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Oragenics Completes Enrollment for the Interim Analysis Cohort in Its Phase 2 Clinical Trial of AG013 for Oral Mucositis

On March 23, 2018 -Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported that it has completed enrollment of the interim analysis cohort of 20 patients in its Phase 2 clinical trial of AG013 for the treatment of oral mucositis (OM) (Press release, , 23 23, 2018, View Source [SID1234524965]).

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"We are very excited to complete this enrollment milestone for our Phase 2 trial of AG013 for oral mucositis, one of the most common and debilitating complications of chemo-radiation therapies. With no approved convenient preventative treatment, oral mucositis represents a serious unmet need for cancer patients receiving treatment on an outpatient basis," said Alan Joslyn, Oragenics’ President and Chief Executive Officer. "After we complete this treatment phase and evaluate the safety of the initial 20 patients enrolled in the trial, we intend on expanding the trial in the United States and Europe to complete study enrollment. We expect to report preliminary data on the initial 20 enrolled patients during the second quarter of 2018 with top-line results of the trial expected in 2019."

The purpose of the Phase II study (NCT03234465) is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time to development, and overall incidence of OM (WHO scale used) during the active treatment phase, beginning from the start of chemoradiation therapy (CRT) until 2 weeks following its completion.

The Phase II trial is a double-blind, placebo-controlled, 2-arm, multi-center trial in which subjects will be randomized in a 1:1 ratio to receive either placebo or AG013. AG013 is a mouth rinse formulation of Lactococcus lactis strain sAGX0085, deficient in the gene coding for thymidylate synthase and producing human TFF1 (Trefoil Factor 1). Approximately 200 subjects will be enrolled in the study. An initial cohort of 10 patients that received AG013 is included in the 20 patients enrolled to date.

Safety will be evaluated on the basis of treatment-emergent AEs (TEAEs), vital signs, weight, physical examinations, clinical laboratory assessments and the presence of AG013-sAGX0085 in whole blood. Tolerability (taste, consistency and smell) will be collected from the patient diary.

In a Phase 1B study the efficacy analysis suggested a 35% reduction in percentage of days with UOM in AG013-subjects versus placebo. All placebo subjects experienced 2 days of UOM, whereas 29% of AG013 subjects had UOM for 0 or 1 day. AG013 use resulted in fewer unscheduled office and emergency room visits. No differences were noted in mouth and throat soreness, opioid use, or gastrostomy tube placement.

In terms of safety and dosing, Oral live AG013 bacterial and hTFF1 levels in saliva and oral mucosa were equivalent among treatment groups. The most frequently occurring adverse events were nausea, oral pain, fatigue, diarrhea, and mucosal inflammation. Only 12% (3 of 25 adverse events), mainly nausea, were attributed to the investigational medicinal product: AG013 or placebo. Importantly, AG013 bacteria were not detected in blood.

AG013 is an ActoBiotics therapeutic candidate formulated as a convenient oral rinsing solution and designed by our strategic collaboration partner ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation (NYSE: XON) to deliver the therapeutic molecule Trefoil Factor 1 to the mucosal tissues in the oral cavity. Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and play an important role in subsequent repair. AG013 received Fast Track designation from the U.S. Food and Drug Administration (FDA) in November 2016.

Under an Exclusive Channel Collaboration Agreement with ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation , Oragenics has an exclusive worldwide license to develop and commercialize AG013 to treat OM in cancer patients.

IntelGenx to Report Fourth Quarter and Full-Year 2017 Financial Results on March 29, 2018 – Conference Call to Follow

On March 23, 2018 IntelGenx Technologies Corp. (TSX VENTURE:IGX) (OTCQX:IGXT) reported that it will release its fourth quarter and full year 2017 financial results after market close on March 29, 2018 (Press release, IntelGenx, MAR 23, 2018, View Source;Conference-Call-to-Follow/default.aspx [SID1234524964]).

