Market Newsdesk

CAMBRIDGE, Mass., Nov. 12, 2020 /PRNewswire/ — Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the third quarter ended September 30, 2020.

Leap Third Quarter Highlights:

• First patient dosed in Phase 2a study of Leap’s anti-Dickkopf-1 (DKK1) antibody DKN-01 in combination with tislezumab, BeiGene’s anti-PD-1 antibody, for the treatment of metastatic gastric or gastroesophageal junction (G/GEJ) cancer
• Presented updated data from DKN-01 in esophagogastric (EGC) cancer demonstrating positive outcomes in DKK1-high patients
• Presented updated data for DKN-01 in endometrial cancer demonstrating single agent activity in biomarker-selected patients
• U.S. Food and Drug Administration (FDA) Fast Track designation granted to DKN-01 for the treatment of  G/GEJ cancer

“Data from our ongoing studies continue to demonstrate the potential of DKN-01 as both a single-agent or combination treatment with chemotherapy or anti-PD1 therapies for the treatment of biomarker-defined cancer patients,” said Douglas E. Onsi, President and Chief Executive Officer of Leap. “We are also excited by the progress we’ve made with BeiGene this quarter, having dosed the first patient  in the combination study of DKN-01 plus tislelizumab, BeiGene’s anti-PD-1 antibody, for the treatment of gastric or gastroesophageal junction cancer patients.”

DKN-01 Development Update

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment.

• 
  Leap and BeiGene Announced First Patient Dosed in Study of DKN-01 in Combination with Tislelizumab for the Treatment of Metastatic G/GEJ Cancer –
  Leap and BeiGene, Ltd. announced that the first patient was dosed in the DisTinGuish trial (NCT04363801), a Phase 2a, nonrandomized, open-label, multicenter study of Leap’s DKN-01 in combination with BeiGene’s tislelizumab with or without chemotherapy as first-line or second-line therapy in adult patients with inoperable, locally advanced G/GEJ adenocarcinoma. The study, which will be conducted in two parts, is expected to enroll up to 72 patients.

  Part A will enroll up to 24 patients with G/GEJ adenocarcinoma who have received no prior systemic treatment in the locally advanced/metastatic setting (first-line treatment), and Part B will enroll up to 48 patients with previously treated, inoperable, locally advanced or metastatic DKK1-high G/GEJ adenocarcinoma (second-line treatment). The study is designed to evaluate safety, tolerability, and efficacy of the combination therapy of intravenous DKN-01 and tislelizumab ± CAPOX (capecitabine + oxaliplatin) in G/GEJ adenocarcinoma patients. Treatment will be conducted in repeating 21-day cycles until the patient meets pre-established criteria for discontinuation or is no longer deriving clinical benefit. Part A and Part B of the study will be conducted concurrently.

• 
  Leap Presented Updated Data from DKN-01 in EGC Demonstrating Positive Outcomes in DKK1-high Patients –
  At the Society for Immunotherapy of Cancer’s (SITC) 35^th Anniversary Annual Meeting, Leap presented clinical data from the Phase 1b/2a clinical trial of DKN-01 in patients with advanced EGC. In the study, high levels of tumoral DKK1 expression correlated with improved clinical outcomes in heterogeneous EGC patients treated with DKN-01 monotherapy or in combination with paclitaxel or the anti-PD-1 antibody, pembrolizumab. Important patient subgroups in this study demonstrated consistent benefit in DKK1-high patients, including:

• Anti-PD-1/PD-L1 refractory patients (all):  The four DKK1-high patients had a significantly longer median progression-free survival (PFS) of 12.8 weeks and median overall survival (OS) of 46 weeks as compared to the five DKK1-low patients who experienced PFS of 6 weeks and OS of 16 weeks.
• Anti-PD1/PD-L1 refractory GEJ/GC patients:  The three DKK1-high patients had a best response of stable disease (SD) and a longer PFS of 13.4 weeks and OS of 37.4 weeks, as compared to the two DKK1-low patients who both had progressive disease (PD) with a PFS of 3.6 weeks and OS of 11.7 weeks.
• Anti-PD-1/PD-L1 naïve GEJ/GC patients:  As previously reported, DKK1-high patients experienced over 22 weeks PFS and nearly 32 weeks OS, with a 50% overall response rate (ORR) and 80% disease control rate (DCR) in ten evaluable patients. DKK1-low patients experienced nearly 6 weeks PFS and over 17 weeks OS, with a 20% DCR in fifteen evaluable patients. PD-L1 Combined Positive Scores (CPS) did not predict efficacy on the combination of DKN-01 plus pembrolizumab. In multi-variate analysis, DKK1-high status correlated with longer PFS independent of PD-L1 CPS scores.

• 
  Leap Presented Updated Data for DKN-01 in Endometrial Cancer Demonstrating Single Agent Activity in Biomarker-selected Patients –
  At the American Association for Cancer Research (AACR) Virtual Special Conference on Endometrial Cancer: New Biology Driving Research and Treatment, Leap presented additional clinical data from the epithelial cancer (EEC) patients treated with DKN-01 monotherapy as part of its ongoing Phase 2 clinical trial for DKN-01, as both a monotherapy and in combination with paclitaxel chemotherapy, in patients with advanced gynecological malignancies. Twenty-nine EEC patients were enrolled in the DKN-01 monotherapy arm, over 75% of whom had experienced three or more prior lines of therapy. Of those patients, 26 were evaluable for response. Three important biomarker-selected subgroups were the focus of the data presentation:

