UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): January 8, 2017
 
ACELRX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

DELAWARE	 	001-35068	 	41-2193603	
(State of incorporation)	 	(Commission File No.)	 	(IRS Employer Identification No.)	

351 Galveston Drive
Redwood City, CA 94063
(Address of principal executive offices and zip code)
 
Registrant’s telephone number, including area code: (650) 216-3500
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 
 
Item 2.02 Results of Operations and Financial Condition.
 
AcelRx Pharmaceuticals, Inc. (the “Company” or “AcelRx”) will be providing financial information about the Company’s cash and outstanding loan balances as of December 31, 2016 in the Company’s presentation handout to be utilized in various meetings with securities analysts and investors during the J.P. Morgan Healthcare Conference from January 9, 2017 through January 12, 2017 in San Francisco, and The Trout Group Annual 1x1 Management Access Event from January 10, 2017 through January 13, 2017, also in San Francisco. The aforementioned financial information is included on slides #36 and #39 of the presentation handout, as furnished in Exhibit 99.1 to this Current Report and is incorporated herein by reference.
 
The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 to this Current Report shall be deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 to this Current Report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission under the Securities Act or the Exchange Act made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 
Item 7.01. Regulation FD Disclosure.
 
AcelRx will participate in various meetings with securities analysts and investors during the J.P. Morgan Healthcare Conference from January 9, 2017 through January 12, 2017 in San Francisco, and The Trout Group Annual 1x1 Management Access Event from January 10, 2017 through January 13, 2017, also in San Francisco, and will utilize a presentation handout during those meetings. The presentation handout, together with a slide setting forth certain cautionary language intended to qualify the forward-looking statements included in the presentation handout, are furnished as Exhibit 99.1 to this Current Report and are incorporated herein by reference. The presentation handout will also be made available in the “Investor Relations” section of AcelRx Pharmaceuticals, Inc.’s website, located at www.acelrx.com.
 
The information contained in this Item 7.01 and in the accompanying Exhibit 99.1 to this Current Report shall be deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act. The information contained in this Item 7.01 and in the accompanying Exhibit 99.1 to this Current Report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission under the Securities Act or the Exchange Act made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 
Item 8.01. Other Events.
 
On January 8, 2017, the Company issued a press release entitled “AcelRx Pharmaceuticals Announces DSUVIA™ as Brand Name for ARX-04” a copy of which is attached as Exhibit 99.2 to this Report.  
 
Also on January 8, 2017, the Company issued a press release entitled “AcelRx Pharmaceuticals Provides Guidance on 2017 Milestones for ARX-04, now known as DSUVIA™ in the United States, for the Treatment of Moderate-to-Severe Acute Pain” a copy of which is attached as Exhibit 99.3 to this Report.  

 
Item 9.01.	Financial Statements and Exhibits.	
 
(d) Exhibits.
Exhibit
Number	 	Description	
 	 	
99.1	 	Slide presentation entitled, “AcelRx Pharmaceuticals Corporate Overview January 2017”	
99.2	 	Press release dated January 8, 2017 entitled, “AcelRx Pharmaceuticals Announces DSUVIA™ as Brand Name for ARX-04 in the United States”	
99.3	 	Press release dated January 8, 2017, entitled “AcelRx Pharmaceuticals Provides Guidance on 2017 Milestones for ARX-04, now known as DSUVIA™ in the United States, for the Treatment of Moderate-to-Severe Acute Pain”	

 

 
 
Signatures
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 9, 2017	ACELRX PHARMACEUTICALS, INC.
  	 	
 	By:  	/s/ Jane Wright-Mitchell	 	
 	 	Jane Wright-Mitchell	 	
 	 	Chief Legal Officer 	 	

 

 
 
INDEX TO EXHIBITS

Exhibit
Number	  	Description	
 	 	
99.1	 	Slide presentation entitled, “AcelRx Pharmaceuticals Corporate Overview January 2017”	
99.2	 	Press release dated January 8, 2017 entitled, “AcelRx Pharmaceuticals Announces DSUVIA™ as Brand Name for ARX-04 in the United States”	
99.3	 	Press release dated January 8, 2017, entitled “AcelRx Pharmaceuticals Provides Guidance on 2017 Milestones for ARX-04, now known as DSUVIA™ in the United States, for the Treatment of Moderate-to-Severe Acute Pain”	

 

Exhibit 99.1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit 99.2

	

AcelRx Pharmaceuticals Announces DSUVIA™ as Brand Name for ARX-04 in the United States
 
REDWOOD CITY, Calif., January 8, 2017 – AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the brand name, DSUVIA™ (sufentanil sublingual tablet, 30 mcg), for the company’s investigational product candidate, ARX-04. In addition, AcelRx has applied to the U.S. Patent and Trademark Office to obtain federal registration of the DSUVIA mark.
 
