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Barinthus Biotherapeutics (BRNS) Earnings Call Presentation
2025-07-07 08:32
Company Overview - Barinthus Bio is developing immunotherapies for autoimmunity and inflammatory diseases, focusing on restoring immune tolerance using the SNAP-TI platform[5] - The company has a strong financial position with $100.6 million in cash as of March 31, 2025, and an estimated cash runway into 2027[5, 92] - Barinthus Bio has 40.4 million outstanding ordinary shares and no debt or outstanding warrants[5] SNAP-TI Platform & VTP-1000 - The SNAP-TI platform is designed for antigen-specific immune tolerance, aiming to reduce inflammation and restore immune non-responsiveness to healthy tissue[5] - VTP-1000, the lead candidate for Celiac disease, is in an ongoing Phase 1 clinical trial with data readout expected in Q3 2025[5, 24, 92] - Approximately 1% of people worldwide have Celiac disease, equating to about 80 million people[27] - Around 60% of Celiac patients, or about 48 million people, cannot adhere to a strict Gluten-Free Diet[27] - Roughly 20% of Celiac patients are Non-Responsive, meaning about 16 million people's symptoms continue despite avoiding gluten[27] Viral Vector Platform Programs - VTP-300, a viral vector-based program for Chronic Hepatitis B, is pursuing partnership opportunities for advancement[56] - Approximately 254 million people are chronically infected with HBV, and there are 1.2 million new HBV infections per year[60] - In the HBV003 Phase 2b trial, 31.8% in Group 1 and 34.8% in Group 2 achieved >1 log HBsAg decline at Day 169, while only 4.2% in Group 3 achieved the same[77] - In the IM-PROVE II trial, 25% (2/8) of participants with starting baseline HBsAg levels less than 1000 IU/mL who received IDR+VTP-300+LDN reached Functional Cure[89]
Barinthus Biotherapeutics plc (BRNS) Conference Transcript
2025-06-10 16:00
Summary of Barinthus Biotherapeutics plc (BRNS) Conference Call Company Overview - Barinthus Biotherapeutics plc focuses on next-generation immunotherapies targeting autoimmune and inflammatory diseases, utilizing a platform called SnapTI [4][5] Key Developments - The lead candidate, VTP 1000, is currently in phase one clinical trials for celiac disease, with expected data readout by the end of Q3 or early Q4 2025 [6][48] - The company has approximately $100 million in cash, providing a runway into 2027 with no debt or outstanding warrants [6][48] SnapTI Platform - SnapTI is a self-assembling nanoparticle platform designed to restore immune system balance by co-delivering multiple disease-associated antigens with an immunomodulator [5][11] - The platform allows for patient-friendly administration via intramuscular (IM) or subcutaneous (SubQ) routes, enhancing tolerability and broadening antigen coverage [12][13] Celiac Disease Focus - Celiac disease affects about 1% of the global population, with current treatment limited to a strict gluten-free diet [16] - VTP 1000 aims to rebalance the immune system by reducing T effector cells and stimulating T regulatory cells, addressing the underlying immune imbalance in celiac disease [18] Clinical Trials - The phase one trial is a double-blind, placebo-controlled study involving 18 patients in a single ascending dose (SAD) design, with safety and biomarker changes being key focuses [29][30] - A multiple ascending dose (MAD) portion has received FDA approval, involving 24 patients and a gluten challenge to assess efficacy [30] Viral-Based Platform - The company is winding down its viral-based platform, which includes VTP 300 for chronic hepatitis B and VTP 850 for prostate cancer, seeking partners to advance these programs [35][36] - Chronic hepatitis B presents a significant market opportunity, with over 250 million people affected globally and current treatments yielding low cure rates [37][38] Encouraging Data - VTP 300 is designed to stimulate both exhausted T cells and new T cells to combat hepatitis B, with a focus on achieving a functional cure defined as surface antigen loss after stopping nucleoside treatments [39][40] - Recent studies showed promising results, with 20-25% functional cure rates, significantly higher than current standard care [46][47] Financial Outlook - The company has no immediate plans for fundraising, relying on existing cash reserves and upcoming clinical data to guide future financial strategies [50]
