Category: news

November 2, 2020 at 1:00 AM EST

This is a joint press release by Sanofi (“Sanofi“) and Kiadis Pharma N.V. (“Kiadis“), pursuant to the provisions of Section 4, paragraphs 1 and 3, Section 5, paragraph 1 and Section 7, paragraph 4 of the Netherlands Decree in Public Takeover Bids (Besluit openbare biedingen Wft) (the “Decree“) in connection with the intended public offer by Sanofi for all the issued and outstanding ordinary shares in the capital of Kiadis (the “Offer“). This announcement does not constitute an offer, or any solicitation of any offer, to buy or subscribe for any securities. Any offer will be made only by means of an offer memorandum (the “Offer Document“) approved by the Dutch Authority for the Financial Markets (Autoriteit Financiële Markten) (the “AFM“) and recognized by the Belgian Authority for the Financial Markets (Autoriteit voor Financiële Diensten en Markten) (the ”FSMA”). This announcement is not for release, publication or distribution, in whole or in part, in or into, directly or indirectly, the United States, Canada and Japan or in any other jurisdiction in which such release, publication or distribution would be unlawful.

Sanofi offers to acquire Kiadis for €308 million

Transaction highlights 

• Kiadis and Sanofi have reached conditional agreement on a recommended all-cash public offer (the “Offer“) by Sanofi for Kiadis of EUR 5.45 in cash (cum dividend) (the “Offer Price“) for each issued and outstanding ordinary share in the capital of Kiadis (the “Shares“) representing an aggregate adjusted equity value of EUR 308 million¹
• The Offer Price represents a premium of 272% over the closing price on 30 October 2020, a premium of approximately 247% over the 30 trading days VWAP and a premium of approximately 200% over the 90 trading days VWAP
• Kiadis’ proprietary next generation NK-cell technology platform and pipeline complements Sanofi’s existing therapeutic expertise
• Sanofi’s infrastructure and capabilities will be leveraged to advance the development of Kiadis’ pipeline
• Kiadis’ Boards unanimously support and recommend the Offer and believe the Offer is a fair reflection of the Kiadis’ potential, given the risk/reward typical to a biotech company and the capital required to execute its business plan; additionally they believe that the Transaction is in the best interests of Kiadis, the sustainable success of its business, its shareholders, patients, employees, business partners and other stakeholders
• Funds managed by Life Sciences Partners have irrevocably committed to Sanofi to support the Offer and tender their 18.3%² shareholding in the Offer
• The Offer is subject to certain customary conditions, including obtaining required competition clearance, and is expected to complete in the first half of 2021
• Kiadis to hold conference call for investors and analysts at 13:00 CET today

       
Paris, France and Amsterdam, The Netherlands, 2 November 2020 – Sanofi (Euronext: SAN and NYSE: SNY) and Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS) today announce that they have entered into a definitive merger agreement under which Sanofi will offer to acquire all of the outstanding ordinary shares of Kiadis at a price per Kiadis share of €5.45 in cash (272% premium to the closing price on 30 October 2020), representing an aggregate adjusted equity value of approximately €308 million. The Kiadis Management Board and Supervisory Board unanimously approve the intended transaction and recommend the Offer to holders of Kiadis’ Shares.

John Reed, M.D., Ph.D., Global Head of Research and Development of Sanofi, commented, “We believe Kiadis’ ‘off the shelf’ K-NK cell technology platform will have broad application against liquid and solid tumors, and create synergies with Sanofi’s emerging immuno-oncology pipeline, providing opportunities for us to pursue potential best-in-disease approaches.”

Arthur Lahr, Chief Executive Officer of Kiadis, commented, “Kiadis’ vision is to bring novel cell-based medicines to people with life-threatening diseases, and this transaction will help achieve that vision. After the discontinuation of our lead product candidate and subsequent reorganization in 2019, we restarted Kiadis early in 2020 as an entirely new company focused solely on the proprietary and differentiated NK-cell platform that we obtained through the acquisition of CytoSen Therapeutics. Sanofi’s offer is a clear testimony to the uniqueness of our NK-cell platform and the rapid success of Kiadis’ transformation. The Kiadis Boards unanimously believe that Sanofi has the resources and financial strength to accelerate development of our NK-cell products, to the benefit of patients. We believe this transaction represents compelling value to shareholders and offers a fair reflection of the potential of our platform and pipeline, given the risk/reward profile typical to biotech and the capital required to execute our business plan. Finally, this transaction will provide excellent career opportunities for our employees, who will be viewed by Sanofi as their internal cell-therapy experts.” 

