On November 12, 2021 Vaccitech plc (NASDAQ: VACC) reported its financial results for the third quarter, ended September 30, 2021, and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, NOV 12, 2021, View Source [SID1234595510]). 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 and cancer.
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"We continue to advance our promising pipeline with the recent publication of data on our MERS vaccine program. We also anticipate that initial clinical data on two of our chronic infectious disease therapeutic programs will be presented at scientific conferences next week," commented Bill Enright, Vaccitech’s CEO. "As we continue to expand and advance our programs, we will need additional lab and office space for our talented staff so we have planned a move mid next year into a new, state of the art facility."
Third Quarter and Recent Corporate Developments
Signed a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate an innovative therapeutic combination for the treatment of subjects with chronic hepatitis B virus infection (CHB) who are already receiving standard-of-care nucleoside or nucleotide analog (NA) therapy. The Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus’s RNAi therapeutic, AB-729, followed by the Company’s immunotherapy candidate, VTP-300, in NA-suppressed subjects with CHB.
Preclinical research demonstrated that VTP-600, a ChAdOx1/MVA prime-boost immunotherapeutic, demonstrated potential as an anti-cancer therapeutic. The research was conducted by scientists at the University of Oxford and the Ludwig Institute for Cancer Research.
Signed a lease for 31,000 square feet within the Zeus development at Harwell Science and Innovation Campus. The site will house the Company’s headquarters, state-of-the-art wet laboratory and offices. Vaccitech anticipates completing the relocation by mid-2022.
Announced online publication in The Lancet Microbe of the results of a Phase 1 clinical trial of VTP-500, a vaccine candidate in development to prevent Middle East Respiratory Syndrome (MERS). The study, conducted by researchers at The King Abdullah International Medical Research Centre and Oxford University, showed that the vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses.
Upcoming Milestones
At the virtual AASLD’s The Liver Meeting in November, two posters will present safety and immunogenicity data from the Phase 1 and Phase 1b/2a trials of VTP-300: HBV001, in healthy volunteers and patients with chronic hepatitis B (CHB) infection and HBV002 in patients with CHB infection. The posters become available for viewing by attendees at 8 a.m. EST on November 12.
At the virtual 34th International Papillomavirus Conference in November, the Company expects to present safety and immunogenicity data from the lead-in portion of the Phase 1/2a clinical trial of VTP-200.
In the fourth quarter, the Company expects to initiate dosing in a Phase 1/2a trial of VTP-600 in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy. The trial is currently open for enrollment.
In the first quarter of 2022, the Company intends to conduct an interim efficacy review of HBV002, the Phase 1b/2a clinical trial of VTP-300 in patients with chronic HBV infection.
In the second quarter of 2022, the Company expects to initiate dosing in a Phase 1/2a clinical trial of VTP-800/850, in combination with a checkpoint inhibitor, in patients with prostate cancer.
In the third quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1/2a clinical trial of VTP-200, a potential non-invasive treatment for persistent high-risk HPV infection.
Third Quarter 2021 Financial Highlights:
Cash position: As of September 30, 2021, cash and cash equivalents were $233.9 million, compared to $43.3 million as of December 31, 2021. The increase was primarily due to completion of the Series B financing in the first quarter of 2021, which raised $168 million including the conversion of our previously issued convertible loan notes, and to the initial public offering in the second quarter, which raised gross proceeds of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into the first half of 2024.
Research and development (R&D) expenses: Research and development expenses were $4.4 million for the third quarter of 2021 compared to $3.7 million for the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on progressing the development of VTP-300 and VTP-850.
General and administrative expenses: General and administrative expenses were $1.2 million for the third quarter of 2021 compared to $1.0 million for the comparable period of the prior year. The third quarter of 2021 expense includes a $5.8 million unrealized foreign exchange gain on revaluation of Company’s cash balances. Net of this gain, the increase in general and administrative expenses between the periods was attributable to higher personnel costs, reflecting an increase in the Company’s headcount over the prior period and higher insurance costs associated with operating as a public company.
Net loss: The Company generated a net loss attributable to its shareholders of $4.6 million, or ($0.13) per share on both basic and fully diluted bases, for the third quarter of 2021 compared to a net income of $0.2 million, or $0.02 per share a basic basis and $0.01 on a fully diluted basis, for the same period of the prior year.