• Patients with Wnt Signaling Alterations: Patients with a Wnt signaling alteration had a higher response rate, greater clinical benefit, and longer PFS and OS compared to patients without a Wnt signaling alteration. In the group of 20 patients with a Wnt signaling alteration, one patient (5%) has an ongoing complete response, one patient (5%) had a partial response, eight patients (40%) had a best response of SD, and 10 patients (50%) had PD, representing an ORR of 10% and a DCR of 50%. In the group of six patients without any Wnt signaling alterations, one patient (16.6%) had a best response of SD and five patients (83.3%) had PD. The patients with a Wnt signaling alteration experienced PFS of 1.9 months and OS of 15.1 months, compared to the patients without a Wnt signaling alteration who experienced PFS of 1.8 months and OS of 8.4 months.
• Patients with Wnt Activating Mutations: Patients with Wnt activating mutations had longer PFS and OS than patients without Wnt activating mutations. The nine patients with a Wnt activating mutation experienced PFS of 5.5 months and had not reached a median OS, compared to the 20 patients without a Wnt activating mutation who experienced PFS of 1.8 months and OS of 12.2 months.
• Patients expressing high tumor levels of DKK1: DKK1 expression data was available for 19 EEC patients treated with DKN-01 monotherapy. DKK1-high patients had a higher response rate, greater clinical benefit, and longer PFS than patients who were DKK1-low. In the group of seven patients with DKK1-high tumors, one patient (14.3%) had a partial response, three patients (42.9%) had SD, and three patients (42.9%) had PD, representing an ORR of 14.3% and a DCR of 57.1%. In the group of 12 patients with DKK1-low tumors, one patient (8.3%) had SD and 11 patients (91.7%) had PD. The DKK1-high patients experienced PFS of 3.0 months, compared to the DKK1-low patients who experienced PFS of 1.8 months.

• Leap Announced FDA Fast Track Designation Granted to DKN-01 for the Treatment of Gastric or Gastroesophageal Junction Cancer – Leap announced that the FDA granted Fast Track designation to DKN-01 for the treatment of patients with G/GEJ adenocarcinoma whose tumors express high DKK1, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy. The Fast Track program is intended to facilitate the development and expedite the review of drug candidates and vaccines that treat serious conditions and fill an unmet medical need. The purpose of Fast Track is to get important new drugs to the patient earlier. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application. DKN-01 has also received Orphan Drug Designation for the treatment of G/GEJ cancer from the FDA.

Selected Third Quarter 2020 Financial Results

Net loss was $7.1 million for the third quarter 2020, compared to $7.9 million for the same period in 2019. This decrease was primarily due to revenue recognized from the BeiGene agreement, a decrease in clinical development expenses and non-cash foreign currency gains associated with changes in the Australian dollar exchange rate related to certain manufacturing activities.

Research and development expenses were $5.4 million for the third quarter 2020, compared to $5.8 million for the same period in 2019. The decrease was primarily driven by reductions in clinical trial costs due to the deprioritization of the TRX518 program in November 2019 and the timing of patient enrollment. These decreases were partially offset by an increase in payroll and other related expeneses for research and development employees.

General and administrative expenses were $2.5 million for the third quarter 2020, compared to $2.2 million for the same period in 2019. The increase was due to higher professional fees primarily attributable to recruiting and information technology costs.

Cash, cash equivalents and marketable securities totaled $58.0 million at September 30, 2020. Research and development incentive receivables, current and long term, totaled approximately $0.2 million at September 30, 2020.

About Leap Therapeutics

Leap Therapeutics (Nasdaq:LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has entered into a strategic partnership with BeiGene, Ltd. for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New Zealand. For more information about Leap Therapeutics, visit http://www.leaptx.com or view our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via https://investors.leaptx.com/.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include Leap’s expectations with respect to the development and advancement of DKN-01, including the initiation, timing and design of future studies, enrollment in future studies, potential for the receipt of future option exercise, milestones or royalty payments from BeiGene, and other future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. Such risks and uncertainties include, but are not limited to: that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by COVID-19 related issues; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; the size and growth potential of the markets for our drug product candidates; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics’ periodic filings with the SEC, including Leap’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as filed with the SEC on March 16, 2020 and as may be updated by Leap’s Quarterly Reports on Form 10-Q and the other reports Leap files from time to time with the SEC. Any forward-looking statements contained in this release speak only as of its date. Leap undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACT:

Douglas E. Onsi

President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
[email protected]

Heather Savelle

Investor Relations
Argot Partners
212-600-1902
[email protected]

 

 

 

View original content to download multimedia:http://www.prnewswire.com/news-releases/leap-therapeutics-reports-third-quarter-2020-financial-results-301171475.html

SOURCE Leap Therapeutics, Inc.

Two-day online auction attracted 11,300+ bidders from 67 countries; up 39% year over year

HOUSTON, Nov. 12, 2020 /PRNewswire/ – Demand for equipment at Ritchie Bros.’ online auctions continues to break records, as the company saw bidder registrations jump 39 percent year over year for this week’s US$53+ million auction in Houston, TX.

Due to COVID, the November 10 – 11 auction was conducted 100% online, attracting interested bidders from 67 countries. Approximately 85 percent of the assets in the auction were purchased by U.S. buyers, including 40 percent purchased by buyers from Texas, while international buyers from as far away as Mexico, Australia, and the United Kingdom purchased 15 percent.

“As one of the first big auctions of our fourth quarter, we are excited by the continued record-breaking demand and strong pricing we achieved this week in Houston,” said Alan McVicker, Regional Sales Manager, Ritchie Bros. “Auction after auction we continue to prove that no matter the format—onsite, online, or both—we deliver unmatched demand and results. In fact, we saw more international participation in Houston this week than the site had seen in 12 – 18 months. If you have equipment to sell, we encourage you to contact us today to be a part of one of the many events we have before the end of the year.”

Sales highlights include:

• A 2012 Link-Belt HTC3140LB 140-ton 10x6x4 hydraulic truck crane sold for US$425,000
• A 2005 Terex HC275 275-ton crawler crane sold for US$350,000
• A 2019 Komatsu PC360LC-11 hydraulic excavator sold for US$185,000
• A 2017 Volvo A40G 6×6 articulated dump truck sold for US$177,500
• A 2016 Caterpillar 930M wheel loader sold for US$125,000

AUCTION QUICK FACTS: HOUSTON, TX (NOVEMBER 2020)

• Gross Transaction Value (GTV): US$53+ million
• Total Registered Bidders: 11,300+
• Total Number of Lots: 5,900+
• Total Number of Consignors: 700

Ritchie Bros.’ final Texas auction of the year will be held in Fort Worth on December 8 – 9, 2020. For more information about buying and selling with Ritchie Bros., visit RitchieBros.com.

