Spyre Therapeutics Inc (SYRE) FY Conference June 09, 2025 09:20 AM ET Speaker0 Thank you for joining us. I'm Paul Choi, and I cover biotechnology here at the firm. It's our pleasure to welcome Spire, and we have Cameron here on on stage with us. Maybe to to kick it off, Cameron, can just give us a brief overview of Spire and just sort of the key programs and technologies under pending pending the company? Yeah. Speaker1 Of course. And so and thanks for having us. It's a great event as always. So the backgro ...

Core Insights - Avidity Biosciences announced positive topline data from the Phase 1/2 FORTITUDE™ program for delpacibart braxlosiran (del-brax) in treating Facioscapulohumeral Muscular Dystrophy (FSHD), showing improvements in function, strength, and patient-reported outcomes compared to placebo [1][3][6] - The company plans to submit a Biologics License Application (BLA) for accelerated approval in the second half of 2026 [1][3] - Del-brax is the first investigational therapy targeting the underlying cause of FSHD by directly addressing the DUX4 gene, with no approved therapies currently available for this condition [2][13] Group 1: Clinical Data and Results - The FORTITUDE™ trial included a randomized, placebo-controlled, double-blind study evaluating 39 participants on doses of 2 mg/kg or 4 mg/kg of del-brax over 12 months [5][10] - Results indicated consistent improvements in functional mobility and muscle strength, as measured by the 10-Meter Walk-Run test, Timed Up and Go, and quantitative muscle testing [6][9] - Significant reductions in biomarkers such as KHDC1L and creatine kinase were observed, indicating muscle damage [6][7] Group 2: Safety and Regulatory Pathway - Del-brax demonstrated favorable long-term safety and tolerability, with most adverse events being mild or moderate, and no serious adverse events reported [7][9] - The U.S. FDA has opened the accelerated approval regulatory pathway for del-brax, and a global Phase 3 FORWARD™ study has been initiated [3][4] Group 3: Future Developments - The ongoing biomarker cohort of the FORTITUDE trial aims to assess the impact of del-brax on KHDC1L levels, with topline data expected in Q2 2026 [7][11] - Avidity is advancing its clinical development pipeline, focusing on RNA therapeutics through its proprietary Antibody Oligonucleotide Conjugates (AOCs™) platform [16]

Summary of Key Points from the Conference Call Industry Overview - **Industry**: China Pharma and Biotech - **Focus**: Updates from ASCO 2025 regarding various cancer treatments, particularly in extensive stage small cell lung cancer (ES-SCLC) and non-small cell lung cancer (NSCLC) Core Insights and Arguments 1. **Zai Lab's ZL-1310 (DLL3 ADC)**: - Reported a 68% overall response rate (ORR) in the dose escalation group (n=28) for ES-SCLC - Notable results in 2L patients: 67% ORR across doses (n=33) and 79% ORR in the 1.6 mg/kg group (n=14) [1][8] - Safety profile shows 23% Grade ≥3 treatment-related adverse events (TRAE) [1] - Potential for best-in-class (BIC) status, pending survival data [1] 2. **Innovent's IBI363 (PD-1/IL-2 bispecific)**: - High ORR of 37% and median progression-free survival (mPFS) of 9.3 months in squamous NSCLC patients who failed PD-(L)1 treatment [2][10] - Efficacy significantly surpasses Dato-Dxd (Daiichi Sankyo/AstraZeneca) in cross-trial comparisons [2] 3. **Hengrui's SHR-1826 (c-met ADC)**: - Demonstrated a 29% confirmed ORR and 40% unconfirmed ORR in NSCLC patients with c-met alterations [2][10] - C-met alterations are prevalent in 10-60% of NSCLC globally, indicating a substantial market opportunity [2] 4. **Market Potential**: - NSCLC has a total addressable market (TAM) of approximately US$30 billion, with 1L treatment representing over 60% of this market [4] - Breast cancer market estimated at US$35 billion, with emerging products but no significant efficacy improvements over leading global products [4] 5. **Investment Ratings**: - Outperform ratings maintained for Akeso, Hansoh, Innovent, and Hengrui [6] - Market-Perform ratings for BeiGene, CSPC, Sino Biopharm, and Zai Lab [6] Additional Important Content - All updates are derived from Phase 1 trials, typically lacking control groups [3] - The competitive landscape includes various other companies and products, with specific mentions of Akeso, 3S Bio, and Kelun Biotech in relation to their respective therapies [4][7] - The report emphasizes the importance of survival data for ZL-1310 to validate its potential in the market [1][8] This summary encapsulates the critical developments and insights from the conference call, highlighting the advancements in cancer therapies and their implications for the market and investment opportunities.