Barinthus(BRNS) - 2025 Q1 - Quarterly Report
2025-05-07 12:12
Financial Performance - For the three months ended March 31, 2025, the company incurred a net loss of $19.7 million, with an accumulated deficit of $257.3 million[87]. - The company reported a net loss of $19.7 million for the three months ended March 31, 2025, compared to a net loss of $15.5 million in the same period of 2024, reflecting an increase in loss of $4.1 million[115]. - The company has incurred net losses in each reporting period since 2023 and does not expect positive cash flows from operations in the foreseeable future[87]. - For the three months ended March 31, 2025, total operating expenses increased to $20.9 million from $17.1 million in the same period of 2024, representing a change of $3.8 million[115]. - General and administrative expenses rose significantly to $12.6 million in Q1 2025, compared to $6.0 million in Q1 2024, an increase of $6.6 million[120]. - The company anticipates continued net negative cash flows from operations for at least the next few years as it progresses clinical development and seeks regulatory approval[127]. - The company expects to incur significant losses and negative cash flows from operations for the foreseeable future, driven by ongoing research and development efforts[135][136]. Research and Development - The company is currently advancing its lead candidate VTP-1000 for celiac disease in a Phase 1 clinical trial, leveraging its proprietary SNAP-TI platform[83]. - VTP-300, a Phase 2 immunotherapeutic treatment for chronic hepatitis B, showed that 33% of participants achieved HBsAg declines of ≥1 log at Day 169[93]. - The company is seeking partners for the continued development of VTP-300 and VTP-850, which it does not intend to develop beyond ongoing trials[99]. - The company plans to prioritize the development of VTP-1000 in celiac disease and focus future pipeline efforts on immunology and inflammation indications[112]. - Research and development expenses are expected to increase as the company progresses its programs through the next stages of development[99]. Cash and Financing - As of March 31, 2025, the company had cash, cash equivalents, and restricted cash totaling $100.6 million[125]. - The company received gross proceeds of approximately $330.1 million from the issuance of ordinary and preferred shares and convertible loan notes through March 31, 2025[125]. - The company anticipates that existing cash and equivalents will fund operations into early 2027, although this estimate is subject to change[142]. - The company may require substantial additional financing in the future to meet operational needs and capital requirements, which could impact its ability to develop and market product candidates independently[143]. - The company anticipates financing future cash needs through public or private equity offerings, debt financings, or collaborations[89]. Operational Metrics - For the three months ended March 31, 2025, net cash used in operating activities was $14.9 million, compared to $11.8 million for the same period in 2024, reflecting an increase of 26.5%[130][131]. - Cash used in investing activities was $0.005 million for the three months ended March 31, 2025, down from $0.3 million in the same period of 2024, indicating a decrease of 98.3%[132]. - Cash provided by financing activities was $0.002 million for the three months ended March 31, 2025, compared to $0.5 million in the same period of 2024, a decline of 99.6%[133]. - The effect of foreign exchange on cash resulted in a gain of $3.1 million for the three months ended March 31, 2025, compared to a loss of $0.5 million in the same period of 2024[134]. Partnerships and Collaborations - The company has partnerships for additional product candidates, including VTP-500 for MERS and VTP-600 for multiple cancer indications[85]. - The fair value of contingent consideration related to the acquisition of Avidea Technologies, Inc. could result in additional payments of up to $40.0 million upon achieving certain milestones[114].