Strategic rationale
Innovative K-NK-cell Platform
Kiadis’ proprietary platform is based on allogeneic or ‘off-the-shelf’ NK-cells from a healthy donor. NK-cells seek and identify malignant cancer cells and have broad application across various tumor types. The platform has the potential to make products rapidly and economically available for a broad patient population across a wide range of indications.

Kiadis’ NK cell-based medicines will be developed alone and in combination with Sanofi’s existing platforms.

Complementary Strong Science to Generate First-in-Class Medicines and Strategic Fit Across Core Therapeutic Areas 
Sanofi’s research, development, manufacturing and commercial expertise will be leveraged to advance Kiadis’ pipeline, which includes NK-cell-based medicines for the treatment of patients undergoing hematopoietic stem cell transplant, liquid and solid tumors, as well as infectious disease.

In July 2020, Sanofi licensed Kiadis’ pre-clinical K-NK004 program for multiple myeloma.

Kiadis’ pipeline of NK-cell therapies has the potential to deliver adjunctive therapy for patients undergoing hematopoietic stem cell transplantation or who have acute myeloid leukemia (AML). 

• K-NK002 is in a Phase 2 study evaluating NK-cells to prevent post-transplant relapse in patients with AML and myelodysplastic syndromes. The trial will be conducted in collaboration with premier U.S. transplant centers.
• K-NK003 is in a Phase 1 study evaluating NK-cells for patients with relapsed or refractory AML.
• KNK-ID-101 is a program evaluating the properties of K-NK cells and their suitability to fight SARS-CoV-2 and the option to develop K-NK cells as a post-exposure pre-emptive therapy for COVID-19 in high risk patients. Kiadis plans to initiate a Phase 1/2a clinical trial evaluating the use of K-NK cells to treat COVID-19 patients with government grant funding.

Accelerates the clinical development and broadens patient reach of current Kiadis pipeline
Subject to the completion of the Offer, Sanofi will provide the resources and capabilities necessary to accelerate the development of current Kiadis programs for the treatment of blood tumors, solid cancers and infectious diseases, maximizing their potential to the benefit of patients.

Transaction details
The proposed transaction envisions the acquisition of the Shares of Kiadis pursuant to a recommended public offer by Sanofi. The Offer Price represents an implied equity value for 100% of Kiadis on a fully diluted basis of EUR 308 million.

The Offer Price, delivering immediate, certain and significant value to Kiadis’ shareholders, represents the following premiums:

• a premium of 272% to Kiadis’ closing price on 30 October 2020 of EUR 1.464;
• a premium of 247% to Kiadis’ volume-weighted average price for the 30 trading days up to and including 30 October 2020 of EUR 1.571; and
• a premium of 200% to Kiadis’ volume-weighted average price for the 90 trading days up to and including 30 October 2020 of EUR 1.819.

Support and recommendation by the Boards 
This announcement follows constructive interactions between the companies. Kiadis’ Management Board and Supervisory Board (together, the “Boards“) have frequently discussed the developments of the proposed transaction and the key decisions in connection therewith throughout the process. Consistent with their fiduciary responsibilities, the Boards, with the support of their financial and legal advisors, have given careful consideration to all aspects of the proposed transaction. Having taken the interests of all stakeholders into account the Boards have unanimously concluded that the Offer is in the best interests of Kiadis, the sustainable success of its business, its shareholders, employees, patients, business partners and other stakeholders.

Accordingly, the Boards have decided to fully support and recommend the Offer to the holders of the Shares and to furthermore recommend the holders of the Shares to vote in favor of the resolutions relating to the Offer (the “Resolutions“) at the upcoming extraordinary general meeting of Kiadis (the “EGM“) to be held during the offer period. Furthermore, all members of the Boards who hold Shares for their own account have committed to tender all those Shares into the Offer.

