On March 25, 2022 Vaccitech plc (NASDAQ: VACC) reported its financial results for the full year ended December 31, 2021 and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, MAR 25, 2022, View Source [SID1234610991]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"2021 was a pivotal year for Vaccitech during which we achieved a number of strategic, operational, and financial objectives, advanced multiple immunotherapeutic and prophylactic candidates in clinical development and strengthened and expanded our T cell activating discovery engine platform via the acquisition of Avidea Technologies," commented Bill Enright, Vaccitech’s CEO. "All of this progress puts us in a strong position to deliver on our long-term plans. We anticipate that 2022 will be a year where we continue to advance our product pipeline with key data readouts in several programs. We look forward to reporting on these developments throughout the year."
2021 and Recent Corporate Developments
·Raised $166.5 million of proceeds in a Series B private financing, including $41.2 million from previously issued convertible loan notes that converted into Series B shares.
·Completed a public listing on NASDAQ, raising gross proceeds of $110.5 million through an offering of American Depository Shares.
·Initiated patient dosing in HPV001, a Phase 1/2 clinical trial of VTP-200, an immunotherapeutic candidate in development for the treatment of persistent infection with high-risk HPV.
·Signed a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate an innovative therapeutic combination for the treatment of patients with chronic Hepatitis B virus (HBV) infection who are already receiving standard-of-care nucleos(t)ide reverse transcriptase inhibitor, or Nrtl, therapy. The Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus’s RNAi therapeutic, AB-729, followed by Vaccitech’s immunotherapy candidate, VTP-300, in Nrtl-suppressed patients with chronic HBV infection.
·Signed a lease for 31,000 square feet within the Zeus development at Harwell Science and Innovation Campus in Oxfordshire, United Kingdom. The site will house Vaccitech’s headquarters, state-of-the-art wet laboratory, and offices. Vaccitech anticipates completing the relocation by mid-2022.
·Online publication in The Lancet Microbe results of a Phase 1 clinical trial of VTP-500, a vaccine candidate in development to prevent Middle East Respiratory Syndrome (MERS). The study, sponsored and conducted by researchers at The King Abdullah International Medical Research Centre in Saudi Arabia in partnership with Oxford University, showed that the vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses.
·Presented at the AASLD The Liver Meeting data from a Phase 1 (HBV001) and Groups 1 and 2 of a Phase 1/2a (HBV002) clinical trial demonstrating that VTP-300 was tolerated and induced T cells against targeted HBV antigens in both healthy volunteers and patients with chronic HBV infection.
·Reported efficacy data from an interim analysis of the HBV002 clinical trial of VTP-300 in patients with chronic HBV infection. The data from 27 patients who completed three months in the trial demonstrated reductions in surface antigen (HbsAg) levels in patients receiving VTP300 both alone and in combination with nivolumab.
·Acquired Avidea Technologies, Inc. in a cash and stock transaction that added complementary synthetic T cell boosting technologies and expands Vaccitech’s pipeline to include autoimmunity to its current infectious disease and oncology therapeutic areas of focus. The transaction also furthers Vaccitech’s scientific expertise and establishes U.S.-based research and development capabilities.
·Cancer Research UK and the Ludwig Institute for Cancer Research initiated patient dosing in a Phase 1/2a clinical trial to test the safety and initial efficacy of VTP-600, an immunotherapeutic candidate in development for the treatment of non-small cell lung cancer. The therapeutic candidate employs Vaccitech’s viral vector prime-boost platform to induce T cell immunity against two cancer-associated proteins, MAGE-A3 and NY-ESO-1, found on some tumor cells.
Upcoming Milestones
·In the second quarter of 2022, the Company expects to present additional Phase 1/2a interim efficacy data of VTP-300 in patients with chronic HBV infection at the International Liver Congress on June 22 to 26, 2022, which is also expected to be followed by Phase 1/2a full efficacy clinical trial data in the second half of this year.
·In the third quarter of 2022, the Company expects to initiate dosing in a Phase 1/2 clinical trial of VTP-850 in patients with prostate cancer and also expects to initiate dosing of a Phase 2 clinical trial of VTP-300 in patients with chronic HBV infection.
·In the fourth 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 low grade HPV-related cervical lesions.
Full Year 2021 Financial Highlights:
·Cash position: As of December 31, 2021, cash and cash equivalents were $214.1 million, compared to $43.3 million as of December 31, 2020. The increase was primarily due to completion of the Series B financing in the first quarter of 2021, which raised gross proceeds of $125.2 million, 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 second half of 2024.
·Research and development expenses: Research and development expenses were $20.4 million in 2021 compared to $14.4 million in the prior year. The increase in R&D expenses was primarily due to increased spending on the development of VTP-200, VTP-300, and VTP-850.
·General and administrative expenses: General and administrative expenses were $25.1 million in 2021 compared to $10.5 million in the prior year. This includes the share-based payment charge of $14.2 million and $6.0 million unrealized foreign exchange gain on revaluation of Company’s cash balances recorded in 2021. Net of this gain, the increase in general and administrative expenses between the periods was mainly attributable to higher personnel costs, reflecting an increase in the Company’s headcount over the 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 $50.9 million, or $1.96 per share on both basic and fully diluted bases in 2021, compared to a net loss of $17.7 million, or $2.24 per share on both basic and fully diluted bases, for the prior year.