ARS Pharmaceuticals Highlights Progress and Reports First Quarter 2023 Financial Results
15 May 2023 - 11:00PM
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 highlighted recent progress and reported
first quarter 2023 financial results.
“For the millions of people living with Type I allergic
reactions including anaphylaxis, we believe that
neffy (nasal epinephrine spray), a small,
needle-free and easy-to-use nasal spray, could provide a
much-needed alternative to the currently approved epinephrine
injection devices. Despite their effectiveness, these devices are
limited in usage because many patients and caregivers do not carry,
avoid using or hesitate to use them,” said Richard Lowenthal,
president and chief executive officer of ARS Pharmaceuticals.
“Throughout the first quarter, we’ve made important strides toward
bringing neffy to patients. We are glad to have
had the opportunity to discuss neffy with the
FDA’s Advisory Committee during our recent meeting and are
incredibly pleased with the outcome and the committee’s support of
neffy for adults and children.”
Eric Karas, chief commercial officer added, “As we look ahead,
with both our NDA and MAA for neffy currently
under review by the regulators in the U.S. and EU, we are laser
focused on our commercial preparedness activities. Over the last
several months, we’ve made significant progress in our Commercial
Launch Readiness. We are preparing to launch a 125-person
salesforce focusing on specialists and healthcare providers who
prescribe epinephrine and will have an array of patient and
provider services established to ensure affordability. Access to
neffy is a key focus and priority for us, and we
have started to work with drug benefit plans to educate and raise
awareness about new routes of administration that will help ensure
the prompt use of epinephrine for severe allergic reactions,
including anaphylaxis.”
neffy® Progress
- FDA Advisory Committee
Supports neffy Potential for the
Treatment of Allergic Reactions (Type I),
Including Anaphylaxis, Under Review with FDA and
EMA: The U.S. Food and Drug Administration’s (FDA) held a
Division of Pulmonary-Allergy Drug Advisory Committee (PADAC)
meeting on May 11, 2023, to review the New Drug Application (NDA)
for neffy. The committee voted 16:6 in favor for
adults, and 17:5 in favor for children (<18 years of age and ≥30
kg), that available data support a favorable benefit-risk
assessment for neffy in the treatment of severe
allergic reaction (Type I), including anaphylaxis, for adults and
children who weigh more than 30kg. The PADAC decision was based on
a review of comprehensive data from clinical studies developed in
agreement with the FDA, which support a positive risk-benefit
profile for intranasal (IN) epinephrine safety and effectiveness,
compared to epinephrine injection. We believe the studies
demonstrated and the majority of the Committee’s discussion
supported that neffy shows:
- Comparable or greater pharmacodynamic
(PD) response (systolic blood pressure and heart rate) vs.
intramuscular injection that is observed even at 1 minute after
dosing of neffy. Increases in systolic blood
pressure and heart rate are the outcomes monitored by physicians to
assess clinical response, and therefore ARS considered PD response
to be a surrogate for efficacy. The majority conclusion of the
Committee also suggests that PD was more important and informative
given the high PK variability of injection products.
- Comparable or greater pharmacokinetic
(PK) data (epinephrine levels in the blood) vs. intramuscular
injection at all time points based on integrated data across the
three primary clinical studies. This includes a “real-world”
self-administration study in allergic reaction (Type I) patients,
where PK was statistically greater than intramuscular injection
during the early timepoints when clinical response is observed.
Importantly, exposures with neffy in all clinical
studies were less than the upper limit represented by EpiPen to
ensure safety.
- Effective IN delivery of systemic
epinephrine and PD response even with nasal congestion or runny
nose (e.g., during allergic rhinitis or upper respiratory tract
infection)
- Comparable safety to injection that is
generally mild in nature without any meaningful nasal irritation or
pain, without needle-related risks
- FDA PDUFA Target Action Date Anticipated
Mid-2023: The Company’s new drug application (NDA) and
marketing authorization application (MAA) for
neffy for the emergency treatment of allergic
reactions (Type I) including anaphylaxis in adults and children ≥30
kg (66 lbs), are under review by the FDA and the European Medicines
Agency (EMA), respectively. The FDA has assigned a Prescription
Drug User Fee Act (PDUFA) target action date anticipated mid-2023.
If approved, neffy would be the first
non-injectable treatment available to patients with allergic
reactions (Type I) including anaphylaxis.
First Quarter 2023 Financial Results
- Cash Position: Cash,
cash equivalents and short-term investments were $264.5 million as
of March 31, 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 $6.6 million for
the quarter ended March 31, 2023.