About Ritchie Bros.:

Established in 1958, Ritchie Bros. (NYSE and TSX: RBA) is a global asset management and disposition company, offering customers end-to-end solutions for buying and selling used heavy equipment, trucks and other assets. Operating in a number of sectors, including construction, transportation, agriculture, energy, oil and gas, mining, and forestry, the company’s selling channels include: Ritchie Bros. Auctioneers, the world’s largest industrial auctioneer offers live auction events with online bidding; IronPlanet, an online marketplace with featured weekly auctions and providing the exclusive IronClad Assurance® equipment condition certification; Marketplace-E, a controlled marketplace offering multiple price and timing options; Mascus, a leading European online equipment listing service; and Ritchie Bros. Private Treaty, offering privately negotiated sales. The company’s suite of multichannel sales solutions also includes Ritchie Bros. Asset Solutions, a complete end-to-end asset management and disposition system. Ritchie Bros. also offers sector-specific solutions including GovPlanet, TruckPlanet, and Kruse Energy, plus equipment financing and leasing through Ritchie Bros. Financial Services. For more information about Ritchie Bros., visit RitchieBros.com.

Photos and video for embedding in media stories are available at rbauction.com/media. 

View original content:http://www.prnewswire.com/news-releases/strong-pricing-continues-in-us53-million-ritchie-bros-auction-in-houston-tx-301171743.html

SOURCE Ritchie Bros.

MINNEAPOLIS, Nov. 12, 2020 /PRNewswire/ — Target Corporation (NYSE: TGT) is celebrating the one-year anniversary of its popular, easy-to-use loyalty program, Target Circle, and will be offering its nearly 80 million members more ways to save big this holiday season. As one of the nation’s largest loyalty programs, Target Circle members have:

• Saved nearly $2 billion through Target Circle offers
• Earned nearly $200 million by getting 1% rewards on purchases to put toward their future Target visit
• Directed more than $7 million to more than 2,500 local and national nonprofit organizations

This holiday season, Target guests will find nearly 1 million more deals than last year. And Target Circle members have easy access to all of these great offers in one place – no membership fee required. It makes it easier than ever to save whether they shop in store or choose from Target’s suite of industry-leading, same-day fulfillment options – getting their orders in as little as one hour.

“In just one year, it’s been amazing to see how our guests have embraced Target Circle, saving millions of dollars and helping give back to their local communities,” said Rick Gomez, executive vice president and chief marketing, digital and strategy officer, Target. “Heading into the holidays, our nearly 80 million members – and growing – will have access to even more great deals. Combined with the safety and ease of our contactless same-day services, it’s an unparalleled offer – with no membership fee required.”

No Need to Wait
Target Circle is easy to use and free to join. New members can sign up by creating a Target.com account, downloading the Target App or by providing their phone number in a Target store.

Throughout the holiday season and always, Target is here to make it easy and safe to get the items guests need quickly and conveniently. With Target’s contactless, same-day fulfillment options, guests can get their orders in as little as one hour, with no membership required.

The retailer’s suite of same-day services include:

• Drive Up in 1,800 stores nationwide, allowing guests to shop for thousands of items via the Target app and have them brought directly to their cars within minutes of arriving at the store. 
• Order Pickup is available at all stores, which allows guests to shop online and grab their items at an Order Pickup counter – ready within a few hours.
• Same-Day Delivery with Shipt via a free, four-week trial, a $99 annual membership or $9.99 per-order option.

To sign up for the Target Circle loyalty program for free and start saving today, visit Target.com/circle. For more information on Target’s holiday deals or its suite of pickup and delivery options, visit Target.com. 

About Target


Minneapolis-based Target Corporation (NYSE: TGT) serves guests at nearly 1,900 stores and at Target.com. Since 1946, Target has given 5 percent of its profit to communities, which today equals millions of dollars a week. For the latest store count or for more information, visit Target.com/Pressroom. For a behind-the-scenes look at Target, visit Target.com/abullseyeview or follow @TargetNews on Twitter.

View original content to download multimedia:http://www.prnewswire.com/news-releases/target-circle-celebrates-one-year-anniversary-unlocks-holiday-deals-for-nearly-80-million-members-301171428.html

SOURCE Target Corporation

DUBLIN, Nov. 12, 2020 /PRNewswire/ — Fly Leasing Limited (NYSE: FLY) (“FLY”), a global leader in aircraft leasing, today announced its financial results for the third quarter of 2020.

Highlights

• Net loss of $8.1 million, $0.26 loss per share
• 2.1x net debt to equity
• $285.1 million of unrestricted cash and cash equivalents at quarter end
• New $180.0 million five-year senior secured term loan closed in October

“Despite the challenges of the COVID-19 pandemic, we are encouraged by improved domestic air travel demand in the quarter and the recent news of successful vaccine trials, which we believe will drive a recovery in air travel demand in 2021,” said Colm Barrington, Chief Executive Officer of FLY. “Total cash collected improved from the prior quarter and we have begun to receive repayment of some deferred rents. A number of our lessees have received government support, which is helping the airlines meet their payment obligations.”

“To buttress the balance sheet, we recently raised a new $180 million term loan,” said Barrington. “FLY continues to have a historically low debt to equity ratio, no orders for aircraft or other capital commitments and no significant near-term refinancing requirements. FLY also benefits from BBAM’s decades of experience and expertise in navigating industry cycles, which is a truly invaluable resource at this time.”

Financial Results

FLY is reporting a net loss of $8.1 million, or $0.26 per share, for the third quarter of 2020. This compares to net income of $51.7 million, or $1.67 per share, for the same period in 2019. The decrease in net income is primarily due to the non-recognition of revenue for certain lessees and no aircraft sales in the current quarter.

