Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to ________ Commission File Number: 001-40367 BARINTHUS BIOTHERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) Engl ...

Barinthus Bio Reports Second Quarter 2025 Financial Results and Updates on Corporate Developments GERMANTOWN, Maryland, August 7, 2025 (GLOBE NEWSWIRE) – Barinthus Biotherapeutics plc (NASDAQ: BRNS) ("Barinthus Bio," or the "Company"), an immunology and inflammation ("I&I") company focused on developing therapies that promote immune tolerance with curative potential, today announced its financial results for the quarter ended June 30, 2025, and provided an overview of the Company's corporate developments. " ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to ________ Commission File Number: 001-40367 BARINTHUS BIOTHERAPEUTICS PLC (Exact Name of Registrant as Specified in its Charter) Eng ...

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, reflecting a 26.5% increase in losses[17]. - Comprehensive loss for Q1 2025 was $15,012,000, compared to a comprehensive loss of $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, totaled $100.6 million, down from $112.4 million as of December 31, 2024, reflecting a net cash used in operating activities of $14.9 million[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]. - 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]. Expenses - General and administrative expenses rose to $12.6 million in Q1 2025 from $6.0 million in Q1 2024, primarily due to foreign exchange losses and increased personnel costs[12]. - General and administrative expenses increased significantly to $12,639,000 in Q1 2025, compared to $5,994,000 in Q1 2024, representing a 110.5% increase[17]. - Research and development expenses decreased to $8.3 million in Q1 2025 from $11.1 million in Q1 2024, attributed to reduced clinical development activity and workforce[12]. - Research and development expenses for Q1 2025 were $8,290,000, down 25.5% from $11,125,000 in Q1 2024[17]. - Total operating expenses rose to $20,929,000 in Q1 2025, up 22.5% from $17,119,000 in Q1 2024[17]. Clinical Trials and Strategic Focus - In the HBV003 study, 33% of participants with baseline HBsAg ≤200 IU/mL achieved ≥1 log decline in HBsAg by Day 169[6]. - The company reported that 71% of participants in the HBV003 study met criteria for discontinuation of NUC therapy 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's strategic focus includes prioritizing immunology and inflammation indications, with plans to seek partners for VTP-300 beyond the ongoing Phase 2b trial[7]. - Encouraging results from the Phase 2 trials of VTP-300 were presented at the EASL Congress 2025, supporting ongoing partnering efforts[5]. Shareholder Information - The weighted-average ordinary shares outstanding increased from 38,773,482 in Q1 2024 to 40,265,216 in Q1 2025, indicating a growth of approximately 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].

Financial Performance - For the year ended December 31, 2022, the company generated net income of $5.3 million, primarily from revenues related to AstraZeneca's sales of Vaxzevria and an agreement with OUI[287]. - The company incurred net losses of $61.2 million and $73.4 million for the years ending December 31, 2024 and 2023, respectively[287]. - As of December 31, 2024, the company had an accumulated deficit of $237.7 million[287]. - The company’s cumulative carryforward tax losses amounted to approximately $101.7 million as of December 31, 2024, up from $92.7 million as of December 31, 2023[419]. 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 may need to raise additional funding, which may not be available on acceptable terms, potentially affecting its ability to continue operations[302]. - The company may require substantial additional funding to support ongoing operations and product development, with potential financing sources including public or private equity offerings and debt financings[307]. - The company may need to pursue equity or debt financings to meet capital needs, which could lead to significant dilution for existing stockholders[310]. Research and Development - The company does not expect to generate significant revenue from current or future product candidates until successful completion of clinical development and marketing authorization[290]. - The company has not yet generated any material revenue from its current product candidates[290]. - The company anticipates substantial increases in expenses as it pursues clinical and preclinical development of product candidates and expands operational capabilities[287]. - The company anticipates that research and development expenses will increase significantly as it continues preclinical and clinical development activities[308]. Clinical Trials and Regulatory Risks - The company faces significant translational risk as product candidates advance through clinical stages, with promising preclinical results not guaranteed to replicate in human trials[291]. - The company faces risks related to the successful completion of clinical trials, which are