Board Change • May 20
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Joseph Caspar Scheeren was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Ankündigung • Jan 07
Nasdaq Grants Barinthus Biotherapeutics 180-Calendar Day Period to Regain Compliance with Nasdaq Listing Rules On December 30, 2025, Barinthus Biotherapeutics plc (the “Company”) received a letter from the Nasdaq Stock Market LLC (“Nasdaq”) indicating that the closing bid price of the Company’s American Depositary Shares (the “ADS”), each representing one ordinary share of the Company, was below $1.00 per share for 30 consecutive business days, and that, therefore, the Company is not in compliance with Nasdaq Listing Rule 5450(a)(1), which is the minimum bid price requirement for continued listing on the Nasdaq Global Market. The notice from Nasdaq has no immediate effect on the listing of the ADSs, and the ADSs will continue to be listed on the Nasdaq Global Market under the symbol “BRNS.” Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has automatically been afforded a 180-calendar day period, or until June 29, 2026, to regain compliance with the minimum bid price requirement. The continued listing standard will be met if the closing bid price of the ADSs is at least $1.00 per share for a minimum of ten consecutive business days during the 180-calendar day period. If the Company is not in compliance by June 29, 2026, the Company may be afforded a second 180-calendar day period to regain compliance if it meets certain requirements. The Company intends to monitor the closing bid price of the ADSs and is currently evaluating its options for regaining compliance, which could include a reverse stock split of the ADSs. Ankündigung • Dec 11
Barinthus Bio Announces Update on Phase 1 AVALON Clinical Trial of VTP-1000 for the Treatment of Celiac Disease Barinthus Biotherapeutics plc announced an update on its first-in-human Phase 1 trial of VTP-1000 in adults with celiac disease. In the single ascending dose ("SAD") portion of the trial, VTP-1000 was wellolerated with no treatment-related serious adverse events ("SAEs") and a dose-dependent pharmacological effect observed. The multiple ascending dose ("MAD") portion of the trials, which includes a gluten challenge, is ongoing with data expected in the second half of 2026. Celiac disease is an area of high unmet need with no currently approved treatments; instead, people with celiac disease are advised to strictly avoid consuming gluten, which can be difficult due to the presence of gluten in many foods and cross-contamination of food production surfaces. Ankündigung • Oct 02
Barinthus Biotherapeutics plc and Clywedog Therapeutics, Inc Announces Executive and Board Changes Barinthus Biotherapeutics plc and Clywedog Therapeutics, Inc. announced that Dr. Iain Dukes, a venture partner at OrbiMed will serve as Executive Chairman of Clywedog Therapeutics after the transaction closes. He is MA, D.Phil (current Chief Executive Officer of Clywedog), and will consist of designees of each of Clywedog and Barinthus Bio. The combined company will be led by Bill Enright, Chief Executive Officer, Dr. Leon Hooftman, Chief Medical Officer, and Nick Fullenkamp, Vice President Corporate Development from Barinthus Bio, as well as Dr. Iain Dukes and Dr. Nikolay Savchuk, currently serving as Clywedog’s Chief Executive Officer and Chief Operating Officer, respectively. Ankündigung • Sep 30
Clywedog Therapeutics, Inc. entered into a definitive merger agreement to acquire Barinthus Biotherapeutics plc (NasdaqGM:BRNS). Clywedog Therapeutics, Inc. entered into a definitive merger agreement to acquire Barinthus Biotherapeutics plc (NasdaqGM:BRNS) on September 29, 2025. Upon the closing of the transaction, the combined company will be renamed “Clywedog Therapeutics, Inc.” and is expected to trade on the NASDAQ under the new ticker symbol “CLYD.” Upon completion of the transaction, the shareholders of Barinthus Bio are expected to own approximately 34%, and the stockholders of Clywedog are expected to own approximately 66% of the combined company on a fully diluted basis, based on the respective valuations of Barinthus Bio and Clywedog as of the execution of the merger agreement. Shareholders of Barinthus Bio will receive one share of common stock in the new combined company for each American Depositary Share (“ADS”) or ordinary share owned, and each stockholder of Clywedog will receive 4.358932 shares of common stock in the new combined company for each common or preferred share owned. Prior to the closing of the transaction, the combined company may commence a partial tender offer to acquire shares of the combined company then issued and outstanding and held by Barinthus Bio shareholders for an aggregate offer price of up to $27 million. The transaction is subject to approval by both companies’ stockholders as well as to customary closing conditions and regulatory approvals. The transaction was unanimously approved by the Boards of Directors of each of the companies. The expected completion of the transaction is January 1, 2026 to June 30, 2026.