An accompanying conference call will be hosted by Dr. Horst G. Zerbe, President and Chief Executive Officer, and Mr. Andre Godin, Executive Vice-President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Date: Thursday, March 29, 2018

Time: 4:30 p.m. EDT

Conference dial-in: (833) 211-3233

International dial-in: (647) 689-3955

Conference ID: 6786519

Webcast Registration: Click here

Following the live call, a replay will be available on the Company’s website, www.intelgenx.com, under "Investor Relations."

Clovis Oncology Initiates Early Access Program for Rucaparib as Treatment and as Maintenance Therapy in Recurrent Ovarian Cancer in Europe

On March 23, 2018 – Clovis Oncology, Inc. (NASDAQ:CLVS) reported the initiation of an early access program in Europe for rucaparib for treatment and as maintenance therapy in recurrent ovarian cancer (Press release, Clovis Oncology, MAR 23, 2018, View Source;p=RssLanding&cat=news&id=2339489 [SID1234524963]). The program will be overseen and implemented by Caligor Coghlan, which specializes in early access to medicines.

The program, to be known as the Rucaparib Access Program (RAP), will enable participation from certain countries in Europe, where permitted by applicable rules, procedures and regulatory authorities. The RAP protocol allows for rucaparib treatment of an individual patient with third-line or greater BRCA mutant epithelial, fallopian tube, or primary peritoneal ovarian cancer who has platinum-sensitive disease and is unable to tolerate further platinum-based chemotherapy or has platinum-resistant disease and needs treatment with single agent rucaparib. The RAP protocol will also provide access to rucaparib for maintenance therapy of an individual patient with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who has received at least two prior platinum-based treatment regimens, has platinum-sensitive disease, and is in a complete or partial response to the most recent platinum-based regimen. In all cases, the patient must have a special clinical need that cannot be met by current licensed available medicines. Patients must be ineligible for Clovis’ ARIEL4 clinical trial or unable to access a participating ARIEL4 site to qualify for Clovis’ early access program.

Questions or inquiries regarding the RAP should be directed to [email protected].

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved on an accelerated basis as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. In December 2017, the U.S. Food and Drug Administration (FDA) accepted the Company’s supplemental New Drug Application (sNDA) for Rubraca for a second-line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data. The FDA granted Priority Review status to the application with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018.

Rubraca is an unlicensed medical product outside of the U.S.

About Early Access Programs

Early Access Programs provide companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests, in a fully compliant manner, where no alternative treatment options are available.

Aradigm Announces Fourth Quarter 2017 and Full Year Financial Results

On March 23, 2018 Aradigm Corporation (NASDAQ: ARDM) (the "Company") reported financial results for the fourth quarter and full year ended December 31, 2017 (Press release, Aradigm, MAR 23, 2018, View Source [SID1234524961]).

Fourth Quarter 2017 Results

The Company recorded $2.4 million in revenue in the fourth quarter of 2017 compared with $125,000 in revenue in the fourth quarter of 2016. The Company recognized $2.3 million in contract revenue – related party, $27,000 in government contract revenue and $71,000 in government grant revenue for the fourth quarter of 2017, as compared to $116,000 in government contract revenue and $9,000 in government grant revenue for the fourth quarter of 2016. The increase in revenue was from the Company’s adoption of ASC Topic 606, Revenue from Contracts with Customers and primarily resulted from regulatory submission services provided for the New Drug Application (NDA) filing.

Total operating expenses for the fourth quarter of 2017 were $5.6 million, compared with total operating expenses of $7.2 million for the fourth quarter of 2016. The decrease in operating expenses was primarily due to lower research and development expenses because the Linhaliq Phase 3 clinical trials in non-cystic fibrosis bronchiectasis (NCFBE) are complete. This decrease was offset by higher consulting expenses in support of the regulatory approval process and higher costs in general and administrative expenses related to stock compensation expense, bonus expense and corporate insurance expense.

