LexaGene Receives Purchase Order from a Multinational Biotechnology Company

BEVERLY, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) — LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, is pleased to announce that it has received a purchase order for a MiQLab™ system from a multinational biotechnology company that generates billions in annual revenue.

MiQLab is the first commercially available open-access multiplex PCR system of its kind. The open-access feature means it is extremely easy for operators to use the automated MiQLab system at their facility to perform customized, highly multiplexed PCR tests. This is highly desirable over the alternative, which is to ship collected samples to a reference laboratory for manual PCR processing by skilled molecular biologists or waiting days for cultures to grow.

The biotechnology company that has provided LexaGene a purchase order is a manufacturer of biologics, vaccines, and chemicals. Many of these biologics are grown in bioreactors that can be thousands of liters in size. During scale-up manufacturing, it is possible to have a bioreactor become contaminated with bacteria. The failure to detect such bacteria during the transfer of the product from a small bioreactor to a large bioreactor can cost the company hundreds of thousands of dollars to a million or more dollars.

To help prevent massive product losses late in the manufacturing process, the biotechnology company was looking for an easy to use and reliable sample-to-answer system that could process bioreactor material looking for a variety of different bacteria. One of the slower growing bacteria they are targeting can take as much as two weeks to grow sufficiently to be detectable by traditional plate-based culture methods. LexaGene’s customizable MiQLab system solves this problem by automating a PCR test for this slow growing bacterium. PCR amplifies targeted sequences by > 1 billion-fold to provide much earlier detection than is possible when waiting for culture.

Earlier this fall, the biotechnology company requested an in-house demonstration of LexaGene’s MiQLab. For this demonstration, LexaGene designed a test for the slow growing C. acnes bacteria and combined it with tests already developed for E. coli, Staphylococcus, and Streptococcus. The biotechnology company arrived at LexaGene with representative samples that were taken from a bioreactor. These samples were separately spiked with each of the targeted bacteria. MiQLab successfully detected all four bacteria – even the slowest growing bacteria, proving LexaGene’s sample preparation cartridge successfully handled the complex sample type from the bioreactor and the MiQLab system achieved very strong detection of the targeted bacteria.

Dr. Jack Regan, LexaGene’s CEO and Founder, states, “Years ago, I recognized the life sciences sector lacked automated instrumentation that allows end-users to easily create a customized test. I’m excited to announce that we now have a commercial system available for sale to help solve this problem. It is very gratifying that our first sale will be to a company that wants our technology for open-access use. This is just the beginning. Over the coming weeks and months, we expect to continue to roll out our technology into the open-access market, as well as to the veterinary diagnostics market, and eventually the human clinical diagnostics market.”

To be added to the LexaGene email list, please subscribe on the Company website.

On Behalf of the Board of Directors

Dr. Jack Regan

Chief Executive Officer
& Director

About LexaGene Holdings Inc.

LexaGene is a molecular diagnostics company that develops molecular diagnostic systems for pathogen detection and genetic testing for other molecular markers for on-site rapid testing in veterinary diagnostics, food safety and for use in open-access markets such as clinical research, agricultural testing and biodefense. End-users simply need to collect a sample, load it onto the instrument with a sample preparation cartridge, enter sample ID and press ‘go’. The MiQLab™ system delivers excellent sensitivity, specificity, and breadth of detection and can return results in approximately one hour. The unique open-access feature is designed for custom testing so that end-users can load their own real-time PCR assays onto the instrument to target any genetic target of interest.

For further information, please contact:

Media Contacts

Nicole Ridgedale
Director of Corporate Marketing, LexaGene
800.215.1824 ext 206
[email protected]

Investor Relations

Jay Adelaar
Vice President of Capital Markets, LexaGene
800.215.1824 ext 207
[email protected]

The TSX Venture Exchange Inc. has in no way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release. Neither 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.

This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors — including the availability of funds, the results of financing efforts, the success of technology development efforts, the cost to procure critical parts, performance of the instrument, market acceptance of the technology, regulatory acceptance, and licensing issues — that could cause actual results to differ materially from the Company’s expectations as disclosed in the Company’s documents filed from time to time on SEDAR (see 

www.sedar.com

). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.



Hilton Announces Launch of Senior Notes Offering

Hilton Announces Launch of Senior Notes Offering

MCLEAN, Va.–(BUSINESS WIRE)–
Hilton Worldwide Holdings Inc. (NYSE: HLT) (“Hilton”) announced today that its indirect subsidiary Hilton Domestic Operating Company Inc. (the “Issuer”) intends to offer $1.0 billion aggregate principal amount of the Issuer’s Senior Notes due 2029 and Senior Notes due 2031 (collectively, the “Notes”). The Issuer intends to use the proceeds of the offering together with available cash to redeem all of its outstanding 4.250% Senior Notes due 2024.

