
Financial Data and Key Metrics Changes - As of September 30, 2022, the company reported cash and cash equivalents and investments of approximately $185.1 million [30] - Research and development expenses for Q3 2022 were $18.9 million, an increase from $15.1 million in Q3 2021 [30] - General and administrative expenses rose to $6.6 million in Q3 2022 from $4.3 million in Q3 2021 [30] - The net loss for Q3 2022 was $24.6 million, or a loss of $0.58 per share, compared to a net loss of $17.4 million, or $0.41 per share, in Q3 2021 [30] Business Line Data and Key Metrics Changes - The lead program, SL-172154 (154), completed enrollment in the monotherapy dose escalation portion of its Phase I trial for advanced platinum-resistant ovarian cancer [10][21] - In Q3 2022, the company began enrolling patients in the first chemotherapy combination cohort for 154, selecting a starting dose of 3 mg/kg [11] - The second clinical stage compound, SL-279252 (252), is in Phase I development for advanced solid tumors and lymphomas, with top-line data expected in Q1 2023 [14][27] Market Data and Key Metrics Changes - The company is focusing on the platinum-resistant ovarian cancer market, where the single-agent response rate for liposomal doxorubicin is typically 10% to 12% [12] - The clinical trial for 154 in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) is expected to begin enrolling patients in Q4 2022 [12][25] Company Strategy and Development Direction - The company aims to differentiate 154 from other CD47 inhibitors by combining CD47 blockade with CD40 agonism, potentially leading to improved response rates [13] - The GADLEN platform is being developed alongside the ARC platform, with a focus on harnessing gamma delta T cells in cancer therapy [15][16] - The company is strategically positioned to fund operations into the second half of 2024, maintaining strong financial discipline [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical execution and the upcoming key milestones for 154 and 252, with significant data expected in 2023 [32][34] - The company believes that the combination of experienced team, innovative science, and financial resources positions it strongly for future growth [34] Other Important Information - The company has made progress in its preclinical pipeline, with multiple publications on its ARC and GADLEN programs [15] - Initial clinical data from the 154 program is expected to be reported mid-2023 [21][33] Q&A Session Summary Question: Update on the 3 mg and 10 mg doses for the combination trial - Management confirmed that the 3 mg/kg dose is solid for evaluation in combination, supported by pharmacokinetic and pharmacodynamic analyses [38] Question: Infusion reactions and dosing time - The company is using a longer infusion time of over two hours for the combination trials to mitigate infusion reactions [40] Question: Toxicity at the 10 mg/kg dose - The decision to not pursue the 10 mg/kg dose was based on pharmacokinetic and pharmacodynamic analyses, showing no significant benefit over the 3 mg/kg dose [46] Question: Thoughts on CD47 inhibitors and recent abstracts - Management noted that the trends in CD47 inhibitors are evolving, particularly in the TP53 mutant AML population, and emphasized the need for detailed data to assess efficacy [50] Question: Patient expectations for AML and MDS trials - The company anticipates enrolling between 10 and 20 patients across the dose escalation for both monotherapy and combination cohorts [56] Question: Combination with venetoclax - The dose escalation will initially focus on azacitidine, with plans for an expansion cohort that includes venetoclax later [57] Question: GADLEN platform and potential partnerships - The GADLEN platform is broad, and while there are opportunities for partnerships, the company is currently focused on independent development [66]