Amsterdam, The Netherlands, August 1, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing a T-cell immunotherapy product candidate designed to reduce Graft versus Host Disease (GVHD) and relapse after hematopoietic stem cell transplantations (HSCT), today announces that it has received a new debt facility from Kreos Capital providing the Company with up to €20 million of additional financing. This is in addition to the Company’s €15 million debt financing from Kreos Capital in 2017.
The new loan consists of two tranches, with the first tranche of €5 million being immediately drawn down and a second tranche of up to an additional aggregate amount of €15 million, which Kiadis Pharma can at its option draw down until March 31, 2019, conditional on the Company having received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for the Company’s T-cell product candidate ATIR101. Kiadis Pharma will use funds drawn down under the debt facility to advance the Phase 3 clinical development of ATIR101, to prepare for a possible commercial launch in Europe and for general corporate purposes. If drawn down in full, this new €20 million debt facility would extend the Company’s cash runway into the first quarter of 2020.
Arthur Lahr, CEO of Kiadis Pharma, commented: “This additional agreement with Kreos Capital gives us the option to comfortably extend our cash runway into the first quarter of 2020, with limited dilution, once we have received the anticipated opinion from the CHMP in the fourth quarter of 2018.”
Maurizio PetitBon, General Partner of Kreos Capital, commented: “Kiadis Pharma is advancing treatment in the field of allogeneic hematopoietic stem cell transplantations and has the potential to improve the outcomes of patients suffering from blood cancers. We are proud to extend our relationship with Kiadis Pharma as they enter the next phase to further drive the development of ATIR101.”
About the loan agreement
|Draw down||Tranche A: €5 million upon closing Tranche B: loans of up to an aggregate additional amount of €15 million may be drawn down at the option of the Company prior to March 31, 2019, conditional on the Company receiving a positive opinion for ATIR101 from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency|
|Term||Tranche A: 45 months
Tranche B: 48 months
|Repayment||Tranche A: Interest only for the first 9 months, with the remaining 36 months amortizing in equal monthly instalments comprising principal and interest
Tranche B: Interest only for the first 12 months, with the remaining 36 months amortizing in equal monthly instalments comprising principal and interest
|Interest||9% annual fixed interest rate|
|End of loan payment||5% of the amount drawn down|
|Structure||Security over assets including IP; no financial covenants|
|Warrants||In connection with the drawdown of Tranche A, at closing the Company granted 41,212 warrants giving Kreos Capital the right to subscribe for 41,212 new Company shares at a price of €9.71 per share
In connection with any potential drawdowns under Tranche B, Kreos Capital is entitled to receive warrants to purchase new Company shares worth 8% of the amounts drawn down under Tranche B, with the exercise price being the average 10-day closing share price prior to the date the Company delivers a drawdown request to Kreos Capital
The warrants can be exercised over a 5-year period after grant
For more information, please contact:
|Kiadis Pharma: Karl Hård, Head of IR & Communications Tel. +31 611 096 298 firstname.lastname@example.org||Optimum Strategic Communications: Mary Clark, Supriya Mathur, Hollie Vile Tel: +44 203 714 1787 email@example.com|
About Kiadis Pharma
Kiadis Pharma’s allodepleted T-cell immunotherapy product candidate, given after a haploidentical hematopoietic stem cell transplantation (HSCT), is designed to reduce Graft versus Host Disease (GVHD) and relapse. Single dose Phase 2 data with lead product candidate ATIR101 has demonstrated substantial and clinically relevant improvements over historical observational cohort data for a similar HSCT without ATIR101, and also shows an improvement over the Post-Transplant Cyclophosphamide (PTCy), or Baltimore protocol, data reported in scientific literature. Based on the positive results from the Phase 2 trial, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in April 2017, for approval of ATIR101 across the EU as an adjunctive treatment in HSCT for adult malignant disease. Kiadis Pharma submitted responses to the Day 120 List of Questions in March 2018 and received the Day 180 List of Questions in May 2018, and is on track to obtain a CHMP opinion for ATIR101 in Q4 2018 and, if positive, (conditional) approval from the European Commission in Q1 2019, which would allow for a European launch in H2 2019. Kiadis Pharma is conducting a Phase 3 trial with ATIR101 across Europe and North America (head to head against the PTCy/Baltimore protocol). The first patient was enrolled in December 2017.
In September 2017 the U.S. Food and Drug Administration (FDA) granted ATIR101 the Regenerative Medicine Advanced Therapy (RMAT) designation. ATIR101 has been granted Orphan Drug Designations both in the U.S. and Europe.
The Company’s shares are listed on Euronext Amsterdam and Brussels under the ticker KDS.
About Kreos Capital
Kreos was founded 20 years ago with the single mission of pioneering unique financing solutions for high-growth companies across Europe and Israel. Since then, Kreos has committed more than €2 billion in over 500 portfolio company transactions, in a variety of industry sectors and located in 14 countries.
Kreos understands the needs of high-growth companies and the unique challenges that they face as global competitors. Kreos has worked with companies at all stages of development offering everything from operational runway extensions through acquisition financing. The common threads of our approach include operational flexibility, patience and commitment to creating value.
The Kreos team has the experience to understand what companies across all stages require and is able to provide debt funding facilities that meet the real-world demands of growing businesses and equity sponsors and investors.
Forward Looking Statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis Pharma’s or, as appropriate, Kiadis Pharma’s directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis Pharma expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis Pharma nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.