Core Points - Barinthus Biotherapeutics plc has announced the promotion of Geoffrey Lynn, M.D., Ph.D. to Chief Scientific Officer, effective December 1, 2024, succeeding Nadège Pelletier, Ph.D. [1][2] - Dr. Pelletier has been instrumental in developing a robust preclinical pipeline targeting autoimmune and inflammatory diseases and will assist in the transition process [2] - Barinthus Bio has achieved functional cures with VTP-300 for chronic hepatitis B and has initiated a Phase 1 trial for VTP-1000, aimed at treating celiac disease [3] - Dr. Lynn brings over 15 years of experience in immunotherapeutic R&D and previously led Avidea Technologies, Inc. before its acquisition by Barinthus Bio [3] Company Overview - Barinthus Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapeutic candidates to combat chronic infectious diseases and autoimmunity [4] - The company’s pipeline includes VTP-300, targeting chronic HBV infection, and VTP-1000, designed for celiac disease, along with VTP-850, aimed at recurrent prostate cancer [4] - Barinthus Bio's proprietary platform technologies and scientific expertise position it well for advancing treatments that improve patient outcomes in chronic diseases [4]

Core Insights - Barinthus Biotherapeutics plc announced significant data from the Phase 2b HBV003 clinical trial, which will be presented at the AASLD meeting on November 18, 2024 [2][3] - The trial aims to evaluate the immunotherapeutic candidate VTP-300 in combination with low-dose nivolumab for chronic hepatitis B treatment [3][8] Study Details - The HBV003 trial has fully recruited 121 participants, with 69 having HBsAg levels below 200 IU/mL [3] - Eight participants achieved complete HBsAg loss, and two met the criteria for functional cure [3][4] - Two participants who discontinued nucleos(t)ide analogue (NUC) therapy seroconverted to HBsAb positivity [4][5] Treatment Efficacy - The combination of VTP-300 and low-dose nivolumab showed stronger immune responses, with durable HBsAg declines observed across all treatment groups [5][6] - Among 40 participants assessed for NUC discontinuation, 66% (6 out of 9) remained off NUC therapy for over six months, with two achieving functional cure [5][6] Safety Profile - Preliminary safety data indicate that VTP-300 combined with low-dose nivolumab was well tolerated, with no treatment-related serious adverse events reported [5][6] Company Overview - Barinthus Bio is focused on developing immunotherapeutic candidates for chronic infectious diseases and autoimmunity, with VTP-300 being a key component in their pipeline [9]

Core Insights - The combination of imdusiran, VTP-300, and low-dose nivolumab shows promising results in achieving HBsAg loss in chronic hepatitis B virus patients, with 23% of participants reaching HBsAg loss by Week 48 [1][3][4] Group C Clinical Trial Data - Group C consisted of 22 non-cirrhotic, virally suppressed cHBV participants, with 13 eligible for low-dose nivolumab [3][6] - Participants receiving the combination treatment of imdusiran, VTP-300, and nivolumab experienced significantly greater mean declines in HBsAg levels (p <0.017) compared to other groups [1][3] - Increases in immune biomarkers associated with T-cell activation were observed in participants who achieved HBsAg loss [3] IM-PROVE II Trial Overview - The IM-PROVE II Phase 2a clinical trial initially enrolled 40 participants, with Groups A and B receiving imdusiran followed by either VTP-300 or placebo [5] - An amendment added Group C, which included participants receiving imdusiran followed by VTP-300 and low-dose nivolumab [6] Mechanism of Action - Imdusiran is designed to reduce HBV viral proteins and antigens, facilitating immune system reawakening [8] - VTP-300 is an immunotherapeutic candidate that induces sustained reductions in HBsAg, aiming to counteract immune suppression caused by chronic HBV infection [9] Company Profiles - Arbutus Biopharma Corporation focuses on developing therapeutics for chronic hepatitis B, with a pipeline that includes imdusiran and an oral PD-L1 inhibitor [10] - Barinthus Biotherapeutics is advancing immunotherapeutic candidates, including VTP-300, targeting chronic infectious diseases and autoimmunity [11]