lengthy and expensive, and may not yield predictable outcomes[320]. - The company may experience delays in obtaining regulatory approvals for clinical trials, which could impact the timelines for product development[322]. - The marketing authorization processes from regulatory authorities like the FDA and EMA are lengthy and unpredictable, potentially harming the business if approvals are not obtained[396]. Product Development and Market Risks - The company’s ability to generate product revenues is heavily dependent on the successful development and commercialization of its product candidates, which may take several years[318]. - The company acknowledges that the addressable patient population for its product candidates may be limited, potentially impacting profitability without additional marketing authorizations for first or second-line therapies[346]. - The commercial success of the company's product candidates will depend on public acceptance of immunotherapies and could be adversely affected by negative developments in the field[347]. - The company faces substantial competition from various sources, including major pharmaceuticals and biotechnology companies, which may hinder its ability to successfully market its product candidates[354]. Manufacturing and Supply Chain Risks - The company does not currently own any facility for clinical-scale manufacturing and must rely on third-party manufacturers, exposing it to risks related to quality and supply[387]. - The production process for product candidates is complex, requiring specific know-how from a limited number of contract manufacturing organizations (CMOs), which may lead to competition for scarce manufacturing capacities[391]. - The company may face delays in clinical trials or commercial distribution if any CMO fails to perform its obligations, as alternative supply sources may not be secured on reasonable terms[392]. Intellectual Property Risks - The company relies heavily on in-licensed patents and patent applications, with no issued patents for its product candidates, which could materially harm its competitive position[457]. - The company cannot assure that its product candidates do not infringe existing patents, which could lead to costly litigation[473]. - The competitive landscape for acquiring third-party intellectual property rights is challenging, with more established companies having greater resources[482]. - Litigation to protect intellectual property rights could be expensive and time-consuming, with no guarantee of success[483]. Compliance and Legal Risks - The company must comply with Good Clinical Practice (GCP) regulations, and failure to do so could result in unreliable clinical data and regulatory delays[381]. - The company is subject to the Foreign Corrupt Practices Act and similar laws, which could result in significant penalties if violated[433]. - Non-compliance with data protection laws could result in fines up to €20 million or 4% of annual global revenue, whichever is greater[451]. - The company will face ongoing regulatory obligations and potential penalties if it fails to comply with regulatory requirements for its product candidates[424].

Financial Performance - For the year ended December 31, 2024, total revenue was $15.0 million, a significant increase from $0.8 million in 2023, primarily due to royalties from Vaxzevria® sales[15] - The net loss for 2024 was $61.1 million, or $(1.55) per share, an improvement from a net loss of $73.3 million, or $(1.91) per share, in 2023[16] - Total revenue for Barinthus Biotherapeutics in 2024 was $14,969,000, a significant increase from $802,000 in 2023[20] - The net loss for 2024 was $61,183,000, compared to a net loss of $73,447,000 in 2023, reflecting an improvement in financial performance[20] Research and Development - Total research and development expenses decreased to $42.2 million in 2024 from $44.9 million in 2023, mainly due to reduced spending on VTP-200 and VTP-850 programs[15] - Research and development expenses decreased to $42,236,000 in 2024 from $44,874,000 in 2023, indicating a reduction in R&D spending[20] - The company reported 19% undetectable HBsAg levels in participants from two Phase 2 trials of VTP-300, indicating potential for functional cure in chronic hepatitis B[6] - The first data from the Phase 1 AVALON trial for VTP-1000 in celiac disease is expected in the third quarter of 2025[5] - The company completed enrollment of 22 participants in the Phase 1 PCA001 clinical trial for VTP-850 in prostate cancer in October 2024[8] - Barinthus Biotherapeutics anticipates ongoing clinical trials and product development activities, with a focus on regulatory filings and approvals[18] Financial Position - As of December 31, 2024, cash and cash equivalents totaled $112.4 million, down from $142.1 million at the end of 2023, with a net cash used in operating activities of $28.9 million[15] - Cash and cash equivalents decreased to $110,662,000 in 2024 from $142,090,000 in 2023, indicating a decline in liquidity[19] - Total assets decreased to $160,327,000 in 2024 from $214,506,000 in 