INVIVYD Q1 2025 FINANCIAL RESULTS & BUSINESS HIGHLIGHTS May 15, 2025 © 2025 Invivyd, Inc. Invivyd , Pemgarda , and the Ribbon logos are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are ...

PEMGARDA™ (pemivibart) net product revenue of $11.3 million reported for Q1 2025, influenced by planned transition (Jan/Feb) from a contracted to an internalized sales forcePEMGARDA revenue re-acceleration observed in Q2 2025 to dateInvivyd continues to target near-term profitability (1H 2025) with existing cash and cash equivalents, anticipated growth of net product revenue, and continued reduction of operating expensesSince Emergency Use Authorization (EUA) of PEMGARDA in March 2024, no documented cases o ...

Core Insights - Mersana Therapeutics is advancing its clinical-stage biopharmaceutical pipeline, particularly focusing on the development of antibody-drug conjugates (ADCs) for cancer treatment, with a significant emphasis on addressing high unmet medical needs in oncology [1][17] Clinical Development - The company is developing Emi-Le (emiltatug ledadotin), a B7-H4-directed Dolasynthen ADC, and has reported promising preliminary clinical data at the ESMO Breast Cancer 2025 conference, indicating an increase in the objective response rate (ORR) to 31% among evaluable patients with B7-H4 high tumors [2][4][6] - The ongoing Phase 1 clinical trial of Emi-Le is focused on triple-negative breast cancer (TNBC) patients who have received one to four prior lines of therapy, with significant progress in patient enrollment for both dose expansion cohorts [9][10] - The company plans to report initial clinical data from the expansion portion of the Phase 1 trial in the second half of 2025 [6][10] Financial Performance - As of March 31, 2025, Mersana reported cash and cash equivalents of $102.3 million, with net cash used in operating activities for the first quarter amounting to $29.3 million [14] - Collaboration revenue for the first quarter of 2025 was $2.8 million, a decrease from $9.2 million in the same period in 2024, primarily due to reduced revenue from collaborations with Johnson & Johnson and Merck KGaA [14] - The net loss for the first quarter of 2025 was $24.1 million, or $0.19 per share, compared to a net loss of $19.3 million, or $0.16 per share, for the same period in 2024 [19][24] Collaborations and Partnerships - Mersana continues to support collaborations with Johnson & Johnson and Merck KGaA, focusing on research related to its Dolasynthen and Immunosynthen ADC platforms [13][17] - GSK plc holds an exclusive global license option to co-develop and commercialize Mersana's lead Immunosynthen ADC candidate, XMT-2056 [12]

Core Insights - AbbVie announced the accelerated approval of EMRELIS™ (telisotuzumab vedotin-tllv) by the FDA for treating adult patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have high c-Met protein overexpression and have received prior systemic therapy [1][2][3] - Lung cancer remains the leading cause of cancer-related deaths globally, with approximately 85% classified as NSCLC [2][3] - The approval is based on the overall response rate (ORR) and duration of response (DOR) from the Phase 2 LUMINOSITY study, which showed a 35% ORR and a median DOR of 7.2 months in patients with high c-Met overexpression [2][3] Company Overview - EMRELIS is AbbVie's first internally developed solid tumor medicine and represents a significant step in their commitment to developing cancer therapies [2][3] - The company is expanding its antibody-drug conjugate (ADC) portfolio to deliver targeted therapies to patients with difficult-to-treat tumors [2][3] - AbbVie is also focused on patient access, offering support programs to reduce out-of-pocket costs for eligible patients [6][21] Industry Context - The c-Met protein is overexpressed in approximately 25% of advanced EGFR wild type, non-squamous NSCLC patients, with about half of these patients having high c-Met overexpression [2][3] - There is a critical unmet need for targeted therapies in this patient population, as they often face poor prognosis and limited treatment options [2][3] - The FDA has also approved the Roche VENTANA® MET (SP44) RxDx Assay as a companion diagnostic to identify patients eligible for EMRELIS treatment [4][3]

