Financial Status and Strategy - CureVac has a strong financial position with €550.9 million in cash as of September 30, 2024, and an expected cash runway into 2028[82, 87] - The company streamlined costs and enhanced financial discipline, including a 30% workforce reduction expected by the end of 2024[8, 85, 88] - CureVac refocused its portfolio on innovation and R&D, concentrating on high-value programs in infectious diseases and oncology[8, 9] - A strategic transformation is on track, with OPEX expected to decrease by over 30% from 2025 onwards, including a €25 million decrease in personnel costs[85] Pipeline and Development - CureVac is advancing key pipeline milestones for novel medicines targeting unmet needs, with a focus on expanding the pipeline in oncology and infectious diseases[10, 14] - In oncology, a new shared-antigen lung cancer program is set to start clinical trials in H2 2025, and personalized cancer vaccines are progressing with the first candidate expected to enter the clinic in H2 2026[14] - For infectious diseases, a new non-respiratory program was initiated for Uropathogenic E coli (UPEC) in urinary tract infections, with promising preclinical data[14] - Respiratory infectious disease programs, including seasonal influenza, avian influenza, and COVID-19, are fully out-licensed to GSK, with Phase 3 starting for seasonal flu in 2025[13, 37, 86] Technology and Manufacturing - CureVac's mRNA platform is versatile, featuring precision mRNA backbone, improved LNP delivery systems, and a strong intellectual property portfolio[12, 13] - The company utilizes advanced delivery systems, including proprietary therapeutic area-specific next-generation lipid nanoparticles, and scalable manufacturing, including The RNA Printer®[12] - CureVac's Infectious Disease LNP offers thermostability for more than 12 months at refrigerator temperature (2-8°C)[60]

Summary of Moderna (MRNA) Update / Briefing June 16, 2025 Company Overview - **Company**: Moderna (MRNA) - **Focus**: Oncology pipeline and commercial strategy Key Points on Oncology Pipeline 1. **Oncology as a Key Focus**: The company emphasizes the importance of oncology in its future development, with a focus on individualized therapies and cancer antigen therapies [3][4] 2. **Lead Program - Intisiran Auto Gene (INT)**: This individualized neoantigen therapy has shown a 49% reduction in the risk of recurrence or death in a Phase 2 study for adjuvant melanoma, with pivotal study data expected in 2026 [7][39] 3. **Expansion of INT**: The company is exploring INT in various cancer settings, including combinations with pembrolizumab and as a monotherapy [7][8] 4. **Off-the-Shelf Cancer Antigen Therapies**: These therapies are designed for broader patient use and are currently in development, with lead programs mRNA-4106 and mRNA-4359 targeting specific tumor antigens and training the immune system [10][11] 5. **T Cell Engagers**: The company is developing multiplexed T cell engagers that can target multiple proteins on cancer cells, enhancing the immune response [16][17] 6. **In Vivo Cell Therapies**: Moderna is pursuing innovative approaches to enhance the efficacy of cell therapies, including engineered T cells that can be modified within the patient's body [20][24] Clinical Development and Data 1. **Phase 2 and Phase 3 Studies**: The company is preparing for Phase 3 trials based on encouraging Phase 2 data, with a focus on event-driven trial designs [34][40] 2. **Control Arm Performance**: The performance of the pembrolizumab control arm in Phase 2 is reported to be in line with historical data, addressing investor concerns about patient allocation [32][36] 3. **Safety and Tolerability**: The safety profile of mRNA-4359 and INT is favorable, with low-grade adverse events and no dose-limiting toxicities reported [15][62] Market and Competitive Landscape 1. **Partnerships and Collaborations**: Moderna is closely monitoring competitive developments, including BioNTech's recent acquisition of CareVac and their oncology programs [78] 2. **Regulatory Environment**: The company is navigating a changing political landscape that affects vaccine development and approval processes, particularly in the context of COVID-19 and RSV vaccines [82][86] Financial Guidance and Market Outlook 1. **Revenue Guidance**: Moderna has provided a broad revenue guidance range of $1.5 billion to $2.5 billion for the year, considering potential declines in vaccination rates and other market factors [96] 2. **Future Approvals**: The company is optimistic about upcoming FDA approvals and the potential for expanded indications for its vaccines, particularly for high-risk populations [85][89] Additional Insights 1. **Combination Therapies**: The company is exploring combination therapies with checkpoint inhibitors and other agents, aiming to enhance overall response rates and progression-free survival (PFS) [65][66] 2. **Clinical Trial Design**: The design of clinical trials is being carefully considered, with a focus on achieving statistically significant outcomes that can support regulatory filings [50][52] This summary captures the essential points discussed during the call, highlighting Moderna's strategic focus on oncology, clinical development progress, market positioning, and financial outlook.

