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This is a long explanation of the merger agreement, ,
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers.
Revised Employment Agreement with Richard W. Pascoe
On August 30, 2018, Apricus Biosciences, Inc. (the “Company”) entered into an amended and restated employment agreement with Richard W. Pascoe, the Company’s current Chief Executive Officer and Secretary (the “Amended and Restated Employment Agreement”). Under the terms of the Amended and Restated Employment Agreement, Mr. Pascoe’s employment will be involuntarily terminated by the Company effective at the closing of the transactions contemplated by that certain Agreement and Plan of Merger and Reorganization dated as of July 30, 2018 (the “Merger Agreement”), by and among the Company, Arch Merger Sub, Inc., a wholly-owned subsidiary of the Company, and Seelos Therapeutics, Inc. (the “Merger”), and Mr. Pascoe will be entitled to receive the severance payments and benefits set forth in the Amended and Restated Employment Agreement for an involuntary termination within 12 months following a change of control as a result of such termination, which include:
• A lump sum payment in an amount equal to 18 months’ base salary, plus 100% of his target bonus for the year in which the date of his involuntary termination occurs.
• Full acceleration of the vesting of all equity awards held by Mr. Pascoe at the time of the termination, including any options, restricted stock, RSUs or other awards.
• Reimbursement for the cost of continuation of health insurance benefits provided to him immediately prior to the termination pursuant to the terms of the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”) or other applicable law for a period continuing until the earlier of 18 months following the termination or the date upon which he is no longer eligible for such COBRA or other benefits under applicable law.
In the event the payment of the cash severance to Mr. Pascoe consisting of 18 months of his base salary and his target annual bonus (the “Base and Bonus Severance Obligation”) in cash (and assuming that all other Company employees are terminated at the closing of the Merger and become entitled to severance pursuant to their employment arrangements) would cause the “Apricus Net Cash” (as defined in the Merger Agreement) to be less than $0, then Mr. Pascoe’s severance shall be paid as follows:
• Such portion of the Base and Bonus Severance Obligation payable to Mr. Pascoe under his employment agreement as would cause the Apricus Net Cash to be less than $0 (but in no event more than 40% of the Base and Bonus Severance Obligation) (the “Equity-Settled Severance Portion”) shall be paid as follows:
• At the closing of the Merger, Mr. Pascoe will be granted a restricted stock unit under the 2012 Stock Long Term Incentive Plan, as amended from time to time (the “2012 Plan”), denominated with a dollar value equal to 120% of the Equity-Settled Severance Portion (the “Pascoe Closing RSU”).
• The Pascoe Closing RSU will vest in two equal installments on each of March 1, 2019 and March 1, 2020, subject to Mr. Pascoe’s continued service to the Company on the applicable vesting date, subject to accelerated vesting in the event of (1) a change of control of the Company (following the closing of the Merger), or (2) the failure of Mr. Pascoe to be nominated for reelection to the Company board of directors or Mr. Pascoe’s failure to be reelected to the Company’s board of directors at any meeting of the Company’s stockholders (or any failure to be reelected by a written consent of the Company’s stockholders) or any other involuntary termination of Mr. Pascoe’s status as a member of the board of directors of the Company, or (3) Mr. Pascoe’s death or disability.
• The Pascoe Closing RSU will provide for settlement within 10 days of vesting in either (1) shares of the Company's common stock with an aggregate value equal to the denominated dollar value vesting on the applicable vesting date (which value shall be converted into the Company’s shares based on the average closing price of the Company common stock over the 20 trading days preceding the settlement date) or (2) in the event any shares cannot be issued under the terms of the 2012 Plan for any reason, including as a result of there being insufficient shares available for issuance thereunder or the issuance of shares causing any individual award limit under the plan to be exceeded, in cash with respect to such shares. In addition, the Company may elect to settle the Pascoe Closing RSU in cash, in its discretion. If the settlement of the Pascoe Closing RSU would not be possible as of the grant date as a result of there being insufficient shares available for issuance under the 2012 Plan, or the issuance of such shares causing the award to exceed any individual award limits contained in the 2012 Plan, the Pascoe Closing RSU will still be granted but any share settlement
Apricus Biosciences beats by $0.02
Aug. 9, 2018 4:41 PM ET|About: Apricus Biosciences, Inc (APRI)|By: Niloofer Shaikh, SA News Editor
Apricus Biosciences (NASDAQ:APRI): Q2 EPS of -$0.10 beats by $0.02.
