Monthly Archives: July 2019

Aztec Minerals Completes Earn-in and Exercises Option to Acquire a 65% Interest in the Cervantes Project in Sonora, Mexico from Kootenay Silver Appoints Andy Bowering to Advisory Committee

Appoints Andy Bowering to Advisory Committee

VANCOUVER, BC / ACCESSWIRE / JULY 30, 2019 / Aztec Minerals Corp. (TSX-V:AZT)(OTCQB:AZZTF) announces that it has completed the terms of its earn-in and has exercised its option to acquire a 65% interest in the Cervantes porphyry gold-copper project in Sonora, Mexico from Kootenay Silver Inc.. Kootenay retains the remaining 35% interest in Cervantes.

Aztec and Kootenay expect to finalize the terms of the joint venture agreement shortly, then form a joint venture management committee, review the exploration results to date and approve the next exploration program and budget at Cervantes.

Aztec also announces the appointment of Andrew Bowering to its business and technical advisory board. Mr. Bowering is a venture capitalist with 30 years of experience in mineral exploration and development worldwide. He has founded, funded and built management teams that have operated numerous companies in the pursuit of precious, base and industrial metals from early exploration through to production.

Mr. Bowering has a financial background as a stock broker and a business background as the founder and an owner of Sunrise Drilling Ltd. In recent years, Andy has held senior leadership roles in public and private companies from investor relations to CEO. He is a founder and significant shareholder of Millennial Lithium Corp and is the founder and current CEO of Prime Mining Corp.

Joey Wilkins, Aztec CEO, stated: “We are pleased to reach this milestone after four years of productive mineral exploration on the Cervantes property. The results of our geophysical surveys, geochemical sampling, and geologic mapping have outlined a district-scale porphyry gold-copper system with multiple targets, most of which have never been drilled.”

“Our first drill program at the California prospect resulted in the discovery of a large, well mineralized gold oxide zone hosted by a strongly altered and brecciated quartz feldspar porphyry intrusion. A strong, broad IP chargeability anomaly underlies the California gold oxide zone down to at least 500 meters depth, is interpreted to be an underlying sulfide zone and has not yet been tested by drilling.”

“A recently completed Phase 2 geophysical survey has uncovered additional high priority chargeability and resistivity anomalies on trend with the California prospect in two separate porphyry targets, more details to follow. The number of high-quality targets continues to grow as we explore the full extent of this prospective 3,500 hectare property.”

“I would like to welcome Andy Bowering to our advisory committee. Andy has enjoyed much success in the management of and capital formation for exploration and mining ventures. We look forward to working with him as we advance our mineral exploration projects through the discovery phase.”

About Aztec Minerals – Aztec is a mineral exploration company focused on the discovery of large mineral deposits in the Americas. Our core assets include the prospective, district scale Cervantes porphyry gold-copper property in Sonora, Mexico, and the Tombstone CRD silver-lead-zinc-copper district in Arizona. The Company board and management have successful track records of value creation through discovery, development and production in the mining sector. Aztec’s shares trade on the TSXV (symbol AZT) and on the OTCQB (symbol AZZTF).

Contact Information – For more information, please contact:

Joey Wilkins, President / CEO or Bradford Cooke, Chairman
Tel: (604) 685-9770
Fax: (604) 685-9744
Email: joey@aztecminerals.com
Website: www.aztecminerals.com

Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

SOURCE: Aztec Minerals Corp.

ReleaseID: 553902

Linde Starts Up New Plants to Supply EverDisplay Optronics in China

GUILDFORD, UK / ACCESSWIRE / July 30, 2019 / Linde (NYSE: LIN; FWB: LIN) announced today it has started up its new air separation plants to supply a combined 720 tons per day of high purity nitrogen to Shanghai EverDisplay Optronics Co., Ltd. (EDO) supporting its sixth generation AMOLED project. Under the terms of the contract, Linde will also supply EDO with oxygen, helium, argon and hydrogen.

“We are pleased to have started supplying Everdisplay while expanding our industrial gas capacity and pipeline network in Shanghai and Yangtze River Delta.” said Steven Fang, Head of Linde Greater China. “These new plants will increase our network density and ability to reliably supply the growing consumer electronics market in China.”

Huiran Liu, General Manager of EDO, said, “EDO is committed to the development of AMOLED display technology and we have great confidence in Linde’s track record of reliable and high-quality industrial gas supply.”

About Linde
Linde is a leading industrial gases and engineering company with 2018 pro forma sales of USD 28 billion (EUR 24 billion). The company employs approximately 80,000 people globally and serves customers in more than 100 countries worldwide. Linde delivers innovative and sustainable solutions to its customers and creates long-term value for all stakeholders. The company is making our world more productive by providing products, technologies and services that help customers improve their economic and environmental performance in a connected world.

For more information about the company, please visit www.linde.com

Contacts:

Investor Relations
Juan Pelaez
Phone: +1 203 837 2213
Email: juan.pelaez@linde.com
Media Relations
Anna Davies
Phone: +44 1483 244705
Email: anna.davies@linde.com

SOURCE: Linde plc

ReleaseID: 553951

Antibacterial Glass Market Report 2019 By Regional Revenue, Growth & Trends Analysis 2023

Antibacterial glass finds extensive application across hospitals, household, food & beverages, and defense sectors. Antibacterial glass market value in hospitals sector was estimated at over USD 60 million in 2015, and is anticipated to grow noticeably over the coming timeframe.

Selbyville, United States – July 30, 2019 /MarketersMedia/

According to the Global Market Insights, Inc., “Antibacterial glass market revenue is projected to hit USD 270 million by 2023.” Popular use of antimicrobial items in consumer electronics will positively impact global antibacterial glass industry trends. Furthermore, antibacterial glass finds its application across healthcare and medical sectors, owing to its ability to prevent the spread of infections. As per WHO estimates, more than 10% of patients in emerging economies and nearly 7% in developed countries acquire infections during their hospital stays.

High occurrence of nosocomial infections leading to escalating demand for antibacterial coatings will drive global antibacterial glass market expansion. Ability to inhibit the spreading of microbes and kill surface bacteria makes the product more desirable over other alternatives.

Request sample copy of this report @ https://www.gminsights.com/request-sample/detail/444

Antibacterial glass finds extensive application across hospitals, household, food & beverages, and defense sectors. Antibacterial glass market value in hospitals sector was estimated at over USD 60 million in 2015, and is anticipated to grow noticeably over the coming timeframe. Increased acceptance of the products across isolation rooms, oncology & hematology units, and burn units will fuel the revenue.
Household applications will witness a prominent growth over the coming years, driven by high product demand for mirrors, wall coverings, and vision glazing. Food & Beverages applications sector, worth USD 20 million in 2015, is expected to grow at a rate of 7% over the period of 2016-2023.
High demand for enhancing the shelf life of food along with the intense requirement for retaining food quality in the restaurants, hotels, and canteens will favorably influence the antibacterial glass industry growth.
Heavy healthcare spending along with rising elderly population more prone to hospital acquired infections is expected to boost LATAM antibacterial glass industry size over the next few years.

