Inc.
Transplant Genomics, Inc. (“TGI”) is a personalized diagnostics company committed to improving organ transplant outcomes worldwide through innovative tests that detect early signs of graft injury, differentiate among actionable causes, and enable the optimization of therapy. Working alongside the transplant community and within the Eurofins family, TGI is commercializing a suite of tests enabling diagnoses and prediction of transplant recipient immune status. Our flagship product is TruGraf, the only blood test approved by CMS for surveillance and to rule out “silent” subclinical acute rejection in kidney transplant recipients with stable graft function. Test services are offered through TGI’s CLIA laboratory in Fremont, CA. TGI was acquired by Eurofins Scientific in 2019.

Learn more about Transplant Genomics at http://www.trugraf.com.

About Eurofins Scientific
Eurofins Scientific, through its subsidiaries (hereinafter “Eurofins” or “the Group”), believes it is the global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In addition, Eurofins is one of the leading global emerging players in esoteric and molecular clinical diagnostic testing. With over 50,000 staff across a network of more than 900 independent companies in over 50 countries generally specialised by end client markets and operating more than 800 laboratories, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of a wide range of products, as well as providing innovative clinical diagnostic testing services. The Group’s objective is to provide its customers with high-quality and innovative services, accurate results on time and, when requested, expert advice by its highly-qualified staff.

Eurofins is committed to pursuing its dynamic growth strategy by expanding both its technology portfolio and its geographic reach. Through R&D and acquisitions, the Group draws on the latest developments in the field of biotechnology and analytical chemistry to offer its clients unique analytical solutions and a very large range of testing methods.

As one of the most innovative and quality-oriented international groups in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the increasing demands of regulatory authorities and healthcare practitioners around the world.

Shares in Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP).

Learn more about Eurofins at https://www.eurofins.com.

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/eurofins-transplant-diagnostics-introduces-trugraf-liver-at-aasld–the-liver-meeting-301172995.html

SOURCE Transplant Genomics, Inc.

Merck KGaA, Darmstadt, Germany, to present at the dbVIC – Deutsche Bank ADR Virtual Investor Conference on 19 November 2020

Merck KGaA invites individual and institutional investors, as well as advisors, to attend interactive, real-time virtual event

PR Newswire

DARMSTADT, Germany, Nov. 13, 2020 /PRNewswire/ — Merck KGaA, Darmstadt, Germany (LOCAL EXCHANGE: Deutsche Börse, US EXCHANGE: OTC), a leading science and technology company, today announced that Merck KGaA, Darmstadt, Investor Relations Director llja Doering will present at the dbVIC – Deutsche Bank American Depositary Receipt (ADR) Virtual Investor Conference on November 19.  This virtual investor conference is aimed exclusively at introducing global companies with ADR programs to investors.

DATE: November 19, 2020
TIME: 11:00 – 11:30 AM ET
LINK: https://bit.ly/3jNDfgr

This will be a live, interactive online event where investors are invited to ask the company questions in real-time – both in the presentation hall as well as the organization’s “virtual trade booth.” If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.

It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates.


Participation is free of charge.

Recent Company Highlights in Q3 2020:

  • Healthcare: Mavenclad® up 72% organically YoY after dip in Q2, Oncology up 7% strongly supported by early U.S. Bavencio® 1L UC ramp-up; sequential recovery of Fertility back to pre COVID-19 levels
  • Life Science: Process Solutions up 27% organically, strong rebound in Research Solutions with 10% organic growth, Applied Solutions recovery slower with 4% organic growth
  • Performance Materials: Semiconductor Solutions’ organic growth mitigates Display and Surface decline in pandemic; Versum performance & integration ahead of plan
  • Group: New ESG-targets – enhanced sustainability strategy leverages strengths and manifests company’s commitment

About Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, is a leading science and technology company in healthcare, life science and performance materials. Around 57,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals and OLEDs for smartphones and televisions. In 2019, Merck KGaA, Darmstadt, Germany, generated sales of € 16.2 billion in 66 countries.

About Virtual Investor ConferencesSM

Virtual Investor Conferences is the leading proprietary investor conference series that provides an interactive forum for publicly-traded companies to meet and present directly with investors.

A real-time solution for investor engagement, Virtual Investor Conferences is part of OTC Market Group’s suite of investor relations services specifically designed for more efficient Investor Access.  Replicating the look and feel of on-site investor conferences, Virtual Investor Conferences combine leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.

Cision View original content:http://www.prnewswire.com/news-releases/merck-kgaa-darmstadt-germany-to-present-at-the-dbvic—deutsche-bank-adr-virtual-investor-conference-on-19-november-2020-301172994.html

SOURCE dbVIC – Deutsche Bank Depositary Receipts Virtual Investor Conference

Bentley Systems to Present at the RBC Global Technology, Internet, Media & Telecom Conference

Bentley Systems to Present at the RBC Global Technology, Internet, Media & Telecom Conference

EXTON, Pa.–(BUSINESS WIRE)–
Bentley Systems, Incorporated (Nasdaq: BSY), the infrastructure engineering software company, today announced that Greg Bentley, Bentley Systems’ chief executive officer, will present virtually at the RBC Global Technology, Internet, Media & Telecom Conference on Tuesday, November 17, 2020 at approximately 4:00 p.m. Eastern Time.

