Virios Therapeutics(VIRI)
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Virios Therapeutics(VIRI) - 2025 Q4 - Annual Report
2026-03-18 20:30
Company Overview - The company is a pre-revenue, development-stage biopharmaceutical firm focused on developing new medicines for pain and neuropathy, having acquired Pharmagesic and its subsidiaries[22]. Halneuron® Development - The Halneuron® program is in late-stage clinical development for chemotherapy-induced neuropathic pain (CINP), utilizing highly purified Tetrodotoxin (TTX) as a sodium channel modulator[24]. - The CINP market is estimated at approximately $2.8 billion annually, with a significant opportunity for Halneuron® as the first FDA-approved treatment for CINP[33]. - In a previous Phase 2 study, 51% of patients receiving Halneuron® experienced at least a 30% reduction in pain compared to 35% in the placebo group[34]. - The HAL-CINP-203 Phase 2b clinical trial commenced in Q1 2025, involving approximately 240 patients to assess the efficacy of Halneuron®[41]. - An interim analysis in December 2025 indicated that Halneuron® was separating from placebo, with a sample size of 210-240 expected to provide over 80% power for statistical significance[41]. - The safety profile of Halneuron® is well understood, with common adverse events including numbness and tingling, which are related to sodium channel inhibition[42]. - The company has conducted multiple studies demonstrating that Halneuron® is well tolerated, with no evidence of cumulative toxicity observed over time[45]. - A synthetically formulated version of Halneuron® is under development for Phase 3 and commercialization, with FDA engagement planned for the second half of 2026[81]. - The company plans to advance the Halneuron® Phase 2b clinical trial for the treatment of CINP, with top-line data readout expected in the third quarter of 2026[172]. Other Product Developments - IMC-1 is a combination of famciclovir and celecoxib, with a Phase 3 program including two pivotal trials to demonstrate safety and efficacy in treating fibromyalgia (FM) patients[48]. - The Phase 3 studies will include a four-arm trial comparing IMC-1 to celecoxib, famciclovir, and placebo, and a two-arm study comparing IMC-1 to placebo[48]. - IMC-2, a combination of valacyclovir and celecoxib, is being developed for the treatment of long COVID (LC), with a Phase 2 study planned to assess fatigue improvement as a primary endpoint[50]. - The SP16 program, targeting chemotherapy-induced peripheral neuropathy (CIPN), is in early Phase 1 development, with first in-human studies expected to start in mid-2026[54]. - SP16 has shown preclinical efficacy in alleviating paclitaxel-induced neuropathy and does not interfere with the anticancer activity of taxanes[53]. Intellectual Property and Licensing - The company holds 7 issued families of patents related to Halneuron® as of December 31, 2025, with exclusivity expiring between 2027 and 2030, and pending patents extending exclusivity to 2042 and 2045[59]. - The antiviral portfolio includes 14 issued patents related to IMC-1, with exclusivity extending to 2033[67]. - The company entered into a Know-How License Agreement with the University of Alabama in 2012, granting a 10% membership interest in exchange for a 25-year license to utilize herpesvirus-related technical information[76]. - An Exclusive Licensing Agreement was established with Serpin Pharma and Rejuvenation Labs on September 29, 2025, allowing the company a royalty-free, sublicensable global license for SP16 development[78]. - A Licensing Agreement was established with Serpin, granting a royalty-free global license for the development of SP16, with the issuance of 191,017 shares of common stock and Series A-2 Preferred Stock[152]. Financial Overview - The Company incurred consolidated net losses of $34,257,370 and $12,349,724 for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $108,076,316 as of December 31, 2025[168]. - The Company has not yet generated revenue from the commercialization of any products and anticipates incurring significant additional operating losses for the foreseeable future[169]. - The Company raised approximately $12.5 million in gross proceeds from the January 2026 Offering, with net proceeds of about $11.4 million after deducting fees and expenses[160]. - The company is dependent on obtaining additional capital to fund operations and may face challenges in raising necessary financing[171]. - The