NOXXON Pharma N.V. hereby announces the launch and terms of a share capital increase with shareholders’ preferential rights for an amount of up to € 3.9 million.
Berlin, Germany, June 26, 2019, 8.00 a.m. CEST - NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX, the “Company”), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), hereby announces today the launch and terms of a share capital increase with shareholders’ preferential rights for an amount of up to € 3.9 million (issue premium included) (the “Rights Issue”).
Subscription ratio: 3 New Shares for 5 subscription rights presented
Subscription price: € 0.65 per share (15.7% discount on the closing price on the day before the decision of the Board of Directors on this transaction – June 24, 2019)
Each shareholder on June 28 at closing will receive 1 right per share held to subscribe in preference to the transaction
Rights trading period: from July 1 to 15, 2019 (inclusive)
Subscription period: from July 3 to 17, 2019 (inclusive)
Based on the additional funds provided by this right issue, the Company could finance its clinical pipeline independently for the next 12 months.
NOXXON has translated a validated RNA-based platform into two clinical-stage drug candidates addressing critical molecular pathways to treat solid tumors:
- NOX-A12: Targeting the adaptive immune system through the chemokine CXCL12, key player in the tumor microenvironment
- Compelling activity and safety data from the Phase 1/2 anti-PD-1 (pembrolizumab) combo trial in metastatic, microsatellite-stable colorectal and pancreatic cancer, collaboration with Merck & Co./MSD
- Company primed to start 1st line treatment in brain cancer trial combining NOX-A12 and radiotherapy in Q3 2019
The NOX-A12 and NOX-E36 are also currently the subject of 15 ongoing academic collaborations. In addition, as disclosed on Monday June 24, 2019, a leading international pharmaceutical company amongst the top-10 pharmaceutical companies by worldwide revenue is testing NOX-A12 in a new indication, which will remain undisclosed for competitive reasons. The market for this new indication has been valued at more than a billion Euros.
- NOX-E36: Complementary mechanism of action targeting the innate immune system through the chemokine CCL2 involved in the recruitment of immuno-suppressive tumor associated macrophages
- Established safety and on-target activity in multiple non-oncology clinical trials
- Preclinical data showing monotherapy activity in solid tumors
NOXXON’s pipeline
The pipeline addresses solid tumors with significant unmet medical needs despite the advances of immune-oncology and targeted therapies using a unique tumor microenvironment approach.
NOX-A12 consistently triggered an immune response in tumor tissue above a certain threshold of target neutralization in both pancreatic and colorectal cancer tissue. In heavily pretreated patients the combination of NOX-A12 + Keytruda® yielded 25% stable disease and 35% with longer time on treatment than prior therapy. Overall survival for these patients compared favorably with that of approved drugs with 48% at 6 months and 33% at 12 months. NOXXON has designed subsequent trials that could lead to approval and would initiate such studies with the support of a pharma partner. The combination of NOX-A12 with radiotherapy in a relevant brain cancer preclinical model showed 100% complete responses of which 66% were durable. The upcoming clinical study would assess the safety and efficacy of multiple doses of NOX-A12 combined with radiotherapy in first line brain cancer patients. Subsequent studies may target other brain cancer populations including rare pediatric indications where there is potential both for breakthrough status and other regulatory advantages.
The proceeds of the capital increase would be allocated 60% to advancing the Company’s pipeline, including initiation of the NOX-A12 and radiotherapy trial in brain cancer and completion of patient follow-up from the pancreatic and colorectal cancer trial, as well as for further preclinical work on the NOX-E36 molecule. The remaining funds would be dedicated to finance the Company’s other operating expenses including general and administrative costs.
In case the transaction is not fully subscribed, it should be noted that NOXXON:
- has issued warrants to Acuitas, Yorkville and Kreos, that could bring complementary cash to the Company in case they would be exercised by their owners.
- expects to be able to sign out-licensing or co-development partnerships with top pharma groups, obtaining upfronts or milestones payments by licensing its proprietary molecules NOX-A12 and NOX-E36.
As at the date of publication of the current press release, the Company anticipates its cash needs for the next 12 months to be covered based on the present capital increase, under the conditions and the limits stated above.
“We are encouraged by the recent demonstrated interest in NOXXON’s compounds from pharma companies and are confident that we will be able to secure additional partnerships. Securing these funds will provide the company with additional leverage in these negotiations,” said Aram Mangasarian, CEO of NOXXON.