About Bentley Systems

Bentley Systems (Nasdaq: BSY) is the infrastructure engineering software company. We provide innovative software to advance the world’s infrastructure – sustaining both the global economy and environment. Our industry-leading software solutions are used by professionals, and organizations of every size, for the design, construction, and operations of roads and bridges, rail and transit, water and wastewater, public works and utilities, buildings and campuses, and industrial facilities. Our offerings include MicroStation-based applications for modeling and simulation, ProjectWise for project delivery, AssetWise for asset and network performance, and the iTwin platform for infrastructure digital twins. Bentley Systems employs more than 4,000 colleagues and generates annual revenues of more than $700 million in 172 countries. www.bentley.com.

Investor Contact:

Ankit Hira or Ed Yuen

Solebury Trout for Bentley Systems

[email protected]

1-610-458-2777

Media Contact:

Carey Mann

[email protected]

1-610-458-3170

KEYWORDS: United States North America Pennsylvania

INDUSTRY KEYWORDS: Engineering Technology Manufacturing Telecommunications Software Internet

MEDIA:

Howmet Aerospace Board Approves Preferred Stock Dividend

Howmet Aerospace Board Approves Preferred Stock Dividend

PITTSBURGH–(BUSINESS WIRE)–
The Board of Directors of Howmet Aerospace (NYSE:HWM), declared a dividend of 93.75 cents per share on the outstanding $3.75 Cumulative Preferred Stock (“Class A Stock”) of the Company, to be paid on January 1, 2021 to the holders of record of the Class A Stock at the close of business on December 11, 2020.

About Howmet Aerospace

Howmet Aerospace Inc., headquartered in Pittsburgh, Pennsylvania, is a leading global provider of advanced engineered solutions for the aerospace and transportation industries. The Company’s primary businesses focus on jet engine components, aerospace fastening systems, and titanium structural parts necessary for mission-critical performance and efficiency in aerospace and defense applications, as well as forged wheels for commercial transportation. With nearly 1,200 granted and pending patents, the Company’s differentiated technologies enable lighter, more fuel-efficient aircraft to operate with a lower carbon footprint. In 2019, the businesses of Howmet Aerospace reported annual revenue of over $7 billion. For more information, visit www.howmet.com. Follow: LinkedIn, Twitter, Instagram, Facebook, and YouTube.

Dissemination of Company Information

Howmet Aerospace intends to make future announcements regarding Company developments and financial performance through its website at www.howmet.com.

Investor Contact

Paul T. Luther

(412) 553-1950

[email protected]

Media Contact

Paul Erwin

(412) 553-2666

[email protected]

KEYWORDS: United States North America Pennsylvania

INDUSTRY KEYWORDS: Aerospace Manufacturing

MEDIA:

Logo
Logo

SELLAS Life Sciences Provides Business Update and Reports Third Quarter 2020 Financial Results


Received
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NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today provided a business update and reported financial results for the quarter ended September 30, 2020. 

“In the third quarter, we announced an important milestone for our Phase 3 REGAL study of galinpepimut-S (GPS) in acute myeloid leukemia (AML) when we received approval from the French regulatory authorities for our Investigational Medicinal Product Dossier (IMPD), which allows SELLAS to commence patient enrollment for the REGAL study in France,” said Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “We also strengthened our balance sheet during the quarter with a $9.2 million private placement of shares and warrants priced at-the-market. We are using the proceeds from the financing to continue to progress our ongoing GPS studies, as the Company moves closer to the multiple data readouts that are expected over the next 18 months, including the initial data review of our mesothelioma study by year end.”

Pipeline Highlights

  • Galinpepimut
    -S (GPS)

    • In September 2020, SELLAS announced the approval of its Investigational Medicinal Product Dossier (IMPD) from Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the French regulatory authority, to advance the enrollment in France for the Phase 3 REGAL study of GPS in patients with AML who have achieved complete remission after second-line anti-leukemic therapy (CR2).
  • Nelipepimut
    -S

    • Finalized data from the National Cancer Institute-sponsored Phase 2 randomized trial of nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) in women with ductal carcinoma in situ (DCIS) of the breast who are HLA-A2+ or A3+ positive, express HER2 at IHC 1+, 2+, or 3+ levels, and are pre- or post-menopausal. The VADIS study will be presented in a Spotlight Poster-Discussion Session, PD11-09, at the 2020 San Antonio Breast Cancer Symposium, December 8-12, 2020: 

      https://www.sabcs.org/Program/Spotlight-Sessions/Spotlight-Poster-Discussion-11 Session Date – Time: Friday, December 11, 2020: 2:15 pm – 3:30 pm

Corporate Highlights

  • In August 2020, SELLAS received gross proceeds of approximately $9.2 million from a private placement financing with certain institutional and accredited investors.

Third Quarter 2020 Financial Results

R&D Expenses: Research and development expenses were $2.4 million for the third quarter of 2020, as compared to $1.8 million for the third quarter of 2019. Research and development expenses for the nine months ended September 30, 2020 were $6.5 million, as compared to $5.0 million for the same period in 2019. The increases in research and development expenses during the third quarter and the nine months ended September 30, 2020 compared to the same periods in 2019 were primarily due to clinical trial expenses incurred for the REGAL study commencing in 2020.