Browse Complete Summary of this report @ https://www.gminsights.com/industry-analysis/antibacterial-glass-market-report

Europe antibacterial glass market revenue, which was USD 95 million in 2015, is forecast to witness a substantial surge over the coming timeframe. Stringent legislations to annihilate microbial infection in food & beverages sector is predicted to influence the regional growth. In addition to this, the presence of major firms in this region will further drive the demand.

North America antibacterial glass industry will witness a considerable growth over the coming six years. Growing inclination for reducing hospital acquired infections along with high focus on improving healthcare infrastructure will propel the regional revenue. In addition to this,
technological innovations along with beneficial regulations will favorably impact the business in the region. U.S. is forecast to contribute significantly towards the regional share.

Partial Chapter of the Table of Content:

Chapter 2. Executive Summary
2.1. Antibacterial glass industry 3600 synopsis, 2012 – 2023
2.1.1. Business trends
2.1.2. Application trends
2.1.3. Regional trends
Chapter 3. Antibacterial Glass Industry Insights
3.1. Industry segmentation
3.2. Industry Size and forecast, 2012 – 2023
3.3. Industry ecosystem analysis
3.5. Industry Impact forces
3.5.1. Growth drivers
3.5.1.1 Growing nosocomial infections
3.5.1.2 Medical device coatings demand
3.5.2. Industry pitfalls & challenges
3.5.2.1 Regulatory concerns
3.5.2.2 Low degree of awareness
3.6. Growth potential analysis
3.7. Porter’s analysis
3.8. Company market share analysis, 2015
3.9. PESTEL analysis
Chapter 4. Antibacterial Glass Active Ingredient Insights
4.1. Antibacterial glass market share by active ingredient, 2015 & 2023
4.2. Silver
4.2.1. Market estimates and forecasts, 2012 -2023
4.2.2. Market estimates and forecasts by region, 2012 -2023
4.3. Others
4.3.1. Market estimates and forecasts, 2012 -2023
4.3.2. Market estimates and forecasts by region, 2012 -2023

Make an inquiry for purchasing this report @ https://www.gminsights.com/inquiry-before-buying/444

Market participants will try to increase their revenue as well as geographical presence by enforcing business strategies such as product innovation, strategic collaborations, and joint ventures. Key industry players include Saint-Gobain S.A., JiYan-Tech Co. Ltd, Corning Inc., Nippon Sheet Glass Co. Ltd, Glas Trösch Holding AG, AGC Glass Europe, Archello, Vetraria Bergamasca Tecnovetroamong, Ishizuka Glass Co. Ltd, BÜFA Glas, and Sprinz.

Contact Info:
Name: Arun Hedge
Email: Send Email
Organization: Global Market Insights, Inc.
Website: https://www.gminsights.com/industry-analysis/antibacterial-glass-market-report

Source URL: https://marketersmedia.com/antibacterial-glass-market-report-2019-by-regional-revenue-growth-trends-analysis-2023/88902315

Source: MarketersMedia

Release ID: 88902315

New EB-5 Financing Offered Same Day as New Regulation Raising Price to $900,000

EB-5 Investments offers new EB-5 investment where the applicant for US Citizenship only needs to have a deposit of $250,000 down and assets of the other $250,000 for their application to be filed.

دبي, United Arab Emirates – July 30, 2019 /PressCable/

EB-5 Investments announces a new financing option for EB-5 Visas.

Prior to this announcement by the US Government, an EB-5 investment was $500,000 and now with this groundbreaking new offer, the applicant only needs to put down $250,000 in order to qualify for a permanent green card for their entire family. The only other qualification is they must have additional assets worth the remaining $250,000.

The EB-5 Immigrant Investor Program has been rewritten and modernized and applicants have 120 days to apply under the old guidelines before the investment almost doubles. The new amounts are $900,000 for TEA investments and $1 million to $1.8 million for non-TEA investments.

The Final Rule will be effective on November 21, 2019, 120 days from the date of publication in the Federal Register, giving investors an opportunity to file under current EB-5 regulations and investment amounts. Investors filing for I-526 petitions before the effective date will be grandfathered under the current rules and lower investment amounts of $500,000 for TEA projects.

EB-5 Investments has an exciting new EB-5 investment where you can apply by making only a $250,000 USD investment and the project will finance the other $250,000 of the $500,000 investment at a 10% per annum interest rate if the applicant and family invest in one of the pre-approved projects, the return from the project negates the interest on the loan.

This type of investment structure has never been available before and there is only a limited number of spots open. As of this date, there are only 16 spots left that qualify for this kind of an investment.

In a recent interview, Mr. Zac Gawn, the executive director of EB-5 Investments.com was quoted as saying that he be surprised if this offering would be available for the next 30 days. He went on to say; “If we had this type of option available last year, we could have helped a lot more families realize their dream of moving to America”.

Contact Info:
Name: Zac Gawn
Email: Send Email
Organization: EB-5 Investments
Address: undefined 2 Marasi Dr, دبي, United Arab Emirates
Website: https://eb-5investments.com/

Source: PressCable

Release ID: 88901535

Resonant Inc. to Present at Oppenheimer’s 22nd Annual Technology, Internet & Communications Conference

GOLETA, CA / ACCESSWIRE / July 30, 2019 / Resonant Inc. (NASDAQ: RESN), a leader in transforming the way radio frequency, or RF, front-ends are being designed and delivered for mobile handset and wireless devices, is scheduled to present at Oppenheimer’s 22nd Annual Technology, Internet & Communications Conference in Boston. The event is being held on August 6th and 7th, 2019, at the Four Seasons Hotel Boston.

Management plans to provide a business update and industry overview focusing on the company’s unique Infinite Synthesized Networks® (ISN®) software design platform, 5G XBAR™ resonator technology, recently introduced Filter IP Standard Library, and highly leverageable IP licensing business model that have positioned Resonant to capitalize on the current 5G transition in the mobile market.

Resonant management will host one-on-one meetings throughout the day on Wednesday, August 7th and is scheduled to present as follows:

Oppenheimer Technology, Internet & Communications Conference
Date: Wednesday, August 7th, 2019
Presentation Time: 11:05a.m. ET
Location: Four Season Hotel Boston

The presentation will be webcast live and available for replay following the live presentation. The webcast can be viewed at https://ir.resonant.com/events.

About Resonant Inc.
Resonant (NASDAQ: RESN) is transforming the market for RF front-ends (RFFE) by disrupting the RFFE supply chain through the delivery of solutions that leverage our Infinite Synthesized Network (ISN) software tools platform, capitalize on the breadth of our IP portfolio, and are delivered through our services offerings. In a market that is critically constrained by limited designers, tools and capacity, Resonant addresses these critical problems by providing customers with ever increasing design efficiency, reduced time to market and lower unit costs. Customers leverage Resonant’s disruptive capabilities to design cutting edge filters and modules, while capitalizing on the added stability of a diverse supply chain through Resonant’s fabless ecosystem-the first of its kind. Working with Resonant, customers enhance the connectivity of current mobile devices, while preparing for the demands of emerging 5G applications.