The Notes to be offered have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws.  The Notes may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. The Notes will be offered, by the initial purchasers, only to persons reasonably believed to be “qualified institutional buyers” in reliance on the exemption from registration provided by Rule 144A under the Securities Act and to certain non-U.S. persons in offshore transactions in reliance on Regulation S under the Securities Act.

This press release is being issued pursuant to and in accordance with Rule 135c under the Securities Act, and it is neither an offer to sell nor a solicitation of an offer to buy any securities and shall not constitute an offer to sell or a solicitation of an offer to buy, or a sale of, the Notes or any other securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include but are not limited to, statements related to our expectations regarding the impact of the COVID-19 pandemic, the performance of our business, our financial results, our liquidity and capital resources and other non-historical statements. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “projects,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties, including, among others, risks inherent to the hospitality industry, macroeconomic factors beyond Hilton’s control, risks related to the impact of the COVID-19 pandemic, competition for hotel guests and management and franchise contracts, risks related to doing business with third-party hotel owners, performance of Hilton’s information technology systems, growth of reservation channels outside of Hilton’s system, risks of doing business outside of the United States of America and Hilton’s indebtedness. Accordingly, there are or will be important factors that could cause Hilton’s actual outcomes or results to differ materially from those indicated in these statements. Hilton believes these factors include but are not limited to those described under the section entitled “Part I—Item 1A. Risk Factors” of Hilton’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the Securities and Exchange Commission (“SEC”), as updated under “Part II. Other Information—Item 1A. Risk Factors” of Hilton’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020, filed with the SEC, as such factors may be further updated from time to time in Hilton’s periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this press release and in Hilton’s filings with the SEC. Hilton undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

Investors

Jill Slattery

+1 703 883 6043

Media

Nigel Glennie

+1 703 883 5262

KEYWORDS: Virginia United States North America

INDUSTRY KEYWORDS: Lodging Travel

MEDIA:

Logo
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Large Global Convenience Store Brand Selects Mobivity to Power Mobile Messaging Program

Adds Second Major Customer Vertical, Significantly Expanding Mobivity’s Addressable Market

PHOENIX, Nov. 16, 2020 (GLOBE NEWSWIRE) — Mobivity Holdings Corp. (OTCQB: MFON) a global provider of personalized customer engagement solutions that increase customer engagement through mobile messaging and personalized digital offers, and drives digital transformation for restaurants, retail and personal care brands, today announced that it has been selected to power mobile messaging programs for one of the largest operators of convenience store brands around the globe. This new relationship in a new market vertical validates the broad appeal for Mobivity’s technology and solutions in the post-COVID-19 digital marketing business environment. Furthermore, this new customer engagement proves that Mobivity’s ability to offer scalable products to large customer segments sets it apart from the competition.

Seeking higher throughput and capacity for their existing SMS text marketing campaigns, with deeper data and reporting features, the brand chose Mobivity’s Recurrency platform through a competitive vendor selection process. Rich features and capabilities such as machine learning-powered segmentation and personalization, as well as the ability to operate local, regional, or national programs all from a comprehensive cloud-based platform, were key differentiators of Mobivity’s award-winning platform. The brand expects to launch its new Mobivity-powered mobile messaging campaigns across its thousands of North American locations as soon as December of this year.

Dennis Becker, Mobivity Chairman and CEO, commented, “We couldn’t be more excited to enter a new major customer vertical and increase our addressable market. Mobivity was able to demonstrate that our machine learning, deep data, Unified Mobile Messaging, and proven scale are key differentiators that set our Recurrency platform apart from competitors. This win represents a significant opportunity to accelerate our transaction volumes and leverage our ‘one platform’ strategy to reach an entirely new group of consumers. We are preparing to launch with this well-recognized brand in December and expect revenue contributions to our fourth quarter and full year 2021 results. I want to thank all the Mobivity employees for their steadfast efforts in continuing to move the company forward in these most difficult times.”

About Mobivity

Brick and mortar stores struggle to manage customer connections in a digital world. Mobivity provides a platform to connect national restaurants, retailers, personal care brands, and their partners with customers to increase retention, visits, and spend. Mobivity’s Recurrency platform increases customer engagement and frequency by capturing detailed POS transaction data, analyzing customer habits, and motivating customers and employees through data-driven messaging applications and rewards. For more information about Mobivity, visit mobivity.com or call (877) 282-7660.