Cash of $6.84M
Press Release
Ligand Licenses Four Programs to Seelos Therapeutics
September 22, 2016 09:00 AM Eastern Daylight Time
SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces the licensing of rights to four programs to Seelos Therapeutics, Inc., a newly formed biopharmaceutical company focused on central nervous system (CNS), respiratory and other disorders.
“We are pleased to announce the collaboration for a portfolio of CNS products with our partner Ligand Pharmaceuticals”
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The licensed therapeutic programs include Ligand's aplindore program for the treatment of various CNS disorders, a CRTH2 antagonist program for the treatment of respiratory disorders, a Captisol-enabled™ acetaminophen program for pain and fever management and an H3 receptor antagonist program for the treatment of narcolepsy.
Under the license agreement, Ligand is entitled to receive initial payments in equity or cash of $1.3 million upon Seelos’ completing a minimum of $7.5 million financing and up to an additional $3.5 million if Seelos becomes a public company and up to $145 million of additional cash milestones. In addition, Ligand is entitled to net sales royalties ranging from 4% to 10% for the various programs licensed. Ligand has also entered into a supply agreement for Captisol. If certain conditions are met, Ligand will provide a three-year convertible loan facility to Seelos in an amount up to $500,000. Seelos is responsible for all development activities under the license.
"Seelos is assembling a great team of industry veterans to focus on a promising portfolio of mid- and late-stage programs. We are impressed with their development plans and with the outlook for building their business," said John Higgins, CEO of Ligand Pharmaceuticals. "Ligand has a track record of success with licensing foundational assets at the early stage of company formation, such as with Retrophin, Sage and Viking. All were private companies at the time of the Ligand license and all subsequently became public off lead programs licensed from Ligand. We are eager to watch Seelos progress."
"We are pleased to announce the collaboration for a portfolio of CNS products with our partner Ligand Pharmaceuticals," said Dr. Raj Mehra, Chairman, Founder and Chief Executive Officer of Seelos Therapeutics, Inc. "This partnership highlights Seelos' focus on developing late-stage CNS product candidates with proven mechanism of action. SLS-006, one of the lead assets acquired in this agreement, is a Phase-3 ready and clinically-validated partial dopamine agonist that is well-positioned to advance in development with a goal to provide relief to an estimated 1.5 million Parkinson's disease patients in the developed world."
About Seelos Therapeutics, Inc.
Seelos Therapeutics, Inc. is an emerging CNS company with late-stage clinical assets focused on neurological and psychiatric disorders, including orphan diseases. One of Seelos’ lead clinical product candidates, SLS-006 (formerly known as aplindore), is a Phase 3-ready, first-in-class, small molecule, partial dopamine agonist that has shown remarkable efficacy in early stage Parkinson's disease as a monotherapy. SLS-006 has also shown potent activity as an adjunctive therapy to highly reduced dosages of L-Dopa in late-stage Parkinson's disease. SLS-006 has been tested in more than 340 patients and has exhibited impressive efficacy similar to L-Dopa and an attractive safety profile. Seelos’ other Phase-3 ready product candidates, SLS-002 and SLS-004, have also been tested in clinical trials in more than 500 patients each and have shown promising efficacy. Seelos’ mission is to apply its clinical expertise to develop novel therapeutics to address unmet medical needs for the benefit of patients with psychiatric and movement disorders. For more information, please contact Raj.Mehra@Seelostx.com.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.
Follow Ligand on Twitter @Ligand_LGND.
Forward-Looking Statements
seelos pipeline , If this is accurate,. . then the combined company with all of apricus Bjo. drugs looks like a much higher valuation then apri's present value. All you shareholders look for yourself and see what you think!
