Request for Emergency Use Authorization of Niyad™ submitted
to the FDA in April
Divestment of DSUVIA® to Alora Pharmaceuticals closed
April 3, 2023
$13.4 million in cash as
of March 31, 2023
Webcast and conference call to be held today at 4:30
p.m. EDT
HAYWARD,
Calif., May 10, 2023 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for use in medically
supervised settings, today reported its first quarter 2023
financial results and provided a corporate update.
"We have embarked on a new AcelRx chapter by closing the DSUVIA
transaction and submitting the request for an Emergency Use
Authorization for Niyad," stated Vince
Angotti, Chief Executive Officer of AcelRx. "We're
very excited about the prospects for Niyad following interactions
with key opinion leaders during our latest advisory board meeting.
Feedback from this meeting, combined with data from our recently
completed 150-physician market research study highlight the
urgent need for an alternative anticoagulant for in-hospital
dialysis and support our submission of a request for an EUA. Our
focus is now on initiating the FDA-informed single registrational
study for Niyad, expected in the second half of this year. We
have agreed upon terms for the supply of the active pharmaceutical
ingredient and, through our contract manufacturer, have already
made finished product that has met all stability specifications to
date," continued Angotti.
2023 First Quarter and Recent Corporate Highlights
- On April 27, 2023, AcelRx
submitted a request for an EUA for Niyad and responded to previous
questions outlined by the FDA in a prior EUA submission made by
Lowell Therapeutics. AcelRx's submission included information on
nafamostat mesylate, the API in Niyad, and the finished drug
product, including stability testing data and a process validation
protocol, amongst other items requested by the FDA.
- On April 3, 2023, AcelRx
announced the closing of the divestment of its FDA-approved drug,
DSUVIA to Alora Pharmaceuticals (Alora). The agreement allows
AcelRx to participate in the long-term value expected to be created
by Alora as they expand the commercialization of DSUVIA. The
agreement provides AcelRx with a 15% royalty on commercial sales of
DSUVIA, a 75% royalty on sales of DSUVIA to the Department of
Defense (DoD), DSUVIA's single largest customer, and up to
$116.5 million in sales-based
milestones. AcelRx will provide, and be reimbursed for, transition
services during a period of up to 6 months post-closing. In
exchange for the 75% royalty on net sales to the DoD, AcelRx will
lead the relationship to ensure continued engagement and expected
expansion of sales to the DoD.
First Quarter 2023 Financial Information
- The cash and cash equivalents balance was $13.4 million as of March
31, 2023.
- Combined R&D and SG&A expenses for the first quarter of
2023 totaled $5.3 million compared to
$4.9 million for the first quarter of
2022. Excluding non-cash stock-based compensation expense, these
amounts were $4.8 million for the
first quarter of 2023, compared to $4.3
million for the first quarter of 2022. The increase in
combined R&D and SG&A expenses in the first quarter of 2023
was primarily due to legal costs related to the divestment of
DSUVIA and Niyad-related research and development costs.
- The divestment of DSUVIA represents a discontinued operation;
accordingly, all historical operating results for the business are
reflected within discontinued operations. For the three months
ended March 31, 2023, we recognized
an impairment on net assets held for sale of $7.0 million and a loss from discontinued
operations of $1.2 million. For the
three months ended March 31, 2022, we
recognized a loss from discontinued operations of $4.1 million.
- Net loss attributable to common shareholders for the first
quarter of 2023 was $8.2 million, or
$0.75 per basic and diluted share,
compared to a net loss of $8.7
million, or $1.19 per basic
and diluted share, for the first quarter of 2022.
Webcast Information and Conference Call Information
As
previously announced, AcelRx management will host a live webcast
and conference call at 4:30 p.m. Eastern Daylight
Time/1:30 p.m. Pacific Daylight Time
on May 10, 2023 to discuss the financial results and
provide an update on the Company's business.
The webcast can be accessed here or by visiting the
"Investors" section of the Company's website
at www.acelrx.com and clicking on the webcast link within
the News & Events/Upcoming Events section. The webcast will
include a slide presentation and a replay will be available on the
AcelRx website for 90 days following the event.
Investors who wish to participate in the conference call may do
so by dialing 1-866-361-2335 for domestic callers, 1-855-669-9657
for Canadian callers, 1-412-902-4204 (toll applies) for
international callers. The conference ID is 10177890.
About Nafamostat
Nafamostat is a broad spectrum,
synthetic serine protease inhibitor with anticoagulant,
anti-inflammatory and potential anti-viral activities. Niyad™ is a
lyophilized formulation of nafamostat and is currently being
studied under an investigational device exemption, or IDE, as an
anticoagulant for the extracorporeal circuit, and has received
Breakthrough Device Designation Status from the FDA. A request for
an Emergency Use Authorization has been submitted to the FDA for
Niyad. LTX-608 is a proprietary nafamostat formulation for direct
IV infusion that will be investigated and developed as a potential
anti-viral for the treatment of COVID, acute respiratory distress
syndrome (ARDS), disseminated intravascular coagulation (DIC) and
acute pancreatitis.
About AcelRx Pharmaceuticals, Inc.
AcelRx
Pharmaceuticals, Inc. is a specialty pharmaceutical company focused
on the development and commercialization of innovative therapies
for use in medically supervised settings. AcelRx's lead product
candidate, Niyad is a lyophilized formulation of nafamostat and is
currently being studied under an investigational device exemption,
or IDE, as an anticoagulant for the extracorporeal circuit, and has
received Breakthrough Device Designation Status from the FDA.
AcelRx is also developing two pre-filled syringes in-licensed from
its partner Aguettant: Fedsyra™, a pre-filled ephedrine syringe,
with an expected NDA filing in the first half of 2023, and PFS-02,
a pre-filled phenylephrine syringe with an expected NDA filing in
2024. This release is intended for investors only. For
additional information about AcelRx, please
visit www.acelrx.com.
Forward-looking statements
This press release contains
forward-looking statements based upon AcelRx's current
expectations. These and any other forward-looking statements are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by the use of forward-looking terminology such as
"potential," "believe," "expect," "expects," "expected,"
"anticipate," "may," "will," "enable," "should," "seek,"
"approximately," "intends," "intended," "plans," "planned,"
"planning," "estimates," "benefits," or the negative of these words
or other comparable terminology. The discussion of financial
trends, strategy, plans or intentions may also include
forward-looking statements, which are predictions, projections and
other statements about future events that are based on current
expectations and assumptions. These forward-looking statements
involve risks and uncertainties that could cause actual results to
differ materially from those projected, anticipated or implied by
such statements, including: (i) risks relating to AcelRx's product
development activities and ongoing commercial business operations;
(ii) risks related to the ability of AcelRx and its business
partners to implement development plans, launch plans, forecasts
and other business expectations; (iii) risks related to unexpected
variations in market growth and demand for AcelRx's commercial and
developmental products and technologies; (iv) risks related to
AcelRx's liquidity and our ability to maintain capital resources
sufficient to conduct the required clinical studies; (v) AcelRx's
ability to retaining its listing on the Nasdaq exchange; and (vi)
risks relating to AcelRx's ability to obtain
regulatory approvals for our developmental product candidates.
Although it is not possible to predict or identify all such risks
and uncertainties, they may include, but are not limited to, those
described under the caption "Risk Factors" and elsewhere in
AcelRx's annual, quarterly and current reports (i.e., Form 10-K,
Form 10-Q and Form 8-K) as filed or furnished with
the Securities and Exchange Commission (SEC) and any
subsequent public filings. You are cautioned not to place undue
reliance on any such forward-looking statements, which speak only
as of the date such statements were first made. To the degree
financial information is included in this press release, it is in
summary form only and must be considered in the context of the full
details provided in AcelRx's most recent annual, quarterly or
current report as filed or furnished with the SEC.
AcelRx's SEC reports are available
at www.acelrx.com under the "Investors" tab. Except to
the extent required by law, AcelRx undertakes no obligation to
publicly release the result of any revisions to these
forward-looking statements to reflect new information, events or
circumstances after the date hereof, or to reflect the occurrence
of unanticipated events.
Selected Financial
Data
|
(in thousands, except
per share data)
|
(unaudited)
|
|
|
|
|
|
Three Months
Ended
|
|
March
31
|
|
2023
|
|
2022
|
Statement of
Comprehensive Income (Loss) Data
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
Research and
development (1)
|
$
1,047
|
|
$
836
|
Selling, general and
administrative (1)
|
4,281
|
|
4,100
|
Total operating costs
and expenses
|
5,328
|
|
4,936
|
Loss from
operations
|
(5,328)
|
|
(4,936)
|
|
|
|
|
Other income
(expense):
|
|
|
|
Interest
expense
|
(119)
|
|
(390)
|
Interest income and
other income (expense), net
|
5,511
|
|
38
|
Non-cash interest
income on liability related to sale of future royalties
|
-
|
|
673
|
Total other income
(expense)
|
5,392
|
|
321
|
Net income (loss) from
continuing operations
|
$
64
|
|
$
(4,615)
|
Net loss from
discontinued operations
|
(8,216)
|
|
(4,059)
|
Net
loss
|
$
(8,152)
|
|
$
(8,674)
|
|
|
|
|
|
|
|
|
Net income (loss) per
share attributable to stockholders:
|
|
|
|
|
|
|
|
Basic and diluted,
continuing operations
|
$
-
|
|
$
(0.63)
|
|
|
|
|
Basic and diluted,
discontinued operations
|
$
(0.75)
|
|
$
(0.56)
|
|
|
|
|
Basic and diluted loss
per share
|
$
(0.75)
|
|
$
(1.19)
|
|
|
|
|
Shares used in
computing net loss per common share, basic and
diluted
|
10,894
|
|
7,281
|
|
|
|
|
(1)
Includes the following non-cash stock-based compensation
expense:
|
|
|
|
|
|
|
|
Research and development
|
$
93
|
|
$
174
|
Selling, general and administrative
|
457
|
|
464
|
Discontinued operations
|
19
|
|
145
|
Total
|
$
569
|
|
$
783
|
|
|
|
|
|
|
|
|
|
Selected Balance
Sheet Data
|
(in
thousands)
|
|
|
|
|
|
March 31,
2023
|
|
December 31,
2022(1)
|
|
(Unaudited)
|
|
|
Cash, cash equivalents,
restricted cash and investments
|
$
13,353
|
|
$
20,770
|
Total assets
|
26,292
|
|
47,487
|
Total
liabilities
|
12,050
|
|
25,673
|
Total stockholders'
equity
|
14,242
|
|
21,814
|
|
|
|
|
(1)
Derived from the audited financial
statements as of that date included in the Company's Annual Report
on Form 10-K for the year ended December 31, 2022.
|
Reconciliation of
Non-GAAP Financial Measures
|
(Operating expenses
less stock-based compensation expense)
|
|
|
Three Months
Ended
|
|
March
31
|
|
2023
|
|
2022
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
Research and
development
|
$ 1,047
|
|
$
836
|
General and
administrative
|
4,281
|
|
4,100
|
Total operating
expenses
|
5,328
|
|
4,936
|
Less stock-based
compensation expense
|
550
|
|
638
|
Operating expenses
(non-GAAP)
|
$ 4,778
|
|
$ 4,298
|
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SOURCE AcelRx Pharmaceuticals, Inc.