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Candel Therapeutics secures $130M to fund lead program – ICYMI
Proactiveinvestors NA· 2025-10-18 13:32
Core Insights - Candel Therapeutics has secured a $130 million term loan facility with Trinity Capital, which is a significant development for the company [1][2] - The non-dilutive funding will primarily support the BLA submission for CAN-2409, the company's lead asset in prostate cancer, and aid in commercialization efforts [2][3] Financial Developments - The loan facility is structured to allow an immediate drawdown of $50 million upon closing, with access to remaining funds contingent on meeting specific milestones [5] - This financing strategy is designed to avoid unnecessary dilution for shareholders while providing the necessary capital for ongoing projects [3][5] Strategic Focus - Candel is prioritizing its lead asset CAN-2409 for prostate cancer, followed by therapy-resistant non-small cell lung cancer, and has decided to pause the launch of a large clinical program in pancreatic cancer to manage resources effectively [6][7] - The company has completed enabling work for its programs and received orphan drug designation from both the EMA and FDA, indicating readiness to advance once additional funding is secured [8] Partnership Opportunities - Candel is actively exploring strategic partnerships to secure further non-dilutive funding, with ongoing discussions with potential partners showing significant interest [9][10] - The company emphasizes the importance of entering into agreements that align strategically with its goals, ensuring that any partnership is beneficial for its long-term objectives [10]
Appili Therapeutics Reports Financial and Operational Results for First Quarter of Fiscal Year 2026
Globenewswire· 2025-08-14 21:05
Core Insights - Appili Therapeutics has submitted a total of seven U.S. government funding proposals, with a potential combined award value of up to US$137 million, aimed at advancing infectious disease and biodefense products [3][4][6] - The company has been accepted as a member of the U.S. Medical CBRN Defense Consortium, enhancing its partnerships in government and biodefense sectors [4][5] - Financial results for the first quarter of fiscal 2026 show a net loss of $1.2 million, a decrease from $1.6 million in the same period last year, attributed to reduced financing costs and lower research and development expenses [16] Funding Proposals - Appili has submitted seven non-dilutive funding proposals to U.S. government agencies, which include submissions to the Congressionally Directed Medical Research Program, the U.S. Medical CBRN Defense Consortium, and the National Institute of Allergy and Infectious Diseases [3][4] - If awarded, these funds will support the development of projects through manufacturing, non-clinical development, and regulatory activities necessary for IND submissions and Phase 1 clinical trials [3] Biodefense Initiatives - The company is advancing its live-attenuated vaccine candidate, ATI-1701, for the prevention of tularemia, with approximately US$11.6 million in funding from the U.S. Air Force Academy [6][7] - Recent data published indicates that ATI-1701 provides robust protection against lethal tularemia in non-human primates, supporting its potential as a leading vaccine candidate [7] Product Development - LIKMEZ, a metronidazole oral suspension, has been re-launched in the U.S. and is the first FDA-approved ready-to-use liquid formulation for patients who have difficulty swallowing tablets [10][11] - The company is also advancing ATI-1801, a topical formulation for cutaneous leishmaniasis, with positive Phase 3 data and ongoing efforts to secure non-dilutive funding for its development [12][14] Financial Overview - For the three months ended June 30, 2025, the company reported a net loss of $1.2 million, reflecting a decrease in financing costs and research and development expenses [16] - As of June 30, 2025, the company had cash reserves of $1.1 million, a slight decrease from $1.2 million at the end of the previous quarter [16]
Verrica Pharmaceuticals Reports Second Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-08-12 20:01
Core Insights - Verrica Pharmaceuticals reported a revenue of $12.7 million for Q2 2025, with $4.5 million from YCANTH® and $8.0 million from milestone revenue with Torii Pharmaceutical, marking a sequential growth of 32.5% from Q1 2025 [1][10][21] - The company successfully completed an End of Phase 2 meeting for VP-315 for Basal Cell Carcinoma and is preparing for the Phase 3 program while seeking non-dilutive financing opportunities [1][3][9] - A conference call is scheduled for today at 4:30 pm ET to discuss the financial results and business updates [1][4] Financial Performance - Product revenue, net for Q2 2025 was $4.5 million, a decrease from $4.9 million in Q2 2024, primarily due to a one-time stock-in related to distribution network expansion in the previous year [10][21] - License and collaboration revenue increased significantly to $8.2 million in Q2 2025 from $0.3 million in Q2 2024, driven by an $8.0 million milestone payment from Torii [12][21] - The company reported a net income of $0.2 