To learn more about Resonant, view the series of videos published on its website that explain Resonant’s technologies and market positioning:

Resonant Corporate Video
ISN and XBAR: Speeding the Transition to 5G
Infinite Synthesized Networks, ISN Explained
What is an RF Filter?
RF Filter Innovation
Transforming the Mobile Filter Supply Chain

For more information, please visit www.resonant.com.

Resonant uses its website (https://www.resonant.com) and LinkedIn page (https://www.linkedin.com/company/resonant-inc-/) as channels of distribution of information about its products, its planned financial and other announcements, its attendance at upcoming investor and industry conferences, and other matters. Such information may be deemed material information, and Resonant may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor the company’s website and its social media accounts in addition to following the company’s press releases, SEC filings, public conference calls, and webcasts.

About Resonant’s ISN® Technology
Resonant can create designs for difficult bands, modules and other complex RF Front End requirements that we believe have the potential to be manufactured for half the cost and developed in half the time of traditional approaches. ISN is a suite of proprietary mathematical methods, software design tools and network synthesis techniques that enable us to explore a much larger set of possible design solutions that regularly incorporate our proprietary technology. We then quickly deliver design simulations to our customers, which they manufacture or have manufactured by one of our foundry partners. These improved solutions still use Surface Acoustic Wave (SAW) or Temperature Compensated Surface Acoustic Wave (TC-SAW) manufacturing methods and perform as well as those using higher cost manufacturing methods such as Bulk Acoustic Wave (BAW). Resonant’s method delivers excellent predictability, enabling achievement of the desired product performance in roughly half as many turns through the fab. In addition, because Resonant’s models are fundamental, integration with its foundry and fab customers is seamless because its models speak the “fab language” of basic material properties and dimensions.

Investor Relations Contact:

Moriah Shilton, LHA Investor Relations, 1-415-433-3777, RESN@lhai.com

SOURCE: Resonant Inc.

ReleaseID: 553932

SE4 launches first VR-based robot control technology with AI, enabling highly accelerated & adaptable remote operation

Poised to race to outer space, SE4’s unique approach eliminates latency challenges in teleoperation; VR actions in 3D simulation can be sent to multiple robotic devices in one process

LOS ANGELES, CA / ACCESSWIRE / July 30, 2019 / SIGGRAPH – SE4 Inc., a company specializing in remote robotics software for high latency environments, is introducing a robot operating system which combines virtual reality (VR), Computer Vision (CV) and artificial intelligence (AI) software to enable highly accelerated remote robotic control. It also provides adaptive operational capability for dynamically changing environments at any distance. The company is initially targeting repetitive tasks such as excavation and construction, with a view towards deployment in robots in outer space, as their software sidesteps the speed of light constraints that cause latency issues.

SE4’s innovative technology, called Semantic Control™, eliminates the need for tedious and complex programming steps in controlling robots – such as which joint to move, where… – and removes the need for the involvement of a vast range of programming teams for installation and continued operation. Instead, operators use VR in a safe, simulated 3D environment, where they can “annotate” objects and perform actions on them. AI interprets the actions, and the tasks are organized and sent to the robot as a series of tasks, like a to-do list. At that point the robot itself can determine the best way, and order, to accomplish each task using local information, adapting intelligently to changes in its workspace.

“The majority of robot teaching programs use 2D methods – such as a touchscreen pendant – to interact with 3D environments,” said Pavel Savkin, chief technology officer, SE4 Inc. “We control objects in 3D space using VR, which is far more efficient and eliminates the learning curve. It also increases robot and operational safety because tasks are sanity checked first by the simulator. They have to make physical sense before they can be executed.”

SE4’s unique approach manages the significant problem of latency in the instruction process. By uploading a directive to the robot and providing it with operational flexibility, there is no need for a stream of constant instructions and the resulting delays which in outer space can take 12.5 minutes (on average) one way from Mars to Earth, making direct and real-time control impossible.

“Imagine a robotic construction project on Mars right now – it is like King George telling the colonists in the New World how to build a single structure with a one-month sea delay each way. That’s the status of where we are now,” said Savkin. “SE4’s solution delivers instructions as a to-do list, with dependencies included for flexibility in execution, so that latency becomes manageable. A general directive can go out to a single robot, or to many devices for simultaneous control, using command queueing and automated delegation.”

The software is targeted at both new and existing robots equipped with the necessary sensor technology and is designed to make robotics far more useful in a wider variety of settings, including areas of danger or high latency, or inhospitable environments. SE4 will supply its software to companies engaged in repetitive terrestrial work such as construction, where autonomous diggers can be told via a virtual environment which sector to excavate, to what depth, and where to put the excavated earth. Once the robot has received its instructions, the operator can walk away while the system uses computer vision, machine learning and a semantic structure to adapt to environmental changes, for example if the digger were to come across a boulder it might contact the operator for additional guidance.

SE4 will demonstrate its one-of-a-kind robot operating system at SIGGRAPH’s Real-Time Live! July 30, 2019.

Images and Video: https://drive.google.com/drive/folders/1ZPBwdF6vbZvYC2PN0gYoWl99hJSApNsH

About SE4, Inc.
SE4 is a robotics company specializing in remote robotics using VR simulation to enable remote operation at vast distances, as well as nearby. SE4’s vision is to effectively enable an off-world robot-driven industrial revolution to increase the prosperity and long-term survivability of humanity. The company is part of the NVIDIA Inception accelerator, which supports AI start-ups with tools and expertise. Based in Tokyo, SE4 has received initial investment from Mistletoe Inc. since its founding in 2018. For information, visit se4.space.

For more information contact:

Erica Zeidenberg
erica@hottomato.net
925-631-0553 – office
925-518-8159 – mobile
www.hottomato.net

SOURCE: SE4 Inc.

ReleaseID: 553937

Coral Gold Provides Q2 Report on Nevada Gold Mines’ Progress at Robertson Project in Nevada

VANCOUVER, BC / ACCESSWIRE / July 30 2019 / Coral Gold Resources Ltd. (TSX-V: CLH; OTCQX: CLHRF) (“Coral” or the “Company”) reports that Nevada Gold Mines (“NGM”) continues to advance activities on the Robertson Project in the Cortez region of Nevada where Coral retains a net smelter returns royalty (NSR). NGM’s work during the quarter focused on analyzing data from 2018 drilling and continuing the 2019 drill program.

NGM recently delivered its Q2 2019 summary of work completed at Robertson, reporting that the 2019 core drilling program (13,290-meters), which began in early March, continued through the quarter with 5,517 meters completed. NGM reports that infill and comparison drilling at the Porphyry and Altenburg Hill zones was completed while infill drilling at the Gold Pan/39A zone was delayed.

