GlobeNewswire by notified

Saniona Announces Strategic Program Prioritization and Restructuring to Streamline Operational Costs

Share

PRESS RELEASE

March29, 2022

Saniona (OMX: SANION), a clinical-stage biopharmaceutical company focused on rare diseases, today announced a strategic program reprioritization and restructuring intended to immediately and substantially reduce operating expenses and maximize the utility of current and future cash resources. The Board has resolved to implementmultiple actions including a voluntary pause of the Phase 2b clinical trials of Tesomet™ for hypothalamic obesity (HO) and Prader-Willi syndrome (PWS) and a workforce reduction of approximately 30%.The decision to voluntarily pause the Phase 2b clinical trials of Tesomet is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations.

Comments from Rami Levin, President and CEO of Saniona:
“We are extremely disappointed to have to undertake such drastic measures to conserve resources, especially since we know HO and PWS patients and their families are desperately waiting for treatments, and because our employees had made such significant progress in 2021. Over the past year we have accelerated our efforts to support our operations by evaluating multiple strategic financing and business development options. However, during this time, and particularly recently, the environment for obtaining financing has changed dramatically, given the current global macroeconomic and biotech sector market conditions. We will tirelessly continue these efforts, but we believe it is in the best interest of the company and our shareholders to immediately decrease our operating expenses, which will increase the utility of any future cash inflows obtained by the company.

“I extend my sincere gratitude to the employees who are affected by this decision; their hard work enabled us to achieve multiple significant milestones in 2021, including obtaining orphan drug designation from the FDA and initiating Phase 2b trials in HO and PWS, as well as advancing our ion channel pipeline. We are acutely aware of the high unmet need in these disorders and the multiple setbacks the HO and PWS communities have faced; we thank them for their patience as we temporarily pause these trials. I would also like to address all Saniona shareholders and reassure them that the Board and management are determined and fully committed to lead the company through this difficult time.”

The decision to voluntarily pause the Phase 2b clinical trials of Tesomet for HO and PWS is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations. The Tesomet programs previously achieved highly encouraging results in initial Phase 2 trials, and the international Phase 2b trials were by far the largest expenditure for the company. Saniona will continue its ongoing Phase 1 clinical trial of SAN711, which is expected to deliver data by the end of the first half of 2022. The company will also continue to invest in its ion channel drug discovery engine, including SAN903, which is expected to enter Phase 1 clinical trials in the second half of 2022, and discovery research efforts, which are expected to result in a new ion channel modulator advancing into the preclinical pipeline in 2022. Saniona will also continue to pursue strategic financing options and expand its business development efforts to include opportunities that could allow Tesomet to advance.

Saniona reported cash and cash equivalents of approximately SEK 357 million (USD 37.8 million) as of December 31, 2021. Total operating expenses were approximately SEK 422 million (USD 46.6 million) during 2021. The approximate 30% reduction will include employees and contractors and will have an impact across most areas of Saniona’s organization, including at the executive team level. In addition, the company plans to reduce other operating expenses as well as the physical footprint of its facilities. The company’s current cash resources are expected to fund the company’s current operating plan further into the second half of 2022. The strategic restructuring actions, which will take some time to be fully realized, are expected to decrease Saniona’s anticipated future average quarterly operating expenses by about 50%. Importantly, the reduction in operating expenses will increase the utility of any future cash inflows obtained by the company.

For more information, please contact
Trista Morrison, Chief Corporate Affairs 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 16.00 CET on 29March 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™, has been advanced into 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. These clinical trials are voluntarily paused due to funding limitations. 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 presence 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

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

GOGL - Mandatory notification of trade by primary insiders19.5.2022 22:30:00 CEST | Press release

Eligible option holders in Golden Ocean Group Ltd (the “Company”) have today exercised share options in accordance with the terms previously announced. Ulrik Uhrenfeldt Andersen, CEO, has exercised 300,000 share options and subsequently sold 300,000 shares. Following the exercise, Mr. Andersen holds 250,000 share options. Peder Simonsen, CFO, has exercised 75,000 share options and has subsequently sold 75,000 shares. Following the exercise, Mr. Simonsen holds 200,000 share options and 500 shares. Please see the attached forms for notification and public disclosure of transaction attached for details. This notification has been publicly disclosed in accordance with Article 19 of the Market Abuse Regulation section 5-12 of the Norwegian Securities Trading Act. Attachment GOGL - Disclosure of transaction by PDMR

