ARS Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Updates
09 Novembro 2023 - 6:00PM
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 third quarter of 2023.
“While we remain disappointed in the FDA’s decision to change
the repeat-dose rhinitis study from a post-marketing requirement to
a pre-approval requirement, we are moving quickly to complete the
study and meet the urgent medical need for people with severe
allergic reactions. We continue to expect resubmission of our New
Drug Application for neffy in the first half of
next year, with a U.S. launch anticipated in the second half of
next year, if approved. We are incredibly appreciative of the
outpouring of support we have received from patients and caregivers
following the delay as they eagerly await the approval of
neffy,” said Richard Lowenthal, Co-founder,
President and CEO of ARS Pharma.
Mr. Lowenthal continued: “During our Type A meeting with the FDA
in October, the agency reinforced that the completion of our
repeat-dose rhinitis study for neffy will
sufficiently address the agency’s outstanding questions. Further
bolstering our confidence in the study’s prospects, we were pleased
to announce the publication of positive results from the single and
repeat dose clinical study of neffy in the Journal
of Allergy and Clinical Immunology, which add to the growing body
of clinical evidence for neffy and underscore its
potential to be a safe and efficacious treatment option. ARS Pharma
remains well capitalized to fund our operations for at least the
next three years with anticipated cash and equivalents of
approximately $195 million expected at the time of the anticipated
neffy launch in the second half of 2024.”
U.S. Regulatory Status of neffy®
(epinephrine nasal spray)
- In September, ARS Pharma announced that
the FDA issued a Complete Response Letter (CRL) regarding its NDA
for neffy. In the CRL, the FDA requested
completion of a pharmacokinetic/pharmacodynamic study assessing
repeat doses of neffy compared to repeat doses of
an epinephrine injection product under allergen-induced allergic
rhinitis conditions to support approval.
- No member of the May 2023 FDA Advisory
Committee (PADAC), that concluded a favorable benefit-risk profile
of neffy (16:6 for adults and 17:5 for children),
requested a repeat dose study during allergen-induced allergic
rhinitis, and ARS Pharma aligned with FDA in August 2023 that such
a study could be completed as a post-marketing requirement.
- ARS Pharma expects to report its
findings from this study in the first quarter of 2024. With this
study being previously planned as a post-marketing requirement, ARS
Pharma was able to quickly ramp up following the CRL.
- The company anticipates a resubmission
of its NDA in the first half of 2024, positioning ARS Pharma for an
anticipated FDA action date and potential launch in the second half
of 2024.
- In October, ARS Pharma announced its
participation in a Type A meeting with the FDA to understand the
agency’s view related to the CRL, and to confirm next steps to
support an NDA resubmission seeking approval of
neffy.
- At this Type A meeting, the FDA
confirmed that the previously agreed upon design for the
repeat-dose study to evaluate the similarity of twice dosing
injection and twice dosing neffy under
allergen-induced allergic rhinitis will generate the necessary data
to answer its outstanding questions regarding
neffy.
- The neffy NDA
re-submission will be classified as Class 2, with an action
expected within six months of submission.
Additional Business Updates and Anticipated
Milestones
- Marketing authorization application
(MAA) for neffy is under review by the European
Medicines Agency (EMA) with a decision now expected in the second
quarter of 2024. Submissions to other regulatory authorities in
additional countries are planned for 2024.
- In October, ARS Pharma announced that
results from the single and repeat dose clinical study of
neffy were published in the Journal of Allergy and
Clinical Immunology (JACI). The clinical study evaluated single and
repeat doses of neffy compared to single and
repeat doses of approved injection products in healthy
subjects.
- In November, ARS Pharma
will present positive results during the 2023 American College
of Allergy, Asthma and Immunology (ACAAI) meeting supporting that
neffy is expected to be a safe and effective
treatment option in sub-populations including upper respiratory
tract infection, pediatrics ≥30 kg and patients with varying body
mass index (BMI) or body weight.
- Following the neffy
program delay, ARS Pharma implemented a plan to prioritize
resources on clinical and regulatory activities while maintaining
core commercial readiness status ahead of the anticipated FDA
approval of neffy in H2 2024.
Third Quarter 2023 Financial Results
- Cash Position: Cash,
cash equivalents and short-term investments were $241.9 million as
of September 30, 2023, which ARS Pharma believes is sufficient to
fund its current operating plan for at least three years.
- R&D Expenses:
Research and development (R&D) expenses were $3.0 million for
the quarter ended September 30, 2023.
- G&A Expenses:
General and administrative (G&A) expenses were $15.0 million
for the quarter ended September 30, 2023.
