Summary of Akari Therapeutics Conference Call (May 29, 2025) Company Overview - **Company**: Akari Therapeutics (AKTX) - **Focus**: Development of antibody drug conjugates (ADCs) with novel immuno-oncology payloads aimed at improving cancer treatment outcomes [2][5] Key Points and Arguments Novel Approach to ADCs - Akari is innovating ADCs by using immuno-oncology payloads that differ from traditional cytotoxic agents, aiming to enhance efficacy and safety in cancer treatment [3][5] - The lead asset, AKTX-101, targets TROP-2, a marker on cancer cells, and is conjugated with a novel payload called pH-1 [9][10] Mechanism of Action - The pH-1 payload targets the spliceosome, leading to cancer cell death and priming the immune system to attack similar cancer cells [8][27] - This approach aims to create immunological memory, allowing the immune system to recognize and attack cancer cells upon re-exposure [34] Clinical Development and Safety - Preclinical data shows robust activity for AKTX-101 as a single agent and in combination with checkpoint inhibitors, with favorable safety profiles observed in nonhuman primate studies [10][12] - Akari is advancing its lead ADC into IND-enabling studies to prepare for Phase 1 trials [20] Market Potential and Competitive Landscape - The ADC market is experiencing significant interest, with major pharmaceutical companies investing heavily in this space, indicating a strong opportunity for Akari's differentiated approach [22][23] - Akari's unique payload distinguishes it from competitors, which primarily use microtubule inhibitors or topo-I inhibitors [24][27] Future Directions - Akari plans to explore additional targets for its pH-1 payload, including colon, lung, and prostate cancers, which represent significant unmet medical needs [12][20] - The company is open to partnerships for further development and commercialization of its ADC platform [21][36] Additional Important Content - The transition from an inflammation-focused portfolio to oncology was driven by the potential of the pH-1 platform and the strategic direction of the company [39] - Akari's leadership team includes experienced professionals from major pharmaceutical companies, enhancing its capability to execute its vision [14][15][18] Conclusion - Akari Therapeutics is positioned to leverage its innovative ADC platform to address significant challenges in cancer treatment, with a focus on enhancing patient outcomes through novel immuno-oncology strategies [36][37]

Company Overview - Akari Therapeutics is an oncology biotechnology company focused on developing next-generation spliceosome payload antibody drug conjugates (ADCs) [3] - The company utilizes an innovative ADC discovery platform to generate and optimize ADC candidates for various targets [3] Lead Product Candidate - Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and delivers a novel PH1 payload directly into tumors [3] - PH1 is a spliceosome inhibitor designed to disrupt RNA splicing within cancer cells, leading to cancer cell death and activation of immune cells [3] - Preclinical studies indicate that AKTX-101 has significant activity and prolonged survival compared to traditional ADCs [3] Synergistic Potential - AKTX-101 has shown potential for synergy with checkpoint inhibitors, demonstrating prolonged survival both as a single agent and in combination with these inhibitors [3] Upcoming Presentation - Abizer Gaslightwala, President and CEO of Akari, will present recent corporate events at the Virtual Biotech Investment Webinar on May 29, 2025 [1][2]

LOTIS-7 abstract accepted for presentation at the European Hematology Association 2025 Congress (EHA2025) and the 18th International Conference on Malignant Lymphoma (ICML); ZYNLONTA® plus glofitamab demonstrated ORR of 95.5% and CR of 90.9% with encouraging safety and tolerability Forty patient enrollment reached in LOTIS-7 trial dose expansion arm in patients with relapsed/refractory DLBCL Cash runway expected to fund multiple catalysts into the second half of 2026 Company to host conference call today at ...

