Eupraxia Pharmaceuticals Inc(EPRX)

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Eupraxia Pharmaceuticals to Host Virtual KOL Event to Discuss the Phase 1b/2a RESOLVE Study of EP-104GI for the Treatment of Eosinophilic Esophagitis (EoE) on May 9, 2025
Globenewswire· 2025-05-07 18:00
Core Viewpoint - Eupraxia Pharmaceuticals is hosting a virtual key opinion leader event to discuss clinical data from its Phase 1b/2a RESOLVE Study for EP-104GI, aimed at treating eosinophilic esophagitis (EoE) [1][2][3] Company Overview - Eupraxia Pharmaceuticals is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products to address high unmet medical needs [7] - The company utilizes its proprietary DiffuSphere™ technology for optimized drug delivery, which aims to enhance safety, tolerability, efficacy, and duration of effect [7][8] Clinical Study Details - The RESOLVE trial is a Phase 1b/2a, multicenter, open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with active EoE [5] - EP-104GI is administered via esophageal wall injections, with patients evaluated for up to 52 weeks depending on the cohort [5] - Additional long-term data is expected to be released in Q3 2025 [5] Eosinophilic Esophagitis (EoE) Insights - EoE is an inflammatory disease affecting over 450,000 people in the U.S., characterized by white blood cells accumulating in the esophagus, leading to pain and swallowing difficulties [6] - The condition is rapidly increasing in incidence and prevalence, contributing to significant healthcare burdens and mental health issues for affected individuals [6] Expert Involvement - Dr. Evan Dellon, a leading expert in EoE, will participate in the KOL event to discuss the unmet needs and treatment landscape for EoE, alongside Eupraxia's CEO [2][3][4]
Eupraxia Pharmaceuticals Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-06 22:00
Core Insights - Eupraxia Pharmaceuticals has reported significant clinical milestones for its EP-104GI treatment for Eosinophilic Esophagitis (EoE), showing promising nine-month data from the Phase 1b/2a RESOLVE trial [2][8] - The company has a cash runway projected to fund operations until the third quarter of 2026, with current cash reserves of $27.5 million [5][6] Clinical Development - The RESOLVE trial indicates that a single treatment with a 48mg dose of EP-104GI leads to sustained or improved treatment outcomes over nine months, supporting its potential as a transformative therapy for EoE [2][8] - The company plans to advance into higher-dose cohorts in the upcoming quarters based on the positive results observed [2] Financial Performance - For Q1 2025, the company reported a net loss of $6.8 million, an increase from a net loss of $6.2 million in Q1 2024, primarily due to changes in research and development costs and general administrative expenses [4] - Cash reserves decreased from $33.1 million at the end of Q4 2024 to $27.5 million as of March 31, 2025, with funds allocated for clinical trials and general corporate purposes [5] Management and Operations - Alex Rothwell has been appointed as the new Chief Financial Officer, succeeding Bruce Cousins [8] - The company continues to monitor the impact of potential tariffs on its operations, particularly in light of recent trade announcements between the U.S. and Canada [7][10] Technology and Product Pipeline - Eupraxia's proprietary DiffuSphere™ technology is designed to optimize drug delivery, potentially improving the safety and efficacy of existing and novel drugs [12] - The company is also developing a pipeline of long-acting formulations targeting various therapeutic areas, including inflammatory joint conditions and oncology [13]
Eupraxia Pharmaceuticals Inc(EPRX) - 2025 Q1 - Quarterly Report
2025-05-06 20:59
[Consolidated Balance Sheets](index=3&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) The Company's total assets decreased by approximately $5.7 million from December 31, 2024, to March 31, 2025, primarily driven by a reduction in cash. Total liabilities also decreased by about $0.9 million, while total shareholders' equity saw a decrease of approximately $4.8 million | Metric | March 31, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------- | :---------------- | :----- | | **ASSETS** | | | | | Cash | $27,454,598 | $33,101,294 | $(5,646,696) | | Total current assets | $28,606,412 | $34,436,678 | $(5,830,266) | | Property and equipment, net | $497,282 | $357,893 | $139,389 | | Total assets | $29,233,179 | $34,942,355 | $(5,709,176) | | **LIABILITIES** | | | | | Accounts payable and accrued liabilities | $2,147,217 | $3,031,527 | $(884,310) | | Total liabilities | $2,199,991 | $3,103,386 | $(903,395) | | **SHAREHOLDERS' EQUITY** | | | | | Total shareholders' equity | $27,033,188 | $31,838,969 | $(4,805,781) | [Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) For the three months ended March 31, 2025, the Company reported a net loss of $6,767,275, an increase from the $6,156,933 net loss in the prior year period. Total expenses rose, while other income decreased significantly, contributing to the higher loss. Loss per share remained constant at $(0.21) | Metric | Three months ended March 31, 2025 | Three months ended March 31, 2024 | Change (YoY) | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | General and administrative expenses | $3,274,394 | $2,518,023 | +$756,371 | | Research and development expenses | $3,849,826 | $4,175,453 | -$325,627 | | Total expenses | $7,124,220 | $6,693,476 | +$430,744 | | Total other income/(loss) | $359,739 | $541,543 | -$181,804 | | Net loss for the period | $(6,767,275) | $(6,156,933) | -$(610,342) | | Comprehensive loss for the period | $(6,729,111) | $(6,189,325) | -$(539,786) | | Loss per share – basic and diluted | $(0.21) | $(0.21) | $0.00 | [Consolidated Statements of Changes in Shareholders' Equity](index=5&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20CHANGES%20IN%20SHAREHOLDERS'%20EQUITY) The Company's total shareholders' equity decreased from $31,838,969 at December 31, 2024, to $27,033,188 at March 31, 2025. This decline was primarily due to the net loss for the period, partially offset by share-based payments and redemptions of warrants and options | Item | December 31, 2024 | March 31, 2025 | Change | | :-------------------------------- | :---------------- | :------------- | :----- | | Preferred shares Amount | $31,705,219 | $31,705,219 | $0 | | Common shares Amount | $116,360,066 | $116,840,288 | +$480,222 | | Additional paid-in capital | $20,503,904 | $21,947,012 | +$1,443,108 | | Deficit | $(131,003,831) | $(137,766,439) | -$(6,762,608) | | Accumulated other comprehensive loss | $(4,160,555) | $(4,122,391) | +$38,164 | | Non-controlling interest | $(1,565,834) | $(1,570,501) | -$(4,667) | | Total Shareholders' Equity | $31,838,969 | $27,033,188 | -$(4,805,781) | [Consolidated Statements of Cash Flows](index=7&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) For the three months ended March 31, 2025, cash used in operating activities was $6,003,071, while investing activities used $169,044. Financing activities provided $429,923, resulting in a net decrease in cash of $5,742,192. This contrasts with the prior year period where financing activities provided significant cash, leading to a net increase in cash | Cash Flow Activity | Three Months ended March 31, 2025 | Three Months ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Cash used in operating activities | $(6,003,071) | $(6,136,726) | | Cash used in investing activities | $(169,044) | $(6,789) | | Cash provided by financing activities | $429,923 | $23,170,042 | | Increase (decrease) in cash | $(5,742,192) | $17,026,527 | | Cash, beginning of period | $33,101,294 | $19,341,756 | | Cash, end of period | $27,454,598 | $35,907,527 | [Notes to the Consolidated Financial Statements](index=8&type=section&id=NOTES%20TO%20THE%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) This section details the Company's business nature, accounting policies, financial instrument risks, and specific financial statement line items, including share capital and commitments [1. Nature of Business and Going Concern](index=8&type=section&id=1.%20NATURE%20OF%20BUSINESS%20AND%20GOING%20CONCERN) Eupraxia Pharmaceuticals Inc. is a clinical-stage biotechnology company utilizing its proprietary Diffusphere™ technology for drug delivery. The Company has not yet generated revenue and incurred a net loss of $6.77 million for Q1 2025, with an accumulated deficit of $137.77 million, raising substantial doubt about its ability to continue as a going concern without additional funding - Eupraxia Pharmaceuticals Inc. is a clinical stage biotechnology company focused on optimizing drug delivery using its proprietary Diffusphere™ technology[16](index=16&type=chunk) - The Company has not yet generated revenue from operations and incurred a net loss of **$6,767,275** for the three months ended March 31, 2025, leading to an accumulated deficit of **$137,766,439**[17](index=17&type=chunk) - The Company's continued operations are dependent on its ability to generate future cash flows or obtain additional funding, which casts substantial doubt on its ability to continue as a going concern[19](index=19&type=chunk) [2. Basis of Presentation](index=9&type=section&id=2.%20BASIS%20OF%20PRESENTATION) These unaudited interim consolidated financial statements are presented in U.S. dollars, prepared in accordance with U.S. GAAP and SEC rules for interim financial information, and include normal recurring adjustments. They should be read in conjunction with the audited 2024 annual financial statements - Financial statements are presented in U.S. dollars and prepared in accordance with U.S. GAAP and SEC rules for interim financial information[21](index=21&type=chunk)[22](index=22&type=chunk) - These statements include normal recurring adjustments and should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2024[22](index=22&type=chunk)[23](index=23&type=chunk) [3. Summary of Significant Accounting Policies](index=9&type=section&id=3.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) The financial statements are prepared on a historical cost basis in U.S. dollars, with the Canadian dollar as the functional currency. Management makes estimates for accruals, stock-based compensation, and deferred taxes. The Company adopted ASU 2023-09 in 2025 for income tax disclosures - Financial statements are prepared on a historical cost basis, presented in U.S. dollars (reporting currency), with the Canadian dollar as the functional currency[24](index=24&type=chunk) - Management makes estimates for accruals of expenses, stock-based compensation, and valuation allowance for deferred taxes[25](index=25&type=chunk) - The Company adopted ASU 2023-09, "Income Taxes (Topic 740): Improvements to Income Tax Disclosures," in 2025[27](index=27&type=chunk) [4. Amounts Receivable](index=10&type=section&id=4.