Robert E. Puopolo, Blake Liggio and Jean A. Lee of Goodwin Procter LLP and Andrew Harrow of Goodwin Procter Llp acted as legal advisor, Oppenheimer & Co. Inc. acted as financial advisor for Barinthus Biotherapeutics plc. D. Boral Capital LLC acted as financial advisor and Snell & Wilmer, L.L.P. acted as legal advisor for Clywedog Therapeutics, Inc. Ankündigung • Apr 28
Barinthus Biotherapeutics plc, Annual General Meeting, Jun 10, 2025 Barinthus Biotherapeutics plc, Annual General Meeting, Jun 10, 2025. Location: goodwinprocter(uk)llp, sancroft,10-15newgatestreet, ec1a 7az, london United Kingdom Ankündigung • Jan 12
Barinthus Biotherapeutics plc Plans 65% Reduction in Workforce On January 10, 2025, Barinthus Biotherapeutics plc announced a restructuring plan that aims to prioritize its immune tolerance research and development programs. The Company is planning a 65% reduction in workforce, which is subject to consultation with employee representatives in the UK regarding the plan. The Company anticipates that the majority of the reduction in workforce will occur in the UK and be completed during the first half of 2025. Ankündigung • Nov 26
Barinthus Biotherapeutics plc Announces Executive Changes, Effective December 1, 2024 Barinthus Biotherapeutics plc announced the promotion of Geoffrey Lynn, M.D., Ph.D. to Chief Scientific Officer (CSO), effective as of December 1, 2024. Dr. Lynn succeeds Nadège Pelletier, Ph.D. who decided to pursue alternative opportunities closer to home after having served as Barinthus Bio’s CSO since early 2023. Barinthus Bio is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that guide T cells to control disease. Dr. Pelletier will remain with the Company until the transition of responsibilities to Dr. Lynn is complete. Dr. Lynn is a seasoned biotech innovator and executive with over 15 years of experience leading immunotherapeutic R&D from discovery through early development. Prior to joining the Company, Dr. Lynn led Avidea Technologies Inc. as CEO and Founder from its launch at Johns Hopkins FastForward in 2017 through to its acquisition by Barinthus Bio in 2021. Dr. Lynn holds a M.D. from the Johns Hopkins University School of Medicine (US), as well as a D.Phil. from the University of Oxford. Ankündigung • Oct 01
Barinthus Bio Completes Enrollment for Phase 2b HBV003 Clinical Trial in Chronic Hepatitis B and Phase 1 PCA001 Clinical Trial in Prostate Cancer Barinthus Biotherapeutics plc announced the completion of enrollment for two clinical trials: HBV003, a Phase 2b clinical trial of VTP-300 in adults with chronic hepatitis B (CHB); and PCA001, a Phase 1 clinical trial of VTP-850 in men with rising prostate-specific antigen (PSA) after definitive local therapy for prostate cancer (i.e., biochemical recurrence). The Phase 2b HBV003 trial (NCT05343481) has enrolled 121 participants and is designed to obtain critical dosing information for a potential functional cure regimen for CHB, with participants receiving VTP-300 and low-dose (LD) nivolumab. This trial design builds on positive monotherapy results from the clinical study HBV002, which included an evaluation of VTP-300 given alone and in combination with LD nivolumab. Earlier this year, interim data from the HBV003 trial was presented at the European Association for the Study of the Liver (EASL) Congress and demonstrated that treatment with VTP-300 and LD nivolumab is generally well-tolerated and led to a sustained decline in Hepatitis B surface antigen (HBsAg) levels. Participants reaching Day 169 were assessed for NUC therapy discontinuation eligibility in line with the study criteria, with 76% of participants meeting the criteria (n=16/21). 19% of the eligible participants (n=4/21) reached undetectable levels of HBsAg, with 2 of these patients maintaining undetectable levels for over 16 weeks. The PCA001 Phase 1 trial (NCT05617040) has enrolled 22 participants and is designed to determine the recommended Phase 2 dosing regimen of VTP-850 as well as evaluate safety and efficacy, as measured by PSA and T cell response. VTP-850 is a next-generation prostate cancer immunotherapeutic candidate which utilizes Barinthus Bio’s ChAdOx/MVA platform of two proprietary nonreplicating viral vectors in a sequential dosing approach. Ankündigung • Jun 14
Barinthus Biotherapeutics plc Plans to Priority on the Development of VTP-300 in Chronic Hepatitis B Virus Infection, or CHB, and VTP-1000 in Celiac Disease On June 12, 2024, Barinthus Biotherapeutics plc announced plans to prioritize its pipeline to focus on the development of VTP-300 in chronic Hepatitis B virus infection, or CHB, and VTP-1000 in celiac disease. The development of VTP-300 in CHB and VTP-1000 in celiac disease will be prioritized and the ongoing Phase 1 clinical trial of VTP-850 in prostate cancer will be completed. The Company expects to undergo a restructuring to align resources with the streamlined pipeline, which will include a workforce reduction of approximately 25% and an estimated extension of the cash runway into the second quarter of 2026. Ankündigung • Jun 08
