On August 27, 2020 Vaccibody reported that result of 2nd quarter 2020(Press release, Vaccibody, AUG 27, 2020, View Source [SID1234564136])
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Highlights:
Expansion of Vaccibody’s strategic focus to include Infectious Diseases
• Appointment of Gunnstein Norheim, Ph.D., as Director Infectious Diseases leading this new initiative
• VB C-02 trial with VB10.16 in combination with Roche’s immune-checkpoint inhibitor atezolizumab in advanced cervical cancer patients approved in all six participating countries, including Norway
Highlights after June 30th, 2020:
• Dosing of first patient in VB C-02 Phase II clinical trial with VB10.16 in combination with Roche’s immune-checkpoint inhibitor atezolizumab in advanced cervical cancer
• Vaccibody and Nektar Therapeutics dose first patient in Phase I/IIa trial arm evaluating VB10.NEO in combination with bempegaldesleukin (NKTR-214) and immune-checkpoint inhibitor in patients with head and neck cancer
• Finalization of patient enrolment in VB N-01 Phase I/IIa clinical trial with VB10.NEO neoantigen cancer vaccine in locally advanced or metastatic cancer patients
Michael Engsig, Chief Executive Officer at Vaccibody, comments: "This has been a very strong quarter in terms of bringing our projects forward. With the VB C-02 trial in advanced cervical cancer receiving approvals from relevant regulatory authorities in all the participating countries, followed by finalizing enrolment of the VB N-01 trial, this emphasizes our team’s ability to keep our operations running in spite of the challenging Covid-19 situation"
R&D update
VB10.NEO
VB10.NEO is an individualized neoantigen cancer vaccine:
• Clinical status: Phase I/IIa
• Cancer Indications: Melanoma, non-small cell lung cancer (NSCLC), clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of the head and neck (SCCHN),
Status and highlights
The good momentum in the screening and enrolment was maintained during the second quarter despite the Covid-19 situation. As per 21 August 2020 it was announced that the enrolment target of the 50 patients for the VB N-01 trial had been reached and the enrolment finalized. Patients have been enrolled across all six trial arms covering the respective indications. The best-in-class 100% manufacturing success of producing the VB10.NEO individualized vaccine for patients with a sufficient number of neoantigens continued.
VB10.16:
VB C-02 The clinical trial is based on VB10.16 + atezolizumab in advanced cervical cancer:
• Clinical status: Phase II
• Indication: HPV16+ advanced, non-resectable cervical cancer Status and highlights As per 30 June, four sites had been initiated in Belgium, Czech Republic and Norway and three were activated. Two patients were in screening and on 1 July, the first patient had received the first dose at the Oslo University Hospital in Norway.
Infectious Diseases Discovery and pre-clinical activities within infectious diseases have been initiated and early pre-clinical data are encouraging. Vaccibody’s strategic analysis and planning activities continue with the goal of presenting a comprehensive infectious disease strategy later in 2020.
Financial review
Income statement
The net result for 1H20 was a net loss of NOK 83.7 million compared to a NOK 39.1 million loss in 1H19. The increased loss was caused mainly by an increase in clinical development activities relating primarily to the inclusion and treatment of patients in VB N-01, a larger number of sites for accelerated patient recruitment, and expenses for preparations for the VB C-02 program.
Operating income
Total operating income amounted to NOK 2.6 million in 1H20 (NOK 5.7 million in 1H19) and consisted primarily of accrued grants from SkatteFUNN, a Norwegian government R&D tax incentive program.
Operating expenses
Total operating expenses amounted to NOK 95.1 million in 1H20 compared to NOK 45.8 million in 1H19. Employee expenses increased to NOK 20 million (1H19: NOK 11.5 million). The increase was primarily caused by the planned increase in employees.
Other operating expenses amounted to NOK 75.1 million in 1H20 (1H19: NOK 34.3 million), primarily due to a ramp-up of the ongoing VB N-01 program as well as expenses for preparations for the VB C02 clinical development program.Net financial income and expenses Net financial income and expenses increased to NOK 8.8 million in 1H20 compared to NOK 0.1 million in 1H19. The increase related primarily to currency gains on the Company’s cash held in EUR. Statement of financial position Cash At June 30, 2020, Vaccibody had a cash position of NOK 202.7 million compared to NOK 322.0 million at June 30, 2019. The change reflects the net results of the Company and cash received from the exercise of warrants. Equity At June 30, 2020, total equity amounted to NOK 192.7 million compared to NOK 320.3 million at June 390, 2019.
Outlook Three major clinical objectives for 2020 have already been reached, namely:
• Dose the first patient in the VB N-01 study arm with VB10.NEO in combination with Nektar Therapeutic’s bempegaldesleukin (NKTR-214)
• Complete the enrolment of patients into the Company’s VB N-01 clinical trial including the basket arm 5B which investigates VB10.NEO in combination with Nektar Therapeutic’s bempegaldesleukin (NKTR-214) Initiate enrolment in the VB C-02 trial investigating VB10.16 in combination with atezolizumab in patients with advanced or recurrent cervical cancer
An overview of Vaccibody’s outlook for the remainder of 2020 is provided in the table below. Further, Vaccibody will lay out its strategy for the Infectious Disease area later in 2020. Last, the Company is in continuous dialogue with academic and industrial entities and will announce new key collaborations and partnerships if or when they may occur.
Expected 2020 outlook and news flow regarding Vaccibody’s clinical trial R&D pipeline:At June 30, 2020, the Company had 3 074 986 active warrants outstanding to key employees and members of the board. According to the warrant contracts, any share split, such as the 1:5 split in July 2020, will have a neutral effect on the warrants, i.e. number of warrants are increased and the strike reduced by the split factor.