Barinthus(BRNS) - 2025 Q1 - Quarterly Results
2025-05-07 12:10
Financial Performance - For Q1 2025, Barinthus Bio reported a net loss of $19.6 million, or $(0.49) per share, compared to a net loss of $15.5 million, or $(0.40) per share in Q1 2024[12]. - The net loss attributable to Barinthus Biotherapeutics plc shareholders for Q1 2025 was $19,648,000, compared to a net loss of $15,489,000 in Q1 2024, indicating an increase in loss of approximately 26.5%[17]. - The net loss per share attributable to ordinary shareholders for Q1 2025 was $(0.49), compared to $(0.40) in Q1 2024, indicating a worsening loss per share[17]. - Comprehensive loss for Q1 2025 was $15,012,000, compared to $17,097,000 in Q1 2024, showing an improvement of about 12.2%[17]. Cash and Assets - Cash, cash equivalents, and restricted cash as of March 31, 2025, were $100.6 million, down from $112.4 million as of December 31, 2024, primarily due to $14.9 million used in operating activities[12]. - Total current assets decreased from $125,742,000 on December 31, 2024, to $109,882,000 on March 31, 2025, a decline of approximately 12.6%[16]. - Total stockholders' equity attributable to Barinthus Biotherapeutics plc shareholders decreased from $130,029,000 on December 31, 2024, to $115,494,000 on March 31, 2025, a decline of approximately 11.2%[16]. Expenses - Research and development expenses decreased to $8.3 million in Q1 2025 from $11.1 million in Q1 2024, reflecting a reduction in preclinical activity and workforce[12]. - General and administrative expenses increased to $12.6 million in Q1 2025 from $6.0 million in Q1 2024, largely due to foreign exchange losses[12]. - Research and development expenses for Q1 2025 were $8,290,000, down 25.5% from $11,125,000 in Q1 2024[17]. - General and administrative expenses increased significantly to $12,639,000 in Q1 2025, compared to $5,994,000 in Q1 2024, representing a rise of 110.5%[17]. Clinical Trials and Research - In the HBV003 study, 33% of participants with baseline HBsAg levels ≤200 IU/mL achieved ≥1 log decline in HBsAg by Day 169[6]. - The company expects to announce Phase 1 single ascending dose data for VTP-1000 in celiac disease in Q3 2025 and initiate multiple ascending dose trials in the second half of 2025[5]. - Barinthus Bio aims to seek partners for VTP-300 for chronic hepatitis B after the completion of the ongoing Phase 2b HBV003 clinical trial[7]. - The company reported that 71% of participants in the HBV003 study met criteria for discontinuation of NUC therapy by Day 169[6]. - Barinthus Bio's lead candidate, VTP-1000, is designed to restore immune non-responsiveness to gluten in patients with celiac disease and is currently in a Phase 1 clinical trial[14]. Liabilities - Total liabilities decreased from $30,192,000 on December 31, 2024, to $26,403,000 on March 31, 2025, a reduction of about 12.5%[16]. Future Outlook - The company anticipates its available resources will fund operations into 2027 based on current research and development plans[12]. - The weighted-average ordinary shares outstanding increased from 38,773,482 in Q1 2024 to 40,265,216 in Q1 2025, reflecting a growth of about 3.8%[17]. - Other comprehensive gain from foreign currency translation adjustments was $4,646,000 in Q1 2025, contrasting with a loss of $1,577,000 in Q1 2024[17].