Barthus Biotherapeutics plc Announces Updated Data from Two Clinical Trials in People with Chronic Hepat B Barinthus Biotherapeutics plc announced the presentation of updated data from two clinical trials in people with chronic hepatitis B (CHB) at the European Association for the Study of the Liver (EASL) Congress 2024. The presentations include updated interim data from the Phase 2b clinical trial (HBV003), as well as new interim EOT data from the Phase 2a clinical trial (IM-PROVE II, AB-729-202) in partnership with Arbutus Biopharma, both in people with CHB receiving ongoing SoC NUC therapy. Interim data from the HBV003 trial indicate that treatment with VTP-300 and low-dose nivolumab is generally well-tolerated and sustained HBsAg declines were observed across all groups, with some participants reaching undetectable levels of HBsAg. As of the data cutoff on April 15, 2024, 91 out of a planned 120 virally suppressed patients with CHB on stable NUC therapy were enrolled in the trial, 40 of whom had screening HBsAg =200 IU/mL as per the study protocol amendment in 2023 and 21 of whom had been assessed for NUC discontinuation. Participants reaching Day 169 were assessed to confirm if they were eligible to discontinue NUC therapy in line with the study criteria. Data presented focuses on participants with baseline HBsAg =200 IU/mL: 76% of assessed participants (n=16/21) were eligible for NUC discontinuation at EOT, 7 of these discontinued. 71% (n=5/7) remained off NUC therapy, up to 44 weeks post-discontinuation in one case. 19% of participants (n=4/21) across the groups assessed for NUC discontinuation, had undetectable HBsAg at any time. This has been maintained for =16 weeks in 2 cases. 67% of participants (n=14/21) across all groups assessed for NUC discontinuation had HBsAg <10 IU/mL at Week 24 or later. Robust T cell responses as measured by IFN? ELISpot were observed to all encoded antigens. There were no Serious Adverse Events (SAEs), Grade 3 or 4 Adverse Events (AEs) related to treatment. There was one treatment discontinuation due to an AE. The most common treatment-related AE was thyroid dysfunction, reported in 9% of participants (n=8/91) with normal Thyroid Function Tests reported in 7 of 8 (88%) at last recorded visit. Transient alanine transaminase (ALT) elevations occurred in 14 participants through to Day 85. Data from IM-PROVE II as of the data cutoff on April 12, 2024, indicate that treatment with imdusiran, Arbutus’ RNAi therapeutic candidate, followed by Barinthus Bio's T-cell stimulating immunotherapeutic candidate, VTP-300, was generally well-tolerated and observed to maintain low HBsAg levels during the post-treatment follow-up period. The data were presented today by Dr. Kosh Agarwal, MD, Consultant Hepatologist and Transplant Physician at the Institute of Liver Studies at King’s College Hospital, London, during a session focused on new treatments for viral hepatitis B at the EASL Congress. Dr. Agarwal presented the following data from 38 of 40 participants that were on stable NUC therapy throughout the treatment period. They received imdusiran (60mg every 8 weeks) for 24 weeks and were then randomized to receive either VTP-300 or placebo at Weeks 26 and 30: Robust reductions of HBsAg were observed during the imdusiran lead-in period with 95% of patients achieving HBsAg <100 IU/mL before undergoing dosing in the VTP-300 treatment or placebo groups. At 24-weeks post-EOT, there was a significant difference (p<0.05) in HBsAg levels between the VTP-300 treatment group (n=5) and placebo (n=6). 94% of participants (n=18/19) in the VTP-300 treatment group achieved HBsAg levels of <100 IU/mL and 36% had <10 IU/mL (n=7/19) at EOT (Week 48) compared to the placebo group, 84% (n=16/19) and 21% (n=4/19), respectively. ?Similarly, at 24-weeks post-EOT (Week 72), the VTP-300 treatment group had lower HBsAg levels with 80% of participants at <100 IU/mL (n= 4/5) and 60% at <10 IU/mL (n=3/5) than the placebo group, 16% (n=1/6) and 0% (n=0/6), respectively. 84% of participants (n=16/19) in the VTP-300 treatment group met criteria at EOT (Week 48) to discontinue NUC therapy vs 52% in the placebo group (n=10/19). In the VTP-300 treatment group, 20% of participants (n=1/5) achieved undetectable HBsAg at 24-weeks post-EOT and a further 20% of participants (n=1/5) had a >1.5log10 decline between the last two visits during the NUC therapy discontinuation follow-up period. Treatment with imdusiran and VTP-300 was generally well-tolerated. There were no reported SAEs, Grade 3 or 4 AEs or discontinuations due to treatment. The most common treatment-related AEs in two or more patients were injection site-related (both imdusiran and VTP-300) and transient ALT increases (imdusiran). Reported Earnings • May 14