Financial Performance - For the year ended December 31, 2023, the company generated a net loss of $73.4 million, with an accumulated deficit of $217.1 million as of September 30, 2024[78]. - The net loss for the nine months ended September 30, 2024, was $40.6 million, an improvement from a net loss of $56.2 million in 2023[124]. - Net loss for the three months ended September 30, 2024, was $8.13 million, an improvement of $5.98 million compared to a net loss of $14.11 million in the same period in 2023[113]. - The company expects to continue incurring significant losses and negative cash flows from operations for the foreseeable future, primarily due to ongoing research and development efforts[141][142]. Revenue Generation - The company recognized $15.0 million in revenue in Q3 2024 from royalties related to prior commercial sales of Vaxzevria, compared to $0.8 million for the same period in 2023[89]. - License revenue for the three months ended September 30, 2024, was $14.97 million, compared to $0 in the same period in 2023, representing a significant increase[113]. - Revenue for the nine months ended September 30, 2024, was $15.0 million, a substantial increase from $0.8 million in the same period of 2023, attributed to the OUI License Agreement Amendment[124]. Operating Expenses - Total operating expenses increased to $24.56 million for the three months ended September 30, 2024, from $16.11 million in the same period in 2023, an increase of $8.45 million[113]. - Total operating expenses for the nine months ended September 30, 2024, were $60.5 million, down from $64.7 million in 2023, reflecting a decrease in research and development expenses[124]. - General and administrative expenses surged to $13.42 million for the three months ended September 30, 2024, compared to $0.96 million in the same period in 2023, an increase of $12.46 million[113]. Research and Development - The company has incurred significant research and development expenses, which are expected to increase as clinical trials progress[94]. - Enrollment was completed in the HBV003 trial of VTP-300 for chronic hepatitis B with 121 adult participants, aimed at obtaining critical dosing information[85]. - The first-in-human Phase 1 trial of VTP-1000 for celiac disease was initiated in September 2024, evaluating safety and pharmacodynamics[87]. - The PCA001 trial of VTP-850 for recurrent prostate cancer completed enrollment of 22 participants, with data expected in the first half of 2025[88]. - Research and development expenses decreased to $11.14 million for the three months ended September 30, 2024, down from $15.14 million in the same period in 2023, a reduction of $4.00 million[113]. Cash Flow and Financing - As of September 30, 2024, the company had cash, cash equivalents, and restricted cash totaling $106.1 million, which is expected to fund operations into the second quarter of 2026[133][148]. - For the nine months ended September 30, 2024, the company reported a net cash used in operating activities of $42.0 million, compared to $31.3 million for the same period in 2023, indicating a 34.1% increase in cash outflow[136][138]. - Cash provided by financing activities was $1.3 million for the nine months ended September 30, 2024, slightly down from $1.8 million in the same period of 2023[139]. - The company raised gross proceeds of approximately $329.2 million from the issuance of ordinary and preferred shares and convertible loan notes since inception[133]. Market and Operational Risks - The company may face limitations in claiming research and development tax credits in the future due to changes in eligibility criteria and caps introduced by the UK government[103]. - The company is not significantly exposed to market risk from interest rate changes, as it has no substantial interest-bearing liabilities[160]. - For the nine months ended September 30, 2024, a hypothetical 10% weakening of the U.S. dollar against the pound sterling would have significantly impacted current and projected expenses denominated in pounds[158].

