Capital raise closed in July, led by new
healthcare investors; provides access to up to $26.3 million in capital, with $10 million immediately available
AcelRx awaits response to Emergency Use
Authorization (EUA) of Niyad™ submitted to the FDA in April;
registrational study set to initiate in Q4 2023
Proforma $17.4 million in cash as of June
30, 2023, including gross proceeds from financing closed in
July 2023
Senior debt with Oxford fully repaid in Q2
2023
Webcast and conference call to be held today
at 4:30 p.m. EDT
SAN
MATEO, Calif., Aug. 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 second quarter 2023 financial results and
provided a corporate update.
"We are pleased that the transformation of AcelRx through the
divestment of DSUVIA in April and the pivot to our late-stage
product portfolio has attracted a new group of healthcare investors
to support achieving our key milestones," said Vince Angotti, Chief Executive Officer of
AcelRx. "We are on track to begin our registrational study for
Niyad later this year with an expected data readout mid-2024.
Niyad's Breakthrough Designation has facilitated our interactions
with the FDA, and we expect this continued support for our planned
PMA submission in the second half of 2024. In addition, a potential
earlier milestone for Niyad is the receipt of an Emergency Use
Authorization, which was submitted to the FDA in April. We remain
highly focused on achieving these milestones to advance the
transformation of AcelRx and give us the opportunity to provide
essential products for medically supervised settings," continued
Angotti.
2023 Second Quarter and Recent Corporate Highlights
- 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 access to up to $26.3 million of 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.
- In April, 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.
- In April, 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.
- In the second quarter, AcelRx received six-month stability data
from our initial development batch of Niyad, with all criteria
being met, which should allow for two-years dating at room
temperature.
Second Quarter 2023 Financial Information
- The cash and cash equivalents balance was $7.4 million as of June
30, 2023. The senior debt with Oxford was fully repaid in
the second quarter.
- Revenues of $0.3 million for the
second quarter primarily represents 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 second quarter
of 2023 totaled $4.2 million compared to $5.1
million for the second quarter of 2022. Excluding non-cash
stock-based compensation expense, these amounts were $3.8
million for the second quarter of 2023, compared to $4.3
million for the second quarter of 2022. The decrease in
combined R&D and SG&A expenses in the second 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 June 30, 2023, the Company recognized net income from
discontinued operations of $0.1 million. For the three months
ended June 30, 2022, the Company recognized a net loss from
discontinued operations of $3.7 million.
- Net loss attributable to common shareholders for the second
quarter of 2023 was $4.4 million, or $0.40 per basic
and diluted share, compared to a net income of $63.2 million,
or $8.58 per basic and diluted share, for the second
quarter of 2022.
Webcast Information
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 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.
Conference Call Information
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
10181172.
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 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.
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.
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
|
|
Six Months
Ended
|
|
June 30
|
|
June
30
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Statement of Comprehensive Income (Loss)
Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty
revenue
|
$
253
|
|
$
-
|
|
$
253
|
|
$
-
