NASDAQ OMX

Apricus Biosciences Provides Corporate Update and Second Quarter 2017 Financial Results

Dela

Vitaros Drug-Device Human Factor Studies Successfully Completed

Vitaros U.S. NDA Final Draft Completed with Re-Submission Expected in Current Quarter

Conference Call / Webcast Today, August 2, 2017 at 4:30 p.m. ET

SAN DIEGO, Aug. 02, 2017 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reported financial results for the second quarter of 2017 and provided a corporate update on its priorities for the remainder of the year.

"In the second quarter of this year, we continued to execute on our strategy by creating a stable, financially healthier organization focused on resubmission of the Vitaros NDA," stated Richard W. Pascoe, Chief Executive Officer. "We have improved our financial outlook through a combination of fundraising and expense reduction, resulting in a balance sheet that is expected to fund our current operating plan through the third quarter of 2018.  Importantly, we have completed the final draft of the Vitaros NDA and we expect to re-submit the Vitaros NDA this quarter with an anticipated FDA approval decision in the first quarter of 2018.  For the remainder of 2017, we will focus on working with the FDA regarding the Vitaros NDA, maintaining a productive dialogue with Allergan regarding the commercial potential for Vitaros in the United States, securing a development partner for RayVa, and continuing to diligently manage our corporate resources."

Recent Highlights

Apricus continues to execute on its corporate strategy as highlighted below:

Vitaros(TM) (alprostadil)

  • 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, Apricus has confirmed the necessary drug-device engineering and compliance requirements, including human factor testing, and those studies are now complete; and
  • Continued to ensure a smooth transition of the Vitaros ex-US rights and assets to Ferring International.  Under the agreement, Apricus has received approximately $12.45 million to date, including an upfront payment of $11.5 million, approximately $0.7 million for the delivery of certain product-related inventory and $0.25 million related to transition services.  Apricus is eligible to receive an additional $0.25 million payment related to transition services, subject to certain limitations, during the third quarter of 2017.

RayVa(TM) (alprostadil)

  • Continued a partnering process to secure a global or regional RayVa partnership prior to initiating a Phase 2b clinical study.

Corporate/Financial

  • Closed on an underwritten public offering of common stock and warrants for gross proceeds of approximately $7.0 million; and
  • Regained compliance with all criteria for continued listing on The NASDAQ Capital Market.

Second Quarter and Year-to-Date Financial Results

Net loss for the quarter ended June 30, 2017 was $1.5 million, or loss per share of $0.13, compared to a net loss of $3.3 million, or loss per share of $0.54, for the second quarter of 2016. Net loss during the second quarter of 2017 was primarily due to expenses related to the preparation of our resubmission of the Vitaros NDA and other general and administrative expenses.

Net income for the six months ended June 30, 2017 was $6.6 million, or income per share of $0.69, compared to a net loss of $5.8 million, or loss per share of $1.00, for the second quarter of 2016. Net income during the six months ended June 30, 2017 was primarily due to the $12.1 million gain recorded for the sale of our ex-U.S. Vitaros rights and assets to Ferring.

For all periods presented, financial statement activity related to our ex-U.S. Vitaros business has been presented as discontinued operations.  As of June 30, 2017, the Company's cash totaled $7.8 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 58725002. 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 second transition services payment 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, 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
 June 30,
  Six Months Ended
 June 30,
  2017   2016   2017   2016
Operating expense              
Research and development $ (839 )   $ (2,503 )   $ (1,266 )   $ (5,104 )
General and administrative (1,602 )   (2,122 )   (3,043 )   (4,328 )
Total other income (expense) 719     1,372     (832 )   3,684  
Loss from continuing operations (1,722 )   (3,253 )   (5,141 )   (5,748 )
Income (loss) from discontinued operations 248     (85 )   11,740     (95 )
Net income (loss) $ (1,474 )   $ (3,338 )   $ 6,599     $ (5,843 )
               