%20AMOUNTS%20RECEIVABLE) Amounts receivable increased slightly to $238,531 as of March 31, 2025, primarily consisting of GST/HST recoverable and other refundable tax credits, which are R&D incentives for Eupraxia Australia | Category | March 31, 2025 | December 31, 2024 | | :------------------------ | :------------- | :---------------- | | GST/HST recoverable | $90,700 | $82,097 | | Other refundable tax credits | $147,831 | $146,775 | | Total | $238,531 | $228,872 | - Other refundable tax credits represent tax incentives for R&D costs incurred by Eupraxia Australia[30](index=30&type=chunk) [5. Property and Equipment](index=10&type=section&id=5.%20PROPERTY%20AND%20EQUIPMENT) The net book value of property and equipment increased to $497,282 as of March 31, 2025, from $357,893 at December 31, 2024, driven by additions, particularly in lab equipment. Depreciation expense for Q1 2025 was $28,619, with the majority allocated to research and development | Metric | March 31, 2025 | December 31, 2024 | | :---------------- | :------------- | :---------------- | | Net Book Value | $497,282 | $357,893 | - Depreciation expense for the three months ended March 31, 2025, was **$28,619**, with **$26,815** included in research and development[32](index=32&type=chunk) [6. Right-of-Use Asset](index=11&type=section&id=6.%20RIGHT-OF-USE%20ASSET) The right-of-use asset decreased to $49,255 as of March 31, 2025, from $67,023 at December 31, 2024, primarily due to depreciation. The Company extended its office space lease until November 30, 2025, which had increased the asset by $78,580 in 2024 | Metric | March 31, 2025 | December 31, 2024 | | :---------------- | :------------- | :---------------- | | Balance, ending | $49,255 | $67,023 | - The Company extended its office space lease until November 30, 2025, which increased the right-of-use asset by **$78,580** in 2024[33](index=33&type=chunk) - Depreciation expense for the three months ended March 31, 2025, was **$17,868**, with **$11,173** included in research and development[33](index=33&type=chunk) [7. Accounts Payable and Accrued Liabilities](index=11&type=section&id=7.%20ACCOUNTS%20PAYABLE%20AND%20ACCRUED%20LIABILITIES) Total accounts payable and accrued liabilities decreased to $2,147,217 as of March 31, 2025, from $3,031,527 at December 31, 2024. This reduction was mainly due to the absence of employee bonus payable in Q1 2025, while research and development payables significantly increased | Category | March 31, 2025 | December 31, 2024 | | :-------------------------- | :------------- | :---------------- | | Research and development | $1,264,405 | $573,465 | | General and administrative | $837,602 | $943,376 | | Employee bonus payable | — | $1,493,981 | | Total | $2,147,217 | $3,031,527 | [8. Loans Payable](index=11&type=section&id=8.%20LOANS%20PAYABLE) The Company's loan agreement, initially for $235,000 to purchase equipment, was fully repaid on September 19, 2024. As a result, the balance of loans payable was $0 as of March 31, 2025, and December 31, 2024 - The loan agreement, entered into on September 10, 2021, for **$235,000** to purchase equipment, was fully repaid on September 19, 2024[35](index=35&type=chunk)[36](index=36&type=chunk) | Metric | March 31, 2025 | December 31, 2024 | | :------------- | :------------- | :---------------- | | Balance, ending | $— | $— | [9. Lease Liability](index=12&type=section&id=9.%20LEASE%20LIABILITY) The Company's lease liability for its Victoria, BC facility was $52,774 as of March 31, 2025, with a weighted average remaining lease term of 0.67 years. An extension agreement was signed in May 2024, extending the lease until November 30, 2025. Lease payments for Q1 2025 were $20,368, and the Company subleased office space, reducing general and administrative expenses by $6,833 - The Company extended its operating lease for the Victoria, BC facility until November 30, 2025[38](index=38&type=chunk) | Metric | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Lease liability – current portion | $52,774 | $71,859 | | Weighted average remaining lease term (years) | 0.67 | 0.92 | | Weighted average discount rate | 9.02% | 9.02% | - Sublease income of **$6,833** for Q1 2025 was recorded as a reduction to general and administrative expenses[41](index=41&type=chunk) [10. Auritec License Agreement](index=13&type=section&id=10.%20AURITEC%20LICENSE%20AGREEMENT) Eupraxia LLC holds an exclusive license from Auritec Pharmaceuticals Inc. for the use of its "Plexis Platform" for fluticasone delivery in specific medical fields. The agreement includes an upfront fee, potential milestone payments up to $25 million, a 4% royalty on net sales, and a percentage of non-royalty monetization revenue ranging from 10% to 30% based on development stage - Eupraxia LLC has an exclusive license from Auritec Pharmaceuticals Inc. for the "Plexis Platform" technology for fluticasone delivery in all medical fields except otolaryngology and eye-related conditions[43](index=43&type=chunk) - The agreement includes an upfront fee of **$5,000,000**, potential milestone payments up to **$25,000,000**, and a **4%** royalty on net sales of Licensed Products[44](index=44&type=chunk)[46](index=46&type=chunk) - Eupraxia LLC also agreed to pay Auritec a percentage of Non-Royalty Monetization Revenue, ranging from **10% to 30%** depending on the development stage of the most-advanced Licensed Product, up to a maximum of **$100,000,000**[47](index=47&type=chunk) [11. Convertible Debt](index=14&type=section&id=11.