SEC Filing | Talphera

Date: February 9, 2015

ACELRX PHARMACEUTICALS, INC.

/s/ Timothy E. Morris

Timothy E. Morris

Chief Financial Officer

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8-K

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): February 9, 2015

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 7.01.

Regulation FD Disclosure.

AcelRx Pharmaceuticals, Inc. (the “Company” or “AcelRx”) will participate in various meetings with securities analysts and investors 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 9.01.

Financial Statements and Exhibits.

(d) Exhibits.


Exhibit Number		Description

99.1		Slide presentation entitled, “AcelRx Pharmaceuticals, Inc. February 2015”

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.

INDEX TO EXHIBITS


Exhibit Number		Description

99.1		Slide presentation entitled, “AcelRx Pharmaceuticals, Inc. February 2015”

EX-99.1

February 2015

Exhibit 99.1

Forward Looking Statements

This presentation contains forward-looking statements, including, but not limited to, statements related to future financial results,

potential proceeds under the Grunenthal agreement, the process and timing of anticipated future development of AcelRx’s product

candidates, including Zalviso, the NDA submission and the CRL, the Type A meeting held with the FDA to discuss the CRL,

AcelRx’s

plans

address

the

issues

raised

the

CRL,

and

anticipated

resubmission

the

Zalviso

NDA

the

FDA,

including

the scope

of the resubmission and the timing of the resubmission and FDA review time, the impact, if any, of the FDA’s review of the

amendments to the Zalviso NDA that were not previously reviewed,

planned initiation of the Phase 3 clinical trial for ARX-04, and the

therapeutic and commercial potential of AcelRx Pharmaceuticals' product candidates, including Zalviso. These forward-looking

statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties.

AcelRx Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward-looking

statements as a result of these risks and uncertainties, which include, without limitation, risks related to: AcelRx Pharmaceuticals'

ability to receive regulatory approval for Zalviso; any delays or inability to obtain and maintain regulatory approval of its product

candidates, including Zalviso, in the United States and Europe; AcelRx's ability to build an effective commercial organization; its ability

to receive any milestones or royalty payments under the Grunenthal agreement; its ability to obtain sufficient financing to

commercialize Zalviso and proceed with clinical development of ARX-04; the success, cost and timing of all product development

activities and clinical trials, including the planned Phase 3 ARX-04 trial; the market potential for its product candidates; the accuracy of

AcelRx’s estimates regarding expenses, capital requirements and needs for financing; and other risks detailed in the "Risk Factors" and

elsewhere

AcelRx

Pharmaceuticals'

U.S.

Securities

and

Exchange

Commission

filings

and

reports,

including

its

Quarterly

Report

Form 10-Q filed with the SEC on November 10, 2014. AcelRx Pharmaceuticals 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.

AcelRx–Working to Improve Acute Pain Management

Zalviso

profile from Phase 3 studies

Efficacy: Demonstrated in two placebo controlled studies, 1 active comparator study

Adverse

events:

Most

common

AE’s

were

nausea,

vomiting,

desaturation,

itching

High patient satisfaction and nurse ease of care reported

Grünenthal partnership to commercialize Zalviso in EU & Australia established

Upcoming regulatory catalysts in US and EU

US:

NDA

resubmission

targeted

2015

EU:

Day

120

submission

planned

for

2015

Strong balance sheet with $75 million cash on hand December 31, 2014

(unaudited)

Terms:

$250M

upfront

and

potential

milestones,

mid-teens

mid-twenties

royalty

Other

Territories:

Continue

seek

additional

partnerships

Asia

South

America

Mark:

