On August 27, 2020 Saniona reported its interim report for the second quarter 2020 (Press release, Saniona, AUG 27, 2020, View Source,of%20Tesomet%20in%20hypothalamic%20obesity.&text=On%20May%201%2C%202020%20Saniona,and%20Head%20of%20Clinical%20Development. [SID1234564100])

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Financial highlights

H1 2020 (H1 2019)

Net revenues were SEK 2.5 M (2.4 M)
EBIT was SEK -56.1 (-49.7 M)
Net profit/loss was SEK -64.6 M (-44.6)
Earnings per share were SEK -2.18 (-1.89)
Diluted earnings per share were SEK -2.18 (-1.89)
Q2 2020 (Q2 2019)

Net revenues were SEK 2.0 M (0.7 M)
EBIT was SEK -25.5 M (-20.6 M)
Net profit/loss was SEK -36.4 (-19.8 M)
Earnings per share were SEK -1.23 (-0.83)
Diluted earnings per share were SEK -1.23 (-0.83)
Business highlights in Q2 2020

In April, Saniona reported positive topline results from its Phase 2 trial of Tesomet in hypothalamic obesity. The double-blind, placebo-controlled results showed that Tesomet was safe, well tolerated and led to statistically significant reductions in the key efficacy endpoints, including change in body weight, waist circumference and glycemic control compared to placebo.
On May 1, 2020 Saniona appointed Rudolf Baumgartner, M.D., as Chief Medical Officer and Head of Clinical Development.
In June, Saniona announced that it received positive feedback from the United States Food and Drug Administration (FDA) following a pre-investigational new drug (IND) meeting regarding the proposed regulatory pathway for Tesomet in Prader-Willi syndrome (PWS). The agency confirmed that Tesomet may be advanced via the 505(b)2 pathway, and indicated agreement with Saniona on the design, proposed doses, and duration of Saniona’s planned Phase 2b clinical trial in PWS.
Saniona strengthened its balance sheet through the sale of shares in Scandion Oncology A/S, which raised SEK 38.2 million, and through the execution of a warrant exercise resulting in proceeds of approximately SEK 24.3 million before issue costs.
Significant events after the reporting period

On August 10, 2020 Saniona announced the successful direct issue of shares raising USD $65 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.
Comments from the CEO

"Saniona has met some major milestones since last quarter by advancing our clinical programs for rare eating disorders and further establishing our presence in the U.S. Our recent raise of $65 million through a direct offering of shares to well-respected U.S. and international institutional healthcare investors leaves us well positioned to rapidly advance Tesomet’s clinical development and is a testament to the potential of our programs and growing U.S. presence. In addition, the appointment of Rudolf Baumgartner, M.D., as Chief Medical Officer and Head of Clinical Development strengthens our management team and further bolsters our establishment as a U.S.-based rare disease company. On the clinical and regulatory front, we are excited to build upon positive data from our Phase 2 study in patients with hypothalamic obesity (HO) showing statistically significant changes in key efficacy endpoints as we move toward a pre-IND meeting with the FDA in the second half of the year. Importantly, we also achieved a key milestone in our Prader-Willi syndrome program, with Saniona and the FDA agreeing on a 505(b)2 regulatory pathway and Phase 2b trial design following a positive pre-IND meeting. Together, these accomplishments bring us closer to our ultimate goal of advancing Tesomet to the market to provide a solution for patients with these rare eating disorders," says Rami Levin, President & Chief Executive Officer of Saniona.

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 CET on August 27, 2020.