Altimmune(US:ALT)2023-08-10 15:32Financial Data and Key Metrics Changes - Altimmune ended Q2 2023 with approximately $160 million in cash, cash equivalents, and short-term investments, down from $184.9 million at the end of 2022 [20] - Research and development expenses were $13.3 million in Q2 2023, compared to $16 million in the same period in 2022 [20] - Net loss for Q2 2023 was $16.1 million or $0.32 net loss per share, an improvement from a net loss of $20.1 million or $0.42 net loss per share in Q2 2022 [21] Business Line Data and Key Metrics Changes - Pemvidutide, the lead product candidate, showed a greater than 75% relative reduction in liver fat at 24 weeks in the Phase 1b trials, with over 50% of subjects achieving normalization of liver fat in the 1.8 mg dose group [7] - In the Phase 2 MOMENTUM trial, interim results indicated weight loss of 10.7% at the 2.4 mg dose and 9.4% at the 1.8 mg dose after 24 weeks, compared to a 1% weight loss in the placebo group [9][16] Market Data and Key Metrics Changes - The obesity market is expected to segment, with increasing demand for novel therapies, as indicated by recent acquisitions in the sector [30][31] - The prevalence of comorbidities such as dyslipidemia and high liver fat content is significant among the obesity population, with 60% to 75% of patients affected [9] Company Strategy and Development Direction - The company is focused on advancing pemvidutide for obesity and NASH, with plans to initiate Phase 3 development in obesity in the second half of next year [38] - Altimmune aims to secure a partner for the development of pemvidutide, targeting both NASH and obesity indications [44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving significant rates of NASH resolution and fibrosis improvement from the upcoming IMPACT trial, with data readout anticipated in Q1 2025 [7][14] - The company is optimistic about the competitive positioning of pemvidutide in the NASH marketplace, emphasizing the importance of weight loss and liver fat reduction [8][9] Other Important Information - The Phase 2 clinical trial of HepTcell in chronic hepatitis B is expected to report results in Q1 2024, with a focus on antiviral effects [10][18] - The company has completed enrollment in the HepTcell trial, which aims for a 1-log reduction in hepatitis B surface antigen [18] Q&A Session Summary Question: Expectations for weight loss at 48 weeks - Management still targets mid to upper teens for weight loss at 48 weeks, believing that the combination of GLP-1 and glucagon will yield better results than GLP-1 monotherapy [25][26] Question: Update on M&A interest - There is growing interest in M&A, with companies looking for novel obesity mechanisms, and management is encouraged by ongoing discussions with potential partners [30][31] Question: Readiness for Phase 3 obesity trial - The company is preparing for Phase 3 and plans to have a partner lined up before starting the trial [38][39] Question: Comorbidities in trial design - Management believes that the prevalence of comorbidities in the obesity population will facilitate patient recruitment for the trials [39] Question: Ideal partner for pemvidutide development - The ideal partner would be interested in both NASH and obesity indications, as both are metabolic diseases [44] Question: Combinability with existing GLP-1 therapies - Pemvidutide is believed to be safe for use alongside existing GLP-1 therapies, with potential for additional benefits [47][48] Question: NASH resolution and fibrosis improvement at 24 weeks - Management is confident that 24 weeks is sufficient to see benefits in NASH resolution and fibrosis improvement, supported by preclinical data [62][64]