Received

December

2014

MAA filed in Switzerland

AcelRx Update Q1 2015

Zalviso resubmission

•

Received FDA comments on bench testing

•

–

Healthy volunteers study completed

at risk, testing successful

–

Post-op

patient

study

initiated

Zalviso EU Day 120 Response

•

Expected submission in Q1

ARX-04

•

Discussion with DoD continues, funding

targeted for H1 2015

•

Pivotal Phase 3 study to be initiated in Q1

without DoD funding

Bench testing initiated, anticipated

completion end of February

Awaiting FDA comments on Human

Factors protocol

Proposed HF study to FDA in two

populations: healthy volunteers, post-op

patients

All questions to be addressed and in

process of preparing a response

CE mark approved and to be included

as part of response

Major items in CRL:

System errors were noted in the clinical setting at a single digit rate

Did not appear to impact Phase 3 safety and efficacy results

Improvements have been made to reduce error rate

Formal bench testing in process to confirm error rate reduction

15 misplaced tablets of ~30,000 doses

IFU modified to address this issue

HF studies underway to confirm IFU/GUI changes are adequate

Data to be provided to support 24 month dating

Zalviso NDA Status-CRL received July 25, 2014

Demonstration of a reduction in the incidence of system errors

Changes

the

Instructions

for

Use

(IFU)

address

inadvertent

dosing

Support for shelf life (not approvability issue)

Proposed Indication: Management of

Moderate to Severe In-Hospital Acute Pain

Investigational drug and delivery system not FDA approved for commercial use

Clinical Data

Invasive route of delivery

IV infiltration causes analgesic gaps

IV connection restricts patient mobility

Risk of IV site infection

Programming errors

1/9 harmful hospital errors due to IV PCA

IV PCA –

Current Standard of Care

In-hospital, post-operative

moderate to severe pain control

Higher Patient satisfaction when

patients control their own pain

IV-PCA

FDA

AAMI

Summit

Meeting

held

October

2010;

http://www.aami.org/infusionsummit/AAMI_FDA_Summit_Report.pdf

Calculated from “The rate and costs attributable to intravenous patient-controlled analgesia errors.” Brian Meissner et al, Hospital Pharmacy April 2009

Infusion pumps large source of morbidity /

mortality

Zalviso: Leveraging Sufentanil

High Therapeutic Index Opioid

In animal studies

High Lipophilicity

6 minute brain:plasma equilibration

No active metabolites

OPIOID

THERAPEUTIC

INDEX

Morphine

Hydromorphone

232

Fentanyl

277

Sufentanil

26,716

Sublingual Sufentanil Delivery

May reduce IV peaks & troughs

Small size may minimize swallowed drug

May result in high bioavailability

Helps with goal of consistent dose

delivery

Supplied in cartridge of 40 Tablets

2 days for average patient

1. Mather, Clin Exp Pharmacol Physiol 1995; 22:833.

2. Kumar, Eur J Pharmacol 2008; 597:39 (ED50) and Purdue Pharma MSDS, 2009 (LD50)

Enables rapid transmucosal uptake

Zalviso: Delivery Device Design and Feature Set

Non-invasive (sublingual) delivery

Eliminates IV infection risk

May enhance ambulation

Pre-programmed delivery

Factory set 20-minute lockout period

Addresses end-user programming

error risk

Design safety features

Set-up tablet, RFID cartridge provides full inventory loop tracking of sufentanil tablets

RFID thumb tag co-located to device helps reduce proxy dosing

HCP controlled access, device tether reduces risk of product loss

Battery power ensures 72-hour function even in the event of power outage

Investigational drug and delivery system not FDA

approved for commercial use

Zalviso Phase 3 Program

Surgery Type

Study

Type

Sites

Data

Primary

Endpoint

Results

Abdominal &

Orthopedic

Surgery (IAP309)

Open-label,

Active-comparator

EP: Patient Global

Assessment of Method of

Pain Control over 48 hrs

359

1:1

Nov

2012

Zalviso

non-inferior to IV PCA

(p<0.001)

Zalviso

also demonstrates

superiority

to IV

PCA

(p=0.007)

Abdominal

Surgery (IAP310)