Financial Performance - Revenue for Q3 2024 was $15.0 million, compared to nil in Q2 2024, primarily from royalties related to prior sales of Vaxzevria® by AstraZeneca[10] - Total revenue for the three months ended September 30, 2024, was $14.969 million, compared to $0.802 million for the same period in 2023, representing a significant increase[20] - The net loss attributable to shareholders for Q3 2024 was $8.1 million, or $(0.21) per share, an improvement from a net loss of $16.9 million, or $(0.43) per share, in Q2 2024[15] - The net loss for the three months ended September 30, 2024, was $8.129 million, compared to a net loss of $14.110 million for the same period in 2023, reflecting an improvement of about 42%[20] - The company reported a comprehensive income of $1.062 million for the three months ended September 30, 2024, compared to a comprehensive loss of $21.930 million for the same period in 2023[20] - The company recognized license revenue from related parties of $15.0 million for the three months ended September 30, 2024, compared to nil for the same period in 2023[20] Cash and Assets - As of September 30, 2024, Barinthus Bio reported cash, cash equivalents, and restricted cash of $106.1 million, down from $117.8 million as of June 30, 2024, with a net cash used in operating activities of $18.2 million in Q3 2024[9] - Cash, cash equivalents, and restricted cash as of September 30, 2024, totaled $106.102 million, down from $142.090 million as of December 31, 2023[19] - Total assets decreased to $188.689 million as of September 30, 2024, from $214.506 million as of December 31, 2023, representing a decline of approximately 12%[19] - Total liabilities increased to $29.228 million as of September 30, 2024, compared to $27.511 million as of December 31, 2023, indicating a rise of about 6%[19] - Total stockholders' equity attributable to Barinthus Biotherapeutics plc shareholders decreased to $159.294 million as of September 30, 2024, from $186.784 million as of December 31, 2023[19] Research and Development - Research and development expenses decreased to $11.1 million in Q3 2024 from $11.7 million in Q2 2024, mainly due to reduced personnel-related costs[11] - Research and development expenses for the three months ended September 30, 2024, were $11.139 million, down from $15.144 million in the same period of 2023, indicating a reduction of approximately 26%[20] - Enrollment in the HBV003 trial of VTP-300 for chronic hepatitis B was completed with 121 adult participants, aimed at obtaining critical dosing information for a potential functional cure[3] - The first-in-human Phase 1 AVALON trial of VTP-1000 for celiac disease was initiated in September 2024, evaluating safety and tolerability[5] - The PCA001 trial of VTP-850 for prostate cancer completed enrollment of 22 participants, with data expected in the first half of 2025[5] - Upcoming milestones include updated data from the VTP-300 program at the AASLD meeting scheduled for November 15-19, 2024[7] - An additional $15.0 million in revenue is expected from Oxford University Innovation related to royalties, which will support R&D plans into Q2 2026[6] Expenses - General and administrative expenses increased to $13.4 million in Q3 2024 from $7.2 million in Q2 2024, largely due to a foreign exchange loss of $7.7 million[14]

Core Insights - Barinthus Biotherapeutics plc is advancing its clinical trials and has reported financial results for Q3 2024, highlighting significant progress in its pipeline, particularly in chronic hepatitis B and celiac disease treatments [1][2]. Clinical Developments - The company completed enrollment in the HBV003 trial of VTP-300 for chronic hepatitis B with 121 adult participants, aiming for a potential functional cure [3]. - Interim data from the HBV003 trial showed that 76% of participants met criteria for nucleos(t)ide analogue therapy discontinuation, with 19% achieving undetectable HBsAg levels [4]. - The first-in-human Phase 1 AVALON trial of VTP-1000 for celiac disease was initiated, focusing on safety and pharmacokinetics [5]. - Enrollment for the PCA001 trial of VTP-850 in prostate cancer was completed with 22 participants, with data expected in the first half of 2025 [6]. Financial Performance - As of September 30, 2024, the company reported cash and equivalents of $106.1 million, down from $117.8 million at the end of Q2 2024, with a net cash usage of $18.2 million in Q3 [9]. - Revenue for Q3 2024 was $15.0 million, attributed to royalties from Oxford University Innovation, compared to no revenue in Q2 2024 [9]. - Research and development expenses decreased to $11.1 million in Q3 2024 from $11.7 million in Q2 2024, primarily due to reduced personnel costs [9][10]. - General and administrative expenses rose to $13.4 million in Q3 2024, largely due to a foreign exchange loss of $7.7 million [12]. - The net loss for Q3 2024 was $8.1 million, or $(0.21) per share, an improvement from a net loss of $16.9 million in Q2 2024 [12][19]. Upcoming Milestones - Updated data from the VTP-300 program is expected in Q4 2024, with presentations at the AASLD – The Liver Meeting® 2024 [7]. - Data from the Phase 1 AVALON trial of VTP-1000 is anticipated in the first half of 2025 [8]. - Results from the Phase 1 PCA001 trial of VTP-850 are also expected in the first half of 2025 [8].