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SLS-002: intranasal racemic ketamine for patients with suicidality in post-traumatic stress disorder (PTSD) and major depressive disorder (MDD). SLS-002 has shown promising efficacy in suicidality (with depression) with an unremarkable safety profile. Ketamine’s rapid antidepressant action is independent of NMDAR inhibition and involves early and sustained activation of AMPAR activation. With no other drugs currently approved in this indication, SLS-002 has the potential to address approximately 600,000 cases of suicidality in U.S. emergency rooms alone each year.
SLS-006: first-in-class, small molecule, partial dopamine agonist for Parkinson’s Disease that has successfully completed Phase II studies. Seelos intends to meet with the FDA and the European Medicines Authority (EMA) to discuss the plans for pivotal registration studies in 2019. SLS-006 has shown extraordinary efficacy in early-stage Parkinson’s disease patients as a monotherapy and as a potential adjunctive therapy in late-stage Parkinson’s disease patients upon co-administration with a low dosage of L-Dopa.
SLS-008: once-daily, oral CRTH2 (Chemo-attractant Receptor-homologous molecule expressed on TH2 cells) that focuses on a pediatric orphan indication. Seelos has a “family” of compounds under its SLS-008 program.
SLS-010: oral, Histamine 3 Receptor inverse agonist.
SLS-012: 505(b)(2) post-op pain program
© 2018 Seelos Therapeutics, Inc. All Rights Reserved.
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Thanks for your response, I would like a $10. PPS price versus a #$2.00
The BIG question is. . At what price will SEEL open at when it starts trading on NASDAQ? If it starts at $10. PSP does that mean we are getting 14 % of the currently owners stock? Say 1000 shares will be 140 shares of SEEL ?
Apricus Biosciences, Inc. Announces Merger Agreement with Seelos Therapeutics, Inc. to Advance Late-Stage Pipeline of Products for Central Nervous System (CNS) Disorders
Mon July 30, 2018 8:00 AM|GlobeNewswire|About: APRI, LGND
Transaction to result in Nasdaq-listed company focused on developing novel products to treat central nervous system diseases
Transaction expected to advance Seelos’ robust, late-stage pipeline of five programs, with near-term clinical and regulatory milestones
Ownership split of merged company anticipated to be approximately 86% Seelos shareholders and 14% Apricus (APRI) shareholders
Terms of the transaction to include a Contingent Value Right (CVR) per share to Apricus shareholders of record for Vitaros assets at the time of closing
Conference call and webcast to be held today at 8:30 AM U.S. Eastern Time
NEW YORK, July 30, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq: APRI) announced the signing of a definitive agreement to merge with Seelos Therapeutics, Inc., a privately-held biotechnology company, in an all-stock transaction. The merged company will focus on the development and commercialization of central nervous system (CNS) therapeutics with known mechanisms of action in areas with a highly unmet medical need. Upon completion of the proposed merger, the name of the merged company will be Seelos Therapeutics, Inc., and the company is expected to begin trading on the Nasdaq Capital Market under the ticker symbol “SEEL.” Seelos will maintain its headquarters in New York, New York.
When the merger is complete it will trade under the stock symbol SEEL on the Nasdaq.
Apricus Biosciences, Inc. Announces Merger Agreement with Seelos Therapeutics, Inc. to Advance Late-Stage Pipeline of Products for Central Nervous System (CNS) Disorders
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Apricus Biosciences, Inc. Announces Merger Agreement with Seelos Therapeutics, Inc. to Advance Late-Stage Pipeline of Products for Central Nervous System (CNS) Disorders
Transaction to result in Nasdaq-listed company focused on developing novel products to treat central nervous system diseases
Transaction expected to advance Seelos’ robust, late-stage pipeline of five programs, with near-term clinical and regulatory milestones
Ownership split of merged company anticipated to be approximately 86% Seelos shareholders and 14% Apricus shareholders
Terms of the transaction to include a Contingent Value Right (CVR) per share to Apricus shareholders of record for Vitaros assets at the time of closing
Conference call and webcast to be held today at 8:30 AM U.S. Eastern Time
NEW YORK, July 30, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq: APRI) announced the signing of a definitive agreement to merge with Seelos Therapeutics, Inc., a privately-held biotechnology company, in an all-stock transaction. The merged company will focus on the development and commercialization of central nervous system (CNS) therapeutics with known mechanisms of action in areas with a highly unmet medical need. Upon completion of the proposed merger, the name of the merged company will be Seelos Therapeutics, Inc., and the company is expected to begin trading on the Nasdaq Capital Market under the ticker symbol “SEEL.” Seelos will maintain its headquarters in New York, New York.
