2014 – A pivotal year for Genticel

Genticel (Euronext Paris and Brussels: FR0011790542 - GTCL), a French biotechnology company and leading developer of therapeutic vaccines, presents today its 2014 full year results in accordance with International Financial Reporting Standards (IFRS).
 

• Operating and Corporate highlights
  • Inclusion of 1^st patient in ProCervix Phase 2 clinical trial on January 30^th, 2014; completion of enrollment (239 patients) as of November 10^th, 2014, more than 4 months ahead of schedule;
  • Data Safety Monitoring Board (DSMB) met for the first time as scheduled on July 1^st, 2014 and recommended pursuing the ProCervix Phase 2 clinical trial with no changes to protocol;
  • Preclinical development of 2^nd therapeutic vaccine candidate called Multivalent HPV on track;
  • Five new patents granted in the US and Asia during H1 2014;
  • Strengthened human resources with recruitment of Dr. Sophie Olivier as Chief Medical Officer;
  • Appointment of Ms. Mary Tanner as independently-acting member to the Supervisory Board;
  • Genticel awarded “Prix Biotech d'Avenir” (Most Promising Biotech) in the SW France category of the Deloitte Technology Fast 50 Benchmark.

• Post 2014 highlights
  • DSMB met for the second time as scheduled on January 22nd, 2015 and recommended pursuing the ProCervix Phase 2 clinical trial with no changes to protocol;
  • License agreement signed with Serum Institute of India on February 2^nd for use of Vaxiclase technology in multivalent combination vaccines containing pertussis antigens ($57 million in upfront, development & sales milestones + single digit royalties on sales).

• Upcoming Milestones
  • Investigational New Drug (IND) approval by the US Food & Drug Administration (FDA) for ProCervix Phase 1 clinical study in the USA (H1 2015);
  • Start of US Phase 1 clinical trial with ProCervix in the USA; enrollment of 1^st patient (H2 2015).
  • Pre-clinical proof of concept for Multivalent HPV (H1 2015).

• Financial highlights
  • On January 24^th, 2014, exercise of 1,046,876 share subscription warrants conferring the right to 1,046,876 shares for a total cash contribution of €4.2 million (issue premium included);
  • On March 7^th, 2014, issuance of convertible bonds (CBs) representing a total borrowing of €2.5 million, converted later into 310,328 shares at €7.90 per share;
  • On April 4^th, 2014, €34.7 million raised in a nearly two-fold oversubscribed, successful IPO on Euronext Brussels & Paris;
  • Annual cash burn from 2014 operations of €9.8 million, in line with management expectations;
  • Strong FINANCIAL position at the end of 2014 with cash & cash equivalents and liquid investments of €32.8 million as of December 31^st, 2014.

Commenting on the 2014 results, Benedikt Timmerman, ceo of Genticel, said:

“2014 was truly a pivotal year for Genticel. ProCervix, our first therapeutic vaccine candidate entered its Phase 2 clinical trial early in the year and we were able to complete the recruitment of all 239 patients by November, well ahead of schedule. The DSMB reviewed all the safety data available at the time and each time, allowed the trial to pursue per protocol, which is very reassuring. In the financial arena, our successful stock market listing enabled us to raise close to €35 million. This major step in our company's development increases our visibility with current and future partners. We now have the financial resources to move forward with confidence as we develop our portfolio of therapeutic vaccines designed to eliminate, at an early stage, the human papillomavirus (HPV) responsible for cervical cancer
Earlier this year, we initiated a partnership with Serum Institute of India, the largest vaccine producer in the world. This deal opens an entirely new field of applications for Vaxiclase, which complements our core activities in the HPV field and will also provide Genticel with access to improved production and process methods that the Serum Institute may implement to our Vaxiclase platform. Given Serum's extensive experience and track record in this area, this is of strategic value to Genticel. Overall, the agreement entitles Genticel to up to $57 million in upfront & milestones payments plus single digit royalties on net sales. ”
 

• Operating review

In 2014, Genticel reached a number of key milestones in its product development with the launch of a Phase 2 clinical trial for ProCervix, which is intended for women already infected with HPV 16 and/or 18 but before the appearance of high-grade or cancerous lesions. It is the first therapeutic vaccine that meets the medical needs of this high-risk population, as preventive HPV vaccines are only effective in women who are not yet infected.
The purpose of this multi-center Phase 2 trial is to evaluate the efficacy of ProCervix in clearing the viral infection. The protocol had previously received a favorable opinion from the European Medicines Agency (EMA). Thirty-nine investigation sites in seven European countries (Germany, Belgium, Spain, Finland, France, the Netherlands and the United Kingdom) are actively participating in this clinical trial.

