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IMUNON Announces Data Presented at ASCO Reinforces Unprecedented Overall Survival in Ovarian Cancer Phase 2 Study
Globenewswire· 2025-06-03 12:05
Core Insights - IMUNON, Inc. announced positive results from its Phase 2 OVATION 2 Study, demonstrating the efficacy of IMNN-001 in improving overall survival and progression-free survival in women with newly diagnosed advanced ovarian cancer [1][4][9] Group 1: Study Results - The Phase 2 OVATION 2 Study involved 112 participants randomized to receive IMNN-001 plus neoadjuvant and adjuvant chemotherapy versus standard of care, with a median follow-up of 31 months [2][5] - IMNN-001 treatment resulted in a median overall survival increase of 13 months (46 months vs. 33 months) and a median progression-free survival increase of 3 months (14.9 months vs. 11.9 months) compared to standard care [4][5] - The chemotherapy response score indicated a response rate of 26.1% in the IMNN-001 group versus 13.0% in the control group, highlighting a significant therapeutic effect [4] Group 2: Safety Profile - IMNN-001 exhibited a favorable safety profile with no serious immune-related adverse events reported, and the most common adverse events included abdominal pain, nausea, and vomiting [4][6] - The study showed a surgical response rate of 64.6% for the IMNN-001 treatment arm compared to 52.1% for the control arm, indicating better surgical outcomes [4] Group 3: Mechanism and Technology - IMNN-001 is based on IMUNON's proprietary TheraPlas technology, designed to induce a potent anti-cancer immune response through the local secretion of IL-12 [6][9] - The treatment is particularly effective in patients with homologous recombination deficiency (HRD+), including those with BRCA1 and BRCA2 mutations, as indicated by a hazard ratio of 0.42 [4][6] Group 4: Future Directions - The company plans to advance its pivotal Phase 3 OVATION 3 trial of IMNN-001, with initial trial sites recently initiated [3][9] - IMUNON aims to leverage its non-viral DNA technology to develop innovative treatments for various diseases, focusing on solid tumors [8][9]
Pharvaris Presents Data Supporting Ongoing Clinical Development of Deucrictibant in Bradykinin-Mediated Angioedema
Globenewswire· 2025-06-02 10:50
Core Insights - Pharvaris is advancing its late-stage clinical development of deucrictibant, a novel oral bradykinin B2 receptor antagonist aimed at treating bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][18] - The company plans to present pivotal data readouts for deucrictibant in the next 18 months, highlighting its commitment to addressing unmet medical needs in this area [2][4] Prophylaxis - The ongoing Phase 2 CHAPTER-1 open-label extension study shows that oral deucrictibant maintains a low attack rate for over a year and a half, regardless of baseline attack rates [3] - Participants in the CHAPTER-1 study reported significant improvements in health-related quality of life (HRQoL) and treatment satisfaction, with all participants indicating well-controlled HAE [4] - A pharmacokinetics study demonstrated that the extended-release (XR) formulation of deucrictibant supports once-daily dosing, showing a four-fold higher mean plasma concentration than the therapeutic threshold at 24 hours [5][7] On-Demand Treatment - A post-hoc analysis of the RAPIDe-1 and RAPIDe-2 trials indicated that 95-100% of HAE attacks treated with a single dose of deucrictibant achieved symptom relief without recurrence [9] - The median time to onset of symptom relief was reported as 1.1 hours, with 97.8% of attacks achieving relief within 12 hours [10][11] - Deucrictibant was well tolerated across various attack types, including upper airway attacks, with no treatment-related adverse events reported [11] Expansion Beyond HAE - Pharvaris is exploring a novel biomarker assay for diagnosing bradykinin-mediated angioedema, which could enhance the identification and management of related conditions [12] - The company is also assessing the patient experience and outcome measures for AAE-C1INH, aiming to develop a conceptual model to support clinical assessments [14] - A systematic literature review estimated the prevalence of HAE-C1INH in the EU and UK to be between 0.05-0.33 per 10,000 individuals, indicating a significant need for effective treatments [15]
ImmuCell (ICCC) 2025 Conference Transcript
2025-05-29 14:30
