Saniona publishes its year-end report for 2021
February 24 2022 - 1:00AM
Saniona publishes its year-end report for 2021
PRESS RELEASE
February 24,
2022
Three Months Ended December 31, 2021 (2020)
Revenue was SEK 2.9 M (1.6 M)Operating loss was SEK -125.7 M
(-68.6 M)Net loss was SEK -129.9 M (-44.4 M)Basic loss per share
was SEK -2.08 (-0.71)Diluted loss per share was SEK -2.08
(-0.71)
Twelve Months Ended December 31, 2021
(2020)Revenue was SEK 10.5 M (8.2 M)Operating loss was SEK
-411.6 M (-159.4 M)Net loss was SEK -410.9 M (-73.4 M)Basic loss
per share was SEK -6.59 (-1.79)Diluted loss per share was SEK -6.59
(-1.79)
Business highlights in Q4
2021
- Saniona initiated a Phase 2b clinical trial of
Tesomet in patients with Prader-Willi syndrome (PWS); data are
expected in the first half of 2023.
- Saniona initiated a Phase 2b clinical trial of
Tesomet in patients with hypothalamic obesity (HO); data are
expected in the second half of 2023.
- 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. Tesomet capsules are being
utilized in both ongoing Phase 2b trials.
- Saniona's Chairman and the CEO, as well as additional members
of the Board of Directors and executive management team,
purchased shares of the company in the open
market.
Significant events after the reporting
period
- Saniona initiated the Multiple Ascending Dose
stage of its Phase 1 trial of SAN711; data are expected by
the end of the first half of 2022.
- Saniona received SEK 7.3 million (US$0.8 million) from
Novartis related to Novartis’s January 2021 acquisition of
Cadent Therapeutics, in which Saniona held a 3% ownership stake.
This payment, in addition to the previously received SEK 24.2
million (US$2.9 million), together complete Saniona’s portion of
the upfront payment connected to the acquisition. Saniona may also
receive a portion of the remaining SEK 5.1 billion (US$560 million)
in contingent payments associated with the achievement of
undisclosed future milestones relative to its previous ownership
stake and class of shares held, when and if these milestones are
achieved.
Comments from the
CEO “In
2021, we significantly strengthened the fundamentals of our
business. We initiated three rare disease clinical trials: two
Phase 2b trials of our lead candidate Tesomet for HO and PWS, and a
Phase 1 trial of SAN711 for rare neuropathic disorders. We also
secured orphan drug designation from the FDA for Tesomet in both HO
(the first time ever granted for this indication) and PWS, and we
reduced manufacturing risks by completing the transition to Tesomet
capsules,” said Rami Levin, President & Chief Executive Officer
of Saniona. “As we enter 2022, we look forward to continuing to
advance our pipeline: delivering Phase 1 data for SAN711, advancing
SAN903 into the clinic, and selecting a new ion channel modulator
for our pipeline. We will also continue to focus on business
development opportunities to generate non-dilutive capital and
continuing to ensure Saniona is well-positioned for the
future.”
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.
The information was submitted for publication, through the agency
of the contact person set out above, at 8.00 CET on 24 February
2022.
About Saniona Saniona 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™, a 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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