Acquisition of 100%
Sanofi’s willingness to pay the Offer Price and pursue the Offer is predicated on the acquisition of 100% of the Shares or the entirety of Kiadis’ assets and operations, the ability to delist Kiadis, and the ability to fully integrate the respective businesses of Kiadis and Sanofi and realize the operational, commercial, organizational, financial and tax benefits of the combination of the parties. Such benefits could not, or would only partially, be achieved if Kiadis were to continue as a standalone entity with a minority shareholder base. As soon as possible following the settlement of the Offer, Kiadis and Sanofi shall seek to procure delisting of the Shares on Euronext Amsterdam and Euronext Brussels.

If Sanofi acquires at least 95% of the Shares, Sanofi shall commence statutory squeeze-out proceedings, unless Sanofi and Kiadis after reasonable consultation, taking into account the interests of the remaining stakeholders and other relevant circumstances, agree that Sanofi can pursue the Post-Offer Restructuring (as defined below).

If the Shares held by Sanofi after expiry of the post acceptance period of the Offer will represent at least 80% and less than 95% of Kiadis’ aggregate issued and outstanding ordinary share capital on a fully diluted basis or such lower percentage as may be agreed between Sanofi and Kiadis prior to settlement and the Offer being declared unconditional, Sanofi will have the right to pursue an asset sale and liquidation (the “Asset Sale“) whereby Kiadis will sell and transfer all of its assets and liabilities to Sanofi against payment of a purchase price equal to the offer consideration (the “Sale Price”). Following the completion of the Asset Sale, Kiadis will effectuate the dissolution and liquidation of Kiadis (the “Company Dissolution” and, together with the Asset Sale, the “Post-Offer Restructuring“) and make an advance liquidation distribution per Share that is intended to take place on or about the date the Asset Sale is completed and in an amount that is to the fullest extent possible equal to the Offer Price, without any interest and less any applicable withholding taxes and other taxes. The Post-Offer Restructuring is subject to Kiadis’ shareholders’ approval at the EGM to be held prior to closing of the offer period.

Sanofi and Kiadis may explore and agree on potential alternative Post-Offer Restructurings, such as a combination of a statutory legal (triangular) merger and a sale of the shares in the surviving successor of Kiadis to Sanofi.

Sanofi may utilize all other available legal measures in order to acquire full ownership of Kiadis’ outstanding Shares and/or its business in accordance with the terms of the Merger Agreement.

Fairness opinions

Moelis & Company LLC (“Moelis”), acting as exclusive financial advisor to Kiadis, has issued a fairness opinion to the Boards as to the fairness, as of such date, and based upon and subject to the factors, assumptions, qualifications and other matters set forth in the fairness opinion, to the effect that each of the Offer Price and the Sale Price is fair to the holders of Shares from a financial point of view. The full text of such fairness opinion, which sets forth the assumptions made, procedures followed, matters considered and limitations on the review undertaken in connection with such opinion, will be included in the Boards’ position statement.

The support and recommendation of the Boards, and the obligations of Sanofi in relation thereto, are subject to the terms and conditions of the Merger Agreement.

Irrevocable undertaking from Life Sciences Partners

Funds managed by Life Sciences Partners have committed to tender approximately 18.3%³ of the outstanding Shares under the Offer, if and when made, and to vote in favor of the Resolutions. The irrevocable undertaking contains certain customary undertakings and conditions.

Certain funds
Sanofi intends to finance the Offer by utilizing available cash resources.

Non-financial covenants  
Kiadis and Sanofi have agreed to certain non-financial covenants in respect of, amongst others, corporate governance, strategy, employees, financing and disposals for a duration of 18 months after settlement of the Offer (the “Non-Financial Covenants“), including the covenants summarized below.

Corporate governance

It is envisaged that upon completion of the Offer the Supervisory Board of Kiadis will be composed of:

• Three members to be identified by Sanofi prior to the launch of the Offer;
• Two members qualifying as independent within the meaning of the Dutch Corporate Governance Code whereby these two members will be current members of the Supervisory Board to be identified prior to the launch of the Offer. The independent members will continue to serve for at least one year from settlement of the Offer or, if later, until the earliest of (i) the date on which all Shares are held by Sanofi, (ii) the date on which Sanofi has irrevocably initiated statutory buy-out proceedings and the Offer Price is deemed to be the fair price (billijke prijs) pursuant to section 2:359c(6) of the DCC, (iii) the date on which the Enterprise Chamber of the Amsterdam Court of Appeal has determined the price payable by Sanofi to the other shareholders pursuant to statutory buy-out proceedings, and (iv) the date on which, following the Post-Offer Restructuring, the holders of Shares have received the liquidation distribution.

