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May 26, 2021
Q1 2021 (Q1 2020)
Revenue was SEK 3.4 M (2.4 M)
Operating loss was SEK -94.1 (-27.4 M)
Net profit/loss was SEK -83.4 M (43.2 M)
Earnings per share were SEK -1.34 (1.47)
Diluted earnings per share were SEK -1.34 (1.47)
Business highlights in Q1 2021
The U.S. Food and Drug Administration (‘FDA’) granted orphan drug designation to Tesomet for the treatment of Prader-Willi syndrome (PWS). This designation qualifies Saniona for certain development benefits, including tax credits, elimination of certain FDA license application fees, and seven years of market exclusivity in the U.S. following approval.
The U.S. FDA provided further clarity on a regulatory path for Tesomet in the treatment of hypothalamic obesity (HO). The FDA indicated overall agreement with Saniona’s Risk Evaluation and Mitigation Strategy (REMS) proposal and cardiovascular monitoring proposal.
Saniona continued to make progress in preparing for its Phase 2b Tesomet clinical trials, including selecting the clinical research organization (CRO) that will support the clinical trials, identifying clinical trial sites in the U.S. and globally, engaging the contract manufacturer to produce Tesomet for Phase 2b and Phase 3 clinical trials, and establishing partnerships with patient advocacy organizations relating to patient community education and insights.
Saniona received an upfront payment of approximately USD 2.9 million (SEK 24.2 million) relating to Novartis AG’s acquisition of Cadent Therapeutics Inc. (‘Cadent Therapeutics’), in which Saniona held an ownership stake of approximately 3%. The acquisition may result in additional contingent consideration upon the achievement of future milestones.
Saniona’s Board of Directors and executive management team purchased shares of the company in the open market for a total value of approximately SEK 1.5 million.
Significant events after the reporting period
Saniona announced the receipt of manufacturing feedback from the FDA that will delay the start of the Tesomet Phase 2b trials into the second half of 2021.
Saniona announced a partnership with the Foundation for Prader-Willi Research (FPWR) to increase awareness about Saniona’s upcoming Phase 2b clinical trial of Tesomet for the treatment of PWS.
Saniona successfully monetized its position in the 2017 spin-out Scandion Oncology A/S (‘Scandion Oncology’), completing the sale of its remaining shares on the open market.
Saniona presented preclinical data on SAN903 in a model of idiopathic pulmonary fibrosis at the American Society of Pharmacology and Experimental Therapeutics (ASPET) Annual Meeting at Experimental Biology (EB) 2021.
Saniona hosted a research and development (R&D) day featuring presentations highlighting its ion channel drug discovery engine, including its IONBASE™ database now consisting of more than 20,000 proprietary molecules targeting various ion channels, and data from ion channel modulators SAN711 and SAN903.
Saniona received a 33.3% ownership stake in Cephagenix, as per the terms of the previously announced February 2020 collaboration agreement through which the company was formed to explore ion channel modulators for the treatment of migraine.
Comments from the CEO
"In the first quarter of 2021, Saniona began to leverage the foundations we built in 2020 and execute on our strategies. Specifically, we received Orphan Drug Designation from the FDA for Tesomet in Prader-Willi syndrome, and we completed many of the necessary preparations to initiate our Phase 2b trials of Tesomet in both PWS and hypothalamic obesity, which we plan on starting in the second half of this year,” said Rami Levin, President & Chief Executive Officer of Saniona. “Additionally, we have made progress with our ion channel drug discovery engine: we presented data on our ion channel programs at the ASPET conference and at our first R&D Day, and we look forward to advancing SAN711 into the clinic shortly.”
Read the full report attached below.
For more information, please contact
Trista Morrison, Chief Communications Officer, Saniona. Office: + 1 (781) 810-9227. Email: email@example.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 08:00 CEST on May 26, 2021.
Saniona is a biopharmaceutical company focused on discovering, developing, and delivering innovative treatments for rare disease patients around the world. The company’s lead product candidate, Tesomet, is in mid-stage clinical trials for hypothalamic obesity and Prader-Willi syndrome, severe rare disorders characterized by uncontrollable hunger and intractable weight gain. Saniona’s robust drug discovery engine has generated a library now consisting of more than 20,000 proprietary modulators of ion channels, a significantly untapped drug class that is scientifically validated. Lead candidate SAN711 is entering Phase 1 for rare neuropathic disorders, with SAN903 for rare inflammatory and fibrotic disorders advancing through preclinical development. Led by an experienced scientific and operational team, Saniona has an established research organization in Copenhagen, Denmark and is building its 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 www.saniona.com.