million, or $0.02 per share, compared to a net loss of $17.2 million, or $3.70 per share, in the same period last year [12][21] Product and Pipeline Developments - YCANTH® (VP-102) saw a record of 13,434 dispensed applicator units in Q2 2025, reflecting a sequential growth of 32.8% over Q1 2025 [3][8] - The company is advancing its global Phase 3 program for common warts in collaboration with Torii Pharmaceutical, with the first patient expected to be dosed in Q4 2025 [11][12] - VP-315 has shown positive proof-of-concept efficacy data in Phase 2 trials for basal cell carcinoma, and the company plans to present additional data at a scientific conference later this year [3][9] Strategic Partnerships and Funding - Verrica expects to receive an additional $10 million in non-dilutive funding from Torii upon Japanese regulatory approval of YCANTH for molluscum contagiosum, with a decision anticipated by the end of 2025 [3][11] - The collaboration with Torii includes a 50/50 cost-sharing agreement for the global Phase 3 program, with Torii covering the first $40 million of trial costs [11][12] Operational Efficiency - Selling, general, and administrative expenses decreased to $8.9 million in Q2 2025 from $16.5 million in Q2 2024, attributed to reduced commercial activity expenses [12][21] - Research and development expenses also declined to $1.8 million in Q2 2025 from $3.3 million in Q2 2024, mainly due to lower clinical trial costs for VP-315 [12][21]
RedHill Receives Positive FDA Feedback on Pathway to Approval of Groundbreaking RHB-204 for Crohn's Disease
Prnewswire· 2025-07-21 13:00
Core Viewpoint - RedHill Biopharma received positive FDA feedback for its RHB-204 Crohn's disease development program, indicating a promising pathway to approval for a potentially groundbreaking therapy targeting the root cause of the disease [1][2]. Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on developing and commercializing drugs for gastrointestinal diseases, infectious diseases, and oncology [15]. - The company is actively pursuing non-dilutive funding options for its RHB-204 program, including grant applications and discussions with external funding sources [1][10]. Product Development - RHB-204 is a next-generation formulation of RHB-104, designed to enhance tolerability, safety, and patient adherence, with a 40% reduction in pill burden [5][13]. - The drug is patent protected until 2041 and is expected to receive pediatric orphan drug designation, along with potential breakthrough therapy and fast track designations [1][10][14]. - The Phase 2 study of RHB-204 will be the first clinical trial targeting a specific population of Mycobacterium avium subspecies paratuberculosis infected Crohn's disease patients, aiming to address both the cause and symptoms of the disease [2][6]. Clinical Study Insights - The primary endpoints of the Phase 2 study will focus on mucosal remission, which is considered a new gold standard in efficacy evaluation for Crohn's disease, correlated with MAP status and clinical remission [4]. - The study design allows for a smaller sample size, which could lead to lower costs and faster completion times [4][6]. Market Potential - The Crohn's disease market is projected to grow significantly, with sales expected to increase from $13.6 billion in 2024 to over $19 billion by 2033, representing a compound annual growth rate (CAGR) of 3.87% [9]. - Up to 40% of Crohn's disease patients do not respond to existing anti-TNF treatments, highlighting the need for new, effective therapies like RHB-204 [8]. Competitive Landscape - Current FDA-approved therapies for Crohn's disease include Abbvie's Humira, Janssen's Remicade, and others, which are often expensive and have known safety issues [11][8]. - RHB-204 aims to provide a safe and effective oral therapy alternative, potentially transforming treatment options for Crohn's disease patients [7][8].
OKYO Pharma Receives $1.9 Million in Non-Dilutive Funding to Accelerate Development of Urcosimod for Neuropathic Corneal Pain
Globenewswire· 2025-07-17 13:00
Core Insights - OKYO Pharma Limited has received $1.9 million in non-dilutive funding to support the clinical development of urcosimod for treating neuropathic corneal pain (NCP), a condition with no FDA-approved therapies [1][2][3] Company Overview - OKYO Pharma is a clinical stage biopharmaceutical company focused on developing innovative therapies for neuropathic corneal pain and dry eye disease, with its shares traded on NASDAQ [6] - The company aims to discover and develop novel molecules specifically targeting neuropathic corneal pain and dry eye disease [6] Product Development - Urcosimod, the lead drug candidate, is a lipid conjugated chemerin peptide agonist designed to treat ocular diseases by producing anti-inflammatory and pain-reducing effects [5] - Urcosimod has shown statistical significance in multiple endpoints in a completed Phase 2 trial for dry eye disease and has just completed a Phase 2 trial for neuropathic corneal pain [5][6] Market Need - Neuropathic corneal pain is a severe and underdiagnosed condition characterized by debilitating pain and sensitivity, currently treated off-label with no FDA-approved options available [4][5]