Net income for the nine months ended September 30, 2020 was $39.6 million, or $1.30 per share, compared to net income of $150.7 million, or $4.72 per share, for the nine months ended September 30, 2019.

Adjusted Net Income

Adjusted Net Loss was $9.0 million for the third quarter of 2020, compared to Adjusted Net Income of $59.8 million for the same period in the previous year. On a per share basis, Adjusted Net Loss was $0.30 in the third quarter of 2020, compared to Adjusted Net Income of  $1.93 for the third quarter of 2019.

For the nine months ended September 30, 2020, Adjusted Net Income was $45.9 million, or $1.50 per share, compared to $168.9 million, or $5.28 per share, for the same period last year.

A reconciliation of Adjusted Net Income (Loss) to net income (loss) determined in accordance with GAAP is shown below.

Financial Position

At September 30, 2020, FLY’s total assets were $3.5 billion, including investment in flight equipment totaling $3.0 billion. Total cash at September 30, 2020 was $307.5 million, of which $285.1 million was unrestricted. The book value per share at September 30, 2020 was $29.28. At September 30, 2020, FLY’s net debt to equity ratio was 2.1x, compared to 2.3x at December 31, 2019.

2020 Term Loan

On October 15, 2020, FLY closed a new $180 million Term Loan to be secured by 11 narrowbody aircraft. The proceeds will be used for general corporate purposes, including the repayment of debt.

Aircraft Portfolio

At September 30, 2020, FLY had 86 aircraft and seven engines in its portfolio. FLY’s aircraft and engines are on lease to 39 airlines in 24 countries. The table below does not include the engines.

At September 30, 2020, the average age of the portfolio, weighted by net book value of each aircraft and engine, was 8.3 years. The average remaining lease term was 4.9 years, also weighted by net book value. At September 30, 2020, FLY’s portfolio had contracted annualized rental revenue of approximately $316 million.

Conference Call and Webcast

FLY’s senior management will host a conference call and webcast to discuss these results at 9:00 a.m. U.S. Eastern Time on Thursday, November 12, 2020. Participants should call +1 (409) 220-9381 (International) or (866) 438-0730 (North America) and enter confirmation code 3499165. A live webcast with slide presentation will be available on the Events and Presentations page in the Investor Relations section of FLY’s website at www.flyleasing.com. A webcast replay will be available on the company’s website for one year.

About FLY

FLY is a global aircraft leasing company with a fleet of modern, high-demand, and fuel efficient commercial jet aircraft. FLY leases its aircraft under multi-year lease contracts to a diverse group of airlines throughout the world. FLY is managed and serviced by BBAM LP, a worldwide leader in aircraft lease management and financing. For more information about FLY, please visit our website at www.flyleasing.com.

Non-GAAP Financial Measures

FLY provides all financial information in accordance with Generally Accepted Accounting Principles in the United States (GAAP). To supplement our consolidated financial statements presented in accordance with GAAP, we are also providing with this press release, and on our conference call, certain non-GAAP financial measures, including Adjusted Net Income and Adjusted Return on Equity.  In calculating these non-GAAP financial measures, we have excluded certain amounts, as detailed in the reconciliation below.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will,” or words of similar meaning and include, but are not limited to, statements regarding the outlook for FLY’s future business, operations and financial performance. Forward-looking statements are based on management’s current expectations and assumptions, which are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Actual outcomes and results may differ materially due to global political, economic, business, competitive, market, regulatory and other factors and risks, and the risk that FLY may be unable to achieve its portfolio growth expectations, or to reap the benefits of such growth. Additional or unforeseen effects from the COVID-19 pandemic and the global economic climate may give rise to or amplify many of these risks. The extent to which the COVID-19 pandemic ultimately impacts FLY’s business, results of operations and financial condition will depend on future developments, which are highly uncertain and cannot be predicted. Further information on the factors and risks that may affect FLY’s business is included in filings FLY makes with the Securities and Exchange Commission from time to time, including its Annual Report on Form 20-F and its reports on Form 6-K. FLY expressly disclaims any obligation to update or revise any of these forward-looking statements, whether because of future events, new information, a change in its views or expectations, or otherwise.

 

Contact:
Matt Dallas
Fly Leasing Limited
+1 203-769-5916
[email protected]

 

 

 

 

FLY defines Adjusted Net Income (Loss) as net income (loss) plus or minus (i) unrealized foreign exchange gains and losses; (ii) deferred income taxes; (iii) the fair value changes associated with interest rate derivative contracts that are not accounted for as cash flow hedges; and (iv) non-recurring expenses. The adjustments included within Adjusted Net Income (Loss) are primarily non-cash or non-recurring items that we consider unrelated to the ongoing performance of our operations. Adjusted Return on Equity is calculated by dividing Adjusted Net Income (Loss) by average shareholders’ equity for each period presented. For periods of less than one year, the resulting return is annualized.

FLY uses Adjusted Net Income (Loss) and Adjusted Return on Equity, in addition to GAAP net income (loss) and earnings (loss) per share, to assess our core operating performance on a consistent basis from period to period. Management believes these measures are helpful in evaluating the operating performance of our ongoing operations and identifying trends in our performance, because they remove the effects of certain non-cash or non-recurring items and certain other items that are not indicative of our overall operating trends. In addition, Adjusted Net Income (Loss) and Adjusted Return on Equity help us compare our performance to our competitors. These measures should be considered in addition to, and not as substitutes for, net income or other financial measures determined in accordance with GAAP. FLY’s definitions may be different from those used by other companies.

View original content to download multimedia:http://www.prnewswire.com/news-releases/fly-leasing-reports-third-quarter-2020-financial-results-301171700.html

SOURCE Fly Leasing Limited

Starting November 12^th, the campaign will be featured nationally across social and digital platforms, including Facebook, Instagram, YouTube

VANCOUVER, BC, Nov. 12, 2020 /PRNewswire/ – ELSE NUTRITION HOLDINGS INC. (TSXV: BABY.V) (OTC-QB: BABYF) (Frankfurt: 0YL.F) (“Else” or the “Company”) the plant-based baby, toddler and children’s nutrition company, today announced the launch of its first National U.S. brand campaign, ‘In an Else World.’

