Market Newsdesk

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.

“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:

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.

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.

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.

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:

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.

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.

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.

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.

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SOURCE Palatin Technologies, Inc.

CHICAGO, Nov. 17, 2020 /PRNewswire/ — Morningstar, Inc. (Nasdaq: MORN), a leading provider of independent investment research, today announced it has begun formally integrating environmental, social, and governance (ESG) factors into its analysis of stocks, funds, and asset managers.

Morningstar equity research analysts will employ a globally consistent framework to capture ESG risk across over 1,500 stocks. Analysts will identify valuation-relevant risks for each company using Sustainalytics’ ESG Risk Ratings, which measure a company’s exposure to material ESG risks, then evaluate the probability those risks materialize and the associated valuation impact. Results from this research will inform Morningstar’s assessment of a stock’s intrinsic value and the margin of safety required before assigning a Morningstar Rating™ for stocks between five- and one-star. Morningstar acquired Sustainalytics, a globally recognized leader in ESG ratings and research, in July 2020. 

Morningstar manager research analysts will analyze the extent to which strategies and asset managers are incorporating ESG factors as part of its new Morningstar ESG Commitment Level evaluation. In conducting the strategy evaluation, the analysts will assess the analytics and personnel committed to each strategy and the extent to which the strategy incorporates those resources into the investment process. To perform the evaluation of asset managers, analysts will consider how clearly the firm has articulated its ESG philosophy and policies, and the degree to which it has driven those policies through its culture and investment processes. The ESG Commitment Level evaluation of strategies and asset managers will follow a four-point scale of Leader, Advanced, Basic, and Low.   

“Investors are expressing their investment objectives in more-encompassing terms than ever before, and they’re putting their money where their mouth is,” said Haywood Kelly, Morningstar’s head of research. “For companies, evaluating ESG risk is a business imperative to both meet diverse stakeholder needs and mitigate potential legal, operational, or reputational risks. Morningstar’s equity and manager research teams aim to address these trends and empower investors through long-term, methodological research approaches, bolstered by qualitative analysis and independent thinking.”

Integrating Sustainalytics ESG Research into Morningstar’s Equity Research Methodology

Morningstar equity research analysts will utilize Sustainalytics research to capture ESG risk using a consistent process across industries, and in a manner that aligns with Morningstar’s long-term oriented and fundamentals-focused investment philosophy through two principal channels: the Morningstar® Economic Moat Rating™ and the Uncertainty Rating. These ratings inform Morningstar’s assessment of intrinsic value and required margin of safety, respectively, and ultimately, are rolled into the Morningstar Rating™ for stocks.

1. Economic Moat Rating: The framework to determine a company’s Economic Moat Rating, Morningstar’s measure of a firm’s sustainable competitive advantage, will be updated to capture the long-term threat ESG risks may pose to the value creation capabilities of an otherwise competitively advantaged business, thereby precluding or limiting an economic moat.
2. Uncertainty Rating: The framework for Morningstar’s Uncertainty Rating, which gauges the relative predictability of future cash flows, will be updated to formally capture long-term ESG risks alongside other factors, such as a firm’s sensitivity to the overall economy, product concentration, and pricing power.

Additionally, Morningstar will rename the Stewardship Rating to Morningstar Capital Allocation Rating and refine the framework to isolate and evaluate management performance across three key dimensions: balance sheet health, investment efficacy, and shareholder distributions. Analysts have identified these three factors as being important in measuring management’s impact on total shareholder returns.

“Integrating ESG directly into the marrow of our research methodology helps us to widen the aperture of the traditional financial analysis and more precisely capture ESG risks that can exert a profound influence on long-term competitive dynamics and the sustainability of a company’s earnings,” said Dan Rohr, head of equity research for Morningstar.

Analysts will use Sustainalytics’ ESG Risk Ratings as the basis for identifying valuation-relevant risks. The ESG Risk Ratings measure a company’s exposure to industry-specific material ESG risks and how well a company is managing those risks. This approach to measuring ESG risk combines the concepts of management and exposure to arrive at an assessment of ESG risk – the ESG Risk Rating – which is comparable across all industries.