%20CONVERTIBLE%20DEBT) The Company's convertible debt with Silicon Valley Bank, initially CDN$10 million, matured and was fully repaid by September 2024, resulting in a zero balance as of December 31, 2024. A new CDN$12 million convertible debt facility with Yabema Capital Limited, entered into in August 2024, was subsequently terminated and all security interests discharged on October 31, 2024, following a convertible preferred share offering - The contingent convertible debt agreement with Silicon Valley Bank (SVB) matured on June 21, 2024, and the remaining balance was fully repaid by September 11, 2024[50](index=50&type=chunk) - A new **CDN$12 million** convertible debt facility with Yabema Capital Limited, entered into on August 1, 2024, was terminated on October 31, 2024, following a convertible preferred share offering[51](index=51&type=chunk)[53](index=53&type=chunk) [12. Share Capital and Other Components of Equity](index=16&type=section&id=12.%20SHARE%20CAPITAL%20AND%20OTHER%20COMPONENTS%20OF%20EQUITY) The Company's share capital includes unlimited authorized common and preferred shares. During Q1 2025, common shares were issued from warrant and option exercises. Convertible preferred shares, issued in October 2024, are classified as permanent equity with specific conversion and potential dividend terms. The Company also has an Amended Stock Option Plan and outstanding warrants, and Class B non-voting shares exchangeable into common shares. The calculation of loss per share for Q1 2025 includes an implied dividend on preferred shares [12(a) Authorized Shares](index=16&type=section&id=12(a)%20Authorized) - The Company has an unlimited number of authorized Common shares and Preferred shares, both without par value[55](index=55&type=chunk) [12(b) Issued Common Shares](index=16&type=section&id=12(b)%20Issued%20(Common%20Shares)) | Event (Three months ended March 31, 2025) | Common Shares Issued | Gross Proceeds | | :---------------------------------------- | :------------------- | :------------- | | Exercise of warrants | 200,000 | $416,406 | | Exercise of options | 7,750 | $13,517 | [12(b) Issued Preferred Shares](index=17&type=section&id=12(b)%20Issued%20(Preferred%20Shares)) - On October 31, 2024, the Company issued **8,905,638** convertible preferred shares in a non-brokered private placement for aggregate gross proceeds of **$31,997,837**[56](index=56&type=chunk) - Each Preferred Share is convertible into one common share at the holder's option and mandatorily convertible upon certain conditions (e.g., common shares trading at **CDN$15.00** or **75%** holder consent)[57](index=57&type=chunk)[58](index=58&type=chunk) - Preferred Shares are classified as permanent equity due to the Company's control over redemption features and will not initially be entitled to dividends, but may receive quarterly dividends (**1.5% PIK** or **2% cash**) after the third anniversary, subject to shareholder approval[59](index=59&type=chunk)[60](index=60&type=chunk) [12(d) Options](index=18&type=section&id=12(d)%20Options) - The Amended Stock Option Plan allows for grants up to **18.5%** of outstanding common shares, with vesting typically over three years (**25%** on grant, remainder annually)[62](index=62&type=chunk)[63](index=63&type=chunk) | Metric | December 31, 2024 | March 31, 2025 | | :-------------------------------- | :---------------- | :------------- | | Options Outstanding | 5,307,870 | 5,572,120 | | Weighted average exercise price (CDN$) | $5.50 | $5.15 | - Share-based compensation expense for Q1 2025 was **$1,493,407**, significantly higher than **$213,130** in Q1 2024. Unrecognized stock-based compensation expense as of March 31, 2025, was **$2,399,667**, to be recognized over **2.55 years**[65](index=65&type=chunk)[66](index=66&type=chunk) [12(e) Warrants](index=20&type=section&id=12(e)%20Warrants) | Metric | December 31, 2024 | March 31, 2025 | | :-------------------------------- | :---------------- | :------------- | | Warrants Outstanding | 8,807,977 | 8,607,977 | | Weighted average exercise price (CDN$) | $5.48 | $5.53 | - As of March 31, 2025, the Company had **8,607,977** warrants outstanding and exercisable, with various exercise prices and expiry dates, including a significant portion expiring in April 2026[67](index=67&type=chunk) [12(f) Class B Non-Voting Shares](index=21&type=section&id=12(f)%20Class%20B%20Non-Voting%20shares) - The Company issued **225** non-voting Class B shares in Eupraxia Pharma Inc. to the Chief Scientific Officer, representing **5%** equity interest in Eupraxia USA[69](index=69&type=chunk) - Each Class B Share is exchangeable into **2,500** common shares of the Company, with potential for forced exchange by the Company under certain conditions (e.g., after January 31, 2031, or earlier if listed and reporting issuer)[70](index=70&type=chunk) [12(g) Earnings (Loss) per