ARS Reports Second Quarter 2023 Financial Results and Provides Business Updates
10 Août 2023 - 10:00PM
ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical
company dedicated to empowering at-risk patients and caregivers to
better protect themselves from severe allergic reactions that could
lead to anaphylaxis, today reported business updates and financial
results for the second quarter of 2023.
“Our primary focus is on making neffy, an
investigational new drug, available to people as quickly as
possible and we believe that our interactions with FDA are nearly
complete,” said Richard Lowenthal, president and chief executive
officer of ARS. “With a PDUFA date next month, we continue to
advance our preparations to ensure we are well-positioned for a
successful launch of neffy in the U.S., if
approved. We are in the final stages of labeling and post-marketing
commitment discussions with FDA and are putting the right
structures in place to enable patient access to
neffy quickly, within about eight weeks from the
final label. We are excited to not only transition the company to a
commercial organization, but to potentially bring to the allergy
community the first medical treatment advancement in more than 35
years: an easy-to-carry, simple-to-administer, needle-free nasal
spray to address the anxiety and hesitation associated with today’s
injectable devices.”
Preparing for U.S. launch of neffy®
- In May, the U.S. Food and Drug
Administration (FDA) convened an Advisory Committee meeting, which
concluded a favorable benefit-risk profile of
neffy, with a 16:6 vote in favor for adults and
17:5 vote in favor for children (≥30 kg) for the treatment of
patients with allergic reactions (Type 1), including anaphylaxis.
The Advisory Committee vote, while not binding, will be considered
by FDA when making its decision regarding the potential approval of
neffy.
- In June, FDA extended the Prescription
Drug User Fee Act (PDUFA) target action date to September 19, 2023,
for the New Drug Application (NDA) for neffy
(Intranasal (IN) Epinephrine) for the treatment of allergic
reactions (Type 1), including anaphylaxis, for adults and children
≥30 kg. If approved, neffy would be the first
needle-free, non-injectable epinephrine treatment available.
- ARS’s U.S. commercial preparedness
activities are well underway, and its commercial leadership team
and area sales managers are in place. The recruitment process for
the expected 115 field-based representatives is progressing on
track, pending FDA approval. The company is currently implementing
marketing and market access strategies to increase awareness and
readiness for the potential launch of neffy.
Additional Business Updates and Anticipated
Milestones
- ARS further broadened the scope of its intellectual property
position for neffy with a recently issued U.S.
patent on August 8, 2023, and an allowed second patent application
by the U.S. Patent and Trademark Office. The issued patent and the
allowed patent application are directed to the use of intranasal
epinephrine formulations, including the use of bile acid absorption
enhancers, for the treatment of allergic diseases, such as
urticaria. Topline data from the company’s ongoing Phase 2
randomized, placebo-controlled study of neffy in
urticaria patients are expected by the fourth quarter of 2023.
- Marketing authorization application
(MAA) for neffy is under review by the European
Medicines Agency with a decision expected by year end 2023.
Second Quarter 2023 Financial Results
- Cash Position: Cash,
cash equivalents and short-term investments were $252.2 million as
of June 30, 2023, which ARS believes are sufficient to fund its
current operating plan for at least three years.
- R&D Expenses:
Research and development (R&D) expenses were $7.3 million for
the quarter ended June 30, 2023.
- G&A Expenses:
General and administrative (G&A) expenses were $13.3 million
for the quarter ended June 30, 2023.
- Net Loss: Net loss was
$17.4 million for the quarter ended June 30, 2023.
About Type I Allergic Reactions including
Anaphylaxis Type I severe allergic reactions are serious
and potentially life-threatening events that can occur within
minutes of exposure to an allergen and require immediate treatment
with epinephrine, the only FDA-approved medication for these
reactions. While epinephrine autoinjectors have been shown to be
highly effective, there are well published limitations that result
in many patients and caregivers delaying or not administering
treatment in an emergency situation. These limitations include fear
of the needle, lack of portability, needle-related safety concerns,
lack of reliability, and complexity of the devices. There are
approximately 25 to 40 million people in the United States who
experience Type I severe allergic reactions. Of those, only 3.3
million currently have an active epinephrine autoinjector
prescription, and of those, only half consistently carry their
prescribed autoinjector. Even if patients or caregivers carry an
autoinjector, more than half either delay or do not administer the
device when needed in an emergency.