NGM also continued to develop updated geological and metal models. This work includes data addition from 45 core holes drilled in 2018 to develop the mineral inventory, upgrade the geology understanding and advance metallurgy. In its Q1 report, NGM noted that “Results from 2018 whole core assaying increased the grade thickness and highlights a previous under sampling trend.”

“NGM continues to make steady, methodical progress at Robertson,” said Coral Gold President and CEO David Wolfin. “They are gaining new insights into geology, grades and metallurgy, and we believe this thorough approach is the best way to bring the property onstream. We’re very pleased with both the results and the exceptional team developing the property.”

As in the previous quarter, NGM continued its baseline study work, including waste/ore characterization, along with Phase II Heap leach column testing. Baseline study work must be completed prior to the permitting stage.

Coral’s NSR at Robertson

After sale of the Robertson Project to Barrick in 2017 (now held within Nevada Gold Mines), Coral retains a sliding scale, 1% to 2.25% NSR on the project. Coral’s NSR is subject to potential advance royalty payments as well as a right of first refusal enabling Barrick to acquire the NSR if the Company wishes to sell the NSR to any third party. The royalty increases with an increase in the price of gold. Details of the NSR are available on Coral’s website.

About Coral Gold Resources Ltd.

Coral Gold Resources is a precious metals exploration company operating in Nevada, where it has explored one of the world’s richest gold districts for over 30 years. The Company’s primary asset is a sliding scale net smelter returns production royalty on Nevada Gold Mines’ Robertson Property in Nevada. The Company also holds a portfolio of strategically-located exploration projects near Nevada Gold Mine’s Pipeline/Cortez Mine Complex on Nevada’s Battle Mountain/Cortez Trend. Coral remains debt free with a strong balance sheet. Our overall objective is to generate long-term wealth for shareholders.

ON BEHALF OF THE BOARD

“David Wolfin”

David Wolfin
President & Chief Executive Officer
Coral Gold Resources Ltd.

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. This release contains statements that are forward-looking statements and are based on numerous assumptions, and involve known and unknown risks, uncertainties and other factors, including risks inherent in mineral exploration and development, which may cause the actual results, performance, or achievements of the Company to be materially different from any projected future results, performance, or achievements expressed or implied by such forward-looking statements. Such information contained herein represents management’s best judgment as of the date hereof based on information currently available. The Company does not assume the obligation to update any forward-looking statement.

SOURCE: Coral Gold Resources Ltd.

ReleaseID: 553918

NeoGenomics Reports 50% Revenue Growth to Record $102 Million in the Second Quarter

Second-Quarter Highlights:

Consolidated revenue increased 50% to $101.7 millionClinical Services revenue increased 49% to $89.0 millionPharma Services revenue increased 55% to $12.7 millionPharma Services backlog increased 18% to $106.1 millionGross profit increased 60% to $49.0 millionCompleted $160.8 million net equity offering and refinanced credit facility to $250.0 millionFull-year 2019 guidance increased

FORT MYERS, FL / ACCESSWIRE / July 30, 2019 / NeoGenomics, Inc. (NASDAQ: NEO) (the “Company”), a leading provider of cancer-focused genetics testing services, today announced second-quarter and first-half results for the period ended June 30, 2019.

Douglas M. VanOort, the Company’s Chairman and CEO, commented, “Our second quarter financial results were strong, building on the momentum that we saw in the first quarter. Our Clinical Services revenue growth remains well above our expectations and is driven by continued market share gains. Our Pharma Services revenue growth accelerated to more than 50%, even as we grew our backlog of contracted business to record levels. The integration of Genoptix is proceeding on schedule and profitability continued to improve as a result of better operating leverage and cost efficiency.

During the quarter we significantly strengthened our Balance Sheet, launched a critical new companion diagnostic test for breast cancer patients and announced plans for a new state-of-the art laboratory and global headquarters.

We are pleased with our 2019 first-half performance, optimistic about our prospects for the second half of this year, and confident in our strategies for the future.”

Second-Quarter Results

Consolidated revenues for the second quarter of 2019 were $101.7 million, an increase of 50% over the same period in 2018. Clinical test volume(1) increased by 34% year over year. Average revenue per clinical test (“revenue per test”) increased by 12% to $355, primarily due to the acquisition of Genoptix. Clinical Services revenue was $89.0 million resulting in a 49% increase over the second quarter of prior year. Pharma Services reported record revenue of $12.7 million, which represented a 55% growth rate over the second quarter of 2018.

Gross profit improved by $18.4 million, or 60%, compared to the second quarter of 2018, to $49.0 million. Gross margin improved by approximately 300 basis points year-over-year to 48.1%. Gross margin improvement reflects the impact of volume growth, higher revenue per test, productivity gains, and cost efficiencies. Average cost of goods sold per clinical test (“cost per test”) increased by 8% year over year reflecting the impact of the Genoptix acquisition, partially offset by continued efficiencies.

Operating expenses increased by $14.8 million, or 50%, compared to the second quarter of 2018, primarily due to the Genoptix acquisition and an increase in investments in information technology and growth initiatives.

Net income for the quarter was $2.0 million compared to a net loss of $0.4 million for the same period a year ago.

Adjusted EBITDA(2) was $14.9 million for the quarter, a 49% improvement from the prior year. Adjusted Net Income(2) was $7.2 million compared to Adjusted Net Income of $4.5 million in the prior year.

Cash and cash equivalents was $167.4 million at the end of the second quarter, reflecting the proceeds from the equity offering. Days sales outstanding (“DSO”) increased 3 days to 81 days when compared to the first quarter of 2019.

2019 Financial Outlook:

The Company is increasing its full-year 2019 guidance, initially issued on February 19, 2019.

(in millions)

Initial Guidance Q1 Updated Guidance Q2 Revised Guidance Consolidated revenue

$379 – $395 $384 – $400 $388 – $402 Net (loss)/income

($3)- $3 ($3) – $1 ($1) – $3 Adjusted EBITDA(2)

$49 – $53 $52 – $56 $54 – $58

Please also refer to the tables reconciling forecasted Adjusted EBITDA, Adjusted Net Income and Adjusted Diluted EPS to their closest generally accepted accounting principles (“GAAP”) equivalent in the section of this report entitled “Reconciliation of Non-GAAP Financial Guidance to Corresponding GAAP Measures.”

The Company reserves the right to adjust this guidance at any time based on the ongoing execution of its business plan. Current and prospective investors are encouraged to perform their own due diligence before buying or selling any of the Company’s securities, and are reminded that the foregoing estimates should not be construed as a guarantee of future performance.Please also refer to the tables reconciling forecasted Adjusted EBITDA, Adjusted Net Income and Adjusted Diluted EPS to their closest generally accepted accounting principles (“GAAP”) equivalent in the section of this report entitled “Reconciliation of Non-GAAP Financial Guidance to Corresponding GAAP Measures.”

____________________

(1) Clinical tests exclude tests performed for Pharma Services customers.