The Company’s net loss for the fourth quarter of 2017 was $4.2 million, or $0.28 per share, compared with a net loss of $7.9 million, or $0.54 per share, for the same period in 2016. For the quarter ended December 31, 2017, the decrease in net loss resulted primarily from an increase in revenue of $2.2 million and a decrease in operating expenses of $1.6 million, partially offset by an increase in interest expense of $0.1 million.

Full Year Results

Revenues for the year ended December 31, 2017 were $14.5 million, compared with revenues of $195,000 thousand in 2016. The Company recognized $14.1 million in contract revenue – related party, $268,000 in government contract revenue and $122,000 in government grant revenue for the year ended December 31, 2017, as compared to $40,000 in contract revenue – related party, $116,000 in government contract revenue and $39,000 in government grant revenue for the year ended December 31, 2016. The increase in revenue was primarily from the Company’s adoption of ASC Topic 606, Revenue from Contracts with Customers, which resulted in the recognition of $9.5 million in contract revenue – related party associated with regulatory submission and approval of services provided for the NDA filing combined with $4.5 million in contract revenue – related party from a change in estimated variable consideration associated with the $5 million regulatory milestone for the NDA filing allocated to performance obligations satisfied in the current or prior periods.

Total operating expenses for 2017 were $21.4 million, compared with total operating expenses of $30.2 million in 2016. Research and development expenses decreased by $10.6 million and general and administrative expenses increased by $1.8 million. The decrease in research and development expenses was due to lower contract manufacturing, contract testing and clinical trial costs because the Linhaliq Phase 3 clinical trials in non-cystic fibrosis bronchiectasis (NCFBE) are complete. The decrease was offset by higher employee-related expenses, higher consulting, meeting and travel expenses in support of the Linhaliq regulatory process towards U.S. and European Union approvals for market authorization. The increase in general and administrative expenses of $1.8 million was primarily related to higher performance bonus expense, higher legal expense, higher corporate insurance expense, higher non-cash stock compensation expense and higher consulting expense.

The net loss for the year ended December 31, 2017 was $10.7 million, or $0.72 per share, compared with a net loss of $32.9 million, or $2.23 per share, in 2016. Net loss decreased primarily from an increase in revenue of $14.3 million, a decrease in operating spend of $8.8 million related to the completion of the Phase 3 clinical trials for Linhaliq in non-CF BE in the fourth quarter of 2016, a decrease in other expense of $0.6 million in 2017, offset by an increase in interest expense of $1.5 million related to the Note Financing.

Liquidity and Capital Resources and Related Matters

As of December 31, 2017, the Company’s cash and cash equivalents totaled $7.1 million.

Aradigm received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa).

The CRL states that the FDA has determined that it cannot approve the NDA in its present form and provides specific reasons for this action along with recommendations needed for resubmission; the areas of concern include clinical data, human factor validation study and product quality.

The Aradigm Board of Directors approved temporary measures on February 9, 2018 intended to preserve the Company’s cash resources. The cash preservation measures include the termination of the Amended and Restated Aradigm Corporation Executive Officer Severance Benefit Plan, the reduction of the annual base salary by 50% of certain executive officers and the reduction of the cash compensation paid to members of the Board for service on the Board and committees by 50%. Effective February 11, 2018 the three Senior Executive Officers resigned all offices and positions; the Board appointed Dr. John Siebert as the Principal Executive Officer and the Principal Financial Officer.

"We are pursuing potential alternatives to resolve our cash position in the short term as well as developing strategic options that would provide for our long term viability. We feel it is important to bring Linhaliq to commercialization in as many geographies as possible to allow patients suffering from NCFBE to get the benefits of Linhaliq. Patients, patient advocacy groups and key opinion leaders have expressed support as we work towards this goal. The MAA was filed in early March which is the first step in achieving regulatory approval in Europe," said John M. Siebert, PhD

About Non-Cystic Fibrosis Bronchiectasis

Non-CF BE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. Non-CF BE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.