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Viewpoint - Moderna has faced a significant decline in stock value, approximately 80% over the past three years, due to reduced demand for its coronavirus vaccine, despite recent positive developments in its product pipeline and cost-cutting measures [1][2][10]. Group 1: Company Performance - Moderna's revenue peaked at $18.4 billion in 2022 from its coronavirus vaccine, but demand has since dropped, leading to a decline in sales [5][10]. - The company has received approval for a second product, its respiratory syncytial virus (RSV) vaccine, but initial sales have been disappointing [2][6]. - Moderna aims to achieve between $1.4 billion and $1.7 billion in GAAP operating cost reductions by 2027 [7]. Group 2: Product Pipeline and Future Goals - Moderna has a robust late-stage pipeline with goals for up to 10 product approvals in the coming years, including multiple cancer vaccines [8][9]. - Currently, there are seven cancer-vaccine candidates in phase 2 or phase 3 studies, which could provide multiple revenue streams if successful [9]. - The company continues to focus on advancing its mRNA technology across various treatment areas, including latent viruses and cancer vaccines [4][5]. Group 3: Market Challenges and Investor Sentiment - Despite positive developments, investor sentiment remains cautious due to the ongoing decline in coronavirus vaccine sales and early disappointments in the RSV market [10][12]. - Uncertainty surrounding government vaccine policies may also pose challenges for Moderna's stock performance [11]. - Long-term prospects for revenue growth remain, particularly as key product approvals approach, suggesting potential for future stock appreciation [13][14].

Company Overview - Moderna has developed a robust mRNA platform over many years, focusing on infectious disease vaccines, oncology, and rare genetic diseases, with potential expansion into autoimmune diseases [3]. Current Business Status - The company aims to drive revenue growth with existing products as its top priority [4]. - The second priority is to launch new products, although specific details on these launches were not provided in the excerpts [4]. Market Context - The current environment includes factors such as COVID-19 demand, regulatory changes from HHS and FDA, and drug pricing dynamics, all of which impact Moderna's business strategy [2].

Company Overview - Moderna is focused on building a diverse portfolio of products utilizing mRNA technology, targeting areas such as infectious diseases, cancer, rare diseases, and autoimmune diseases [3]. Strategic Priorities - The company has outlined three main priorities for the year: 1. To drive sales through approved products, specifically COVID-19 and RSV vaccines [3]. 2. To launch new products to diversify and grow the top line, with up to 10 launches planned over the next few years and several Biologics License Applications (BLAs) already filed [4]. 3. To resize the company from a cost perspective in response to the transition from pandemic-related sales [4].