Share](index=21&type=section&id=12(g)%20Earnings%20(loss)%20per%20Share) - Due to the classification of Preferred Shares as increasing rate preferred stock, an implied dividend of **$620,515** was included in the Q1 2025 loss per share calculation, increasing the adjusted loss attributable to owners of the Company to **$(7,383,123)**[71](index=71&type=chunk) | Metric | Three Months ended March 31, 2025 | Three Months ended March 31, 2024 | | :---------------------------------------- | :-------------------------------- | :-------------------------------- | | Loss attributable to the Owners of the Company | $(6,762,608) | $(6,043,038) | | Less: implied dividend on Preferred Shares | $620,515 | — | | Adjusted Loss attributable to the Owners of the Company | $(7,383,123) | $(6,043,038) | | Loss per Share - Basic and Diluted | $(0.21) | $(0.21) | [13. General and Administrative Expenses](index=22&type=section&id=13.%20GENERAL%20AND%20ADMINISTRATIVE%20EXPENSES) General and administrative expenses increased to $3,274,394 for Q1 2025 from $2,518,023 in Q1 2024. This rise was primarily driven by a significant increase in share-based payments and higher office expenses and insurance, partially offset by lower professional fees and travel | Category | Three Months ended March 31, 2025 | Three Months ended March 31, 2024 | Change (YoY) | | :------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | Office expenses | $240,116 | $111,309 | +$128,807 | | Insurance | $261,223 | $101,433 | +$159,790 | | Professional fees | $447,450 | $1,101,798 | -$654,348 | | Salaries and benefits | $709,931 | $521,876 | +$188,055 | | Share based payments | $1,127,033 | $154,627 | +$972,406 | | Total expenses | $3,274,394 | $2,518,023 | +$756,371 | [14. Research and Development Expenses](index=22&type=section&id=14.%20RESEARCH%20AND%20DEVELOPMENT%20EXPENSES) Research and development expenses decreased to $3,849,826 for Q1 2025 from $4,175,453 in Q1 2024. This reduction was mainly due to lower clinical, manufacturing & analytical, and regulatory costs, despite increases in preclinical, pipeline development, and share-based payments | Category | Three Months ended March 31, 2025 | Three Months ended March 31, 2024 | Change (YoY) | | :-------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Preclinical | $231,277 | $261,636 | -$30,359 | | Clinical | $704,085 | $1,032,960 | -$328,875 | | Manufacturing & analytical | $1,312,645 | $1,746,744 | -$434,099 | | Regulatory | $2,182 | $34,984 | -$32,802 | | Direct research and development | $2,250,189 | $3,076,324 | -$826,135 | | Pipeline development | $932 | — | +$932 | | Salaries and benefits | $949,276 | $867,680 | +$81,596 | | Share based payments | $366,374 | $58,503 | +$307,871 | | Total expenses | $3,849,826 | $4,175,453 | -$325,627 | [15. Commitments and Contingencies](index=23&type=section&id=15.%20COMMITMENTS%20AND%20CONTINGENCIES) The Company has potential future obligations including milestone, royalty, and R&D funding payments under license agreements, which are not accrued due to uncertainty. It also has service contracts with cancellation clauses and customary indemnification provisions, for which no liabilities have been recognized - The Company may be required to make milestone, royalty, and R&D funding payments under agreements with third parties (e.g., Auritec License Agreement), which are contingent and not accrued due to uncertainty[78](index=78&type=chunk) - Service contracts with vendors may include cancellation fees (**15% to 100%** of next milestone), but no such fees have been triggered as of March 31, 2025[78](index=78&type=chunk) - The Company has indemnification provisions in service agreements, but historically has not made payments and believes the fair value of these obligations is minimal[75](index=75&type=chunk)[78](index=78&type=chunk) [16. Segmented Information](index=23&type=section&id=16.%20SEGMENTED%20INFORMATION) The Company operates as a single reportable segment, with the CEO acting as the Chief Operating Decision Maker (CODM). Performance is assessed through preclinical and clinical research goals and net loss, with resources allocated on a total company basis. The majority of assets are located in Canada - The Company operates as a single reportable segment, with the Chief Executive Officer (CEO) as the Chief Operating Decision Maker (CODM)[76](index=76&type=chunk) - The CODM assesses performance through the achievement of pre-clinical and clinical research goals and monitors net loss and cash flows[77](index=77&type=chunk)[78](index=78&type=chunk) - A majority of the Company's assets are located in Canada[78](index=78&type=chunk) | Segment Expense Category | Three Months ended March 31, 2025 | Three Months ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Direct external research and development costs | | | | EP-104IAR | $9,764 | $2,075,762 | | EP-104GI | $1,982,822 | $738,926 | | Pre-clinical | $258,536 | $261,636 | | Salaries and benefits | $1,659,207 | $1,389,556 | | Share based payments | $1,493,407 | $213,130 | | Other Research and Development expenses | $283,054 | $172,946 | | Other General and Administrative expenses | $1,437,430 | $1,841,520 | | Total segment expenses | $7,124,220 | $6,693,476 | [17. Financial Instruments](index=24&type=section&id=17.