Boundless Bio (NasdaqGS:BOLD) 2026 Conference February 12, 2026 03:00 PM ET Speaker0A fireside chat with Boundless Bio. I'm really pleased to welcome Zach Hornby, CEO. Zach, welcome. Thanks for joining us.Speaker1Thank you, Michael. Thanks for hosting.Speaker0All right, I'm gonna, I'm gonna start out, just discuss with a really high-level question. It's probably as high as they come. Zach, can you start by discussing your view on some of the largest unmet need in cancer?Speaker1Yeah, absolutely. Happy to. S ...

Summary of DBV Technologies Conference Call Company Overview - **Company**: DBV Technologies (NasdaqCM:DBVT) - **Focus**: Immunology, specifically food allergies in children - **Lead Product**: Viaskin Peanut, aimed at treating peanut allergies in children aged 1-7 Key Points Product Development and Regulatory Filings - **BLA Filings**: Two Biologics License Applications (BLAs) are planned for 2026: - **Children aged 4-7**: Expected filing by mid-2026 - **Children aged 1-3**: Expected filing by the end of 2026 - **FDA Designation**: The product has received breakthrough designation from the FDA and will seek priority review for the first filing [1][2][3] Market Opportunity - **Prevalence of Food Allergies**: Approximately 670,000 children in the U.S. have diagnosed peanut allergies: - 390,000 children aged 4-7 - 280,000 children aged 1-3 - **Response Rates**: In the 1-3 age group, the response rate was 67% for active treatment compared to 33.5% for placebo, with a 22.4% delta [24][25] Clinical Trial Insights - **VITESSE Trial**: The largest trial for peanut allergy with 654 patients, showing a placebo-adjusted efficacy of 32 points [13][14] - **Long-term Benefits**: Open-label extensions indicate improved efficacy and safety over time, with 68% of children in the 1-3 age group able to consume significant amounts of peanuts without anaphylaxis after three years of treatment [25][26] Competitive Landscape - **Comparison with IgE Blockade**: DBV Technologies focuses on desensitization, which is seen as disease-modifying, while IgE blockade is viewed as a temporary solution [5][7][58] - **Palforzia Comparison**: DBV believes Viaskin Peanut is superior due to its ease of use and lower risk of anaphylaxis compared to Palforzia, which requires frequent physician visits and has a higher rate of anaphylaxis during treatment [63][64] Commercial Strategy - **Target Audience**: Approximately 4,500 allergists and immunologists in the U.S. will be targeted for prescribing [43] - **Sales Force**: Estimated need for 50-70 sales representatives to reach the target audience effectively [46] - **Pricing Strategy**: While no final price has been set, Palforzia's pricing at around $1,000 per month is considered a reference point [47][48] Future Directions - **Expansion Plans**: After the approval of Viaskin Peanut, the company plans to pursue other allergies, with cow's milk allergy as the next target [82] - **Manufacturing Capacity**: Current manufacturing is sufficient for initial launch, but plans to triple capacity in the coming years are in place [83] Financial Position - **Funding**: As of Q3, the company has $320 million, which is deemed sufficient to support the launch in 2027 and necessary investments [88][91] Additional Insights - **Engagement with Families**: The company emphasizes the importance of communication with families and patient advocacy groups, as parents of children with food allergies are highly engaged [46] - **Safety Profile**: The Viaskin Peanut patch has shown no severe adverse events in clinical studies, which may lead to a cleaner label compared to other treatments [74][75] This summary encapsulates the critical aspects of DBV Technologies' conference call, highlighting the company's strategic direction, product development, market potential, and competitive positioning in the food allergy treatment landscape.