“Following a comprehensive review of strategic alternatives conducted through a structured process, the Apricus Board of Directors has concluded that the proposed merger with Seelos is in the best interest of our shareholders, as it will provide an opportunity to create value from a diversified pipeline of late-stage clinical assets in areas of high unmet need,” said Richard Pascoe, Chief Executive Officer (CEO) of Apricus. “Moreover, we believe that the Seelos management, led by Dr. Raj Mehra, is well positioned to advance Seelos’ robust pipeline towards regulatory approval and commercialization in the United States.”
Item 5.07 Submission of Matters to a Vote of Security Holders.
On May 15, 2018, Apricus Biosciences, Inc. (the “Company”) held its 2018 Annual Meeting of Stockholders (the “Annual Meeting”). The following is a brief description of each matter submitted to a vote at the Annual Meeting on May 15, 2018, as well as the number of votes cast for, withheld or against, the number of abstentions and the number of broker non-votes with respect to each matter, as applicable. For more information about these proposals, please refer to the Company’s proxy statement filed with the Securities and Exchange Commission on April 6, 2018.
The number of shares of common stock entitled to vote at the Annual Meeting was 23,441,080. The number of shares of common stock present or represented by valid proxy at the Annual Meeting was 18,351,680. Certain matters submitted to a binding vote of stockholders at the Annual Meeting were approved as described below.
Proposal No. 1: Election of Class II Directors
Richard Pascoe and Sandford Smith were elected to serve as Class II directors. Mr. Pascoe received 4,949,463 votes for and 2,059,649 withheld and Mr. Smith received 5,046,490 votes for and 1,962,622 votes withheld. There were 11,342,568 broker non-votes regarding the election of directors.
Proposal No. 2: Ratify Selection of Auditors
Stockholders ratified the appointment of BDO USA, LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2018. The results of the voting included 14,215,730 votes for, 485,007 votes against and 3,650,943 votes abstained. There were no broker nonvotes regarding this proposal.
Proposal No. 3: Conduct an Advisory (Non-Binding) Vote on Executive Compensation
Stockholders approved, on an advisory basis, the executive compensation paid to the Company’s named executive officers. The results of the voting included 4,765,617 votes for, 414,192 votes against and 1,829,303 votes abstained. There were 11,342,568 broker non-votes regarding this proposal.
Proposal No. 4: Amend the Company’s Amended and Restated Articles of Incorporation to Increase the Number of Authorized Shares of Common
Stock
Stockholders approved an amendment to the Company’s Amended and Restated Articles of Incorporation (the “Charter Amendment”) to increase the number of authorized shares of common stock from 30,000,000 shares to a total of 60,000,000 shares. The results of the voting included 14,611,256 votes for, 3,615,299 votes against and 125,125 votes abstained. There were no broker non-votes regarding this proposal.
Item 8.01 Other Events.
As previously announced, in April 2018, the Company issued, in a best efforts public offering, an aggregate of 7,100,000 units (the “Units”). Each Unit consisted of one share of the Company’s common stock, and one warrant to purchase 0.50 of a share of common stock (the “April 2018 Warrants”). Pursuant to their terms, the April 2018 Warrants are exercisable upon the Company’s announcement that it has received stockholder approval of the Charter Amendment and the Charter Amendment became effective. In connection with the transaction, the Company issued warrants to purchase up to 355,000 shares of common stock (the “April 2018 Placement Agent Warrants”) to H.C. Wainwright & Co., LLC. The April 2018 Placement Agent Warrants are also exercisable upon the announcement of the effectiveness of the 2018 Charter Amendment.