Ahead of its nationwide retail launch in 380 stores across the U.S., the company has enlisted the global creative agency, Allenby Concept House and the award-winning Animation Director, Sivan Kidron to conceptualize the creative for the campaign. Click here to  view the full version video.

The campaign includes an interactive Instagram Live series with featured appearances from leading pediatricians, registered nurses and dietitians, including Kacie Barnes, MCN, RDN, LD and Hillary Sadler, MSN, RCN-OB, IBCLC as well as celebrity mom, Hilaria Baldwin. Tune into the series on Tuesdays at 1:00 p.m. EST, by following @elsenutrition on Instagram.

The campaign aims to spread Else Nutrition’s mission of providing real, plant-based and no-compromise nutrition alternatives for parents to feed their child, building the kind of world where families can choose nutrition that aligns with their values and needs.

Coming to life through bold and colorful animation, Else Nutrition welcomes all consumers to an ‘Else World’ where whole-food, plant-based nutrition is everywhere, especially in the baby aisle.  Focusing on the brand’s core values of providing natural products that are better for the baby, the parent and the planet, Else is excited to showcase its sustainable and cleaner offerings, including its first, breakthrough product – ‘Else Plant-Based Complete Nutrition for Toddlers’.

“We’re excited to launch our first, national marketing campaign. We’re inviting all parents to join us in building an Else World: the kind of world our babies and children deserve: with cleaner, less processed, whole-food plant-based nutrition, and a healthier planet. Since launching Else Nutrition we’ve seen how our ground-breaking plant-based nutrition has helped families around the U.S. provide their children with proper nutrition,” said Mrs. Hamutal Yitzhak, CEO and Co-Founder of Else Nutrition. “We believe that babies and children should have the same clean label, plant-based nutrition choices as their parents do, without compromise. We are excited to have the opportunity to increase awareness with consumers that will bring these ideals and values to life for millions of families across North America.”

“Together with the inspiring Else Nutrition team, we have created a world in which alternative possibilities are always available and all you need to do is to be open  to them,” said Sivan Kidron, Animation Director. “The animation plays on this idea, showing us what is behind and beyond what we currently see, while continuously opening our minds to new and exciting alternatives and innovations.”

Follow @elsenutrition on Instagram. Join an Else World on Instagram and Facebook by following #ElseWorld. 

About Else Nutrition Holdings Inc.

Else Nutrition GH Ltd. is an Israel-based food and nutrition company focused on developing innovative, clean and plant-based food and nutrition products for infants, toddlers, children, and adults. Its revolutionary, plant-based, non-soy, formula is a clean-ingredient alternative to dairy-based formula. Else Nutrition (formerly INDI) won the “2017 Best Health and Diet Solutions” award at the Global Food Innovation Summit in Milan. The holding company, Else Nutrition Holdings Inc., is a publicly traded company, listed as TSX Venture Exchange under the trading symbol BABY and is quoted on the US OTC Markets QX board under the trading symbol BABYF and on the Frankfurt Exchange under the symbol 0YL. Else’s Executives includes leaders hailing from leading infant nutrition companies. Many of Else advisory board  members had past executive roles in companies such as Mead Johnson, Abbott Nutrition, Plum Organics and leading infant nutrition Societies,  and some of them currently serve in different roles in leading medical centers and academic institutes such as Boston Children’s Hospital, Pediatrics at Harvard Medical School, USA, Tel Aviv University, Schneider Children’s Medical Center of Israel, Rambam Medical Center and Technion, Israel and University Hospital Brussels, Belgium.

For more information, visit: elsenutrition.com or @elsenutrition on Facebook and Instagram.

TSX Venture Exchange

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

Caution Regarding Forward-Looking Statements

This press release contains statements that may constitute “forward-looking statements” within the meaning of applicable securities legislation. Forward-looking statements are typically identified by words such as “will” or similar expressions. Forward-looking statements in this press release include statements with respect to the anticipated dates for filing the Company’s financial disclosure documents.  Such forward-looking statements reflect current estimates, beliefs and assumptions, which are based on management’s perception of current conditions and expected future developments, as well as other factors management believes are appropriate in the circumstances. No assurance can be given that the foregoing will prove to be correct. Forward-looking statements made in this press release assume, among others, the expectation that there will be no interruptions or supply chain failures as a result of COVID 19 and that the manufacturing, broker and supply logistic agreement with the Company do not terminate.  Actual results may differ from the estimates, beliefs and assumptions expressed or implied in the forward-looking statements.  Readers are cautioned not to place undue reliance on any forward-looking statements, which reflect management’s expectations only as of the date of this press release. The Company disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

View original content to download multimedia:http://www.prnewswire.com/news-releases/else-launches-a-nationwide-brand-campaign-in-the-us-in-an-else-world-301171411.html

SOURCE Else Nutrition Holdings Inc.

ST. LOUIS, Nov. 12, 2020 /PRNewswire/ — Ambetter is utilizing technology to offer consumers personalized, step-by-step, virtual guidance to make the enrollment process easier and help members get the most out of their health plan coverage. From Ambetter’s one-stop online enrollment platform to Amber, an artificial intelligence (AI)-powered virtual assistant, consumers are able to easily navigate the experience of enrolling in and using their health coverage during open enrollment and beyond.

“As technology evolves, Ambetter must also adapt to the new ways people prefer to engage with their health coverage,” said Michael F. Neidorff, Chairman, President and CEO for Centene. “We are committed to making the insurance experience personalized and seamless, and through these new technologies, we’re able to alleviate any roadblocks that prevent people from getting the most out of their healthcare.” 