2023, showing a reduction in overall asset base[19] - The total stockholders' equity attributable to Barinthus Biotherapeutics shareholders decreased to $130,029,000 in 2024 from $186,784,000 in 2023[19] Goodwill and Impairment - Goodwill impairment expense increased to $12.2 million in 2024, reflecting an impairment assessment based on expected asset utilization and market conditions[16] - The company reported a goodwill impairment of $12,209,000 in 2024, which was not present in 2023[20] Future Outlook - The company expects its available resources to fund operating expenses and capital expenditures into 2027[15] - The company has a cash runway that is subject to various risks, including global economic uncertainties and potential delays in clinical trial data[18] - Barinthus Bio's proprietary SNAP-TI platform is anticipated to drive multiple future pipeline and partnership opportunities, particularly in autoimmune diseases[5] - The weighted-average ordinary shares outstanding increased to 39,348,240 in 2024 from 38,386,491 in 2023, indicating a potential dilution of shares[20]

Financial Performance - The company reported a net loss of $73.4 million for the year ended December 31, 2023, and incurred a net loss of $8.1 million and $40.6 million for the three and nine months ended September 30, 2024, respectively[92][93]. - As of September 30, 2024, the company had an accumulated deficit of $217.1 million and does not expect positive cash flows from operations in the foreseeable future[92]. - The net loss for the three months ended September 30, 2024, was $8.13 million, a decrease of $5.98 million from a net loss of $14.11 million in the same period of 2023[129]. - The net loss for the nine months ended September 30, 2024, was $40.6 million, an improvement of $15.6 million compared to a net loss of $56.2 million in 2023[139]. - 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[153][161]. Revenue Generation - The company recognized $15.0 million in revenue in Q3 2024 from royalties related to prior sales of the Vaxzevria vaccine, with no expectation of future payments[105][109]. - For the three months ended September 30, 2024, the company reported license revenue of $14.97 million, compared to $0 in the same period of 2023, marking a significant increase[130]. - License revenue for the nine months ended September 30, 2024, was $15.0 million, a significant increase from $0.8 million in the same period of 2023[139]. Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $24.56 million, an increase of $8.45 million from $16.11 million in the same period of 2023[129]. - General and administrative expenses rose to $13.42 million for the three months ended September 30, 2024, an increase of $12.46 million compared to $961,000 in the same period of 2023[129]. - 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 costs[139]. Research and Development - The company is advancing two key product candidates: VTP-300 for chronic hepatitis B in Phase 2 and VTP-1000 for celiac disease in Phase 1[87][102]. - Enrollment was completed for the VTP-300 trial with 121 participants, aimed at obtaining dosing information for a potential functional cure for chronic hepatitis B[100]. - The company expects research and development expenses to increase in the future as it prepares for clinical trials and potential commercialization of product candidates[112]. - Total research and development expenses for the nine months ended September 30, 2024, were $33.9 million, a decrease of $4.6 million from $38.5 million in 2023[143]. Cash Flow and Financial Resources - As of September 30, 2024, the company had cash, cash equivalents, and restricted cash totaling $106.1 million, with an accumulated deficit of $217.1 million[151][160]. - The company expects to fund its operating expenses and capital requirements into the second quarter of 2026 based on current cash resources[97]. - The company anticipates that existing financial resources will fund operating expenses and capital expenditures into the second quarter of 2026[167]. - For the nine months ended September 30, 2024, net cash used in operating activities was $42.0 million, compared to $31.3 million for the same period in 2023[154][156]. Market and Geopolitical Factors - The company has no operations or suppliers in conflict-affected regions, minimizing the impact of geopolitical issues on its business[106]. - The company incurs significant operating costs in the U.K. and is exposed to a potential 10% weakening of the U.S. dollar against the pound sterling, which could materially affect current and projected expenses denominated in pounds[178]. Other Financial Metrics - Interest income increased to $631,000 for the three months ended September 30, 2024, compared to $196,000 in the same period of 2023, an increase of $435,000[129]. - Interest income for the nine months ended September 30, 2024, was $2.0 million, slightly down from $2.3 million in 2023[148]. - The effect of foreign exchange on cash, cash equivalents, and restricted cash resulted in a gain of $5.3 million for the nine months ended September 30, 2024[159].

