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07-Jul-2021

TheraVet Provides Its Half-year Operational Update Of 2021

  • BIOCERA-VET enters in commercial phase
  • Positive safety and efficacy results of VISCO-VET in osteoarthritis and cranial cruciate ligament deficiency in dogs
  • Strengthened financial position following to the success of the Initial Public Offering, resulting in a capital increase of over €7 million

JUMET, Wallonia, Belgium--(BUSINESS WIRE)--Regulatory News:

TheraVet S.A. (Paris:ALVET) (Brussels:ALVET), a pioneering company in the management of osteoarticular diseases in pets, provides today its half-year operational update ending 30 June 2021.

Enrico Bastianelli, Chief Executive Officer of TheraVet, said: “The first semester of 2021 was very fruitful for the Company. First the successful Initial Public Offering closed with more than €7 million allowing TheraVet to pursue the development of its 2 product lines, BIOCERA-VET and VISCO-VET. The commercial development of BIOCERA-VET started in April 2021 with the launch of BIOCERA-VET – Bone Surgery in Belgium. For VISCO-VET, very promising results were announced in the 2 target indications making of VISCO-VET a potential game-changer in the articular field. The Company has now new objectives with the commercial expansion of BIOCERA-VET and the completion of the proof-of-concept study for VISCO-VET in osteoarthritis in owner dogs and the launch of the European pivotal clinical trial for VISCO-VET in the same indication.”

Recent operational highlights

Positive results of VISCO-VET in its two target indications, canine osteoarthritis and cranial cruciate ligament deficiency

On January 26, 2021, the Company announced positive safety and efficacy results of VISCO-VET, its injectable visco-regenerative gel, in the prevention of cranial cruciate ligament (CCL) deficiency in dogs. In this proof-of-concept study including 12 dogs, a unique intra-articular administration of VISCO-VET 3 months before was able to statistically significantly decrease by 61% (p<0.05) the signs of degeneration of the partially injured ligament compared to control (saline intra-articular injection), leading to the preservation of the microarchitecture of the ligament (histological Bonar Score).

On March 4, 2021, the Company announced the positive safety and efficacy results of VISCO-VET in a canine model of osteoarthritis, its lead clinical indication. In this proof-of-concept study including 16 dogs, a single intra-articular administration of VISCO-VET allowed to statistically significantly improve by 47% and 49% the lameness of dogs (%TPI and GLS)1 at 2 and 3 months compared to control (i.e., single intra-articular hyaluronic acid injection). Additionally, VISCO-VET significantly slows down the radiological progression of arthritis as soon as 1 month (p<0.05) and up to 3 months (p<0.05) as compared to control. VISCO-VET also significantly decreased the cartilage damage at lateral femoral condyle (central zone) (p<0.05) as compared to control. Together, these results shown that VISCO-VET significantly improves limb function and significantly reduces the progression of osteoarthritis.

Launch of BIOCERA-VET- Bone Surgery

On April 1, 2021, the Company announced the commercial launch in Belgium of BIOCERA-VET, its new generation bone substitute for the treatment of bone surgeries in small companion animals. BIOCERA-VET is indicated in bone surgeries where there is a need for bone grafting such as arthrodesis, complex fractures, corrective osteotomy used in correction of limb deformities.

Positive results of BIOCERA-VET - Bone Surgery in canine arthrodesis

On April 27, 2021, the Company announced the positive safety and efficacy results of BIOCERA-VET - Bone surgery in canine arthrodesis2 (fusion of carpal or tarsal joint). In this study including 29 canine clinical cases, 13 arthrodesis treated with BIOCERA-VET were compared to 16 cases treated with autologous bone graft3 (standard of care), all in addition to the standard surgical procedure. Independent radiological evaluation showed that BIOCERA-VET displayed comparable fusion score at 44 and 85 weeks compared to the autologous bone graft (respective mean scores of 1.70 vs 1.41, p>0.05 at 4 weeks and of 2.08 vs 1.88, p>0.05 at 8 weeks). No complication was reported with BIOCERA-VET against 15 to 30% with autologous bone graft. In conclusion, in this arthrodesis study, BIOCERA-VET was at least as effective as autologous bone graft but reduces complication rate and surgery time.