Summary of Tango Therapeutics Conference Call Company Overview - **Company**: Tango Therapeutics (NasdaqGM:TNGX) - **New CEO**: Malte Peters, who has been a board member since 2018 and emphasizes continuity in strategy following the transition from former CEO Barbara. Key Priorities and Strategic Focus - **Regulatory Approval**: The primary focus is to achieve regulatory approval for vopimetostat, either as a monotherapy or in combination with RAS inhibitors [4][5]. - **Clinical Development**: Transitioning Tango into a late-phase drug development company is a key priority, with a pivotal trial protocol developed for second-line pancreatic cancer [4][6]. Clinical Trials and Data - **Pivotal Trial for Pancreatic Cancer**: A pivotal trial protocol for second-line pancreatic cancer has been developed, with positive feedback from the FDA regarding trial design and statistical analysis [6][11]. - **Combination Trials**: A combination trial of vopimetostat with RevMed's RAS inhibitors (daraxonrasib and zoldonrasib) has been initiated, showing early signs of clinical activity [6][16]. - **Monotherapy Study**: A 300-patient study is planned, focusing on progression-free survival (PFS) and overall survival [9][12]. - **Promising Data**: Previous monotherapy data indicated a 25% overall response rate (ORR) and approximately 7 months PFS in pancreatic cancer [12]. Market and Competitive Landscape - **Global Trial Design**: The study will be conducted globally, including the USA, Europe, and Asia Pacific, to enhance patient recruitment [11]. - **Chemo-Free Regimen**: There is significant interest in developing a chemotherapy-free regimen for pancreatic cancer, which could greatly benefit patients [37][41]. - **Comparison with Competitors**: Tango is pursuing a different strategy than competitors like BMS, focusing on non-chemotherapy combinations due to scientific and financial considerations [40][41]. Future Directions and Opportunities - **Expansion into Other Tumor Types**: The company is exploring opportunities in other tumor types with MTAP deletions, showing promising signals in head and neck cancer [45][46]. - **TNG456 Development**: The TNG456 clinical trial is in dose escalation, with plans to explore its potential in glioblastoma and non-small cell lung cancer [42][43]. - **Combination with Abemaciclib**: There are plans to pursue a combination with abemaciclib based on preclinical data suggesting potential benefits [49]. Upcoming Updates - **Data Releases**: Updates on pancreatic cancer monotherapy data, combination data with Revolution Medicines, and TNG456 dose escalation data are expected later this year [51][56]. Conclusion - **Exciting Year Ahead**: The company anticipates a year filled with significant developments and data releases, positioning itself for potential breakthroughs in cancer treatment [56].

Summary of Apogee Therapeutics Conference Call Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Industry**: Biotechnology, specifically focused on treatments for atopic dermatitis and asthma - **Key Product**: Zumilokibart, targeting type two inflammation Core Insights and Arguments 1. **Company Vision and Progress**: Apogee was founded to provide better treatment options for patients with atopic dermatitis and related conditions. The company is transitioning from a dosing schedule of every 2-4 weeks to potentially every 3-6 months without sacrificing efficacy, aiming to prove this in upcoming studies [2][3][10]. 2. **Phase 1b Asthma Data**: The company reported a 60% reduction in FeNO (Fractional Exhaled Nitric Oxide) from baseline in a study of 19 mild to moderate asthma patients, indicating competitive efficacy compared to other approved agents [5][6]. 3. **Market Opportunity**: There is a 30% overlap between atopic dermatitis and asthma patients, which allows Apogee to expand its market reach into allergist and pulmonologist offices, potentially increasing revenue [7][8]. 4. **Efficacy and Safety**: Apogee aims to demonstrate rapid itch relief and lesional benefits comparable to existing treatments like Dupixent. The company is also focused on maintaining a favorable safety profile, particularly concerning conjunctivitis rates, which are common in this treatment class [10][18][19]. 5. **Phase 3 Studies**: The company is preparing to initiate Phase 3 studies to confirm dosing and efficacy, with expectations of replicating positive results from earlier trials [13][35]. Additional Important Points 1. **Dosing Flexibility**: Apogee's formulation allows for flexible dosing without compromising efficacy, which could lead to better patient adherence and outcomes [36][39]. 2. **Financial Position**: The company has over $900 million in cash, providing a runway into the second half of 2028, which supports ongoing clinical trials and potential product launch [70][71]. 3. **Launch Timeline**: Apogee plans to launch Zumilokibart in 2029, positioning itself as a first-line treatment in the atopic dermatitis market, directly competing with Dupixent [66][67]. 4. **Combination Therapies**: The company is exploring combination therapies with its lead product, Zumilokibart, and other agents, aiming to enhance treatment efficacy for patients who may not respond adequately to monotherapy [54][57]. Conclusion Apogee Therapeutics is positioned to make significant advancements in the treatment of atopic dermatitis and asthma with its innovative product, Zumilokibart. The company is focused on proving its efficacy and safety through ongoing clinical trials while preparing for a strategic market entry in 2029.

