Listing of Isofol Medical on Nasdaq First North Premier and publication of prospectus

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES.

Isofol Medical AB (publ) (”Isofol” or the ”Company”), a clinical stage pharmaceutical company, announced on March 13, 2017, its intention launch an initial public offering and list its shares on Nasdaq First North Premier (“the Offering”). Today, the Company publishes the price and prospectus for the Offering.

The Offering in brief

  • The Offering comprises 14,828,000 newly issued shares , corresponding to approximately 46.9 percent of the outstanding shares and votes after the Offering.
  • In addition, in order to cover any overallotment, the Company has committed to, upon Pareto Securities’ request, issue a maximum of an additional 1,482,800 new shares in the Company, corresponding to a maximum of 10 percent of the shares included in the Offering (the "Overallotment Option" ).
  • If the Overallotment Option is fully exercised, the Offering will comprise a maximum of 16,310,800 shares, corresponding to approximately 49.3 percent of the total number of shares in the Company after the Offering.
  • The Offering will be conducted at a fixed price of SEK 29 per share, corresponding to a total value of the Company’s shares of SEK 487 million, before the Offering.  
  • The new share issue that is conducted as a part of the Offering is expected to render proceeds of
    SEK 430–473 million to the Company before transaction costs, depending on the extent of the exercise of the Overallotment Option.
  • In total, the Company has received subscription commitments of SEK 235 million or 55 percent of the Offering excluding the Over-allotment Option.
    - A number of Swedish and international institutions have committed to, under certain conditions and at the same price as other investors, subscribe for a total of circa SEK 215 million or 50 percent of the Offering excluding the Over-allotment Option. These subscription commitments consist of, among others, the Cornerstone Investors: Handelsbanken Fonder (SEK 50 million) and AFA Försäkring (SEK 20 million).
    - In addition, a number of existing shareholders have subscribed for shares in the Offering corresponding to circa SEK 20 million.
  • Isofol has applied for listing of the Company’s shares on Nasdaq First North Premier in Stockholm. Expected first day of trading of Isofol’s shares is April 4, 2017, under the ticker “ISOFOL” and expected settlement day is April 6, 2017.
  • A prospectus with full terms and conditions is published today March 20, 2017, on Isofol’s website and on Pareto Securities’ website.
  • Pareto Securities is acting as Global Coordinator and Sole Bookrunner, Avanza and Nordnet are Selling Agents and Vinge is the legal advisor in connection with the Offering.

Background to the Offering
The primary purpose of the Offering is to fund the market registration study for Isofol’s drug candidate Modufolin®, which study will be conducted in first line treatment of patients with metastatic colorectal cancer. Given a successful study, Isofol expects to receive regulatory approval for Modufolin® within this indication. In addition, as part of Isofol’s development plan for Modufolin®, the Company is planning to conduct studies within rescue therapy following high-dose methotrexate treatment of osteosarcoma patients as well as other supporting studies aiming at benefitting Modufolin’s® route to market.

Furthermore, the Board and management of Isofol believe that the Offering is a logical and important next step in the Company’s development and will further increase awareness among current and potential partners, customers and key opinion leaders within the pharmaceutical industry. The Offering will also expand Isofol’s shareholder base and improve the Company’s access to Swedish and international capital markets, which is expected to support the Company’s continued development. For these reasons, the Board has applied for a listing on Nasdaq First North Premier.  

Anders Rabbe, CEO, comments:
“We have had a good journey and we are now very close to the goal of being able to offer hundreds of thousands of cancer patients a significantly improved outlook. There has been a large interest among institutional investors, with investors such as Handelsbanken Fonder and AFA Försäkring leading the pack and with several others behind them. We now face the pivotal clinical study aimed to get our drug Modufolin approved for treatment of colorectal cancer. We have regulatory support from both the EMA and FDA for our clinical development program and results from ongoing studies are very promising.”

Jan-Eric Österlund, Chairman of the Board, comments:
“We are very proud that the current owners have had the ability and interest to finance the company all the way through development until the crucial final clinical study. However, in order to verify the effectiveness of Modufolin, we need additional resources and an IPO will give us this opportunity. A large proportion of patients still don’t respond to the cancer treatment, and we hope to improve the lives of many of these with Modufolin. It is rare to encounter an opportunity that combines patient benefits with commercial opportunities as clearly as with Modufolin. I would therefore like to, on behalf of the company, welcome institutions and the general public to subscribe for shares in the IPO and take part in the company's future development.”

Prospectus and application form
Prospectus and application form are published on Isofol’s website isofol.se/en/ipo/ and on Pareto Securities’ website www.paretosec.com/corp/isofolmedical . Application can also be made through Avanza’s internet service www.avanza.se and Nordnet’s internet service www.nordnet.se .

Preliminary timetable

Application period for the general public: March 21, 2017–March 31, 2017
Application period for institutional investors: March 21, 2017–April 3, 2017
Notification about allotment: April 4, 2017
First day of trading on Nasdaq First North Premier: April 4, 2017
Settlement day: April 6, 2017

Third most common cancer
Colorectal cancer is the third most common cancer, affecting both men and women, and is the third leading cause of cancer-related death. Approximately 1.35 million people per year are diagnosed with the disease worldwide. In the US, Western Europe and Japan, where an estimated 550,000 patients are diagnosed with colorectal cancer, about 365,000 patients annually receive a treatment regimen including 5-FU and the folate leucovorin or levoleucovorin, which Isofol is aiming to replace with Modufolin®.

About Isofol Medical AB (publ)
Isofol is a clinical stage oncology company developing Modufolin® as a first-line treatment of metastatic colorectal cancer and as a rescue drug after high-dose methotrexate treatment in osteosarcoma. Isofol aims to replace the existing folate-based compounds leucovorin and levoleucovorin, which today are considered the standard treatment within these indications. Through an exclusive license agreement, Isofol Medical holds all rights to commercialising Modufolin® globally for cancer treatment with access to the unique patented production process and the production capabilities of Merck KGaA, Darmstadt, Germany.

About Modufolin®
Modufolin® (active ingredient [6R]-5,10-methylenetetrahydrofolate), is a novel folate-based compound developed to increase the efficacy and reduce the side effects of antimetabolites used in cancer treatment. It is the key active metabolite of the widely used folate-based drugs leucovorin and levoleucovorin, and therefore does not require metabolic activation. This makes Modufolin® suitable for all patients irrespective of their genetical capacity to activate folates, and it is currently being evaluated in two clinical Phase II studies.

For additional information, please contact:
Anders Rabbe, CEO, Isofol
Mob: +46 70 764 65 00
Email: anders.rabbe@isofolmedical.com  

Jan-Eric Österlund, Executive Chairman of the Board, Isofol
Mob: +44 77 853 68 155
Email: jan-eric@osterlund.co.uk  

Important information
This announcement is not and does not form a part of any offer for sale of securities. Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, New Zealand, Hong Kong, 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 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.

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