It is envisaged that upon completion of the Offer the Management Board of Kiadis will be composed of the members of Kiadis’ Management Board as per the date of the Merger Agreement and may be expanded with one additional member to be identified by Sanofi prior to launch of the offer.

Organization / location

There will be R&D and CMC activities at the Company’s offices in Amsterdam, the Netherlands.

Sanofi is focused on ensuring that the Company group’s key management and key staff is retained and offered suitable career opportunities.

Sanofi fosters a culture of excellence, where qualified employees are offered suitable training and career progression.

Employees

There will be no material redundancies with respect to the Company group’s employees as a direct consequence of the Offer and necessary redundancies going forward will be part of an integration committee process.

The existing rights and benefits of the Company group’s employees shall be respected by Sanofi, including existing rights and benefits under their individual employment agreements and (at least) existing redundancy practices applied by the Company’s group.

Any redundancies that need to occur will be done in accordance with all legal requirements.

The existing pension rights of the Company group’s current and former employees shall be respected by Sanofi.

Following settlement of the Offer, the nomination, selection and appointment of staff for functions within Sanofi’s group’s NK activities will, subject to the applicable rules, be based on the “best person for the job” principle, or, where not feasible or appropriate, or non-discriminatory, fair and business-oriented transparent set of criteria.

Financing

It is intended that the Company remains prudently financed to safeguard the continuity of the business and to continue the Company’s current business strategy including R&D and pipeline.

Sanofi will allocate suitable resources for the Company’s R&D and CMC activities.

Pre-Offer and Offer Conditions
The commencement of the Offer is subject to the satisfaction or waiver of pre-offer conditions customary for a transaction of this kind, including:

• no material adverse effect having occurred and is continuing;
• no material breach of the Merger Agreement having occurred;
• the AFM having approved the offer document;
• the FSMA having recognized the offer document;
• no revocation or amendment of the recommendations by the Boards;
• no Superior Offer (as defined below) having been agreed upon by the third-party offeror and Kiadis, or having been launched;
• no third party being obliged and has announced to make, or has made a mandatory offer pursuant to Dutch law for consideration that is at least equal to the Offer Price;
• no order, stay, injunction, judgment or decree having been issued prohibiting or materially delaying the making of the Offer and/or the Post-Offer Restructuring;
• no notification having been received from the AFM stating that the preparations for the Offer are in breach of the Dutch offer rules or that one or more investment firms will not be allowed to cooperate with the Offer; and
• trading in the Shares on Euronext Amsterdam or Euronext Brussels not having been suspended or ended as a result of a listing measure (noteringsmaatregel) by Euronext Amsterdam or Euronext Brussels.

If and when made, the consummation of the Offer will be subject to the satisfaction or waiver of offer conditions customary for a transaction of this kind, including:

• minimum acceptance level of at least 95% of Kiadis’ issued share capital on a fully diluted basis which will be automatically adjusted to 80% of Kiadis’ issued share capital on a fully diluted basis if the Resolutions in connection with the Post-Offer Restructuring are passed at the EGM provided, however, that Sanofi may waive, to the extent permitted by applicable laws and regulations, the minimum acceptance level conditions without the consent of Kiadis if the acceptance level is at least 66.67% of Kiadis’ issued share capital on a fully diluted basis;
• competition clearances having been obtained;
• no material breach of the Merger Agreement having occurred;
• no material adverse effect having occurred and is continuing;
• no revocation or amendment of the recommendations by the Boards;
• no recommended Superior Offer (as defined below) having been agreed upon by the third-party offeror and Kiadis, or having been launched;
• no third party being obliged and has announced to make, or has made a mandatory offer pursuant to Dutch law for consideration that is at least equal to the Offer Price;
• no governmental or court order having been issued prohibiting the consummation of the transaction or the Post-Offer Restructuring;
• no notification having been received from the AFM stating that the preparations for the Offer are in breach of the Dutch offer rules or that one or more investment firms will not be allowed to cooperate with the Offer; and
• trading in the Shares on Euronext Amsterdam or Euronext Brussels not having been suspended or ended as a result of a listing measure (noteringsmaatregel) by Euronext Amsterdam or Euronext Brussels.

The Offer Conditions will have to be satisfied or waived ultimately on 31 December 2021.