G&A Expense: General and administrative expenses were $2.1 million for the third quarter of 2020, as compared to $2.4 million for the third quarter of 2019. General and administrative expenses for the nine months ended September 30, 2020 were $6.3 million, as compared to $7.5 million for the same period in 2019. The decreases during the third quarter and the nine months ended September 30, 2020 compared to the same periods in 2019 were primarily due to a reduction in legal fees and personnel related expenses partially offset by an increase in insurance premiums due to hardening insurance markets.

Net Loss: Net loss attributable to common stockholders was $4.5 million for the third quarter of 2020, or a basic and diluted loss per share attributable to common stockholders of $0.53, as compared to a net loss attributable to common stockholders of $11.5 million for the third quarter of 2019, or a basic and diluted loss per share attributable to common stockholders of $2.68. Net loss attributable to common stockholders was $13.1 million for the nine months ended September 30, 2020, or a basic and diluted loss per share attributable to common stockholders of $1.83, as compared to a net loss attributable to common stockholders of $20.5 million for the nine months ended September 30, 2019, or a basic and diluted loss per share attributable to common stockholders of $11.37.

Cash Position: As of September 30, 2020, cash and cash equivalents totaled approximately $8.2 million.

Impact of COVID-19

During the third quarter of 2020, the Company continued to initiate additional sites for its GPS clinical program as planned. However, the Company has observed that clinical site initiations and patient enrollment may be delayed due to prioritization of hospital resources towards the COVID-19 pandemic. Clinicians and patients may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt the operations at sites. Additionally, several European Union countries in which the Company plans to initiate clinical sites, including Germany, France, and Italy, have imposed new “lockdown” restrictions in response to the recent surge in coronavirus cases throughout the European Union and coronavirus cases in the United States continue to accelerate. Because of the uncertainty as to the impact that the surge in coronavirus cases could have on the operations of newly initiated sites in the United States and the European Union, which could then impact the projected timelines for the REGAL study, the Company now believes that the planned interim safety and futility analysis for the REGAL study may occur by the end of 2021 or early 2022.

About SELLAS Life Sciences Group, Inc.

SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy or in combination to address a broad spectrum of hematologic malignancies and solid tumor indications. SELLAS’ second product candidate, NPS, is a HER2-directed cancer immunotherapy with potential for the treatment of patients with early stage breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, which includes triple negative breast cancer patients, following standard of care.

For more information on SELLAS, please visit www.sellaslifesciences.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the Company’s plans for further development of and regulatory plans for GPS, including the timing of clinical results and the potential for GPS as a drug development candidate. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, 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 COVID-19 pandemic and its impact on the Company’s clinical plans and business strategy, risks and uncertainties associated with immune-oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 13, 2020 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

Investor Contacts

Adam Holdsworth
PCG Advisory
646-862-4607
[email protected]

Investor Relations
SELLAS Life Sciences Group, Inc.
917-438-4353
[email protected]



SmileDirectClub to Participate in Upcoming Investor Conferences

NASHVILLE, Tenn., Nov. 13, 2020 (GLOBE NEWSWIRE) — SmileDirectClub, Inc. (Nasdaq: SDC), the oral care company with the first medtech platform for teeth straightening, today announced that management will attend two upcoming conferences on Wednesday, November 18th, including the Stifel Virtual Healthcare Conference and the Wolfe Virtual Healthcare Conference.

Stifel Virtual Healthcare Conference

  • Date: Wednesday, November 18th
  • Presentation Time: Wednesday, November 18th at 10am ET

Wolfe Virtual Healthcare Conference

  • Date: Wednesday, November 18th
  • Presentation Time: Wednesday, November 18th at 4:25pm ET

The audio portions of these presentations will be webcast live and can be accessed in the “Events and Presentations” section at https://investors.smiledirectclub.com.

About SmileDirectClub

SmileDirectClub, Inc. (Nasdaq: SDC) (“SmileDirectClub”) is an oral care company and creator of the first medtech platform for teeth straightening, now also offered directly via dentist and orthodontists’ offices. Through its cutting-edge teledentistry technology and vertically integrated model, SmileDirectClub is revolutionizing the oral care industry, from clear aligner therapy to an affordable, premium oral care product line. SmileDirectClub’s mission is to democratize access to a smile each and every person loves by making it affordable and convenient for everyone. SmileDirectClub is headquartered in Nashville, Tennessee and operates in the U.S., Canada, Australia, New Zealand, United Kingdom, Ireland, Germany, Austria, Hong Kong, Singapore and Spain. For more information, please visit SmileDirectClub.com.

Contact:
SmileDirectClub Media Relations: [email protected] 
SmileDirectClub Investor Relations: [email protected]



Color Star Technology Reports Audited Financial Results for the Fiscal Year Ended June 30, 2020

PR Newswire

NEW YORK, Nov. 13, 2020 /PRNewswire/ — Color Star Technology Co., Ltd. (Nasdaq CM: CSCW) (the “Company”, or “Color Star”), an entertainment and education company that provides online entertainment performances and online music education services, today announced its audited financial results and the filing of its Annual Report on Form 20-F with the Securities and Exchanges Commission for the fiscal year ended June 30, 2020. A copy of the Annual Report is available at www.sec.gov

“Today’s announcement marks the filing of our Annual Report for the first time since we disposed the ready-mix concrete business and started to reposition the Company as a global, online+offline entertainment and paid knowledge sharing company. Looking ahead, with a continuously growing registered user base which now tops 500,000 and the combination of offline music festivals and online businesses that include online education academy, online concert, and online store, we firmly believe that Color Star is well positioned to succeed in years to come,”  commented Biao (Luke) Lu, Chairman and Chief Executive Officer of Color Star. 