Part I - Financial Information [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the period ended June 30, 2024, including the balance sheet, statement of operations, statement of cash flows, and accompanying notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2024, total assets decreased to $186.7 million from $214.5 million, primarily due to a reduction in cash, cash equivalents, and restricted cash from $142.1 million to $117.8 million, while total liabilities slightly increased and stockholders' equity declined | | As of June 30, 2024 (in thousands) | As of December 31, 2023 (in thousands) | | :--- | :--- | :--- | | **Total Current Assets** | $131,879 | $156,905 | | **Total Assets** | $186,749 | $214,506 | | **Total Current Liabilities** | $15,589 | $12,598 | | **Total Liabilities** | $29,959 | $27,511 | | **Total Stockholders' Equity** | $156,790 | $186,995 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q2 2024, the company reported no license revenue, with net loss narrowing to $16.9 million from $23.8 million year-over-year due to reduced operating expenses, resulting in a six-month net loss of $32.5 million | Metric (in thousands, except per share) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | $0 | $334 | $0 | $802 | | **Total Operating Expenses** | $18,863 | $26,671 | $35,982 | $48,623 | | **Loss from Operations** | $(18,286) | $(26,337) | $(35,200) | $(47,821) | | **Net Loss** | $(16,943) | $(23,824) | $(32,463) | $(42,047) | | **Net Loss Per Share (basic & diluted)** | $(0.43) | $(0.62) | $(0.83) | $(1.10) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2024, net cash used in operating activities increased to $23.8 million, while net cash used in investing activities significantly decreased to $0.5 million, with financing activities providing $0.9 million | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(23,828) | $(20,131) | | Net cash used in investing activities | $(500) | $(5,530) | | Net cash provided by financing activities | $861 | $1,717 | | **Net decrease in cash** | **$(24,316)** | **$(21,355)** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes confirm the company's going concern status with sufficient cash for at least the next twelve months, detail a June 2024 pipeline prioritization that triggered an impairment assessment with no impairment found, and report $0.8 million in grant income from CEPI - The company expects its cash, cash equivalents, and restricted cash of **$117.8 million** will be sufficient to fund current operations for **at least the next twelve months** from the financial statement issuance date[16](index=16&type=chunk) - In June 2024, the company prioritized its pipeline to focus on VTP-300 for chronic Hepatitis B and VTP-1000 for celiac disease. This led to an impairment assessment for intangible assets and goodwill, but management determined their carrying amounts were recoverable[31](index=31&type=chunk)[49](index=49&type=chunk)[96](index=96&type=chunk) - The company received **$1.6 million** in proceeds from the CEPI Funding Agreement for the VTP-500 (MERS) program and recognized **$0.8 million** as other operating income during the six months ended June 30, 2024[34](index=34&type=chunk)[36](index=36&type=chunk) - As of June 30, 2024, the company had a contingent consideration liability of **$1.9 million** related to the acquisition of Avidea Technologies, Inc., which is fair valued at each reporting period[47](index=47&type=chunk) [Management's Discussion and Analysis (MD&A)](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift to prioritize VTP-300 and VTP-1000 programs, highlighting a reduced net loss driven by lower G&A expenses, and confirms cash runway into Q2 2026 with future funding plans [Overview and Strategic Update](index=18&type=section&id=Overview%20and%20Strategic%20Update) Barinthus Bio, a clinical-stage biopharmaceutical company, strategically prioritized VTP-300 for chronic hepatitis B and VTP-1000 for celiac disease in June 2024, anticipating continued net losses as clinical programs advance - The company is prioritizing a pipeline of two key product candidates: VTP-300 for chronic hepatitis B virus (HBV) infection and VTP-1000 for celiac disease[63](index=63&type=chunk) - The company has an effective Shelf Registration Statement on Form S-3 for up to **$200.0 million** and an "at-the-market" (ATM) sales agreement for up to **$75.0 million**, under which it has raised net proceeds of **$3.8 million** as of June 30, 2024[65](index=65&type=chunk) - The company expects its existing cash, cash equivalents, and restricted cash will fund operating expenses and capital expenditure requirements **into the second quarter of 2026**[68](index=68&type=chunk) [Recent Developments and Pipeline](index=20&type=section&id=Recent%20Developments%20and%20Pipeline) In June 2024, the company presented positive interim Phase 2 data for VTP-300 in chronic hepatitis B, with further updates expected in Q4 2024, and anticipates IND acceptance and Phase 1 initiation for VTP-1000 in Q3 2024 | Priority Program | Indication | Status/Anticipated Milestones | | :--- | :--- | :--- | | **VTP-300** | Chronic Hepatitis B (HBV) | Phase 2b interim analysis & Phase 2a interim results (Q4 2024) | | **VTP-1000** | Celiac Disease | IND acceptance & Phase 1 initiation (Q3 2024) | - Interim data from the HBV003 trial showed robust T cell responses and that **76% of participants** were eligible for NUC