Barinthus Bio Reports First Quarter 2025 Financial Results and Updates on Corporate Developments
Globenewswire· 2025-05-07 12:00
Core Insights - Barinthus Biotherapeutics plc focuses on developing therapies for immunological and inflammatory diseases, with a strategic emphasis on its lead asset, VTP-1000, for celiac disease [2][3] - The company is on track to announce Phase 1 single ascending dose data for VTP-1000 in Q3 2025 and will initiate the multiple ascending dose part of the trial in the second half of 2025 [2][12] - Recent data from Phase 2 trials of VTP-300 for chronic hepatitis B (CHB) show promising results, supporting its potential as a functional cure [3][4][5] Clinical Developments - Data from two Phase 2 trials of VTP-300 will be presented at the EASL Congress 2025, showcasing significant findings from the HBV003 and IM-PROVE II studies [3][4] - The HBV003 study indicated that 33% of participants with HBsAg levels ≤200 IU/mL achieved ≥1 log decline in HBsAg by Day 169 [6] - The IM-PROVE II study demonstrated that 25% of participants receiving a combination therapy achieved functional cure [11] Financial Highlights - For Q1 2025, the company reported a net loss of $19.6 million, or $(0.49) per share, compared to a net loss of $15.5 million, or $(0.40) per share in Q1 2024 [18][22] - Research and development expenses decreased to $8.3 million in Q1 2025 from $11.1 million in Q1 2024, attributed to reduced preclinical activity and workforce [13][22] - As of March 31, 2025, the company had cash and cash equivalents of $100.6 million, expected to fund operations into 2027 [13][20] Corporate Updates - In January 2025, Barinthus Bio announced a strategic refocus on immunology and inflammation, planning to seek partners for VTP-300 after the completion of the ongoing Phase 2b trial [7] - The company aims to leverage its differentiated capabilities in achieving sustained HBsAg loss and functional cure in CHB patients [7] - Upcoming milestones include topline results from the Phase 1 PCA001 trial for prostate cancer (VTP-850) [8]
Barinthus(BRNS) - 2024 Q4 - Annual Report
2025-03-20 20:01
Financial Performance - For the year ended December 31, 2022, the company generated net income of $5.3 million, primarily from revenues arising from AstraZeneca sales of Vaxzevria and an agreement with OUI[285]. - The company incurred net losses of $61.2 million and $73.4 million for the years ending December 31, 2024 and 2023, respectively[285]. - As of December 31, 2024, the company had an accumulated deficit of $237.7 million[285]. - The company has cumulative carryforward tax losses of approximately $101.7 million as of December 31, 2024, up from $92.7 million as of December 31, 2023[417]. Cash and Funding - The company's cash, cash equivalents, and restricted cash were $112.4 million as of December 31, 2024, which is expected to support operations into the start of 2027 without additional financing[301]. - The company expects to finance future cash needs through public or private equity offerings, debt financings, collaborations, and licensing arrangements[303]. - The company may need to raise additional funding, which could result in dilution to existing shareholders and restrict operations[302]. - The company anticipates substantial increases in expenses as it pursues clinical and preclinical development of product candidates and expands operational capabilities[286]. - The company may need to pursue additional funding through public or private equity offerings, debt financings, or strategic partnerships to support ongoing operations[307]. Product Development and Clinical Trials - The company does not expect to generate significant revenue from current or future product candidates until successful completion of clinical development and marketing authorization[289]. - The company has not yet generated any material revenue from its current product candidates and faces significant translational risks as it advances them through clinical stages[290]. - The company has discontinued further development of the MVA-based influenza vaccine candidate, VTP-100, after it did not meet primary clinical endpoints in two Phase 2b trials[316]. - The company may experience delays in clinical trials or may not be able to complete them on expected timelines, impacting the commercialization of product candidates[320]. - The company may face delays in clinical trials due to various factors, including regulatory holds, unforeseen safety issues, or lack of adequate funding[325][326]. - The company’s product candidates are based on novel approaches, making it difficult to predict development timelines and costs, which could lead to significant delays or unanticipated costs[333]. - The company may need to conduct additional clinical trials if existing therapies used in combination with its product candidates are replaced as the standard of care[340]. - The integrity of clinical trial data may be questioned due to financial relationships between the company and principal investigators, potentially delaying approval processes[327]. Regulatory and Compliance Risks - The marketing