Forward Looking Statement

This press release contains forward-looking statements concerning Mobivity Holdings Corp. within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those forward-looking statements include statements regarding the expansion of the Company’s addressable markets and the Company’s expectations for the timing and growth of the Company’s revenue from a new customer. Such statements are subject to certain risks and uncertainties, and actual circumstances, events or results may differ materially from those projected in such forward-looking statements. Factors that could cause or contribute to differences include, but are not limited to, our ability to successfully market and sell our products and services to the convenience store industry; deploy our product and services to a new customer; changes in the laws and regulations affecting the mobile marketing industry and those other risks set forth in Mobivity Holdings Corp.’s annual report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 30, 2020 and subsequently filed quarterly reports on Form 10-Q. Mobivity Holdings Corp. cautions readers not to place undue reliance on any forward-looking statements. Mobivity Holdings Corp. does not undertake, and specifically disclaims any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur.

Media Contacts

Jennifer Handshew • Marketing Communications, Mobivity

[email protected] • (917) 359-8838

Investor Relations Contact:

Brett Maas • Managing Partner, Hayden IR

[email protected] • (646) 536-7331



IIROC Trading Halt – UUU.P

Canada NewsWire

VANCOUVER, BC, Nov. 16, 2020 /CNW/ – The following issues have been halted by IIROC:

Company: Unilock Capital Corp.

TSX-Venture Symbol: UUU.P

All Issues: Yes

Reason: At the Request of the Company Pending News

Halt Time (ET): 7:45 AM

IIROC can make a decision to impose a temporary suspension (halt) of trading in a security of a publicly-listed company. Trading halts are implemented to ensure a fair and orderly market. IIROC is the national self-regulatory organization which oversees all investment dealers and trading activity on debt and equity marketplaces in Canada.

SOURCE Investment Industry Regulatory Organization of Canada (IIROC) – Halts/Resumptions

CBD OF DENVER, INC. (CBDD) Releases 3rd Quarter Financial Statements

PR Newswire

DENVER, Nov. 16, 2020 /PRNewswire/ — CBD of Denver, Inc. (OTC: CBDD), a full-line CBD and Hemp oil company (“CBDD”) selling Black Pearl CBD hemp products and the owner of CBD Social Network today announces the release of its financial statements for the 3rd quarter of 2020.

CBDD has posted their Financial Statements for the 3rd quarter ended September 30, 2020, on OTCMarkets.com.  Third quarter results exceeded management’s expectations.  Gross revenues increased nearly 10-fold over the second quarter to $5,963,820.00 with gross profits of $484,666.00.

Rockflowr GmbH generated the bulk of that revenue and is still growing.  Rockflowr has be able to source hemp flower from the United States in large quantities and its distribution has grown to more than 7 countries in Europe.  CBDD CEO Marcel Gamma explains “Business is so good, we have dealers waiting in line outside of our offices to buy product. We are thrilled with the growth of our company.”  Growth does come with challenges, with the company having to move its office/warehouse from the current 160 square meters to a larger 260+ square meter space.  The pandemic and ensuing business closures allowed the company to actually reduce its per square meter cost, saving money. Rockflowr hired 2 additional highly qualified employees, who were available only due to the pandemic.  The addition of pollen to the product line has also increased Rockflwr’s profit margins.

CBD Welt 24 also performed well during the quarter, adding additional space and lights to grow approximately 30-40% more plants.

CBDD is focused on using equity to acquire profitable Swiss assets at attractive valuations to create value for all our shareholders

CBDD offers a superior CBD product that is full spectrum without depending on THC to activate the benefits of cannabidiol. Black Pearl CBD has 0% THC, but is not an Isolate where the THC is stripped from the product rendering it ineffective. We use a proprietary technique adding terpenes as the activation ingredient, resulting in a product that is the finest in the industry. Products are available at www.blackpearlcbd.com.

Information contained herein includes forward-looking statements. These statements relate to future events or future financial performance, involving known and unknown risks and you should not place undue reliance on these statements. Any forward-looking statement reflects our current views with respect to future events. We assume no obligation publicly about update or revise these forward-looking statements for any reason.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/cbd-of-denver-inc-cbdd-releases-3rd-quarter-financial-statements-301173326.html

SOURCE CBD of Denver, Inc.

Leaders from Cogstate Join the Davos Alzheimer’s Collaborative to Accelerate Innovation and Preparedness for Disease Interventions

Melbourne, VIC, Australia; New Haven, CT, USA, Nov. 16, 2020 (GLOBE NEWSWIRE) — Neuroscience technology company, Cogstate Ltd (ASX.CGS), announced today that four members of its executive leadership team have joined the Davos Alzheimer’s Collaborative (DAC), a pre-competitive coalition and a 5-year, ~$300 million plan focused on driving global scientific, business, policy and financial coordination in Alzheimer’s disease preparedness.  

