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Viridien: Viridien’s governance is evolving
GlobeNewswire· 2024-12-18 16:45
Governance Changes - The governance structure of Viridien is evolving with a temporary unification of the roles of Chairman and Chief Executive Officer under Sophie ZURQUIYAH, effective April 30, 2025 [1][3] - Philippe SALLE will be appointed as Lead Director, subject to the renewal of his mandate as a director at the General Meeting on April 30, 2025 [1][2] Succession Planning - The Board has decided to implement a succession plan, allowing Sophie ZURQUIYAH to assume the combined roles of Chairwoman and Chief Executive Officer for a transitional period until the General Meeting of 2026 [3][4] - The Board aims to restore a separate governance structure by 2026 [4] Acknowledgments - Colette LEWINER, Chair of the Appointment, Remuneration and Governance Committee, expressed gratitude to Philippe SALLE for his contributions since 2018 and acknowledged Sophie ZURQUIYAH's leadership in the ongoing transformation of the Group [4] Company Overview - Viridien is an advanced technology, digital, and Earth data company focused on sustainable solutions, employing around 3,500 people globally and listed on Euronext Paris SA [5]
Virios Therapeutics(VIRI) - 2024 Q3 - Quarterly Report
2024-11-08 13:15
Company Overview - The company is a pre-revenue, development-stage biopharmaceutical firm focused on developing new medicines for pain and fatigue-related disorders, with a pipeline centered on NaV 1.7 modulation and combination antiviral therapies [88]. Product Development - The lead development candidate, Halneuron®, has shown statistically significant pain reduction in a Phase 2 study for cancer-related pain, with an interim efficacy readout expected in the second half of 2025 [90]. - The antiviral program includes IMC-1 and IMC-2, with top-line data from an ongoing IMC-2 Phase 2 study for Long-COVID expected in November 2024 [88]. - Halneuron® has received fast track status from the FDA for the treatment of chemotherapy-induced neuropathic pain (CINP) [92]. - IMC-1 is ready for Phase 3 development for fibromyalgia, with agreed-upon program requirements from the FDA [94]. Corporate Actions - The company completed a Combination with Pharmagesic on October 7, 2024, acquiring 100% of its common shares, which is expected to enhance its asset pipeline [97]. - Under the terms of the Combination, the company issued 211,383 shares of common stock and 2,108.3854 shares of Series A Non-Voting Convertible Preferred Stock to Sealbond, representing 19.99% of the outstanding shares [98]. - The Company changed its name from "Virios Therapeutics, Inc." to "Dogwood Therapeutics, Inc." effective October 9, 2024, and began trading under the ticker symbol "DWTX" on Nasdaq [119]. - A reverse stock split was executed, converting every 25 shares of Common Stock into one share, resulting in 1,110,317 outstanding shares prior to the Exchange Agreement [121]. Financial Performance - The Company incurred net losses of $2,280,684 and $4,621,852 for the three and nine months ended September 30, 2024, respectively, compared to $1,235,074 and $4,192,842 for the same periods in 2023 [132]. - As of September 30, 2024, the company had an accumulated deficit of $66,091,074 and cash of $2,039,819 [132]. - Net cash used in operations for the nine months ended September 30, 2024, was $2,659,297, compared to $3,401,318 for the same period in 2023, indicating a 21.7% improvement [143]. - Net cash provided by financing activities during the nine months ended September 30, 2024, was $1,382,170, compared to $1,156,443 in the same period of 2023 [145]. - The company raised gross proceeds of $1.7 million from a public offering on May 22, 2024, with net proceeds of approximately $1.4 million after expenses [135]. Expenses and Funding - Research and development expenses increased by $0.2 million for the three months ended September 30, 2024, primarily due to a $0.3 million increase associated with a grant to BHC for a proof-of-concept study [129]. - General and administrative expenses increased by $0.9 million (70.8%) for the three months ended September 30, 2024, compared to the prior year period [130]. - Research and development expenses for the three months ended September 30, 2024, were $535,162, up from $374,200 in the same period of 2023, representing a 43.0% increase [130]. - The company plans to explore various funding sources to support the Phase 2b study for IMC-2, contingent on positive results from the ongoing study [96]. - The Company plans to secure an additional $3,000,000 in loan proceeds in February 2025 to fund operations through the end of 2025 [140]. Debt and Financing - The Company entered into a Loan Agreement for a total principal amount of $19,500,000, with $16,500,000 disbursed on October 7, 2024, and $3,000,000 to be disbursed on February 18, 2025 [106]. - There were no debt financings during the nine months ended September 30, 2024, and no debt outstanding as of September 30, 2024 [138]. - A contingent value rights agreement was established, allowing holders to receive 87.75% of any upfront or milestone payments received by the company [103]. Compliance and Governance - The Company received a letter from Nasdaq on November 2, 2023, notifying it of non-compliance with the minimum bid price requirement, but regained compliance by October 29, 2024 [127][128]. - Holders of Series A Preferred Stock are entitled to receive payment-in-kind dividends at a rate of 5.0% per annum, payable in shares of Series A Preferred Stock [113]. - The Company has agreed to indemnify holders of Common Stock and Series A Preferred Stock under the Registration Rights Agreement [110]. - The Company will file a Form S-1 registration statement within 60 days if requested by holders of at least 40% of Registrable Securities [107]. - The anticipated aggregate offering price for a Form S-3 registration statement must be at least $7,500,000 if requested by holders of at least 30% of Registrable Securities [108]. Operational Status - The company has experienced negative cash flows from operations since inception and will require additional financing to fund ongoing clinical trials and operations beyond 2025 [133]. - The company is not currently involved in any material pending or ongoing litigation that could impact operations [155]. - No changes in internal control over financial reporting were identified during the quarter that materially affected the company's internal controls [153].
Virios Therapeutics(VIRI) - 2024 Q3 - Quarterly Results
2024-11-07 12:15
Financial Performance - The net loss for Q3 2024 was $2.3 million, or $2.05 per share, compared to a net loss of $1.2 million, or $1.62 per share in Q3 2023[10]. - General and administrative expenses rose by $0.9 million in Q3 2024 compared to Q3 2023, mainly due to higher legal and professional fees of $1.0 million related to the business combination[9]. - Research and development expenses increased by $0.2 million in Q3 2024 compared to Q3 2023, primarily due to a $0.3 million increase in expenses related to a grant for a Long-COVID study[8]. - The company has a current cash balance of $2.0 million as of September 30, 2024, which is insufficient to fund operations for the next 12 months without securing additional financing[11]. - Total liabilities as of September 30, 2024, were $1.33 million, compared to $0.36 million as of December 31, 2023[17]. - Total stockholders' equity decreased to $949,431 as of September 30, 2024, from $3.81 million as of December 31, 2023[17]. Funding and Financing - Dogwood Therapeutics raised $19.5 million in committed debt financing, with $16.5 million funded as of October 7, 2024, and an additional $3.0 million expected in Q1 2025[4]. Clinical Development - Top-line results from the ongoing IMC-2 Long-COVID Phase 2a study are expected by mid-November 2024[5]. - Interim data from the Halneuron® Phase 2b study for chemotherapy-induced neuropathic pain is anticipated in the second half of 2025[6]. - Dogwood's pipeline includes three late-stage assets: Halneuron® in Phase 2b, IMC-1 ready for Phase 3, and IMC-2 in Phase 2[3].
Virios Therapeutics(VIRI) - 2024 Q2 - Quarterly Report
2024-08-09 14:15
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ 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: 001-39811 Virios Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 85-4314201 (St ...
