The offering in Ascelia Pharma AB in connection with the listing on Nasdaq Stockholm was, as previously communicated, significantly oversubscribed. The offering provided Ascelia Pharma with approximately SEK 200 million before deductions for expenses related to the offering. The listing on Nasdaq Stockholm gives Ascelia Pharma access to the capital market and creates liquidity in the Company’s shares. The listing also adds new shareholders to the Company which can strengthen Ascelia Pharma’s development and are deemed to have a positive effect on the Company’s relationship with potential partners. The Initial Public Offering generated strong interest amongst notable Swedish and International institutions such as Alto Invest, Handelsbanken Fonder, The Fourth Swedish National Pension fund, Sunstone Capital, and Øresund-Healthcare Capital.
Magnus Corfitzen, CEO of Ascelia Pharma
“We are very pleased and proud of the interest that many quality investors have shown in our company. We will now continue our work with completing the clinical Phase III study and begin commercial preparations for our leading product candidate Mangoral. We can now also commence the Phase II preparations for our second important product candidate, Oncoral."
Vator Securities is the Sole Global Coordinator and Bookrunner in connection with the offering and the Company's financial advisor. Baker McKenzie is legal advisor to Vator Securities. Setterwalls Advokatbyrå is the Company's legal advisor. The issuing agent of the Offering is Erik Penser Bank.
For more information, please contact
Magnus Corfitzen, CEO
Tel: +46 735 179 110
Mikael Widell, IR & Communications Manager
Tel: +46 703 11 99 60
This information is such information as Ascelia Pharma 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 5.30 p.m. CET on 12 March 2019.
About Ascelia Pharma
Ascelia Pharma is an oncology-dedicated orphan drug development company located in Malmö, Sweden. The Company’s strategy is to develop drugs, which target unmet medical needs, have an established mode of action and a relatively low development risk. Ascelia Pharma has two drug candidates currently under development: Mangoral® and Oncoral.
Mangoral® (MR contrast agent ready for the final clinical Phase):
Ascelia Pharma's leading product candidate, Mangoral, is a contrast agent used in Magnetic Resonance Imaging (MRI) to improve the visualization of focal liver lesions (liver metastases). Detecting liver metastases at an early stage is crucial for determining the right treatment method and the patient’s chances of survival.
The target group for Mangoral is patients with severely impaired kidney function who, due to the risk of serious, and potentially fatal, side effects cannot use today's heavy-metal gadolinium-based contrast agents. It is for this specific patient group that Mangoral can provide the contrast agent they currently lack.
Mangoral is now entering clinical Phase III studies (the last clinical Phase before market approval). Patient recruitment for the study is expected to commence during H2 2019 and final results from the study are expected to be presented at the end of 2020/early 2021.
The addressable market for Mangoral is estimated at USD 350–500 million and Mangoral is expected to be the only product on the market in its segment.
Mangoral has received Orphan Drug Designation from the US Food and Drug Administration (FDA). One major advantage of orphan drug status is, among other things, that orphan drugs can obtain market exclusivity for a number of years after market approval (seven years in the US and ten years in the EU/EEA).
Positive response from the FDA on the Phase III study design for Mangoral
The six clinical studies already completed provide strong support for Mangoral and reduce the risks associated with the Phase III study. Ascelia Pharma estimates that Mangoral has greater chances of success in Phase III clinical trials than an average cancer drug. This is due to the known mode of action and a high degree of similarity between the primary endpoints for Mangoral in Phase II and Phase III.
The Phase III program for Mangoral also requires fewer patients compared to typical Phase III studies in oncology; and the follow-up time for patients is only a few days, compared to months or years for a regular oncology Phase III study. For orphan drugs, the time to approval is usually shorter and the proportion of orphan drugs that are approved is higher than for ordinary drugs.
Oncoral (chemotherapy treatment in tablet form, ready for Phase II):
Ascelia Pharma's second drug candidate, Oncoral, is an oral chemotherapy tablet focused on the treatment of gastric cancer. which is also considered an orphan drug indication. Oncoral is taken in tablet form, giving patients the opportunity to take part of their chemotherapy at home and at the same time enabling cost savings for the hospitals.
Oncoral completed Phase I studies in 2018 with promising results that were presented at the European Society for Medical Oncology (ESMO) annual congress. Oncoral is now ready for Phase II development. The clinical development strategy for Oncoral is to obtain Phase II data and then enter into collaborations with a suitable partner for further development, market approval and commercialization.
This announcement is not and does not form a part of any offer for sale of securities.
This announcement is not being made and may not be released, published or distributed, directly or indirectly, into the United States, Australia, Canada, Japan or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.
Any offering of the securities referred to in this announcement will only be made by means of a prospectus. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.
In any EEA Member State other than Sweden that has implemented the Prospectus Directive, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State.
This communication is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “Relevant Persons”). This communication must not be acted on or relied on by persons who are not Relevant Persons. Any investment or investment activity to which this communication relates is available only to Relevant Persons and will be engaged in only with Relevant Persons. Persons distributing this communication must satisfy themselves that it is lawful to do so.
Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intends”, “estimate”, “will”, “may”, "continue", “should” and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.
In connection with the offer or sale of securities referred to herein, the Erik Penser Bank AB may over-allot securities/conduct stabilization or effect transactions with a view to supporting the market price of the securities at a level higher than that which might otherwise prevail. Any stabilisation action or over-allotment will be conducted by the Erik Penser Bank AB in accordance with all applicable laws and rules.