Fiscal Year 2020 Financial Highlights


For the Fiscal Year Ended June 30,


($ millions, except per share data)


2020


2019


% Change

Revenues

$nil

$nil

NA

Loss from operations

($5.16)

($6.66)

22.4%

Net loss

($11.63)

($14.39)

19.2%

Loss per share

($0.99)

($2.46)

59.8%

Financial Conditions

As of June 30, 2020, the Company had cash, cash equivalents of $0.99 million, compared to $0.32 million as of June 30, 2019. Other receivables were $1.00 million as of June 30, 2020, compared to $2,300 as of June 30, 2019. Prepayment and advances were $1.17 million as of June 30, 2020, compared to $25,000 as of June 30, 2019. Working capital was $2.63 million as of June 30, 2020, compared to working capital deficit of $1.14 million as of June 30, 2019.

Net cash used in operating activities was $2.54 million for fiscal year 2020, compared to $1.08 million for fiscal year 2019. Net cash used in investing activities was $1.39 million for fiscal year 2020, compared to $0.14 million for fiscal year 2019. Net cash provided by financing activities was $4.80 million for fiscal year 2020, compared to $0.52 million for fiscal year 2019. 

Recent Developments

On October 30, 2020, the Company announced that it had secured the naming rights for the Wu Muye Piano World Tour, under the name “Color World – Wu Muye Piano World Tour”.

On October 25, 2020, the Company officially added online “Star Mall” feature to its Color World App.

On October 16, 2020, the Company announced that it will kick off its “Color World”-branded Music Festival Series in mainland China.

On October 9, 2020, the Company announced the launch of a series of interactive live events featuring its growing band of Star Teachers.

On October 6, 2020, the Company announced that it had signed separate cooperation agreements with three renowned South Korean musicians.

On October 1, 2020, the Company announced that its ordinary shares would commence trading on the NASDAQ Capital Market under the new ticker symbol “CSCW”.

On September 28, 2020, the Company announced adding online store feature to its Color World App.

On September 25, 2020, the Company announced upgrading its Color World App with interactive live video streaming feature.

On September 23, 2020, the Company announced that it entered into a memorandum of understanding on September 21, 2020 with FENT Co. Ltd., a South Korean K-pop entertainment and artist agency service company, to acquire 100 percent equity interest in FENT.

On September 16, 2020, the Company announced that it had entered into a securities purchase agreement on September 15, 2020 with certain accredited investors to purchase $6.6 million of its ordinary shares in a registered direct offering and warrants to purchase ordinary shares in a concurrent private placement.

On September 14, 2020, the Company announced the debut of the Color World App.

On September 9, 2020, the Company announced the lineup of its “Fearless, Color World” cloud concert.

On September 4, 2020, the Company announced entry into strategic agreement with China-Korea Culture and Art Exchange Association, expanding its online star education services internationally.

August 28, 2020, the Company announced collaboration with Red Phoenix Entertainment to strategically expand into sports education.

On August 25, 2020, the Company announced cooperation with the Romanian Chamber of Commerce and Industry, expanding its online star education services.

On August 21, 2020, the Company announced press conference to be held in Beijing on September 2, 202 for Color World App

On August 19, 2020, the Company announced that it reached a long-term strategic agreement with Thailand’s “Sing Sian Yer Pao Daily News”.

On August 17, 2020, the Company announced that its online star education mobile application platform “Color Star” had successfully completed its testing phase and many international celebrities had joined the platform in advance to create an all-star lineup of entertainment education network.

On August 14, 2020, the Company announced that Hung-Jen Kuo had been named to its Board of Directors.

On August 10, 2020, the Company received a letter from Nasdaq notifying the Company that it had regained compliance with Nasdaq Listing Rules 5550(a)(2), as the Company maintained a closing bid price of $1.00 per share or greater for twenty (20) consecutive days from July 13 through August 7, 2020.

On August 10, 2020, the Company announced that Na Ying joined the Company’s “Fearless, Color World” online concert.

On August 7, 2020, the Company announced that American rapper, singer, songwriter and actor Machine Gun Kelly joined the Company’s “Fearless, Color World” online concert.

On August 5, 2020, the Company announced multi-platinum selling, Grammy and Golden Globe nominated recording artist Wiz Khalifa joined the Company’s “Fearless, Color World” online concert.

On August 4, 2020, the Company announced that Syncopated Ladies, the team of Emmy nominated choreographer and international tap star Chloé Arnold joined the Company’s “Fearless, Color World” online concert as the latest guest and opening dancers.

On August 3, 2020, the Company announced the launch of its official website.

On July 30, 2020, the Company announced that the famous Japanese idol Ryuta Hayashi joined the Company’s “Fearless, Color World” online concert.

