Apricus Biosciences Provides Corporate Update and First Quarter 2017 Financial Results
Vitaros U.S. NDA Re-Submission Remains on Track for Third Quarter 2017
Vitaros Drug-Device Human Factor Studies Underway
Operations Funded Through the Third Quarter of 2018
Conference Call / Webcast Today, May 11, 2017 at 4:30 p.m. ET
SAN DIEGO, May 11, 2017 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reported financial results for the first quarter of 2017 and provided a corporate update on its priorities for the year.
"In the first quarter of this year, we continued to execute on our strategy by creating a more focused and capital efficient organization with the potential to deliver on multiple regulatory, business development and commercial milestones over the next twelve months," stated Richard W. Pascoe, Chief Executive Officer. "More recently we have significantly improved our financial outlook through a combination of fundraising, venture debt retirement, and expense reduction resulting in a balance sheet that is expected to fund our current operating plan through the third quarter of 2018. Finally, we remain on track to re-submit the Vitaros NDA in the third quarter of this year with an anticipated approval decision in the first half of 2018."
Apricus continues to execute on its corporate strategy as highlighted below:
- Continued implementation of the U.S. regulatory approval strategy to address issues raised by the FDA in the original Vitaros NDA submission. Specifically, all safety, chemistry, manufacturing and control (CMC) related issues raised in the original Non-Approvable Letter will be addressed in the re-submission. In addition, the FDA has determined that the Vitaros product will be considered a drug-device combination product and as such, Apricus has confirmed the necessary device engineering and compliance requirements, including human factor testing, and those studies are currently underway in accordance with the applicable FDA guidance; and
- Sold Vitaros ex-US rights and assets to Ferring International in March 2017 for approximately $12.7 million, including an $11.5 million upfront payment received at closing, a $700,000 inventory payment received last month, and $500,000 in transition services that Apricus is eligible to receive over two quarters, subject to certain limitations, and eliminated certain future ex-US Vitaros liabilities.
- Initiated a partnering process to secure a global or regional RayVa partnership prior to initiating a Phase 2b clinical study; and
- Continued to refine the clinical trial protocol and clinical trial material formulation needed to initiate a Phase 2b study.
- Closed on an underwritten public offering of common stock and warrants in April 2017 for gross proceeds of approximately $7.0 million;
- Paid $6.6 million to retire our remaining venture debt with Oxford Finance and Silicon Valley Bank;
- Reduced our monthly cash burn to approximately $500,000; and
- Regained compliance with all criteria for continued listing on The NASDAQ Capital Market, including the minimum stockholders' equity requirement.
First Quarter Financial Results
Net income for the quarter ended March 31, 2017 was $8.1 million, or basic earnings per share of $1.04, compared to a net loss of $2.5 million, or basic loss per share of $0.46, for the first quarter of 2016. Net income during the first quarter of 2017 was primarily due to the $11.8 million gain recorded in Q1 2017 for the sale of our ex-U.S. Vitaros rights and assets to Ferring. For both periods presented, financial statement activity related to our ex-U.S. Vitaros business has been presented as discontinued operations.
As of April 26, 2017, the Company's cash totaled $10.6 million, compared to $2.1 million as of December 31, 2016.
Conference Call Details
Apricus will host a live conference call and webcast today at 4:30 p.m. Eastern Time to discuss the Company's financial results and provide a corporate update. To participate by telephone, please dial (855) 780-7196 (Domestic) or (631) 485-4867 (International). The conference ID number is 18008306. The live and archived audio webcast can be accessed through the Investors Relations' section of the Company's website at www.apricusbio.com. Please log in approximately five to ten minutes before the event to ensure a timely connection. The archived webcast will be available for 30 days following the live call.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has two product candidates currently in development. Vitaros is a product candidate in the United States for the treatment of erectile dysfunction, which is in-licensed from Warner Chilcott Company, Inc., now a subsidiary of Allergan plc (Allergan). RayVa is our product candidate in Phase 2 development for the treatment of the circulatory disorder Raynaud's phenomenon, secondary to scleroderma, for which we own worldwide rights.
For further information on Apricus, visit http://www.apricusbio.com.