Core Viewpoint - Moderna Inc. has experienced a significant decline in stock price, down 35% in 2025 and over 80% in the last 12 months, indicating a loss of all gains made during the COVID-19 vaccine market entry [1][2] Group 1: Stock Performance - The stock is currently priced at $25.80, with a 52-week range between $23.15 and $170.47 [1] - Analysts have set a 12-month price target of $53.95, suggesting a potential upside of 109.10% from the current price [4][12] - The stock has shown a slight recovery with single-digit gains in the last month, indicating possible bottoming out [2] Group 2: Market Sentiment and News Impact - Vaccine skepticism has become a significant concern, particularly with the appointment of Robert Kennedy Jr. as Secretary of Health & Human Services, affecting vaccine approval perceptions [3] - Moderna's decision to withdraw its application for a combination flu/COVID-19 vaccine candidate has contributed to stock volatility, with expectations for approval now pushed to 2026 [5] - The Trump administration's move to implement "most-favored nation" status for pharmaceutical prices has raised concerns about potential price controls, although the stock has seen some gains since the announcement [6] Group 3: Future Prospects and Technology - mRNA technology, which was relatively unknown before 2020, is now recognized for its potential in drug discovery, particularly in vaccine development [7] - The advantages of mRNA vaccines include ease of production, lower costs, safety, and high potency, which are beneficial for treating infectious diseases [8] - Moderna is also developing oncology vaccine candidates in partnership with Merck & Co., indicating a broader pipeline beyond COVID-19 [9] Group 4: Short Squeeze Potential - Current short interest data shows over 60 million shares are short, suggesting conditions are ripe for a potential short squeeze if market sentiment shifts positively [10] - Positive news regarding vaccine boosters could serve as a catalyst for a sentiment reversal, as the sell-off appears overdone [10] Group 5: Analyst Ratings and Market Position - Despite recent declines, analysts have lowered price targets but maintain a consensus target of $53.95, which is significantly higher than the current price [12] - Currently, Moderna holds a "Hold" rating among analysts, with some suggesting that other stocks may present better investment opportunities [14]

Group 1: Investment Opportunities - Equity markets present bargains with stocks that have underperformed but may rebound as conditions improve [1] - Moderna is highlighted as a beaten-down stock with promising prospects due to its advancements in mRNA technology and a strong pipeline of potential products [2][4] - Moderna's revenue guidance is projected at $2 billion, primarily from its COVID vaccine efforts, and the company plans to cut operating expenses by $1.4 billion to $1.7 billion by 2027 [8][9] Group 2: Company-Specific Analysis - Moderna - Moderna's mRNA-4157, a personalized cancer vaccine, has shown strong results in phase 2 studies and is currently in phase 3 trials [6] - The company is also developing a standalone influenza vaccine and a combined COVID/flu shot, both nearing approval [7] - Despite a decline in stock performance over the past three years, Moderna's potential for growth remains strong due to its innovative pipeline and cost-cutting measures [9] Group 3: Investment Risks - Teladoc Health, a telemedicine company, has seen a slowdown in revenue growth and remains unprofitable despite high gross margins [10] - In the first quarter, Teladoc's revenue decreased by 3% year over year to $629.4 million, with a net loss per share of $0.53 [11] - The company faces significant challenges, including a competitive landscape and declining membership in its therapy service, BetterHelp [13][14]