On July 28, 2020, the Company announced that its wholly owned subsidiary, Color China Entertainment Limited had signed a Cooperation Agreement with a famous Chinese singer Win (Wei Xun) and an international musician Mike Mclaughlin to serve as Star Teachers on the Company’s online education platform Color World.

On July 27, 2020, the Company announced that the famous Grammy Award Winning American singer Ashanti joined the Company’s “Fearless, Color World” online concert.

On July 24, 2020, the Company announced that its wholly owned subsidiary, Color China Entertainment Limited had signed a Cooperation Framework Agreement with Hong Kong’s renowned tourbillon watch brand Memorigin to jointly design, produce and sell customized watches.

On July 23, 2020, the Company announced its wholly-owned subsidiary Color China Entertainment Limited had entered into cooperation agreements with Xiuzhu Chen, a renowned Asian music producer, and Bowan Wang, a renowned Asian dancer to serve as Star Teachers on the Company’s online education platform Color World.

On July 20, 2020, the Company announced it had entered into a securities purchase agreement with certain accredited investors to purchase approximately $4.2 million worth of its ordinary shares in a registered direct offering and warrants to purchase ordinary shares in a concurrent private placement.

On July 17, 2020, the Company announced the resignation of Yang (Sean) Liu as CEO and chairman of the board of directors and the appointment of Mr. Biao (Luke) Lu as his successor.

On July 17, 2020, the Company announced that its wholly owned subsidiary, Color China Entertainment Limited had entered into a cooperation agreement with Shenzhen Yuren Production Culture Media Co., Ltd. , through which renowned music producers Nianhe Li and Peirong Qiu, and music instructor Muheng Shen serving as Star Teachers on the Company’s online education platform Color World.

On July 15, 2020, the Company announced its “Fearless, Color World” online concert to hold on September 9, 2020.

On July 9, 2020, the Company announced that its wholly owned subsidiary, Color China Entertainment Limited had signed a Framework Agreement with Moremoon Cartoon Cultural Diffusion (Shenzhen) Co., Ltd. to release multiple series of Moremoon products on the Company’s Color World platform.

On July 7, 2020, the Company announced that its wholly owned subsidiary, Color China Entertainment Limited had signed a cooperation agreement with a renowned American musician, Larry Carlton to serve as a Star Teacher on the Company’s online education platform Color World.

On July 2, 2020, the Company announced that its wholly owned subsidiary, Color China Entertainment Limited had just signed a cooperation agreement with a renowned guitarist, Zhengyan You (a.k.a. Masa) to serve as a Star Teacher on the Company’s online education platform Color World.

On July 1, 2020, the Company announced that its wholly owned subsidiary, Color China Entertainment Limited had signed a Broadcast and Educational Licensing Agreement with the famous American director Bobby Roth.

About Color Star Technology

Color Star Technology Co, Ltd. (Nasdaq CM: CSCW) is an entertainment and education company that provides online entertainment performances and online music education services. Its business operations are conducted through its wholly-owned subsidiaries Color China Entertainment Ltd. and CACM Group NY, Inc. The Company’s online education is provided through its Color World music and entertainment education platform. More information about the Company can be found at www.colorstarinternational.com.


Forward-Looking Statement

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as “may,” “will,” “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements.  Forward-looking statements are not guarantee of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the following:  the Company’s goals and strategies; the Company’s future business development; product and service demand and acceptance; changes in technology; economic conditions; the growth of the educational and training services market in China and other countries where CSCW conducts its business; reputation and brand; the impact of competition and pricing; government regulations; fluctuations in general economic and business conditions and assumptions underlying or related to any of the foregoing and other risks contained in reports filed by the Company with the Securities and Exchange Commission.  For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward–looking statements to reflect events or circumstances that arise after the date hereof unless required by applicable laws, regulations or rules.

For more information, please contact:

Sherry Zheng

Weitian Group LLC 
Email: [email protected]
Phone: +1-718-213-7386

 


COLOR STAR TECHNOLOGY CO., LTD. AND SUBSIDIARIES


(FORMERLY KNOWN AS HUITAO TECHNOLOGY CO., INC.)


CONSOLIDATED BALANCE SHEETS

June 30,

June 30,

2020

2019

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

$

988,696

$

319,514

Other receivables

1,002,300

2,300

Prepayments and advances

1,170,000

25,000

Current assets of discontinued operations

52,158,699

Total current assets

3,160,996

52,505,513

OTHER ASSETS

Property, plant and equipment, net

3,958,335

Other assets of discontinued operations

1,659,520

Total other assets

3,958,335

1,659,520

Total assets

$

7,119,331

$

54,165,033

LIABILITIES AND SHAREHOLDERS’ EQUITY

CURRENT LIABILITIES:

Other payables and accrued liabilities

$

518,122

$

353,292

Other payables – related parties

10,711

540,000

Loans payable – employee

308,089

Current liabilities of discontinued operations

52,442,854

Total current liabilities

528,833

53,644,235

Total liabilities

528,833

53,644,235

COMMITMENTS AND CONTINGENCIES

SHAREHOLDERS’ EQUITY:

Preferred shares, $0.001 par value, 1,000,000 shares authorized, no shares issued or

outstanding

Ordinary shares, $0.001 par value, 74,000,000 shares authorized, 25,623,822 and

7,174,626 shares issued and outstanding as of June 30, 2020 and 2019, respectively

25,624

7,175

Additional paid-in-capital

69,689,789

54,237,082

Deferred stock compensation

(1,201,183)

(3,161,200)

Deficit

(61,923,732)

(64,031,446)

Statutory reserves

6,248,092

Accumulated other comprehensive income

7,221,095

Total shareholders’ equity

6,590,498

520,798

Total liabilities and shareholders’ equity

$

7,119,331

$

54,165,033

 


COLOR STAR TECHNOLOGY CO., LTD. AND SUBSIDIARIES


(FORMERLY KNOWN AS HUITAO TECHNOLOGY CO., INC.)


CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

For the Years ended June 30,

2020

2019

2018

SELLING, GENERAL AND ADMINISTRATIVE EXPENSES

$

(1,598,984)

$

(2,065,829)

$

(918,605)

RESEARCH AND DEVELOPMENT EXPENSES

(120,000)

STOCK COMPENSATION EXPENSE

(3,444,617)

(4,592,200)

(1,388,501)

LOSS FROM OPERATIONS

(5,163,601)

(6,658,029)

(2,307,106)

OTHER INCOME (EXPENSE), NET

Interest income

84

13

Finance expense

(5,041)

(1,477)

(26)

TOTAL OTHER EXPENSE, NET

(5,041)

(1,393)

(13)

LOSS BEFORE PROVISION FOR INCOME TAXES

(5,168,642)

(6,659,422)

(2,307,119)

PROVISION FOR INCOME TAXES

LOSS FROM CONTINUING OPERATIONS

(5,168,642)

(6,659,422)

(2,307,119)

DISCONTINUED OPERATIONS:

Loss from discontinued operations, net of applicable income taxes

(12,245,168)

(7,729,108)

(5,092,846)

Net gain on sale of discontinued operations, net of applicable income

 taxes

5,787,213

LOSS FROM DISCONTINUED OPERATIONS

(6,457,955)

(7,729,108)

(5,092,846)

NET LOSS

$

(11,626,597)

$

(14,388,530)

$

(7,399,965)

COMPREHENSIVE LOSS

Net loss

$

(11,626,597)

$

(14,388,530)

$

(7,399,965)

Other comprehensive (loss) income – foreign currency translation (loss) gain

(335,080)

347,097

COMPREHENSIVE LOSS

$

(11,626,597)

$

(14,723,610)

$

(7,052,868)

LOSS PER ORDINARY SHARE

Weighted average number of shares:

Basic

11,640,018

5,841,614

2,942,945

Diluted

11,640,018

5,841,614

2,942,945

Loss per share – basic and diluted

Continuing operations

$

(0.44)

$

(1.14)

$

(0.78)

Discontinued operations

$

(0.55)

$

(1.32)

$

(1.73)

Total

$

(0.99)

$

(2.46)

$

(2.51)

 


COLOR STAR TECHNOLOGY CO., LTD. AND SUBSIDIARIES


(FORMERLY KNOWN AS HUITAO TECHNOLOGY CO., INC.)


CONSOLIDATED STATEMENTS OF CASH FLOWS

For the years ended June 30,

2020

2019

2018

CASH FLOWS FROM OPERATING ACTIVITIES:

Net loss

$

(11,626,597)

$

(14,388,530)

$

(7,399,965)

Net loss from discontinued operations

(6,457,955)

(7,729,108)

(5,092,846)

Net loss from continuing operations

(5,168,642)

(6,659,422)

(2,307,119)

Adjustments to reconcile net loss to net cash (used in) provided by

operating activities:

Stock compensation expense

3,444,617

4,592,200

1,388,501

Changes in operating assets and liabilities

Other receivables

(2,300)

Prepayments and advances

(1,145,000)

15,458

(40,458)

Other payables and accrued liabilities

130,036

509,381

2,000

Other payables – related parties

540,000

720,000

Net cash used in operating activities from continuing operations

(2,738,989)

(1,002,383)

(239,376)

Net cash provided by (used in) operating activities from

discontinued operations

203,854

(73,759)

2,689,394

Net cash (used in) provided by operating activities

(2,535,135)

(1,076,142)

2,450,018

CASH FLOWS FROM INVESTING ACTIVITIES:

Purchase of equipment

(2,000,000)

Cash acquired through acquisition of Color China

5,272

Proceeds from sales of discontinued operations

600,000

Net cash used in investing activities from continuing operations

(1,394,728)

Net cash used in investing activities from discontinued operations

(135,705)

(138,151)

Net cash used in investing activities

(1,394,728)

(135,705)

(138,151)

CASH FLOWS FROM FINANCING ACTIVITIES:

Borrowings from shareholders

300,000

Proceeds from sale of ordinary shares, net of offering costs

4,502,901

950,000

600,000

Net cash provided by financing activities from continuing operations

4,802,901

950,000

600,000

Net cash used in financing activities from discontinued operations

(7,294)

(427,333)

(6,395,823)

Net cash provided by (used in) financing activities

4,795,607

522,667

(5,795,823)

EFFECTS OF EXCHANGE RATE CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH

(1,943)

(62,025)

149,203

NET CHANGE IN CASH, CASH EQUIVALENTS AND

RESTRICTED CASH

863,801

(751,205)

(3,334,753)

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, beginning of year

347,486

1,098,691

4,433,444

CASH AND CASH EQUIVALENTS, end of year

$

1,211,287

$

347,486

$

1,098,691

 

 

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SOURCE Color Star Technology Co., Ltd.