authorization process from regulatory authorities like the FDA and EMA is lengthy and unpredictable, potentially delaying market access for product candidates[396]. - Regulatory authorities have substantial discretion in the approval process, and even promising clinical trial data may not be sufficient for approval, introducing uncertainty into the commercialization process[399]. - The company must comply with Good Clinical Practice (GCP) regulations, and any failure to do so may result in unreliable clinical data and regulatory delays[382]. - The company is subject to varying regulatory requirements in different jurisdictions, which could delay or prevent the introduction of its product candidates[412]. - The company faces ongoing regulatory obligations that may result in significant additional expenses and potential penalties if compliance is not maintained[422]. Market and Competitive Landscape - The commercial success of product candidates will depend on public acceptance of immunotherapies and the absence of adverse events in clinical trials[346]. - The company faces substantial competition from major pharmaceuticals and biotechnology companies, which may have greater financial resources and expertise[355]. - Product candidates based on SNAP-TI will compete against various existing and emerging therapies, including anti-inflammatory compounds and monoclonal antibodies[356]. - The company may not achieve market acceptance for its product candidates, which is critical for generating significant revenue[370]. Intellectual Property and Licensing - The company relies heavily on in-licensed patents and does not own any issued patents for its product candidates, which could harm its competitive position if patent protection is not maintained[455]. - The patent prosecution process is complex and costly, and failure to secure patents could adversely affect the company's ability to commercialize its products[458]. - The company is dependent on third-party licenses for critical technology, and any breach of these agreements could result in the loss of significant rights[462]. - The uncertainty surrounding patent laws and their interpretation may diminish the company's ability to protect its inventions and intellectual property rights[456]. Insurance and Liability - The company is exposed to significant uninsured liabilities due to the high costs of insurance and the potential for contamination or injury claims[378]. - The company may face challenges in maintaining insurance coverage at reasonable costs, which could adversely affect its financial position[377]. Data Protection and Compliance - The GDPR imposes strict obligations on personal data processing, requiring significant resources for compliance and increasing liability risks[441]. - Non-compliance with data protection laws in the EU and U.K. could result in fines up to €20 million or 4% of annual global revenue, whichever is greater[450]. - The CCPA and other U.S. state privacy laws impose new compliance obligations, increasing risks for potential fines and class actions[446]. Future Outlook and Strategic Initiatives - The company may evaluate acquisitions and strategic partnerships in the future, which could increase capital requirements and dilute shareholders[294]. - The company intends to develop certain product candidates in combination with other therapies, exposing it to additional risks if those therapies face regulatory issues[340]. - The company intends to market VTP-300 in Asian markets, particularly for chronic hepatitis B, but faces regulatory challenges and limited development experience in this region[413].
Barinthus(BRNS) - 2024 Q4 - Annual Results
2025-03-20 11:47
Financial Estimates - The preliminary estimated cash, cash equivalents, and restricted cash for Barinthus Biotherapeutics plc as of December 31, 2024, is expected to be $112 million[5]. Workforce Reduction - The company plans a 65% reduction in workforce, primarily in the UK, with pre-tax costs estimated at $2.5 million related to employee severance and other costs[7]. - The majority of the workforce reduction is anticipated to be completed during the first half of 2025[7]. - The company has announced the termination of employment for two key executives as part of the restructuring[8]. Restructuring Plan - The restructuring plan aims to prioritize immune tolerance research and development programs[7]. - The restructuring costs and potential operating expense reductions are subject to various assumptions, and actual results may vary[7]. Strategic Focus - The company issued a press release on January 10, 2025, outlining its strategic focus in immunology and inflammation[10]. - A corporate presentation was updated for investor meetings, reflecting the company's current strategies and financial updates[11]. Forward-Looking Statements - Forward-looking statements indicate that actual results may differ materially from preliminary estimates due to various risks and uncertainties[13]. - The company cautions against placing undue reliance on forward-looking statements, which are based on current expectations and beliefs[13].