About ARS Pharmaceuticals, Inc.ARS is a
biopharmaceutical company dedicated to empowering at-risk patients
and caregivers to better protect themselves from severe allergic
reactions that could lead to anaphylaxis. The Company is developing
neffy® (also referred to as
ARS-1), an intranasal epinephrine product in clinical development
for patients and their caregivers with Type I allergic reactions
including food, medications and insect bites that could lead to
life-threatening anaphylaxis. For more information, visit
www.ars-pharma.com.
Forward-Looking Statements Statements in this
press release that are not purely historical in nature are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements include,
but are not limited to, ARS’s projected cash runway; the
anticipated timing for regulatory review decisions on
neffy and the potential approval of
neffy; ARS’s belief that its interactions with FDA
are nearly complete; the anticipated successful US launch of
neffy, if approved, and the timing thereof; ARS’s
expectation that it will be able to enable patient access to
neffy within about eight weeks after approval; the
expected number of field-based representatives and the expectation
that ARS will complete its hiring goal upon approval of
neffy; the expected reporting of topline data from
ARS’s Phase 2 study of neffy in urticaria patients
and the timing thereof; the estimated addressable patient
population for neffy; and other statements that
are not historical fact. Because such statements are subject to
risks and uncertainties, actual results may differ materially from
those expressed or implied by such forward-looking statements.
Words such as “anticipate,” “plans,” “expects,” “on track to,”
“will,” “potential” and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements are based upon ARS’s current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include, without limitation, the ability to obtain and maintain
regulatory approval for neffy; the Advisory
Committee decision should not be relied on as an indication that
neffy will ultimately be approved; the FDA is not
bound by the Advisory Committee decision or any of its
recommendations and there are a number of instances where the FDA
has voted against the recommendations of advisory committees; the
PDUFA target action date may be further delayed due to various
factors outside ARS’s control; even though ARS believes its
interactions with the FDA are nearly complete, there is no
guarantee that new issues will not be identified which could delay
or prevent the approval of neffy, and ARS’s belief
that its interactions with the FDA are nearly complete should not
be relied on as an indication that the FDA will ultimately approve
neffy; results from clinical trials may not be
indicative of results that may be observed in the future; potential
safety and other complications from neffy; the
labelling for neffy, if approved; the scope,
progress and expansion of developing and commercializing
neffy; the size and growth of the market therefor
and the rate and degree of market acceptance thereof vis-à-vis
intramuscular injectable products; ARS’s ability to protect its
intellectual property position; and the impact of government laws
and regulations. Additional risks and uncertainties that could
cause actual outcomes and results to differ materially from those
contemplated by the forward-looking statements are included under
the caption “Risk Factors” in ARS’s Quarterly Report on Form 10-Q
for the quarter ended March 31, 2023, filed with the Securities and
Exchange Commission (“SEC”) on May 15, 2023, and in ARS’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2023, being
filed with the SEC today. This document can also be accessed on
ARS’s web page at ir.ars-pharma.com by clicking on the link
“Financials & Filings.”
The forward-looking statements included in this press release
are made only as of the date hereof. ARS assumes no obligation and
does not intend to update these forward-looking statements, except
as required by law.