DAC expert representatives from Cogstate include:

  • Brad O’Connor, Chief Executive Officer, serving on the DAC Leadership Group;
  • Paul Maruff, Chief Innovation Officer, serving on the Global Cohort Working Group, focused on building a large, diverse participant base to identify new therapeutic targets;
  • Chris Edgar, Chief Science Officer, serving on the Clinical Trials Working Group, focused on connecting trials globally to standardize, expedite and diversify recruitment and enrollment; and
  • Tanya O’Connor, Vice President, Healthcare & Research, serving on the Healthcare System Preparedness Working Group, focused on the required infrastructure that can dramatically improve rates of early and accurate testing, detection and diagnosis.

Convened by the Global CEO Initiative on Alzheimer’s Disease (CEOi) and the World Economic Forum (WEF), DAC aims to create a global innovation ecosystem that speeds up and scales the global response to Alzheimer’s disease and changes its trajectory for good.

“The already-staggering prevalence of Alzheimer’s disease will triple by 2050, as will it’s devastating impacts on individuals and societies around the word. To meaningfully accelerate the pace and scale of advancements we must collaborate across sectors like never before,” said Brad O’Connor, Cogstate CEO. “We are truly honored to be part of this global community of committed leaders who are so focused on addressing together the urgent challenges for the development and delivery of Alzheimer’s disease interventions.”

“The Davos Alzheimer’s Collaborative welcomes Cogstate’s deep understanding of Alzheimer’s disease research and clinical care and its critical perspective on how to scale solutions globally; two key elements in making timely progress in this global initiative,” said George Vradenburg, Co-Chair of the Davos Alzheimer’s Collaborative Leadership Group and Convener of The Global CEO Initiative on Alzheimer’s Disease. 

About Cogstate

Cogstate Ltd (ASX:CGS) is a leading neuroscience technology company optimizing brain health assessments to advance the development of new medicines and to enable earlier clinical insights in healthcare. Cogstate technologies provide rapid, reliable and highly sensitive computerized cognitive tests across a growing list of domains and support electronic clinical outcome assessment (eCOA) solutions to replace costly and error-prone paper assessments with real-time data capture. The company’s clinical trials solutions include quality assurance services for study endpoints that combine innovative operational approaches, advanced analytics and scientific consulting. For 20 years, Cogstate has proudly supported the leading-edge research needs of biopharmaceutical companies and academic institutions and the clinical care needs of physicians and patients around the world. Cogstate and pharmaceutical company, Eisai, recently established a global exclusive partnership to develop and market cognitive assessment tools for individuals and doctors around the world.



Rachel Colite
Cogstate
203-773-5010 x157
[email protected]

IIROC Trading Halt – SMAR.P

Canada NewsWire

VANCOUVER, BC, Nov. 16, 2020 /CNW/ – The following issues have been halted by IIROC:

Company: Smartset Services Inc.

TSX-Venture Symbol: SMAR.P 

All Issues: Yes

Reason: Failure to Complete a Qualifying Transaction within 24 Months Of Listing

Halt Time (ET): 7:45 AM

IIROC can make a decision to impose a temporary suspension (halt) of trading in a security of a publicly-listed company. Trading halts are implemented to ensure a fair and orderly market. IIROC is the national self-regulatory organization which oversees all investment dealers and trading activity on debt and equity marketplaces in Canada.

SOURCE Investment Industry Regulatory Organization of Canada (IIROC) – Halts/Resumptions

Hammer Fiber Optics Holdings Corp Announces Results for Year Ended July 31, 2020

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Hammer Fiber Optics Holdings Corp (OTCQB: HMMR) announced operating and financial results for the fiscal year ended July 31, 2020. “During this fiscal year Hammer continued to evolve its operations in support of its Everything Wireless strategy,” said Erik Levitt, Hammer’s CEO. “As we move into the new year more of our revenues will be derived from our Over-the-Top applications, such as SMS and HammerCall, as well as our Fixed Wireless business unit, beginning with our network in Huntsville, AL.”