“Investors need to understand what the long-term risks to a company are, how much of that risk is well managed by a company, and how much unmanaged risk remains,” said Wilco van Heteren, Sustainalytics’ executive director of ESG research. “By affording material ESG issues a central role in a risk-based approach to valuation, Morningstar is reinforcing its long-term investment philosophy. We are excited that Morningstar is incorporating our ESG Risk Ratings into its equity research environment.”

Morningstar will begin to roll out the equity research rating enhancements on Dec. 9, 2020 and apply to Morningstar’s global equity research coverage universe of more than 1,500 companies. The incorporation of ESG factors will update on a rolling basis through 2021.

The new methodology for Morningstar’s equity research is available here. Further detail on how ESG will be integrated into each component is available here and more specifically for the Capital Allocation Rating here.

The Morningstar ESG Commitment Level

Morningstar manager research analysts will analyze the extent to which strategies (The Morningstar ESG Commitment Level for Strategies) and asset managers (The Morningstar ESG Commitment Level for Asset Managers) are incorporating ESG factors. The ESG Commitment Level assessment is qualitative in nature, with analysts assigning a Commitment Level to strategies and asset managers on a four-point scale of Leader, Advanced, Basic, and Low.

Analysts determine the ESG Commitment Level for Strategies by evaluating each strategy’s process, resources, and the asset manager behind the strategy. The analysts will assign an ESG Commitment level of “Leader” to strategies that have top-flight resources, including dedicated ESG investment professionals as well as comprehensive ESG data and analytics. Moreover, these strategies fully incorporate those resources and analysis into the investment process, spanning initial screening, issue selection, portfolio construction, and risk management, and have transparent and well-implemented programs to actively engage with portfolio holdings on ESG issues and vote proxies.

Analysts assign the ESG Commitment Level for Asset Managers by assessing each firm’s philosophy and process, resources, and active ownership activities. The analysts will assign an ESG Commitment Level of “Leader” to firms that incorporate ESG principles into their investment programs to the greatest extent relative to peers. This includes a clearly articulated ESG philosophy and associated policies, top-of-line ESG resources and data, and incorporation procedures that span all asset classes and extend to the majority of assets under management. These firms also follow best-in-class engagement and proxy voting practices.

Morningstar’s manager research team today published ESG Commitment Level assignments to a global set of funds and asset managers in a new research paper, “The Morningstar ESG Commitment Level: Our first assessment of 100-plus strategies and 40 asset managers.”  

“In an increasingly confusing area of investing with different approaches, standards, disclosures, and more, the ESG Commitment Level will help investors discern funds and asset managers that truly focus on sustainable investing from those that incorporate ESG factors but in a limited way,” said Hortense Bioy, director of sustainability research for Morningstar in EMEA and APAC.

The analysts will continue to extend the ESG Commitment Level to additional strategies and asset managers under analyst coverage and receive the Morningstar Analyst Rating™ for funds in the regular course of their work. As of November 2020, analyst coverage includes more than 5,400 vehicles, including open-end funds, closed-end funds, exchange-traded funds, and other vehicle types globally. In 2021, the ESG Commitment Level will be made available on Morningstar platforms, including Morningstar’s flagship investment research platform Morningstar Direct^SM, and individual investor website, Morningstar.com.

The full research paper and first set of ESG Commitment Level designations is available here. The methodology for the ESG Commitment Level is available here.

About Morningstar, Inc.

Morningstar, Inc. is a leading provider of independent investment research in North America, Europe, Australia, and Asia. The Company offers an extensive line of products and services for individual investors, financial advisors, asset managers, retirement plan providers and sponsors, and institutional investors in the debt and private capital markets. Morningstar provides data and research insights on a wide range of investment offerings, including managed investment products, publicly listed companies, private capital markets, debt securities, and real-time global market data. Morningstar also offers investment management services through its investment advisory subsidiaries, with approximately $215 billion in assets under advisement and management as of Sept. 30, 2020. The Company has operations in 29 countries. For more information, visit www.morningstar.com/company. Follow Morningstar on Twitter @MorningstarInc.

