Business update

Abzena plc

Business update - strong second half momentum

Cambridge, UK, 9 March 2016 - Abzena plc (AIM: ABZA, 'Abzena' or the 'Group'), a life sciences group providing services and technologies enabling the development and manufacture of biopharmaceutical products, provides the following update.

Broadening of service offering

As part of its strategy to broaden its service offering Abzena completed the acquisition of PacificGMP, a contract biopharmaceutical manufacturing and development company based in San Diego (USA), in September 2015. It also acquired The Chemistry Research Solution (TCRS), a contract chemistry and bioconjugation business based in Bristol, near Philadelphia (USA), in December 2015.

The integration of both PacificGMP and TCRS is progressing well. Work is underway to develop the capability to provide GMP manufacture of conjugation reagents for antibody drug conjugates (ADCs) in Bristol (USA). A programme of work to expand the GMP manufacturing capacity in San Diego (USA) is also due to commence this month.

The Group has seen a positive response from customers to the integrated services it can offer for biopharmaceutical development following the acquisitions of PacificGMP and TCRS. Contract bookings have been strong across the Group from new and existing customers with significant opportunities for customers to benefit from leveraging the breadth of Abzena's offering which includes immunogenicity assessment, antibody engineering and manufacturing, chemistry services and bioconjugation technologies.

Following the two recent acquisitions, the Abzena Group now comprises four separate trading companies: Antitope, PacificGMP, PolyTherics and TCRS. By the middle of 2016 it is intended that all Group businesses will be branded and trading under the Abzena name. The change will help reinforce Abzena's integrated offering and will provide a single identity for its services and technologies. 

FairJourney Biologics marketing alliance

Further to its drive to continue to expand its range of offerings, Abzena has formed a marketing alliance with antibody discovery services company, FairJourney Biologics (Portugal). This alliance enables Abzena to offer antibody discovery services to its partners and FairJourney Biologics to offer immunogenicity assessment and analytical services to its clients. The combined offering from both companies will provide a continuum of services from antibody discovery to GMP manufacture for Phase I and II clinical trials. 

Licence portfolio progress

The portfolio of "Abzena inside" products has shown good progress with an additional Composite Human Antibody™ product being taken into clinical development by a US biotech company. It is currently being evaluated in a Phase I study in cancer patients. This takes the number of "Abzena inside" products at a clinical stage to eleven.

Another Composite Human Antibody™ being developed by a different US biotech partner completed a Phase Ia clinical study in healthy volunteers in which proof-of-mechanism was demonstrated. A Phase Ib study has now been initiated in patients with a range of rare diseases.

On 2 February 2016, Gilead Sciences, Inc. ('Gilead') announced that GS-5745, a Composite Human Antibody™, will go into Phase II clinical testing in both chronic obstructive pulmonary disease (COPD) and cystic fibrosis this year. Gilead previously announced that it would also start a Phase II study of GS-5745 in rheumatoid arthritis in 2016.

In the same announcement, Gilead also reiterated that Phase II studies with another Composite Human Antibody™, simtuzumab, were continuing in patients with non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) following a review by the data monitoring committee for these studies. They had previously announced that a Phase II study in patients with idiopathic pulmonary fibrosis (IPF) had been stopped.  

ThioBridge™

In January, Abzena signed a significant licence agreement for ThioBridge™, its proprietary ADC linker technology, which links antibodies and other proteins to drugs. The partner is a publicly listed US biotech company developing and commercialising oncology therapies, including ADCs.

Abzena will receive an initial licence and target nomination fee and has the potential to receive further licence fees and milestone payments of up to $150 million as well as royalties on the sale of ThioBridge™ ADC products developed under this agreement.

Fundraising

In December 2015, Abzena raised £21.0 million (gross) by way of a placing of 35,004,972 new Ordinary Shares with certain existing and new shareholders. Part of the new money was used to acquire TCRS and for capital expenditure on building manufacturing capacity. It is also being used for existing R&D and working capital.

Dr John Burt, CEO of Abzena said:

"Progress has been strong during the period. Both US acquisitions are settling into the Group well and plans are being implemented to upgrade their capabilities and expand their facilities. We have also seen continued positive progress in the licence portfolio with another "Abzena inside" product entering clinical development.

The agreement for ThioBridge™ with a large US biotech company demonstrates the value of our proprietary technology in creating novel ADCs. We continue to find new ways of expanding our range of offerings, by working with specialists such as FairJourney Biologics.

We expect to maintain this level of momentum for the foreseeable future. More partner projects will move towards the clinic and, as part of that journey, they will benefit from our increased capabilities."

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About Abzena

Abzena (AIM: ABZA) provides proprietary technologies and complementary services to enable the development and manufacture of biopharmaceutical products, a growing area that requires specialist knowledge and expertise. The Group has a global customer base which includes the majority of the top 20 biopharmaceutical companies as well as large and small biotech companies and academic groups.

The term "Abzena inside" is used by Abzena to describe products that have been created using its proprietary technologies and are being developed by its partners, and include Composite Human Antibodies™ and ThioBridge™ antibody drug conjugates. Abzena has the potential to earn future licence fees, milestone payments and/or royalties on "Abzena inside" products.

Abzena offers the following services and technologies across its principal sites in Cambridge (UK), San Diego, California (USA) and Bristol, Pennsylvania (USA).

§ Immunogenicity assessment, protein engineering to create humanized antibodies and deimmunised therapeutic proteins, and cell line development for manufacture.

§ Contract process development and manufacture of biopharmaceuticals, including monoclonal antibodies, recombinant proteins, vaccines, and gene therapy and cell therapy products, for preclinical and clinical studies.

§ Proprietary site-specific conjugation technologies for antibody drug conjugate development and solutions for optimizing the therapeutic properties of biopharmaceuticals.

§ Contract chemistry and bioconjugation business focused on ADCs and is establishing the capability to manufacture ADCs to GMP standards.

For more information, please see www.abzena.com