First quarter 2024 earnings released: US$0.40 loss per share (vs US$0.48 loss in 1Q 2023) First quarter 2024 results: US$0.40 loss per share (improved from US$0.48 loss in 1Q 2023). Net loss: US$15.5m (loss narrowed 15% from 1Q 2023). Revenue is forecast to grow 65% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 32% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings. Ankündigung • May 01
Barinthus Biotherapeutics plc Appoints Leon Hooftman as Chief Medical Officer, Effective from Beginning of June 2024 Barinthus Biotherapeutics plc announced the appointment of Leon Hooftman, M.D., as Chief Medical Officer (CMO). Dr. Hooftman brings significant drug development expertise across a broad array of therapeutic areas including oncology, infectious diseases, and inflammation. His R&D portfolio includes successful clinical trial programs that resulted in the development of novel agents: mycophenolate mofetil (transplantation), rituximab (Non-Hodgkin’s Lymphoma), gemtuzumab ozogamycin (Leukemia), and lipid complex amphotericin B (serious fungal infections). He has held senior management positions at Roche and UCB Celltech and has subsequently been a CMO of several biotechnology companies. He joins Barinthus Bio from ISA Pharmaceuticals, a specialist immune-oncology company. Dr. Hooftman holds a MD from Utrecht State University (Netherlands) and performed his specialist training in Cambridge and London (UK). Dr. Hooftman will step into his new role at the beginning of June 2024. Ankündigung • Apr 19
BarinthuBarinthus Biotherapeutics plc Announces Topline Data from Phase 1b/2 APOLLO Trial of VTP-200 in Persistent High-Risk Human Papillomavirus (HPV) Infections Barinthus Biotherapeutics plc announced topline final data from the APOLLO trial (also known as HPV001), a completed randomized, placebo-controlled Phase 1b/2 dose-ranging trial of VTP-200 in women with low-grade cervical lesions associated with persistent hrHPV infection. APOLLO (NCT04607850) was a randomized, placebo-controlled Phase 1b/2 multi-center trial of 108 participants across the UK and EU evaluating the safety, tolerability and immunogenicity of VTP-200 in women aged 25-55 with persistent hrHPV infection and low-grade cervical lesions. The primary objective was to evaluate the safety and tolerability of VTP-200. The trial was also designed to assess the effect of VTP-200 on clearance of hrHPV infection and cervical lesion(s), as well as select appropriate doses for further development. The APOLLO study met its primary safety endpoint, demonstrating that VTP-200 was generally well-tolerated and was administered with no treatment-related grade 3 or higher unsolicited AEs and no treatment-related SAEs. The hrHPV clearance rate of 60% at Month 12 was observed in group 2, which included the dose of ChAdOx, compared to a 33% clearance rate in the placebo group. Groups 1, 3, 4 and 5 showed 12%, 11%, 33% and 36% hrHPV clearance rates, respectively. The study also evaluated cervical lesion clearance rates in participants with both reported lesions at screening and visualization of the cervical transformation zone at 12 months (n=57). The cervical lesion clearance rate of 67% was observed in group 2 and group 5, both received the dose of ChAdOx, compared to 39% in the placebo group. Groups 1, 3 and 4 showed 40%, 20% and 33% cervical lesion clearance rates, respectively. Pooled data from the five active dose groups showed no significant improvement in hrHPV clearance or cervical lesion clearance rates in comparison to the placebo group. Future development options for the VTP-200 program are currently being evaluated with further analyses ongoing. New Risk • Apr 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Revenue is less than US$1m (US$802k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$126m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Major Estimate Revision • Mar 27
Consensus revenue estimates increase by 29% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$520.0k to US$670.0k. Forecast losses expected to reduce from -US$2.27 to -US$2.17 per share. Biotechs industry in the US expected to see average net income decline 9.5% next year. Consensus price target down from US$8.80 to US$7.40. Share price was steady at US$2.40 over the past week. Ankündigung • Mar 23
Barinthus Biotherapeutics plc, Annual General Meeting, May 10, 2024 Barinthus Biotherapeutics plc, Annual General Meeting, May 10, 2024, at 08:00 US Eastern Standard Time. Location: Goodwin Procter (UK) LLP, Sancroft 10-15 Newgate Street - London United Kingdom Agenda: To re-elect as a director William Enright, who retires by rotation in accordance with the Company's Articles of Association; to re-elect as a director Alex Hammacher, who retires by rotation in accordance with the Company's Articles of Association; to re-elect as a director Robin Wright, who retires by rotation in accordance with the Company's Articles of Association; to re-appoint pricewaterhouseCoopers LLP, as U.K. statutory auditors of the Company, to hold office until the conclusion of the next annual general meeting of shareholders; to ratify the appointment of PricewaterhouseCoopers LLP as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2024. New Risk • Mar 22