Barinthus Bio Reports Full Year 2024 Financial Results and Updates on Corporate Developments
GlobeNewswire News Room· 2025-03-20 11:22
Core Insights - Barinthus Biotherapeutics plc is focusing on immunological and inflammatory diseases, particularly with its lead asset VTP-1000 for celiac disease, which is expected to show promising results in upcoming clinical trials [2][3][4] - The company reported a net loss of $61.1 million for the year ended December 31, 2024, an improvement from a net loss of $73.3 million in 2023, indicating a reduction in losses [12][16] - Barinthus Bio's cash position decreased to $112.4 million as of December 31, 2024, down from $142.1 million in 2023, but the company expects its resources to fund operations into 2027 [12][15] Financial Performance - Total revenue for 2024 was $15.0 million, a significant increase from $0.8 million in 2023, primarily due to royalties from Vaxzevria® sales [12][16] - Research and development expenses decreased to $42.2 million in 2024 from $44.9 million in 2023, mainly due to reduced spending on certain programs [12][16] - General and administrative expenses were reduced to $29.7 million in 2024 from $39.8 million in 2023, reflecting cost management efforts [12][16] Clinical Developments - VTP-1000 is currently in a Phase 1 clinical trial for celiac disease, with initial data expected in the third quarter of 2025 [2][4][6] - The Phase 2 trials for VTP-300 in chronic hepatitis B showed that eight participants achieved undetectable HBsAg levels, with two meeting functional cure criteria [2][6] - The company completed enrollment for the Phase 1 PCA001 trial for VTP-850 in prostate cancer, with results anticipated in the second quarter of 2025 [5][8] Strategic Focus - Barinthus Bio has undergone a strategic restructuring to prioritize immunology and inflammation, aiming to leverage its SNAP-TI platform for future pipeline opportunities [2][3][7] - The company plans to seek partnerships for VTP-300 after the completion of the ongoing Phase 2b HBV003 trial, indicating a shift in focus towards collaboration [7][12] - The leadership team has seen changes, including the appointment of a new Chief Medical Officer and a promotion to Chief Scientific Officer, reflecting a commitment to strengthen the executive team [7]
Barinthus Biotherapeutics PLC Sponsored ADR (BRNS) Upgraded to Strong Buy: Here's Why
ZACKS· 2025-01-31 18:01
Core Viewpoint - Barinthus Biotherapeutics PLC Sponsored ADR (BRNS) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks rating system is based on changes in earnings estimates, tracking EPS estimates from sell-side analysts through a consensus measure known as the Zacks Consensus Estimate [2]. - Barinthus Biotherapeutics is expected to earn -$1.38 per share for the fiscal year ending December 2024, reflecting a year-over-year change of 27.8% [9]. - Over the past three months, the Zacks Consensus Estimate for Barinthus has increased by 17.4%, indicating a positive trend in earnings estimates [9]. Impact on Stock Price - The correlation between changes in earnings estimates and stock price movements is strong, with institutional investors using these estimates to determine the fair value of stocks [5]. - The upgrade to Zacks Rank 1 positions Barinthus in the top 5% of Zacks-covered stocks, suggesting potential for higher stock prices in the near term [11]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. - The system maintains a balanced distribution of 'buy' and 'sell' ratings, ensuring that only the top 20% of stocks are considered for strong recommendations [10][11].
Barinthus Bio Announces Strategic Focus in Immunology and Inflammation (I&I) and Provides a Financial Update
Globenewswire· 2025-01-10 13:00
Core Insights - Barinthus Biotherapeutics plc is a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic candidates to guide T cells in disease control [1][8] - The company is undergoing a strategic restructuring to prioritize its SNAP-TI platform for autoimmune diseases and extend its cash runway to early 2027 [5][6] Strategic Business Focus and Restructuring - The company will prioritize the development of VTP-1000 for celiac disease, with Phase 1 data expected in mid-2025 [5][6] - Further clinical development of VTP-300 for chronic hepatitis B is postponed until a partner is identified [5][6] - A significant workforce reduction of approximately 65% is planned, along with the closure of the U.K. site, focusing future operations in Germantown, Maryland [5][6] Financial Update - Cash, cash equivalents, and restricted cash are projected to be $112 million as of December 31, 2024, which is expected to fund operations until early 2027 [6][7] - The company aims to streamline operating costs as part of its restructuring efforts [6] Anticipated 2025 Corporate Milestones - Results from the Phase 1 PCA001 clinical trial for VTP-850 in prostate cancer are expected in Q2 2025 [4][5] - Announcement of single ascending dose data from the AVALON Phase 1 trial for VTP-1000 in celiac disease is anticipated in mid-2025 [6] - Results from the Phase 2b HBV003 clinical trial for VTP-300 are expected in Q2 2025 [6]