AcelRx recently announced the submission of a New Drug Application (NDA) with the FDA for DSUVIA for the treatment of patients experiencing moderate-to-severe acute pain in a medically supervised setting. This market is comprised of the adult emergency department setting, ambulatory and outpatient surgical settings, short-stay inpatient settings and certain office settings that serve patients undergoing painful procedures. In total, based on internal market research and published national surveys, AcelRx expects the peak market for DSUVIA in the U.S. to be an estimated $1.1 billion.
 
“Our initial target market will be the emergency medicine market,” commented Gina Ford, AcelRx’s vice president of commercial strategy. “Pending a favorable review by the FDA, we anticipate initiating a pilot launch program into identified centers of excellence around the country shortly after approval. During the next three quarters, we plan to add the necessary commercial staff and infrastructure to support these initial commercialization efforts.”
 
The FDA is expected to determine by mid-February 2017 whether the DSUVIA NDA is complete and acceptable for review. Should the Agency accept the NDA for review, a Prescription Drug User Fee Act (PDUFA) decision could be expected in the fourth quarter of 2017.

  
About DSUVIA (formerly known as ARX-04)
DSUVIA is a non-invasive investigational product candidate consisting of 30 mcg sufentanil tablets delivered sublingually by a healthcare professional using a disposable, pre-filled, single-dose applicator (SDA). Sufentanil is a synthetic opioid analgesic with a high therapeutic index and no known active metabolites.

 

 
 
Clinical and Rehabilitative Medicine Research Program (CRMRP)
DSUVIA is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046. The CRMRP was established in 2008 to foster research and technology advances for regeneration, restoration, and rehabilitation of traumatic injuries.
 
In accordance with USAMRMC guidelines, in the conduct of clinical research, AcelRx has adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).
 
About AcelRx Pharmaceuticals, Inc. 
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. An NDA for DSUVIA (sufentanil sublingual tablet, 30mcg), known as ARX-04 outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, was recently submitted to the FDA for review.
 
The Company’s follow on product, ZALVISO® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting, is currently enrolling patients in a Phase 3 clinical trial, IAP312. ZALVISO delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. ZALVISO is approved in the EU and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for ZALVISO in Europe, where a commercial launch has begun.
 
For additional information about AcelRx's clinical programs, please visit www.acelrx.com.
 
Forward-Looking Statements 
This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx's product candidates, DSUVIA TM  (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, and ZALVISO (sufentanil sublingual tablet system), including U.S. Food and Drug Administration, or FDA, review of the New Drug Application, or NDA, for DSUVIA; the potential approval of the DSUVIA NDA by the FDA; the DSUVIA and ARX-04 clinical trial results; AcelRx's pathway forward towards gaining approval of ZALVISO in the U.S., including successful completion of the IAP312 clinical study for ZALVISO; and the therapeutic and commercial potential of AcelRx's product candidates, including potential market opportunities and market size for DSUVIA, ARX-04 and ZALVISO. These forward-looking statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals' actual results and timing of events could differ materially from those anticipated in such forward-looking statements, and as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx Pharmaceuticals' DSUVIA and ARX-04 development programs, including the FDA review of the DSUVIA NDA and the possibility that the FDA may dispute or interpret differently clinical results obtained from the DSUVIA Phase 3 studies; the ZALVISO development program, including successful completion of IAP312 and the resubmission of the ZALVISO NDA to the FDA; any delays or inability to obtain and maintain regulatory approval of its product candidates, including DSUVIA in the United States, ARX-04 in Europe and ZALVISO in the United States; the uncertain clinical development process; the success, cost and timing of all development activities and clinical trials; actual market size for AcelRx product candidates; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on November 2, 2016. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

 

 
 
Contacts:
Timothy E. Morris
Chief Financial Officer
650.216.3511
tmorris@acelrx.com
 
Brian Korb
The Trout Group LLC
646.378.2923
bkorb@troutgroup.com

###

Exhibit 99.3

 
AcelRx Pharmaceuticals Provides Guidance on 2017 Milestones for ARX-04, now known as DSUVIA™ in the United States, for the Treatment of Moderate-to-Severe Acute Pain
 
 	●	Expected FDA Acceptance of the NDA	
 	●	Planned Submission of MAA in the EU	
 	●	Potential Approval and Commercialization in the U.S.	
 