%20FINANCIAL%20INSTRUMENTS) The Company's financial instruments include cash, amounts receivable, and accounts payable. It faces credit risk (minimal due to cash held with a large Canadian bank), liquidity risk (managing cash to meet liabilities, actively seeking additional funding), and market risk (interest rate, currency, and other price risk). The carrying values of financial instruments approximate their fair values due to short-term maturities [Credit Risk](index=24&type=section&id=Credit%20risk) - The Company believes it has no significant credit risk, as its primary exposure (cash and cash equivalents) is held with a large Canadian bank[80](index=80&type=chunk) [Liquidity Risk](index=24&type=section&id=Liquidity%20risk) - As of March 31, 2025, the Company had cash of **$27,454,598** and current liabilities of **$2,199,991**[81](index=81&type=chunk) - Management is actively pursuing strategic alternatives, including raising additional capital, but there is no assurance that future funding will be available on a timely or acceptable basis[81](index=81&type=chunk)[82](index=82&type=chunk) [Market Risk](index=25&type=section&id=Market%20risk) - Market risk encompasses interest rate risk, currency risk, and other price risk[83](index=83&type=chunk) [Interest Rate Risk](index=25&type=section&id=Interest%20rate%20risk) - The Company is exposed to interest rate cash flow risk and interest rate price risk due to potential fluctuations in market interest rates affecting its monetary assets and liabilities[84](index=84&type=chunk) [Currency Risk](index=25&type=section&id=Currency%20risk) - The Company is exposed to currency risk due to frequent transactions in US dollars and Australian dollars, but does not use derivatives to hedge this risk[85](index=85&type=chunk)[86](index=86&type=chunk) - A **10%** change in exchange rates would impact profit or loss by approximately **$1,574,241** for US dollar denominated assets/liabilities and **$32,736** for Australian dollar denominated assets/liabilities as of March 31, 2025[86](index=86&type=chunk) [Other Price Risk](index=25&type=section&id=Other%20price%20risk) - The Company is not exposed to significant price risk related to commodity or equity prices[87](index=87&type=chunk) [Fair Value Measurement](index=26&type=section&id=Fair%20Value%20Measurement) - Financial instruments are categorized into Level 1, 2, or 3 based on observable inputs, and their carrying values approximate fair values due to short-term maturities[88](index=88&type=chunk) | Financial Instrument | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Cash | $27,454,598 | $33,101,294 | | Amounts receivable | $238,531 | $228,872 | | Accounts payable and accrued liabilities | $2,199,991 | $3,031,527 | [18. Interest Expense](index=26&type=section&id=18.%20INTEREST%20EXPENSE) The Company reported no interest expense for the three months ended March 31, 2025, compared to $321,140 in the prior year period. This change is primarily due to the full repayment of the SVB debt facility in 2024 | Category | Three Months ended March 31, 2025 | Three Months ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Interest on SVB debt facility | $— | $320,318 | | Total Interest Expense | $— | $321,140 | - The absence of interest expense in Q1 2025 is due to the full repayment of the SVB debt facility in 2024[90](index=90&type=chunk) [19. Supplemental Disclosure with Respect to Cash Flows](index=27&type=section&id=19.%20SUPPLEMENTAL%20DISCLOSURE%20WITH%20RESPECT%20TO%20CASH%20FLOWS) For the three months ended March 31, 2025, the Company paid no interest, a decrease from $162,195 in the prior year, and received $308,188 in interest, an increase from $236,369. There were no non-cash transactions in either period | Metric | Three Months ended March 31, 2025 | Three Months ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Interest paid | $nil | $162,195 | | Interest received | $308,188 | $236,369 | - The Company had no non-cash transactions for the three months ended March 31, 2025, and March 31, 2024[91](index=91&type=chunk)
Eupraxia Pharmaceuticals Announces Sustained Positive Treatment Outcomes in Patients with Eosinophilic Esophagitis (EoE) After Nine Months of Receiving EP-104GI
Globenewswire· 2025-05-05 11:00
Core Insights - Eupraxia Pharmaceuticals announced positive outcomes from its RESOLVE Phase 1b/2a trial for EP-104GI, showing sustained or improved treatment results in all three patients after nine months of therapy [1][3][4] Company Overview - Eupraxia Pharmaceuticals is a clinical-stage biotechnology company focused on developing drug delivery systems for unmet medical needs, utilizing its proprietary DiffuSphere™ technology [16][17] - The company is currently evaluating EP-104GI for eosinophilic esophagitis (EoE), a chronic inflammatory condition affecting the esophagus [1][15] Trial Details - The RESOLVE trial is a multi-center, open-label, dose-escalation study assessing the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with active EoE [12] - Cohort 5 data revealed that patients receiving 48 mg of EP-104GI showed significant improvements in symptom severity, tissue health, and eosinophil counts after nine months [3][4][5] Key Findings - Symptom Improvement: Patients reported an average reduction of 3.7 points (65%) on the Straumann Dysphagia Index (SDI) after nine months [4][6] - Tissue Health: There was a 56% average reduction in EoEHSS Stage score and a 45% reduction in Grade score [4][5] - Eosinophil Reduction: A mean decrease of 77% in eosinophil counts was observed, with a 52% remission rate across biopsy sites [5][6] Future Plans - Additional long-term data with higher doses is expected to be released in Q3 2025 [3][13] - The company will host a webinar on May 9, 2025, to discuss the RESOLVE trial data [11]