In addition, in March 2018, the Company entered into a warrant amendment with the holders of the Company’s warrants to purchase common stock of the Company previously issued in September 2017 (the “September 2017 Warrants”), pursuant to which, among other things, the date upon which the September 2017 Warrants become exercisable was changed to the effective date of the Charter Amendment.
As a result, in connection with the effectiveness of the Charter Amendment and the filing of this Current Report on Form 8-K, the April 2018 Warrants are now exercisable for up to 3,550,000 shares of common stock, the April 2018 Placement Agent Warrants are now exercisable for up to 355,000 shares of common stock and the September 2017 Warrants are now exercisable for up to 1,102,779 shares of common stock, each pursuant to their terms.
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2
A buyout of $5.00 per share would be good IMO
Whats up? Possible sale or Partner?
SAN DIEGO, May 03, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company seeking to advance innovative medicines in urology and rheumatology, today reported financial results for the first quarter of 2018 and provided a corporate update on its near-term priorities.
“Since our recent end-of-review meeting on the NDA for Vitaros with the FDA, we have been focused on pursuing U.S. Vitaros partnership discussions with interested parties. Our objective is to enable continued development and potential approval of the Vitaros product and receive financial terms commensurate with this development stage asset in exchange for a sublicense or assignment of our U.S. development and/or commercialization rights. In parallel, the Company is evaluating strategic alternatives, which may include a sale of the company, a business combination, a merger or reverse merger or a license, and in order to maximize shareholder value, the Company has engaged Canaccord Genuity LLC to assist in that process,” said Richard Pascoe, Chief Executive Officer.
First Quarter Financial Results
Net loss during the quarter ended March 31, 2018 was $2.3 million, or loss per share of $0.14, compared to net income of $8.1 million, or earnings per share of $1.04, during the first quarter of 2017. Net income during the quarter ended March 31, 2017 was primarily due to the $11.8 million gain recorded upon 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 March 31, 2018, the Company’s cash totaled $5.7 million, compared to $6.3 million as of December 31, 2016, which is expected to fund operations through the end of 2018. The Company’s cash balance as of March 31, 2018 does not include net proceeds of approximately $2.9 million from the Company’s public equity offering, which closed on April 2, 2018.
Apricus Biosciences Announces Outcome of Vitaros™ End-of-Review Meeting with FDA
FDA Confirms Vitaros Regulatory Pathway
Company Seeking Partner to Develop Vitaros in U.S.
Company Evaluating Strategic Alternatives
SAN DIEGO, April 16, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced the outcome of its end-of-review meeting with the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Vitaros™ (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction.
The preliminary end-of-review meeting minutes support a plan to address issues cited by the FDA in its February 15, 2018 Complete Response Letter (CRL) for the Vitaros NDA. Specifically, the FDA confirmed during the meeting that the company should develop a new Vitaros formulation that reduces the concentration of DDAIP.HCl from 2.5% to 0.5% in order to address the tumor promotion and partner transference safety concerns noted in the CRL. The FDA also confirmed that two new Phase 3 clinical efficacy trials with the reformulated product should be conducted prior to resubmitting the NDA and that the trials should include an assessment of the potential risk of enhanced sexually transmitted infections with the new formulation. In addition, the FDA requested certain pharmacokinetic assessments that we expect can be completed as part of the requested Phase 3 program and any additional clinical or commercial safety data generated prior to a resubmission. Lastly, the FDA stated that the Chemistry, Manufacturing and Control (CMC) section in the resubmission will need to be updated with data generated during development of the new formulation.
The FDA previously issued a CRL for the Vitaros NDA, indicating that it could not approve the NDA for Vitaros in its present form, identifying deficiencies related to CMC and whether the modest treatment effect of Vitaros outweighed certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.
“While we are pleased that the FDA has outlined a clear regulatory pathway for Vitaros, which we believe provides a path to approval in the U.S., the cost and timeline associated with a reformulation effort and completing additional phase 3 clinical trials exceeds our current resources and our ability to raise additional capital. Therefore, we have initiated discussions with interested parties for the U.S. Vitaros rights to enable its continued development and potential approval in exchange for financial terms commensurate with a development stage asset. In parallel, the Board of Directors has determined that Apricus should evaluate strategic alternatives or other business combinations, with the goal of maximizing shareholder value,” said Richard Pascoe, Chief Executive Officer.