Summary of ImmuCell Corporation Conference Call Company Overview - **Company**: ImmuCell Corporation (Ticker: ICCC) - **Industry**: Animal Health, specifically focusing on products that reduce antibiotic use in livestock [1][2] Core Products and Market Position - **First Defense**: A USDA licensed product aimed at providing immediate immunity to newborn calves, reducing the need for traditional antibiotics [3][5][17] - **Retain**: A novel alternative to traditional antibiotics for treating mastitis, currently in the investigational phase due to FDA approval delays [6][38] - **Market Dynamics**: The company positions itself against competitors by emphasizing immediate immunity rather than delayed responses typical of vaccines [17][19] Sales and Financial Performance - **Historical Growth**: From 2011 to 2018, the company experienced an 11.6% CAGR, which accelerated to 15.8% CAGR from 2018 to 2024 following the launch of Tri Shield [12][14] - **Recent Sales Data**: Q1 2024 revenue was $8.1 million, with trailing twelve-month growth reaching $27.3 million, indicating strong recovery from previous production issues [14][15] - **Production Capacity**: The company has successfully doubled its production capacity to over $30 million annually and has been operating without contamination issues since April 2024 [16][15] Operational Challenges and Strategies - **Contamination Issues**: The company faced contamination problems during capacity expansion in late 2022 and throughout 2023, which limited supply [15][16] - **Backlog Management**: The backlog of orders was reduced from over $4 million to just over $3 million, with expectations to clear it in the upcoming quarters [27][28] - **Capital Expenditures**: Plans to increase production capacity from 30 million to 40 million annually, requiring approximately $3 million in capital expenditures [29][30] Product Development and Future Outlook - **First Defense Product Suite**: The product line has evolved since its initial approval in 1991, with the introduction of new formulations to enhance efficacy [34][35] - **Retain Investigational Use**: The company is initiating investigational use of Retain to gather field data, which is crucial for future strategic decisions [39][40] - **Gross Margin Improvement**: Gross margins improved from 22% during contamination issues to 42% in Q1 2025, with a target of reaching 45% [42][45] Strategic Financial Tools - **At-the-Market (ATM) Offering**: The company has utilized the ATM offering judiciously, with significant activity in 2024 but minimal in 2025, allowing for flexibility in financing [31][33] Conclusion - **Optimistic Outlook**: The management expresses optimism for the latter half of 2025, focusing on growth in First Defense and resolving strategic options for Retain [45]
New Research from Sprout Social Finds Social Media is the Top Place Gen Z Turns to for Search, Surpassing Traditional Search Engines
Globenewswire· 2025-05-29 13:01
Core Insights - Gen Z is increasingly turning to social media as their primary source for information, surpassing traditional search engines, with 41% preferring social platforms first [2][3] - The shift towards social media is significantly impacting consumer behavior, with 76% of users indicating that social content influenced their purchases in the last six months, rising to 90% among Gen Z [2][5] - Social media is perceived positively by users, with 60% reporting a net-positive impact on mental health, and 47% stating it has improved their financial decision-making [6] Consumer Behavior Trends - 37% of consumers across all age groups prefer social media for product reviews and recommendations, while 35% use it to find local restaurants and activities [2] - The top content categories consumers seek on social media include cooking inspiration (50%), TV/movie recommendations (43%), and music discovery (36%) [6] - 51% of global users plan to spend more time on community-based platforms like Reddit, with this figure rising to 63% for Gen Z and Millennials [6] Marketing Implications - The findings suggest that marketers should prioritize social media as a key channel for brand awareness and customer engagement, as it is now the primary avenue for product discovery [3] - The survey indicates that younger generations are using social media more intentionally, curating their feeds to align with their interests and values, which presents opportunities for targeted marketing strategies [3][5] - The rise of creator-driven platforms like Substack and Patreon is being led by Gen Z (52%) and Millennials (53%), indicating a shift towards personalized content consumption [6]