Mereo BioPharma Group plc Sued for Securities Law Violations - Investors Should Contact The Gross Law Firm Before April 6, 2026 to Discuss Your Rights - MREO [Accessibility Statement] Skip NavigationNEW YORK, Feb. 12, 2026 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Mereo BioPharma Group plc (NASDAQ: MREO).Shareholders who purchased shares of MREO during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment ...

Neurocrine Biosciences Inc (NASDAQ:NBIX) on Wednesday reported fourth-quarter adjusted earnings of $1.88 per share, missing the consensus of $1.89.Sales reached $805.5 million, beating the consensus of $792.47 million.Fourth-quarter net product sales were $798.3 million, up 29% year over year.Ingrezza (drug for involuntary movements) fourth-quarter and full-year 2025 net product sales were $657.5 million and $2.51 billion, reflecting 7% and 9% growth year-over-year, respectively.Results reflected double-dig ...

Guardant Health Launches Community Colorectal Cancer Screening Grant Program in Recognition of CRC Awareness Month, Applications Now Open [Accessibility Statement] Skip NavigationPatient and Public Health Groups Invited to Apply for Up to 100 Shield Colorectal Cancer Blood Tests to Support Community Screening Events and Educational Outreach in MarchPALO ALTO, Calif., Feb. 12, 2026 /PRNewswire/ -- Ahead of Colorectal Cancer (CRC) Awareness Month in March, Guardant Health, Inc. (Nasdaq: GH), a leading precisi ...

Surrozen (NasdaqCM:SRZN) Conference Call Summary Company Overview - Surrozen is a biotech company founded in 2016, focusing on Wnt biology and antibody engineering, particularly in retinal diseases [3][4] Core Points and Arguments Wnt Pathway and Retinal Diseases - The Wnt pathway is critical for the development and maintenance of various tissues, including the eye [3] - Surrozen is targeting the Fzd4 receptor, which is essential for normal retinal vessel function [4] - Diseases associated with the loss of function of the Wnt pathway include rare conditions like Norrie Disease and FEVR, but the focus is on more prevalent retinal vascular diseases such as diabetic macular edema (DME) and wet age-related macular degeneration (AMD) [6][7] Competitive Landscape - Surrozen's lead molecule is positioned against competitors like Merck, which has a similar pharmacological approach and is currently in Phase III trials [6][7][29] - The current market is dominated by Roche's Vabysmo and Eylea, which are anti-VEGF therapies [29] Mechanism of Action - Surrozen's approach involves activating the Wnt pathway to restore normal vessel architecture and function, contrasting with existing therapies that inhibit pathological factors like VEGF [17][20] - Activation of the Wnt pathway is shown to upregulate tight junction proteins, which help seal leakage in retinal endothelial cells, particularly relevant in DME [19][20] Clinical Development - Surrozen has three programs: two internal molecules (8141 and 8143) and one partnered with Boehringer Ingelheim (SZN-413) [27][82] - The IND for molecule 8141 is expected to clear in 2026, with ongoing IND-enabling work [41][61] - Molecule 8141 is a bispecific tetravalent antibody targeting Wnt and VEGF, while 8143 adds IL-6 inhibition, making it trifunctional [71][72] Upcoming Milestones - The first Phase III trial data for Merck's molecule is expected in September 2026, which could validate the Wnt pathway's role in treating retinal diseases [75] - Surrozen anticipates updates on the IND timelines and further details on clinical trial designs soon [70][88] Intellectual Property and Financial Health - Surrozen has a robust patent estate with approximately 38 applications, focusing on multivalent Frizzled and LRP5/6 binding antibodies [89] - The company completed a PIPE in March 2025, raising $175 million, with $80 million in cash reported at the end of Q3 2025 [90] Other Important Information - The partnership with Boehringer Ingelheim has yielded $22.5 million, with hopes for clinical advancement of SZN-413 [82][85] - Roche's acquisition of Frizzled and LRP binders from University of Toronto is noted, but no updates on their progress have been provided [87] This summary encapsulates the key points discussed during the conference call, highlighting Surrozen's strategic focus, competitive positioning, and future milestones in the context of retinal disease treatment.

