Niyad™ Investigational Device Exemption (IDE)
approval by the FDA achieved in third quarter
Company plans to begin its Niyad
registrational study this quarter with topline data expected
mid-2024
Cash and investments of $13.4 million as of September 30,
2023
Financing closed in July led by new healthcare
investors providing up to $26.3
million, of which $10 million
was made immediately available
Key Opinion Leader panel discussion on Niyad
planned for December
6th
Webcast and conference call to be held today
at 4:30 p.m. ET
SAN
MATEO, Calif., Nov. 8, 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 third quarter
2023 financial results and provided a corporate update.
"We continue to advance our lead product candidate Niyad™, that
has FDA Breakthrough Device designation, by prioritizing our
resources to achieve regulatory and development milestones on this
asset," said Vince Angotti, Chief
Executive Officer of AcelRx. "Importantly, at the close of
the third quarter, we received IDE approval from the FDA to proceed
with the Niyad NEPHRO CRRT Study. NEPHRO stands for
Nafamostat Efficacy in Phase
3 Registrational Continuous Renal
Replacement Therapy Study. The NEPHRO study is set to
start this quarter with top-line data expected by mid-2024 and
submission of an application for Premarket Approval, or PMA,
planned in the second half of next year. Niyad would be the
first-ever U.S. approved regional anticoagulant for use in a
dialysis circuit."
"In addition, we have a Key Opinion Leader panel discussion that
we will host on December
6th featuring nephrology and critical care
experts where we plan to discuss the results from our market
research, as well as the NEPHRO Study," continued Angotti.
The NEPHRO Study, which recently received central Institutional
Review Board (IRB) approval, is designed as a prospective,
double-blinded trial to be conducted at up to 10 U.S. hospital
intensive care units. The study will enroll and evaluate 166 adult
patients undergoing renal replacement therapy, who cannot tolerate
heparin or are at risk for bleeding. The primary endpoint of the
study is mean post-filter activated clotting time using Niyad
versus placebo over the first 24 hours. Key secondary endpoints
include filter lifespan, number of filter changes over 72 hours,
number of transfusions over 72 hours and dialysis efficacy (based
on urea concentration) over the first 24 hours.
2023 Third Quarter and Recent Corporate Highlights
- In October, AcelRx announced the approval of an Investigational
Device Exemption (IDE) submission to the United States Food and
Drug Administration (FDA) allowing the Company to advance Niyad
into a registrational study. This study will evaluate the safety
and efficacy of Niyad to support a PMA application expected to be
submitted to the FDA in the second half of 2024.
- In July, AcelRx announced a private placement of common stock,
pre-funded warrants and common warrants for aggregate gross
proceeds to the Company of $10
million, before deducting the placement agent's fees and
other offering expenses payable by the Company, with an additional
potential $16.3 million upon the
exercise of common warrants, which include an acceleration feature
should the Company achieve certain performance milestones.
This financing provides up to $26.3
million in gross proceeds upon the exercise of
milestone-affected warrants. The private placement was priced
"at-the-market" under the rules and regulations of The Nasdaq
Stock Market LLC. The private placement was led by new
investors including Nantahala Capital Management and closed on
July 21, 2023.
Third Quarter 2023 Financial Information
- The cash and cash equivalents balance was $13.4
million as of September 30, 2023. The senior debt with
Oxford was fully repaid in the second quarter of 2023.
- Revenues of $0.1 million for the
third quarter primarily represent the royalty revenue earned on the
sales of DSUVIA by Alora, principally driven by sales to the
Department of Defense. Revenues in the prior period are
included within the net loss from discontinued operations line item
of the Statement of Operations.
- Combined R&D and SG&A expenses for the third quarter of
2023 totaled $3.4 million compared to $4.5
million for the third quarter of 2022. Excluding non-cash
stock-based compensation expense, these amounts were $3.0
million for the third quarter of 2023, compared to $3.9
million for the third quarter of 2022. The decrease in
combined R&D and SG&A expenses in the third quarter of 2023
was primarily due to a reduction in headcount partially offset by
an increase in 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 September 30, 2023, the Company
recognized net loss from continuing operations of $1.4 million. For the three months ended
September 30, 2022, the Company
recognized a net loss from continuing operations of $4.6 million.
- Net loss attributable to common shareholders for the third
quarter of 2023 was $1.4 million, or $0.08 per basic
and diluted share, compared to a net loss of $6.9 million,
or $0.94 per basic and diluted share, for the third
quarter of 2022.
Conference Call and Webcast Information
AcelRx will host a live webcast and conference call today,
Wednesday, November 8, 2023 at
4:30 p.m. Eastern Standard
Time/1:30 p.m. Pacific Standard
Time to discuss the 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 Investors/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, or 1-412-902-4204 (toll
applies) for international callers. The conference ID is
10182244.