Clinical Trials - Enrollment in the HBV003 trial of VTP-300 for chronic hepatitis B was completed with 121 adult participants[3] - Interim data from the HBV003 trial showed 76% of participants met criteria for nucleos(t)ide analogue therapy discontinuation, and 19% reached undetectable levels of HBsAg[4] - The first-in-human Phase 1 AVALON trial of VTP-1000 for celiac disease was initiated in September 2024[5] - The PCA001 trial of VTP-850 for prostate cancer completed enrollment with 22 participants, with data expected in the first half of 2025[6] - Upcoming milestones include updated data from VTP-300 at AASLD 2024 and results from VTP-1000 and VTP-850 trials in the first half of 2025[8][9] Financial Performance - Cash position as of September 30, 2024, was $106.1 million, down from $117.8 million as of June 30, 2024[12] - Revenue for Q3 2024 was $15.0 million, compared to nil in Q2 2024, attributed to royalties from prior sales of Vaxzevria®[12] - Total revenue for the three months ended September 30, 2024, was $14.969 million, compared to $0 for the same period in 2023, representing a significant increase[18] - License revenue from related parties for the three months ended September 30, 2024, was $15.0 million, compared to nil for the same period in 2023[18] Expenses - Research and development expenses for Q3 2024 were $11.1 million, a decrease from $11.7 million in Q2 2024[12] - 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 26.5% decrease[18] - General and administrative expenses increased to $13.4 million in Q3 2024, primarily due to a foreign exchange loss of $7.7 million[12] - General and administrative expenses increased to $13.420 million for the three months ended September 30, 2024, compared to $0.961 million in the same period of 2023[18] Net Loss and Income - Net loss 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[12] - The net loss attributable to Barinthus Biotherapeutics plc shareholders for the three months ended September 30, 2024, was $8.114 million, compared to a net loss of $14.072 million for the same period in 2023, showing a 42.5% improvement[18] - 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[18] Assets and Liabilities - Total assets decreased to $188.689 million as of September 30, 2024, from $214.506 million as of December 31, 2023, reflecting a decline of 12.1%[17] - Total current liabilities increased to $15.072 million as of September 30, 2024, compared to $12.598 million as of December 31, 2023, marking a 19.6% increase[17] - The accumulated deficit increased to $217.124 million as of September 30, 2024, from $176.590 million as of December 31, 2023[17] - The 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, a decline of 14.7%[17]

Financial Performance - For the year ended December 31, 2023, the company generated a net loss of $73.4 million, with accumulated deficits reaching $209.0 million as of June 30, 2024[87]. - License revenue for the three months ended June 30, 2024 was $0, a decrease of $334,000 compared to $334,000 in the same period of 2023[121]. - For the six months ended June 30, 2024, the company reported a net loss of $32.5 million, an improvement of $9.6 million compared to a net loss of $42.0 million for the same period in 2023[130]. - The company expects to continue incurring significant losses and negative cash flows from operations for the foreseeable future, with an accumulated deficit of $209.0 million as of June 30, 2024[150]. Research and Development - The company has prioritized two key product candidates: VTP-300 for chronic hepatitis B in Phase 2 and VTP-1000 for celiac disease in preclinical stage[82]. - Interim data from the Phase 2b trial of VTP-300 showed nearly 20% of participants had undetectable HBsAg, with 76% eligible for NUC discontinuation[96]. - Research and development expenses are expected to increase as the company advances its product candidates through clinical development[105]. - The company has partnerships to advance three additional product candidates, including VTP-500 for MERS and VTP-400 for Zoster[84]. - Research and development expenses totaled $11.7 million for the three months ended