Termination
On termination of the Merger Agreement by Sanofi on account of a material breach of the Merger Agreement by Kiadis or in case the Merger Agreement is terminated by either Kiadis or Sanofi pursuant to a Superior Offer that is not matched by Sanofi (see below), Kiadis will forfeit a gross EUR 2,880,600 termination fee to Sanofi.

On termination of the Merger Agreement by Kiadis, because of a material breach of the Merger Agreement by Sanofi, or because the competition clearance has not been obtained, Sanofi will forfeit a gross EUR 2,880,600 termination fee to Kiadis.

The foregoing termination fees are without prejudice to each party’s rights under the Merger Agreement to demand specific performance.

Superior Offer
Sanofi and Kiadis may terminate the Merger Agreement in the event of a bona fide third-party offeror making an offer that the Boards determine in good faith to be substantially more beneficial than Sanofi’s offer, also taking into account, amongst other things, all legal, financial and regulatory aspects, timing, certainty, conditionality and non-financial covenants, provided that (i) the offer exceeds the Offer Price by at least 8% and (ii) the third-party offeror has conditionally committed itself to Kiadis in the event of an offer, under customary conditions to the Company to launch such offer within the applicable time periods prescribed by applicable laws following announcement of such offer (a “Superior Offer”). In the event of a Superior Offer, Sanofi will be given the opportunity to match such offer. If Sanofi matches the Superior Offer, the third party offer may not be accepted and the Merger Agreement may not be terminated by Kiadis. Any additional subsequent competing offer will have a 4% offer threshold and matching right for Sanofi. As part of the agreement, Kiadis has entered into customary undertakings not to solicit third party offers.

Indicative Timetable
Sanofi and Kiadis will seek to obtain all necessary competition clearances as soon as practicable. The combination of Kiadis and Sanofi is not expected to raise antitrust concerns.

Sanofi expects to submit a request for review and approval of the Offer Document with the AFM at short notice and to publish the Offer Document after approval and recognition thereof by the FSMA, in accordance with the applicable statutory timeline.

Kiadis will hold the EGM at least ten business days prior to the closing of the Offer period to inform the shareholders about the Offer and to adopt the Resolutions.

Based on the required steps and subject to the necessary approval of the Offer Document, Kiadis and Sanofi anticipate that the Offer will close in the first half of 2021.

Bridge Loan

Sanofi and Kiadis have agreed upon the principal terms of a bridge loan facility in the aggregate amount of EUR 28 million to be provided by one of Sanofi’s wholly owned subsidiaries to Kiadis, to be entered into within five weeks from today.

Advisors
Moelis & Company is acting as financial advisor and Allen and Overy LLP (Amsterdam) is acting as legal advisor to Kiadis. PJT Partners is acting as financial advisor and NautaDutilh N.V. is acting as legal advisor to Sanofi.

• 9% secured convertible bonds replace €5 million in Kreos debt
• Conversion price €2 per share 
• Remaining Kreos debt facilities reduced to €1.6 million  

Amsterdam, The Netherlands, October 1, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company developing innovative NK-cell-based medicines for the treatment of life-threatening diseases, announces the placement of €5 million of secured convertible bonds to Kreos Capital V (UK) Limited (“Kreos”) in consideration for Kreos waiving the equivalent amount of €5 million in cash repayments under the Kreos debt facilities that the Company entered into with Kreos in 2017 and 2018. As a result of the placement of the bonds, the outstanding amount under the Kreos debt facilities has decreased to €1.6 million.

Arthur Lahr, chief executive officer of Kiadis, commented, “The restructuring of our debt with Kreos reduces our cash burn. We have been paying €1.9 million per quarter in cash instalments of principal and interest to Kreos and the execution of these convertible bonds eliminates those payments well into 2021 and reduces our remaining Kreos debt burden to €1.6 million.”

Maurizio PetitBon, general partner of Kreos Capital, commented, “We have been an investor in Kiadis for many years and are very pleased with Kiadis’ developments especially with its recent refocus on its proprietary K-NK platform. The conversion of a sizeable portion of our loan into a convertible structure is a confirmation of our belief in the long-term potential of both the Company and its K-NK platform.”

The bonds are unlisted, will be issued at par and will carry a coupon of 9.00% per annum, with interest on the bonds paid at maturity. The bonds can be converted into ordinary shares of the Company with the conversion price being €2.00, subject to adjustment in the case of share split or consolidation. The bonds are due September 30, 2021 but this due date may be extended by Kreos to September 30, 2022.