Core Insights - Genmab is presenting 14 abstracts on epcoritamab at the 30th European Hematology Association Congress, showcasing its development across various patient populations and treatment settings [1][4] - Epcoritamab is a T-cell engaging bispecific antibody designed for treating diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) [6][7] Development Program - The abstracts include data from Phase 1/2 trials evaluating epcoritamab in combination with other therapies for relapsed/refractory DLBCL and previously untreated DLBCL [2][4] - Key trials include EPCORE NHL-2 and NHL-5, focusing on combinations with rituximab and polatuzumab vedotin [2][5] Presentation Details - Oral presentations will occur on June 15, 2025, featuring significant findings from the EPCORE NHL-2 and NHL-5 trials [5] - Additional results from NHL-1 and NHL-3 trials will be presented as posters, highlighting three years of follow-up data [2][5] Regulatory Status - Epcoritamab has received regulatory approval in specific lymphoma indications in the U.S., Japan, and the EU, and is co-developed with AbbVie [7][10] - The companies are pursuing further international regulatory approvals for additional indications [7] Future Directions - Genmab and AbbVie are conducting five ongoing Phase 3 trials to evaluate epcoritamab's efficacy as a monotherapy and in combination therapies across various hematologic malignancies [8][9] - The companies aim to establish epcoritamab as a core therapy for B-cell malignancies [4][8]

Sutro Biopharma (STRO) 2025 Conference Summary Company Overview - Sutro Biopharma is focused on advancing its next-generation antibody-drug conjugates (ADCs) technology, aiming to differentiate from conventional ADCs and enhance commercial viability [3][4][5] Key Points and Arguments 1. **Strategic Reprioritization**: The company has deprioritized its late-stage program for loveltomab tazavibulin, focusing instead on a new pipeline strategy that emphasizes innovative ADCs [3][4] 2. **Next-Generation ADCs**: Sutro is developing ADCs targeting hard-to-reach targets, which are more complex and widely expressed across solid tumors, ensuring better commercial viability [4][5] 3. **Clinical Development Plans**: Sutro aims to deliver three Investigational New Drug (IND) applications over the next three years, starting with STRO-four in the second half of 2025, followed by STRO-six in 2026 and a dual payload ADC in 2027 [4][6] 4. **Innovative Technology**: The company claims to have one of the most powerful ADC technologies, optimizing every component of the ADC to achieve a wider therapeutic index [3][9] 5. **Dual Payload ADCs**: Sutro is focusing on dual payload ADCs, which have the potential to overcome resistance seen in single payload ADCs, providing a competitive edge in the market [6][24][25] 6. **Clinical Efficacy**: Preliminary data suggests that STRO-four has significantly higher exposure and antitumor activity compared to conventional ADCs, with a 17-fold increase in Cmax and a 50-fold increase in exposure at HNSCD [14][20] 7. **Target Selection**: The company emphasizes the importance of selecting patients based on target antigen expression, which enhances the likelihood of positive clinical outcomes [21] Additional Important Content 1. **Collaboration and Partnerships**: Sutro is collaborating with Astellas on dual payload ADCs, which is advancing rapidly and is seen as a significant opportunity for the company [26][29] 2. **Manufacturing Capabilities**: Sutro has developed a robust external CDMO network to improve cost efficiency and speed in ADC manufacturing, which supports its early pipeline [4][7] 3. **Competitive Landscape**: The ADC market is becoming congested, particularly with common targets like FR alpha, which may affect commercial viability; Sutro's focus on unique targets aims to mitigate this risk [5][6] 4. **Regulatory Simplicity**: The development of dual payload ADCs is seen as advantageous due to regulatory simplicity compared to combining multiple compounds [25][30] 5. **Pipeline Execution**: Sutro's leadership team, with extensive ADC oncology experience, is focused on executing the innovative pipeline and achieving key deliverables [31][32]

Core Viewpoint - MacroGenics, Inc. is advancing its clinical pipeline, particularly with the initiation of the Phase 2 LINNET study for lorigerlimab, targeting unmet needs in ovarian and gynecologic cancers, while also reporting financial results for Q1 2025 [1][2]. Clinical Development Updates - The first patient has been dosed in the LINNET Phase 2 study of lorigerlimab for platinum-resistant ovarian cancer and clear cell gynecologic cancer, with a focus on addressing significant unmet needs [2][7]. - The LORIKEET Phase 2 trial, involving 150 patients, is ongoing to evaluate lorigerlimab in combination with docetaxel for metastatic castration-resistant prostate cancer (mCRPC), with results expected in the second half of 2025 [6][7]. - MacroGenics is developing three antibody-drug conjugates (ADCs) in collaboration with Synaffix, including MGC026, MGC028, and MGC030, targeting various solid tumors [4][6]. Financial Performance - Total revenue for Q1 2025 was $13.2 million, an increase from $9.1 million in Q1 2024, primarily due to collaborative agreements and contract manufacturing [8][13]. - Research and development expenses decreased to $39.7 million in Q1 2025 from $46.0 million in Q1 2024, while selling, general and administrative expenses also fell to $10.7 million from $14.7 million [8][13]. - The net loss for Q1 2025 was $41.0 million, compared to a net loss of $52.2 million in Q1 2024, indicating improved financial performance [8][13]. Cash Position and Guidance - As of March 31, 2025, MacroGenics had cash, cash equivalents, and marketable securities totaling $154.1 million, down from $201.7 million at the end of 2024, which supports operations into the second half of 2026 [8][11]. - The company plans to implement cost-saving measures to extend its financial runway while continuing to progress its clinical pipeline [8][11].