company expects its financial condition and operating results to fluctuate significantly from quarter to quarter and year to year[182]. Regulatory Challenges - The company faces significant challenges in obtaining regulatory approval for its product candidates, which is essential for generating sufficient revenue to support future developments[184]. - The regulatory approval process is lengthy and unpredictable, with many factors influencing the timeline, often taking several years after clinical trials commence[196]. - The FDA charges user fees for drug applications, with the NDA application fee exceeding $4.1 million for fiscal year 2025, and an annual program fee of over $400,000 per program[200]. - Compliance with regulatory requirements necessitates substantial investment in manufacturing, quality control, and oversight, which can strain resources[185]. - The company must demonstrate substantial evidence of safety and efficacy through well-controlled clinical trials to gain regulatory approval[199]. - Changes in regulatory policies or requirements could adversely affect the approval process and the company's ability to market its products[188]. - The company may encounter delays in clinical trials due to various factors, including regulatory disagreements and patient recruitment challenges[194]. - Serious adverse events during clinical trials could lead to interruptions or halts, impacting the approval process and commercial viability of products[210]. - The company lacks experience in obtaining regulatory approval in international markets, which could further limit market potential[221]. Market Considerations - The global cancer-related pain market is projected to reach approximately $7.5 billion in annual sales by 2027, with chemotherapy treatment expected to increase by over 50% in the next decade[33]. - The market opportunities for Halneuron® and SP16, if approved, may be smaller than anticipated, with potential target populations being small, which could hinder profitability without additional marketing approvals for other indications[215]. - Even with FDA approval in the United States, the company may face challenges in obtaining approval in other jurisdictions, limiting global market potential[218]. - Coverage and reimbursement from third-party payors are critical for product sales, with significant uncertainty regarding their decisions impacting market access[121][125]. Corporate Structure and Operations - The company has eight full-time employees, with a significant portion of development work outsourced to independent contractors[143]. - The company does not own or lease any location in the U.S. other than a virtual office, while leasing office space for Canadian employees[144]. - The company completed a reverse stock split, converting every 25 shares of common stock into one share, effective October 7, 2024[149]. - The company filed a Form S-3 Registration Statement for the resale of up to 6,433,126 shares of Common Stock, which was declared effective by the SEC on January 29, 2026[161].
Virios Therapeutics(VIRI) - 2025 Q4 - Annual Results
2026-03-18 13:00
Financial Performance - Net loss attributable to common stockholders for Q4 2025 was $3.8 million, or $0.26 per share, compared to a net loss of $8.2 million, or $6.29 per share, in Q4 2024[6] - Net loss attributable to common stockholders for the full year 2025 was $35.5 million, or $7.13 per share, compared to a net loss of $12.9 million, or $12.52 per share, in 2024[9] Expenses - Research and development expenses for Q4 2025 were $2.3 million, consistent with Q4 2024[4] - Full year 2025 research and development expenses increased to $21.8 million from $3.5 million in 2024, driven by acquired in-process research and development expenses of $12.0 million[7] - General and administrative expenses for Q4 2025 decreased to $1.5 million from $5.2 million in Q4 2024, primarily due to a reduction in nonrecurring transaction costs[5] - Full year 2025 general and administrative expenses were $6.1 million, down from $8.7 million in 2024, mainly due to lower transaction costs[8] Cash Position - As of December 31, 2025, cash and cash equivalents totaled $6.5 million, expected to fund operations through the Phase 2b final data readout[10] Clinical Trials - The Halneuron® Phase 2b trial has enrolled 143 patients, with top-line results expected in Q3 2026[2] Financing - A financing of up to $26.9 million was completed in January 2026, with gross proceeds of $12.5 million received[5] Regulatory Status - Halneuron® has received fast track designation from the FDA for treating chemotherapy-induced neuropathic pain[13]