Key results include:

  • Total revenues for the fiscal year from the remaining ongoing operations decreased to $1,781,139 from $2,179,152. This decrease was primarily due to the discontinuation of Endstream Communications’ toll free termination business. Some of those losses were replaced by revenues from messaging services.
  • Although operating loss adjusted for the remaining ongoing business increased to $277,665 from $137,459, operating loss year over year decreased from $468,366 from the prior year reported 10-K, a decrease of 40.71%. This loss was primarily due to the discontinuation of Endstream Communication’s toll free termination business, and we anticipate the losses will be substantially offset by the SMS services business on a forward-looking basis.
  • Hammer reduced its operating costs by discontinuing its Open Data Centers colocation business. These cost reductions are expected to produce a material impact in the first quarter of 2020, ended October 31, 2020.
  • Construction has begun on the new fixed wireless network in Huntsville, AL.
  • Hammer expanded its US SMS network with presence in Mississippi, Alabama, Texas, New York, New Jersey and other states across the country while simultaneous increasing messaging revenues.
  • Hammer completed the alpha phase of its HammerCall conferencing and collaboration application.

A further update on our operations will be available via a HammerLive broadcast viewable online at https://hammercorp.info/hammerlive/ .

About Hammer

Hammer Fiber Optics Holdings Corp. (OTCQB:HMMR) is a telecommunications company investing in the future of wireless technology. Hammer’s “Everything Wireless” go to market strategy includes the development of high-speed fixed wireless service for residential and small businesses using its wireless fiber platform, Hammer Wireless® AIR, Over-the-Top services such as voice, SMS and video collaboration services, the construction of smart city networks and hosting services including cloud and colocation. For more information contact our Investor Relations Team at info@hammerfiber.com.



Windtree Therapeutics Reports Third Quarter 2020 Financial Results and Provides Key Business Updates

PR Newswire

WARRINGTON, Pa., Nov. 16, 2020 /PRNewswire/ — Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical device company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today reported financial results for the third quarter ended September 30, 2020 and provided key business updates.


Key Business and Financial Updates

  • Announced the dosing of the first patient in the Company’s Phase 2 study of istaroxime for the acute treatment of early cardiogenic shock. The Phase 2 study is an international, randomized, double blind, placebo controlled study to assess the effect of istaroxime in patients with early cardiogenic shock due to heart failure. This study will include 60 patients (30 assigned to istaroxime and 30 assigned to placebo) receiving study drug infusion over 24 hours. The primary endpoint is the change in systolic blood pressure over six hours after initiating the infusion. Secondary endpoints will include characterization of blood pressure changes over 24 hours, the number of patients requiring rescue therapy (vasopressors, inotropes or mechanical devices), assessment of renal function and measures associated with safety and tolerability.
  • Announced U.S. Food and Drug Administration (FDA) acceptance of an Investigational New Drug application for a Phase 2 clinical trial studying lyophilized lucinactant, its synthetic KL4 surfactant, in COVID-19 associated lung injury and acute respiratory distress syndrome (ARDS) patients. The initial study will evaluate changes in physiological parameters in patients who are intubated and mechanically ventilated for COVID-19 associated lung injury and ARDS. The study will evaluate the dosing regimen, tolerability, and functional changes in gas exchange and lung compliance after KL4 surfactant administration. The Company plans to enroll up to 20 patients with COVID-19 and ARDS who are on mechanical ventilation, from 4 to 5 U.S. sites beginning in the fourth quarter with results expected in one to two quarters.
  • With Windtree focused on KL4 surfactant development in COVID-19 lung Injury, it has been decided Lee’s Pharmaceutical (HK) (the license partner for KL4 surfactant in Asia) will execute the AEROSURF bridge study in premature infants with respiratory distress syndrome (RDS) within its licensed territory. Lee’s will continue to fund clinical development of Aerosurf with Windtree providing technical support.
  • Presented a corporate overview at the virtual H.C. Wainwright 22nd Annual Global Investment Conference in September.

“Windtree has made significant progress on advancing our clinical and regulatory goals over the past quarter,” said Craig Fraser, president, and chief executive officer of Windtree. “With the IND acceptance by the FDA, we expect to start our clinical trial for the treatment of COVID-19 associated lung injury in the next several weeks. We are working with top institutions and investigators and both interest and urgency for the study has only increased given the recent surge in COVID-19 rates and the further understanding of the harmful impact of the virus on these patients’ lungs. In the third quarter we were also pleased to start dosing in our Phase 2 trial of istaroxime for the treatment of early cardiogenic shock in heart failure patients and will continue to work to expand sites to ramp enrollment for this trial globally. We continue to focus on the successful execution of our planned upcoming milestones this quarter, and anticipate 2021 to be another meaningful year with important milestones and pipeline progress including the planned start of the next acute heart failure study with istaroxime.”


Select Financial Results for the Third Quarter ended September 30, 2020

For the third quarter ended September 30, 2020, the Company reported an operating loss of $8.7 million, compared to an operating loss of $7.2 million in the third quarter of 2019.