Lowe’s Companies, Inc. Declares Cash Dividend

PR Newswire

MOORESVILLE, N.C., Nov. 13, 2020 /PRNewswire/ — The Board of Directors for Lowe’s Companies, Inc. (NYSE: LOW) has declared a quarterly cash dividend of sixty cents($0.60) per share, payable February 3, 2021, to shareholders of record as of January 20, 2021.

Lowe’s Companies, Inc. (NYSE: LOW) is a FORTUNE® 50 home improvement company serving approximately 18 million customers a week in the United States and Canada. With fiscal year 2019 sales of $72.1 billion, Lowe’s and its related businesses operate or service more than 2,200 home improvement and hardware stores and employ approximately 300,000 associates.  Based in Mooresville, N.C., Lowe’s supports the communities it serves through programs focused on creating safe, affordable housing and helping to develop the next generation of skilled trade experts. For more information, visit Lowes.com.

LOW-IR


Contacts:      


Shareholder /Analyst Inquiries:


Media Inquiries:        

Kate Pearlman 

Jackie Pardini Hartzell

704-775-3856

704-758-4317

[email protected] 

[email protected] 

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SOURCE Lowe’s Companies, Inc.

NeuroBo Pharmaceuticals Reports Third Quarter 2020 Financial Results

PR Newswire

BOSTON, Nov. 13, 2020 /PRNewswire/ — NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced financial results for the third quarter ended September 30, 2020.

“Throughout the third quarter and recent weeks, we continued to evaluate a variety of potential options for bringing the NB-01 asset to the market through a different regulatory pathway, including as an orphan drug or a rare disease indication,” stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo.

“We had continued work on preparing an Investigational New Drug (IND) application for submission to the U.S. Food and Drug Administration (FDA) for NB-02, our multi-component drug compound that, in pre-clinical models, has shown to impact multiple pathways involved in neurodegenerative disease.  Given the global resurgence of COVID-19, we have postponed continued work on the IND and the first human clinical trials for NB-02 until global health and macroeconomic conditions improve, with a view toward commencing clinical trial activity in the second half of 2021.

“We are also evaluating a number of potential opportunities that complement our multi-modal drug platforms.  Our development activity is mindful of conserving financial resources.  Toward that end, we believe we have the resources to fund our operations into the third quarter of 2021,” concluded Dr. Kang.

Third Quarter Financial and Operating Results Highlights

Upon the merger between Gemphire Therapeutics, Inc. and NeuroBo Pharmaceuticals, Inc. at year-end 2019, the formerly private NeuroBo was considered the accounting acquirer. In accordance with generally accepted accounting principles, the historical financial statements of private company, NeuroBo, are considered the financial statements of the combined company, with the merger accounted for as an acquisition of the Gemcabene family of related assets on December 30, 2019. The following highlights, therefore, represent the combined operations of both companies for the quarter ended September 30, 2020 and the operations of NeuroBo as a private company for the comparable quarter ended September 30, 2019.

  • Research and Development (R&D) Expenses were $1.3 million for the three months ended September 30, 2020, compared to $1.2 million for the three months ended September 30, 2019. The $0.1 million increase in the third quarter of 2020 was primarily attributed to CRO termination costs of $0.6 million, offset in part by the reduction in clinical trial activity of $0.3 million, given the determination in March 2020 to postpone Phase 3 clinical trials of NB-01. R&D expenses during the three months ended September 30, 2020 and 2019 included stock-based compensation of zero and $60,000, respectively.
  • General and Administrative Expenses were $1.8 million for the three months ended September 30, 2020, compared with $2.5 million for the three months ended September 30, 2019. The decrease of $0.7 million was primarily due to the reduction in transaction related costs that occurred during the third quarter of 2019 associated with legal, accounting and other consulting support of $1.6 million, offset by cost increases in the current quarter of $0.9 million related largely to director and officer insurance premiums of $0.4 million, public company related costs of $0.2 million, stock based compensation costs of $0.2 million, and payroll related costs of $0.1 million. Stock-based compensation costs during the three-month periods ended September 30, 2020 and 2019 were $0.2 million and a credit of $(6,000), respectively.
  • Net Loss for the third quarter ended September 30, 2020 was approximately $3.1 million, or $0.19 per basic and diluted share, based on 16,427,307 weighted average common shares outstanding, compared with a net loss of approximately $3.6 million, or $0.70 per basic and diluted share, based on 5,166,812 weighted average common shares outstanding for the same period in 2019.
  • Cash and Cash Equivalents were $12.4 million as of September 30, 2020, compared with $13.9 million at December 31, 2019. The Company expects that its cash position will be adequate to fund operations into the third quarter of 2021.