Paramount Offers Millions To Trump To End $20B '60 Minutes' Suit & Let Skydance Merger Go Through
Deadline· 2025-05-29 00:24
Core Points - Donald Trump and Paramount are in negotiations regarding a $20 billion lawsuit related to a 60 Minutes segment, with Paramount reportedly offering $15 million while Trump's team demands $25 million and an apology [1][4][8] - The lawsuit alleges violations of Texas' Deceptive Trade Practices Act, typically used for false advertising claims, and is seen as meritless by many observers [3][8] - The ongoing negotiations are critical for Paramount as they seek regulatory approval for a multi-billion dollar merger with Skydance, which has faced delays [10][8] Group 1 - Paramount has made an opening offer of $15 million, while Trump's team is seeking $25 million and an apology from CBS News [4][2] - The lawsuit was filed in October 2024, alleging deceptive practices related to an edited interview with Kamala Harris [2][5] - The outcome of the negotiations could impact CBS News, as leadership changes and concerns over the settlement have arisen [7][6] Group 2 - The merger between Paramount and Skydance requires approval from the FCC, which has been slow, leading to a 90-day extension [10][8] - Trump's legal team has indicated that further legal action may be pursued if CBS and Paramount continue to air segments they deem defamatory [12][8] - The situation has created tension within CBS News, with staff interpreting leadership changes as a sign that a settlement may be imminent [7][6]
IMUNON Closes Up To $9.75 Million Private Placement Priced At-The-Market Under Nasdaq Rules
Globenewswire· 2025-05-28 21:16
Core Viewpoint - IMUNON, Inc. has successfully closed a private placement, raising approximately $3.25 million, with potential additional proceeds of up to $6.5 million from short-term warrants [1][3]. Group 1: Financial Details - The company sold 7,222,223 shares of common stock at a price of $0.45 per share, along with short-term warrants to purchase up to 14,444,446 additional shares [1]. - The total gross proceeds from the private placement are approximately $3.25 million before deducting fees and expenses [3]. - If fully exercised, the short-term warrants could provide an additional $6.5 million in gross proceeds [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for working capital and general corporate purposes [3]. Group 3: Regulatory and Offering Details - The securities were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933 and Regulation D, and have not been registered under the Act [4]. - The offering was made only to accredited investors, and the company has agreed to file registration statements with the SEC for resale of the shares [4]. Group 4: Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using non-viral DNA technology [6]. - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, which has completed multiple clinical trials [7]. - IMUNON is also advancing a COVID-19 booster vaccine (IMNN-101) and aims to leverage its technologies to address difficult-to-treat conditions [7].
iHeartMedia: Is A Turnaround Occurring?
Seeking Alpha· 2025-05-28 13:19
Group 1 - The media industry, particularly traditional broadcast radio companies, has faced significant challenges in recent years, exacerbated by the Covid-19 pandemic [1] - Prior to the pandemic, some companies in this sector appeared to be recovering from previous financial difficulties and were managing their debt loads effectively [1] Group 2 - The article does not provide specific financial data or performance metrics related to the companies discussed [2][3]
PyroGenesis Confirms Receiving Accelerated Customer Request for Fumed Silica Samples
Globenewswire· 2025-05-28 11:30
MONTREAL, May 28, 2025 (GLOBE NEWSWIRE) -- PyroGenesis Inc. (“PyroGenesis”) (http://pyrogenesis.com) (TSX: PYR) (OTCQX: PYRGF) (FRA: 8PY1), a high-tech company that designs, develops, manufactures and commercializes all-electric plasma processes and sustainable solutions to support heavy industry in their energy transition, emission reduction, commodity security, and waste remediation efforts, announced today that, further to its news releases dated May 13, 2025 & May 15, 2025, and that of today’s press rel ...