- G&A Expenses:
General and administrative (G&A) expenses were $12.2 million
for the quarter ended March 31, 2023.
- Net Loss: Net loss was
$15.0 million for the quarter ended March 31, 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 StatementsStatements 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; the anticipated US launch of
neffy, if approved, and the timing thereof; ARS’s
strategy of pursuing potential strategic transactions or
partnerships for neffy in Europe, if approved; the
estimated addressable patient population for
neffy; ARS’s plan to file a supplemental
regulatory application for a neffy 1 mg product
for children 15 kg to <30 kg immediately after the approval of
neffy 2 mg in the United States and/or Europe;
andother 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,” “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; 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—Risks Related to ARS Pharma” in the company’s definitive
merger proxy statement filed with the Securities and Exchange
Commission on October 6, 2022. 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 Contact:Justin ChakmaARS
Pharmajustinc@ars-pharma.com
ARS Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets(in
thousands, except share and par value data)
|
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
$ |
87,862 |
|
|
$ |
210,518 |
|
Short-term investments |
|
|
|
176,687 |
|
|
|
63,863 |
|
Prepaid expenses and other current assets |
|
|
|
2,801 |
|
|
|
3,319 |
|
Total current assets |
|
|
|
267,350 |
|
|
|
277,700 |
|
Right-of-use asset |
|
|
|
398 |
|
|
|
445 |
|
Fixed assets, net |
|
|
|
584 |
|
|
|
329 |
|
Other assets |
|
|
|
2,860 |
|
|
|
2,961 |
|
Total assets |
|
|
$ |
271,192 |
|
|
$ |
281,435 |
|
Liabilities, convertible
preferred stock and stockholders’ equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable and accrued liabilities (including related party
amounts of $307 and $16, respectively) |
|
|
$ |
9,596 |
|
|
$ |
4,931 |
|
Lease liability, current |
|
|
|
232 |
|
|
|
230 |
|
Contract liability, current |
|
|
|
10 |
|
|
|
283 |
|
Total current liabilities |
|
|
|
9,838 |
|
|
|
5,444 |
|
Lease liability, net of current
portion |
|
|
|
199 |
|
|
|
251 |
|
Contract liability, net of
current portion |
|
|
|
— |
|
|
|
2,854 |
|
Total liabilities |
|
|
|
10,037 |
|
|
|
8,549 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
Preferred stock, $0.0001 par
value per share; 10,000,000 shares authorized at March 31, 2023 and
December 31, 2022; no shares issued and outstanding at March 31,
2023 and December 31, 2022 |
|
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value
per share; 200,000,000 shares authorized at March 31, 2023 and
December 31, 2022; 94,448,028 and 93,943,316 shares issued and
outstanding at March 31, 2023 and December 31, 2022,
respectively |
|
|
|
9 |
|
|
|
9 |
|
Additional paid-in capital |
|
|
|
352,977 |
|
|
|
349,408 |
|
Accumulated other comprehensive
gain |
|
|
|
68 |
|
|
|
407 |
|
Accumulated deficit |
|
|
|
(91,899 |
) |
|
|
(76,938 |
) |
Total stockholders’ equity |
|
|
|
261,155 |
|
|
|
272,886 |
|
Total liabilities, convertible
preferred stock and stockholders’ equity |
|
|
$ |
271,192 |
|
|
$ |
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 March 31, |
|
|
|
2023 |
|
|
2022 |
|
Revenue under collaboration
agreements |
|
$ |
20 |
|
|
$ |
663 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development (including related party amounts of $591
and $540, respectively) |
|
|
6,552 |
|
|
|
5,423 |
|
General and administrative (including related party amounts of $337
and $165, respectively) |
|
|
12,181 |
|
|
|
2,339 |
|
Total operating expenses |
|
|
18,733 |
|
|
|
7,762 |
|
Loss from operations |
|
|
(18,713 |
) |
|
|
(7,099 |
) |
Other income (expense),
net |
|
|
3,752 |
|
|
|
(151 |
) |
Net loss |
|
$ |
(14,961 |
) |
|
$ |
(7,250 |
) |
Change in unrealized gain on
available-for-sale securities |
|
|
(339 |
) |
|
|
— |
|
Comprehensive loss |
|
$ |
(15,300 |
) |
|
$ |
(7,250 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.16 |
) |
|
$ |
(0.24 |
) |
Weighted-average shares
outstanding used in computing net loss per share, basic and
diluted |
|
|
94,227,313 |
|
|
|
30,369,413 |
|
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