Eupraxia Pharmaceuticals to Present at Investor and Scientific Conferences in April and May
Newsfilter· 2025-04-24 21:00
Core Viewpoint - Eupraxia Pharmaceuticals Inc. is actively participating in multiple upcoming investor and scientific conferences to present its clinical data and advancements in drug delivery technology, particularly focusing on its proprietary DiffuSphere™ technology and ongoing clinical trials for its product candidates [1][9]. Conference Presentations - The company will present at the Osteoarthritis Research Society International World Congress from April 24-27, 2025, with a poster on EP-104IAR, highlighting sustained pain response in knee osteoarthritis patients [2][3]. - At the Digestive Disease Week Annual Meeting from May 3-6, 2025, data from the Phase 1b study of EP-104GI for eosinophilic esophagitis will be presented, including results from the ongoing RESOLVE trial [4][5]. - The CEO will present at the Bloom Burton & Co. Healthcare Investor Conference on May 5, 2025, and participate in investor meetings [5][6]. Product Development - Eupraxia's EP-104GI is in a Phase 1b/2a trial for eosinophilic esophagitis, utilizing a unique local delivery method via injection into the esophageal wall [10]. - The company recently completed a Phase 2b clinical trial (SPRINGBOARD) for EP-104IAR, which met its primary endpoint and three of four secondary endpoints, indicating potential for effective treatment in knee osteoarthritis [10]. Technology Overview - The DiffuSphere™ technology is designed for targeted drug delivery, aiming to improve the safety, tolerability, efficacy, and duration of effect of existing and novel drugs, with applications extending beyond pain and inflammatory gastrointestinal diseases to oncology and infectious diseases [9][10].
Eupraxia Pharmaceuticals Reports Fourth Quarter 2024 Financial Results
Prnewswire· 2025-03-20 21:31
Core Insights - Eupraxia Pharmaceuticals Inc. reported financial results for Q4 2024, highlighting a net loss reduction and successful clinical trial data for its product EP-104GI [1][4][2] Financial Performance - The company incurred a net loss of $7.5 million in Q4 2024, an improvement from a net loss of $10.6 million in Q4 2023, attributed to lower research and development costs and reduced expenses [4] - Cash reserves increased to $33.1 million as of December 31, 2024, up from $19.3 million at the end of Q4 2023, providing sufficient funding for clinical trials and operational needs into Q3 2026 [5] Clinical Developments - Positive data from the Phase 1b/2a RESOLVE trial for EP-104GI indicated improved tissue health and symptom reduction in eosinophilic esophagitis patients, with higher doses showing better outcomes [2][13] - The company also completed a Phase 2b trial (SPRINGBOARD) for EP-104IAR, which met its primary endpoint and three of four secondary endpoints [13] Operational Highlights - The appointment of Dr. Amanda Malone as Chief Operating and Scientific Officer was announced, along with the return of Alex Rothwell as Chief Financial Officer [6] - The company presented significant trial data at various medical conferences, receiving accolades for its research quality [6] Market and Trade Considerations - Management is monitoring the potential impact of proposed tariffs on Canadian goods by the U.S. government and retaliatory tariffs from Canada, assessing their implications for the company's operations [8][10] - Eupraxia sources its active pharmaceutical ingredients from the U.S. and maintains U.S. dollar balances to mitigate exchange rate fluctuations [9]
Eupraxia Pharmaceuticals Announces Positive Data from RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis
Prnewswire· 2025-02-25 12:00
Core Insights - Eupraxia Pharmaceuticals announced positive clinical data from its ongoing RESOLVE Phase 1b/2a trial for EP-104GI, aimed at treating eosinophilic esophagitis (EoE) [1][3] - The trial has shown improvements in both tissue health and symptom relief, with no serious adverse events reported [3][5] Company Overview - Eupraxia Pharmaceuticals is a clinical-stage biotechnology company focused on precision local drug delivery, particularly for conditions with high unmet medical needs [14][15] - The company utilizes its proprietary DiffuSphere™ technology to facilitate targeted drug delivery, aiming to improve safety and efficacy compared to traditional methods [14] Clinical Trial Details - The RESOLVE trial is a multi-center, open-label, dose-escalation study evaluating the safety and efficacy of EP-104GI in adults with active EoE [9] - Cohort 6 of the trial received 16 injections of 4 mg EP-104GI, targeting the lower three-quarters of the esophagus, resulting in significant improvements in symptom relief and tissue health [4][5] Key Findings from the RESOLVE Trial - Cohort 6 demonstrated the highest symptom relief scores (SDI) and the greatest improvement in tissue health scores (EoEHSS) to date [5][6] - A mean reduction of 94% in peak eosinophil counts (PEC) was observed, with a 62% remission rate across biopsy sites [6][8] - No serious adverse events or cases of oral or gastrointestinal candidiasis were reported in any of the cohorts [5][6] Future Expectations - Cohort 7 is fully enrolled, with 12-week data expected in late Q2 2025 [10] - The company plans to explore higher dosing levels and expanded esophageal coverage in future cohorts based on the positive outcomes observed [3][5]