New major risk - Revenue size The company makes less than US$1m in revenue. Total revenue: US$802k This is considered a major risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Revenue is less than US$1m (US$802k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$126m net loss in 3 years). Shareholders have been diluted in the past year (3.6% increase in shares outstanding). Market cap is less than US$100m (US$94.7m market cap). Reported Earnings • Mar 22
Full year 2023 earnings released: US$1.91 loss per share (vs US$0.14 profit in FY 2022) Full year 2023 results: US$1.91 loss per share (down from US$0.14 profit in FY 2022). Net loss: US$73.3m (down US$78.7m from profit in FY 2022). Revenue is expected to decline by 19% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 17%. Board Change • Mar 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Independent Non-Executive Director Karen Dawes was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. New Risk • Feb 07
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$99.1m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$103m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (3.4% increase in shares outstanding). Market cap is less than US$100m (US$99.1m market cap). Major Estimate Revision • Nov 30
Consensus revenue estimates decrease by 20%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$1.33m to US$1.07m. EPS estimate increased from -US$2.04 to -US$2.00 per share. Biotechs industry in the US expected to see average net income growth of 8.2% next year. Consensus price target of US$8.82 unchanged from last update. Share price fell 3.2% to US$2.85 over the past week. Ankündigung • Nov 11
Arbutus Biopharma Corporation and Barinthus Biotherapeutics plc Present Preliminary Data from Phase 2A Clinical Trial Combining Imdusiran with VTP-300 at AASLD Arbutus Biopharma Corporation and Barinthus Biotherapeutics plc announced preliminary data from the Phase 2a clinical trial (AB-729-202) combining Arbutus' RNAi therapeutic, imdusiran (AB-729), with Barinthus Bio's T-cell stimulating immunotherapeutic, VTP-300, and standard-of-care nucleos(t)ide analogue (NA) therapy. Clinical trial AB-729-202 enrolled 40 non-cirrhotic, virally suppressed cHBV patients that were on stable NA therapy. The patients initially received imdusiran (60mg every 8 weeks) for 24 weeks and were then randomized to receive either VTP-300 or placebo at week 26 and 30 (and conditionally at week 38 if they experienced a >0.5 log10 decline in HBsAg between weeks 26 and 34), in addition to ongoing NA therapy. The preliminary data include a subset of patients that received the two dose VTP- 300 regimen (28/40 patients) and available follow-up data to week 48 (12/40 patients) and showed the following: · Robust reductions of HBsAg were seen during the imdusiran treatment period (-1.86 log10 mean reduction from baseline after 24 weeks of treatment). This decline in HBsAg is comparable to the declines seen with imdusiran in other clinical trials conducted to date. · 97% of the imdusiran treated patients (33/34) had HBsAg <100 IU/mL at the time of the first VTP-300/placebo dose. VTP-300 treatment appears to contribute to the maintenance of low HBsAg levels in the early post-treatment period, as the mean HBsAg levels in the placebo group begin to increase starting ~12 weeks after the last dose of imdusiran. All VTP-300 treated patients have maintained HBsAg <100 IU/mL through week 48, 60% have maintained HBsAg <10 IU/mL, and all have qualified to stop NA therapy. Preliminary immunology data suggests HBV-specific T cell IFN- production is enhanced in patients receiving imdusiran plus VTP-300 compared to placebo. The preliminary safety data from this trial demonstrate that imdusiran and VTP-300 were both safe and well-tolerated. There were no serious adverse events, Grade 3 or 4 adverse events or treatment discontinuations. Reported Earnings • Nov 11
Third quarter 2023 earnings released: US$0.36 loss per share (vs US$0.22 profit in 3Q 2022) Third quarter 2023 results: US$0.36 loss per share (down from US$0.22 profit in 3Q 2022). Net loss: US$14.1m (down 271% from profit in 3Q 2022). Revenue is expected to decline by 75% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 15%. Ankündigung • Nov 08
Vaccitech plc(NasdaqGM:VACC) dropped from NASDAQ Composite Index Vaccitech plc has been removed from NASDAQ Composite Index . Price Target Changed • Sep 25
Price target decreased by 24% to US$9.31 Down from US$12.33, the current price target is an average from 4 analysts. New target price is 195% above last closing price of US$3.16. Stock is up 2.9% over the past year. The company is forecast to post a net loss per share of US$2.13 compared to earnings per share of US$0.14 last year. Major Estimate Revision • Sep 22