Viridien : 2025 annual results
Globenewswire· 2026-02-26 16:45
Core Insights - The company achieved strong operational performance in 2025, generating significant cash flow dedicated to debt reduction, reflecting the success of its asset-light strategy initiated in 2018 [2][16][19] - For 2026, the company anticipates generating an additional $100 million in net cash flow, which will also be allocated to further deleveraging [2][27] Financial Performance - Q4 2025 revenue was $277 million, down 18% from Q4 2024, while full-year revenue increased by 4% to $1,165 million [6][36] - Adjusted EBITDAs for FY 2025 reached $551 million, a 21% increase year-on-year, with a margin improvement to 47% from 41% in 2024 [6][36] - IFRS net income for FY 2025 was $71 million, up 40% compared to 2024, with a significant increase in net cash flow to $107 million, nearly doubling from $56 million in 2024 [14][16] Segment Performance - The Data, Digital and Energy Transition (DDE) segment reported revenue of $850 million, an 8% increase year-on-year, driven by strong performance across its businesses [4][36] - Geoscience revenue grew by 10% to $444 million, supported by core basin activities and market demand for high-end data [6][7] - The Sensing and Monitoring (SMO) segment saw a revenue decline of 5% to $315 million, with new business activities increasing by 8% [9][10] Cash Flow and Debt Management - The company generated a net cash flow of $107 million in 2025, exceeding its guidance, and significantly reduced net debt to $888 million, a 4% decrease from 2024 [16][21] - The company repaid $97 million of outstanding bonds and an additional $28 million asset-backed facility, demonstrating a commitment to deleveraging [19][20] Governance Changes - The company announced a governance restructuring, with Sophie Zurquiyah transitioning to a non-executive Chair role and Henning Berg appointed as the new CEO effective June 3, 2026 [23][25] Outlook - The company expects a recovery in the second half of 2026, projecting a net cash flow of around $100 million, with plans for expansion in U.S. HPC infrastructure [27][28]
Publication of the 2025 annual financial results on Thursday, February 26, after market close
Globenewswire· 2026-02-12 06:30
Group 1 - Viridien will publish its full year 2025 financial results on February 26, 2026, after market close [1][4] - A conference call will be held on the same day at 6.00 pm (CET) to discuss the financial results [5] - Participants must register for the conference call to receive a dial-in number and PIN code, and a replay will be available for 12 months on the company's website [2] Group 2 - Viridien is an advanced technology, digital, and Earth data company focused on sustainable solutions for natural resource, digital, energy transition, and infrastructure challenges [3] - The company employs approximately 3,200 people globally and is listed as VIRI on the Euronext Paris SA [3]
Viridien : Full-year 2025 financial update
Globenewswire· 2026-01-12 06:30
Core Insights - The company achieved solid operational performance in 2025, driven by growth in Data, Digital & Energy Transition, while completing the restructuring of Sensing & Monitoring [2] - The company generated over $130 million in cash, which was allocated to debt repayment, enhancing its financial position as it enters 2026 [2] - The focus remains on delivering outstanding products and services with operational excellence to support sustainable cash generation and ongoing debt reduction [2] Financial Performance - Segment revenue is expected to exceed $1,150 million, with Geoscience revenue exceeding $440 million (a 10% year-on-year increase) and Earth Data revenue exceeding $400 million [6] - Solid cash flow generation above $130 million resulted in a Net Cash Flow for 2025 exceeding $100 million after repaying a $28 million asset-backed facility related to the Group's HPC infrastructure [6] - Bond repayments totaled $97 million, fully utilizing the 10% annual optional redemption clause included in the bond documentation [6] - Net debt (pre-IFRS 16) is expected to be around $750 million at year-end [6] Company Overview - Viridien is an advanced technology, digital, and Earth data company focused on resolving complex challenges in natural resources, digital, energy transition, and infrastructure [4] - The company employs approximately 3,200 people worldwide and is listed as VIRI on the Euronext Paris SA [4]
