Saniona publishes its interim report for the third quarter of 2021
November 18 2021 - 1:00AM
Saniona publishes its interim report for the third quarter of 2021
PRESS RELEASE
November 18,
2021
Three Months Ended September
30, 2021 (2020)
Revenue was SEK 2.3 M (2.2 M)Operating loss was SEK -88.2 M
(-37.3 M)Net loss was SEK -93.7 M (-48.3 M)Basic loss per share was
SEK -1.50 (-1.14)Diluted loss per share was SEK -1.50 (-1.14)
Nine Months Ended
September 30, 2021 (2020)Revenue
was SEK 7.6 M (6.6 M)Operating loss was SEK -286.7 M (-90.8 M)Net
loss was SEK -281.8 M (-29.0 M)Basic loss per share was SEK -4.52
(-0.86)Diluted loss per share was SEK -4.52 (-0.86)
Business highlights in
Q3 2021
- Saniona achieved orphan
drug designation (ODD) from the FDA for Tesomet for the
treatment of hypothalamic obesity (HO). Tesomet is the first and
only investigational treatment for HO to receive ODD, and it
previously received ODD for Prader-Willi syndrome (PWS). ODD
qualifies Saniona for certain benefits including tax credits,
elimination of certain FDA license application fees, and seven
years of market exclusivity in the U.S. following approval.
- Saniona entered into a
non-dilutive term loan agreement for SEK 87
million ($10 million) with Formue Nord Fokus A/S to support new
activities aimed at accelerating clinical development
programs.
- Saniona appointed Wendy Dwyer as
Chief Business Officer to focus on out-licensing
of assets in non-core markets and/or non-core therapeutic areas in
order to generate non-dilutive capital while expanding the
potential reach of Saniona’s medicines globally.
- Finance veteran Robert E. Hoffman
was appointed as a member of the board of
directors and Chairman of the Audit Committee, as resolved
at an extraordinary shareholders’ meeting.
Significant events
after the reporting period
- Saniona completed the submission of all
information previously requested by the U.S. Food and Drug
Administration (FDA) regarding its chemistry, manufacturing and
controls program for Tesomet capsules.
- Saniona initiated a Phase 2b clinical trial of Tesomet
in patients with HO. The company also confirmed, and
continues to confirm, that it remains on track to initiate its
Phase 2b clinical trial of Tesomet for PWS before the end of 2021,
as planned.
Comments from the
CEO "With
two clinical trials now underway and a third poised to begin before
the end of this year, Saniona has made significant progress on our
mission to discover, develop and ultimately commercialize our
medicines to treat rare diseases,” said Rami Levin, President &
Chief Executive Officer of Saniona. “This progress is a direct
result of the hard work by the talented and experienced team we
have hired, and it positions us well to continue to achieve
important milestones in the fourth quarter of 2021 as well as
throughout 2022 and 2023.”
Read the full report attached below.
For more information, please
contact Trista Morrison, Chief Communications Officer,
Saniona. Office: + 1 (781) 810-9227. Email:
trista.morrison@saniona.com
This information is such information as Saniona AB (publ) is
obliged to make public pursuant to the EU Market Abuse Regulation
and the Securities Markets Act. The information was submitted for
publication, through the agency of the contact person set out
above, at 08:00 CET on November 18, 2021.
About SanionaSaniona is a
clinical-stage biopharmaceutical company focused on discovering,
developing and commercializing innovative therapies for patients
suffering from rare diseases for which there are a lack of
available treatment options. The company’s lead product candidate,
Tesomet, is in mid-stage clinical trials for hypothalamic obesity
and Prader-Willi syndrome, serious rare disorders characterized by
severe weight gain, disturbances of metabolic functions and
uncontrollable hunger. Saniona has developed a proprietary ion
channel drug discovery engine anchored by IONBASE, Saniona’s
database of more than 130,000 compounds, of which more than 20,000
are Saniona’s proprietary ion channel modulators. Through its ion
channel expertise, Saniona is advancing two wholly-owned ion
channel modulators, SAN711 and SAN903. SAN711 is in a Phase 1
clinical trial and may be applicable in the treatment of rare
neuropathic disorders, and SAN903 is in preclinical development for
rare inflammatory, fibrotic and hematological disorders. Led by an
experienced scientific and operational team, Saniona has an
established research organization in the Copenhagen area, Denmark,
and a corporate office in the Boston, Massachusetts area, U.S. The
company’s shares are listed on Nasdaq Stockholm Small Cap (OMX:
SANION). Read more at http://www.saniona.com.
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