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Table of Contents
APRICUS BIOSCIENCES, INC.
11975 El Camino Real, Suite 300
San Diego, California 92130
NOTICE OF ANNUAL MEETING OF STOCKHOLDERS
To Be Held on May 15, 2018
Dear Stockholder:
You are cordially invited to attend the Annual Meeting of Stockholders of Apricus Biosciences, Inc., a Nevada corporation (the “ Company ”). The Annual Meeting will be held on Tuesday, May 15, 2018 at 8:00 a.m., local time, at Latham & Watkins LLP, located at 12670 High Bluff Drive, San Diego, California 92130, for the following purposes:
(1)
To elect two Class II directors, nominated by our Board of Directors, to serve until our 2021 Annual Meeting of Stockholders and until their successors are duly elected and qualified;
(2)
To ratify the selection of BDO USA, LLP (“ BDO ”) as our independent registered public accounting firm for the fiscal year ending December 31, 2018 ;
(3)
To conduct an advisory (non-binding) vote on executive compensation;
(4)
To approve an amendment to the Company’s Amended and Restated Articles of Incorporation to increase the number of authorized shares of Common Stock, par value $0.001 per share, to a total number of 60,000,000 shares;
(5)
To transact such other business as may properly come before the Annual Meeting or any adjournment(s) thereof.
The record date for the Annual Meeting is April 4, 2018 . Only stockholders of record at the close of business on that date may vote at the meeting or any adjournment(s) or postponement(s) thereof. The accompanying Proxy Statement more fully describes the details of the business to be conducted at the Annual Meeting. Our proxy materials (which include the Proxy Statement attached to this notice, our most recent Annual Report on Form 10-K and form of proxy card) are also available to you via the Internet at www.proxyvote.com.
By Order of the Board of Directors,
(4/12): Apricus Biosciences (NASDAQ:APRI): Pre-IND meeting with FDA on Vitaros for erectile dysfunction.
Apricus Biosciences Announces Scheduling of Vitaros™ End-of-Review Meeting with FDA
Meeting Scheduled for April 12, 2018
SAN DIEGO, March 26, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that its end-of-review meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the New Drug Application (“NDA”) for Vitaros™ (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction, is now scheduled to be held on April 12, 2018.
The FDA previously issued a Complete Response Letter (“CRL”) for the Vitaros NDA, indicating that the FDA could not approve the NDA for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.
“We are looking forward to our end-of-review meeting with the FDA. We intend to further clarify the deficiencies raised in the CRL and the information that may be needed to resolve such deficiencies and to assess the path forward for further development and a potential approval of Vitaros,” stated Richard W. Pascoe, Chief Executive Officer. “Following receipt of the end-of-review meeting minutes, we intend to update the market on our future plans for Vitaros.”
Yes we dont know at this time , But we might as well stay in for a possible sale, to sell at this price is not a good option!
SAD , BUT THE CASINOKID HAD HIM NAILED! HE WILL RUN THE LAST OUNCE OF JUICE OUT OF THE COMPANY! ThE IDEA THAT HE SOME HOW WILL TURN IT AROUND WITH A RECONFIGURATION OF VITAROS IN APRIL AND SAVE THE DAY SEEMS IMPROBABILE! IF HE DOES PULL IT OFF IT WILL BE THE MIRACLE OF THE CENTURY!!
Link to Web cast Today 4:30 PM
http://ir.apricusbio.com/phoenix.zhtml?c=118007&p=irol-irhome[url][/url][tag]insert-text-here[/tag]
History usually repeats. .Pascoe sold the last company He was CEO of., so If my memory is correct He will do the same with Apri.