Research and development expenses were $3.9 million for the third quarter of 2020, compared to $3.8 million for the third quarter of 2019. The increase in research and development expenses is primarily due to increases in clinical program costs.

General and administrative expenses for the third quarter of 2020 were $4.8 million, compared to $3.4 million for the third quarter of 2019. The increase in general and administrative expenses is primarily due to an increase in professional fees and $0.9 million in severance costs associated with the departure of two executives during the third quarter of 2020.

The Company reported a net loss of $9.0 million ($0.54 per basic share) on 16.6 million weighted-average common shares outstanding for the quarter ended September 30, 2020, compared to a net loss of $7.1 million ($0.66 per basic share) on 10.7 million weighted average common shares outstanding for the comparable period in 2019.

As of September 30, 2020, the Company reported cash and cash equivalents of $22.4 million which is expected to be sufficient to fund operations through at least the next twelve months. 

Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which will be filed with the Securities and Exchange Commission on November 16, 2020, which includes detailed discussions about the Company’s business plans and operations, financial condition and results of operations.

About Windtree Therapeutics
Windtree Therapeutics, Inc. is advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders to treat patients in moments of crisis. Using new clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate istaroxime being developed as a first-in-class treatment for acute heart failure and early cardiogenic shock in heart failure. Windtree has also focused on developing AEROSURF® as a non-invasive surfactant treatment for premature infants with respiratory distress syndrome, and is facilitating transfer of clinical development of AEROSURF® to its licensee in Asia, Lee’s HK, while Windtree evaluates other uses for its synthetic KL4 surfactant for the treatment of acute pulmonary conditions including lung injury due to COVID-19 infection. Also in its portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.

For more information, please visit the Company’s website at www.windtreetx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include: risks and uncertainties associated with the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the Company’s clinical trials or disruption in supply chain; the success and advancement of the clinical development programs for istaroxime, AEROSURF®, KL4 surfactant and the Company’s other product candidates; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, aerosol delivery systems (ADS) and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the FDA or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; and the rate and degree of market acceptance of the Company’s product candidates, if approved. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release
.


Condensed Consolidated Balance Sheets


(in thousands, except share and per share data)


September
30, 2020


December
31, 2019

Unaudited


ASSETS

Current Assets:

Cash and cash equivalents

$

22,356

$

22,578

Prepaid expenses and other current assets

1,692

1,283

Total current assets

24,048

23,861

Property and equipment, net

702

798

Restricted cash

154

154

Operating lease right-of-use assets

855

1,390

Intangible assets

77,090

77,090

Goodwill

15,682

15,682

Total assets

$

118,531

$

118,975


LIABILITIES & STOCKHOLDERS’ EQUITY

Current Liabilities:

Accounts payable

$

726

$

1,708

Collaboration and device development payable, net

1,972

Accrued expenses

4,279

3,226

Operating lease liabilities – current portion

605

750

Loans payable – current portion

704

161

Total current liabilities

6,314

7,817

Operating lease liabilities – non-current portion

358

794

Loans payable – non-current portion

2,364

4,608

Restructured debt liability – contingent milestone payments

15,000

15,000

Other liabilities

2,400

Deferred tax liabilities

16,370

15,821

Total liabilities

42,806

44,040

Stockholders’ Equity:

Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2020 and December 31, 2019

Common stock, $0.001 par value; 120,000,000 shares authorized at September 30, 2020 and December 31, 2019; 16,921,506 and 13,697,419 shares issued at September 30, 2020 and December 31, 2019, respectively; 16,921,482 and 13,697,395 shares outstanding at September 30, 2020 and December 31, 2019, respectively

17

14

Additional paid-in capital

788,996

763,097

Accumulated deficit

(710,234)

(685,122)

Treasury stock (at cost); 24 shares

(3,054)

(3,054)

Total stockholders’ equity

75,725

74,935

Total liabilities & stockholders’ equity

$

118,531

$

118,975

 


Condensed Consolidated Statements of Operations

(Unaudited)


(in thousands, except per share data)


Three Months Ended


Nine Months Ended


September 30,


September 30,


2020


2019


2020


2019

Revenues:

License revenue with affiliate

$

$

$

$

198

Total revenues

198

Expenses:

Research and development

3,882

3,792

11,838

10,547

General and administrative

4,823

3,395

11,518

9,990

Total operating expenses

8,705

7,187

23,356

20,537

Operating loss

(8,705)

(7,187)

(23,356)

(20,339)

Other (expense) income:

Interest income

21

25

115

124

Interest expense

(46)

(105)

(121)

(358)

Other (expense) income, net

(290)

141

(1,750)

473

Total other (expense) income, net

(315)

61

(1,756)

239

Net loss

$

(9,020)

$

(7,126)

$

(25,112)

$

(20,100)

Net loss per common share

Basic and diluted

$

(0.54)

$

(0.66)

$

(1.65)

$

(1.87)

Weighted average number of common shares outstanding

Basic and diluted

16,579

10,730

15,228

10,724

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/windtree-therapeutics-reports-third-quarter-2020-financial-results-and-provides-key-business-updates-301173301.html

SOURCE Windtree Therapeutics, Inc.

