- Entering field
of RNA therapeutics through acquisition of Trasir Therapeutics,
Inc.
- Trasir’s innovative peptide-based
OligoPhoreTM platform designed to enable extrahepatic delivery of
oligonucleotides
- Trasir’s founder, Dr. Samuel
Wickline, joining leadership team as Chief Scientific Officer
- Strategic repositioning around RNA
therapeutics and plans for spin-off or divestiture of existing
programs in medium term
- Extraordinary general meeting of
shareholders to vote on change of Company’s name to Altamira
Therapeutics Ltd. and election of Margrit Schwarz as new Board
member
- Conference call
and webcast today at 8 am EDT
Hamilton, Bermuda, June 3, 2021 – Auris Medical
Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to
developing therapeutics that address important unmet medical needs
in neurotology, rhinology and allergy and CNS disorders, today
announced the acquisition of privately held Trasir Therapeutics,
Inc. (“Trasir”), based in Tampa, FL, a pioneer in extrahepatic
oligonucleotide delivery. The purchase price comprises 0.77 million
common shares of the acquiring Company, the assumption of certain
selling shareholders’ cash outlays as well as a future share-based
payment contingent on reaching a specific development milestone.
The transaction, which closed on June 1, 2021, is the starting
point for a strategic repositioning under which the Company intends
to focus on the development of RNA therapeutics while in the medium
term aiming to spin off or divest its existing assets in
neurotology, rhinology and allergology. Dr. Samuel Wickline,
Trasir’s founder and Professor of Medicine, has been appointed
Chief Scientific Officer and joined the Company’s leadership
team.
Repositioning the Company to focus on
emerging RNA therapeutic opportunities
“Following a thorough review of various
strategic options, we are very excited to enter with the Trasir
acquisition the field of oligonucleotide delivery, which we believe
will provide us with a new range of RNA-based therapeutics with
disruptive potential”, commented Thomas Meyer, Auris Medical’s
founder, Chairman and CEO. “The global market for RNA therapeutics
has been growing fast, exceeding $1 billion in 2020. However,
appropriate delivery technologies have remained a key rate-limiting
step for unlocking their potential. Trasir’s groundbreaking
OligoPhore technology allows for effective delivery of RNA payloads
to tissues beyond the liver, which is inadequately addressed with
current delivery approaches. We look forward to applying OligoPhore
for the development of truly innovative RNA therapeutics and
advancing them to clinical proof of concept.” He added: “Although
we continue to believe that our existing business holds great
promise, we acknowledge investors’ preferences for highly focused
company strategies. Therefore, we will prepare for its separation
either through a divestiture or a spin-off to shareholders within
the next 12-18 months. Through the strategic repositioning and
transformation of the Company, we aim to unlock and create
significant shareholder value.”
Overcoming key challenges in RNA
delivery
Trasir was founded in 2014 by Dr. Wickline based
on extensive NIH-sponsored research on technologies that enable
safe and effective oligonucleotide delivery to extrahepatic tissues
at Washington University, St. Louis MO. Its core technology is the
proprietary peptide polyplex platform OligoPhoreTM that can engage
any type of RNA in rapid self-assembly. OligoPhoreTM allows for
safe and effective systemic delivery of oligonucleotide payloads
with efficient cellular uptake and full endosomal release.
Importantly, OligoPhoreTM enables delivery to target tissues
outside the liver, creating the potential for developing RNA-based
therapies for a range of indications with substantial unmet
need.
In various murine models of disease,
OligoPhoreTM has been shown to protect the RNA payload (siRNA
and/or mRNA) from degradation in the circulation, while enabling
pH-dependent nucleotide endosomal escape and cytoplasmic delivery.
Proof-of-concept for efficient delivery and target knockdown has
been demonstrated for targets in the NF-kB family, various members
of the ETS transcription factor family, and targets in the JNK and
TAM pathways, enabling a preclinical development pathway for
several oncology indications, rare diseases, as well as rheumatoid
and osteoarthritis and inflammatory pathologies such as
atherosclerosis.
Based on the extensive work of Dr Wickline and
collaborators, the Company intends to initiate under project code
AM-401 the preclinical development of the first pipeline program in
an oncology or rare disease indication. The submission of an IND is
targeted for the end of 2022. In parallel, the Company will explore
further potential applications of the OligoPhoreTM platform for
delivery of siRNA, mRNA and gene editing constructs, and seek to
leverage the platform’s potential through strategic partnering.