Basic and diluted earnings (loss) per share              
Continuing operations $ (0.15 )   $ (0.53 )   $ (0.54 )   $ (0.98 )
Discontinued operations $ 0.02     $ (0.01 )   $ 1.23     $ (0.02 )
Total earnings (loss) per share $ (0.13 )   $ (0.54 )   $ 0.69     $ (1.00 )
               
Weighted average common shares outstanding for basic and diluted earnings (loss) per share 11,335     6,182     9,547     5,843  

Condensed Consolidated Balance Sheets
(In thousands)
 
  June 30,
 2017
  December 31,
 2016
  (Unaudited)    
Assets      
Cash $ 7,821     $ 2,087  
Other current assets 322     177  
Property and equipment, net 121     164  
Other long term assets 45     60  
Assets of discontinued operations $ 506     $ 2,212  
Total assets $ 8,815     $ 4,700  
       
Liabilities and stockholders' equity (deficit)      
Current liabilities $ 1,513     $ 2,536  
Current liabilities of discontinued operations 331     2,108  
Notes payable, net -     6,650  
Warrant liabilities 339     846  
Other long term liabilities 60     76  
Stockholders' equity (deficit) 6,572     (7,516 )
Total liabilities and stockholders' equity (deficit) $ 8,815     $ 4,700  

CONTACT:

Matthew Beck
mbeck@troutgroup.com
The Trout Group
(646) 378-2933




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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 OMX
NASDAQ OMX



Följ NASDAQ OMX

Skriv in din e-postadress så får du ett mejl när vi har något nytt att berätta.

Senaste pressmeddelandena från NASDAQ OMX

XBiotech Announces First Patient in Study Evaluating MABp1 in Combination with Onivyde® and 5-fluorouracil/folinic acid for the Treatment of Pancreatic Cancer18.10.2017 16:53Pressmeddelande

AUSTIN, Texas, Oct. 18, 2017 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today enrollment of the first patient into a Phase I single arm study evaluating the maximum tolerated dose of Onivyde® (Irinotecan liposome injection) and 5-fluorouracil/folinic acid in combination with MABp1 in a cohort of patients with advanced pancreatic adenocarcinoma and cachexia. The patient has begun treatment at Cedars-Sinai Medical Center under the care of Dr. Andrew Hendifar, the Study's Principle Investigator, Medical Oncology lead for the Gastrointestinal Disease Research Group and Co-Director of Pancreas Oncology at Cedars-Sinai. A total of 16 patients are expected to be enrolled in the study. Dr. Hendifar commented, "We are excited to enroll our first patient in this novel combinatorial therapy for the treatment of advanced pancreatic cancer and cachexia. This is the first attempt to add an anti-inflammatory therapy to standard chemotherapy in an effort to improve the performanc

Nasdaq and SGX Establish Collaborative Listings Agreement18.10.2017 15:42Pressmeddelande

NEW YORK and SINGAPORE, Oct. 18, 2017 (GLOBE NEWSWIRE) -- Nasdaq Inc. (Nasdaq:NDAQ) and Singapore Exchange (SGX) today announced the signing of a collaborative agreement in a move to leverage their strengths as two of the leading listings venues in the U.S. and Asia respectively. The new agreement seeks to enhance the channels available for companies to access capital market funding and enhance their corporate profile in both markets. As part of this agreement, Nasdaq and SGX -- who also share a successful, long-term market technology relationship -- are currently exploring the demand among corporates for a concurrent or sequential listing on both exchanges. Nasdaq and SGX are committed to supporting companies that are interested in pursuing this route. "The business landscape today is borderless," said Loh Boon Chye, CEO, SGX. "Fast-growing Asian companies looking to tap the capital markets can choose to list on SGX on Asian home ground, and embark on a listing on Nasdaq

Momentum Group acquires remaining 70 percent of Knut Sehlins Industrivaruhus in Örnsköldsvik18.10.2017 15:00Pressmeddelande