The first patient was treated on January 30^th, 2014. Eight months later, on November 10^th, 2014, Genticel had recruited 239 patients for this Phase 2 trial, well ahead of its projections.

Furthermore, DSMB, a group of independent experts that reviews the tolerance data from the trial every six months, recommended continuing the trial unchanged after its scheduled meetings on July 1^st, 2014 and on January 22^nd, 2015.

The Company's second drug candidate is a multivalent therapeutic HPV vaccine (called Multivalent HPV) that targets 6 of the most relevant HPV types (HPV 16, 18 and four others), which cause cervical cancer. The preclinical results during 2014 were very encouraging. Specifically, Genticel was able to achieve the pharmacological proof of concept, that is, simultaneous delivery of multiple antigens of several oncogenic HPV types using the Vaxiclase technology.

Furthermore, Genticel enriched its intellectual property portfolio in 2014 with five patents granted in major territories. These patents encompass granted claims protecting ProCervix and contain claims that also cover Genticel's Multivalent HPV. With the addition of these patents, Genticel now holds multiple patents layers, protecting ProCervix across key mature and emerging markets, namely the US, Europe, Japan, South Korea and India.

In November 2014, the Company won the “Prix Biotech Régional d'Avenir 2014” (Most Promising Biotech Award) of the Deloitte Technology Fast 50 benchmark awards for technology companies.

The Technology Fast 50 regional jury chose to recognize Genticel for its excellent performance in capital increase in 2013 prior to its market listing in April 2014. Genticel did indeed raise €18.2 million in 2013, one of the most significant capital increases in the Life Sciences sector in Europe for that year (excluding listed companies).

• Corporate review

To run its clinical development pipeline, and the Phase 2 ProCervix trial in particular, Genticel has strengthened its management TEAM with the addition of Dr Sophie Olivier as Chief Medical Officer as of March 3^rd, 2014. Dr Olivier comes to Genticel with expertise spanning more than 20 years in gynecology & obstetrics (Marseille, France); clinical development in women's health, bone repair and vaccines (Wyeth, France & USA); and regulatory affairs (European Medicines Agency, UK). Sophie Olivier's extensive experience in these fields is a perfect match with Genticel's clinical development programs that are ongoing and planned in Europe and the USA.

On September 11^th, 2014, Genticel also appointed Ms. Mary Tanner to the Supervisory Board as a new independently-acting member and as Audit Committee chairman. Mary Tanner replaces a resigning board member, Amundi Private Equity Fund.

Mary Tanner has devoted more than 25 years to the global healthcare industry. Her expertise includes the ethical pharmaceutical industry, biotechnology, diagnostics, medical devices, healthcare services and consumer medicine industries. Her broad experience will be very useful to Genticel with US investors, the US pharma industry, and in Genticel's preparation of its first US-based clinical trial with ProCervix. Moreover, her financial expertise and her knowledge of internal control and reporting requirements will be key assets for Genticel's Audit Committee.

• Upcoming milestones

Genticel plans to file an IND with the FDA for ProCervix during the first half of 2015 in order to run a Phase 1 trial in the United States. Since women over the age of 50 have not yet been included in a clinical trial with ProCervix, Genticel seeks to evaluate the tolerability of ProCervix in this population in this study. This is also an opportunity to obtain the FDA's opinion on ProCervix and its clinical development plan and provides for ample time prior to Phase 3 initiation to comply with any specific regulatory requirements that the FDA may have. Genticel expects to begin patient enrolment for this Phase 1 study in the second half of 2015.

After demonstrating in 2014 that the Vaxiclase technology allows for simultaneous delivery of multiple antigens of various oncogenes HPV types, Genticel also expects to complete the pre-clinical efficacy proof of concept for the therapeutic vaccine candidate, Multivalent HPV.