Viridien announces new seismic reimaging program over block 22 offshore Angola to support upcoming licensing round
Globenewswire· 2025-12-10 06:30
Core Insights - Viridien has launched a multi-client seismic reimaging program over Angola's offshore block 22 to support the upcoming licensing round, covering an area of 4,300 sq km [1] - The new data set aims to provide insights into underexplored structures along the Atlantic Hinge zone, similar to the proven Cameia and Golfinho fields, with fast-track results expected in Q1 2026 and final products in Q3/Q4 2026 [1][2] - The reimaging will utilize advanced proprietary technologies, enhancing the existing 2,900 sq km data from nearby block 20/11, resulting in over 7,200 sq km of broadband PSDM data for regional play evaluation in the Kwanza Basin [2][3] Company Overview - Viridien is a technology-driven company focused on Earth data, aiming to provide innovative solutions for natural resources and energy transition challenges [4] - The company employs approximately 3,200 people globally and is listed on Euronext Paris SA under the ticker VIRI [4]
Virios Therapeutics(VIRI) - 2025 Q3 - Quarterly Report
2025-11-07 13:45
Financial Performance - Total operating expenses for the three months ended September 30, 2025, were $15,809,125, compared to $2,301,172 for the same period in 2024 [157]. - The company has incurred losses and generated negative cash flows from operations since inception, with cash totaling $10.1 million as of September 30, 2025 [161]. - For the nine months ended September 30, 2025, net cash used in operations was $12.0 million, consisting of a net loss of $30.5 million [168]. - The company experienced a decrease in cash of $4.7 million for the nine months ended September 30, 2025, compared to a decrease of $1.3 million for the same period in 2024 [167]. Research and Development - Research and development expenses increased by $14.0 million and $18.3 million for the three and nine months ended September 30, 2025, respectively, compared to prior periods [158]. - The HALT-CINP-203 clinical trial is assessing Halneuron® in approximately 200 patients with moderate to severe neuropathic pain, with top-line data expected in the second half of 2026 [148]. - The company licensed the rights to the IV formulation of SP16 for the treatment of chemotherapy-induced peripheral neuropathy, with initial Phase 1 evaluation expected to start in the first half of 2026 [149]. - Halneuron® has been granted FDA fast-track review designation as a treatment for chemotherapy-induced neuropathic pain (CINP) [147]. Financing Activities - The company entered into a Loan Agreement for a total principal amount of $19.5 million, with $16.5 million disbursed on October 7, 2024 [150]. - A registered direct offering on March 12, 2025, resulted in gross proceeds of approximately $4.78 million from the sale of 578,950 shares at $8.26 per share [152]. - The company raised approximately $4.78 million through a registered direct offering of 578,950 shares of Common Stock on March 14, 2025 [163]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $7.3 million, attributed to loan proceeds and gross proceeds from the registered direct offering [170]. Equity and Debt Management - The company issued 191,017 shares of common stock and 89.5939 shares of Series A-2 Preferred Stock as part of a licensing agreement with Serpin Pharma [154]. - The company received $3 million in loan proceeds on February 18, 2025, with no debt outstanding as of September 30, 2025 due to a Debt Exchange and Cancellation Transaction [164]. - The company reclassified approximately $5.5 million from temporary equity to permanent equity due to waivers by holders of Series A Preferred Stock [174]. Going Concern - The company has substantial doubt regarding its ability to continue as a going concern within 12 months from the issuance of the Quarterly Report [166]. - The company will need to secure additional financing to fund ongoing clinical trials and operations beyond the first quarter of 2026 [166]. - There were no off-balance sheet arrangements as of September 30, 2025 [173]. Administrative Expenses - General and administrative expenses increased by $1.2 million for the nine months ended September 30, 2025, compared to the prior year period [160].