ARS Investor Contacts:Justin ChakmaARS
Pharmaceuticalsjustinc@ars-pharma.com
Monique AllaireTHRUST Strategic
Communicationsmonique@thrustsc.com
ARS Media Contact:Laura O'NeillFINN
Partnerslaura.oneill@finnpartners.com
ARS Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets(in
thousands, except share and par value data)
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
119,017 |
|
|
$ |
210,518 |
|
Short-term investments |
|
|
133,191 |
|
|
|
63,863 |
|
Prepaid expenses and other current assets |
|
|
2,826 |
|
|
|
3,319 |
|
Total current assets |
|
|
255,034 |
|
|
|
277,700 |
|
Right-of-use asset |
|
|
349 |
|
|
|
445 |
|
Fixed assets, net |
|
|
594 |
|
|
|
329 |
|
Other assets |
|
|
2,775 |
|
|
|
2,961 |
|
Total assets |
|
$ |
258,752 |
|
|
$ |
281,435 |
|
Liabilities,
convertible preferred stock and stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable and accrued liabilities (including related party
amounts of $170 and $16, respectively) |
|
$ |
9,821 |
|
|
$ |
4,931 |
|
Lease liability, current |
|
|
233 |
|
|
|
230 |
|
Contract liability, current |
|
|
— |
|
|
|
283 |
|
Total current liabilities |
|
|
10,054 |
|
|
|
5,444 |
|
Lease liability, net of
current portion |
|
|
146 |
|
|
|
251 |
|
Contract liability, net of
current portion |
|
|
— |
|
|
|
2,854 |
|
Total liabilities |
|
|
10,200 |
|
|
|
8,549 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Preferred stock, $0.0001 par
value per share; 10,000,000 shares authorized at June 30, 2023 and
December 31, 2022; no shares issued and outstanding at June 30,
2023 and December 31, 2022 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par
value per share; 200,000,000 shares authorized at June 30, 2023 and
December 31, 2022; 95,322,953 and 93,943,316 shares issued and
outstanding at June 30, 2023 and December 31, 2022,
respectively |
|
|
9 |
|
|
|
9 |
|
Additional paid-in
capital |
|
|
357,992 |
|
|
|
349,408 |
|
Accumulated other
comprehensive (loss) gain, net |
|
|
(180 |
) |
|
|
407 |
|
Accumulated deficit |
|
|
(109,269 |
) |
|
|
(76,938 |
) |
Total stockholders’
equity |
|
|
248,552 |
|
|
|
272,886 |
|
Total liabilities, convertible
preferred stock and stockholders’ equity |
|
$ |
258,752 |
|
|
$ |
281,435 |
|
ARS Pharmaceuticals,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive Loss(in thousands,
except share and per share
data)(unaudited)
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue under collaboration agreements |
$ |
10 |
|
|
$ |
464 |
|
|
$ |
30 |
|
|
$ |
1,127 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development (including related party amounts of $484,
$572, $1,075 and $1,112, respectively) |
|
7,308 |
|
|
|
4,350 |
|
|
|
13,860 |
|
|
|
9,773 |
|
General and administrative (including related party amounts of
$181, $106, $518 and $271, respectively) |
|
13,305 |
|
|
|
2,458 |
|
|
|
25,486 |
|
|
|
4,797 |
|
Total operating expenses |
|
20,613 |
|
|
|
6,808 |
|
|
|
39,346 |
|
|
|
14,570 |
|
Loss from operations |
|
(20,603 |
) |
|
|
(6,344 |
) |
|
|
(39,316 |
) |
|
|
(13,443 |
) |
Other income (expense),
net |
|
3,233 |
|
|
|
(76 |
) |
|
|
6,985 |
|
|
|
(227 |
) |
Net loss |
$ |
(17,370 |
) |
|
$ |
(6,420 |
) |
|
$ |
(32,331 |
) |
|
$ |
(13,670 |
) |
Change in unrealized gains and
losses on available-for-sale securities |
|
(248 |
) |
|
|
— |
|
|
|
(587 |
) |
|
|
— |
|
Comprehensive loss |
$ |
(17,618 |
) |
|
$ |
(6,420 |
) |
|
$ |
(32,918 |
) |
|
$ |
(13,670 |
) |
Net loss per share, basic and
diluted |
$ |
(0.18 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.45 |
) |
Weighted-average shares
outstanding used in computing net loss per share, basic and
diluted |
|
94,911,268 |
|
|
|
30,606,773 |
|
|
|
94,571,180 |
|
|
|
30,488,749 |
|
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