- Net Loss: Net loss was
$14.9 million for the quarter ended September 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 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 Pharma 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 Pharma’s plan to complete the
repeat-dose study under allergen-induced allergic rhinitis
conditions and file its NDA re-submission to the FDA in the first
half of 2024, with an anticipated launch of neffy,
if approved, in the second half of 2024; ARS Pharma’s expectation
to report topline data from its repeat-dose study in the first
quarter of 2024; ARS Pharma’s projected cash runway; ARS Pharma’s
belief that it is well capitalized to support the launch of
neffy in the U.S., if approved; whether the
repeat-dose study under allergen-induced allergic rhinitis
conditions will sufficiently address the FDA’s outstanding
questions; the potential for neffy to be a safe
and efficacious treatment option; the classification of the
neffy re-submission, anticipated timing for
regulatory review decisions on neffy and the
potential approval of neffy; the timing of the
EMA’s decision of ARS Pharma’s MAA and submissions to other foreign
regulatory authorities; 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,” “believes,” “expects,” “on track to,”
“will,” “potential” and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements are based upon ARS Pharma’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 ability to
successfully complete the repeat-dose study under allergen-induced
allergic rhinitis conditions within the anticipated timeframe, as a
result of challenges inherent to enrolling, conducting and
completing clinical trials; even though the FDA has stated that
completion of the repeat-dose study under allergen-induced allergic
rhinitis conditions for neffy will sufficiently
address the agency’s outstanding questions, there is no guarantee
that new issues will not be identified which could delay or prevent
the approval of 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 Pharma’s
ability to protect its intellectual property position;
uncertainties related to capital requirements; 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 Pharma’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2023, filed with
the Securities and Exchange Commission (“SEC”) on August 10, 2023,
and in ARS Pharma’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2023, being filed with the SEC today. This
document can also be accessed on ARS Pharma’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 Pharma assumes no
obligation and does not intend to update these forward-looking
statements, except as required by law.
ARS Pharma Investor Contacts:Justin ChakmaARS
Pharmaceuticalsjustinc@ars-pharma.com
ARS Pharma Media Contact:Sherry KorczynskiARS
Pharmaceuticalssherryk@ars-pharma.com
ARS Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets(in
thousands, except share and par value data)
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
60,532 |
|
|
$ |
210,518 |
|
Short-term investments |
|
181,370 |
|
|
|
63,863 |
|
Prepaid expenses and other current assets |
|
2,564 |
|
|
|
3,319 |
|
Total
current assets |
|
244,466 |
|
|
|
277,700 |
|
Right-of-use asset |
|
300 |
|
|
|
445 |
|
Fixed
assets, net |
|
617 |
|
|
|
329 |
|
Other
assets |
|
3,173 |
|
|
|
2,961 |
|
Total
assets |
$ |
248,556 |
|
|
$ |
281,435 |
|
Liabilities, convertible preferred stock and stockholders’
equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable and accrued liabilities (including related party
amounts of $208 and $16, respectively) |
$ |
10,945 |
|
|
$ |
4,931 |
|
Lease liability, current |
|
235 |
|
|
|
230 |
|
Contract liability, current |
|
— |
|
|
|
283 |
|
Total
current liabilities |
|
11,180 |
|
|
|
5,444 |
|
Lease
liability, net of current portion |
|
92 |
|
|
|
251 |
|
Contract
liability, net of current portion |
|
— |
|
|
|
2,854 |
|
Total
liabilities |
|
11,272 |
|
|
|
8,549 |
|
Commitments and contingencies |
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
Preferred stock, $0.0001 par value per share; 10,000,000 shares
authorized at September 30, 2023 and December 31, 2022; no shares
issued and outstanding at September 30, 2023 and December 31,
2022 |
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value per share; 200,000,000 shares authorized
at September 30, 2023 and December 31, 2022; 95,796,254 and
93,943,316 shares issued and outstanding at September 30, 2023 and
December 31, 2022, respectively |
|
9 |
|
|
|
9 |
|
Additional paid-in capital |
|
361,571 |
|
|
|
349,408 |
|
Accumulated other comprehensive (loss) gain, net |
|
(161 |
) |
|
|
407 |
|
Accumulated deficit |
|
(124,135 |
) |
|
|
(76,938 |
) |
Total
stockholders’ equity |
|
237,284 |
|
|
|
272,886 |
|
Total
liabilities, convertible preferred stock and stockholders’
equity |
$ |
248,556 |
|
|
$ |
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 September 30, |
|
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue under collaboration agreements |
$ |
— |
|
|
$ |
189 |
|
|
$ |
30 |
|
|
$ |
1,316 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development (including related party amounts of $307,
$776, $1,382 and $1,888, respectively) |
|
3,002 |
|
|
|
3,893 |
|
|
|
16,862 |
|
|
|
13,666 |
|
General and administrative (including related party amounts of
$322, $73, $840 and $344, respectively) |
|
14,976 |
|
|
|
2,926 |
|
|
|
40,462 |
|
|
|
7,723 |
|
Total operating expenses |
|
17,978 |
|
|
|
6,819 |
|
|
|
57,324 |
|
|
|
21,389 |
|
Loss
from operations |
|
(17,978 |
) |
|
|
(6,630 |
) |
|
|
(57,294 |
) |
|
|
(20,073 |
) |
Other income (expense),
net |
|
3,112 |
|
|
|
47 |
|
|
|
10,097 |
|
|
|
(180 |
) |
Net
loss |
$ |
(14,866 |
) |
|
$ |
(6,583 |
) |
|
$ |
(47,197 |
) |
|
$ |
(20,253 |
) |
Change
in unrealized gains and losses on available-for-sale
securities |
|
19 |
|
|
|
— |
|
|
|
(568 |
) |
|
|
— |
|
Comprehensive loss |
$ |
(14,847 |
) |
|
$ |
(6,583 |
) |
|
$ |
(47,765 |
) |
|
$ |
(20,253 |
) |
Net loss
per share, basic and diluted |
$ |
(0.16 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.50 |
) |
|
$ |
(0.66 |
) |
Weighted-average shares outstanding used in computing net loss per
share, basic and diluted |
|
95,576,627 |
|
|
|
30,755,123 |
|
|
|
94,910,012 |
|
|
|
30,578,516 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ARS Pharmaceuticals (NASDAQ:SPRY)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
ARS Pharmaceuticals (NASDAQ:SPRY)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024