Tectonic Therapeutic (TECX) 2025 Conference May 15, 2025 12:20 PM ET Speaker0 Hey, everyone. Good morning, and welcome to day three of the twenty twenty five Bank of America Healthcare Conference. And thanks for joining this session with Tectonic Therapeutics. My name is Alex Stranahan. I'm senior biotech analyst at Bank of America. And I'm pleased to introduce Elise Raisin, president and CEO of Tectonic. She'll be running through some slides and going over the company. So with that, Elise, over to you. Spe ...

Summary of Maris Conference Call Company Overview - Maris is an oncology-focused company with multiple assets, including an approved drug, Bizengri, and several clinical-stage assets. The company specializes in bispecific antibodies and T cell engagers, aiming to improve treatment outcomes in cancer therapy [4][5]. Recent FDA Interactions - Maris has had successful interactions with the FDA regarding its approved drug Bizengri and its clinical asset pitocentimab, both of which have received multiple breakthrough therapy designations. The company is currently executing Phase III registration trials and has established its Project Optimus Phase III dose [6][7]. Upcoming Catalysts - An important presentation at the ASCO conference is scheduled for June, with an investor call on May 22 to discuss clinical data related to the treatment of frontline head and neck cancer in combination with Keytruda. The presentation will include updated efficacy data from a cohort of 45 patients [9][10][11]. Key Efficacy Metrics - The twelve-month landmark overall survival (OS) rate is a critical metric for the trial, as it provides insight into the drug's effectiveness. Historical control rates for pembrolizumab alone show a 50% to 59% survival rate, which will serve as a benchmark for Maris's data [16][18]. Response Rate and Progression-Free Survival (PFS) - Maris reported a 67% response rate in the initial cohort of patients treated with pedosemtamab in combination with pembrolizumab, significantly higher than the historical response rates of 19% to 25% for pembrolizumab alone. The company is optimistic about maintaining this response rate as data matures [15][19]. Safety Profile - The safety profile of pedosemtamab is considered favorable, with infusion-related reactions occurring in approximately 35% of patients during the first infusion. The company has implemented a premedication regimen to manage these reactions effectively [37][38]. Differentiation in Treatment Approach - Maris's approach includes treating both HPV-positive and HPV-negative patients, which is a point of differentiation from competitors that focus solely on HPV-negative patients. The company believes this broad approach aligns with regulatory precedents and enhances the potential patient population [30][34][39]. Competitive Landscape - Maris's treatment strategy is compared to Exelixis's ZANZA plus pembrolizumab. Concerns about tolerability and safety arise with multi-kinase inhibitors like ZANZA, while Maris emphasizes the favorable safety profile of its bispecific antibody [35][36]. Enrollment and Future Steps - Maris has around 120 active sites for its Phase III trials and aims to be substantially enrolled by the end of the year. The company is also preparing for potential accelerated approval based on early endpoints such as overall response rate (ORR) [40][42]. Financial Position - As of the last quarter, Maris reported a cash balance of $638 million, which is expected to sustain operations through 2028 and cover the top-line readout of its Phase III trials [55]. Conclusion - Maris is positioned to make significant advancements in oncology with its innovative bispecific antibody platform, promising clinical data, and a strong financial foundation. The upcoming ASCO presentation and ongoing trials will be critical in determining the company's trajectory in the competitive oncology landscape.

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Core Points - The Combined Ordinary and Extraordinary General Meeting of Transgene's shareholders took place on May 15, 2025, where various resolutions were voted on and approved [1][2] - The meeting resulted in the renewal of the terms of office for several Board Members, maintaining a diverse and independent Board composition [3][4] - A share capital reduction was approved, decreasing the par value of shares from €0.50 to €0.30, along with the delegation of authority for a potential reverse stock split [5] Company Overview - Transgene is a biotechnology company focused on developing targeted immunotherapies for cancer treatment, with a portfolio that includes viral vector-based immunotherapeutics [7] - The lead asset, TG4050, is an individualized therapeutic vaccine aimed at head and neck cancers, showcasing the company's innovative approach to precision medicine [8] - Transgene utilizes its proprietary Invir.IO® platform to engineer multifunctional oncolytic viruses, enhancing its capabilities in viral vector technology [9]

Quince Therapeutics ( QNCX ) is pursuing the treatment of ataxia-telangiectasia, a rare neurodegenerative disorder, which starts in early childhood. I have covered the company in the summer of 2024, and the stock has performedI am working in the financial sector. My areas of interest are technology, biotech, pharmaceutical companies, banks and a bit of shipping when an actionable trade passes on my radar.Analyst’s Disclosure: I/we have a beneficial long position in the shares of QNCX either through stock ow ...

VANCOUVER, Washington, May 15, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today shared the Company's poster presented at the European Society for Medical Oncology's ("ESMO") Breast Cancer meeting on May 14-17, 2025, in Munich, Germany. This news release may contain forward-looking statements relating to, among other things, clinical trial results, p ...