Investment Rating - The report assigns an "Overweight" (OW) rating to Akeso with a price target of HK$99.00 by December 2025 [2][5]. Core Insights - Akeso's AK104, a PD-1/CTLA-4 bispecific antibody, has received approval in China for first-line treatment of persistent, recurrent, or metastatic cervical cancer, which is expected to significantly boost sales in China [1][4]. - The report anticipates a global development plan for AK104 to be announced in the second half of 2025, which could attract investor interest [1][4]. - Upcoming catalysts include sales figures for AK104 and AK112, the potential global development plan announcement, and detailed data from the HARMONi studies [4][5]. Summary by Sections Approval and Efficacy - AK104's approval is based on strong results from the Phase 3 COMPASSION-16 study, showing a median overall survival (mOS) not reached in the AK104+chemo cohort compared to 22.8 months in the control group, and a median progression-free survival (mPFS) of 12.7 months versus 8.1 months [4]. Market Potential - The report estimates that AK104 could generate approximately RMB 6 billion in peak sales in China, while AK112 is expected to achieve over RMB 5 billion in peak sales in non-small cell lung cancer (NSCLC) [5]. Valuation - The price target of HK$99.00 is based on a discounted cash flow (DCF) valuation, assuming a terminal growth rate of 3.0% and a weighted average cost of capital (WACC) of 9.4% [6].

Core Insights - Bristol Myers Squibb (BMY) has entered a strategic collaboration with BioNTech (BNTX) for the co-development and co-commercialization of the bispecific antibody BNT327, targeting multiple solid tumor types [1][9]. Company Developments - BNT327 is a next-generation bispecific antibody that targets PD-L1 and VEGF-A, currently in trials with over 1,000 patients, including phase III studies for extensive stage small cell lung cancer (ES-SCLC) and non-small cell lung cancer (NSCLC) [2][4]. - BMY will make an upfront payment of $1.5 billion to BioNTech, with additional non-contingent anniversary payments of $2 billion through 2028, and up to $7.6 billion in potential milestone payments [3][9]. Financial Performance - BMY's shares have declined by 13.6% year-to-date, compared to a 3.3% decline in the industry [8]. - The company is trading at a price/earnings ratio of 7.31x forward earnings, lower than its historical mean of 8.55x and the large-cap pharma industry's average of 14.95x [10]. Earnings Estimates - The Zacks Consensus Estimate for BMY's 2025 earnings per share has increased to $6.85 from $6.75 over the past 60 days, while the estimate for 2026 has decreased [11].

Core Insights - OBI Pharma and TegMine Therapeutics have entered into a Master Services Agreement (MSA) to collaborate on antibody-drug conjugates (ADCs) [1][2] - The partnership aims to leverage OBI's GlycOBI ADC enabling technologies to identify ADC therapeutic candidates for clinical development [2][3] Company Overview - OBI Pharma is a clinical-stage global oncology company based in Taiwan, established in 2002, focusing on developing novel cancer therapies for patients with high unmet medical needs [5] - TegMine Therapeutics, founded in 2017 and based in San Francisco, specializes in developing next-generation antibody-based therapies targeting cancer-associated glycans and glycoproteins [8][9] Technology and Innovation - OBI's GlycOBI technology is a unique glycan-based ADC platform that is compatible with various antibodies, linkers, and payloads, allowing for site-specific homogenous ADCs [4] - The GlycOBI platform utilizes proprietary enzymatic and linker technologies to enhance conjugation efficiency and reduce aggregation propensity, leading to improved antitumor activity and stability [4][6] Strategic Collaboration - The collaboration is expected to combine the strengths of both companies, with OBI's ADC technology complementing TegMine's focus on targeting cancer-specific glycans [3] - Both companies anticipate developing ADCs with unprecedented tumor specificity and therapeutic impact, addressing significant medical needs [3]

Pyxis Oncology Inc (PYXS) 2025 Conference June 05, 2025 04:55 PM ET Speaker0 Good afternoon, everyone. My name is Farzin Hak. I'm one of the biotech analysts at Jefferies. I'm happy to introduce and welcome Lara Selivan, CEO of Pyxis Oncology. This is a fireside chat format. Thank you for joining us today. Speaker1 Thank you for having us. We appreciate it. Speaker0 So for those who are new to the story, can you provide a short overview of your program? Speaker1 Yes. So Pixis Oncology is an EDC focused comp ...

CytomX Therapeutics (CTMX) 2025 Conference June 05, 2025 02:35 PM ET Speaker0 All right. All right. Welcome, everyone, to Jefferies twenty twenty five Global Healthcare Conference. My name is Roger Sung, one of the senior analysts cover SMICHA Biotech in The US. It is my pleasure to have the next fireside chat with Atomic Therapeutics CEO, Sean. Good. Yeah. Good to see you. Speaker1 Pleasure to be here, Roger. Speaker0 Awesome. Maybe before we start, we know you just announced a very exciting data from your ...

ALX Oncology Holdings (ALXO) 2025 Conference June 05, 2025 01:25 PM ET Speaker0 People here with us. And I would love to give the opportunity for, perhaps Jason, to make some opening comments about, where ALX is at now. They obviously are interrogating an anti CD47 antibody. There was gastric results. They talked with FDA about it. But there's no doubt they continue to have a lot of promise on that with other modalities, ADCs, etcetera. Should talk a little bit about that and where you are with that program ...

Compass Therapeutics (CMPX) 2025 Conference June 05, 2025 11:05 AM ET Speaker0 And one of the biotech analysts at Jefferies. It's with great pleasure I'd like to welcome Tom Schutz, the CEO of Compass Therapeutics. Thanks so much for joining us today, Tom. Speaker1 Thanks, Maury. Thanks for inviting us. Appreciate it. Speaker0 And we're gonna do fireside chat format. So maybe for those who are new to this story, if you can give a one minute intro to Compass. Speaker1 Sure, thanks. Compass, we're based in Bo ...