(2) The Company has provided adjusted financial information that has not been prepared in accordance with GAAP, including Adjusted EBITDA, Adjusted Net Income, and Adjusted Diluted EPS. Each of these measures is defined in the section of this report entitled “Use of Non-GAAP Financial Measures.” See also the tables reconciling such measures to their closest GAAP equivalent.

Conference Call

The Company has scheduled a webcast and conference call to discuss its second-quarter results on Tuesday, July 30, 2019 at 08:30 AM EDT. Interested investors should dial (844) 602-0380 (domestic) and (862) 298-0970 (international) at least five minutes prior to the call. A replay of the conference call will be available until 08:30 AM EDT on August 6, 2019, and can be accessed by dialing (877) 481-4010 (domestic) and (919) 882-2331 (international). The playback conference access code is 49691. The webcast may be accessed under the Investor Relations section of our website at http://neogenomics.com/. An archive of the webcast will be available until 08:30 AM EDT on October 30, 2019.

About NeoGenomics, Inc.

NeoGenomics, Inc. specializes in cancer genetics testing and information services. The Company’s Clinical Services division provides one of the most comprehensive oncology-focused testing menus in the world for physicians to help them diagnose and treat cancer. The Company’s Pharma Services division serves pharmaceutical clients in clinical trials and drug development.

Headquartered in Fort Myers, Florida, NeoGenomics operates College of American Pathologists (“CAP”) accredited and Clinical Laboratory Improvement Amendments (“CLIA”) certified laboratories in Fort Myers and Tampa, Florida; Aliso Viejo, Carlsbad and Fresno, California; Houston, Texas; Atlanta, Georgia; Nashville, Tennessee; Rolle, Switzerland, and Singapore. NeoGenomics serves the needs of pathologists, oncologists, academic centers, hospital systems, pharmaceutical firms, integrated service delivery networks, and managed care organizations throughout the United States, and pharmaceutical firms in Europe and Asia. For additional information about NeoGenomics, visit http://neogenomics.com/.

Forward Looking Statements

Certain information contained in this press release constitutes forward-looking statements for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including the information set forth in the “Full-Year 2019 Financial Outlook”. These forward looking statements involve a number of risks and uncertainties that could cause actual future results to differ materially from those anticipated in the forward-looking statements as the result of the Company’s ability to continue gaining new customers, offer new types of tests, integrate its acquisition of the Genoptix business and otherwise implement its business plan, as well as additional factors discussed under the heading “Risk Factors” and elsewhere in the Company’s Annual Report on Form 10-K filed with the SEC on February 26, 2019, amended by a 10K/A filed with the SEC on May 8, 2019. As a result, this press release should be read in conjunction with the Company’s periodic filings with the SEC. In addition, it is the Company’s practice to make information about the Company available by posting copies of its Company Overview Presentation from time to time on the Investor Relations section of its website at http://ir.neogenomics.com/.

Forward-looking statements represent the Company’s estimates only as of the date such statements are made (unless another date is indicated) and should not be relied upon as representing the Company’s estimates as of any subsequent date. While the Company may elect to update forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if its estimates change.

For further information, please contact:

NeoGenomics, Inc.

William Bonello
Chief Strategy and Corporate Development Officer
Director, Investor Relations
(239)690-4238 (w) (239)284-4314 (m)
bill.bonello@neogenomics.com

NeoGenomics, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands)

ASSETS

June 30, 2019 December 31, 2018 Cash and cash equivalents

$ 167,436 $ 9,811 Accounts receivable

89,991 76,919 Inventory

8,733 8,650 Other current assets

10,185 8,288 Total current assets

276,345 103,668 Property and equipment (net of accumulated depreciation and amortization of $59,455 and $50,127, respectively)

59,334 60,888 Operating lease right-of-use assets

26,057 – Intangible assets, net

135,301 140,029 Goodwill

196,298 197,892 Other assets

3,332 2,538 TOTAL ASSETS

$ 696,667 $ 505,015

LIABILITIES AND STOCKHOLDERS??? EQUITY

Accounts payable and other current liabilities

$ 44,909 $ 46,753 Short-term portion of financing obligations

10,825 14,172 Short-term portion of operating lease liabilities

3,428 – Total current liabilities

59,162 60,925

Long-term portion of financing obligations

99,032 98,130 Long-term portion of operating lease liabilities

24,179 – Deferred income tax liability, net

20,117 22,457 Other long-term liabilities

4,443 3,060 Total long-term liabilities

147,771 123,647 TOTAL LIABILITIES

206,933 184,572

TOTAL STOCKHOLDERS’ EQUITY

489,734 320,443 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$ 696,667 $ 505,015

NeoGenomics, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share amounts)

Three Months Ended June 30, Six Months Ended June 30,

2019 2018 2019 2018 Net revenue:

Clinical Services

$ 88,982 $ 59,540 $ 175,192 $ 116,511 Pharma Services

12,731 8,206 22,098 14,658 Total revenue

101,713 67,746 197,290 131,169

Cost of revenue

52,747 37,216 101,209 73,336 Gross profit

48,966 30,530 96,081 57,833

Operating expenses:

General and administrative

29,577 20,983 61,719 38,050 Research and development

2,587 1,073 3,796 2,029 Sales and marketing

12,324 7,680 23,540 14,455 Total operating expenses

44,488 29,736 89,055 54,534 Income from operations

4,478 794 7,026 3,299

Interest expense, net

1,304 1,407 3,130 2,892 Other (income) expense

(10) 124 5,159 62 Loss on extinguishment of debt

1,018 – 1,018 – Income (loss) before taxes

2,166 (737) (2,281) 345 Income tax expense (benefit)

175 (357) (1,848) 81 Net income (loss)

$ 1,991 $ (380) $ (433) $ 264

Deemed dividends on preferred stock

– 947 – 1,950 Amortization of preferred stock beneficial conversion feature

– 1,824 – 3,677 Gain on redemption of preferred stock

– (9,075) – (9,075)Net income (loss) attributable to common stockholders

$ 1,991 $ 5,924 $ (433) $ 3,712

Net income per common share:

Basic

$ 0.02 $ 0.07 $ – $ 0.05 Diluted

$ 0.02 $ 0.07 $ – $ 0.04

Weighted average shares used in computation of earnings per common share:

Basic

98,297 81,017 96,734 80,789 Diluted

102,336 90,168 96,734 89,305

NeoGenomics, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)

Six Months Ended June 30, CASH FLOWS FROM OPERATING ACTIVITIES

2019 2018 Net (loss) income

$ (433) $ 264 Adjustments to reconcile net (loss) income to net cash provided by operating activities:

Depreciation and amortization

10,352 7,444 Impairment/loss on sale of assets

404 106 Loss on debt extinguishment

1,018 – Amortization of intangibles

5,102 2,834 Amortization of debt issue costs

250 242 Stock based compensation

4,452 3,957 Non cash operating lease expense

2,218 – Changes in assets and liabilities, net

(21,987) 6,105 NET CASH PROVIDED BY OPERATING ACTIVITIES

$ 1,376 $ 20,952

CASH FLOWS FROM INVESTING ACTIVITIES

Purchases of property and equipment

(6,637) (8,943)Acquisition working capital adjustment

399 – NET CASH USED IN INVESTING ACTIVITIES

$ (6,238) $ (8,943)

CASH FLOWS FROM FINANCING ACTIVITIES

Advances on revolving credit facility

– 10,000 Redemption of preferred stock

– (50,096)Repayment of revolving credit facility

(5,000) – Repayment of equipment and other loans

(3,644) (3,014)Proceeds from term loan

100,000 30,000 Repayment of term loan

(96,750) (7,275)Payments of debt issue costs

(954) (576)Issuance of common stock, net

8,061 5,588 Proceeds from equity offering, net

160,774 – NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES

$ 162,487 $ (15,373)Effects of foreign exchange rate changes on cash and cash equivalents

– (22)NET CHANGE IN CASH AND CASH EQUIVALENTS

$ 157,625 $ (3,386)

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

9,811 12,821 CASH AND CASH EQUIVALENTS, END OF PERIOD

$ 167,436 $ 9,435

Use of Non-GAAP Financial Measures

The Company’s financial results and financial guidance are provided in accordance with GAAP and using certain non-GAAP financial measures. Management believes that the presentation of operating results using non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of core operating results across reporting periods. Management also uses non-GAAP financial measures for financial and operational decision making, planning and forecasting purposes and to manage the Company’s business. Management believes that these non-GAAP financial measures enable investors to evaluate the Company’s operating results and future prospects in the same manner as management. The non-GAAP financial measures do not replace the presentation of GAAP financial results and should only be used as a supplement to, and not as a substitute for, the Company’s financial results presented in accordance with GAAP. There are limitations inherent in non-GAAP financial measures because they exclude charges and credits that are required to be included in a GAAP presentation, and do not present the full measure of the Company’s recorded costs against its net revenue. In addition, the Company’s definition of the non-GAAP financial measures below may differ from non-GAAP measures used by other companies.

Definitions of Non-GAAP Measures

Non-GAAP Adjusted EBITDA

“Adjusted EBITDA” is defined by NeoGenomics as net income from continuing operations before: (i) interest expense, (ii) tax expense, (iii) depreciation and amortization expense, (iv) non-cash stock-based compensation expense, and if applicable in a reporting period, (v) acquisition and integration related expenses, (vi) non-cash impairments of intangible assets, (vii) debt financing costs, (viii) and other significant non-recurring or non-operating (income) or expenses.

Non-GAAP Adjusted Net Income

“Adjusted Net Income” is defined by NeoGenomics as net income available to common shareholders from continuing operations plus: (i) non-cash amortization of customer lists and other intangible assets, (ii) non-cash stock-based compensation expense, (iii) non-cash deemed dividends on preferred stock, (iv) non-cash amortization of preferred stock beneficial conversion feature, and if applicable in a reporting period, (v) acquisition and integration related expenses, (vi) non-cash impairments of intangible assets, (vii) debt financing costs, (viii) and other significant non-recurring or non-operating (income) or expenses.

Non-GAAP Adjusted Diluted EPS

“Adjusted Diluted EPS” is defined by NeoGenomics as adjusted net income divided by adjusted diluted shares outstanding. Adjusted diluted shares outstanding is the sum of diluted shares outstanding and the weighted average number of common shares that would be outstanding if the preferred stock were converted into common stock on the original issue date based on the number of days such common shares would have been outstanding in the reporting period. In addition, if GAAP net income is negative and adjusted net income is positive, adjusted diluted shares will also include any options or warrants that would be outstanding as dilutive instruments using the treasury stock method.

Reconciliation of GAAP Net Income to Non-GAAP EBITDA and Adjusted EBITDA
(Unaudited)
(In thousands)

Three Months Ended June 30, Six Months Ended June 30,

2019 2018 2019 2018 Net income (loss) (GAAP)

$ 1,991 $ (380) $ (433) $ 264 Adjustments to net income (loss):

Interest expense, net

1,304 1,407 3,130 2,892 Income tax expense (benefit)

175 (357) (1,848) 81 Amortization of intangibles

2,543 1,421 5,102 2,834 Depreciation

5,081 3,810 10,352 7,444 EBITDA (non-GAAP)

$ 11,094 $ 5,901 $ 16,303 $ 13,515 Further adjustments to EBITDA:

Acquisition and integration related expenses

512 – 1,778 – Facility moving expenses

– 1,822 – 1,816 Loss on extinguishment of debt

1,018 – 1,018 – Other significant non-recurring (income)/expense

– – 5,145 – Non-cash, stock-based compensation

2,313 2,333 4,452 3,957 Adjusted EBITDA (non-GAAP)

$ 14,937 $ 10,056 $ 28,696 $ 19,288

Reconciliation of GAAP Net Income Available to Common Stockholders to Non-GAAP Adjusted Net Income and GAAP EPS to Non-GAAP Adjusted EPS
(Unaudited)
(In thousands, except per share amounts)

Three Months Ended June 30, Six Months Ended June 30,

2019 2018 2019 2018 Net income (loss) attributable to common stockholders (GAAP)

$ 1,991 $ 5,924 $ (433) $ 3,712 Adjustments to net income (loss), net of tax:

Amortization of intangibles

2,009 1,123 4,031 2,239 Deemed dividends on preferred stock

– 9,195 – 10,198 Amortization of preferred stock beneficial conversion feature

– (15,499) – (13,646)Non-cash stock-based compensation expenses

2,019 2,284 3,978 3,835 Acquisition and integration related expenses

405 – 1,405 – Other significant non-recurring (income)/expenses

– 1,439 4,065 1,439 Loss on extinguishment of debt

804 – 804 – Adjusted net income (non-GAAP)

$ 7,228 $ 4,466 $ 13,850 $ 7,777

Net income (loss) per common share (GAAP)

Diluted EPS

$ 0.02 $ 0.07 $ – $ 0.04 Adjustments to diluted income (loss) per share:

Amortization of intangibles

0.02 0.01 0.04 0.03 Deemed dividends on preferred stock

– 0.10 – 0.11 Amortization of preferred stock beneficial conversion feature

– (0.17) – (0.15)Non-cash stock based compensation expenses

0.02 0.03 0.04 0.04 Acquisition and integration related expenses

– – 0.01 – Other significant non-recurring (income)/expense

– 0.02 0.04 0.02 Loss on extinguishment of debt

0.01 – 0.01 – Rounding and impact of including preferred shares and stock options in Adjusted Diluted Shares in net loss periods (3)

– (0.01) – – Adjusted diluted EPS (non-GAAP)

$ 0.07 $ 0.05 $ 0.14 $ 0.09

Weighted average shares used in computation of adjusted diluted EPS:

Diluted common shares (GAAP)

102,336 90,168 96,734 89,305 Options and restricted stock not included in GAAP diluted shares (using treasury stock method)

– – 3,664 – Adjusted diluted shares outstanding (non-GAAP)

102,336 90,168 100,398 89,305

_____________________

(3) This adjustment is for rounding and in those periods in which there is a net loss attributable to common shareholders, will also compensate for the effects of including the Series A Preferred Shares on an as-converted basis and the treasury stock impact of outstanding stock options in the “Adjusted diluted shares outstanding (non-GAAP)”, both of which are not included in GAAP diluted shares outstanding.