Eupraxia's DiffuSphere™ Technology Demonstrates Targeted Drug Release while Minimizing Systemic Exposure for a Period of More Than Six Months
Prnewswire· 2024-11-20 12:00
Core Insights - Eupraxia Pharmaceuticals Inc. has introduced new pharmacokinetic data from its Phase 2a Eosinophilic Esophagitis program, highlighting the capabilities of its DiffuSphere™ platform for precise drug delivery [1][4][9] Group 1: DiffuSphere™ Technology - DiffuSphere™ enables targeted drug delivery with a flat, stable, and long-lasting release profile, minimizing adverse effects associated with conventional drug delivery methods [2][17] - The technology consists of a pure drug crystal encased in a polymer shell, allowing for controlled release and high concentrations in target tissues while reducing systemic exposure [3][17] - Clinical trials have demonstrated that a single injection of DiffuSphere™ can maintain therapeutic drug levels for over six months, significantly improving treatment outcomes for conditions like eosinophilic esophagitis and osteoarthritis [5][6] Group 2: Clinical Trial Results - In the RESOLVE trial, DiffuSphere™ showed a treatment duration exceeding six months with a steady drug level of 1.5 pg/ml maintained in patients receiving 4 mg of fluticasone propionate [5] - The Phase 2b study of EP-104IAR for osteoarthritis demonstrated significant pain relief for up to 22 weeks, with no adverse effects on blood glucose metabolism or adrenal function [6][12] - Eupraxia's clinical data supports the efficacy of DiffuSphere™ in improving key disease measures, including patient symptoms and tissue health [5][9] Group 3: Broader Applications - DiffuSphere™ has shown versatility across various drug classes and anatomical locations, including intraarticular, intraesophageal, and intravitreal applications [8][17] - The technology has been successfully tested with local anesthetics and anti-infective agents, indicating its potential for diverse therapeutic uses [8][17] - Eupraxia aims to leverage DiffuSphere™ for future treatments in oncology and infectious diseases, expanding its application beyond pain and inflammatory gastrointestinal diseases [17][18]
Eupraxia Pharmaceuticals to Present at American College of Rheumatology Convergence 2024 Annual Meeting
Prnewswire· 2024-11-14 22:00
Core Insights - Eupraxia Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on optimizing drug delivery through its proprietary DiffuSphere™ technology, which addresses significant unmet medical needs [1][5] - The company will present a poster at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting, highlighting its research on EP-104IAR, a long-acting intra-articular injection for osteoarthritis [1][4] Company Overview - Eupraxia specializes in developing locally delivered, extended-release products aimed at therapeutic areas with high unmet medical needs [5] - The DiffuSphere™ technology is designed to facilitate targeted drug delivery, potentially improving safety, tolerability, efficacy, and duration of effect compared to traditional methods [5] Event Details - The ACR Convergence 2024 Annual Meeting will take place in Washington, D.C. from November 14-19, 2024, providing a platform for education and research in rheumatology [3] - Eupraxia's poster presentation will focus on the sustained improvement in pain for subjects with moderate baseline pain and BMI less than 30, based on a Phase 2 study [4]
Eupraxia Pharmaceuticals' CEO Dr. James Helliwell to Participate in Webinar Event, "Eosinophilic Esophagitis: The Emerging Digestive Disorder Frequently Misdiagnosed", on November 15, 2024
Prnewswire· 2024-11-13 22:00
Core Insights - Eosinophilic Esophagitis (EoE) is a rapidly increasing digestive disorder affecting over 450,000 people in the United States, leading to significant healthcare burdens and mental health issues [3][4]. Company Overview - Eupraxia Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products to address high unmet medical needs [4]. - The company utilizes its proprietary DiffuSphere™ technology for optimized drug delivery, aiming to improve safety, tolerability, efficacy, and duration of effect for existing and novel drugs [4]. Product Development - Eupraxia's EP-104GI is currently in a Phase 1b/2a trial (RESOLVE trial) for treating EoE, utilizing a unique injection method for local drug delivery [5]. - The company has also completed a Phase 2b clinical trial (SPRINGBOARD) for EP-104IAR, targeting pain from knee osteoarthritis, achieving its primary endpoint and three of four secondary endpoints [5]. - Eupraxia is developing a pipeline of long-acting formulations for various indications, including inflammatory joint diseases and oncology [5]. Upcoming Events - Eupraxia's CEO, Dr. James A. Helliwell, will present at a Tribe Public Webinar on November 15, 2024, discussing EoE and its implications [1][2].