Summary of Nuvalent Conference Call Company Overview - **Company**: Nuvalent (NasdaqGS:NUVL) - **Focus**: Development of kinase inhibitors targeting clinically validated cancer therapies, particularly ROS1 and ALK inhibitors [2][3] Regulatory Progress - **ROS1 Program**: - FDA accepted NDA for zidesamtinib in TKI-pretreated ROS1-positive non-small cell lung cancer (NSCLC) with a PDUFA date of September 18 [3] - Plans to submit data for TKI-naive ROS1 indication in the second half of the year [3][5] - **ALK Program**: - Completed pre-NDA meeting with FDA for neladalkib in TKI-pretreated ALK-positive NSCLC, with NDA submission planned for the first half of the year [3] - Ongoing phase 3 ALCAZAR study for TKI-naive ALK patients [4] Clinical Data and Differentiation - **Zidesamtinib**: - First drug with a profile targeting original fusion and ROS1 mutations, with CNS activity [8] - Demonstrated durable responses across treatment lines, particularly in CNS disease [9] - **Neladalkib**: - Shows double the durability of lorlatinib in second-line treatment, with over 60% of patients still responding at 1.5 years [10][11] - Well-tolerated with excellent CNS activity, allowing patients to remain on therapy longer [11] Market Strategy - **Commercialization**: - Nuvalent plans to go it alone for ex-U.S. commercialization, citing macro issues around pricing and the desire for flexibility [21][22] - Strong enrollment in clinical trials and positive durability data support the decision to build a global biotech company [22][24] - **Financial Position**: - Ended the previous year with approximately $1.4 billion in cash, providing operational runway into 2029 [36] - Current guidance does not include revenues from sales, indicating a strong position to build globally [36] Market Potential - **Sales Projections**: - ROS1 market could grow to resemble the current ALK market, estimated at over $2 billion [38] - ALK market could expand to match the EGFR market, potentially 2-3 times larger than current levels [38] - **Geographic Sales Distribution**: - Historically, 65%-70% of sales for similar drugs have come from outside the U.S., indicating a significant opportunity for Nuvalent [39] Future Developments - **HER2 Program**: - Focused on developing a drug that effectively targets HER2 mutations while minimizing side effects, with plans to showcase data in the future [44][46] - Potential for expansion beyond lung cancer into other solid tumors [46] - **Fourth Program**: - An unnamed program is set to be announced this year, focusing on unmet medical needs identified through physician feedback [47] Conclusion - Nuvalent is positioned to capitalize on its innovative drug portfolio with a strong regulatory strategy and a clear path to commercialization. The company aims to build a sustainable global biotech presence while addressing significant market needs in oncology.

Steady execution on sales and clinical development builds value over time for biotechs but tends to be rather boring from a market sentiment standpoint. Neurocrine Biosciences ( NBIX ) is doing the right things to build value for its shareholders, but 2026Analyst’s Disclosure: I/we have a beneficial long position in the shares of NBIX either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other tha ...