Vitaros(TM) is Apricus' trademark in the United States, which is pending registration and subject to the agreement with Allergan. Vitaros® is a registered trademark of Ferring International Center S.A. in certain countries outside of the United States. RayVa(TM) is Apricus' trademark, which is registered in certain countries throughout the world and pending registration in the United States.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: Apricus' ability to transition its ex-U.S. assets and rights related to Vitaros to Ferring and receive the transition services payments from Ferring; the timing of regulatory submission and approval of Vitaros in the United States, if any; Apricus' development and partnering plans for RayVa; Apricus' plans to reduce operating expenses and achieve profitability, including projected 2017 cost savings; and Apricus' strategic objectives. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of Apricus, including, but not limited to: the risk that Apricus fails to provide the transition services as required by the transition services agreement with Ferring; the risk that the cost and other negative effects related to the reduction of Apricus' workforce may be greater than anticipated; the risk that Apricus may not realize the benefits expected from cost control measures; competition in the erectile dysfunction market and other markets in which Apricus operates; Apricus' ability to obtain FDA and other requisite governmental approval for Vitaros; Apricus' ability to further develop Vitaros, such as delivery device improvements; Apricus' ability to carry out further clinical studies for Vitaros, if required, as well as the timing and success of the results of such studies; the failure to remain in compliance with NASDAQ continued listing requirements which could result in Apricus' common stock being delisted from the exchange; Apricus' ability to retain and attract key personnel; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus' ability to secure a strategic partner for RayVa; and market conditions. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus' most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC's website at www.sec.gov or without charge from Apricus.
(Financial Information to Follow)
Selected Financial Information
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three Months Ended
|Research and development||$||(412||)||$||(2,602||)|
|General and administrative||(1,441||)||(2,224||)|
|Total other (expense) income||(1,551||)||2,312|
|Loss from continuing operations||(3,404||)||(2,514||)|
|Income from discontinued operations||11,477||9|
|Net income (loss)||$||8,073||$||(2,505||)|
|Earnings (loss) per share|
|Weighted average common shares outstanding|
Condensed Consolidated Balance Sheets
|Other current assets||181||177|
|Property and equipment, net||142||164|
|Other long term assets||65||60|
|Assets of discontinued operations||$||1,203||$||2,212|
|Liabilities and stockholders' equity (deficit)|
|Notes payable, net||-||6,650|
|Current liabilities of discontinued operations||822||2,108|
|Other long term liabilities||67||76|
|Stockholders' equity (deficit)||842||(7,516||)|
|Total liabilities and stockholders' equity (deficit)||$||5,353||$||4,700|
The Trout Group
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Apricus Biosciences, Inc. via Globenewswire
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Abeona Therapeutics Reports Fourth Quarter 2017 Financial Results and Business Highlights16.3.2018 22:32 | Pressemelding
Investor Conference Call on Tuesday, March 27th at 10:00 am ET NEW YORK and CLEVELAND, March 16, 2018 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, today announced financial results for the fourth quarter. The Company will host a call to update investors on recent clinical developments and year-end financial results on Tuesday, March 27th at 10:00 am (Eastern). Interested parties are invited to participate in the call by dialing 877-407-9210 (toll free domestic) or 201-689-8049 (International). "The past year was marked by several defining events in the company's history, having advanced our two lead clinical programs, EB-101 in Epidermolysis Bullosa and ABO-102 in MPS IIIA, and initiated our third clinical program, ABO-101 in MPS IIIB. The strong safety and biopotency data observed in our three active clinical trials and the s
Mandela Golden Hands Collection Sells for US$10 Million at PDAC 2018 Conference16.3.2018 15:40 | Pressemelding
Arbitrade, a new coin and cryptocurrency exchange, to purchase the unique gold collection with Bitcoin NEW YORK, March 16, 2018 (GLOBE NEWSWIRE) -- The Board of Arbitrade, a new coin and cryptocurrency exchange, has announced it will purchase the Nelson Mandela Golden Hands Collection. Made from 20 lbs, 99.999 of pure gold, it includes 3 life size impressions of Mandela's hands and two others of his palm and fist. It was cast in 2002 by South Africa's Harmony Gold mining group, one of the world's leading gold producers, 12 years after Nelson Mandela was released from prison. The seller, Malcolm Duncan, a South African businessman now living in Calgary, Canada, knew Mandela. He said that Harmony's intention was to make one full set of gold artefacts consisting of a fist, a full hand and a palm impression of his right hand for each of the 27 years Mandela had spent behind bars. Duncan had purchased the sets dedicated to 1964 and 1990, marking the year Mandela was incarcerated and the yea