• Financial review 2014 (see appendix for detailed information)

Income statement
As of December 31, 2014, Genticel had an operating loss of €10.8 million compared with a loss of €6.0 million in 2013. This was overall consistent with expectations and reflects:

• Increased investment in R&D (€10.8 million versus €6.9 million), essentially due to the set-up and the initiation of the ProCervix Phase 2 clinical trial, which generated major costs. However, a large part of these costs are non-recurring. The faster recruitment of patients into the trial has led to significant accruals MADE (€824,000) as of December 31^st for invoices not yet received from the investigational centers and led to a corresponding improvement in our working capital requirements;
• The growth of 56% in these expenses over the period was accompanied by a relatively smaller increase in Research Tax Credits (Crédit d'Impôt Recherche in France), which went up by only 37%, from €1.8 million for 2013 to €2.6 million for 2014. This difference in growth rate is due to smaller reimbursements of “redeemable advances*” in 2014 than in 2013 and because a significant contractor of ProCervix Phase 2 trial did not have its CIR accreditation renewed in 2014;
• An increase in general and administrative expenses from €1.3 million to €2.8 million for 2014 was mainly due to costs from the initial public offering, impact of share-based remunerations as well as non-recurring personnel costs.

After taking financial items into account, the 2014 net loss of €10.7 million was consistent with the Company's expectations.

Balance sheet and cash at the end of 2014.

Overall, and in comparison to the €3.8 million held on December 31^st, 2013, Genticel completed 2014 with strong cash & cash equivalents and liquid investments of €32.8 million consisting of €10.1 million in non-current financial assets, €12.5 million in current financial assets and
 €10.2 million in cash and cash equivalents.

In part, the change reflects:

• On March 7^th, the issuance of convertible bonds (CBs) representing a total borrowing of€2.4 million, converted later into 310,328 shares at €7.90 per share;
• Numerous capital increases, for a net amount of €35.9 million (including €31.7 million from the IPO and €4.2 million in January 2014 from the exercise of 1,046,876 share subscription warrants);
• A payment of €200,000 for a liquidity contract administered by Oddo Corporate Finance;
•  €9.8 million cash consumed for Company operations, in line with expectations.

(*): *Cash received from “public redeemable advances” reduced the base on which the CIR is calculated whereas reimbursement of these same “public redeemable advances” increases the basis on which CIR is calculated

Financial calendar 2015

Upcoming Genticel meetings with investors

About Genticel
Genticel is a French biopharmaceutical company specialized in the development of therapeutic vaccines aimed at eliminating, at an early stage, the human papillomavirus (HPV) responsible for cervical cancer.

Genticel's most advanced candidate therapeutic vaccine, ProCervix, is currently in a Phase 2 clinical trial. ProCervix is designed to induce the elimination of cervical cells infected with HPV 16 and/or HPV 18. The company has also established Vaxiclase, a technology platform ideally adapted for use in early-intervention immunotherapies against multiple infectious or cancerous diseases. This platform is being used to develop a second therapeutic vaccine candidate, now in its preclinical stage, targeting six of the most pertinent HPV strains in terms of global epidemiology.

Genticel is based in Paris and Toulouse and was awarded 2014 “Prix Biotech d'Avenir” (Most Promising Biotech) in the SW France category of the Deloitte Technology Fast 50 Benchmark.

Since April 4, 2014, Genticel shares have been listed on the regulated Euronext markets in Paris and Brussels.

For more information, please visit Genticel's website, www.genticel.com
 

This press release contains forward-looking statements as to the targets and development strategies of the Company. Said forward-looking statements can be identified by the use of future or conditional tenses or terms such as “expects”, “could”, “estimates”, “intends”, “plans”, “anticipates” or similar expressions. By their nature, forward-looking statements are subject to known and unknown risks and uncertainties which may result in a substantial divergence between forecast and actual results. These targets and development strategies are not historical data and should not be construed as any form of guarantee that forecast figures or events will materialize, that the hypotheses presented will be verified, or that the targets will be reached. Should the targets not be met and the information in this presentation prove to be erroneous, neither the Company, nor its advisors or their representatives shall be obliged to update said information, unless otherwise required by law.

• Appendix: detailed financial information 2014

The financial statements have been prepared in accordance with IFRS, as adopted by the EU. The financial information included in this press release is an extract from the full IFRS consolidated financial statements which will be published with the 2014 Reference Document (i.e. “Document de Réference”) once approved by AMF.

The 2014 IFRS financial statements have been audited by Grant Thornton and Sygnatures.

(1) Cash receipts related Magenta grant (€129k in 2014, €367k in 2013) are deducted from the self-financing capacity and are presented in the cash flow from financing activities