Consensus revenue estimates increase by 26% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$1.29m to US$1.63m. EPS estimate unchanged from -US$2.10 at last update. Biotechs industry in the US expected to see average net income decline 4.0% next year. Consensus price target of US$12.00 unchanged from last update. Share price fell 4.0% to US$1.69 over the past week. Major Estimate Revision • Aug 17
Consensus revenue estimates decrease by 53%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$1.69m to US$800.0k. EPS estimate increased from -US$2.19 to -US$2.10 per share. Biotechs industry in the US expected to see average net income decline 6.6% next year. Consensus price target of US$12.33 unchanged from last update. Share price fell 5.5% to US$2.07 over the past week. Reported Earnings • Aug 10
Second quarter 2023 earnings: EPS and revenues miss analyst expectations Second quarter 2023 results: US$0.62 loss per share (down from US$0.42 profit in 2Q 2022). Revenue: US$334.0k (down 98% from 2Q 2022). Net loss: US$23.8m (down 252% from profit in 2Q 2022). Revenue missed analyst estimates by 44%. Earnings per share (EPS) also missed analyst estimates by 13%. Revenue is expected to decline by 115% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 15%. Ankündigung • Jul 28
Vaccitech plc Announces Retirement of Margaret Marshall as Chief Medical Officer On July 20, 2023, Dr. Margaret Marshall notified Vaccitech plc of her intention to retire from her position as chief medical officer of the company, effective immediately. Ankündigung • Jun 22
Vaccitech plc Announces Positive Final Data EASL Congress for Phase 1B/2 HBV002 Study in Adults with Chronic Hepatitis B Vaccitech plc announced present positive final data from the HBV002 clinical trial at the European Association for the Study of the Liver (EASL) Congress 2023 – The International Liver CongressTM taking place June 21-24 in Vienna, Austria. HBV002 (NCT04778904) is a Phase 1b/2a clinical trial of VTP-300 in adults with chronic Hepatitis B (CHB). The data will be presented as a poster at EASL on, June 24 (Poster ID: SAT-198), by Eleanor Barnes, Professor of Hepatology and Experimental Medicine at Oxford University. Meaningful, durable reductions of Hepatitis B Surface Antigen (HBsAg) were seen in all participants with a >0.5 log10 reduction in HBsAg who received VTP-300 alone (Group 2) or in combination with a single administration of low-dose PD-1 inhibitor, nivolumab (Group 3). Two of five patients with baseline HBsAg below 100 IU/mL in Group 3, developed a non-detectable HBsAg level, which continued eight months after last dose. Reductions in HBsAg were most prominent in those with lower baseline HBsAg. Importantly, all participants who received VTP-300 and experienced a >0.5 log10 reduction in HBsAg had durable responses with reductions in HBsAg persisting through to the last measurement eight months post-final dose. VTP-300, encoding Hepatitis B virus (HBV) genotype C antigens, led to a decline in HBsAg in the majority of people infected with genotypes B and C viruses. In addition, VTP-300-induced T cells showed cross-reactivity to the core antigen from genotypes A to E in ELISpot assays using PBMC from VTP-300-treated healthy subjects and genotype-specific peptides A-E. A robust T cell response was generated against all VTP-300 antigens and was highest in the VTP-300 alone group. In that group, there was a relation between ELISpot responses and HBsAg decline. Ankündigung • Jun 13
Vaccitech plc Doses First Patient in Pca001, A Prostate Cancer Phase 1/2 Clinical Trial of Vtp-850 Vaccitech plc announced the dosing of the first patient in the PCA001 clinical trial (NCT05617040). PCA001 is a multi-centre, Phase 1/2 clinical trial designed to determine the recommended Phase 2 regimen and evaluate the safety, efficacy, as measured by prostate-specific antigen (PSA) response, and T cell response of VTP-850 monotherapy in men with rising PSA after definitive local therapy for their disease (i.e., biochemical recurrence). VTP-850 is a next-generation prostate cancer immunotherapeutic candidate which utilizes Vaccitech's sequential dosing approach of two proprietary nonreplicating viral vectors, ChAdOx and MVA. PCA001 builds on the previous promising data from the University of Oxford VANCE01 (NCT02390063) and ADVANCE (NCT03815942) trials, Phase 1 and Phase 1/2 clinical trials respectively, of VTP-800, the first-generation product candidate which encoded 5T4, an antigen expressed by most prostate cancers.1,2 VTP-850 is a multi-antigen immunotherapeutic candidate containing four prostate-associated antigens: PSA, PAP, STEAP1 and 5T4. The first phase of the trial is enrolling participants in the US, with plans to open further sites in Italy and Spain. Major Estimate Revision • May 19