Morningstar’s Equity and Manager Research Groups consist of various wholly owned subsidiaries of Morningstar, Inc. including, but not limited to, Morningstar Research Services LLC, registered with and governed by the U.S. Securities and Exchange Commission. Ratings and analyses are based on Morningstar’s Equity or Manager Research Group’s current expectations about future events and therefore involve unknown risks and uncertainties that may cause such expectations not to occur or to differ significantly from what was expected. Ratings and analyses are subjective in nature and should not be used as the sole basis for investment decision, are not guarantees, and should not be viewed as credit ratings or an assessment of the creditworthiness of a security or separately managed account, or (if applicable) their underlying holdings. This press release is for informational purposes only; references to securities or a separately managed account investment strategy in this press release should not be considered an offer or solicitation to buy or sell the securities or to invest in accordance with that strategy.

©2020 Morningstar, Inc. All Rights Reserved.

MORN-R

Media Contact

Sarah Wirth, +1 312 244-7358 or [email protected]

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SOURCE Morningstar, Inc.

CENTREVILLE, Va., Nov. 17, 2020 /PRNewswire/ — Parsons Corporation (NYSE: PSN) announced today that the company has been selected by Houston Airports to support infrastructure projects and other initiatives related to the effective management of capital renewal and operations and maintenance services. The $50 million contract, which includes a five-year base plus one three-year option, will support Houston Airports’ projects at George Bush Intercontinental Airport (IAH), William P. Hobby Airport (HOU) and Ellington Airport (EFD).

“Airports are connectors powering the mobility and economic growth of communities around the world, and Houston Airports connect millions of passengers to their destinations every year,” said Tom Topolski, executive vice president, Connected Communities market for Parsons. “Houston Airports shares our team’s passion for enhancing the travel experience, and we look forward to helping manage planned capital improvements that will provide safe, efficient and convenient travel options to their customers.”

Parsons has supported Houston Airports’ IAH Terminal Redevelopment Program (ITRP) for five years. The new contract will expand the company’s work beyond ITRP.

“We look forward to continuing our partnership with Parsons as we undertake future infrastructure programs, projects and other initiatives,” Chief Development Officer of Houston Airports Bob Barker said. “Houston Airports is committed to serving the traveling public with world-class facilities and features, and these highly qualified professionals will serve as an extension of our staff.”

If all option periods are exercised, Parsons’ staff will support all phases of the assigned projects, including program initiation, program definition, design review and approval, procurement, construction management, commissioning and activation, and contract closeout.

To learn more about Parsons’ critical infrastructure expertise, visit Parsons.com/markets/critical-infrastructure/.  

Parsons (NYSE: PSN) is a leading disruptive technology provider in the global defense, intelligence, and critical infrastructure markets, with capabilities across cybersecurity, missile defense, space, connected infrastructure, and smart cities. Please visit parsons.com, and follow us on LinkedIn and Facebook to learn how we’re making an impact.

Media Contact:                                                           
Bernadette Miller
+1 980.253.9781
[email protected]

Investor Relations Contact:
Dave Spille
+ 1 571.655.8264
[email protected]

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SOURCE Parsons Corporation

DUBLIN, Nov. 17, 2020 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that Jennifer Cook and Mark D. Smith, M.D. have been appointed to the Company’s Board of Directors, effective December 1, 2020.

“We are excited to welcome two industry leaders to the Board whose complementary skills and experiences will help us advance our strategy to transform the lives of patients. Jennifer brings over 30 years of biopharmaceutical experience with significant c-suite, product development and commercialization expertise globally, and Mark, a practicing physician, is a nationally-recognized expert in health policy, reimbursement and delivery systems,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. “Jazz is well-positioned for transformative growth, with strong commercial franchises, a robust and productive pipeline and a commitment to targeted investments in our global platform. As we seek to leverage our robust R&D assets to develop new treatments and utilize our proven commercialization engine to bring these innovations to market, we will benefit from Jennifer’s and Mark’s insights and leadership.”