Financial Data and Key Metrics Changes - In Q1 2025, total revenues were approximately €183 million, a slight decrease from €188 million in Q1 2024, reflecting expected seasonality in the COVID-19 vaccine market [26] - Research and development expenses increased to €526 million from €508 million in the prior year, driven by late-stage clinical studies [26] - The net loss for Q1 2025 was €416 million, compared to a net loss of €350 million in the same period last year, with a basic and diluted loss per share of €1.73 versus €1.31 [27][28] Business Line Data and Key Metrics Changes - The oncology segment is advancing with multiple clinical trials, including BNT327, which is being developed for various cancer types, including triple-negative breast cancer and small cell lung cancer [14][15] - The COVID-19 vaccine franchise remains a significant revenue driver, with preparations for a variant-adapted vaccine for the upcoming season [8] Market Data and Key Metrics Changes - The addressable market for the second-line endometrial cancer treatment is estimated at around 10,000 patients in the US and Europe, indicating a sizable opportunity [41] - The company anticipates stable vaccination rates and market shares for its COVID-19 vaccine, with revenue guidance for 2025 expected to be between €1.7 billion and €2.2 billion [30][31] Company Strategy and Development Direction - The company aims to become a fully integrated biopharmaceutical company with a focus on oncology, particularly through the development of BNT327 and mRNA cancer immunotherapies [28][36] - There is a strong emphasis on combination therapies to improve treatment outcomes across various cancer types, with ongoing investments in clinical development and commercialization capabilities [12][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their oncology pipeline to establish new standards of care and improve patient outcomes [12][25] - The company is closely monitoring regulatory changes and public sentiment regarding COVID-19 vaccines, which could impact future revenues [31][56] Other Important Information - The company announced a new Chief Financial Officer, Ramon Sapater, who will take over in July 2025, as current CFO Jens Holstein prepares for retirement [10][34] - The company is diversifying its manufacturing supply base for BNT323, currently reliant on a China-based CDMO, to mitigate risks associated with tariffs [41][44] Q&A Session Summary Question: What is the addressable population for endometrial cancer? - The estimated second-line market in endometrial cancer is about 10,000 patients in the US and Europe [41] Question: How do you see the NSCLC market evolving in five years? - Both bispecifics and ADCs will play a role in the NSCLC market, with the expectation that clinical benefit thresholds will evolve over time [50][72] Question: What impact do you anticipate from the CDC's upcoming vote on COVID boosters? - The company expects the market is already oriented towards a risk-based vaccination approach, with a base scenario of around 20% vaccination rates continuing [55] Question: Can you elaborate on the Phase II and Phase III trial timelines for BNT327? - The Phase II portion of the Rosetta trial will be completed later this year, with data to inform the Phase III portion [87] Question: How do you plan to manage toxicity observed in initial data for BNT327? - The stomatitis rate in combination with TROP-two ADC was comparable to that observed with BNT325 alone, indicating no additional additive toxicity [94]

Core Viewpoint - Moderna reported a narrower loss of $2.52 per share in Q1 2025, compared to a loss of $3.07 in the same period last year, but total revenues of $108 million fell short of expectations and declined approximately 35% year over year due to lower product sales [1][2][3] Financial Performance - Total revenues for Q1 2025 were $108 million, missing the Zacks Consensus Estimate of $127 million [1] - Product sales decreased by 49% year over year to $86 million, primarily due to lower sales of the COVID-19 vaccine Spikevax [2] - Spikevax sales were $84 million in the quarter, down from $167 million in the previous year, attributed to lower vaccination rates and the normalization of COVID into a seasonal market [3] - mResvia sales were only $2 million, significantly below the estimated $70 million, due to late approval and recommendations [4] - The company generated $22 million from grants, collaborations, licensing, and royalty revenues, with no revenues recorded in the year-ago period [6] Cost Management - Selling, general and administrative (SG&A) expenses were $212 million, down 23% year over year due to cost-cutting measures [7] - Research & development (R&D) expenses decreased by 19% to $856 million, driven by reduced clinical spending [7] Financial Guidance - Moderna reiterated its total revenue guidance for 2025, expecting revenues between $1.5 billion and $2.5 billion, with around $0.2 billion expected in the first half of the year [8] - Full-year R&D expenses are projected to be around $4.1 billion, while SG&A expenses are expected to be approximately $1.1 billion [9] - Capital expenditure is anticipated to be around $0.4 billion in 2025 [9] Pipeline Developments - Moderna submitted three regulatory filings to the FDA in Q4 2024, including for mRNA-1283 (next-generation COVID-19 vaccine) and mResvia for high-risk adults [12] - A third filing for the COVID-19 and influenza combination vaccine, mRNA-1083, is pending further data, which may delay launch plans [13] - The company has over 40 mRNA-based investigational candidates in various clinical stages, including cancer therapies [16] - Moderna is co-developing intismeran autogene with Merck, evaluating it in pivotal phase III studies for melanoma and non-small cell lung cancer [17][18] - The company plans to start a registrational study for mRNA-3705, a therapeutic candidate for methylmalonic acidemia, later this year [19]