Transaction to support potential
commercialization of neffy™, ARS’s needle-free epinephrine nasal
spray
Well-funded with at least three years of
operating runway expected
Companies to host conference call today, July
21, 2022, at 5:00 p.m. ET
Silverback Therapeutics, Inc. (Nasdaq: SBTX) (“Silverback”) and
ARS Pharmaceuticals, Inc. (“ARS”) today announced that the
companies have entered into a definitive agreement under which ARS
will merge with Silverback in an all-stock transaction. The
combined company will focus on the potential regulatory approval
and commercialization of neffy, ARS’s investigational epinephrine
nasal spray for the treatment of Type I allergic reactions
including anaphylaxis. The combined company is expected to have
approximately $265M in cash, cash equivalents and marketable
securities at closing. Upon stockholder approval, the combined
company is expected to operate under the name ARS Pharmaceuticals
and trade on the Nasdaq Capital Market under the ticker symbol
“SPRY.” The merger is currently expected to close in the fourth
quarter of 2022.
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 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.
ARS designed neffy to provide injection-like absorption of
epinephrine, in a small, easy-to-carry, easy-to-use, rapidly
administered, and reliable nasal spray device. With its needle-free
administration, neffy may help eliminate the anxiety and hesitation
associated with using an autoinjector.
“We are extremely pleased to announce this proposed merger with
Silverback, which we believe enables ARS to maximize the
paradigm-changing opportunity of neffy,” said Richard Lowenthal,
M.Sc., MSEL, co-founder and chief executive officer of ARS. “neffy
is on the cusp of achieving what has not been possible before – the
ability to deliver epinephrine with comparable pharmacokinetics to
an intramuscular injection, but with a simple to administer nasal
spray. We have completed a comprehensive registration program with
neffy and based on a favorable pre-NDA meeting with the U.S. Food
and Drug Administration (“FDA”), we are preparing to submit our New
Drug Application (“NDA”) in the third quarter of 2022. This merger
positions ARS and our experienced team to execute on the potential
launch of neffy in 2023 by providing the requisite capital needed
for launch. ARS was founded with a mission of solving many of the
issues that patients and caregivers express about their epinephrine
autoinjectors. Today is an important step toward bringing this
novel treatment to patients and caregivers to improve their
treatment options for these serious and potentially
life-threatening allergic reactions.”
Data across three registration studies supports that neffy
should meet all clinical endpoints recommended by regulators and
that its pharmacokinetics are within the range of approved
efficacious epinephrine injection products. In addition, neffy has
been well-tolerated to date with more than 500 individuals having
received at least one dose, and many with repeat administration.
The majority of adverse events in clinical trials were mild in
nature and comparable to injection products. Based on the totality
of data, ARS is preparing to submit its NDA for neffy for use in
adults and pediatric patients who are 30 kg or greater in the third
quarter of 2022. If approved, ARS is planning to launch neffy in
the United States in 2023.
“This transaction represents the result of a thorough and
thoughtful strategic review process by Silverback,” said Laura
Shawver, Ph.D., chief executive officer of Silverback. “ARS is an
exciting late-stage company with compelling clinical data
demonstrated with neffy, a path to near-term commercialization in a
large and dissatisfied market, and an expert team with proven
experience in launching and commercializing market-leading nasal
spray products, such as NARCAN. I believe we have found the optimal
partner to provide value for our stockholders, and even more so,
the potential to transform treatment for millions of people with or
at-risk for Type I severe allergic reactions.”
About the Proposed Merger
Under the terms of the merger agreement, assuming that
Silverback’s net cash at closing is $240 million, Silverback equity
holders are expected to own approximately 37% of the combined
company and pre-merger ARS equity holders are expected to own
approximately 63% of the combined company on a fully-diluted basis
on a treasury stock method. The percentage of the combined company
that Silverback’s equity holders will own as of the close of the
transaction is subject to certain adjustments as described in the
merger agreement, including the amount of Silverback’s net cash at
closing.
Upon closing of the transaction, Silverback will be renamed ARS
Pharmaceuticals, Inc. and will be headquartered in San Diego,
California. Richard Lowenthal, M.S., MBA, will serve as chief
executive officer and president of the combined company. The merger
agreement provides that the Board of Directors of the combined
company will be comprised of ten members, including seven from ARS
and three from Silverback. The merger agreement has been approved
by the Board of Directors of each company, and the transaction is
expected to close in the fourth quarter of 2022, subject to
approvals by the stockholders of each company and other customary
closing conditions.
SVB Securities is acting as exclusive financial advisor and
Cooley LLP is serving as legal counsel to Silverback.
Inceptiv Law is serving as legal counsel to ARS.
Conference Call Information
ARS and Silverback will host a conference call today, July 21,
2022, at 5:00 p.m. ET, to discuss the merger. A live webcast of the
presentation will be available on the Investors & Media section
of Silverback’s website at https://ir.silverbacktx.com and ARS’s
website at https://ars-pharma.com/news-and-events. A replay of the
webcast will be archived on each company’s website for 30 days
following the presentation.
Dial-in information for conference participants may be obtained
by registering for the event here.
About ARS Pharmaceuticals, Inc.
ARS Pharmaceuticals is 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™ (previously 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.