Core Insights - FibroGen reported financial results for Q1 2025, highlighting a significant decrease in total revenue compared to the same period in 2024, with total revenue of $2.7 million versus $25.4 million [14] - The company is focused on advancing its lead asset, FG-3246, with a Phase 2 monotherapy dose optimization study expected to start in Q3 2025 [2][5] - FibroGen is in the process of selling its China operations to AstraZeneca for approximately $185 million, which is expected to close in Q3 2025 [5][6] Financial Performance - Total revenue for Q1 2025 was $2.7 million, a decrease from $25.4 million in Q1 2024 [14] - The net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49.0 million, or $0.49 per share, in the previous year [14][19] - As of March 31, 2025, FibroGen reported $33.8 million in cash and cash equivalents in the U.S. and $128.4 million in total consolidated cash [14] Strategic Developments - The company has filed a Type C meeting request with the FDA to discuss the potential Phase 3 development program for roxadustat in treating anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) [2][7] - The anticipated initiation of the Phase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) is set for Q3 2025 [5][11] - Topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide are expected in Q4 2025 [5][6] Transaction Details - The sale of FibroGen China to AstraZeneca is expected to provide a total consideration of approximately $185 million, which includes an enterprise value of $85 million plus estimated net cash of $100 million [5][6] - Upon closing, the transaction will extend FibroGen's cash runway into the second half of 2027 [5][14] Upcoming Milestones - The company anticipates feedback from the FDA regarding the development plan for roxadustat in Q3 2025 [7] - The Phase 2 trial of FG-3246 will also include FG-3180 to assess its diagnostic performance and correlation with CD46 expression [6][11]

Core Insights - Dianthus Therapeutics has completed enrollment in the Phase 2 MaGic trial of DNTH103 for generalized Myasthenia Gravis (gMG), with top-line results expected in September 2025, marking the first of three anticipated catalysts for the DNTH103 neuromuscular franchise by the end of 2026 [1][3][11] - The ongoing Phase 3 CAPTIVATE trial for DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is on track for an interim responder analysis in the second half of 2026 [1][6] - The Phase 2 MoMeNtum trial for DNTH103 in Multifocal Motor Neuropathy (MMN) is also ongoing, with top-line results expected in the second half of 2026 [1][7] - The company has a strong cash position of $331.5 million, projected to provide financial runway into the second half of 2027 [1][16] Clinical Development - DNTH103 is a monoclonal antibody designed to selectively inhibit the active form of the C1s protein, targeting the classical complement pathway [4][11] - The drug is intended for convenient subcutaneous self-administration, potentially every two weeks, and aims to address high unmet needs in autoimmune disorders [4][11] Market Opportunity - Despite existing biologics in the gMG market, there are significant opportunities for improved first-line treatment options, with DNTH103 positioned to offer effective symptom control, safety, and convenient administration [3][11] - The company is building a neuromuscular franchise with DNTH103, targeting three indications: gMG, CIDP, and MMN [11][12] Financial Performance - For Q1 2025, the company reported a net loss of $29.5 million, or $0.82 per share, compared to a net loss of $13.7 million, or $0.54 per share, in Q1 2024 [16][22] - Research and development expenses for Q1 2025 were $27.0 million, significantly higher than $13.1 million in Q1 2024, primarily due to increased clinical costs and headcount [16][22]

CytomX Therapeutics (CTMX) Q1 2025 Earnings Call May 12, 2025 08:00 AM ET Company Participants Chris Ogden - Chief Financial OfficerSean A. McCarthy - Chairman & CEOWayne Chu - Chief Medical OfficerRobert Driscoll - SVP - Equity ResearchDaniel Smith - Equity Research Associate Conference Call Participants Roger Song - Senior Equity Research AnalystAnupam Rama - AnalystPeter Lawson - Analyst Operator Good morning, everyone, and thank you for standing by. Welcome to the Citemx Therapeutics CX 2,051 phase one ...