About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc. has a current portfolio of three drug candidates. The company’s NB-01 candidate has been shown in a Phase 2 study to significantly reduce pain symptoms associated with painful diabetic neuropathy (PDN), with a superior safety profile when compared to currently available treatments. Due to global COVID-19 crisis, a planned Phase 3 study was postponed. In the interim, NeuroBo is exploring a potential orphan drug indication targeting chronic pain for NB-01. NeuroBo’s NB-02 drug candidate is focused on the treatment of Alzheimer’s disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. The company’s third program, Gemcabene, was developed for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease.

NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. In December 2019, NeuroBo merged with Gemphire Therapeutics and through such merger, became listed on the Nasdaq Stock Market and added the Gemcabene family of related assets to its portfolio. For more information visit: https://www.neurobopharma.com.

Forward Looking Statements
Any statements in this press release that are not statements of historical fact constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, statements regarding the development of NeuroBo’s product candidates and the therapeutic potential, timing and nature of clinical trials and potential regulatory approval of NeuroBo’s clinical programs and pipeline. Forward-looking statements are usually identified by the use of words, such as “believes,” “anticipates,” “expects,” “intends,” “plans,” “may,” “potential,” “will,” “could” and similar expressions. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors and risks. These factors, risks and uncertainties include, but are not limited to: the occurrence of health epidemics or contagious diseases, such as COVID-19, and potential effects on NeuroBo’s business, clinical trial sites, supply chain and manufacturing facilities; NeuroBo’s ability to continue as a going concern; the timing of completion of NeuroBo’s planned clinical trials; the timing of the availability of data from NeuroBo’s clinical trials; NeuroBo’s plans to research, develop and commercialize its current and future product candidates, including the potential alternative pathways for NB-01; the economic feasibility of developing NB-01 under an alternative pathway including pursuant to the terms of NeuroBo’s exclusive license agreement with Dong-A ST; NeuroBo’s ability to successfully collaborate with existing collaborators or enter into new collaborations and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of NeuroBo’s product candidates; the impact of government laws and regulations; NeuroBo’s ability to protect its intellectual property position; and NeuroBo’s need for additional financing to fulfill its stated goals; and other factors discussed in the “Risk Factors” section of NeuroBo’s Annual Report on Form 10-K and in our other filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent NeuroBo’s views as of the date hereof. NeuroBo anticipates that subsequent events and developments will cause its views to change. However, while NeuroBo may elect to update these forward-looking statements at some point in the future, NeuroBo specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing NeuroBo’s views as of any date subsequent to the date hereof.

Contacts:

Rx Communications Group

Melody Carey

+1-917-322-2571
[email protected]

– Tables to Follow –



 


NeuroBo Pharmaceuticals, Inc.


Condensed Consolidated Balance Sheets


(in thousands, except share amounts and par value)


September 30, 


December 31, 


2020


2019


(unaudited)

Assets

Current assets:

 Cash

$

12,353

$

13,908

 Restricted cash

15

 Prepaid expenses

511

153

 Other assets

34

42

Total current assets

12,898

14,118

Right-of-use assets

100

116

Property and equipment, net

167

200

Other assets

33

34

Total assets

$

13,198

$

14,468

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$

1,101

$

638

Accrued liabilities

2,491

1,422

Lease liability, short-term

23

22

Total current liabilities

3,615

2,082

Lease and other long-term liabilities

77

94

Total liabilities

3,692

2,176

Commitments and contingencies

Stockholders’ equity:

Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares
issued or outstanding as of September 30, 2020 and December 31, 2019.

Common stock, $0.001 par value per share, 100,000,000 shares authorized;
16,427,307 and 15,592,718 shares issued and outstanding as of September
30, 2020 and December 31, 2019, respectively.

17

16

Additional paid–in capital

56,526

49,130

Accumulated other comprehensive (loss) income

(3)

12

Accumulated deficit

(47,034)

(36,866)

Total stockholders’ equity

9,506

12,292

Total liabilities and stockholders’ equity

$

13,198

$

14,468

 

 


NeuroBo Pharmaceuticals, Inc.


Condensed Consolidated Statements of Operations and Comprehensive Loss


(in thousands, except share and per share amounts)


(unaudited)


For the Three Months Ended


For the Nine Months Ended


September 30, 


September 30, 


2020


2019


2020


2019

Operating expenses:

Research and development

$

1,265

$

1,150

$

4,091

$

3,898

General and administrative

1,795

2,495

6,110

4,085

Total operating expenses

3,060

3,645

10,201

7,983

Loss from operations

(3,060)

(3,645)

(10,201)

(7,983)

Interest income (expense), net

6

24

34

(3)

Other (expense) income, net

(1)

Loss before income taxes

(3,054)

(3,621)

(10,168)

(7,986)

Provision for income taxes

Net loss

(3,054)

(3,621)

(10,168)

(7,986)

Other comprehensive income (loss):

 Foreign currency translation gain (loss), net of
tax

13

(11)

(15)

(2)

Total other comprehensive income (loss)

13

(11)

(15)

(2)

Comprehensive loss

$

(3,041)

$

(3,632)

$

(10,183)

$

(7,988)

Loss per share:

Net loss per share, basic and diluted

$

(0.19)

$

(0.70)

$

(0.63)

$

(1.55)

Weighted average common shares outstanding:

Basic and diluted

16,427,307

5,166,812

16,135,000

5,166,812

 

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SOURCE NeuroBo Pharmaceuticals, Inc.