IMUNON Invited to Present Translational Data in Supporting Remarkable Phase 2 Ovarian Cancer Survival Results at ESMO Gynaecological Cancers Congress 2025
Globenewswire· 2025-05-27 12:05
Core Insights - IMUNON, Inc. is advancing its DNA-mediated immunotherapy, IMNN-001, which shows promising survival data for women with advanced ovarian cancer, with presentations scheduled at major oncology conferences [1][2][4] - The OVATION 2 Study demonstrated significant improvements in overall survival and progression-free survival for patients treated with IMNN-001 in combination with standard chemotherapy [2][5] - IMNN-001 utilizes a proprietary TheraPlas technology platform, delivering interleukin-12 (IL-12) to enhance anti-cancer immunity, marking it as the first IL-12 immunotherapy to show clinical efficacy in advanced ovarian cancer [3][7] Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that leverage the body's immune response, with a particular emphasis on non-viral DNA technology [9][10] - The company is developing multiple modalities, including TheraPlas for gene-based delivery of cytokines and PlaCCine for viral antigens, aiming to address solid tumors and other challenging conditions [9][10] Study Details - The Phase 2 OVATION 2 Study involved 112 patients with newly diagnosed advanced epithelial ovarian cancer, evaluating the safety and efficacy of IMNN-001 combined with neoadjuvant and adjuvant chemotherapy [5][6] - The study's design included a randomized approach comparing IMNN-001 plus standard chemotherapy against standard chemotherapy alone, focusing on overall survival as the primary endpoint [4][6] Future Directions - IMUNON is preparing for the pivotal Phase 3 OVATION 3 Study, which will further assess IMNN-001 in a larger cohort of women with advanced ovarian cancer, including those with specific genetic mutations [4][10] - The company anticipates regulatory review for IMNN-001 in the European Union and other global markets, aiming to improve treatment standards for advanced ovarian cancer [4][10]
EyePoint Completes Enrollment in Pivotal Phase 3 LUGANO Trial of DURAVYU™ for Treatment of Wet Age-Related Macular Degeneration
GlobeNewswire News Room· 2025-05-27 11:00
Core Insights - EyePoint Pharmaceuticals has enrolled over 400 patients in the Phase 3 LUGANO trial for DURAVYU, surpassing its enrollment target and indicating strong interest from both physicians and patients [1][3] - The LUGANO trial is part of a pivotal Phase 3 program designed in alignment with the FDA, with topline data expected in mid-2026 [2][3] - DURAVYU aims to provide a sustained-release treatment option for wet age-related macular degeneration (wet AMD), addressing significant patient needs and market potential [3][5] Company Overview - EyePoint Pharmaceuticals is focused on developing innovative therapeutics for serious retinal diseases, leveraging its proprietary Durasert E™ technology for sustained intraocular drug delivery [9][10] - The lead product candidate, DURAVYU, is a sustained delivery treatment for VEGF-mediated retinal diseases, utilizing vorolanib, a selective tyrosine kinase inhibitor [6][9] - The company has established a robust safety and efficacy profile for DURAVYU, with positive results from previous clinical trials demonstrating significant treatment burden reduction [7][9] Clinical Trials - The LUGANO and LUCIA trials are randomized, double-masked, aflibercept-controlled, non-inferiority Phase 3 trials assessing DURAVYU's efficacy and safety in wet AMD patients [3][4] - The LUGANO trial has completed enrollment, while the LUCIA trial is expected to complete enrollment by the third quarter of 2025 [1][3] - Both trials are designed to evaluate the average change in best corrected visual acuity (BCVA) and other secondary endpoints over a two-year period [3][4] Market Context - Wet AMD is a leading cause of vision loss in individuals over 50, requiring continuous treatment and posing a significant burden on patients and healthcare systems [5] - Current treatments require frequent dosing, which can lead to patient noncompliance and further vision loss, highlighting the need for innovative solutions like DURAVYU [5][6] - The potential for DURAVYU to transform the treatment paradigm for wet AMD is underscored by its unique delivery mechanism and favorable safety profile [3][6]