About Silverback Therapeutics, Inc.
Silverback Therapeutics, Inc. is a biopharmaceutical company
focused on leveraging its proprietary ImmunoTAC technology platform
to develop systemically delivered and tissue targeted therapeutics
for the treatment of chronic viral infections, cancer, and other
serious diseases. Silverback’s platform enables the strategic
pairing of proprietary payloads that modulate key disease modifying
pathways with monoclonal antibodies directed at specific disease
sites. Silverback Therapeutics is located in Seattle, Washington.
To learn more, visit www.silverbacktx.com.
Additional Information and Where to Find It
In connection with the merger, Silverback intends to file with
the Securities and exchange commission (“SEC”) preliminary and
definitive proxy statements relating to the merger and other
relevant documents. The definitive proxy statement will be mailed
to Silverback’s stockholders as of a record date to be established
for voting on the merger and any other matters to be voted on at
the special meeting. BEFORE MAKING ANY VOTING DECISION, INVESTORS
AND SECURITY HOLDERS ARE URGED TO READ THE PRELIMINARY AND
DEFINITIVE PROXY STATEMENTS, ANY AMENDMENTS OR SUPPLEMENTS THERETO
AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH
THE MERGER OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENTS
WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION ABOUT SILVERBACK, ARS AND THE MERGER. Investors and
security holders may obtain free copies of these documents (when
they are available) on the SEC’s web site at www.sec.gov, on
Silverback’s website at https://ir.silverbacktx.com/ or by
contacting Silverback’s Investor Relations via email at
IR@silverbacktx.com or by telephone at (206) 736-7946.
Participants in the Solicitation
Silverback and its directors and certain of its executive
officers may be deemed participants in the solicitation of proxies
from the stockholders of Silverback in connection with the merger
and any other matters to be voted on at the special meeting.
Information regarding the names, affiliations and interests of such
directors and executive officers will be included in the
preliminary and definitive proxy statements (when available).
Additional information regarding such directors and executive
officers is included in Silverback’s definitive proxy statement on
Schedule 14A for the 2022 Annual Meeting of the Stockholders, which
was filed with the SEC on April 28, 2022.
Information regarding the persons who may, under SEC rules, be
deemed participants in the solicitation of proxies of Silverback’s
stockholders in connection with the merger and any other matters to
be voted upon at the special meeting will be set forth in the
preliminary and definitive proxy statements (when available) for
the merger.
These documents are available free of charge as described in the
preceding paragraph.
Non-Solicitation
This communication will not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor will there be any sale of securities in any
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction.
Forward-Looking Statements
This communication contains forward-looking statements which
include, but are not limited to, statements regarding expected
timing, completion, effects and potential benefits of the proposed
merger; the expected cash, cash equivalents and marketable
securities of the combined company at closing; the expected
ownership percentages in the combined company; the expected name,
ticker symbol, management team and board of directors of the
combined company; the design and potential benefits of neffy; ARS’s
plans to submit an NDA to the FDA for neffy, the timing thereof and
optimism regarding the support therefor; and the timing of the
commercial launch of neffy, if approved, and the ability of the
merger to provide sufficient capital for such launch. These
forward-looking statements are subject to the safe harbor
provisions under the Private Securities Litigation Reform Act of
1995. Silverback’s expectations and beliefs regarding these matters
may not materialize. Actual outcomes and results may differ
materially from those contemplated by these forward-looking
statements as a result of uncertainties, risks, and changes in
circumstances, including but not limited to risks and uncertainties
related to: the ability of the parties to consummate the merger in
a timely manner or at all; the satisfaction (or waiver) of closing
conditions to the consummation of the merger, including with
respect to: the approval of Silverback’s stockholders; potential
delays in consummating the merger, the ability of the combined
company to timely and successfully achieve the anticipated benefits
of the merger; the impact of health epidemics, including the
COVID-19 pandemic, on the parties’ respective businesses and the
actions the parties may take in response thereto; the occurrence of
any event, change or other circumstance or condition that could
give rise to the termination of the merger agreement; the effect of
the announcement or pendency of the merger on Silverback’s or ARS’s
business relationships, operating results and business generally;
costs related to the merger; the outcome of any legal proceedings
that may be instituted against Silverback, ARS or any of their
respective directors or officers related to the merger agreement or
the transactions contemplated thereby; 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. 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” and elsewhere in Silverback’s most recent filings with the
SEC, including its Quarterly Report on Form 10-Q for the quarter
ended March 31, 2022 and any subsequent reports on Form 10-K, Form
10-Q or Form 8-K filed with the SEC from time to time and available
at www.sec.gov. These documents can be accessed on Silverback’s web
page at https://ir.silverbacktx.com/ by clicking on the link
“Financials & Filings.”
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220721005023/en/
ARS Media Contact: Caroline Cunningham Porter Novelli
Caroline.Cunningham@porternovelli.com
ARS Investor Contact: Justin Chakma ARS Pharma
justinc@ars-pharma.com
Silverback Media Contact: Jason Spark Canale
Communications jason.spark@canalecomm.com
Silverback Investor Contact: Miguel Arcinas Silverback
Therapeutics ir@silverbacktx.com
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