Reconciliation of Non-GAAP Financial Guidance to Corresponding GAAP Measures

“Net (loss) income (GAAP)” in 2019 will be impacted by certain charges, including: (i) expense related to the amortization of customer lists and other intangibles, (ii) non-cash stock based compensation (iii) acquisition and integration related expenses and non-recurring charges, (iv) other one-time charges. These charges have been included in GAAP net income available to common shareholders and GAAP net income per share; however, they have been removed from “Adjusted net income (non-GAAP)” and “Adjusted diluted EPS (non-GAAP).”

The following table reconciles our 2019 outlook for net income and EPS to the corresponding non-GAAP measures of “Adjusted net income (non-GAAP)”, “Adjusted EBITDA (non-GAAP)” and “Adjusted diluted EPS (non-GAAP)” (in thousands except per share amounts):

Year Ended December 31, 2019

Low Range High Range Net (loss) income (GAAP)

$ (1,000) $ 3,000 Amortization of intangibles

9,000 9,000 Non-cash, stock-based compensation (4)

8,000 8,000 Acquisition and integration related expenses

2,000 2,000 Other one-time expenses

6,000 6,000 Adjusted net income (non-GAAP)

$ 24,000 $ 28,000 Interest and taxes

9,000 9,000 Depreciation

21,000 21,000 Adjusted EBITDA (non-GAAP)

$ 54,000 $ 58,000

Net (loss) income per diluted common share (GAAP)

$ (0.01) $ 0.03 Adjustments to diluted (loss) income per share:

Amortization of intangibles

0.09 0.09 Non-cash, stock based compensation expenses

0.08 0.08 Acquisition and integration related expenses

0.02 0.02 Other one-time expenses

0.06 0.06 Impact of dilution on adjusted net income

(0.01) 0.00 Adjusted diluted EPS (non-GAAP)

$ 0.23 $ 0.27

Weighted average assumed shares outstanding in 2019:

Diluted common shares (GAAP)

100,500 104,500 Options and restricted stock not included in diluted shares

4,000 – Adjusted diluted shares outstanding (non-GAAP)

104,500 104,500

___________________

(4) Forecasts of non-cash, stock-based compensation expense assume consistency in the Company’s stock price in 2019 and no further stock-based awards requiring variable accounting in accordance with ASU 2018-07.

Supplemental Information
Pharma Revenue, Cost of Revenue and Gross Profit
(Unaudited)
(In thousands)

Three Months Ended June 30, Six Months Ended June 30, Pharma Operations:

2019 2018
(as adjusted) %Change 2019 2018
(as adjusted) %Change Pharma Revenue

$ 12,731 $ 8,206 55.2% $ 22,098 $ 14,658 50.8% Cost of revenue

$ 6,367 $ 5,181 22.9% $ 12,178 $ 10,260 18.7% Gross profit

$ 6,364 $ 3,025 110.4% $ 9,920 $ 4,399 125.5%

Supplemental Information
Clinical (5) Requisitions Received, Tests Performed, Revenue and Cost of Revenue
(Unaudited)
(In thousands, except test and requisition data)

Three Months Ended June 30, Six Months Ended June 30,

Clinical Operations:

2019 2018 % Change 2019 2018 % Change

Requisitions (cases) received

144,983 109,986 31.8% 282,094 215,215 31.1%

Number of tests performed

250,330 187,189 33.7% 484,647 365,983 32.4%

Average number of tests/requisitions

1.73 1.70 1.5% 1.5 1.70 1.0%

Total clinical testing revenue

$ 88,982 $ 59,540 49.4% $ 175,192 $ 116,511 50.4%

Average revenue/requisition

$ 614 $ 541 13.4% $ 621 $ 541 14.7%

Average revenue/test

$ 355 $ 318 11.8% $ 361 $ 318 13.5%

Cost of revenue

$ 46,380 $ 32,035 44.8% $ 89,031 $ 63,076 41.1%

Average cost/requisition

$ 320 $ 291 9.8% $ 316 $ 293 7.7%

Average cost/test

$ 185 $ 171 8.3% $ 184 $ 172 6.6%

_____________________
(5) Clinical tests exclude tests performed for Pharma Services customers.

SOURCE: NeoGenomics, Inc.

ReleaseID: 553911

Aytu BioScience Expands Natesto(R) Partnership with Acerus Pharmaceuticals to Accelerate Natesto Growth in the U.S.

Acerus to Launch U.S. Specialty Sales Force; Nearly Doubles Natesto Sales Force

ENGLEWOOD, CO / ACCESSWIRE / July 30, 2019 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, today announced the expansion of the company’s partnership with Acerus Pharmaceuticals (“Acerus”) to accelerate the growth of Natesto® in the United States. Through this expanded commercial relationship, Acerus will fund and launch a U.S.-based specialty sales force which will promote Natesto to urologists and endocrinologists. Aytu will continue to book all Natesto revenue and promote Natesto to all other specialties including internal medicine and family practice.

Upon the closing of this revised agreement, Acerus will launch a complementary U.S. commercial team and hire at least twenty-five U.S-based specialty sales representatives, nearly doubling the size of the Natesto field force. This co-promotion significantly increases sales force coverage of targeted U.S. prescribers, puts a higher promotional focus on urologists and endocrinologists, and enables Aytu to increase its promotional efforts in primary care and other specialties.

On July 29, 2019, the companies agreed to expand their commercial partnership and amend and restate the original 2016 Natesto exclusive U.S. license agreement. Under the revised agreement, Aytu will remain the exclusive U.S. supplier of Natesto and retain all rights to revenues generated.

Aytu and Acerus will continue to operate a joint commercialization committee in support of Natesto and will now more closely collaborate on U.S. brand strategy and commercial initiatives. Natesto total prescriptions grew 30% from fiscal 2018 to 2019, and this partnership is expected to drive accelerated growth of the brand through joint promotional efforts and a significantly expanded U.S. presence.

Josh Disbrow, Aytu BioScience Chief Executive Officer, commented, “We are thrilled to be expanding our partnership with Acerus and increasing the U.S. commercial footprint to such a large extent. With a coordinated promotional approach, this nearly doubling of the Natesto commercial team stands to substantially increase Natesto awareness and accelerate prescription growth. Acerus’ increased commitment to Natesto, as evidenced by their significant investment in launching a U.S. commercial team, is an important step in the evolution of the Natesto growth story.”

