Saniona publishes its interim report for the second quarter of 2021

PRESS RELEASE

August 26, 2021

Three Months Ended June 30, 2021 (2020)
Revenue was SEK 1.9 M (2.0 M)
Operating loss was SEK -103.6 M (-26.0 M)
Net profit/loss was SEK -103.9 M (-23.9 M)
Basic loss per share was SEK -1.67 (-0.81)
Diluted loss per share was SEK -1.67 (-0.81)

Six Months Ended June 30, 2021 (2020)
Revenue was SEK 5.3 M (4.4 M)
Operating loss was SEK -197.7 M (-53.5 M)
Net profit (loss) was SEK -187.3 M (19.3 M)
Basic earnings (loss) per share was SEK -3.00 (0.65)
Diluted earnings (loss) per share was SEK -3.00 (0.65)

Business highlights in Q2 2021

• Saniona achieved a key milestone with the initiation of a Phase 1 clinical trial of SAN711, an ion channel modulator that may be applicable in the treatment of rare neuropathic disorders. This is the first wholly-owned asset from Saniona's proprietary ion channel drug discovery engine to advance into a clinical trial. Data from the trial are expected in the first half of 2022.
• Saniona provided multiple updates on its progress toward initiating Phase 2b clinical trials of Tesomet in hypothalamic obesity (HO) and Prader-Willi syndrome (PWS), announcing a partnership with the Foundation for Prader-Willi Research to increase clinical trial awareness and the receipt of manufacturing feedback from the U.S. Food and Drug Administration (FDA) on the transition from tablets to capsules. Both Phase 2b clinical trials are expected to start in the second half of 2021, with top-line data expected from the PWS clinical trial in the first half of 2023 and from the HO clinical trial in the second half of 2023.
• Saniona presented preclinical data from its ion channel program SAN903 in a model of idiopathic pulmonary fibrosis at the American Society of Pharmacology and Experimental Therapeutics (ASPET) Annual Meeting. SAN903 is expected to enter Phase 1 in the second half of 2022. Saniona also presented SAN711 preclinical data in a model of facial neuropathic pain at the prestigious European Academy of Neurology (EAN) Congress.
• 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.
• Saniona provided an update from its partner Medix that additional information requested by a Mexican regulatory committee may delay the anticipated final decision in Mexico regarding tesofensine for obesity into 2022.
• Saniona successfully monetized its position in the 2017 spin-out Scandion Oncology, completing the sale of its remaining shares on the open market.
• Saniona received a minority 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.

Significant events after the reporting period

• Saniona achieved orphan drug designation from the FDA for Tesomet for the treatment of HO. Tesomet is the first and only investigational treatment for HO to receive orphan drug designation.
• 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.

Comments from the CEO        
"In the first half of 2021 and into the subsequent period, Saniona has made significant progress on the clinical and regulatory fronts, achieving orphan drug designations from the U.S. FDA for Tesomet in both hypothalamic obesity and Prader-Willi syndrome. These designations put us in a strong position as we prepare to initiate our Phase 2b trials of Tesomet in HO and PWS before the end of this year,” said Rami Levin, President & Chief Executive Officer of Saniona. "Additionally, in Q2 we initiated a Phase 1 clinical trial of SAN711, our second wholly-owned proprietary pipeline asset to advance into clinical trials. SAN711 is our lead molecule from our ion channel drug discovery engine, which has already generated a number of additional discovery-stage and preclinical assets to fuel our pipeline well into 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 and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CEST on August 26, 2021.

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, Saniona’s database of more than 130,000 ion channel modulators, of which more than 20,000 are Saniona’s proprietary compounds. 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.

Attachment

• 08.26.21 Q2 2021 Report