Brunel AGM 202219.5.2022 18:30:00 CEST | Press release

Amsterdam, 19 May 2022 – Brunel International N.V. (Brunel; BRNL), a global provider of flexible workforce solutions and expertise, today announced the voting results of the Annual General Meeting of Shareholders (AGM) of 19 May 2022. The AGM approved all voting items that were on the agenda. The shareholders adopted the financial statements for the 2021 financial year and approved the proposal to distribute a dividend of € 0.45 per share for the 2021 financial year. The dividend, less 15% dividend withholding tax, will be made payable as of 15 June 2022 at ABN AMRO Bank N.V. in Amsterdam. The shares will be quoted ex-dividend on the stock exchange of Euronext Amsterdam as of 23 May 2022. The record date is 24 May 2022 after closing of the stock exchange. Peter de Laat is reappointed as a member of the board of directors for a new term of four years. At the close of the meeting Mr Jan Arie van Barneveld, retired from the supervisory board after having served on the supervisory board fo

Scandinavian Tobacco Group A/S: Share buy-back programme increased to up to DKK 1,000 million19.5.2022 18:15:00 CEST | Press release

Company Announcement No. 35/2022 Copenhagen, 19 May 2022 Share buy-back programme increased to up to DKK 1,000 million The Board of Directors of Scandinavian Tobacco Group A/S has decided to increase the DKK 700 million share buy-back programme that was initiated 10 March 2022 (see company announcement 16/2022) by DKK 300 million. Consequently, the on-going share buy-back programme now has a value of up to DKK 1,000 million. As of 19 May 2022, Scandinavian Tobacco Group had purchased shares of a total value of DKK 128 million under the programme. Prior to the expansion of the share buy-back programme, Scandinavian Tobacco Group A/S holds a total of 1,338,431 treasury shares, corresponding to 1.44% of the total share capital. The purpose of the share buy-back programme remains to adjust the Group’s capital structure and meet obligations relating to the Group’s share-based incentive programme. The Board of Directors intends to propose to the annual general meeting in 2023 that the shares

Scandinavian Tobacco Group A/S reports Q1 results, maintains guidance for 2022 and presents revised Sustainability Strategy19.5.2022 18:15:00 CEST | Press release

Company Announcement No. 34/2022 Copenhagen, 19 May 2022 Interim report, 1 January - 31 March 2022 Scandinavian Tobacco Group A/S reports Q1 results, maintains guidance for 2022 and presents revised Sustainability Strategy For the first quarter of 2022 Scandinavian Tobacco Group delivered 2% negative organic net sales growth and 3% negative organic EBITDA growth in line with the previously communicated expectations for the quarter. The guidance for the full year of an organic EBITDA growth in the range of 0-6% is maintained. The uncertainty related to key assumptions like consumer behaviour, cost inflation and supply-chain stability remains high. The current share buy-back programme is increased by DKK 300 million to reach up to DKK 1,000 million reflecting the strong financial position of Scandinavian Tobacco Group. Consumer demand for handmade cigars in the US remained robust in the quarter though with signs at the end of the quarter of a return to the structural declining volume tre

KBC Group: Publication of transparency notification(s) received by KBC Group NV19.5.2022 18:00:00 CEST | Press release

Press release Outside trading hours – Regulated information* Brussels, 19 May 2022, 18h00 Publication of transparency notification(s) received by KBC Group NV (art. 14, 1st section of the Act of 2 May 2007 concerning the disclosure of significant participations) Summary of the notification(s) KBC Group NV has received a transparency notification on 18 May 2022, which states that FMR LLC holds 3.32% of voting rights in KBC Group, based on’ voting securities’ and ‘financial instruments that are treated as equivalent to voting securities’ combined (compared to 3.01% in the previous notification dd. 6 September 2018). That is the sum of 2.72% for voting securities (compared to 3.01% in the previous notification) and 0.60% for financial instruments that are treated as equivalent to voting securities (compared to 0% in the previous notification). Content of the notification(s) The notification(s) contain(s) following information: Reason for the notification(s): acquisition or disposal of vot