REDWOOD CITY, Calif., Jan. 8, 2017 – AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, provided guidance today on 2017 milestones for its lead product, ARX-04, known as DSUVIA™ (sufentanil sublingual tablet, 30 mcg) in the United States. Specifically, AcelRx's corporate milestones for DSUVIA and ARX-04 in the upcoming year are as follows:
 
 	●	Advance the NDA. AcelRx submitted a 505(b)2 new drug application (NDA) for DSUVIA for moderate-to-severe acute pain in a medically supervised setting on December 12, 2016. The U.S. Food and Drug Administration (FDA) has 60 days to review an application and determine whether the NDA is acceptable for filing. AcelRx expects to receive this notification from the FDA in the first quarter of 2017. Assuming the FDA, through the Division of Anesthesia, Analgesia and Addiction Products (Division), accepts the NDA for filing, AcelRx will liaise with the Division and any advisory committees that may be convened during the review period.	
 
 	●	Submitthe European Regulatory Application. AcelRx expects to submit a Marketing Authorization Application (MAA) under the Centralized Procedure for ARX-04 with the European Medicines Agency (EMA) in the first half of 2017.	
 
 	●	Plan forU.S. Approval and Commercialization. Should the Division favorably complete its review by the expected Prescription Drug User Fee Act (PDUFA) date, AcelRx anticipates being prepared to begin commercialization of DSUVIA as early as the fourth quarter of 2017.	
 
"The most significant goals we accomplished in 2016 were with DSUVIA: The submission of the NDA; developing the DSUVIA commercial strategy; and establishing the supply chain. As a result, we are well positioned as we begin 2017 to advance DSUVIA in the U.S. and ARX-04 in Europe," stated Howie Rosen, CEO of AcelRx. "Of course, a positive FDA decision on our NDA has the potential to fully transform AcelRx and allow us to begin commercialization of DSUVIA into the emergency medicine market. As we presented in December, we believe the peak revenue potential across all settings for DSUVIA in the U.S. is $1.1 billion. This forecast also reinforced our comfort with designating DSUVIA as our lead product and ZALVISO being a potential follow-on product in the U.S."

 

 
 
Tim Morris, CFO of AcelRx added, "We ended 2016 with $80 million in cash and cash equivalents. We anticipate having about $50 million in cash at the end of the 2 nd  quarter of 2017. Our spending in the 2 nd  half of 2017 will depend on the review process and PDUFA date set by the Division as well as the specific details of our commercial plans. The acceptance of the NDA for DSUVIA by April 1, 2017 also will allow us to refinance the $21 million outstanding debt with Hercules. We expect to provide cash guidance for the full year as regulatory milestones and commercial plans become clearer."
 
Members of AcelRx senior management will be participating in The Trout Group Annual 1x1 Management Access Event in San Francisco, January 10 – 13, 2017.
 
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. An NDA for DSUVIA (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, was recently submitted to the FDA for review.
 
The Company’s follow on product, ZALVISO® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting, is currently enrolling patients in a Phase 3 clinical trial, IAP312. ZALVISO delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. ZALVISO is approved in the EU and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for ZALVISO in Europe, where a commercial launch has begun.
 
For additional information about AcelRx's clinical programs, please visit www.acelrx.com.
 
Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx's product candidates, DSUVIA TM  (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, and ZALVISO ®  (sufentanil sublingual tablet system), including U.S. Food and Drug Administration, or FDA, review of the New Drug Application, or NDA, for DSUVIA; the potential approval of the DSUVIA NDA by the FDA; the DSUVIA and ARX-04 clinical trial results; AcelRx's pathway forward towards gaining approval of ZALVISO in the U.S., including successful completion of the IAP312 clinical study for ZALVISO; projected cash balances; and the therapeutic and commercial potential of AcelRx's product candidates, including potential market opportunities and market size for DSUVIA, ARX-04 and ZALVISO. These forward-looking statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals' actual results and timing of events could differ materially from those anticipated in such forward-looking statements, and as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx Pharmaceuticals' DSUVIA and ARX-04 development programs, including the FDA review of the DSUVIA NDA and the possibility that the FDA may dispute or interpret differently clinical results obtained from the DSUVIA Phase 3 studies; the ZALVISO development program, including successful completion of IAP312 and the resubmission of the ZALVISO NDA to the FDA; any delays or inability to obtain and maintain regulatory approval of its product candidates, including DSUVIA in the United States, ARX-04 in Europe and ZALVISO in the United States; the uncertain clinical development process; the success, cost and timing of all development activities and clinical trials; the accuracy of our cash projections; actual market size for AcelRx product candidates; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on November 2, 2016. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

 

 
 
Contacts:
Timothy E. Morris
Chief Financial Officer
650.216.3511
tmorris@acelrx.com
 
Brian Korb
The Trout Group LLC
646.378.2923
bkorb@troutgroup.com