Consensus revenue estimates decrease by 28% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$2.35m to US$1.69m. EPS estimate unchanged at -US$2.19 per share. Biotechs industry in the US expected to see average net income decline 81% next year. Consensus price target down from US$12.67 to US$12.33. Share price rose 12% to US$2.46 over the past week. Reported Earnings • May 13
First quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2023 results: US$0.48 loss per share (down from US$0.07 profit in 1Q 2022). Revenue: US$468.0k (down 97% from 1Q 2022). Net loss: US$18.2m (down US$20.8m from profit in 1Q 2022). Revenue missed analyst estimates by 67%. Earnings per share (EPS) exceeded analyst estimates by 17%. Revenue is expected to decline by 77% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 19%. Major Estimate Revision • Mar 31
Consensus revenue estimates increase by 12%, EPS downgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$2.10m to US$2.35m. EPS estimate fell from -US$1.79 to -US$2.21 per share. Biotechs industry in the US expected to see average net income decline 51% next year. Consensus price target down from US$19.67 to US$12.67. Share price rose 6.5% to US$2.30 over the past week. Price Target Changed • Mar 25
Price target decreased by 28% to US$14.33 Down from US$20.00, the current price target is an average from 3 analysts. New target price is 490% above last closing price of US$2.43. Stock is down 46% over the past year. The company is forecast to post a net loss per share of US$1.79 compared to earnings per share of US$0.14 last year. Valuation Update With 7 Day Price Move • Mar 20
Investor sentiment improves as stock rises 23% After last week's 23% share price gain to US$2.99, the stock trades at a trailing P/E ratio of 9.8x. Average forward P/E is 10x in the Biotechs industry in the US. Total loss to shareholders of 45% over the past year. Valuation Update With 7 Day Price Move • Feb 24
Investor sentiment deteriorates as stock falls 17% After last week's 17% share price decline to US$2.55, the stock trades at a trailing P/E ratio of 8.3x. Average forward P/E is 11x in the Biotechs industry in the US. Total loss to shareholders of 60% over the past year. Ankündigung • Jan 31
Vaccitech Appoints Nadège Pelletier as Chief Scientific Officer Vaccitech plc announced the appointment of Nadège Pelletier, Ph.D., as Chief Scientific Officer (CSO). Dr. Pelletier is stepping into the role formerly held by Tom Evans, Ph.D., who is retiring but will remain involved as a scientific consultant to the company. Dr. Pelletier will lead Vaccitech’s scientific teams in all phases of drug discovery and platform development, as well as build and oversee the strategic technical direction of the company. Dr. Pelletier brings extensive experience to Vaccitech in the areas of immunology, inflammation and infectious diseases. She joins Vaccitech from the Novartis Institutes for Biomedical Research and prior to that Roche Pharma Research & Early Development, where she served as Project Leader in the fields of autoimmunity, inflammation and infectious diseases. At Novartis, Dr. Pelletier was a discovery leader in a fast-track, multi-indication early clinical program on tolerance induction, and was responsible for maintaining accountability in building solid preclinical packages, biomarker strategies, and translational plans for disease focus and indication expansion. Prior to her role at Novartis, Dr. Pelletier was responsible for several preclinical and clinical projects in all phases of development to restore immune balance in autoimmunity and chronic infectious diseases, and was a key contributor to advancing immune modulation strategies for chronic Hepatitis B and respiratory infections. In addition to her experience with Novartis and Roche, Dr. Pelletier also served as a Senior Scientist at Merck-Serono in Geneva, Switzerland, and as a postdoctoral fellow at the Scripps Research Institute in La Jolla, California. Dr. Pelletier holds a Ph.D. in immunology from Claude Bernard University, ENS-Lyon, in Lyon, France and a Master of Science in Genetics and Immunology from ENS-Lyon. Major Estimate Revision • Nov 17
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$42.0m to US$41.4m. EPS estimate of -US$0.08 up from expected loss of US$0.27 per share previously. Biotechs industry in the US expected to see average net income decline 94% next year. Consensus price target of US$18.75 unchanged from last update. Share price rose 8.1% to US$2.41 over the past week. Reported Earnings • Nov 16
Third quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2022 results: EPS: US$0.22 (up from US$0.13 loss in 3Q 2021). Revenue: US$6.17m (up US$6.15m from 3Q 2021). Net income: US$8.24m (up US$12.8m from 3Q 2021). Revenue missed analyst estimates by 23%. Earnings per share (EPS) exceeded analyst estimates. Revenue is expected to decline by 67% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 14%. Reported Earnings • Nov 13