Mr. Disbrow continued, “We’re pleased to be working together with Acerus to significantly increase our reach to physicians around the country. Additionally, with the recent expansion of Aytu’s therapeutic portfolio, that now includes ZolpiMist™ and Tuzistra® XR, this revised commercial arrangement enables us to employ a more distinct focus on primary care physicians to grow the entire product portfolio, while Acerus increases the promotional focus on Natesto with key specialists.”

Aytu will continue to serve as the exclusive U.S. supplier to purchasers of Natesto, and Acerus will receive performance-based commissions on prescriptions generated by urology and endocrinology specialties. Acerus will assume regulatory and clinical responsibilities and associated expenses and will serve a primary role in the development of key opinion leaders in urology and endocrinology. Aytu will focus on commercial channel management, sales to wholesalers and other purchasing customers, and will direct sales efforts in all other physician specialties.

Under the revised agreement, both companies have committed specific commercial resources, dedicated sales representatives and activity levels, and will jointly develop a Natesto commercialization plan.

The revised agreement extends the original agreement by at least three years to the later of 2027, the launch of an FDA approved, AB-rated generic equivalent to Natesto, or the expiration or invalidation of the last to expire Natesto patent.

The payment structure currently in place will be replaced with a pay-for-performance commission incentive structure intended to drive Natesto prescription growth across all physician specialties. All previously agreed upon milestone payments payable by Aytu have been removed. Additionally, Acerus will now pay all annual FDA fees, current and future clinical trial costs, and all regulatory and pharmacovigilance expenses.

Aytu will continue to book Natesto revenue and will pay Acerus quarterly commissions based on sales from prescriptions generated by urologists and endocrinologists.

The effectiveness of the revised agreement is subject to certain closing conditions.

More information is available on Form 8-K as filed today with the Securities and Exchange Commission.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”). Aytu also has exclusive U.S. and Canadian rights to ZolpiMist™, the only FDA-approved oral spray prescription sleep aid. ZolpiMist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu also acquired exclusive U.S. commercial rights to Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. Tuzistra XR is a prescription antitussive consisting of codeine polistirex and chlorpheniramine polistirex in a patented, extended-release oral suspension. Additionally, Aytu is developing MiOXSYS®, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside of the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved, Mexican COFEPRAS approved product. Aytu is planning U.S.-based clinical trials in pursuit of 510k de novo medical device clearance by the FDA. Aytu’s strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ”may,” ”will,” ”should,” ”forecast,” ”could,” ”expect,” ”suggest,” ”believe,” ”estimate,” ”continue,” ”anticipate,” ”intend,” ”plan,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: risks relating to gaining market acceptance of our products, obtaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ”Risk Factors” in Part I, Item 1A of the company’s Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:

James Carbonara
Hayden IR
(646)-755-7412
james@haydenir.com

Source: Aytu BioScience, Inc.

ReleaseID: 553897

McGill University Health Centre Newest Clinical Study Site for Phase II Non-Muscle Invasive Bladder Cancer Clinical Study

TORONTO, ON / ACCESSWIRE / July 30, 2019 / Theralase® Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTCQB), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDC”) and their associated drug formulations intended to safely and effectively destroy various cancers, is pleased to announce that McGill University Health Centre “MUHC”) Research Ethics Board (“REB”) has approved the commencement of a Phase II Clinical Study to enroll and treat Patients with Non-Muscle Invasive Bladder Cancer (“NMIBC”), who present with Carcinoma In-Situ (“CIS”) and who are considered BCG-Unresponsive or are intolerant to BCG Therapy (“Study II”), subject to a Site Initiation Visit (“SIV”) and Site Qualification Visit (“SQV’), scheduled for early September.

MUHC is one of the leading academic health centres in the world and attracts clinical and research expertise from around the world, assessing the latest in medical technology and training the next generation of medical professionals.

Wassim Kassouf, MD, CM, FRCSC, Professor and Associate Chair, MUHC stated, “We are very excited to open this clinical study that provides access to evaluate the efficacy of a novel therapeutic approach for patients who cannot tolerate Baccilus Calmete Guérin (“BCG”) or have BCG-unresponsive disease; addressing a large unmet need for bladder cancer patients.”

Shawn Shirazi, Ph.D., CEO – Drug Division, Theralase stated that, “I am pleased with the addition of MUHC to the Company’s Phase II clinical study sites. MUHC, pending the completion of a SQV / SIV, is able to commence the enrollment and treatment process of BCG-unresponsive NMIBC patients for the Phase II Study. I believe with the recent announcement of the Trial Management Organization agreement combined with world-class organizations such as University Health Network in Toronto, MUHC in Montreal and numerous other Canadian and US clinical study sites currently in negotiations with Theralase, the opportunity to successfully enroll and treat the approximately 100 patients needed to complete the study.”

About Phase II Study

Study II has been designed in compliance with FDA industry guidelines for BCG-unresponsive NMIBC (issued: February 2018) and defined by the FDA in a Pre-Investigational New Drug (“IND”) conference call in late June 2019. The study will utilize the Therapeutic Dose (0.70 mg/cm2) of the Company’s lead PDC TLD-1433 and will focus on the treatment of approximately 100 BCG-unresponsive NMIBC patients who present with CIS in approximately 20 clinical sites located in Canada and the US, with a primary endpoint of efficacy measured by Complete Response (“CR”) at any time, a secondary endpoint of duration of CR and a tertiary endpoint of safety. The Company is no longer pursuing European study sites due to the exorbitant costs of regulatory approval.

The primary endpoint of the Study will be:

Efficacy – Evaluated by Complete Response (“CR”) at any time in patients with CIS with or without papillary disease post-initial treatment duration response.

The secondary endpoint of the Study will be:

Duration of CR evaluated at 12 to 18 months post-initial treatment.

The tertiary endpoint of the Study will be:

Safety – Evaluated by the incidence and severity of Adverse Events (“AEs”) Grade 4 or higher that do not resolve within 360 days post-treatment; whereby:

Grade 1 = Mild
Grade 2 = Moderate
Grade 3 = Severe
Grade 4 = Life-threatening or disabling
Grade 5 = Death

About Theralase® Technologies Inc.

Theralase is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers.

Additional information is available at www.theralase.com and www.sedar.com.

This news release contains “forward-looking statements” which reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company’s proposed development plans with respect to Photo Dynamic Compounds and their drug formulations. Wherever possible, words such as “may“, “would“, “could“, “should”, “will“, “anticipate“, “believe“, “plan“, “expect“, “intend“, “estimate“, “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to: adequately fund, secure the requisite regulatory approvals to commence and successfully complete a Phase II NMIBC clinical study in a timely fashion and implement its development plans. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements; including, without limitation, those listed in the filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

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

For More Information:

1.866.THE.LASE (843-5273) x304
416.699.LASE (5273) x304
Amelia Tudo, Investor Relations Coordinator
atudo@theralase.com
www.theralase.com

SOURCE: Theralase Technologies Inc.

ReleaseID: 553893