During open enrollment, Ambetter is extending three key technology services to members and those shopping for health insurance to simplify the experience:

• Online Enrollment Platform: Through Ambetter’s online enrollment platform, consumers can browse and compare health plan coverage, determine their eligibility for financial subsidies, and directly enroll in health coverage – all in one place. The platform is optimized for mobile access as well, so consumers can apply and enroll directly on their smartphones and smart devices. The platform even allows applicants to save their progress and sends reminders to those who wish to resume the application where they left off. Ambetter‘s enrollment platform offers the same privacy and security as enrolling through the federal exchange website, which helps ensure that consumers’ personal information is protected.
• Amber Assistant: Upon enrolling in Ambetter, members and new enrollees can engage with Amber, a virtual assistant powered by AI that answers questions about covered services and other health plan benefits. Amber can help members understand deductibles and costs, learn how to earn rewards, make a premium payment, set up a member portal account, and learn the basics of their coverage. Amber also delivers the member’s digital ID card, which can be saved to their Apple Wallet or mobile photo gallery. More than 60% of people who are introduced to Amber choose to engage with her, and users reported very high satisfaction with the experience and their readiness to use their coverage.
• 
  Ambetter Guide: While Amber helps with understanding how their coverage works, the Ambetter Guide helps members get access to the right care. Powered by data science, the Ambetter Guide makes recommendations for healthcare providers based on things that matter to the member. It helps to quickly and reliably match members with a wide range of high-quality, available, in-network providers that are conveniently located. It also eases access to virtual care, including local doctors who offer virtual visits and on-demand network doctors who are dedicated to telehealth.

The open enrollment period for the Health Insurance Marketplace runs through Dec. 15, 2020. For more information about Ambetter and its health coverage plans, please visit www.ambetterhealth.com.

About Ambetter 
Ambetter is a health insurance offering that is available on the Health Insurance Marketplace, or exchange, established by the Affordable Care Act. It is one of the healthcare programs provided by Centene Corporation, a Fortune 100 multi-national healthcare enterprise. Ambetter is made available through local health plans and covers a wide variety of healthcare services, including preventative and wellness services, maternity and newborn care, pediatric services, mental health and substance abuse services, prescription drug coverage, and more. 

View original content:http://www.prnewswire.com/news-releases/ambetter-leverages-technology-to-improve-the-enrollment-and-membership-experience-301171684.html

SOURCE Centene Corporation

PRINCETON, N.J., Nov. 12, 2020 /PRNewswire/ — Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended September 30, 2020.

“We continue to look to the future with our Specialized BioTherapeutics business segment,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “With the recent successful completion of our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 has demonstrated the potential to be a significant new treatment for early-stage cutaneous T-cell lymphoma (CTCL).  In the double-blind, placebo controlled Cycle 1 portion of the study, a statistically significant treatment response (p=0.04) was achieved in the primary endpoint after just 6 weeks of therapy.  This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycles at 12 weeks (Cycle 2) and 18 weeks (Cycle 3), reinforcing the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1.  With the study now concluded, we will begin preparing our new drug application for submission to the FDA.  We also continue to progress our pivotal Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) study for SGX942 (dusquetide), for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy.  With enrollment of 268 subjects completed, top-line final results continue to be expected before the end of the year.”

Dr. Schaber continued, “Under our Public Health Solutions business segment, supported by non-dilutive government funding, we continue to advance our work with the University of Hawaiʻi at Mānoa (UHM) and Hawaii Biotech Inc. on filovirus vaccines (protecting against viruses such as Ebola and Marburg) and the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19.  We recently announced publication of positive pre-clinical data from immunogenicity studies with CiVax™ (heat stable COVID-19 vaccine candidate), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the novel CoVaccine HT™ adjuvant in-licensed from BTG Specialty Pharmaceuticals (a division of Boston Scientific Corporation).  Our heat stable ricin vaccine, RiVax^®, continues to be supported with a National Institute of Allergy and Infectious Disease contract award.  With over $11M in cash, not including our non-dilutive government funding, along with the at-the-market sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including final top-line results in our SGX942 Phase 3 clinical trial in oral mucositis.”

Soligenix Recent Accomplishments

• On October 22, 2020, the Company announced the continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of the trial (Cycle 3), for a total of 6 months in the study, continued to significantly improve responses and remained safe and well-tolerated in its FLASH study. This data reinforces the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. SGX30l treatment in Cycle 3 further improved response rates, with 49% of patients electing to receive SGX301 for a total of 18 weeks demonstrating a 50% or greater reduction in their combined CAILS (Composite Assessment of Index Lesion Score) lesion score compared to 40% of patients demonstrating such a reduction after completing 12 weeks of SGX301 treatment in Cycle 2 (p=0.046). In addition, continued analysis of results has revealed that 12 weeks of SGX301 treatment (Cycle 2) is equally effective on both patch (response 37%, p=0.0009) and plaque (response 42%, p<0.0001) lesions of CTCL when compared to Cycle 1 placebo lesion responses. SGX301 continued to be very well tolerated, benefiting from the lack of hypericin circulation in the blood stream after targeted topical application to the lesions, as well as the use of visible light. To view this press release, please click here.
• On September 15, 2020, the Company announced the publication of nonclinical results characterizing filovirus protein antigens (including for Ebola and Marburg viruses) and their thermostabilization. The article, authored by collaborators at the University of Colorado, University of Hawaiʻi at Mānoa (UHM) and Soligenix, is titled, “Preservation of Quaternary Structure in Thermostable, Lyophilized Filovirus Glycoprotein Vaccines: A Search for Stability-Indicating Assays” and has been accepted for publication in the Journal of Pharmaceutical Sciences. A copy of manuscript has been made available here. To view this press release, please click here.
• On September 10, 2020, the Company conducted an Investor Webcast presentation on the use of its thermostabilized glycoprotein vaccine platform for the development of a COVID-19 vaccine, called CiVax™. To listen to this Webcast Event, please click here and to view the press release, please click here.