Juggernaut Receives Permit for Goldstandard Discovery

VANCOUVER, British Columbia, Nov. 16, 2020 (GLOBE NEWSWIRE) — Juggernaut Exploration Ltd. (TSX-V: JUGR) (OTCQB: JUGRF) (FSE: 4JE) (the “Company” or “Juggernaut”)  is pleased to report it has received its five year advanced exploration permit for drilling its 100% controlled Goldstandard property.  The property contains multiple extensive newly discovered outcropping orogenic gold veins including the Goldzilla vein that measures up to 20 meters wide and has been traced at surface for 938 meters along strike with 300 meters of vertical relief and remains open to the southeast. The fully funded inaugural drilling will focus on the Godzilla Hinge Zone that is part of the large-scale Goldzilla orogenic vein system where channel cut assayed up to 6.00 g/t AuEq (gold equivalent) over 12 metres including 5 metres of 13.03 g/t AuEq true width.  

The planned inaugural drill program will be designed to test the Goldzilla hinge zone both along strike and to depth. The discovery zones are located in alpine areas of recently exposed bedrock due to glacial and snowpack abatement. The Goldzilla Zone is an original new orogenic gold discovery located in a world-class geological setting (high strain zone) that remains largely unexplored, providing tremendous additional untapped gold potential. This discovery has already garnered the attention of the miners and institutions alike, further demonstrating the potential of the Goldstandard property and surrounding area to evolve into a new orogenic gold camp. Approximately 67 % of Canadian gold production comes from this world class geologic setting.(Link to Video)

The company also successfully completed a property wide LiDAR and orthophoto survey in Sept 2020 covering both its Goldstandard and Goldstar properties located in the same area. This data will used to assist in future exploration on both properties.

The Goldstandard property is located in the Central Coastal region of British Columbia Canada, only 4km from major infrastructure and 1km to tidewater and logging roads, providing excellent, cost-effective exploration.

GOLDZILLA HINGE ZONE

Detailed mapping and surface sampling, identified a 100m by up to 20m wide hinge zone containing high grade gold mineralization of up to 6.00 g/t AuEq over 12m including 5m of 13.03 g/t AuEq and 1m of 31.66 AuEq(schematic of hinge zone). This hinge zone is part of the large-scale Goldzilla orogenic system that is traced on surface for 938m with 320m of vertical relief and remains open (hinge zone Image)

The Goldzilla hinge zone planned inaugural drill program will target the high grade gold mineralization discovered at surface and trace it to depth. Drilling will be designed to unlock the full potential of this newly discovered high-grade orogenic vein system and to understand the relationship between the multiple other newly discovered large en-echelon gold bearing orogenic veins at depth.

HIGHLIGHTS OF OTHER OROGENIC VEINS ON GOLD STANDARD:

  • The Leviathan Vein: has been traced on surface for 500 m with 50 m of vertical relief and remains open. Channel sampling from 2019 returned grades of up to 3.65g/t AuEq over 3 m including 10.55g/t AuEq over 1 m true width. (Leviathan Video) (Leviathan Schematic)

  • The Kraken Vein: has been traced on surface for 1000m with 520 m of vertical relief and remains open. Channel samples from 2019 returned grades of 29.48g/t AuEq over 0.7 m and a 1m chip taken 305m along strike grading 6.52g/t Au. (Kraken Video) (Kraken Schematic)

  • The East Vein: is a newly discovered large vein system with grab samples up to 7.22 g/t Au and a 3 m chip sample grading 5.75 g/t Au. The discovery of this vein system has increased the Big Show High Strain zone from 2 km by 1 km to 4.6 km by 1.5 km. (East Vein)

In addition several other en-echelon gold bearing orogenic veins have been found within the Big Show high strain zone that has been expanded in 2019 from 2km by 1km, to 4.5km by 1.5km, containing multiple large en-echelon gold bearing mineralized quartz veins and shear zones. Exploration has further confirmed the extent of gold mineralization within multiple quartz veins and shear zones, within the Big Show high-strain, confirming an extensive orogenic gold system within the property. (link to image)

This mineralized orogenic system is part of a regional high-strain zone, a brittle and ductile, sub-vertical shear zone system that is proximal to the boundary between the Intermontane and Insularsuperterranes, demarked by the Coast shear zone. Localization of high-strain zones within the system are associated with sheeted, oxidized, sulphide-bearing quartz veins and shear zones that have been identified in outcrop with a strike length of 4.6 km and 1.5 km wide, which remains open in all directions. Discrete gold bearing quartz veins and shears trend up to ~1 km in strike with 500m of vertical extent and are up to 15m in width. They host variable amounts of gold mineralization, oxidized pyrite and disseminated pyrite with chalcopyrite.