Third quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2022 results: EPS: US$0.22 (up from US$0.13 loss in 3Q 2021). Revenue: US$6.17m (up US$6.15m from 3Q 2021). Net income: US$8.24m (up US$12.8m from 3Q 2021). Revenue missed analyst estimates by 23%. Earnings per share (EPS) exceeded analyst estimates. Revenue is expected to decline by 75% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 14%. Major Estimate Revision • Nov 12
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$42.0m to US$39.6m. 2022 losses expected to reduce from -US$0.08 to -US$0.07 per share. Biotechs industry in the US expected to see average net income decline 68% next year. Consensus price target of US$18.75 unchanged from last update. Share price fell 11% to US$2.35 over the past week. Major Estimate Revision • Aug 16
Consensus revenue estimates increase by 61% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$26.1m to US$42.1m. Forecast losses expected to reduce from -US$0.90 to -US$0.08 per share. Biotechs industry in the US expected to see average net income decline 77% next year. Consensus price target down from US$20.00 to US$18.75. Share price fell 3.6% to US$4.81 over the past week. Reported Earnings • Aug 11
Second quarter 2022 earnings: EPS and revenues exceed analyst expectations Second quarter 2022 results: EPS: US$0.42 (up from US$0.64 loss in 2Q 2021). Revenue: US$17.1m (up US$17.0m from 2Q 2021). Net income: US$15.7m (up US$31.6m from 2Q 2021). Profit margin: 92% (up from net loss in 2Q 2021). Revenue exceeded analyst estimates by 361%. Earnings per share (EPS) also surpassed analyst estimates. Over the next year, revenue is expected to shrink by 63% compared to a 52% growth forecast for the industry in the US. Price Target Changed • Aug 11
Price target decreased to US$19.50 Down from US$21.25, the current price target is an average from 3 analysts. New target price is 353% above last closing price of US$4.30. Stock is down 71% over the past year. The company is forecast to post a net loss per share of US$1.33 next year compared to a net loss per share of US$1.96 last year. Major Estimate Revision • May 18
Consensus revenue estimates increase by 51% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$17.3m to US$26.1m. Forecast losses expected to reduce from -US$0.98 to -US$0.91 per share. Biotechs industry in the US expected to see average net income decline 52% next year. Consensus price target down from US$21.25 to US$20.00. Share price rose 41% to US$4.60 over the past week. Reported Earnings • May 13
First quarter 2022 earnings: EPS and revenues exceed analyst expectations First quarter 2022 results: EPS: US$0.07 (up from US$1.90 loss in 1Q 2021). Revenue: US$15.0m (up US$14.8m from 1Q 2021). Net income: US$2.60m (up US$17.9m from 1Q 2021). Profit margin: 17% (up from net loss in 1Q 2021). The move to profitability was primarily driven by higher revenue. Revenue exceeded analyst estimates by 305%. Earnings per share (EPS) also surpassed analyst estimates. Over the next year, revenue is forecast to grow 98%, compared to a 25% growth forecast for the industry in the US. Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Karen Dawes was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Major Estimate Revision • Apr 08
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from US$13.5m to US$17.3m. EPS estimate fell from -US$1.26 to -US$1.35 per share. Biotechs industry in the US expected to see average net income decline 46% next year. Consensus price target of US$21.25 unchanged from last update. Share price was steady at US$5.28 over the past week. Board Change • Jan 21
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was an independent director. The company's board is composed of: 1 new director. 11 experienced directors. No highly experienced directors. 3 independent directors (4 non-independent directors). Independent Director Anne Phillips was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Major Estimate Revision • Jan 20
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast increased from US$580.0k to US$890.0k. EPS estimate unchanged from -US$1.72 at last update. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target of US$24.00 unchanged from last update. Share price fell 12% to US$9.94 over the past week. Major Estimate Revision • Jan 20
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast increased from US$580.0k to US$890.0k. EPS estimate unchanged from -US$1.72 at last update. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target of US$24.00 unchanged from last update. Share price fell 12% to US$9.94 over the past week. Reported Earnings • Nov 15
Third quarter 2021 earnings released: US$0.13 loss per share Third quarter 2021 results: Net loss: US$4.56m (flat on 3Q 2020). Ankündigung • May 01
Vaccitech plc has completed an IPO in the amount of $110.5 million. Vaccitech plc has completed an IPO in the amount of $110.5 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 6,500,000
Price\Range: $17
Transaction Features: Reserved Share Offering; Sponsor Backed Offering