Financial Results – Quarter Ended September 30, 2020

Soligenix’s revenues for the quarter ended September 30, 2020 were $0.6 million as compared to $1.3 million for the quarter ended September 30, 2019.  Revenues included payments on a contract in support of RiVax^®, our ricin toxin vaccine candidate, grants received to support the development of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases, ThermoVax^®, our thermostabilization technology, and the assessment of SGX942 safety in juvenile animals.

Soligenix’s basic net loss was $1.8 million, or ($0.06) per share, for the quarter ended September 30, 2020, as compared to $2.7 million, or ($0.14) per share, for the quarter ended September 30, 2019.  This decrease in net loss was primarily the result of decreased research and development spending due to the completion of the CTCL trial.

Research and development expenses were $1.3 million as compared to $2.3 million for the quarters ended September 30, 2020 and 2019, respectively.  The decrease in research and development spending for the quarter ended September 30, 2020 was primarily attributable to the reduction in expense due to the completion of the CTCL trial.

General and administrative expenses were $0.8 million for both the three months ended September 30, 2020 and 2019.

As of September 30, 2020, the Company’s cash position was approximately $11.3 million.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).

Our Public Health Solutions business segment includes active development programs for RiVax^®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax^®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax^® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax^®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

 

View original content:http://www.prnewswire.com/news-releases/soligenix-announces-recent-accomplishments-and-third-quarter-2020-financial-results-301171676.html

SOURCE Soligenix, Inc.

NEW YORK, Nov. 12, 2020 /PRNewswire/ — Shutterstock, Inc. (NYSE: SSTK), a leading global technology company offering a creative platform for high-quality content, tools and services, today announced greater technology support for enterprise customers through a simple sign-on integration—the first offering of its kind among global content providers.

The offering, which can be set up in minutes, provides users with more secure access to a database of 350+ million high-quality licensed images, videos and music tracks through the Shutterstock platform. The seamless integration is designed to eliminate password fatigue and speed up workflows by quickly—and safely—authenticating users across a number of digital platforms and identity management solutions.

“As teams navigate the challenges of working from home, having secure and centralized access to tools and platforms is essential to productivity,” said Alex Reynolds, Shutterstock Vice President and General Manager of Platform Solutions. “The global rollout of SSO stems from our growing commitment to serve the rigorous and ever-changing needs of enterprise customers around the world.”

By implementing SAML 2.0 Single Sign-On (SSO), Shutterstock customers can also expand their access organization-wide, while gaining additional controls over security as marketing and creative teams embrace remote work and turn to online collaboration and tools to improve processes. With browse-only permissions and lightboxes of curated content, Shutterstock can provide more visibility into its content across an entire company, while mitigating risk of accidental purchasing. This will expand content to sales teams for presentations, human resources for intranet projects, business development for customer-facing documentation, and more.

Shutterstock’s SSO is now available to over 250,000 companies globally as Shutterstock partners with industry-leading identity solutions providers including Auth0, Microsoft’s Azure AD, Okta, OneLogin and Ping Identity, with many more in the works. Once deployed across these platforms, the turnkey solution will centralize purchasing activity and reduce employee spend by approximately 10 percent due to the accidental re-licensing of content, according to a recent Shutterstock analysis. Through the integration, greater security access is guaranteed, and users will see productivity gains as hours are relocated from IT discussions to the creative process itself.

To launch the new SSO integration and increase creative efficiency company-wide, contact the Shutterstock Integrations Team directly here: https://www.shutterstock.com/business/sso

About Shutterstock
Shutterstock, Inc. (NYSE: SSTK), directly and through its group subsidiaries, is a leading global provider of high-quality licensed photographs, vectors, illustrations, videos and music to businesses, marketing agencies and media organizations around the world. Working with its growing community of over 1 million contributors, Shutterstock adds hundreds of thousands of images each week, and currently has more than 350 million images and more than 20 million video clips available.

Headquartered in New York City, Shutterstock has offices around the world and customers in more than 150 countries. The company’s brands also include Bigstock, a value-oriented stock media offering; Shutterstock Custom, a custom content creation platform; Offset, a high-end image collection; PremiumBeat, a curated royalty-free music library; and Shutterstock Editorial, a premier source of editorial images and videos for the world’s media.

For more information, please visit www.shutterstock.com and follow Shutterstock on Twitter and on Facebook.

View original content to download multimedia:http://www.prnewswire.com/news-releases/shutterstock-launches-a-turnkey-single-sign-on-integration-offering-brands-seamless-access-to-350-million-creative-assets-301171244.html

SOURCE Shutterstock, Inc.

TORONTO, Nov. 12, 2020 /PRNewswire/ – The Supreme Cannabis Company, Inc. (“Supreme Cannabis” or the “Company”) (TSX: FIRE) (OTCQX: SPRWF) (FRA: 53S1) today announced that the Company has entered into a supply agreement with Medical Cannabis by Shoppers Inc., a subsidiary of Shoppers Drug Mart Inc.

Under the terms of the supply agreement with Medical Cannabis by Shoppers Inc., the Company will offer Truverra-branded medical cannabis products through the Medical Cannabis by Shoppers™ online sales platform accessible to patients across Canada.

“This is an important development that establishes Truverra as a valuable medical cannabis brand and provides further diversification of our revenue,” said Beena Goldenberg, President and CEO of Supreme Cannabis. “We are particularly pleased to introduce Truverra to Canadian patients, who will be able to order dried flower, pre-rolls and full-spectrum CBD oil. Included in our offering will be our Jean Guy strain, which is a tribute to the legendary variety offered by the Montreal Compassion Club. Also, through the Shoppers portal, patients can be assured of expert customer service from a trusted brand.”

The Medical Cannabis by Shoppers online platform is a convenient and trusted source of quality medical cannabis, providing patients with single-source access to a broad range of products. Through their national online platform, the Medical Cannabis by Shoppers business connects patients with cannabis products that meet the highest quality and safety standards and provides guidance and support via a dedicated team of cannabis-trained advisors and Pharmacists.

About Supreme Cannabis.