Use of BIOCERA-VET in a comprehensive approach to the treatment of osteosarcoma in dogs

On July 2, 2021, the company announced a new use of BIOCERA-VET in a multidisciplinary approach to the treatment of osteosarcoma in dogs. In this context, TheraVet participated in the treatment of Flash, a 10-year-old Rottweiler cross with osteosarcoma of the distal radius by a multidisciplinary team supervised by Dr. Vet David Sayag, European specialist in pet oncology (ONCOnseil -Unité d'expertise en oncologie, Toulouse, France). In order to preserve his quality of life and avoid amputation, Flash's bone tumor was destroyed by image-guided microwave ablation followed by consolidation of the affected bone by cementoplasty using the BIOCERA-VET product. Flash is currently being monitored and treated with immunochemotherapy and is doing well. The management of animals with osteosarcoma through a global approach such as the one proposed by Dr. Sayag is a very high potential alternative to amputation.

Upcoming operational milestones for the second half of 2021

  • Results of Proof-of-Concept clinical trial of VISCO-VET in client-owned dogs suffering from osteoarthritis
  • Launch of European pivotal clinical trial of VISCO-VET in canine osteoarthritis
  • Results of clinical trial of BIOCERA-VET as alternative treatment of canine osteosarcoma
  • Launch of BIOCERA-VET- Bone surgery in France and Netherlands

Financial position strengthened thanks to the success of the Initial Public Offering

On June 11, 2021, the Company announced the success of its Initial Public Offering on Euronext Growth® Paris and Brussels. The total demand amounted to €7.15 million for a market capitalization of approximately €31 million. This total demand results in an oversubscription rate of 117% of the initial offering. On June 17, 2021, the Company's shares started trading on Euronext Growth® Paris and Euronext Growth® Brussels.

Next financial updates

  • Half-year Financial Results of 2021, on September 30, 2021

About TheraVet SA

TheraVet is a veterinary biotechnology company specialising in osteoarticular treatments for animals. The Company develops targeted, safe and effective treatments to improve the quality of life of pets suffering from osteoarticular diseases. For pet owners, the health of their pets is a major concern and TheraVet’s mission is to address the need for innovative and curative treatments. TheraVet works closely with international opinion leaders in order to provide a more effective response to ever-growing needs in the field of veterinary medicine. TheraVet is listed on Euronext Growth® Paris et Brussels, its head office is in Jumet, Belgium, and it has a subsidiary in the US.

For more information, visit www.thera.vet


1 Pressure variables, such as limbs pressures distribution and the off-loading of affected limb (lameness) objectively evaluated using a pressure walkaway system (GaitRite®); %TPI: %Total Index Pressure defined as the sum of peak pressure recorded for the affected paw expressed as percentage of the 4 limbs; GLS: Gait4dog® lameness score
2 Surgical procedure to restore function and alleviate pain in carpal and tarsal joints with ligamentous injuries, bone fractures, joint luxation or subluxations
3 Autologous bone graft is defined as the use of bone obtained from the same individual receiving the graft
4 Radiological evaluation performed from 3 to 5 weeks post-surgery
5 Radiological evaluation performed from 6 to 8 weeks post-surgery


Contacts

TheraVet
Sabrina Ena
Chief Operating Officer
sabrina.ena@thera.vet
Tel: +32 (0) 71 18 32 49

Julie Winand
Chief Corporate Officer
julie.winand@thera.vet
Tel: +32 (0) 71 18 32 49

NewCap
Investor Relations and Financial Communications
Louis Tilquin / Olivier Bricaud
theravet@newcap.eu
Tel: +33 (0)1 44 71 94 94

Press Relations
Arthur Rouillé / Ambre Delval
theravet@newcap.eu
Tel: +33 (0)1 44 71 00 15

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Last Updated: 07-Jul-2021