Double-blind,

Placebo-controlled

EP:Sum of Pain Intensity

Difference over 48 hrs

178

2:1

Mar

2013

Sufentanil treatment

superior to placebo

p=0.001

Orthopedic

Surgery (IAP311)

Double-blind,

Placebo-controlled

EP:Sum of Pain Intensity

Difference over 48 hrs

426

3:1

May

2013

Sufentanil treatment

superior to placebo

p<0.001

IAP310 & IAP311 Primary Endpoint:

SPID-48 –

ITT Population

p=0.001

p<0.001

Time (hrs)

Zalviso

100

120

IAP 310 –

Abdominal

Placebo

-20

100

IAP 311 -

Orthopedic

Placebo

Time from first dose of study drug (hours)

Zalviso: Studies Indicate Rapid Ability to Control

Moderate to Severe Acute Pain

0.25

0.5

0.75

Zalviso 309

Zalviso 310

Zalviso 311

IV PCA MS 309

Adverse Reactions >2% in Placebo Studies

* Significantly Different between Zalviso and Placebo (p<0.05)

Possibly or Probably

Related Adverse Reactions

Zalviso

N=429

Placebo

N=162

Nausea

29.4%

22.4%

Vomiting

8.9%

4.9%

Oxygen Saturation Decreased

6.1%

2.5%

Itching*

4.7%

Dizziness

4.4%

1.2%

Constipation

3.7%

0.6%

Headache

3.3%

3.7%

Insomnia

3.3%

1.9%

Hypotension

3.0%

1.2%

Confusional State

2.1%

0.6%

Proposed Indication: Management of

Moderate to Severe In-Hospital Acute Pain

Investigational drug and delivery system not FDA approved for commercial use

Commercial Opportunity

Target Market Potential

Rosetta, 2009 Inpatient sample

Decision Resources, Pain Management Study, Acute Pain, October 2014

•

The potential market for Zalviso is defined as:

•

Acute moderate-to-severe pain population

in the hospital setting

•

Includes post-operative as well as

non-surgical pain

•

The market size for Zalviso is characterized by

hospital in-patient sampling that demonstrates

15M

patients

annually

•

7.6M patients post-op

•

7.4M patients non post-op

2013

U.S.

Acute

Pain

Market

$6.7B

•

43% of which represents post-op pain

•

20% of which represents other acute pain (non post-op)

Anticipated Formulary Adoption after FDA Approval

Earliest –

2 Months; Typical –

8-10 Months

42% Very Likely to

Approve

42% Quite Likely to

Approve

16% Early Approval

Unlikely

might be swayed by

additional,

independent clinical

literature

assume product

expensive, might

accept favorable

cost-benefit analysis

looking for relevant

experts to champion

the product

unsure of cost,

looking for favorable

cost-benefit analysis

convinced by the

clinical benefit

demonstrated

assume ability to

demonstrate

economic benefit or

set cost aside

ZS Associates Qualitative Survey Among 45 P&T Committee Members, Fall 2013, sponsored by AcelRx

Pharmaceuticals, Inc.

Strong Positive Reaction to Zalviso Clinical Profile

Market

Research

Among

Hospital

Specialists

(n=244)

Predicted Zalviso Share of Procedural Volume

* Size of bubble is

representative of size of Zalviso

opportunity in Specialty

10%

20%

30%

40%

50%

60%

Orthopedic Surgeons

Cardiothoracic

Surgeons

General Surgeons

Hospitalist

Anesthesiologist

OB / GYN

1. ZS Associates Quantitative Survey Among Hospital Specialists, Winter 2013, sponsored by AcelRx Pharmaceuticals, Inc.

Current Cost of IV PCA

Data from Premier Database, 2010-12

Data for post surgical pain management

involving IV PCA in total knee/hip

replacement and abdominal surgery

Costs for pumps, tubing, carrier saline and

drug range from $200-240 for 2 days

Zalviso may add value:

Addresses programming errors

Elimination of PCA IV site infection risk

Supports early ambulation

Enhanced patient satisfaction

COST OF INTRAVENEOUS PATIENT-CONTROLLED ANALGESIA (IV PCA) EQUIPMENT AND OPIOID MEDICATION FOR ORTHOPEDIC AND ABDOMINAL SURGERIES IN US HOSPITALS

100

150

200

250

300

Opioids via PCA/ Other

Tubing / Carrier Saline

IVPCA / Carrier Infusion Pump

Total Knee

Total Hip

Abdominal

Xiang (Jay) Ji, MS, Jennifer Stephens, PharmD, Pamela Palmer, MD, PhD. Poster presented at ISPOR meeting, June 2014

US Customer-focused Organization Planned Build

80%

of relevant procedure

volume

identified

top

1,400

accounts

65 sales territories planned

Estimated cost/rep $250K

Estimated salesforce cost

around $16.5M per annum

Medical

Affairs

8 MSL’s in place

Commercial

7 RBD’s (6 hired)

65 Account

Managers to be

hired

Zalviso Publication Strategy

Peer Reviewed Manuscripts in Process

A Phase 3 Study of a Sufentanil Sublingual Microtablet System for the Management of Postoperative Pain

Following

Major

Orthopedic

Surgery

(IAP-311

Primary);

Anesthesiology

Submitted

Peer-Reviewed Manuscripts Available

Cost of Opioid Intravenous Patient-controlled Analgesia: Results From a Hospital Database Analysis and

Literature Assessment.

(Palmer et al.) Clinicoeconomics and Outcomes Research

www.dovepress.com/getfile.php?fileID=20509

Pharmacokinetics of Sublingual Sufentanil Tablets and Efficacy and Safety in the Management of

Postoperative

Pain

(Minkowitz

al.)

Reg

Anesth

Pain

Med

2013;38:

131-139.

Sufentanil Sublingual Microtablet System versus Intravenous Patient-Controlled Analgesia with Morphine for

Postoperative

Pain

Control:

Randomized,

Controlled

Trial

(IAP309

Primary);

Pain

Practice;

http://onlinelibrary.wiley.com/doi/10.1111/papr.12238/full

•

A Phase 3 Study of Sufentanil Sublingual Microtablet System for the Management of Postoperative Pain

Following

Open

Abdominal

Surgery

(IAP-310

Primary);

Reg

Anesth

Pain

Med

–

http://journals.lww.com/rapm/Abstract/onlinefirst/Sufentanil_Sublingual_Tablet_System_for_the.99572.aspx

Investigating Moderate to Severe acute pain

treatment in medically supervised settings

Investigational drug and delivery system not FDA approved for commercial use

ARX-04

HCP Administered

Single 30mcg dose

Sufentanil Tablet

ARX-04 –

Short Term Acute Pain Management

End of Phase 2 Meeting held Dec. ‘13

505(b)(2) submission

500 patient safety database ,

100 multiple dose, 400 single dose

Single & repeat dose PK study -

completed

Phase 3 placebo-controlled study

Abdominal surgery, SPID-12

primary, follow for 48 hours

Results expected H2 2015

Small safety study in ER patients

planned -

results expected H2 2015

Will count as pivotal trial

-0.5

0.5

1.5

2.5

Minutes after Dose

30 mcg

20 mcg

placebo

*p<0.01

**p<0.001

Successful Phase 2 Bunionectomy Study

ARX-04 –

PK Study Results

Demonstration of Bioequivalence of

2 x 15 mcg and 1 x 30 mcg sublingual

sufentanil tablets

Bioavailability:

30 mcg 57.6%

2 x 15 mcg 60.9%

Proposed to FDA that demonstration

of bioequivalence for 2 x 15mcg

dosed 20 mins apart and single

30mcg dose would enable use of

Zalviso database to support ARX-04

In Phase 3 Zalviso studies, 323

patients dosed at t=0 and between

t=20-25mins later

0.0

10.0

20.0

30.0

40.0

50.0

60.0

100

200

300

400

Time (minutes)