The Supreme Cannabis Company, Inc., (TSX: FIRE) (OTCQX: SPRWF) (FRA: 53S1), is a global diversified portfolio of distinct cannabis companies, products and brands. Since 2014, the Company has emerged as one of the world’s most premium producers of recreational, wholesale and medical cannabis products.

Supreme Cannabis’ portfolio of brands caters to diverse consumer and patient experiences, with brands and products that address recreational, wellness, medical and new consumer preferences. The Company’s recreational brand portfolio includes, 7ACRES, 7ACRES Craft Collective, Blissco,sugarleaf, and Hiway. Supreme Cannabis addresses national and international medical cannabis opportunities through its premium Truverra brand.

Supreme Cannabis’ brands are backed by a focused suite of world-class operating assets that serve key functions in the value chain, including, scaled cultivation, value-add processing, automated packaging and product testing and R&D. Follow the Company on Instagram,Twitter, Facebook,LinkedIn and YouTube.

We simply grow better.

Forward-Looking Information.

Certain statements made in this press release constitute “forward-looking information” within the meaning of applicable securities laws. Forward-looking information may relate to anticipated events or results and other statements that are not historical facts. The forward-looking information contained in this press release is made as of the date hereof, and the Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. 

View original content to download multimedia:http://www.prnewswire.com/news-releases/supreme-cannabis-enters-into-supply-agreements-with-medical-cannabis-by-shoppers-301171300.html

SOURCE The Supreme Cannabis Company, Inc.

ROCKVILLE, Md., Nov. 12, 2020 /PRNewswire/ — Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, today announced the appointment of senior biotech executive John Monahan, PhD, to the Company’s Board of Directors, effective immediately. Dr. Monahan replaces Scott L. Tarriff who has stepped down after serving on the board since 2012.     

Dr. Monahan has more than 45 years of executive leadership experience in the pharmaceutical and biotechnology industries. Dr. Monahan Co-Founded Avigen Inc. in 1992, a company which has become a leader in its sector for the development of novel pharmaceutical products for the treatment of serious human diseases. Over a 12 year period as Chief Executive Officer of Avigen he raised over $235 million in several private and public financings including its initial public offering. From 1989-1992, he was Vice President of Research & Development at Somatix Therapy Corp., Alameda, CA and from 1985-1989 he was Director of Molecular & Cell Biology at Triton Biosciences Inc., Alameda, CA. Prior to that from 1982-1985, he was Research Group Chief, Department of Molecular Genetics, Hoffmann-LaRoche, Inc., Nutley, NJ, and from 1975 to 1977 he was an Instructor at Baylor College of Medicine, Houston TX. Dr. Monahan served as a scientific advisory consultant to the Company from 2015 to November 2020 and from 2010 through 2015 he was the Company’s Senior Executive Vice President of Research & Development. Dr. Monahan was also a Scientific Advisory Board member of Agilis Biotherapeutics (recently merged into PTC Therapeutics), from 2014 to 2019. He currently serves on the board of directors of Heat Biologics, Inc., Anixa Biosciences, Inc. (formerly ITUS Corporation), and Cellix Ltd. (Ireland). He has also served on a number of other public and private boards over the years. Dr. Monahan received his Ph.D. in Biochemistry from McMaster University, Canada and his B.Sc. from University College Dublin, Ireland.

“John is a talented and accomplished executive with an impressive track record of scientific achievement and drug development,” said Steven A. Shallcross, Chief Executive and Financial Officer. “John’s considerable expertise as a leader and as a scientist extends from research and development to regulatory and commercial strategy. He will be invaluable to Synthetic Biologics as we continue to advance our clinical programs, and we intend to leverage his deep industry relationships as we explore strategic opportunities to further expand our pipeline. We look forward to John’s contributions as a Director during this important time for our company. I would also like to express my gratitude to Scott Tarriff for his years of service and valuable insights he brought to our Company. We wish him much success in his endeavors.” 

“I am honored to join the board of Synthetic Biologics at this important inflection in the Company’s development,” commented John Monahan, Ph.D.  “Specifically, I believe there is significant potential for both SYN-004 and SYN-020, as both of these therapies have the potential to address large and underserved markets. Moreover, the Company has an impressive team with deep sector expertise that can be easily leveraged by licensing or acquiring new assets.”

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE American: SYN) is a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. The Company’s lead candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent (a) microbiome damage, (b) Clostridioidesdifficile infection (CDI), (c) overgrowth of pathogenic organisms, (d) the emergence of antimicrobial resistance (AMR) and (e) acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.     

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding the expected contributions of Dr. Monahan and leveraging Dr. Monahan’s  deep industry relationships as Synthetic Biologics explores strategic opportunities to further expand its pipeline and continuing to advance Synthetic Biologics’ clinical programs. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the contributions of Dr. Monahan to Synthetic Biologics, Synthetic Biologics’ ability to leverage Dr. Monahan’s industry relationships to further expand its pipeline, ability to obtain FDA clearance of the IND for the SYN-020 program, a failure of additional pre-clinical studies of SYN-020 to achieve similar results to those previously achieved or to provide support for exercise of the option, the ability to enter into a license to advance an expanded clinical development program for SYN-020, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics’ therapeutics, a failure of Synthetic Biologics’ clinical trials, and those conducted by investigators, for SYN-004 and SYN-010 to be commenced or completed on time or to achieve desired results and benefits, especially in light of COVID-19, a failure of Synthetic Biologics’ clinical trials to continue enrollment as expected or receive anticipated funding, a failure of Synthetic Biologics to successfully develop, market or sell its products, Synthetic Biologics’ inability to maintain its material licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products and other factors described in Synthetic Biologics’ Annual Report on Form 10-K for the year ended December 31, 2019 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

 

View original content to download multimedia:http://www.prnewswire.com/news-releases/synthetic-biologics-welcomes-senior-biotech-executive-john-monahan-phd-to-board-of-directors-301171817.html

SOURCE Synthetic Biologics, Inc.