On August 9, 2022 Vaccitech plc (NASDAQ: VACC) reported its financial results for the second quarter ended June 30, 2022 and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, AUG 9, 2022, View Source [SID1234617928]). Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases, autoimmunity, and cancer.
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"The highlight of another productive quarter was interim data from our ongoing Phase 1b/2a clinical trial of VTP-300 in patients with chronic hepatitis B," said Bill Enright, Vaccitech’s CEO. "We saw not only a robust T Cell response, but also sustained HBsAg reductions with a single treatment – interim data points that, to our knowledge, have not been observed together in clinical trials of other immunotherapeutics in this indication. This quarter we have recognized further royalty and milestone payments related to the sales of Vaxzevria, AstraZeneca’s COVID-19 vaccine, which have contributed significant non-dilutive capital to support the company’s clinical and preclinical programs going forward."
Second Quarter 2022 and Recent Corporate Developments
License revenue:
On April 6, 2022, the Company announced that it had been notified of the commencement of royalty payments related to commercial sales of Vaxzevria. The Company’s share of milestone and royalty payments received by Oxford University Innovation, or OUI, from AstraZeneca in the second quarter of 2022 amounted to $17.1 million, relating to commercial sales of Vaxzevria during the first quarter of 2022.
Clinical developments:
On April 29, 2022, the Company received scientific advice from the EMA defining a licensure pathway for its MERS vaccine candidate, VTP-500.
In May, the Company completed enrollment for a Phase 1b/2a clinical trial, HBV002, to evaluate the safety and immunogenicity of VTP-300 with or without an anti-PD-1 therapy in patients with chronic Hepatitis B (HBV) infection whose infection has been suppressed with oral antiviral medication.
In June, Arbutus Biopharma Corporation (Arbutus) and the Company dosed the first patient in a randomized, multi-center, blinded Phase 2a clinical trial to evaluate the safety, antiviral activity, and immunogenicity of the combination of Arbutus’ RNAi therapy, AB-729, with the Company’s immunotherapy, VTP-300, plus standard of care for the treatment of patients with virologically suppressed chronic HBV infection.
In June, at the 2022 EASL International Liver Congress, the Company presented data showing that VTP-300, both as monotherapy and in combination with a single low-dose of nivolumab at the time of the booster dose, induced sustained reductions of HBV surface antigen (HBsAg) in some patients, and a robust T cell response, of which CD8+ T cells were predominant, against all encoded antigens in patients with chronic HBV infection.
In July, the Company enrolled the 60th patient into the Company’s Phase 1b/2 clinical trial of VTP-200, HPV001, to evaluate a potential treatment for persistent high-risk HPV infection.
Pre-clinical development:
In April, the Company launched a program for the treatment of HPV-associated cancers and moved forward with a second immunotherapeutic program designed to induce regulatory T cells in patients with celiac disease, both utilizing the SNAPvax platform.
Upcoming Milestones
In the fourth quarter of 2022, the Company expects to report additional data from the ongoing Phase 1b/2a clinical trial of VTP-300 in patients with chronic HBV infection.
In the fourth quarter of 2022, the Company expects to initiate dosing of HBV003, a Phase 2b clinical trial of VTP-300 in patients with chronic HBV infection.
In the fourth quarter of 2022, the Company expects to initiate dosing in a Phase 1/2 clinical trial of VTP-850 in patients with prostate cancer.
In the first quarter of 2023, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1b/2 clinical trial of VTP-200, a potential treatment for low grade HPV-related cervical lesions.
In 2023, the Company expects to submit Investigational New Drug (IND) applications for its two lead SNAPvax candidates, VTP-1000 for the treatment of celiac disease and VTP-1100 for the treatment of HPV-associated cancers.
Second Quarter 2022 Financial Highlights:
Cash position: As of June 30, 2022, cash and cash equivalents were $192.3 million, compared to $214.1 million as of December 31, 2021. The decrease in cash was primarily due to $15.0 million of net cash used in operating activities, $3.1 million of net cash used in investing activities, and an effect of $3.5 million from exchange rate movements on cash and cash equivalents.
Revenues: Revenues were $17.1 million in the second quarter of 2022 compared to $15.0 million in the first quarter of 2022. Revenues comprised the Company’s share of milestone and royalty payments received by OUI from AstraZeneca related to commercial sales of Vaxzevria.
Research and development expenses: Research and development expenses were $9.7 million in the second quarter of 2022 compared to $10.7 million in the first quarter of 2022. The decrease in R&D expenses from the previous quarter was primarily due to lower R&D personnel-related costs and decreased spending on the development of VTP-200 and VTP-850.
General and administrative expenses: General and administrative expenses were a gain of $6.4 million (after including a foreign exchange gain of $15.2 million) in the second quarter of 2022, compared to an expense of $3.9 million (after including a foreign exchange gain of $5.3 million) in the previous quarter. Excluding the foreign exchange gain, G&A expenses were $8.8 million in the second quarter of 2022, which were mainly attributable to personnel expenses of $4.3 million, including the share-based payment charge of $2.1 million, insurance costs of $1.6 million, and legal and professional fees of $1.0 million. Excluding the foreign exchange gain, G&A expenses for the previous quarter were $9.2 million and were mainly attributable to personnel expenses of $4.3 million, including the share-based payment charge of $3.1 million, insurance costs of $1.7 million, and legal and professional fees of $1.3 million.
Net Income: For the second quarter of 2022, the Company generated a net income attributable to its shareholders of $15.7 million, or $0.41 per fully diluted share and $0.42 per basic share, compared to a net income attributable to shareholders of $2.6 million, or $0.068 per fully diluted share and $0.070 per basic share, for the previous quarter.