June 30, 2024, compared to $13.5 million in 2023, reflecting a decrease of $1.9 million[122]. - Direct research and development expenses decreased to $6.4 million in Q2 2024 from $9.6 million in Q2 2023, a decline of $3.2 million[123]. - Research and development expenses for the six months ended June 30, 2024, were $22.8 million, slightly down from $23.4 million in 2023, a decrease of $0.6 million[131]. - Direct research and development expenses decreased to $12.3 million for the six months ended June 30, 2024, from $15.4 million in 2023, a reduction of $3.1 million[132]. - Indirect research and development expenses increased to $10.5 million for the six months ended June 30, 2024, compared to $7.9 million in 2023, an increase of $2.6 million[133]. Operating Expenses - Total operating expenses decreased to $18.9 million for the three months ended June 30, 2024, down from $26.7 million in 2023, a reduction of $7.8 million[121]. - Total operating expenses decreased to $36.0 million for the six months ended June 30, 2024, down from $48.6 million in 2023, reflecting a reduction of $12.6 million[130]. - General and administrative expenses were $7.2 million for the three months ended June 30, 2024, down from $13.1 million in 2023, a decrease of $5.9 million[125]. - General and administrative expenses significantly decreased to $13.2 million for the six months ended June 30, 2024, from $25.3 million in 2023, a reduction of $12.1 million[134]. Cash and Funding - As of June 30, 2024, the company had cash, cash equivalents, and restricted cash totaling $117.8 million[139]. - The company expects to fund its operating expenses and capital expenditure requirements into Q2 2026 with existing cash and equivalents of $117.8 million as of June 30, 2024[155][167]. - The company anticipates that existing cash resources will fund operations into the second quarter of 2026, based on current assumptions[89]. - Future capital requirements may significantly change based on the outcomes of product candidate developments, necessitating additional funds through equity offerings, debt financing, or collaborations[154]. Contingent Liabilities and Risks - The company recognized a contingent consideration liability related to the acquisition of Avidea, with potential additional payments of up to $40.0 million upon achieving certain milestones[120]. - The company faces potential contingent payment obligations upon achieving clinical, regulatory, and commercial milestones, though amounts and timing are uncertain as of June 30, 2024[160]. - A 10% weakening of the US dollar against the pound sterling could materially affect current and projected expenses denominated in pounds[166]. - The company is exposed to foreign currency exchange rate fluctuations, particularly with the euro, pound sterling, Swiss franc, and Australian dollar[164]. Strategic Plans - The company plans to pursue clinical and preclinical development of current product candidates and advance additional candidates into development[153]. - The company aims to establish manufacturing capabilities and scale-up production to support clinical trials and commercialization efforts[153]. - The company may need to relinquish rights to technologies or revenue streams if additional funds are raised through collaborations or licensing arrangements[156]. Accounting and Compliance - The company is classified as an emerging growth company, allowing it to delay the adoption of certain accounting standards[161][162]. - From April 2023, the SME cash rebate was reduced from an effective rate of 33.4% to 18.6%, impacting future claims for research and development tax credits[113]. Other Income - Other operating income was $0.6 million for the three months ended June 30, 2024, compared to nil in the same period of 2023, resulting from funding provided by CEPI[126]. - The company reported other operating income of $0.8 million for the six months ended June 30, 2024, compared to nil in 2023, due to funding from CEPI[135]. Interest Income - Interest income increased to $0.6 million for the three months ended June 30, 2024, compared to $0.5 million in 2023, an increase of $0.1 million[127].