TOOLS Sweden (part of Momentum Group) has owned 30 percent of the shares in Knut Sehlins Industrivaruhus AB ("Sehlins") in Örnsköldsvik, Sweden since 2007. Today, TOOLS acquired the remaining 70 percent of the shares in Sehlins, which thus becomes a wholly owned subsidiary. Sehlins generates annual revenue of approximately MSEK 40 and has 14 employees. Sehlins is one of the leading industrial resellers in Örnsköldsvik, an attractive and important market with a number of successful industrial companies. The aim of the acquisition for TOOLS is to continue developing Sehlins as a wholly owned business with a focus on delivering optimal service for existing and potential customers in the local market. Sehlins has been part of TOOLS since the chain was formed in 2003. Closing takes place in October 2017. The acquisition is expected to have a marginal impact on Momentum Group's earnings per share during the current financial year. Stockholm, 18 October 2017

Momentum Group förvärvar resterande 70 procent av Knut Sehlins Industrivaruhus i Örnsköldsvik18.10.2017 15:00Pressmeddelande

TOOLS Sverige (inom Momentum Group-koncernen) är sedan 2007 delägare med 30 procent av aktierna i Knut Sehlins Industrivaruhus AB ("Sehlins") i Örnsköldsvik. TOOLS har idag förvärvat resterande 70 procent av aktierna i Sehlins, vilket härigenom blir ett helägt dotterbolag. Sehlins omsätter cirka 40 MSEK per år och har 14 anställda. Sehlins är en av de ledande industriåterförsäljarna i Örnsköldsvik, en intressant och viktig marknad med ett antal framgångsrika industriföretag. Syftet med TOOLS förvärv är att fortsätta utveckla Sehlins som en helägd verksamhet med fokus på att serva nuvarande och potentiella kunder på den lokala marknaden på bästa sätt. Sehlins har varit en del av TOOLS sedan starten av kedjan 2003. Tillträde sker i oktober 2017. Förvärvet bedöms ha en marginell påverkan på Momentum Groups resultat per aktie under innevarande räkenskapsår. Stockholm den 18 oktober 2017 Momentum Group AB (publ) För ytterligare inf

Colliers International Expands in Washington, D.C.18.10.2017 14:30Pressmeddelande

Acquisition of Beltway Real Estate Services Firm Strengthens Ongoing Commitment to the Region TORONTO and WASHINGTON, Oct.  18, 2017  (GLOBE NEWSWIRE) -- Leading global commercial real estate services firm Colliers International Group Inc. (NASDAQ:CIGI)(TSX:CIGI) announced today the acquisition of leading tenant representation advisory firm Serten Advisors. With its office in Tysons Corner, the firm serves global, national, and regional clients with a highly skilled and experienced team of professionals that have more than 100 years of combined experience. "This strategic acquisition positions Colliers to gain additional market share and win new business in the vibrant and competitive Suburban DC markets," said Marty Pupil, Colliers International President | U.S. Brokerage. "Adding Steve and Paul and the rest of their talented leadership team to our existing group of professionals in the region will further position Colliers as the commercial real estate services firm of

InSphero to Present Novel 3D Human Liver Fibrosis Model at Annual Liver Meeting® in Washington, DC18.10.2017 14:00Pressmeddelande

InSphero AG / InSphero to Present Novel 3D Human Liver Fibrosis Model at Annual Liver Meeting® in Washington, DC . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. New 3D InSight(TM) Human Liver Fibrosis Model represents a powerful tool for screening efficacy and safety of anti-fibrotic drugs in vitro. Schlieren, Switzerland, Oct. 18, 2017 (GLOBE NEWSWIRE) -- InSphero AG, the leading supplier of assay-ready 3D cell culture models for accelerating drug discovery and development, will present data characterizing and demonstrating the utility of its new 3D InSight(TM) Human Liver Fibrosis Model for screening efficacy of anti-fibrotic drugs.  The findings will be presented at oral and poster presentations this Friday at the annual meeting of the American Association for the Study of Liver Disease (AASLD) Conference in Washington, DC.  Anti-fibrotic therapi

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum