Santhera takes stock of the company and convenes an extraordinary general meeting to obtain the approval of other financing
Ad hoc announcement in accordance with art. 53 LR
Pratteln, Switzerland, 24 november, 2021 – Santhera Pharmaceuticals (SIX: SANN) takes stock of its activities and is call a Extraordinary General assembly (EDG), who will stand on December 15, 2021, at 10:30 am at the domicile of the Company. At the EGM, Santhera requests authorization for additional funding to enable the prosecution pipeline development and preparations for the marketing of vamorolone.
During this year, Santhera made significant progress in its pipeline development and organizational restructuring, resulting in a significantly lower cost base, and the Company implemented various measures to strengthen its capital structure.
Vamorolone for the treatment of Duchenne muscular dystrophy (DMD)
On November 17, 2021, following the announcement of the positive 24-week results of VISION-DMD,
pivotal phase 2b study on June 2, 2021, Santhera announced the positive outcome of a first pre-NDA meeting with the United States Food and Drug Administration (FDA) in which the FDA agreed that (i) the efficacy of vamorolone, as demonstrated in the 24-week double-blind phase of the pivotal VISION-DMD study supports a demand for NDA and that (ii) the results of the 24-week double-blind phase Weeks of the pivotal VISION-DMD study and open-label studies provide sufficient safety data to support an NDA record of vamorolone for the treatment of DMD. The FDA also noted in its response that as a synthetic steroid vamorolone may have potential public health benefits for other indications. On this basis, Santhera will continue to collaborate with the FDA and assess the opportunities for indications beyond DMD. Additionally, on November 23, 2021, Santhera announced the completion and positive results of the 48-week VISION-DMD study with vamorolone. Santhera expects a continuous filing of NDAs for vamorolone in DMD in the first quarter of 2022 in the US and a filing in the EU in the second quarter of 2022. One would expect a decision from the FDA be obtained in the fourth quarter of 2022 (if Santhera obtains priority review (based on the accelerated designation previously granted by the FDA)). Santhera plans to launch vamorolone soon after FDA approval with her own organization that she is currently setting up in the United States under the leadership of new North America president, Stephanie Brown, and main European markets. Santhera is looking for collaborations outside of these regions for DMD and for additional indications worldwide. Santhera estimates that the leading product sales potential for vamorolone in the DMD indication alone is over $ 500 million in the United States and the five largest European countries combined.
Lonodelestat, a neutrophil elastase (hNE) inhibitor being developed to treat cystic fibrosis (CF)
Following the positive results of the Phase 1b study announced in March 2021, Santhera will continue the clinical development program to advance lonodelestat for the treatment of cystic fibrosis and potentially other inflammatory lung conditions, whether acute or chronic.
During the first three quarters of 2021, Santhera implemented various measures to strengthen its capital structure. A partial restructuring of our convertible bonds of 60 million francs maturing in February 2022 (2017/22 CB), which included the issue of CHF 30,270,375 convertible bonds maturing in July 2024 (2021/24 CB), resulted in an outstanding repayment obligation under CB 2017/22 of just over CHF 15 million. In September 2021, Santhera issued a private convertible bond in the amount of CHF 15 million. Santhera will use the proceeds of this bond to fully repay the 2017/22 OC. As a result of this restructuring, it is not until 2024 that Santhera will have to repay a principal amount of up to CHF 19,561,500 under the 2021/24 BC (the balance of the 2021/24 BC having already been converted. ) and a principal amount of CHF 15 million in respect of the newly issued private convertible bond. On September 27, 2021, the Company announced that it had secured funding of CHF 45 million via an oversubscribed equity financing of CHF 20 million, a placement of the CHF 15 million private convertible bond mentioned above and the ‘increase of an existing financing agreement from to 10 million francs. This funding secures Santhera’s liquidity needs until mid-2022, following the filing of the NDA for vamorolone in the United States which is currently scheduled for the first quarter of 2022.
EGM for funding purposes
Santhera will need additional funding in 2022 to allow further pipeline development and preparations for the commercialization of vamorolone. To this end, the Board of Directors (CA) convenes an Extraordinary General Meeting (EGM), to be held on December 15, 2021, and proposes various capital increases to Santhera shareholders. These should give the Company a flexible instrument allowing the Board of Directors to issue, without delay, new shares for financing purposes at a favorable time for Santhera and to use these shares as the underlying of the bonds. delivery of existing Santhera shares that must otherwise be backed by shares. from other sources as well as to enable continued pipeline development and preparations for the commercialization of vamorolone.
The Board proposes:
Ordinary capital increase from CHF 20,000,000 to CHF 74,607,810 by issuing 20,000,000 fully paid registered shares with a nominal value of CHF 1 each.
Increase of authorised capital from CHF 11,862,424 per CHF 15,441,481 to CHF 27,303,905 and its extension until December 14, 2023.
Increase of conditional capital for financing from CHF 15,038,128 to CHF 21,878,228.
The above figures do not reflect any issuance of shares of authorized or conditional capital that could take place before the EGM.
If the ordinary capital increase can be fully consumed within three months from the date of the EGM, in a second step, the authorized capital and the conditional capital for the financing will be increased again by CHF 10,000,000 each. .
Invitation and agenda items for the EGM
The invitation and the items on the agenda of the Extraordinary General Meeting can be viewed on the Santhera website at https://www.santhera.com/investors-and-media/investor-toolbox/ share-bondholder-meetings.
Due to exceptional circumstances and in accordance with applicable Covid-19 legislation, shareholders may exercise their rights at the EGM exclusively through the independent proxy. It is not possible to attend the EGM in person.
Santhera Pharmaceuticals (SIX: SANN) is a Swiss pharmaceutical company specializing in the development and commercialization of innovative drugs for rare neuromuscular and pulmonary diseases with high unmet medical need. Santhera holds an exclusive license for all indications worldwide for vamorolone, a first-class dissociative steroid with a novel mode of action, which was investigated in a pivotal study in patients with DMD as a alternative to standard corticosteroids. The clinical stage pipeline also includes lonodelestat to treat cystic fibrosis (CF) and other neutrophilic lung diseases, as well as an exploratory gene therapy approach targeting congenital muscular dystrophies. Santhera has licensed the rights to its first approved product, Raxone® (idebenone), outside of North America and France for the treatment of Leber’s hereditary optic neuropathy (LHON) to the Chiesi Group. For more information, please visit www.santhera.com.
Raxone® is a registered trademark of Santhera Pharmaceuticals.
Disclaimer / Forward-looking statements
This communication does not constitute an offer or an invitation to subscribe or buy shares of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its activities. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial position, performance or achievements of the Company to differ materially from those expressed or implied by such statements. Readers should therefore not place undue reliance on such statements, particularly in relation to a contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.
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