Proposed change of Company name to
reflect new strategic focus
To reflect the Company’s strategic
repositioning, the Board of Directors of Auris Medical Holding Ltd.
intends to call an extraordinary general meeting of shareholders to
propose to change its corporate name to Altamira Therapeutics Ltd.
Upon approval of the proposed name change, the Company’s shares
will start trading under the ticker symbol “CYTO” – the word root
for cell in ancient Greek – instead of “EARS”. In addition, the
Board intends to propose the election of Margrit Schwarz, PhD, MBA,
as an additional Board member. Margrit Schwarz brings with her 25
years of experience in drug discovery and development across
multiple indications and modalities, acquired in the global
biopharmaceutical industry (Amgen, Boehringer Ingelheim, Roche,
Genevant) and in international academic research settings.
Conference Call &
Webcast
Auris Medical's management team will host a live
conference call and webcast to present and discuss the Trasir
Therapeutics acquisition and its business implications at 8:00 am
Eastern Time (2:00 pm Central European Time). To participate in
this conference call, dial +1-877-870-9135 (US, toll free) or
+44-2071-928-338 (international), and enter passcode 4581447. A
live webcast of the conference call can be accessed in the Investor
Relations section of the Auris Medical website at
www.aurismedical.com. A replay will be available approximately two
hours following the live call.
About Auris Medical
Auris Medical is dedicated to developing
therapeutics that address important unmet medical needs. The
Company is currently active in three areas: the development of
oligonucleotides for extrahepatic therapeutic targets (OligoPhoreTM
platform; preclinical), nasal sprays for protection against
airborne viruses and allergens (BentrioTM; pre-commercial) or the
treatment of vertigo (AM-125; Phase 2), and the development of
therapeutics for intratympanic treatment of tinnitus or hearing
loss (Keyzilen® and Sonsuvi®, Phase 3). The Company was founded in
2003 and is headquartered in Hamilton, Bermuda with its main
operations in Basel, Switzerland. The shares of Auris Medical
Holding Ltd. trade on the NASDAQ Capital Market under the symbol
“EARS.”
Forward-looking Statements
This press release may contain statements that constitute
“forward-looking statements” within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Forward-looking statements are statements
other than historical facts and may include statements that address
future operating, financial or business performance or Auris
Medical’s strategies or expectations. In some cases, you can
identify these statements by forward-looking words such as “may”,
“might”, “will”, “should”, “expects”, “plans”, “anticipates”,
“believes”, “estimates”, “predicts”, “projects”, “potential”,
“outlook” or “continue”, or the negative of these terms or other
comparable terminology. Forward-looking statements are based on
management’s current expectations and beliefs and involve
significant risks and uncertainties that could cause actual
results, developments and business decisions to differ materially
from those contemplated by these statements. These risks and
uncertainties include, but are not limited to, the approval and
timing of commercialization of AM-301, Auris Medical’s need for and
ability to raise substantial additional funding to continue the
development of its product candidates, the timing and conduct of
clinical trials of Auris Medical’s product candidates, the clinical
utility of Auris Medical’s product candidates, the timing or
likelihood of regulatory filings and approvals, Auris Medical’s
intellectual property position and Auris Medical’s financial
position, including the impact of any future acquisitions,
dispositions, partnerships, license transactions or changes to
Auris Medical’s capital structure, including future securities
offerings. These risks and uncertainties also include, but are not
limited to, those described under the caption “Risk Factors” in
Auris Medical’s Annual Report on Form 20-F for the year ended
December 31, 2020, and in Auris Medical's other filings with the
SEC, which are available free of charge on the Securities Exchange
Commission's website at: www.sec.gov. Should one or more of these
risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those indicated. All forward-looking statements and all
subsequent written and oral forward-looking statements attributable
to Auris Medical or to persons acting on behalf of Auris Medical
are expressly qualified in their entirety by reference to these
risks and uncertainties. You should not place undue reliance on
forward-looking statements. Forward-looking statements speak only
as of the date they are made, and Auris Medical does not undertake
any obligation to update them in light of new information, future
developments or otherwise, except as may be required under
applicable law.
Investor contact:
investors@aurismedical.com
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