Financial Performance - For the year ended December 31, 2023, the company generated a net loss of $73.4 million, following a net income of $5.3 million for the year ended December 31, 2022[84]. - For the three months ended March 31, 2024, total revenue was $0, a decrease of $468,000 compared to $468,000 in the same period of 2023[123]. - The net loss for the three months ended March 31, 2024, was $15.52 million, an improvement of $2.70 million compared to a net loss of $18.22 million in the same period of 2023[123]. - Interest income for the three months ended March 31, 2024, was $775,000, a decrease of $813,000 from $1.59 million in the same period of 2023[123]. - Other operating income for Q1 2024 was $0.2 million, attributed to funding from CEPI, while there was no such income in Q1 2023[130]. - Interest income decreased to $0.8 million in Q1 2024 from $1.6 million in Q1 2023, reflecting lower interest earned on short-term cash deposits[131]. - Research and development incentives fell to $0.6 million in Q1 2024 from $1.2 million in Q1 2023, related to UK corporation tax relief[132]. Cash Flow and Financial Position - As of March 31, 2024, the company had an accumulated deficit of $192.1 million and does not expect positive cash flows from operations in the foreseeable future[84]. - Net cash used in operating activities was $11.8 million in Q1 2024, compared to $3.2 million in Q1 2023, primarily due to a net loss of $15.5 million[138][139]. - As of March 31, 2024, the company had cash, cash equivalents, and restricted cash totaling $130.0 million, with gross proceeds from share issuances amounting to approximately $328.4 million since inception[134]. - The accumulated deficit reached $192.1 million as of March 31, 2024, with expectations of continued significant losses and negative cash flows for the foreseeable future[145]. - The company expects existing financial resources to fund operations into Q4 2025, although this is subject to change based on actual cash usage[150]. Research and Development - The Phase 1b/2 APOLLO trial of VTP-200 showed a highest hrHPV clearance rate of 60% at Month 12 in the highest dose group, compared to 33% in the placebo group[93]. - The highest cervical lesion clearance rate of 67% was observed in the highest dose group of the APOLLO trial, compared to 39% in the placebo group[94]. - The company received IND clearance from the FDA for VTP-1000 to progress to a first-in-human clinical trial in Celiac disease[90]. - Research and development expenses are expected to increase in the future as the company continues to advance its clinical programs[104]. - Direct research and development expenses totaled $5.84 million for the three months ended March 31, 2024, slightly up from $5.80 million in the same period of 2023[125]. - Indirect research and development expenses increased to $5.29 million for the three months ended March 31, 2024, compared to $4.02 million in the same period of 2023, an increase of $1.27 million[128]. Operating Expenses - Research and development expenses increased to $11.1 million for the three months ended March 31, 2024, up from $9.8 million in the same period of 2023, representing a $1.3 million increase[126]. - General and administrative expenses decreased to $5.99 million for the three months ended March 31, 2024, down from $12.14 million in the same period of 2023, a reduction of $6.14 million[123]. - The company expects general and administrative expenses to continue to rise as it expands operations in the UK and US and prepares for manufacturing and commercialization of product candidates[107]. - General and administrative expenses decreased to $6.0 million for Q1 2024 from $12.1 million in Q1 2023, primarily due to a foreign exchange gain of $1.2 million compared to a loss of $3.5 million in the prior year[129]. - The company reported total operating expenses of $17.12 million for the three months ended March 31, 2024, down from $21.95 million in the same period of 2023, a decrease of $4.83 million[123]. Financing and Future Outlook - The company anticipates financing future cash needs through public or private equity offerings, debt financings, collaborations, and licensing arrangements[86]. - Future capital requirements will depend on various factors, including the success of product candidates and the ability to generate revenue, with potential needs for additional financing[149]. - The company is classified as an emerging growth company, allowing it to delay the adoption of certain accounting standards[155]. Geopolitical and Market Risks - The company has no operations or suppliers based in Israel, Gaza, Ukraine, Belarus, or Russia, minimizing the impact of geopolitical conflicts on its business[98][99]. - The company is subject to foreign currency exchange rate fluctuations, particularly with the euro, pound sterling, Swiss franc, and Australian dollar[158]. - A hypothetical 10% weakening of the US dollar against the pound sterling would have resulted in an immaterial change to expenses for the three months ended March 31, 2024[160]. - The company does not currently face significant market risk related to interest rate changes, as it has no significant interest-bearing liabilities[161]. - A hypothetical 10% relative change in interest rates would not have materially impacted the company's financial statements[162].