Ms. Cook said, “I am excited to join the Board and look forward to putting my experience to work as the Company brings new and exciting therapies to market. I am impressed by how the team has navigated the current environment, having launched three new products this year alone, and am confident in Jazz’s future.”

Dr. Smith added, “This has been a transformative year for Jazz, and I am honored to be joining the Company’s Board. Jazz has an important purpose and I am eager to support its mission to deliver life-changing medicines to patients in areas of high unmet need.”

Ms. Cook joins Jazz as a Class II director and will be up for election at the Company’s 2022 annual meeting. Dr. Smith joins Jazz as a Class I director and will be up for election at the Company’s 2021 annual meeting.

The Company also announced that after many years of outstanding service and dedication, Elmar Schnee will not seek reelection when his term expires at the Company’s 2021 annual meeting of shareholders, and Paul Berns will step down on or before the Company’s 2021 annual meeting of shareholders.   

“I want to express our deepest appreciation for Elmar’s and Paul’s numerous contributions to Jazz during their many years of service on the Board of Directors,” said Mr. Cozadd. “Their industry and product development expertise have been invaluable in positioning Jazz as a leader in sleep medicine with a growing hematology/oncology portfolio. It is an honor to work closely with Elmar and Paul and I look forward to their continued counsel and engagement over the next several months.”

About Jennifer Cook

Ms. Cook was the Chief Executive Officer at GRAIL, Inc., a privately-held early cancer detection diagnostic company from January 2018 to June 2019. Prior to that, Ms. Cook was at Roche Pharmaceuticals/Genentech for 25 years where she held a number of senior management positions covering the full lifecycle of product development and commercialization. From 2010 to 2013, she oversaw Genentech’s U.S. Immunology and Ophthalmology Business Unit, and from 2013 to 2016, she led Roche’s European commercial business. She also served as Roche’s Global Head of Clinical Operations throughout 2017. In 2016, Ms. Cook was recognized as Woman of the Year by the Healthcare Businesswoman’s Association.

Ms. Cook currently serves as non-executive director on the boards of two publicly-held biotechnology companies, Denali Therapeutics Inc., and BridgeBio Pharma, Inc. She also serves on the board of Ambys Medicines, Inc., a privately-held biotechnology company. Ms. Cook received a B.A. in human biology and a M.S. in biology from Stanford University and an M.B.A. from the Haas School of Business at University of California, Berkeley.

About Mark Smith, M.D.


Mark Smith, M.D., is a professor of clinical medicine at the University of California at San Francisco, where he has served since 1994. From 1996 to 2013, Dr. Smith was the founding President and Chief Executive Officer of the California HealthCare Foundation, an independent nonprofit philanthropy organization. Prior to that, from 1991 to 1996, he served as Executive Vice President at the Henry J. Kaiser Family Foundation.

Dr. Smith currently serves as non-executive director on the boards of two publicly-held healthcare companies, Phreesia Inc. and Teladoc Health, Inc. He also serves on the board of The Commonwealth Fund, a private health policy foundation, and the Institute for Health Care Improvement, an independent nonprofit organization. Dr. Smith holds a B.A. from Harvard College, an M.D. from the University of North Carolina, and an M.B.A. from the Wharton School at the University of Pennsylvania.

About


 


Jazz Pharmaceuticals


 plc



Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharmaceutical company dedicated to developing and commercializing life-changing medicines that transform the lives of patients with serious diseases — often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep and movement disorders, and in oncology, including hematologic malignancies and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Media Contact:

Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations
Ireland +353 1 697 2141         U.S. +1 215 867 4910

Investor Contact: 

Kathee Littrell, Vice President, Investor Relations
Ireland +353 1 634 7887         U.S. +1 650 496 2717

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SOURCE Jazz Pharmaceuticals plc