Celyad Reports 2017 Financial and Operating Results and Expected Key Milestones for 2018

On March 23, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported consolidated financial results for the twelve-month period ended 31 December 2017, prepared in accordance with IFRS (Press release, Celyad, MAR 23, 2018, View Source [SID1234524957]).

Christian Homsy, CEO of Celyad: "2017 has been another milestone year for Celyad. The responses obtained to date in AML, and in solid tumors, we believe validate NKG2D as a target and allow us to move rapidly forward with the development of this product candidate in 2018. Our intellectual property related to the allogeneic technology, another of our core strengths, has been further strengthened: it was upheld by the US Patent and Trademark Office as part of multiple ex-parte re-examination requests and its importance has been recognized through our licensing agreement with Novartis. As far as 2018 is concerned: we believe it will be an exciting year as we expect to – among other things– complete the dose escalation segment of THINK and explore the various conditions that could lead to a potential registrational Phase 2 trial."

1 THINK: THerapeutic Immunotherapy with CAR-T NKG2D

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Press Release

22 March 2018

10:01 pm CET

Regulated Information

Key 2017 Highlights

First complete response by a CAR-T cell therapy reported in a patient with relapsed and refractory AML in the Phase 1 THINK trial. Complete response obtained without preconditioning therapy

CYAD-01 (CAR-T NKG2D) well tolerated and clinical activity seen in AML patients treated in THINK trial to date

First signs of clinical activity in Colorectal and Ovarian cance

Phase 1 SHRINK2 study initiated to evaluate the synergetic effect of the concurrent administration of CYAD-01 with standard chemotherapy in metastatic colorectal cancer patients

Non-exclusive license agreement signed with Novartis for its allogeneic TCR-deficient CAR-T cell patents

New agreements with Celdara Medical LLC and Dartmouth College following encouraging results from the THINK trial, giving right to an increased share of future revenues generated by our CAR-T platform

Strong central IP position in the allogeneic CAR-T cell field confirmed by USPTO
Expected Milestones for 2018 and Beyond

Dose escalation segment of THINK trial; Enrolment according to plans

Interim read-outs of the LINK3 and the SHRINK clinical trials

Initiation of DEPLETHINK4 study (non-myeloablative preconditioning chemotherapy in relapse/refractory AML or myelodysplastic syndrome (MDS) patients)

Initiation of EPITHINK5 study (CYAD-01 treatment administered concurrently with 5-azacytidine in treatment-naïve AML or MDS patients not candidates for intensive therapy).

Investigational New Drug (IND) filing for our allogeneic CYAD-101 product candidate and enrolment of the first patient of the trial

Finalization of preclinical development of CYAD-02, a CYAD-01 iteration aimed at enhanced in-vivo expansion and persistence

Proof of concept of the CARGO platform, a next generation CAR-T engineered with tumor micro-environment targeting tools and enhanced tumor infiltration capabilities (a cargo CAR). CYAD-03 is the NKG2D CAR of the CARGO platform

2 SHRINK: Standard CHemotherapy Regimen and Immunotherapy with CAR-T NKG2D
3 LINK: Locoregional Immunotheraoy with NKG2D
4 DEPLETHINK: LymphoDEPLEtion and THerapeutic Immunotherapy with NKG2D
5 EPITHINK: EPIgenetic drug treatment and THerapeutic Immunotherapy with NKG2D

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22 March 2018

10:01 pm CET

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Commenting on the 2017 results, Dr. Debasish Roychowdhury, Member of the Board, said: "2017 was a watershed year for Celyad. We saw promising signs of tolerability and clinical activity in the THINK trial, validating NKG2D as a target, thus allowing us to be well positioned to broaden the scope of NKG2D platform and to initiate potential pivotal studies, respectively planned for 2018 and 2019."

Conference Call Details

A conference call will be held on Friday, 23 March 2018, at 2:00 p.m. CET / 9:00am EDT to review the financial results. Christian Homsy, Chief Executive Officer, and Patrick Jeanmart, Chief Financial Officer will deliver a brief presentation followed by a Q&A session.