Core Insights - IMUNON, Inc. announced promising results from its Phase 1 clinical trial of IMNN-101, a DNA plasmid vaccine utilizing the PlaCCine technology platform, demonstrating better durability and safety compared to mRNA vaccines [1][2][4] Group 1: Clinical Trial Results - The Phase 1 trial involved 24 healthy volunteers and showed that IMNN-101 provided a durable immune response, with a median increase of up to 3-fold in serum neutralizing antibody titers at six months post-vaccination [1][6] - The highest observed increase in neutralizing antibody titers among participants was 8-fold from baseline, indicating a strong immune response [1][4] - IMNN-101 was well tolerated with no serious adverse effects reported, reinforcing its safety profile [1][2] Group 2: Technology and Competitive Advantages - The PlaCCine technology platform offers several advantages, including stability at workable temperatures and ease of manufacturing compared to existing mRNA vaccines [2][5] - IMNN-101 is designed to accommodate single or multiple antigens, providing flexibility in vaccine development [5] - The vaccine demonstrated cross-reactivity against the Omicron XBB1.5 variant and other newer variants, indicating its potential effectiveness against emerging pathogens [4][6] Group 3: Future Development and Strategic Goals - The company is in discussions for further development of the PlaCCine platform for prophylactic vaccines, aiming for long-term strategic partnerships to advance these technologies [2][3] - IMUNON's broader goal is to expand its vaccine toolkit to address unaddressed infectious diseases and reduce hospitalizations [3][8] - The company is also advancing its other clinical programs, including IMNN-001 for advanced ovarian cancer, showcasing its commitment to innovative treatments [7][8]

Core Insights - Akari Therapeutics is focused on developing novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads to treat various cancer tumors [1][2] - The company appointed Mark Kubik as the new Head of Business Development for Oncology, enhancing its executive team with deep oncology experience [2] - Akari's lead asset, AKTX-101, targets the Trop2 receptor and utilizes the innovative PH1 payload, which is a spliceosome inhibitor designed to induce cancer cell death while activating immune responses [8] Financial Performance - For Q1 2025, Akari reported a net loss of approximately $3.7 million, a decrease from $5.6 million in Q1 2024 [4][16] - Research and development expenses were $0.8 million in Q1 2025, down from $2.3 million in the same period of 2024, primarily due to the suspension of the HSCT-TMA clinical program [4] - General and administrative expenses decreased to approximately $2.7 million in Q1 2025 from $3.7 million in Q1 2024, attributed to reduced legal and professional fees [5] Pipeline and Development Milestones - The company is advancing a pipeline of potentially first-in-class ADC candidates, with significant tumor-killing activity observed in preclinical models [2] - Upcoming milestones include presenting preclinical data on the PH1 payload's immuno-oncology activity at a scientific conference in the second half of 2025 [6] - Akari is exploring preclinical activity for AKTX-101 in various solid tumor indications and seeking strategic partners for research collaborations [6] Cash Position and Funding - As of March 31, 2025, Akari had cash of approximately $2.6 million, with net proceeds from a March 2025 offering totaling around $6.0 million [7] - The company continues efforts to out-license non-core assets in inflammation, ophthalmology, and rare diseases to generate non-dilutive capital for its ADC platform [3]

Market Overview - As of mid-May 2025, the S&P 500 has turned positive year-to-date for the first time in many weeks, indicating a broad recovery across multiple sectors from previous volatility [1][2] - Despite the market improvement, ongoing trade disputes and the Trump administration's tariff policies remain a concern [2] Cogent Communications - Cogent Communications is currently trading at $50.87, with a 12-month stock price forecast of $75.75, indicating a potential upside of 48.91% based on 8 analyst ratings [5][8] - The company has seen a significant drop in share price since February, nearing a one-year low, but has strong growth potential in wavelength services, which have more than doubled in revenue over two years [6][7] - Cogent expects to capture a quarter of the North American wavelength market in the next three years, with current revenue in this category at $7.1 million [7] Regeneron Pharmaceuticals - Regeneron Pharmaceuticals is trading at $571.36, with a 12-month stock price forecast of $890.60, suggesting a potential upside of 55.87% based on 26 analyst ratings [9][10] - The company has experienced a 20% decline year-to-date and a 42% drop over the last 12 months, reaching a multi-year low [10] - Regeneron benefits from a robust pipeline and recent sales growth, achieving $14 billion in sales in 2024, up from over $13 billion the previous year [11] - The company has a low debt-to-equity ratio of 0.09 and initiated dividend payments in February 2025, enhancing its appeal to investors [13] Atlas Energy Solutions - Atlas Energy Solutions is currently priced at $13.23, with a 12-month stock price forecast of $19.81, indicating a potential upside of 49.75% based on 12 analyst ratings [14][16] - The company has faced a 42% decline year-to-date amid broader energy sector turmoil but benefits from a specialized focus with little competition [14][15] - Atlas Energy's operations in the Permian Basin provide a geographic advantage, helping to reduce costs and streamline logistics [15]

Core Insights - Kraig Biocraft Laboratories, Inc. has received a business license to operate in Cambodia, marking a significant step in its strategy to scale up and diversify production capabilities in response to its 2025 expansion initiatives [1][2][3] Group 1: Expansion Strategy - The decision to launch operations in Cambodia is based on the positive momentum achieved through expanded production efforts this year [2] - The Cambodian business license is expected to support the company's goals of increasing production capacity while diversifying its production footprint [3] Group 2: Production and Technology - The new location in Cambodia is seen as an opportunity to enhance the company's spider silk production scale, leveraging the right combination of climate and infrastructure [3] - Kraig Labs continues to invest in research and infrastructure to advance the performance and scalability of its proprietary recombinant spider silk technologies [3][4] Group 3: Industry Position - Kraig Labs is recognized as a leader in genetically engineered spider silk-based fiber technologies, with significant breakthroughs that have implications for the global textile industry [5][6]