Saniona publishes its interim report for the first quarter of 2021
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 Q12021
- 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: firstname.lastname@example.org
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.
AttachmentTo 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.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire 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
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Bavarian Nordic leverer vacciner til Englands beredskab i forbindelse med nye tilfælde af abekopper11.6.2021 19:12:35 CEST | pressemeddelelse
KØBENHAVN, Danmark, 11. juni 2021 – Bavarian Nordic A/S (OMX: BAVA) meddelte i dag, at selskabet for nylig er blevet anmodet af de engelske sundhedsmyndigheder, Public Health England (PHE) og Medicines and Health Products Regulatory Agency (MHRA), om at levere koppevaccinen IMVANEX® til vaccination i forbindelse med nye, udefrakommende tilfælde af abekopper i mennesker i England. To relaterede tilfælde er blevet bekræftet og er blevet indlagt på et hospital i Liverpool. Den ene er sandsynligvis blevet smittet i Afrika, hvorfra familien ankom et par dage inden sygdommen brød ud, mens den anden sandsynligvis er blevet smittet af det første tilfælde efter hjemkomsten. Abekopper er en sjælden, men alvorlig sygdom, der naturligt forekommer i det centrale og det vestlige Afrika. Sygdommen er beslægtet med den menneskelige koppesygdom, om end den er mindre alvorlig med en dødelighed, der er estimeret til at være fra 1-10% af tilfældene. IMVANEX (MVA-BN) er godkendt af Europa-Kommissionen til
Bavarian Nordic Assists Public Health England in Response to New Cases of Monkeypox11.6.2021 19:12:35 CEST | Press release
COPENHAGEN, Denmark, June 11, 2021 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Company was recently engaged by Public Health England (PHE) and the Medicines and Health Products Regulatory Agency (MHRA) to supply its IMVANEX® smallpox vaccine in response to new cases of monkeypox in the UK. Two related cases were confirmed and admitted to a hospital in Liverpool. One was most likely infected in Africa, where the family arrived from a few days before onset of disease, and a sibling case most likely infected on UK soil by the first case. Monkeypox is a rare, but serious disease, which is endemic in Central and West Africa. The disease is quite similar to human smallpox, although it is less severe with an estimated fatality rate of 1-10%. IMVANEX (MVA-BN) is approved by the European Commission for active immunization against smallpox but has also received approval for monkeypox by the U.S. Food and Drug Administration (FDA) and Health Canada, as the only vaccine approved for
Minister Eriksen Søreide, Deputy Minister Ryabkov, and Deputy Secretary Hicks to Keynote 2021 Carnegie International Nuclear Policy Conference11.6.2021 17:30:00 CEST | Press release
Senior officials, leaders, and experts in defense, security, and nuclear policy convene for a 3-day conference on the most-pressing challenges in nuclear arms control, nonproliferation, deterrence, and security WASHINGTON, June 11, 2021 (GLOBE NEWSWIRE) -- From June 22-24, 2021, the Carnegie Endowment for International Peace will host its biennial International Nuclear Policy Conference virtually, including keynote addresses from: Ine Eriksen Søreide, Minister of Foreign Affairs for NorwaySergey Ryabkov, Deputy Minister of Foreign Affairs of the Russian FederationKathleen Hicks, U.S. Deputy Secretary of Defense Other speakers include: Izumi Nakamitsu, UN-Secretary-General and High Representative for Disarmament Affairs; Bishop Garrison, Senior Advisor to the U.S. Secretary of Defense for Human Capital and Diversity, Equity and Inclusion; Harry Harris, former U.S. ambassador to the Republic of Korea; and Maleeha Lodhi, former UN Representative for Pakistan. The full conference agenda ca
CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK GOVERNMENT BONDS11.6.2021 16:20:00 CEST | Press release
Bid procedure, 2021-06-18BondsSWEDEN I/L BOND: 3114. SE0013748258. 2030-06-01 SWEDEN I/L BOND: 3111, SE0007045745, 2032-06-01 Bid date2021-06-18Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)3114: 250 mln SEK +/-150 mln SEK 3111: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)3114: 250 mln SEK per bid 3111: 500 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 10.15 (CET/CEST) on the Bid dateDelivery and payment date2021-06-22Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2021-06-11 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and conditions can be
CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK TREASURY BILLS11.6.2021 16:20:00 CEST | Press release
Bid procedure, 2021-06-16BillsSWEDISH T-BILL: SE0014808747. 2021-09-15 SWEDISH T-BILL: SE0015244405, 2021-12-15 SWEDISH T-BILL: SE0015659529, 2022-03-16 Bid date2021-06-16Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SE0014808747: 1000 mln SEK +/-500 mln SEK SE0015244405: 1000 mln SEK +/-500 mln SEK SE0015659529: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)SE0014808747: 1000 mln SEK per bid SE0015244405: 1000 mln SEK per bid SE0015659529: 500 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 11.15 (CET/CEST) on the Bid dateDelivery and payment date2021-06-18Delivery of billsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2021-06-11 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between t
CONDITIONS FOR THE RIKSBANK´S PURCHASES OF COMMERCIAL PAPER11.6.2021 16:20:00 CEST | Press release
Bid procedure, 2021-06-16CertificateCommercial paper issued in SEK by non-financial companies with their registered office in Sweden and with a remaining maturity of up to six months on the Bid date. i.e. with the latest maturity date as of 2021-12-16 Delivery may not be made in commercial paper purchased by the Counterparty from the issuer less than one week prior to the date for announcing the Special terms, i.e. the purchase may not have been made after 2021-06-04 BidsCounterparties may make one bid per Credit rating class and maturity class. Bids are made to tel 08-696 69 70 and confirmed by e-mail to EOL@riksbank.se.Bid date2021-06-16Bid times09.00-09.30 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SEK 4 billionHighest permitted bid volume (corresponding nominal amount)The total bid volume from one Counterparty for the two Credit rating classes may not exceed SEK 4 billion. No bid may contain Commercial paper in excess of SEK 250 million issued by the s
CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK COVERED BONDS11.6.2021 16:20:00 CEST | Press release
Bid procedure, 2021-06-17BondsSWEDBANK HYPOTEK AB: 192. SE0010133207. 2023-03-15 STADSHYPOTEK AB: 1588, SE0011063015, 2024-03-01 SWEDISH COVERED BOND: 151, SE0013486156, 2030-06-12 SKANDINAVISKA ENSKILDA: 581, SE0013102043, 2026-12-16 LANSFORSAKRINGAR HYPOTEK: 519, SE0012324341, 2026-09-16 DANSKE HYPOTEK AB: 2512, SE0013877214, 2025-12-17 NORDEA HYPOTEK AB: 5533, SE0010442731, 2023-09-20 Bid date2021-06-17Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)192: 800 mln SEK +/-400 mln SEK 1588: 2000 mln SEK +/-1000 mln SEK 151: 700 mln SEK +/-350 mln SEK 581: 700 mln SEK +/-350 mln SEK 519: 600 mln SEK +/-300 mln SEK 2512: 200 mln SEK +/-100 mln SEK 5533: 1000 mln SEK +/-500 mln SEK Highest permitted bid volume (corresponding nominal amount)192: 800 mln SEK per bid 1588: 2000 mln SEK per bid 151: 700 mln SEK per bid 581: 700 mln SEK per bid 519: 600 mln SEK per bid 2512: 200 mln SEK per bid 5533: 1000 mln SEK per bid Lowest permitted bid volume