Month: March 2017

Cerulean Pharma and Daré Bioscience Enter into Stock Purchase Agreement

On March 20, 2017 Cerulean Pharma Inc. (NASDAQ:CERU) and Daré Bioscience, Inc., a privately-held, clinical-stage pharmaceutical company advancing products for women’s reproductive health, reported that the two companies, together with the equityholders of Daré Bioscience, have entered into a definitive stock purchase agreement under which the equityholders of Daré Bioscience will become the majority owners of Cerulean (Press release, Cerulean Pharma, MAR 20, 2017, View Source [SID1234525204]).

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The transaction and the Cerulean asset sales mentioned below would result in a NASDAQ-listed company with a focus on the development and commercialization of products for women’s reproductive health. Daré Bioscience’s product candidate, Ovaprene, is a clinical stage, non-hormonal contraceptive ring for monthly use that potentially addresses a significant unmet need. Contraception is a $16 billion global market. However, since the approval of the birth control pill by the FDA in 1960, most innovation has focused on hormones. Daré Bioscience’s product candidate, Ovaprene, is a non-hormonal option that is intended to be easy to use and provide protection over multiple weeks. To the knowledge of Daré’s management, no comparable product currently is being marketed. The combined company will operate under the name Daré Bioscience, and its Chief Executive Officer will be Sabrina Martucci Johnson, current Chief Executive Officer of Daré Bioscience. The transaction is subject to approval by stockholders of Cerulean.

"We are thrilled to have the opportunity to grow our business as a public company," said Ms. Johnson. "Women’s reproductive health encompasses a broad spectrum of categories, many of which have unmet needs. Daré is committed to developing a portfolio that expands options, improves outcomes, and enhances safety for women."

Cerulean also announced today that it has entered into two agreements for the sale of assets, the proceeds of which will be used to help fund the combined company’s operations. Cerulean sold its clinical product candidates, CRLX101 and CRLX301, for $1.5 million to BlueLink Pharmaceuticals, a subsidiary of NewLink Genetics Corporation, a biopharmaceutical company engaged in the discovery, development and commercialization of novel immuno-oncology product candidates to improve the lives of patients with cancer. Cerulean also entered into an agreement with Novartis, an existing collaborator with the Company, pursuant to which Novartis will acquire all rights to Cerulean’s Dynamic Tumor Targeting Platform for $6 million. The closing of the sale to Novartis is subject to approval of the sale by holders of at least a majority of the outstanding shares of Cerulean’s common stock and satisfaction of other closing conditions.

Cerulean also announced that, in connection with these transactions, it is paying off its debt facility with Hercules Capital, Inc.

"Cerulean conducted an extensive review of strategic alternatives with the goal of maximizing value for our stockholders," said Christopher D. T. Guiffre, President & Chief Executive Officer of Cerulean. "We believe the Daré transaction, in conjunction with the asset sales, achieves this goal and provides Cerulean stockholders with an exciting opportunity in women’s health under an experienced leadership team. Based on Daré’s current projections, with proceeds from the sale of Cerulean’s assets, we believe the combined company will be well funded to advance Ovaprene through the completion of a postcoital proof of concept study that is expected to be a value inflection point and is expected to commence following closing of this transaction."

Cerulean also announced that it is reducing its workforce by 11 people, or approximately 58%, to a total of eight full-time equivalent employees, under a plan expected to be completed during the second quarter of 2017. Affected employees are being offered transition benefits.

Stock Purchase Agreement Details

Under the terms of the stock purchase agreement, the stockholders of Daré Bioscience will receive shares of newly issued Cerulean common stock, while outstanding Daré Bioscience options and convertible securities will be assumed by Cerulean. Following the issuance of the shares, depending on the relative net cash positions of Cerulean and Daré Bioscience at the time of closing, it is expected that existing Cerulean stockholders will own between 30% and 49% of the combined company, and existing Daré Bioscience stockholders will own between 51% and 70% of the combined company. The transaction has been unanimously approved by the boards of directors of both companies. The transaction is expected to close during the second quarter of 2017, subject to customary closing conditions, including approval by stockholders of Cerulean.

Aquilo Partners, L.P. advised Cerulean. Wilmer Cutler Pickering Hale and Dorr LLP served as legal counsel to Cerulean, and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo PC served as legal counsel to Daré Bioscience.

Management and Organization

Upon the close of the proposed transaction, the board of directors of the combined company will consist of five members, three to be designated by Daré and two to be designated by Cerulean. Officers of the combined company will include Sabrina Martucci Johnson, Chief Executive Officer, and Lisa Walters-Hoffert, Chief Financial Officer.

ERYTECH PRESENTS NEW PRECLINICAL ANTI-TUMOR DATA ON ERYMETHIONASE AT AACR 2017

On March 20, 2017 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY), a French clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases based on its proprietary ERYCAPS platform, encapsulating therapeutic drug substances inside red blood cells, reported the presentation of new anti-tumor data supporting the Company’s preclinical product erymethionase (ERY-MET) at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 1 – 5, 2017 in Washington, D.C (Press release, ERYtech Pharma, MAR 20, 2017, View Source [SID1234518224]).

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Results from the preclinical study demonstrate that erymethionase, methionine gamma-lyase (MGL)-encapsulated in red blood cells using ERYTECH’s proprietary encapsulation platform technology, represents a promising new treatment approach against a broad range of cancers that rely on methionine metabolism. The research will be presented by Dr. Vanessa Bourgeaux, Program Leader at ERYTECH, during a poster session at the conference.

Dr. Bourgeaux stated, "Methionine dependence has emerged as a unique target for anti-cancer activity during the last two decades. While methionine gamma-lyase is a promising strategy for these cancers, its very short half-life in the body prohibited all attempts to develop MGL as cancer therapy. However, our work here shows that when encapsulated in red blood cells using our ERYCAPS technology, MGL is protected from degradation and overcomes the pharmacokinetic limitations resulting in increased half-life in vivo for effective potential use in a broad-range of methionine-dependent cancers."

Gil Beyen, Chairman and CEO of ERYTECH, added, "Erymethionase represents a novel product candidate in our tumor starvation arsenal. ERYTECH is progressively building its cancer metabolism platform with this second product candidate to complement eryaspase (GRASPA), ERYTECH’s lead product candidate. The posters presented at two immunotherapy medical meetings earlier this month and now promising data with erymethionase at AACR (Free AACR Whitepaper) underscore ERYTECH’s intention to develop the scope of products and applications for its technology platform."

Methionine is an essential amino acid, which is necessary for all cells to grow and multiply. More specifically, fast-growing tumor cells exhibit very high requirements of methionine to proliferate. The enzyme methionine gamma-lyase (MGL) mediates tumor starvation via systemic lowering of methionine levels. MGL is an enzyme with a short half-life and is dependent on a co-factor, a Vitamin B6 derivative which is naturally present in red blood cells, to demonstrate enzymatic activity. The preclinical studies in mouse models of erymethionase aimed to investigate the protection of MGL against degradation and immune reactions through encapsulation in erythrocytes (red blood cells).

ERYTECH researchers demonstrated that encapsulation of MGL in red blood cells both strongly improved the half-life of the enzyme and provided active co-factor to increase MGL activity and therefore, tumor starvation. The half-life of MGL increased from less than 24 hours when free to more than 10 days when encapsulated in red blood cells, with no toxicity reported. The preclinical study showed that combining a single weekly intravenous injection of erymethionase with daily pyridoxine (PN) supplementation led to a sustained methionine depletion in the plasma, and an inhibition of tumor growth for 45 days following the fifth erymethionase dose of 85% in the glioblastoma mouse model, and of 72% in the gastric cancer mouse model. Repeated injections of ERY-MET were also effective against established tumors in the gastric cancer model leading to a complete tumor regression.

Full details of the AACR (Free AACR Whitepaper) presentation follow:

Abstract # 2134 / Poster # 3: Use of methionine gamma-lyase-loaded erythrocytes to induce effective methionine depletion of cancer therapy
Presenter: Dr. Vanessa Bourgeaux
Poster Session/Section: PO.ET01.09 – New Targets 2/Section 6
Date: Monday, April 3
Time: 1:00 – 5:00 p.m. EDT
Location: Convention Center, Halls A-C

Blueprint Medicines Announces Enrollment of First Patient in Phase 1 Clinical Trial for BLU-667

On March 20, 2017 Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported that it has dosed the first patient in a Phase 1 clinical trial of BLU-667, an investigational RET inhibitor for patients with non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other advanced solid tumors that harbor a RET alteration (Press release, Blueprint Medicines, MAR 20, 2017, View Source [SID1234518223]).

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"By rapidly initiating a clinical trial for our potent and selective RET inhibitor BLU-667, we have successfully achieved a key 2017 milestone," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "This continued progress underscores our commitment to build Blueprint Medicines into a sustainable company. BLU-667 has a unique product profile differentiated from our other clinical-stage programs by its potential to address predicted resistance mutations that may arise. With BLU-667 enrollment underway, we are further increasing our diversified pipeline of potent, highly selective investigational medicines that target specific disease drivers in genomically-defined patient populations."

"RET fusions and mutations are recognized as important drivers in multiple cancers, but existing multi-kinase inhibitors with RET activity do not provide sufficient, durable benefit for patients with RET alterations," said Andy Boral, M.D., Ph.D., Chief Medical Officer of Blueprint Medicines. "BLU-667 is being developed to potently inhibit RET, and simultaneously prevent the development of on-target resistance, which we believe will provide more lasting clinical benefit and prevent or delay disease recurrence. We look forward to working with patients and physicians to explore BLU-667’s potential."

BLU-667 is an orally available, potent and selective inhibitor designed to target RET mutations, fusions and predicted resistance mutants. RET activating fusions and mutations are a key disease driver in multiple cancers, including NSCLC and MTC, with RET fusions implicated in approximately 1-2% of patients with NSCLC, and RET mutations implicated in approximately 60% of patients with MTC. In addition, genomic analyses published by scientists at Blueprint Medicines have identified RET fusions at low frequencies in colon and breast cancer. Currently, there are no approved therapies that selectively target RET-driven cancers, though there are several approved multi-kinase inhibitors with RET activity being evaluated in clinical trials. Thus far, clinical activity attributable to RET inhibition has been uncertain for these inhibitors, likely due to insufficient inhibition of RET and off-target toxicities. In preclinical studies using biochemical and cellular assays, and tumor models, BLU-667 was active against RET fusions and mutations, including predicted resistance mutations.

About the Phase 1 Clinical Trial for BLU-667 in RET

Blueprint Medicines’ Phase 1 clinical trial of BLU-667 in RET is designed to evaluate the safety and tolerability of BLU-667 in multiple ascending doses in patients with NSCLC, MTC, and other advanced solid tumors with the goal of establishing a maximum tolerated dose (MTD) or a lower recommended dose if appropriate. Once the MTD is reached, or a recommended dose is established, Blueprint Medicines plans to open expansion cohorts for NSCLC patients with a RET rearrangement, patients with MTC, and patients with RET-altered solid tumors other than NSCLC and MTC. Secondary objectives for this Phase 1 clinical trial include assessing the pharmacokinetic profile of BLU-667, assessing RET gene status in plasma and tumor tissue, characterizing the pharmacodynamic effects of BLU-667 and assessing response rate by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, which are criteria commonly used to measure clinical responses in solid tumors. The Phase 1 clinical trial is designed to enroll approximately 115 patients, including approximately 35 patients during dose escalation and approximately 80 additional patients in expansion cohorts, at multiple sites in the United States and the European Union. Please refer to www.clinicaltrials.gov (NCT03037385) for additional details related to this Phase 1 clinical trial. For more information, contact the study director for this Phase 1 clinical trial at [email protected].

Loxo Oncology Announces Larotrectinib Pan-TRK IHC Companion Diagnostic Collaboration with Ventana Medical Systems, Inc., a member of the Roche Group

On March 20, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the Company has entered into a collaboration agreement with Ventana Medical Systems, Inc., a member of the Roche Group (Roche), to develop and commercialize a pan-TRK immunohistochemistry (IHC) test as a companion diagnostic to identify patients across tumor types suitable for treatment with larotrectinib (Press release, Loxo Oncology, MAR 20, 2017, View Source [SID1234518218]).

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"We are excited to partner with Roche, the global leader in developing and commercializing IHC assays for cancer diagnostics. Our initial technology assessment suggests that an IHC pan-TRK assay is feasible, which is exciting since Roche has thousands of VENTANA BenchMark instruments installed worldwide," said Josh Bilenker, M.D., Chief Executive Officer of Loxo Oncology. "IHC remains a mainstay of the cancer pathology workup, due in part to its speed, limited tissue requirements, low cost, and established reimbursement paradigms. Diagnostics are a crucial part of our commercial strategy, and we believe IHC will be an important tool, alongside next-generation sequencing, that pathologists can employ in screening for patients who may benefit from larotrectinib."

Loxo Oncology and Roche will utilize an investigational assay piloted by Loxo Oncology that will be further developed by Roche using its flagship OptiView DAB detection technology. Initially, the parties will optimize and validate the assay to ensure it is sufficiently robust to withstand clinical and regulatory scrutiny. The parties plan to first globally commercialize an analytical assay and then develop a Class III assay for pre-market approval (PMA) from the U.S. Food and Drug Administration (FDA). FDA approval will be based on analyses of patient samples collected from ongoing larotrectinib clinical trials to support clinical claims referencing larotrectinib. Roche is responsible for developing, obtaining and maintaining regulatory approvals for the companion diagnostic test in the United States, specified countries in the European Union and other countries that recognize the CE/ in vitro diagnostic registration process, as mutually agreed.

About Larotrectinib (LOXO-101)
Larotrectinib (LOXO-101) is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, larotrectinib has demonstrated encouraging preliminary efficacy. Larotrectinib is also being evaluated in the NAVIGATE global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions, and the SCOUT Phase 1/2 trial in pediatric patients, including patients with advanced cancer, TRK gene fusions and infantile fibrosarcoma. Larotrectinib has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation by the U.S. FDA. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.

Major Achievements in 2016 Validate Transgene’s Strategy and Provide Promising Outlook for 2017

On March 20, 2017 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotechnology company focused on designing and developing viral-based immune-targeted therapies for the treatment of cancers and infectious diseases, reported its financial results for the fiscal year ended December 31, 2016, and provided its outlook for 2017 (Press release, Transgene, MAR 20, 2017, View Source [SID1234518217]).

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In 2016, Transgene has focused its efforts on implementing its strategy, which looks to combine Transgene’s immunotherapies (therapeutic vaccines and oncolytic viruses, which boost the immune system), with immune checkpoint inhibitors (ICIs). Over the last twelve months, additional data from clinical studies combining active immunotherapies with ICIs have confirmed the strong rationale behind this strategy.

During the second half of 2016, Transgene signed two clinical collaboration agreements that allow clinical studies with:

TG4010 in combination with Bristol Myers-Squibb’s ICI nivolumab in lung cancer patients receiving a 2nd line of treatment and;
TG4001 with Merck KGaA’s and Pfizer’s ICI avelumab in patients with HPV-positive head and neck cancer.
Several clinical trials have recently started or are being initiated to confirm the potential of Transgene’s immunotherapeutics in combination with ICIs. The first results from these studies are expected around the end of 2017.

During the 2016 fiscal year, the Company strengthened its financial structure which will provide it with the funding to execute its clinical development plan through the end of 2018. This improved financial situation was the result of:

a loan of €20 million from the European Investment Bank (EIB), €10 million of which was drawn down in June 2016 ;
a €46.4 million rights issue that was completed in November 2016;
as well as the significant reduction of our net loss €25.2 million compared to €46.4 million in 2015.
In parallel with strengthening its financial position, Transgene completed its reorganization with the result it is now focused on research and clinical development (R&D). As part of the restructuring, Transgene sold its production facility to ABL Europe, a Mérieux Group Company, for €3.5 million.

Philippe Archinard, Chairman and Chief Executive Officer of Transgene said: "Our achievements in 2016 have reinforced our position as a major player in immunotherapy. Our portfolio of immunotherapies, our clinical collaborations and our much-improved financial position have put us in a strong position to execute our clinical plan which is designed to deliver a rich news flow over the coming months. Positive results from these studies would allow us to conclude partnership agreements with pharmaceutical companies. We are looking forward to demonstrating the important clinical benefits that our immunotherapies in combination with ICIs can offer to patients with severe diseases."

Product pipeline review

1. Therapeutic Vaccines

TG4010 in advanced non-squamous non-small cell lung cancer

TG4010 is a therapeutic vaccine that induces an immune response against MUC1 expressing cells. TG4010 is being developed in non-squamous non-small cell lung cancer (NSCLC). TG4010’s mechanism of action and excellent safety profile make it a very suitable candidate for combinations with other therapies.

TG4010’s development plan is focused on Phase 2 studies that can generate a comprehensive data package for TG4010 in 1st- and 2nd-line treatment of advanced NSCLC over the next 9 to 18 months.

The clinical trials aim to confirm the synergies that are expected to result from the combination of a therapeutic vaccine and an ICI. The expected clinical benefits are an increase in the response rate, in the quality and in the duration of the response to current and future standards of care.

TG4010
+ Opdivo (ICI)
(nivolumab)
Phase 2


Non-small cell lung cancer (NSCLC) – 2nd-line

Trial of TG4010 in combination with Opdivo, conducted by UC Davis Medical Center (USA), with the support of Bristol-Myers Squibb (supply of nivolumab)
First patient treated in March 2017 (NCT02823990) and first results expected around the end of 2017
TG4010
+ ICI
+ chemotherapy
Phase 2

Non-small cell lung cancer (NSCLC) – 1st-line

Preparation of a Phase 2 clinical trial combining TG4010 with an ICI and with standard chemotherapy in patients with tumor cells expressing low or undetectable levels of PD-L1
Ongoing discussion with a pharma to conduct this trial
First patient expected to be enrolled towards the end of 2017
TG4001: trial in combination with avelumab following collaboration agreement with Merck KGaA and Pfizer

TG4001 is a therapeutic vaccine that has already been administered to more than 300 patients with high grade cervical intra-epithelial neoplasia (CIN 2/3). This clinical experience has demonstrated good tolerability, a significant HPV clearance rate and promising efficacy results for TG4001. Its mechanism of action and good safety profile make TG4001 an appropriate candidate for combinations with other therapies, such as the anti-PD-L1 ICI avelumab.

TG4001
+ avelumab (ICI)
Phase 2

HPV positive head and neck cancer – 2nd-line

Signed clinical collaboration agreement with Merck KGaA and Pfizer, with supply of avelumab for the trial
First patient expected in 2H 2017
Prof. Christophe Le Tourneau, Institut Curie, principal investigator
TG1050: ongoing recruitment in the Phase 1/1b trial, results expected in 2H 2017

TG1050 is a therapeutic vaccine for the treatment of chronic hepatitis B. In 2015, Transgene started a study (NCT02428400) evaluating the safety and tolerability of TG1050 in patients who are currently being treated for chronic HBV infection with standard-of-care antiviral therapy. The technology of TG1050 is also being developed in China, where Transgene operates a joint-venture with Tasly Biopharmaceutical Technology.

TG1050
+ Standard-of-
Care Antiviral
Phase 1/1b

Chronic hepatitis B

Phase 1/1b clinical trial is progressing following positive recommendation of the Safety Review Committee in July 2016
First data readout in 2H 2017
2. Oncolytic viruses

Pexa-Vec: ongoing Phase 3 trial, initiation of the Phase 2 clinical trials in combination with ICIs

Pexa-Vec is an oncolytic virus designed to selectively destroy cancer cells through intracellular viral replication (oncolysis), and by stimulating the body’s immune response against cancer cells. Its mechanism of action and its tolerability profile make it an appropriate candidate for combinations with immune checkpoint inhibitors (ICIs).

Pexa-Vec
+ sorafenib
(PHOCUS)
Phase 3

Advanced liver cancer (hepatocellular carcinoma – HCC) – 1st-line

1st patient enrolled (January 2016)
Ongoing recruitment in line with forecasts, 1st patient to be treated shortly in Europe
Clinical trial conducted by SillaJen, Inc., Transgene’s partner
First data readout expected in 2019
Pexa-Vec
+ nivolumab (ICI)
Phase 2

Advanced liver cancer (hepatocellular carcinoma – HCC) – 1st-line

1st patient expected to be treated in 2Q 2017
Pexa-Vec
+ ipilimumab (ICI)
Phase 1

Solid tumors

1st patient treated in February 2017 in a clinical trial evaluating the tolerability and efficacy of intratumoral injection regimen
Centre Léon Bérard, sponsor of the trial (NCT02977156)
First readout around the end of 2017
TG6002: preparation of first-in-human trial

TG6002 is a next generation oncolytic immunotherapy. It has been designed to induce the breakdown of cancer cells (oncolysis) and express the FCU1 gene in cancer cells it has infected leading to the local production of 5-FU, a widely used chemotherapy. TG6002 could potentially be used both in combination or as monotherapy.

TG6002
Phase 1

Glioblastoma

Preparation of the clinical trial with AP-HP (Pr Delattre principal investigator), with the support of INCA (French national cancer institute)
Trial to start in 2Q 2017
3. Research and preclinical portfolio

Transgene has delivered multiple important research and preclinical milestones in 2016. Transgene is exploring a new generation of armed oncolytic viruses. These oncolytic viruses can be armed with ICIs and/or therapeutic moieties that modulate the tumor micro-environment. These novel therapeutic payloads are designed to modify cell interactions within the tumor and enhance the efficacy of oncolytic viruses.

Transgene has filed a patent for an oncolytic Vaccinia Virus expressing an anti-PD1 antibody. Transgene presented a poster at the AACR (Free AACR Whitepaper) (American Association for Cancer Research) meeting in April 2016, demonstrating our capacity to engineer advanced multifunctional viruses.

Corporate

Restructuring plan and sale of the production facility to ABL Europe for €3.5 million finalized. Annualized recurring savings are estimated to be approximately €15 million.
Management team strengthened: Maud Brandely, MD, PhD appointed Chief Medical Officer, and John Felitti, JD, LLM appointed General Counsel & Corporate Secretary.
Key financials for 2016

Net cash burn for 2016 was €30.6 million (including €5 million linked to the restructuring), versus €34.8 million in 2015. This was lower than expected due to a delay in an $4 million milestone payment to SillaJen. This payment is to be made in early 2017.
Cash available at year-end 2016: €56.2 million, compared to €31.7 million at the end of 2015. This higher cash balance includes the €10 million draw-down of the EIB loan and the net proceeds of €45.2 million from the rights issue which was concluded in November 2016.
Net operating expenses of €33.0 million in 2016, compared to €45.8 million in 2015.
Significantly reduced net loss of €25.2 million in 2016, compared to a loss of €46.4 million in 2015.
"Transgene’s 2016 financials reflect the completion of the reorganization that started in 2015. This has led to a significant reduction of our operating costs and as a result a 46% reduction in our net loss when compared to 2015. This reduction in fixed costs has enabled us to devote a greater proportion of our increased financial resources to our key strategic clinical and pre-clinical programs," said Jean-Philippe Del, Vice President, Finance.

The financial statements for 2016 as well as management’s discussion and analysis are attached to this press release (Appendices A and B).

Financial Outlook 2017

Transgene expects its cash burn to be around €30 million in 2017. This figure takes into account the increase in costs related to the launch of clinical trials in 2017, as well as a confirmed significant reduction of our fixed costs following the restructuring that has taken place since 2015.

The Company still has access to further funding of up to €10 million from the second tranche of the EIB loan.

Transgene will host a "R&D Day", on June 22, 2017. The event which will be conducted in English will feature presentations from several leading international scientists and clinicians.

The Board of Directors of Transgene met on March 17, 2017, under the chairmanship of Philippe Archinard and closed the 2016 financial statements. Audit procedures have been performed by the statutory auditors and the delivery of the auditors’ report is ongoing. The registration document, which includes the financial report, will be available in April 2017 on Transgene’s website, www.transgene.com.

A conference call in English is scheduled on March 20th at 6 PM CET.