Collaboration marks first contractual partnership with supplier of universal donor material 

Amsterdam, The Netherlands, September 28, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company developing innovative NK-cell-based medicines for the treatment of life-threatening diseases and Gulf Coast Regional Blood Center (GCRBC), a primary supplier of blood components to more than 170 hospitals and health care facilities, today announce a collaboration under which GCRBC will supply universal donor starting material for the manufacture of Kiadis’ off-the-shelf K-NK Natural Killer (NK) cell therapies in the United States.

Kiadis’ proprietary off-the-shelf K-NK cell platform is based on NK cells from unique universal donors. This collaboration will provide Kiadis with an ongoing supply of starting material needed for clinical supply and research and development. The Company is developing multiple K-NK programs utilizing universal donor starting material.

Arthur Lahr, chief executive officer of Kiadis, commented, “Our collaboration with Gulf Coast Regional Blood Center gives us access to their broad donor network to identify universal donors using our proprietary algorithm and selection analytics. We then take the donor immune cells as source material to produce off-the-shelf K-NK cells. This collaboration further helps us ensure a continued supply of universal donor material for our K-NK cell therapy programs.”

Hope Guidry-Groves, Cellular Life Solutions Director at Gulf Coast Regional Blood Center, stated, “Our mission is to partner with the community to help save and sustain lives by providing a safe supply of blood, biotherapies and related services.  With our history of excellence and proven expertise, we can help drive more treatment options to patients through advanced blood therapies. By helping researchers locate willing and eligible participants for these specialized collections, we are doing our part in bringing new hope to patients.”

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR TO THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. PLEASE REFER TO IMPORTANT INFORMATION AT THE END OF THE PRESS RELEASE.

XVIVO Perfusion AB (publ) (“XVIVO” or the “Company) has today signed an agreement to acquire 100 percent of the shares in the Dutch medtech company Organ Assist B.V. (“Organ Assist”) for a cash purchase price of up to EUR 24 million, with an upfront payment of EUR 20 million and potential earn-out payments of up to EUR 4 million. Organ Assist focuses primarily on developing machines and consumables for liver and kidney perfusion. Through the acquisition XVIVO becomes the first organ preservation and evaluation company in the world to be actively involved in all major organs, which accelerates the Company’s strategy of becoming a global all organ provider. The acquisition is to be financed by way of a new share issue of shares of approximately SEK 500 million directed to Swedish and international institutional investors through an accelerated book-building procedure, which is expected to commence today.

Background and the transaction
Organ Assist is a medtech company primarily focusing on developing perfusion machines for liver and kidney. Organ Assist was founded in 2005 and its research and products have since resulted in a number of patents and intellectual property rights, and its products within the area of liver and kidney transplantations are CE-marked.
 
The total purchase price for 100 percent of Organ Assist’s shares amounts to up to EUR 24 million, whereof EUR 20 million will be paid in cash on completion of the transaction, and two additional cash milestone payments, each up to EUR 2 million, become payable based on sales target in 2021 and regulatory approval in the US for Organ Assist’s kidney device, respectively.
 
XVIVO secures that organs are kept in optimal condition during transportation and perfusion/evaluation with focus on lungs and hearts. Organ Assist has, since the company was founded in 2005, focused primarily on developing perfusion machines for liver and kidney. The companies’ synergies enable greater market opportunities for XVIVO’s and Organ Assist’s product portfolio through the integration of XVIVO’s unique and patented STEEN Solution^™ technology with the Organ Assist kidney and liver machines, and by leveraging XVIVO’s international market presence.
 
The acquisition is in line with XVIVO’s commercial strategy to strengthen the Company’s product offering and accelerate the strategy of becoming a global all organ provider. The complementary product portfolio will create a unique position with presence in all major organs (lung, heart, kidney and liver). The combined offering expands XVIVO’s addressable market to approximately 98 percent of the organ transplantation market and aim to position the Company as the “first choice” for all multi-organ clinics.
 
XVIVO has a strong presence in the US and was the first company in the world to receive an U.S. Food and Drug Administration (FDA) approval (HDE approval) for a medical device for warm perfusion of an organ. Organ Assist’s products are CE marked and protected under patents and other intellectual property rights. The plan is to commercialize the Organ Assist machines in the US by utilizing XVIVO’s strong market presence and commercialization- and regulatory experience, once FDA approval has been granted.
 