One 30 mcg

tablet

2 x 15 mcg

tablet

BA for 30 mcg 57.6%

BA for 2 x 15 mcg 60.9%

ARX-04 –

Commercial Opportunity

Market Research Suggests Broad Opportunity in

Moderate to Severe Acute Pain*

ER Department

51MM patients annually

2 doses per patient on average

Inpatient Surgery

8MM patients annually

2-9 doses per patient

Outpatient Surgery

13MM patients annually

3 doses per patient on average

Non-surgical Acute Pain

4MM patients annually

8 doses per patient on average

ZS Associates US Opportunity Sizing, September 2014; Includes only patients 18+ years of age.

Sponsored by AcelRx Pharmaceuticals, Inc.

20%

40%

60%

80%

Physician Stated Share

Scientific Conference Schedule -

2015

Minimally Invasive Surgery Symposium (MISS)

February 25-28; Las Vegas, NV –

poster presentation (ARX-

04)

American Academy of Orthopedic Surgeons (AAOS)

March 24-28; Las Vegas, NV –

Booth & Symposium

American Society of Peri-Anesthesia Nurses (ASPAN)

April

26-30;

San

Antonio,

–

Booth

Symposium

American Congress of Obstetricians (ACOG)

May

2-6;

San

Francisco

–

Booth

Symposium

International Conference on Emergency Medicine (ICEM)

American Society of Pain Management Nursing

(ASPMN)

September

16-19;

Atlanta,

–

Booth

Symposium

American College of Surgeons (ACS)

October

4-8;

Chicago,

–

Booth

Symposium

American Society of Anesthesiologists (ASA)

October

24-28;

San

Diego,

–

Booth

Symposium

American Society of Regional Anesthesia and Pain

Management (ASRA)

November 19-21; Miami, FL –

1 Booth & Symposium

American Society of Health System Pharmacists (ASHP)

December 6-10; New Orleans, LA –

Booth &

Symposium

May

11-12;

Montreal,

Quebec

–

Podium

Presentation

(ARX-04)

February 25-28; Las Vegas, NV –

poster presentation

(ARX-04)

Financial Summary

Cash position at September 30, 2014: $85 million

$10 million drawn June 2014 under debt facility

$5 million received August 2014 from Grünenthal for MAA submission

Currently available cash resources fund operations through launch

Assumes timely regulatory approval of Zalviso in the US in 2015

Supports execution of all planned US pre-commercial launch efforts

Q3 2014 cash usage of ~$12 million

Headcount at December 31, 2014: 50

Cash balance December 31, 2014 $75 million (unaudited)

44 million shares outstanding at December 31, 2014

Future Catalysts

Event

Timing

120 day question response to Zalviso

MAA review

Q1 2015

Zalviso NDA resubmission (pending protocol approval)

Q1 2015

ARX-04 DOD

contract finalized

H1 2015

Zalviso NDA decision

Q3 2015

Zalviso

MAA decision

Q3 2015

ARX-04 Phase

3 data

H2 2015

AcelRx–Working

Improve

Acute

Pain

Management

Zalviso

profile from Phase 3 studies

Efficacy: Demonstrated in two placebo controlled studies, 1 active comparator study

Adverse

events:

Most

common

AE’s

were

nausea,

vomiting,

desaturation,

itching

High patient satisfaction and nurse ease of care reported

Grünenthal partnership to commercialize Zalviso in EU & Australia established

Upcoming regulatory catalysts in US and EU

US:

NDA

resubmission

targeted

2015

EU:

Day

120

submission

planned

for

2015

Strong balance sheet with $75 million cash on hand December 31, 2014

(unaudited)

MAA

filed

Switzerland

Mark:

Received

December

2014

Other

Territories:

Continue

seek

additional

partnerships

Asia,

South

America

Terms:

$250M

upfront

and

potential

milestones,

mid-teens

mid-twenties

royalty