Joining the Conference Call:

1. In the 10 minutes prior to the call start time, call the appropriate participant dial-in number.

• Standard International Dial-In Number: +44 (0) 2071 928338
Local Call Dial-In Numbers:

• Belgium 027933847

• France 0170700781

• UK 08444819752

• Netherlands 0207956614

• US 18778709135

2. Provide the operator with the conference ID: 4391809
Helpful keypad commands: *0—Operator assistance.

2017 Financial and Operating Results

Celyad reported steady progress in 2017 with the advancement of the clinical development of CYAD-01. Data collected thus far from the THINK trial, which started in early 2017, show that CYAD-01 has been well-tolerated, offers an excellent safety profile and validates the activity of the NKG2D receptor.

At year-end 2017, there were no critical toxicity events related to the CYAD-01 product candidate reported by the THINK trial investigators. More importantly, the first signs of clinical activity were reported in both arms of the trial.

In the hematological arm of the THINK trial, Celyad announced in October 2017 a world’s first with the complete response in a patient with refractory and relapsed AML, obtained without preconditioning chemotherapy or other anti-tumor treatments combined with CYAD-01. Furthermore, preliminary signs of clinical activity were observed in all AML patients dosed in 2017. In the solid arm, cases of stable disease (SD) were reported in patients suffering from ovarian cancer and colorectal cancer.

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Press Release

22 March 2018

10:01 pm CET

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Celyad also made important progress on its IP position with the announcement of a non-exclusive license agreement with Novartis and three new patents covering the allogeneic CAR-T cell approach.

In terms of financing, Celyad reported €34 million at year end 2017. This, together with anticipated milestone payments expected to be received by Celyad in 2018 from its strategic partners, should enable the company to finance all its clinical programs and other needs through the first half of 2019.

Here are the operational and financial highlights of 2017 identified by the company’s board of directors:

Clinical Developments

• Data collected in 2017 from the THINK trial showed that CYAD-01 has been well-tolerated to date and validated activity of the NKG2D CAR.

• In October, Celyad achieved an important milestone in oncology with the first ever complete response in a patient with refractory and relapsed AML, obtained without preconditioning chemotherapy or other anti-tumor treatments combined with CYAD-01. Importantly, clinical activity has been observed in AML patients dosed in 2017, with all patients seeing a reduction in their blast counts in the bone marrow and/or improvements in their hematological parameters.

• Data for the THINK trial showed preliminary signs of activity of CYAD-01 in solid tumors. Stabilization of the disease was observed in an ovarian patient and in colorectal cancer patients.

• In late-2017, Celyad initiated the SHRINK trial, an open-label Phase 1 trial evaluating the safety and clinical activity of multiple doses of CYAD-01, administered concurrently with the neoadjuvant standard FOLFOX chemotherapy treatment in patients with potentially resectable liver metastases from colorectal cancer. The trial includes a dose escalation and an extension stage.
The dose escalation design will include three dose-levels of CYAD-01: 1×108, 3×108 and 1×109 CYAD-01 per administration. At each dose-level, patients will receive three successive administrations, two weeks apart, at the specified dose administered at a specific timing within the FOLFOX cycle. The dose escalation portion of the trial is designed to enrol three patients per dose level and the extension phase is expected to enrol twenty-one additional patients. SHRINK is being conducted in key oncology centers in Belgium.

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22 March 2018

10:01 pm CET

Regulated Information

Intellectual property

• In January, the U.S. Patent and Trade Office (USPTO) upheld, for a third time, Celyad’s U.S. Patent No. 9,181,527 relating to allogeneic human primary T-cells that are engineered to be TCR-deficient and express a CAR. In March, the USPTO rejected another request for a re-examination of the same patent.