“This acquisition will enable the execution of an accelerated growth plan, both in terms of sales as well as R&D activities, while building on a solid installed base and a leading position in liver perfusion. It is a token of appreciation of the innovative work done by our employees in Groningen. We are looking forward to working with the XVIVO team building a world leading medtech company, supporting our customers to save and improve patients’ lives” says Organ Assist CEO Wilfred den Hartog
 
“We are happy that Organ Assist becomes part of XVIVO Perfusion; it is the perfect partner to bring the Organ Assist’s innovative systems to the organ transplantation community” Willem van Lawick, Organ Assist’s Chairman added.
 
“XVIVO becomes the first organ preservation and evaluation company in the world to be actively involved with all major organs after this strategically important acquisition” says XVIVO Perfusion CEO Dag Andersson.
 
Financials and synergies
Organ Assist had a turnover of EUR 3.5 million and an EBITDA of EUR 0.1 million in 2019 and a turnover of EUR 1.3 million and an EBITDA of EUR 0.1 million in January – June 2020. Organ Assist has its head office and R&D center in Groningen, The Netherlands, where its 18 employees are based, and Groningen will remain as a competence center for the development and commercialization of machines and solutions for liver and kidney. Both product- and clinical development will be intensified after the acquisition.
 
XVIVO and Organ Assist have limited overlapping businesses within the field of thorax transplantations – lungs and hearts – and XVIVO therefore sees limited cost synergies since the companies as of today have few double costs and resources within this field. Within the field of abdominal transplantations – kidneys and livers – the businesses complement each other.
 
Financing and conditions
Completion of the acquisition is expected to take place during October 2020 and is conditional upon XVIVO raising proceeds to finance the purchase price through a private placement of shares on Nasdaq Stockholm. XVIVO has engaged Carnegie Investment Bank AB (“Carnegie”) to explore the conditions to carry out a directed share issue of up approximately SEK 500 million based on the authorization granted by the annual general meeting on 31 March 2020. The price of any new shares issued in the directed share issue will be determined through an accelerated bookbuilding procedure administered by Carnegie. Further information about the directed share issue and the accelerated bookbuilding procedure, which is expected to commence today, will be disclosed through a separate press release.

Amsterdam, The Netherlands, September 14, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company developing innovative cell-based medicines for the treatment of life-threatening diseases, today announces a collaboration with the Abigail Wexner Research Institute (AWRI) at Nationwide Children’s Hospital to develop Kiadis-NK cells (K-NK cells) as a post-exposure pre-emptive therapy for COVID-19. The U.S. Food and Drug Administration (FDA) approved AWRI’s investigational new drug application (IND) for a study in an adult population with off-the-shelf natural killer (NK) cells produced with Kiadis’ proprietary Universal Donor and PM21 technologies. Kiadis and AWRI are developing the plan for initiation of the clinical study.

Kiadis has exclusively licensed from AWRI intellectual property related to NK cells for treatment of microbial infections, including SARS-CoV-2. The Company has recently initiated the preclinical and clinical development of its K-NK-ID101 COVID-19 program and is expecting to receive US government funding for this program.

Arthur Lahr, CEO of Kiadis commented, “This is the second IND approved by the U.S. FDA for K-NK cells produced with our PM21 platform, and the second IND approved for K-NK cells based on our Universal Donor off-the-shelf platform. We are excited to study whether K-NK cells have the anti-viral properties, safety profile and manufacturing scalability to be widely deployed as an off-the-shelf global countermeasure against COVID-19 and future pandemic threats. This FDA approval marks rapid progress with our K-NK-ID101 COVID-19 program and demonstrates the potential expansion with our K-NK cells into infectious disease.”

“The coronavirus pandemic has had a significant impact on our world, but has also created opportunities for innovation and forward thinking,” says Dean Lee, MD, PhD, Director of the Cellular Therapy and Cancer Immunotherapy program at Nationwide Children’s Hospital. “Data from patients with COVID-19 have demonstrated an important role for NK cells in this disease. Our previous collaborations with Kiadis in developing NK cells for cancer enabled us to design a novel Phase I/II clinical trial that meets FDA rigor in testing whether adoptive transfer of NK cells is safe and effective in mitigating progression of this virus in high-risk patients.”