Virios Therapeutics(VIRI) - 2024 Q2 - Quarterly Results
2024-08-08 13:30
Exhibit 99.1 Virios Therapeutics Announces Second Quarter 2024 Financial Results - Bateman Horne Center completed enrollment in its groundbreaking investigator-initiated Long-COVID phase 2a study featuring valacyclovir and celecoxib (IMC-2) - - Top-line results from the Bateman Horne Center's Long-COVID phase 2a study expected in October 2024, will provide key insights into final design of planned Phase 2b study - ATLANTA, Ga., August 8, 2024 -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the "Company"), a de ...
Virios Therapeutics Announces Second Quarter 2024 Financial Results
GlobeNewswire News Room· 2024-08-08 13:15
- Bateman Horne Center completed enrollment in its groundbreaking investigator-initiated Long-COVID phase 2a study featuring valacyclovir and celecoxib (IMC-2) - - Top-line results from the Bateman Horne Center's Long-COVID phase 2a study expected in October 2024, will provide key insights into final design of planned Phase 2b study - ATLANTA, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the "Company"), a development-stage biotechnology company focused on advancing novel antiv ...
Virios Therapeutics to Report Second Quarter 2024 Financial Results on Thursday, August 8, 2024
Newsfilter· 2024-08-01 13:41
ATLANTA, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the "Company"), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia ("FM") and Long-COVID ("LC"), announced today that it will report second quarter 2024 financial results on Thursday, August 8, 2024 before the open of the financial markets. About Virios Therapeutics Virios Therapeutics (Nasdaq: VIRI) is a development-stage b ...
Virios Therapeutics to Report Second Quarter 2024 Financial Results on Thursday, August 8, 2024
GlobeNewswire News Room· 2024-08-01 13:41
ATLANTA, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the "Company"), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia ("FM") and Long-COVID ("LC"), announced today that it will report second quarter 2024 financial results on Thursday, August 8, 2024 before the open of the financial markets. About Virios Therapeutics Virios Therapeutics (Nasdaq: VIRI) is a development-stage b ...
Virios Therapeutics Announces Completion of Enrollment in IMC-2 Phase 2 Long-COVID Study Being Conducted by Bateman Horne Center
Newsfilter· 2024-07-23 13:15
For more information, please visit www.virios.com. The BHC study is a randomized, double-blind, placebo-controlled evaluation of the combination of valacyclovir and celecoxib (IMC-2) as a treatment for fatigue and other symptoms associated with LC illness. This study follows on from a positive prior investigator-initiated proof of concept study demonstrating that the valacyclovir/celecoxib combination improved fatigue, pain, orthostatic symptoms, anxiety and overall patient LC health when compared with an u ...
Virios Therapeutics Announces Completion of Enrollment in IMC-2 Phase 2 Long-COVID Study Being Conducted by Bateman Horne Center
GlobeNewswire News Room· 2024-07-23 13:15
Core Insights - The article highlights the potential of antiviral therapy targeting Epstein-Barr virus in treating Long-COVID symptoms, particularly fatigue [1][6] - Virios Therapeutics is focused on developing novel antiviral therapies for chronic diseases linked to viral-triggered immune responses, including Long-COVID and fibromyalgia [2][5] Company Overview - Virios Therapeutics (Nasdaq: VIRI) is a development-stage biotechnology company aiming to advance antiviral therapies for diseases like fibromyalgia and Long-COVID [2] - The company’s lead candidates are fixed-dose combinations of antiviral compounds and celecoxib, designed to suppress herpesvirus replication [2] Clinical Studies - The Bateman Horne Center has completed enrollment for a proof of concept study evaluating the combination of valacyclovir and celecoxib (IMC-2) for Long-COVID symptoms, with top-line results expected in October 2024 [3][4] - Previous studies indicated that the valacyclovir/celecoxib combination improved various symptoms associated with Long-COVID compared to untreated controls [4] Market Need - An estimated 17.6% of the U.S. population, nearly 45 million adults, have experienced Long-COVID since the pandemic began, highlighting a significant unmet medical need for effective treatments [5] - Currently, there are no FDA-approved treatments for Long-COVID symptoms, emphasizing the urgency for new therapeutic options [5]