Core Insights - Sutro Biopharma is shifting its focus from luvelta to its pipeline of novel exatecan and dual-payload ADCs, with STRO-004 being prioritized as the lead clinical candidate due to strong preclinical data indicating its best-in-class potential [2][3][6] - The company aims to deliver three new INDs over the next three years, starting with STRO-004 expected to enter clinical studies in the second half of 2025 [2][6][7] - Sutro's financial results for Q1 2025 show revenue of $17.4 million, an increase from $13.0 million in Q1 2024, primarily driven by the Astellas collaboration [13][19] - As of March 31, 2025, Sutro had cash, cash equivalents, and marketable securities totaling $249.0 million, down from $316.9 million at the end of 2024, with a cash runway expected into early 2027 [12][21] Corporate and Program Updates - The company completed a strategic portfolio review in March, leading to the prioritization of wholly-owned next-generation ADC programs while deprioritizing the development of luvelta [3][6] - Sutro is currently conducting an IND-enabling toxicology study for a dual-payload ADC program in collaboration with Astellas, which has triggered a $7.5 million milestone payment [6][8] - The restructuring plan includes a nearly 50% reduction in organizational headcount and the decommissioning of its manufacturing facility by the end of 2025 [11] Pipeline Developments - STRO-004, a next-generation Tissue Factor-targeting ADC, is set to enter clinical studies in the second half of 2025, focusing on solid tumors [7] - STRO-006, an integrin beta-6 ADC, is expected to enter clinical development in 2026 [7] - Sutro anticipates filing an IND for its first wholly-owned dual-payload ADC in 2027 [7] Financial Highlights - Total operating expenses for Q1 2025 were $85.9 million, compared to $69.6 million in Q1 2024, with R&D expenses at $51.6 million and G&A expenses at $13.3 million [14][20] - The net loss for Q1 2025 was $75.97 million, compared to a net loss of $58.21 million in Q1 2024, with a net loss per share of $0.91 [20][19] - Restructuring costs for Q1 2025 amounted to $21.0 million, with expectations for continued recognition of these costs in future periods [16]

Core Insights - ADC Therapeutics SA is a global leader in antibody drug conjugates (ADCs) and will host a conference call on May 14, 2025, to report Q1 2025 financial results and operational updates [1][2][3] Company Overview - ADC Therapeutics is advancing proprietary ADC technology aimed at transforming treatment for patients with hematologic malignancies and solid tumors [3] - The company is based in Lausanne, Switzerland, with operations in London and New Jersey [5] Product Development - ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy, alongside multiple ADCs in ongoing clinical and preclinical development [4]

Core Insights - Sutro Biopharma, Inc. announced promising preclinical findings for STRO-004, a novel antibody drug conjugate (ADC) targeting tissue factor, showcasing its anti-tumor activity and favorable safety profile [1][2] - The company will present its findings at the 2025 American Association for Cancer Research (AACR) Annual Meeting, highlighting the advantages of its XpressCF+ platform in developing dual-payload ADCs [1][2] Preclinical Findings - STRO-004 demonstrated potent, dose-dependent anti-tumor activity and a favorable safety profile across all tested doses in preclinical studies [2] - After a single dose, STRO-004 achieved promising overall response and disease control rates in Tissue Factor-positive patient-derived xenograft models across multiple cancer types [2] Technology and Platform - Sutro's XpressCF+ platform enables the creation of dual-payload ADCs with higher drug-to-antibody ratios and fully site-selective conjugation of two linker payloads [2] - The platform addresses limitations of conventional ADCs and the challenges of targeting complex disease biology, reinforcing the company's technology leadership [2] Presentation Details - The poster presentation titled "Preclinical activity and safety of STRO-004, a novel ADC targeting tissue factor for solid tumors" will take place on April 28, 2025, at the AACR meeting [3] - Another presentation will focus on enhancing Topo1i ADC efficacy through the development of homogeneous dual-payload ADCs [3] Company Overview - Sutro Biopharma is focused on discovering and developing precisely designed cancer therapeutics, leveraging its cell-free XpressCF technology for broader patient benefits [4] - The company is advancing a robust early-stage pipeline of novel exatecan and dual-payload ADCs, supported by high-value collaborations and industry partnerships [4]