Apricus Biosciences Announces Corporate Update, Fourth Quarter and Full Year 2017 Financial Results Conference Call
Wed February 21, 2018 7:00 AM|GlobeNewswire|About: APRI
SAN DIEGO, Feb. 21, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the Company's fourth quarter and full year 2017 financial results will be released on Thursday, March 1, 2018 at 4:01 p.m. Eastern Time. Company management will host a conference call on Thursday, March 1, 2018, at 4:30 p.m. Eastern Time to discuss the financial results and its plans for addressing the Vitaros Complete Response with the FDA.
To participate by telephone, please dial (855) 780-7196 (Domestic) or (631) 485-4867 (International). The conference ID number is 3687726. The live audio webcast can be accessed via the Investor Relations’ section of the Company's website at www.apricusbio.com. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for 30 days following the live call.
About Apricus Biosciences, Inc (APRI).
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has two product candidates: Vitaros, 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); and RayVa, a product candidate which has completed a Phase 2a clinical trial for the treatment of the circulatory disorder Raynaud’s phenomenon, secondary to scleroderma, for which Apricus owns worldwide rights.
Your information appears to be flawed. .I just checked France and England and the product is available on line from these Countries. I will check more Countries so if Ferring is telling you that the product is flawed, then why are they selling it??
It is a failure because, of poor product quality control! Pascoe is sloppy in control of the product the production of vitaros was stopped at one point!
Plain and simple POOR Management!! All these high salaried people was a waste of money!!
ir.apricusbio.com/phoenix.zhtml?c=118007&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTEyMDY1MTMwJkRTRVE9MCZTRVE9MCZTUURFU0M9U0VDVElPTl9FTlRJUkUmc3Vic2lkPTU3
02/16/18 8-K Report of unscheduled material events or corporate event Current [url][/url][tag]insert-text-here[/tag]
Pascoe is a West Point graduate, We are lucky He didn't stay in the Military! With all the approvals in other Countries its hard to believe that they are all allowing a harmful product! So the reasons for rejection
must be beyond harmful into another category??I personally thought that RayVa was a good product and should have been given more attention!
A Form SC 13G/A regarding Apricus Biosciences, Inc. has been filed with the United States Securities and Exchange Commission.
A Form SC 13G/A regarding Apricus Biosciences, Inc. has been filed with the United States Securities and Exchange Commission.
To View the filing please click here
It appears that the board expects you to have a crystal ball with the all seeing eye ! It is projected upon approval the sales would be 150 million a year to start so what are the number of shares outstanding and subtract expenses to get a guesstimate of earnings per share, then give the Pharma multiple for Bios 20- 40 time earnings per share then calculate and deducts for deals made to other Pharmas and you will have the fortune tellers answer. . (: Well, your plan seems reasonable Wait and see. .
GLTA
My calculations show that if Seeking Alpha is correct with projected earnings of 150 M
upon approval then this stock could be worth 10 times its present price!
Any number crunchers on the board do the Math . . .
Seeking alpha. . (2/17): FDA action date: Apricus Biosciences (NASDAQ:APRI): Vitaros topical cream for erectile dysfunction. A decision will likely be announced the day before.
Major Catalyst Inbound
Vitaros faces an FDA PDUFA ruling on February 17th. The ED medication has already been turned down for approval once, though that was in 2008. A decade on, Apricus is facing a whole new FDA. With an estimated market opportunity worth $150 million in sales per year by 2020 in the US market, it is Apricus' only real shot at attaining profitability.
Amended Statement of Beneficial Ownership (sc 13d/a)
Yes He still owns all that you stated The legal ease is what He is stating is his right to Bargain with his shares which is considerable as you stated!. . 1,447,906 shares & 672,455 Warrants for Denner, no change 13.5% of the outstanding Shares Is this the gist of it?
Vitaros NDA resubmission and our PDUFA goal date is February 17, 2018,” ...
APRI RATED STRONG BUY.
http://www.nasdaq.com/symbol/apri/recommendations
I think that Denner will be looking for a $10. PPS at a minimum!
I hope he gets at least that!!
Nice! so many positive posts Quite a change from previous times! I agree Vitaros will get approval and from that point on It could be a BIG winner!!
Erectile dysfunction drugs market This market was valued at US$4.3 billion in 2012 what share can apri take of this market with an aging US market? Vitaros is ideal for the aging male market with fewer side effects!