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Research and
development (1)
|
1,552
|
|
1,094
|
|
2,599
|
|
1,930
|
Selling, general and
administrative (1)
|
2,670
|
|
3,960
|
|
6,951
|
|
8,060
|
Impairment of property
and equipment
|
-
|
|
4,901
|
|
-
|
|
4,901
|
Total operating costs
and expenses
|
4,222
|
|
9,955
|
|
9,550
|
|
14,891
|
Loss from
operations
|
(3,969)
|
|
(9,955)
|
|
(9,297)
|
|
(14,891)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
expense
|
(15)
|
|
(293)
|
|
(134)
|
|
(683)
|
Interest income and
other income (expense), net
|
(441)
|
|
51
|
|
5,070
|
|
89
|
Non-cash interest
income on liability related to sale of future royalties
|
-
|
|
463
|
|
-
|
|
1,136
|
Gain on extinguishment
of liability related to sale of future royalties
|
-
|
|
84,052
|
|
-
|
|
84,052
|
Total other income
(expense)
|
(456)
|
|
84,273
|
|
4,936
|
|
84,594
|
Net income (loss)
before income taxes
|
(4,425)
|
|
74,318
|
|
(4,361)
|
|
69,703
|
Provision for income
taxes
|
(3)
|
|
(3)
|
|
(3)
|
|
(3)
|
Net income (loss) from
continuing operations
|
(4,428)
|
|
74,315
|
|
(4,364)
|
|
69,700
|
Net income (loss) from
discontinued operations
|
57
|
|
(3,652)
|
|
(8,159)
|
|
(7,711)
|
Net income
(loss)
|
(4,371)
|
|
70,663
|
|
(12,523)
|
|
61,989
|
Income allocated to
participating securities
|
-
|
|
(7,511)
|
|
-
|
|
(6,619)
|
Net income (loss)
attributable to Common Shareholders, basic
|
$
(4,371)
|
|
$
63,152
|
|
$
(12,523)
|
|
$
55,370
|
Net income (loss)
attributable to Common Shareholders, diluted
|
$
(4,371)
|
|
$
63,155
|
|
$
(12,523)
|
|
$
55,371
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share attributable to stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss)
per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
(loss) from continuing operations
|
$
(0.41)
|
|
$
9.08
|
|
$
(0.40)
|
|
$
8.62
|
|
|
|
|
|
|
|
|
Income
(loss) from discontinued operations
|
$
0.01
|
|
$
(0.50)
|
|
$
(0.75)
|
|
$
(1.06)
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
$
(0.40)
|
|
$
8.58
|
|
$
(1.15)
|
|
$
7.56
|
|
|
|
|
|
|
|
|
Diluted earnings (loss)
per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
(loss) from continuing operations
|
$
(0.41)
|
|
$
9.08
|
|
$
(0.40)
|
|
$
8.62
|
|
|
|
|
|
|
|
|
Income
(loss) from discontinued operations
|
$
0.01
|
|
$
(0.50)
|
|
$
(0.75)
|
|
$
(1.06)
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
$
(0.40)
|
|
$
8.58
|
|
$
(1.15)
|
|
$
7.56
|
|
|
|
|
|
|
|
|
Shares used in
computing net income (loss) per share of common stock,
basic
|
10,924
|
|
7,357
|
|
10,909
|
|
7,319
|
|
|
|
|
|
|
|
|
Shares used in
computing net income (loss) per share of common stock,
diluted
|
10,924
|
|
7,360
|
|
10,909
|
|
7,321
|
|
|
|
|
|
|
|
|
(1)
Includes the following non-cash stock-based compensation
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
$
80
|
|
$
153
|
|
$
173
|
|
$
327
|
Selling, general and administrative
|
391
|
|
562
|
|
848
|
|
1,026
|
Discontinued operations
|
-
|
|
38
|
|
19
|
|
183
|
Total
|
$
471
|
|
$
753
|
|
$
1,040
|
|
$
1,536
|
Selected Balance Sheet Data
|
(in
thousands)
|
|
|
|
|
|
June 30, 2023
|
|
December 31,
2022(1)
|
|
(Unaudited)
|
|
|
Cash, cash equivalents,
restricted cash and investments
|
$
7,410
|
|
$
20,770
|
Total assets
|
17,725
|
|
47,487
|
Total
liabilities
|
7,306
|
|
25,673
|
Total stockholders'
equity
|
10,419
|
|
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
|
|
Six Months
Ended
|
|
June 30
|
|
June 30
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
Operating expenses
(GAAP):
|
|
|
|
|
|
|
|
Research and
development
|
$
1,552
|
|
$
1,094
|
|
$
2,599
|
|
$
1,930
|
General and
administrative
|
2,670
|
|
3,960
|
|
6,951
|
|
8,060
|
Total operating
expenses
|
4,222
|
|
5,054
|
|
9,550
|
|
9,990
|
Less stock-based
compensation expense
|
471
|
|
715
|
|
1,021
|
|
1,353
|
Operating expenses
(non-GAAP)
|
$
3,751
|
|
$
4,339
|
|
$
8,529
|
|
$
8,637
|
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SOURCE AcelRx Pharmaceuticals, Inc.