discontinuation[74](index=74&type=chunk) - Interim data from the IM-PROVE II trial (in partnership with Arbutus Biopharma) showed **20% of participants** in the VTP-300 group had undetectable HBsAg at week 72, compared to none in the placebo group[76](index=76&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Q2 2024 net loss decreased to $16.9 million from $23.8 million in Q2 2023, driven by a **$5.9 million** reduction in G&A expenses and a **$1.9 million** decrease in R&D expenses, reflecting pipeline shifts and workforce reduction impacts | Expense Category (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development | $11,662 | $13,543 | $(1,881) | | General and administrative | $7,201 | $13,128 | $(5,927) | | **Total operating expenses** | **$18,863** | **$26,671** | **$(7,808)** | - The decrease in R&D expenses for Q2 2024 was primarily due to a **$1.5 million** reduction in VTP-200 (HPV) program costs and a **$1.6 million** reduction in preclinical studies for the SNAP platform[102](index=102&type=chunk) - The decrease in G&A expenses for Q2 2024 was mainly due to a **$4.1 million** reduction in net foreign exchange loss, a **$0.6 million** decrease in professional costs, and a **$0.6 million** decrease in insurance costs[104](index=104&type=chunk) - For the six months ended June 30, 2024, G&A expenses decreased by **$12.1 million** year-over-year, primarily due to a gain on foreign exchange of **$1.1 million** compared to a loss of **$7.7 million** in the prior year period[113](index=113&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2024, the company held **$117.8 million** in cash, cash equivalents, and restricted cash, sufficient to fund operations into Q2 2026, with primary funding from equity placements, grants, and license payments, and plans for additional capital - As of June 30, 2024, the company had cash, cash equivalents and restricted cash of **$117.8 million**[118](index=118&type=chunk) - The company expects its existing cash and other financial resources will enable it to fund operating expenses and capital expenditure requirements **into the second quarter of 2026**[131](index=131&type=chunk) | Cash Flow Summary (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(23,828) | $(20,131) | | Net cash used in investing activities | $(500) | $(5,530) | | Net cash provided by financing activities | $861 | $1,717 | [Quantitative and Qualitative Disclosure About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company's primary market risk stems from foreign currency exchange rate fluctuations, particularly between USD and Pound Sterling, with interest rate risk considered minimal - The company is subject to risk from fluctuations in foreign currency exchange rates, specifically the Pound Sterling, Euro, Swiss Franc, and Australian Dollar, against its reporting currency, the U.S. Dollar[136](index=136&type=chunk) - **A hypothetical 10% weakening** in the U.S. dollar relative to the Pound Sterling would have resulted in a material change to expenses denominated in Pound Sterling[138](index=138&type=chunk) - Interest rate risk is not significant as the company has no major interest-bearing liabilities and **a hypothetical 10% change** in interest rates would not have a material impact[139](index=139&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2024, the company's CEO and CFO concluded that disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that as of June 30, 2024, the company's disclosure controls and procedures were effective[142](index=142&type=chunk) - No change in internal control over financial reporting occurred during the quarter that has materially affected, or is reasonably likely to materially affect, internal controls[143](index=143&type=chunk) Part II - Other Information [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2024, the company is not party to any legal proceedings expected to have a material adverse effect on its business - The company does not believe it is party to any claim or litigation that would be reasonably expected to have a material adverse effect on its business[145](index=145&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company states there have been no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K filed on March 20, 2024 - There have been no material changes from the risk factors previously disclosed in the most recent Annual Report on Form 10-K[146](index=146&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the three and six months ended June 30, 2024, and confirmed no material change in the planned use of IPO net proceeds - No unregistered sales of equity securities were made during the three and six months ended June 30, 2024[151](index=151&type=chunk) - There has been no material change in the planned use of the net proceeds from the IPO as described in the final prospectus[153](index=153&type=chunk)

Barinthus Bio Reports Second Quarter 2024 Update on Corporate Developments and Financial Results OXFORD, United Kingdom, August 8, 2024 (GLOBE NEWSWIRE) – Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinicalstage biopharmaceutical company developing novel T cell immunotherapeutic candidates, provided an overview of the Company's progress and announced its financial results for the second quarter of 2024. "Following the positive VTP-300 Phase 2 data in hepatitis B virus (HBV) in the second quarter, we ma ...

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