Virios Therapeutics(VIRI) - 2025 Q3 - Quarterly Results
2025-11-06 14:15
Clinical Trials - Enrollment of 100 patients in the ongoing Halneuron® Phase 2b trial, with 80 patients completing treatment; interim analysis expected in Q4 2025[1][2] - Halneuron® has received fast track designation from the FDA for the treatment of chemotherapy-induced neuropathic pain (CINP)[7] - SP16 IV Phase 1b trial is fully funded by the National Cancer Institute and will commence after FDA consultation[8] Financial Performance - Research and development expenses for Q3 2025 were $14.5 million, a significant increase from $0.5 million in Q3 2024, primarily due to $12.0 million in acquired in-process R&D expenses for SP16[3] - General and administrative expenses decreased to $1.3 million in Q3 2025 from $1.8 million in Q3 2024, mainly due to reduced legal and accounting fees[4] - Net loss attributable to common stockholders for Q3 2025 was $15.7 million, or $8.20 per share, compared to a net loss of $2.3 million, or $2.05 per share, in Q3 2024[5] Cash and Assets - Cash on hand as of September 30, 2025, was $10.1 million, providing operational runway through Q1 2026[5] - Total assets as of September 30, 2025, were $91.99 million, down from $94.31 million at the end of 2024[16] - Total liabilities decreased to $14.61 million as of September 30, 2025, from $30.03 million at the end of 2024[16] Licensing and Partnerships - The company secured an exclusive worldwide, royalty-free license to develop and commercialize SP16 for cancer-related pain in an all-stock transaction[1]
2025 third-quarter results Strong performance driving Net Cash Flow generation
Globenewswire· 2025-10-30 16:45
Core Insights - Viridien reported a strong performance in Q3 2025, achieving a Net Cash Flow of $62 million and reaffirming its full-year target of $100 million [2][7][22] Financial Performance - Revenue for Q3 2025 reached $313 million, a 27% increase from $246 million in Q3 2024, while year-to-date revenue for 9M 2025 was $888 million, up 14% from $778 million in 9M 2024 [2][32] - Adjusted EBITDAs for Q3 2025 were $167 million, reflecting a 70% increase year-on-year, with a margin of 53% compared to 40% in Q3 2024 [2][32] - IFRS Net Income for Q3 2025 was $41 million, a significant recovery from a loss of $10 million in Q3 2024 [13][32] Segment Performance - The Data, Digital and Energy Transition (DDE) segment generated revenue of $244 million in Q3 2025, a 31% increase year-on-year, driven by strong Earth Data late sales [4][32] - The Geoscience segment reported revenue of $108 million, up 5% year-on-year, while the Earth Data segment saw a substantial 63% increase in revenue to $136 million [8][32] - The Sensing and Monitoring (SMO) segment achieved revenue of $69 million, a 16% increase year-on-year, with profitability improving due to a streamlined cost structure [10][32] Cash Flow and Debt Management - The company generated a Net Cash Flow of $53 million in Q3 2025, bringing the cumulative total to $62 million by the end of September [15][17] - Viridien actively managed its liabilities, executing partial bond redemptions totaling $48 million in early October, which is expected to save approximately $4.5 million in annual interest [17][27] Outlook - Despite volatile oil prices, exploration and seismic activities are expected to remain resilient, supported by positive fundamentals in the E&P sector [20][21] - Viridien is confident in its ability to sustain strong cash generation and advance its deleveraging objectives, aiming for a Net Cash Flow target of $100 million in 2025 [22][28]
Announcement of Q3 2025 Financial Results on Thursday, October 30, after market close
Globenewswire· 2025-10-16 05:30
Core Viewpoint - Viridien is set to announce its third quarter 2025 financial results on October 30, 2025, after market close, indicating a significant upcoming event for stakeholders [1]. Company Overview - Viridien is an advanced technology, digital, and Earth data company focused on sustainable solutions for complex challenges in natural resources, digital, energy transition, and infrastructure [3]. - The company employs approximately 3,200 people globally and is listed on Euronext Paris SA under the ticker VIRI [3]. Conference Call Details - Participants must register for the conference call to receive a dial-in number and PIN code, with options to join via live webcast [2]. - A replay of the conference call will be available for 12 months on the company's website [2]. - The press release and presentation will be accessible on the company's website at 5:45 PM (CET) on the announcement day, followed by an English-language conference call at 6:00 PM (CET) [5].