RSK Chooses Decentral's Jaxx Blockchain Platform, Paving Way For Smart Contracts On Bitcoin16.3.2018 14:44 | Pressemelding
BUENOS AIRES, Argentina, March 16, 2018 (GLOBE NEWSWIRE) -- RSK, the smart contract platform powered by the Bitcoin network, today announced it has launched on Decentral's Jaxx cryptocurrency wallet and multi-token digital platform. This integration paves the way for RSK's open source platform to implement Ethereum-style smart contracts over the Bitcoin network. RSK combines the flexibility of smart contracts with the Bitcoin infrastructure, bringing endless possibilities to build a more flexible and inclusive financial system that will improve the life of billions of people. RSK successfully released its MainNet network, built as a side-chain to the Bitcoin mainnet, in January 2018. It is now presenting the first wallet that will help dApp developers manage their fuel while creating their solutions powered by RSK and the Bitcoin Network. RSK's CEO, Diego Gutierrez Zaldivar said: "We're very happy to partner with Jaxx, a highly-secure and a very easy-to-use wallet that will be the firs
Up to $200 Billion in Illegal Cybercrime Profits Is Laundered Each Year, Comprehensive Research Study Reveals16.3.2018 13:00 | Pressemelding
Cybercriminals turning to virtual currencies, video game currency and digital payment systems like PayPal to convert illegal revenue into clean cash CUPERTINO, Calif., March 16, 2018 (GLOBE NEWSWIRE) -- Bromium®, Inc., the pioneer and leader in application isolation using virtualization-based security, today announced the findings of an independent, academic study into the macro economics of cybercrime and how cybercriminals launder and 'cash out' the profits of criminal endeavours. The findings are part of a larger nine-month study titled Into the Web of Profit, sponsored by Bromium. The full findings will be presented at the RSA Conference in April by Dr. Mike McGuire, Senior Lecturer in Criminology at Surrey University, England. According to the report, cybercriminal proceeds make up an estimated 8-10 percent of total illegal profits laundered globally; amounting to an estimated $80-$200 billion each year 1. Other key findings include: Virtual currencies have become the primary tool
Technology empowering an increasingly connected SEA for financially inclusive communities16.3.2018 11:41 | Pressemelding
Global speakers IFC, MAS shared their views at Ant Financial Technology Exploration Conference in Singapore SINGAPORE, March 16, 2018 (GLOBE NEWSWIRE) -- Ant Financial Services Group ("Ant Financial" or "Ant") today wrapped up its participation at Money20/20 Asia in Singapore with the Ant Technology Exploration Conference (ATEC), with guests Giri Jadeja, Global Head of Financial Innovation at International Finance Corporation (IFC) and Sopnendu Mohanty, Chief Fintech Officer at Monetary Authority of Singapore (MAS) sharing their views on financial inclusion alongside Cheng Li, Chief Technology Officer and Chief Operations Officer for global business group at Ant Financial. Giri Jadeja shared his vision as global head of financial innovation at IFC - to reach out to the 2 billion unbanked and underserved population in the world, the majority of whom reside in Asia. The region has in recent years seen an exponential growth of new fintech companies. Giri is optimistic that technological c
Z-Wave Alliance Dominates Building Automation Space at Light + Building 201816.3.2018 11:00 | Pressemelding
Exhibitors introduce new products and demonstrate interoperability and collaboration in international Z-Wave smart building and IoT ecosystem FRANKFURT, Germany, March 16, 2018 (GLOBE NEWSWIRE) -- Light + Building 2018 - Hall 9.1, Booth E46 - The Z-Wave Alliance, a global membership organization dedicated to advancing the popular Z-Wave wireless smart home protocol, will host the Z-Wave Pavilion at Light + Building from March 18 - 23, 2018. The Alliance is also demonstrating their award-winning installation toolkit to make installation and testing of a Z-Wave smart home mesh network even easier for the pro installer community. The Z-Wave Pavilion will be on display at the show featuring the latest in European home and building automation and connected lighting products. Z-Wave Alliance members will demonstrate smart home lighting, thermostats, switches, air quality monitors and more. Support for the Z-Wave protocol has never been stronger - the Z-Wave Alliance now boasts over 700-membe
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom