- Achieved significant improvement in handling and transport
stability of RNA nanoparticles
- Pursuing partnering opportunities with AM-125 legacy asset in
vertigo and / or potential other CNS indications
- Streamlining corporate structure; switch in financial reporting
from Swiss Francs to US Dollars
HAMILTON, BERMUDA / May 28, 2024 / Altamira
Therapeutics Ltd. (“Altamira” or the “Company”) (Nasdaq:CYTO), a
company dedicated to developing and commercializing RNA delivery
technology for targets beyond the liver, today provided a business
update related to its RNA delivery platform, partnering of its
legacy assets, corporate structuring and financial reporting.
Altamira’s development work has resulted in
significant enhancement of RNA nanoparticle stability, which has
been one of the key challenges in the handling and transport of RNA
formulations. Thanks to its new flow process production method, the
Company obtained formulations of OligoPhore nanoparticles which are
stable in liquid form when stored at 4°C for a period of at least
three weeks. These formulations were, in addition, able to
withstand shaking stress without significant changes in size,
encapsulation or activity.
“The ability of nanoformulations to maintain
their attributes during shaking stress is essential for
transportation and one of the key limitations of lipid
nanoparticles,1 the most common type of RNA delivery vehicles.
These limitations became evident during the COVID-19 pandemic with
significant resources being devoted towards transport logistics and
storage capacity in frozen form,” commented Covadonga Pañeda,
Ph.D., Altamira Therapeutics’ Chief Development Officer. “We are
very excited about this major progress in making our formulations
significantly more stable than the current state of the art, which
requires freezing and other measures. The recently announced merger
between two well-known privately-held RNA companies highlighted
once again the high importance of RNA delivery technologies. Even
the most potent RNA sequence will be useless if it cannot be
delivered effectively and safely to its target. With our OligoPhore
/ SemaPhore platforms we can offer partners in pharma or biotech
effective and safe solutions for delivering their siRNA, mRNA or
other RNA modalities to extrahepatic targets and efficient
endosomal release within those target cells and as the new results
show, we may also be able to reduce the hurdles associated with
transport.”
Pursuing partnering opportunities with
the AM-125 program in vertigo and / or other CNS
indications
Altamira continues to make progress with the
planned partnering of its legacy asset AM-125, a patented nasal
spray formulation of the histamine analog betahistine. AM-125 has
been developed for the treatment of acute vestibular syndrome (AVS)
to provide an alternative to current standard of care treatment
with oral betahistine, which is hampered by poor bioavailability. A
phase 2 clinical trial in Europe demonstrated that a four-week
treatment course with AM-125 in AVS patients was well tolerated and
helped to accelerate vestibular compensation enabling patients to
regain balance and recover faster. To date, Altamira invested about
18 million US dollars in the program.
Apart from its potential in AVS treatment,
AM-125 is expected to have clinical utility in other central
nervous system disorders known for the involvement of histamine.
Studies by independent research groups have shown clinical benefits
of betahistine in the treatment of Attention-deficit /
hyperactivity disorder (ADHD), cognitive function in dementia,
memory loss and weight gain, among others. Altamira’s own research
with intranasal betahistine demonstrated a statistically
significant decrease in weight gain under antipsychotic treatment.
Histamine is also a known pharmacologic target in narcolepsy,
Prader-Willi Syndrome, for which Altamira has an Orphan Drug
designation, or Tourette syndrome. From discussions with potential
partners, Altamira is seeing interest in AM-125’s potential in such
other potential indications in particular for the US market, where
there is currently no oral betahistine marketed.
Continued simplification of group
structure
In the first half of 2024, the Company has
continued its efforts to simplify its corporate structure and align
it with the strategic repositioning around its RNA delivery
platform. In a first step, it partially divested its Bentrio
activities by selling 51% of Altamira Medica AG (including the
Australian subsidiary Auris Medical Pty Ltd) in November 2023. In a
second step, the Company transferred its Irish subsidiary Auris
Medical Ltd. to Altamira Medica AG (which renamed it Altamira
Medica Ltd.). Further, the Company is about to merge two of its
subsidiaries in Basel (Switzerland), Auris Medical AG and Altamira
Therapeutics AG. The merged entity will be called Altamira
Therapeutics AG and continue to serve as the core operating
subsidiary of the Company. Following completion of the merger, the
Altamira Group will comprise the parent company Altamira
Therapeutics Ltd. (Hamilton, Bermuda), and its subsidiaries
Altamira Therapeutics AG (Basel, Switzerland), Altamira
Therapeutics Inc. (Newark DE, USA), Otolanum AG (Basel,
Switzerland) as well as the associated company Altamira Medica AG
(Basel, Switzerland).
Switch to financial reporting in US
Dollars
Altamira plans to release its half-year 2024
financial results and business update report by the end of August
2024. The financial results will be presented for the first time in
US Dollars, which the Company adopted as its new reporting
currency, replacing the Swiss Franc. The Special General Meeting of
Altamira held on October 31, 2023 had already approved to change
the currency denomination of the authorized share capital from
Swiss Francs to US Dollars. Since the Company’s common shares are
publicly listed only in the US and a majority of the Company’s
shareholders are domiciled in the US, Altamira expects the switch
in reporting currency to facilitate the communication with
investors and the financial community.
About Altamira Therapeutics
Altamira Therapeutics (Nasdaq: CYTO) is
developing and supplying peptide-based nanoparticle technologies
for efficient RNA delivery to extrahepatic tissues (OligoPhore™ /
SemaPhore™ platforms). The Company currently has two flagship siRNA
programs using its proprietary delivery technology: AM-401 for KRAS
driven cancer and AM-411 for rheumatoid arthritis, both in
preclinical development beyond in vivo proof of concept. The
versatile delivery platform is also suited for mRNA and other RNA
modalities and made available to pharma or biotech companies
through out-licensing. In addition, Altamira holds a 49% stake
(with additional economic rights) in Altamira Medica AG, its
commercial-stage legacy asset Bentrio®, an OTC nasal spray for
allergic rhinitis. Further, the Company is in the process of
partnering / divesting its inner ear legacy assets. Founded in
2003, Altamira is headquartered in Hamilton, Bermuda, with its main
operations in Basel, Switzerland. For more information, visit:
https://altamiratherapeutics.com/
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, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements are statements other than historical
facts and may include statements that address future operating,
financial or business performance or Altamira’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 success of strategic transactions, including
licensing or partnering, with respect to Altamira’s legacy assets,
Altamira’s need for and ability to raise substantial additional
funding to continue the development of its product candidates, the
clinical utility of Altamira’s product candidates, the timing or
likelihood of regulatory filings and approvals, Altamira’s
intellectual property position and Altamira’s financial position,
including the impact of any future acquisitions, dispositions,
partnerships, license transactions or changes to Altamira’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 Altamira’s Annual Report on
Form 20-F for the year ended December 31, 2023, and in Altamira’s
other filings with the Securities Exchange Commission (“SEC”),
which are available free of charge on the SEC’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 Altamira or to persons
acting on behalf of Altamira 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 Altamira 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:
Hear@altamiratherapeutics.com
1 Ruppl et al., 2024, Don't shake it! Mechanical stress testing
of mRNA-lipid nanoparticles, Eur J Pharm Biopharm 198:114265.
https://pubmed.ncbi.nlm.nih.gov/38492867
Altamira Therapeutics (NASDAQ:CYTO)
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