Saniona publishes its interim report for the third quarter 2020

PRESS RELEASE

November 30, 2020

Financial highlights

Jan - Sep 2020 (Jan - Sep 2019)

• Net revenues were SEK 4.6 M (2.7 M)
• EBIT was SEK -97.0 M (-75.8 M)
• Net profit/loss was SEK -117.3 M (-72.3 M)
• Earnings per share were SEK -3.47 (-2.89)
• Diluted earnings per share were SEK -3.47 (-2.89)

Q3 2020 (Q3 2019)

• Net revenues were SEK 2.2 M (0.3 M)
• EBIT was SEK -40.9 M (-26.0 M)
• Net profit/loss was SEK -52.7 M (-27.7 M)
• Earnings per share were SEK -1.24 (-1.00)
• Diluted earnings per share were SEK -1.24 (-1.00)

Business highlights in Q3 2020

• On August 10, 2020, Saniona announced the direct issue of shares raising USD $65 million (approximately SEK 567 million) with a syndicate of U.S. and international institutional investors and sector specialists. The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital, New Leaf Venture Partners, and other U.S. and international investors including the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4).
• On August 26, 2020, Saniona announced the expansion of its executive team with the appointments of Jason A. Amello as Chief Financial Officer, Trista Morrison as Chief Communications Officer, and Linea Aspesi as Chief Human Resources Officer.
• On September 23, 2020, Saniona completed the exercise of warrants of series TO2, which were issued in connection with Saniona’s rights issue and directed issue in the first quarter of 2020. In total, 1,329,141 warrants of series TO2 were exercised, corresponding to a subscription rate of approx. 90 percent. Saniona will thereby receive proceeds of SEK 33.2 million (USD 3.6 million), before issue costs, which amount to approx. SEK 0.4 million.

Significant events after the reporting period

• On October 9, 2020, Saniona announced that it received written feedback from the U.S. Food and Drug Administration (FDA) regarding pre-Investigational New Drug (IND) submissions for Tesomet in Prader-Willi Syndrome (PWS) and Hypothalamic Obesity (HO). In both indications, the FDA recommended that the clinical development program include a supportive Phase 2b study followed by a Phase 3 study. In PWS, Saniona expects to begin the Phase 2b study in the first half of 2021. In HO, Saniona is working on a plan, which it intends to present to the FDA to ensure that should Tesomet receive regulatory approval for HO, its use would be restricted only to the appropriate patients. Once this is addressed, Saniona anticipates beginning the HO Phase 2b study in the first half of 2021.
• On November 9, 2020, Saniona announced that it had refined its pipeline to align its early-stage discovery research with its strategic focus on rare diseases. Saniona regained exclusive, global rights to its GABAa5 negative allosteric modulator program (“GABAa5 program”) from Boehringer Ingelheim, which terminated this collaboration for strategic reasons. The termination of the collaboration provided Saniona with rights to a portfolio of more than 800 molecules, and it does not impact the 2020 collaboration between Saniona and Boehringer Ingelheim, which remains ongoing. Separately, Saniona and the Treatment Research Center (TRC) at the University of Pennsylvania jointly discontinued their collaboration to develop NS2359 for cocaine addiction. Saniona will evaluate the applicability of the GABAa5 program assets and NS2359 in rare diseases.
• On November 23, 2020, Saniona announced positive top-line results from the Phase 2 open-label extension study of Tesomet in patients with hypothalamic obesity (HO). Patients treated with Tesomet for nearly one year (24 week double-blind [DB] followed by 24 week open label extension [OLE]) demonstrated statistically significant and clinically meaningful reductions in body weight and waist circumference, as well as improvements in glycemic control. Tesomet was well tolerated, and no clinically meaningful differences in heart rate or blood pressure were observed over the course of the trial.

                                                           

"In the third quarter, we continued to transform Saniona into a fully-integrated biopharmaceutical company with the ability to discover, develop and ultimately commercialize our own innovative treatments for rare diseases. We were particularly encouraged by the positive data from the Phase 2 open-label extension study of Tesomet in HO, which we intend to discuss with FDA as we clarify the path forward in this rare indication,” said Rami Levin, President & Chief Executive Officer of Saniona. “During the quarter, one of our most important achievements was raising USD $65 million, which coupled with our existing cash resources, will fund our current operating plan into the second half of 2022, as originally planned. We believe access to U.S. patients, physicians and the U.S. financial market are critical for Saniona to unlock its long-term potential, and as such we are continuing to build our U.S. team and considering listing our shares on the U.S. Nasdaq exchange in addition to our existing listing on Nasdaq Stockholm.”

There are multiple potential advantages to a dual listing, including increased visibility and access to a greater number of potential investors, as well as potential increased liquidity (trading volume) from different markets with different macroeconomic conditions, allowing investors to purchase and sell shares on either exchange.

For more information, please contact

Trista Morrison, Chief Communications Officer, Saniona. Office: + 1 (781) 810-9227. Email:

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 November 30, 2020.

About Saniona

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 the rare diseases Prader-Willi syndrome and hypothalamic obesity. Saniona also has a broad pipeline derived from its proprietary ion channel discovery platform, with lead candidate SAN711 entering Phase 1 studies for rare neuropathic disorders. Saniona intends to develop and commercialize its rare disease products internally. The company has out-licensed other programs, which may provide future supplemental revenue. Saniona is based in Copenhagen, Denmark and Boston, Mass., U.S. The company’s shares are listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at .

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