GEOLOGIC MODEL – NEW OROGENIC GOLD SYSTEM

Exploration programs have confirmed the extent of high grade gold mineralization within multiple quartz veins and shear zones, within the Big Show high-strain zone confirming an extensive orogenic gold system within the Gold Standard property. The prolonged faulting and shearing within this structural corridor on the Gold Standard property provided extensive conduits for mineralizing fluids and favorable sites for mineralization (link to image). Within the Big Show Zone, veins occur in an en-echelon pattern to the regional north-northwest orientation of the major shear zones. These orogenic characteristics are consistent with gold-bearing mineralized veins and shear zones in several mining districts globally.

Orogenic gold systems are often deep rooted and are mined to depths of 1 to 3 kilometres (orogenic Model 1). Approximately 67 % of Canadian gold production comes from this type of geologic setting, with examples including nearby to the south Talisker Resources Bralorne Pioneer camp in British Columbia (4.17 Moz) with depths to 2km, and Couer Mining’s Kensington mine just to the North in Juneau Alaska also including many regions within the Canadian shield including Kirkland Lake (>40 Moz), Timmins (>70 Moz), Val d’Or/Noranda (>69 Moz) and Red Lake gold camps (>29 Moz). These gold deposits typically contain average mining grades of ~5 gpt Au to ~15 gpt Au, similar to what is found at the Gold Standard property. Other orogenic systems are currently being explored such as Great Bear Resources Dixie project that confirm similar grades in drilling (orogenic model 2).

Dan Stuart President and CEO states:

“The Goldstandard property has demonstrated its tremendous gold potential with the discovery of the
Goldzilla
hinge zone and several other high-grade orogenic gold veins. These orogenic gold systems are commonly mined to depths of 1 to 3
kilometres
. This geologic setting and model have proven to host several world-class, high 
grade
, multimillion ounce deposits. Future exploration has excellent potential to expand on these discoveries both along strike and at depth. This project has already garnered the interest of several miners and institutions alike confirming the significance of this discovery. We look forward to the inaugural drill program designed to trace the discovery zone to depth and along strike.”

Qualified Person

Rein Turna, P. Geo. is the qualified person as defined by National Instrument 43-101, for Juggernaut Exploration Ltd., and supervised the preparation of, and has reviewed and approved, the technical information in this release.

Other

All samples were crushed and pulverized at ALS Global ISO 17025:2005 accredited geochemistry lab in North Vancouver, BC. Drill core samples were crushed, split and pulverized to 250 g pulp. The sample pulps were analyzed for gold by fire assay method (Au-AA24) and were also assayed using multi-element aqua regia digestion. Samples were analyzed using ALS assay procedure ME-ICP41m and MS-ICP61m. ME-ICP is an aqua regia (partial) digestion with inductively-coupled plasma (ICP)mass atomic emission spectroscopy (ICP-AES) finish for 36elements. MS-ICP61m is a four acid digestion with ICP mass spectrometry finish for 49 elements. Over-limit samples for copper, lead and zinc were reanalyzed by fire assay with a gravimetric finish (OG46 and OG62). Rigorous procedures are in place regarding sample collection, chain of custody and data entry. QA/QC samples including blanks, standards, and duplicate samples were inserted regularly into the sample sequence.

For more information please contact:

Juggernaut Exploration Ltd.
Dan Stuart
604-559-8028
Director, President and Chief Executive Officer
www.juggernautexploration.com

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.

FORWARD LOOKING STATEMENT

Certain disclosure in this release may constitute forward-looking statements that are subject to numerous risks and uncertainties relating to Juggernaut’s operations that may cause future results to differ materially from those expressed or implied by those forward-looking statements, including its ability to complete the contemplated private placement. Readers are cautioned not to place undue reliance on these statements. NOT FOR DISSEMINATION IN THE UNITED STATES OR TO U.S. PERSONS OR FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES. THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER TO SELL OR AN INVITATION TO PURCHASE ANY SECURITIES DESCRIBED IN IT.