Core Insights - ADC Therapeutics presented promising data on exatecan-based antibody drug conjugates (ADCs) targeting Claudin-6, PSMA, and ASCT2 at the AACR Annual Meeting 2025, indicating their potential in treating various cancers [1][2][3] Group 1: ADC Therapeutics Overview - ADC Therapeutics is a global leader in the field of antibody drug conjugates (ADCs), focusing on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [5] - The company has received FDA accelerated approval for its CD19-directed ADC ZYNLONTA for treating relapsed or refractory diffuse large B-cell lymphoma [6] Group 2: Research Findings - ADCT-242, targeting Claudin-6, showed potent anti-tumor activity in ovarian and non-small cell lung cancer models, demonstrating good tolerability in preclinical studies [2][8] - ADCT-241, a PSMA-targeting ADC, exhibited antitumor activity in xenograft and patient-derived models, with well-tolerated results in rats and cynomolgus monkeys [2][3] - HuB14-VA-PL2202, an ASCT2-targeting ADC, demonstrated specific antitumor activity in both solid and hematological cancer cell lines, also showing good tolerability in cynomolgus monkeys [3]

Company Overview - ADC Therapeutics SA is a commercial-stage global leader in the field of antibody drug conjugates (ADCs) [3] - The company is focused on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [3] Recent Developments - CEO Ameet Mallik will present a company overview at the 24th Annual Needham Virtual Healthcare Conference on April 8, 2025 [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 30 days [2] Product Pipeline - ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [4] - The company has multiple ADCs in ongoing clinical and preclinical development [4] Company Operations - ADC Therapeutics is based in Lausanne, Switzerland, with operations in London, the San Francisco Bay Area, and New Jersey [5]

Core Insights - ADC Therapeutics reported significant progress in clinical trials for ZYNLONTA, with a 94% overall response rate (ORR) and a 72% complete response (CR) rate in the LOTIS-7 Phase 1b trial [1][5] - The company completed enrollment in the LOTIS-5 Phase 3 trial, with data updates expected in late 2025 [1][5] - Financial results for Q4 and full year 2024 showed a net product revenue of $16.4 million for Q4 and $69.3 million for the full year, indicating a slight increase compared to 2023 [8][22] Operational Updates - The LOTIS-7 trial demonstrated promising initial data, with 94% ORR and 72% CR in patients with relapsed or refractory non-Hodgkin lymphoma [5] - Enrollment for the LOTIS-5 trial was completed in December 2024, with data updates anticipated once progression-free survival (PFS) events are reached [5] - The company is also advancing its early research solid tumor program to the IND-enabling stage [2] Financial Performance - Q4 2024 net product revenues were $16.4 million, compared to $16.6 million in Q4 2023, while full-year revenues increased from $69.1 million in 2023 to $69.3 million in 2024 [8][22] - Research and development expenses decreased to $27.1 million for Q4 2024 from $30.3 million in Q4 2023, and full-year expenses dropped from $127.1 million to $109.6 million [8][22] - The net loss for Q4 2024 was $30.7 million, a significant reduction from $85.0 million in Q4 2023, and the full-year net loss decreased from $240.1 million to $157.8 million [8][22] Cash Position - As of December 31, 2024, the company had $250.9 million in cash and cash equivalents, down from $278.6 million in 2023, providing a runway expected to fund operations into the second half of 2026 [1][8]

Core Insights - ADC Therapeutics is set to present preclinical data on its exatecan-based antibody-drug conjugates (ADCs) targeting Claudin-6, PSMA, and ASCT2 at the upcoming AACR Annual Meeting 2025, highlighting its commitment to advancing targeted cancer treatments [1][2][3] Company Overview - ADC Therapeutics is a commercial-stage global leader in the field of antibody-drug conjugates (ADCs), focusing on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [3][4] - The company is based in Lausanne, Switzerland, with operations in London and New Jersey [5] Upcoming Presentations - The oral presentation will focus on ADCT-242, a novel exatecan-based ADC targeting Claudin-6, in ovarian and non-small lung cancer models, scheduled for April 27, 2025 [2] - Poster presentations will include: - ADCT-241, targeting PSMA for prostate cancer, on April 30, 2025 [2] - HuB14-VA-PL2202, targeting ASCT2, on April 28, 2025 [2] Product Development - ADC Therapeutics' CD19-directed ADC ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma [4]