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. 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, and PFS-02, a pre-filled
phenylephrine syringe. 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 clinical studies required for our
developmental products; (v) risks related to AcelRx's ability to
retain its listing on the Nasdaq exchange; (vi) risks related to
the ability of AcelRx to successfully design and conduct safe,
effective and timely clinical studies for our developmental
products; and (vii) risks relating to AcelRx's ability to fund,
seek and 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
|
|
|
September
30
|
|
|
2023
|
|
2022
|
|
Statement of
Comprehensive Income (Loss) Data
|
|
|
|
|
|
|
|
|
|
Royalty
revenue
|
$
117
|
|
$
-
|
|
Operating costs and
expenses:
|
|
|
|
|
Research and
development (1)
|
1,178
|
|
799
|
|
Selling, general and
administrative (1)
|
2,248
|
|
3,724
|
|
Impairment of property
and equipment
|
-
|
|
-
|
|
Total operating costs
and expenses
|
3,426
|
|
4,523
|
|
Loss from
operations
|
(3,309)
|
|
(4,523)
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Interest
expense
|
-
|
|
(245)
|
|
Interest income and
other income (expense), net
|
1,893
|
|
140
|
|
Non-cash interest
income on liability related to sale of future royalties
|
-
|
|
-
|
|
Gain on extinguishment
of liability related to sale of future royalties
|
-
|
|
-
|
|
Total other income
(expense)
|
1,893
|
|
(105)
|
|
Net income (loss)
before income taxes
|
(1,416)
|
|
(4,628)
|
|
Provision for income
taxes
|
(2)
|
|
(11)
|
|
Net income (loss) from
continuing operations
|
(1,418)
|
|
(4,639)
|
|
Net income (loss) from
discontinued operations
|
61
|
|
(2,111)
|
|
Net income
(loss)
|
(1,357)
|
|
(6,750)
|
|
Deemed dividends
related to Series A Redeemable Convertible Preferred
Stock
|
-
|
|
(186)
|
|
Income allocated to
participating securities
|
-
|
|
-
|
|
Net income (loss)
attributable to Common Shareholders, basic
|
$
(1,357)
|
|
$
(6,936)
|
|
Net income (loss)
attributable to Common Shareholders, diluted
|
$
(1,357)
|
|
$
(6,936)
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share attributable to stockholders:
|
|
|
|
|
|
|
|
|
Basic earnings (loss)
per share
|
|
|
|
|
|
|
|
|
|
Income
(loss) from continuing operations
|
$
(0.08)
|
|
$
(0.65)
|
|
|
|
|
|
|
Income
(loss) from discontinued operations
|
$
0.00
|
|
$
(0.29)
|
|
|
|
|
|
|
Net income
(loss)
|
$
(0.08)
|
|
$
(0.94)
|
|
|
|
|
|
|
Diluted earnings (loss)
per share
|
|
|
|
|
|
|
|
|
|
Income
(loss) from continuing operations
|
$
(0.08)
|
|
$
(0.65)
|
|
|
|
|
|
|
Income
(loss) from discontinued operations
|
$
0.00
|
|
$
(0.29)
|
|
|
|
|
|
|
Net income
(loss)
|
$
(0.08)
|
|
$
(0.94)
|
|
|
|
|
|
|
Shares used in
computing net income (loss) per share of common stock,
basic
|
16,758
|
|
7,377
|
|
|
|
|
|
|
Shares used in
computing net income (loss) per share of common stock,
diluted
|
16,758
|
|
7,377
|
|
|
|
|
|
|
(1)
Includes the following non-cash stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
Research and development
|
$
210
|
|
$
139
|
|
Selling, general and administrative
|
168
|
|
519
|
|
Discontinued operations
|
-
|
|
43
|
|
Total
|
$
378
|
|
$
701
|
|
Selected Balance
Sheet Data
|
(in
thousands)
|
|
|
|
|
|
September 30,
2023
|
|
December 31,
2022(1)
|
|
(Unaudited)
|
|
|
Cash, cash equivalents,
restricted cash and investments
|
$
13,389
|
|
$
20,770
|
Total assets
|
23,261
|
|
47,487
|
Total
liabilities
|
4,954
|
|
25,673
|
Total stockholders'
equity
|
18,307
|
|
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
|
|
|
September
30
|
|
|
2023
|
|
2022
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
Research and
development
|
$
1,178
|
|
$
799
|
|
General and
administrative
|
2,248
|
|
3,724
|
|
Total operating
expenses
|
3,426
|
|
4,523
|
|
Less stock-based
compensation expense
|
378
|
|
658
|
|
Operating expenses
(non-GAAP)
|
$
3,048
|
|
$
3,865
|
|
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SOURCE AcelRx Pharmaceuticals, Inc.