• In May, Celyad obtained a new patent related to its method of treating cancer by administering allogeneic primary human T cells that are engineered to be TCR-deficient and to express a CAR. U.S. Patent no. 9,663,763 is the third patent in Celyad’s allogeneic intellectual property portfolio awarded by the USPTO. This new patent claims specific methods of treating cancer patients with allogeneic TCR-deficient CAR-T immunotherapies.
The combination of this patent with earlier granted U.S. patents, consolidates Celyad’s strong intellectual property position in the allogeneic CAR-T field and strengthens the Celyad’s IP portfolio covering key elements in the allogeneic TCR-deficient CAR-T cells production value chain.

Corporate and financial highlights

• In May, Celyad announced a non-exclusive license agreement with Novartis regarding U.S. patents related to allogeneic CAR-T cells. The agreement includes Celyad’s intellectual property rights under U.S. Patent No. 9,181,527. This agreement is related to two undisclosed targets currently under development by Novartis.
Under the terms of the agreement, Celyad received an upfront payment and is eligible to receive payments in aggregate amounts of up to $96 million. In addition, Celyad is eligible to receive single digit percentage royalties based on net sales of the licensed target. Celyad retains all rights to grant further licenses to third parties for the use of allogeneic CAR-T cells.

• In August, Celyad amended its agreements with Celdara Medical LLC and Dartmouth College related to the CAR-T NK cell drug product candidates and related technology licensed in January 2015 following the acquisition of OnCyte LLC. Under the amended agreements Celyad is entitled to receive an increased share of future revenues generated by these assets, including revenues from its sub-licensees. In return, Celyad paid Celdara Medical LLC and Dartmouth College an upfront payment of $12.5 million (€10.6 million) and issued to Celdara Medical LLC $12.5 million worth of Celyad’s ordinary shares at a share price of €32.35.

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Press Release

22 March 2018

10:01 pm CET

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Financial highlights

For the full year ended December 31, 2017, our revenues generated by our strategic collaborations amounted to €3.5 million and corresponded to the non-refundable upfront payment received from Novartis, as a result of the non-exclusive license agreement signed in May 2017. The revenues of 2016 corresponded to the payment received from ONO.

In 2017, our research and development expenses decreased by €4.7 million at €23.0 million compared to 2016. The general and administrative expenses are almost stable over the 2 periods.

As a result, the operating loss of our recurring operations (REBIT) amounted to €26.6 million compared to €25.6 million in 2016.

In 2017, we recognized non-recurring expenses related to the amendment of the agreements with Celdara Medical, LLC and Dartmouth College and the write-off of the C-Cure and Corquest assets together with the derecognition of related liabilities (respectively for €24.3 million, €0.7 million and €1.2 million). There were no non-recurring items in the income statement of 2016.

At year end 2017, the loss from operations before financial results and taxes (EBIT) amounted to €52.9 million versus €25.6 million in 2016.

The 2017 financial income & charges covered mainly interest received on cash deposits and currency exchange rates differences and bank charges. Due the depreciation of the USD compared to EUR, the Group recognized an unrealized loss on foreign exchange differences of €4.4 million in 2017. In 2016, the unrealized gain on foreign exchange differences amounted to €0.8 million.

Taking into account the net financial loss, the net loss of 2017 amounted to €56.4 million versus a net loss of €23.6 million for same period in 2016.

For 2018, we expect to receive additional sublicensing income from our strategic partners and a reasonable increase of our operating expenses, mainly research and development expenses as we will be running multiple clinical trials in parallel.

Cash and short-term deposits were €34 million as of 31 December 2017.

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22 March 2018

10:01 pm CET

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Annual Report 2017

Celyad plans to publish its audited Annual Report for the year ended 31 December 2017 on 6 April 2018. The statutory auditor, BDO Réviseurs d’Entreprises SCCRL, represented by Bert Kegels, has confirmed that the audit, which is substantially complete, has not to date revealed any material misstatement in the draft consolidated financial statements, and that the accounting data reported in the press release are consistent, in all material respects, with the draft consolidated financial statements from which it has been derived.

***END***

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