For more detailed information please see the annex of this press release.
Please contact:
NOXXON Pharma N.V.
Aram Mangasarian, Ph.D., Chief Executive Officer
Tel. +49 (0) 30 726247 0
amangasarian@noxxon.com
MC Services AG
Raimund Gabriel, Managing Partner
Tel. +49 (0) 89 210228 0
noxxon@mc-services.eu
Trophic Communications
Gretchen Schweitzer or Joanne Tudorica
Tel. +49 (0) 89 2388 7730 or +49 (0) 176 2103 7191
schweitzer@trophic.eu
NewCap
Alexia Faure
Tel. +33 (0) 1 44 71 98 51
afaure@newcap.fr
About NOXXON
NOXXON’s oncology-focused pipeline acts on the tumor microenvironment (TME) and the cancer immunity cycle by breaking the tumor protection barrier and blocking tumor repair. By neutralizing chemokines in the tumor microenvironment, NOXXON’s approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and enable greater therapeutic impact. Building on extensive clinical experience and safety data, the lead program NOX-A12 has delivered top-line data from a Keytruda® combination trial in metastatic colorectal and pancreatic cancer patients in December 2018 and further studies are being planned in these indications. The company initiated preparations for an additional trial with NOX-A12 in brain cancer in combination with radiotherapy. The combination of NOX-A12 and radiotherapy has been granted orphan drug status in the US and EU for the treatment of certain brain cancers. The company’s second clinical-stage asset NOX-E36 is a Phase 2 TME asset targeting the innate immune system. NOXXON plans to test NOX-E36 in patients with solid tumors both as a monotherapy and in combination. Further information can be found at: www.noxxon.com
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp
Disclaimer
Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The Company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The Company is neither responsible nor liable for updating such information, which only represents the state of affairs on the day of publication.
This press release, and the information it contains, does not constitute an offer to sell or subscribe, or the solicitation of an order to buy or subscribe for NOXXON shares in any country.
In France, pursuant to the provisions of Article L.411-2 of the French Monetary and Financial Code and Article 211-2 of the AMF General Regulation, the present issue will not give rise to preparation of a Prospectus in the meaning of the Prospectus Directive (as defined below), because the total amount of the offer is less than € 8,000,000.
The distribution of this press release in certain countries may constitute a violation of the legal provisions in force. Persons physically present in these countries and for whom this press release is being issued must inform themselves of such restrictions and comply with them.
This press release does not constitute a prospectus within the meaning of Directive 2003/71 / EC of the European Parliament and of the Council of November 4, 2003 as amended, in particular by Directive 2010/73 / EU of the European Parliament and of the Council of November 24, 2010, as amended and as transposed in each of the member states of the European Economic Area (the “Prospectus Directive”).
With regard to the member states of the European Economic Area (the “Member States”), other than France, having transposed the Prospectus Directive, no action has been taken and will be undertaken to allow an offer to be made to the public of the actions covered by this press release making it necessary to publish a prospectus in one or other of the Member States. As a result, the shares may only be offered and will be offered in Member States only by virtue of an exemption under the Prospectus Directive.
The shares that would be issued in connection with this capital increase have not been and will not be registered under the US Securities Act of 1933, as amended (the “US Securities Act”) and may not be offered or assigned to any United States of America without registration or exemption from registration under the US Securities Act. NOXXON does not intend to register the offer, in whole or in part, in the United States of America, nor to make an offer to the public in the United States of America.
This announcement does not constitute an offer to the public of securities in the United Kingdom. It is intended only for those who are considered as (i) investment professionals (persons with professional investment experience) within the meaning of Article 19 (5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended, the “Ordinance”), (ii) being persons falling within the scope of section 49 (2) (a) to (d) (“high net corporations, unincorporated associations, etc. ") of the Ordinance, or (iii) persons to whom an invitation or an incentive to participate in an investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000) in the context of the issue or sale of financial securities could be lawfully addressed (all these persons being referred to together as the “Authorized Persons”). Anyone other than an Authorized Person must refrain from using or hitting on this release in the UK. Any investment or investment activity related to this press release may only be carried out by Authorized Persons.
The information contained in this release does not constitute an offer of securities in the United States, Canada, Australia, Japan or any other country. This press release must not be published, transmitted or distributed, directly or indirectly, in the United States, Canada, Australia or Japan.
