Altimmune ((ALT)) has held its Q4 earnings call. Read on for the main highlights of the call.
Altimmune’s recent earnings call painted a picture of both progress and challenges for the company. While the sentiment was largely positive due to significant advancements in their pipeline and a robust financial position, concerns were raised over increased expenses, a net loss, and the retirement of a key executive.
Significant Progress in 2024
2024 marked a year of substantial progress for Altimmune, highlighted by the completion of enrollment in the Phase 2b biopsy-based trial of pemvidutide in NASH. The company is on track for a top-line data readout in the second quarter of 2025, indicating a promising future for their pipeline.
New INDs and Phase 2 Trials
Altimmune made strides by submitting new INDs for pemvidutide in two additional indications during the fourth quarter of 2024, both of which were cleared by the FDA. The company plans to commence Phase 2 efficacy trials in mid-2025, showcasing their commitment to expanding their research and development efforts.
Strong Financial Position
The company ended 2024 with a strong financial footing, boasting $132 million in cash and investments. This financial health is expected to sustain operations well into the second half of 2026, providing a solid foundation for future endeavors.
R&D Day Announcement
Altimmune has scheduled a virtual R&D Day for March 13th, where they plan to unveil additional indications and opportunities for pemvidutide. This event is anticipated to provide further insights into the company’s strategic direction and innovation pipeline.
No Safety Signals from FDA
The FDA’s review of pemvidutide revealed no safety signals in over 500 subjects treated in prior studies. This clearance underscores the drug’s potential safety profile, bolstering confidence in its ongoing development.
Increased R&D Expenses
The company reported an increase in R&D expenses, rising from $65.8 million in 2023 to $82.2 million in 2024. This surge was primarily attributed to the costs associated with the development of pemvidutide, reflecting the company’s intensified focus on advancing its pipeline.
Net Loss for 2024
Altimmune reported a net loss of $95 million for 2024, compared to $88 million in 2023. While this reflects the financial challenges faced, it also highlights the company’s substantial investment in its future growth and development.
Scott Harris Retirement Announcement
The retirement of Scott Harris, the Chief Medical Officer, was announced for early 2026. This upcoming change in leadership may impact the company’s continuity, although it also presents an opportunity for new perspectives within the executive team.
Forward-Looking Guidance
Looking ahead, Altimmune provided significant guidance on its future plans and expected milestones. The company aims to complete the Phase 2b IMPACT trial for pemvidutide in NASH, with top-line data expected in Q2 2025. They plan to seek an end-of-Phase 2 meeting with the FDA in 2025, with hopes of initiating a Phase 3 program in early 2026 if results are favorable. Additionally, two new INDs for pemvidutide have been cleared, with Phase 2 trials set to begin in mid-2025.
In summary, Altimmune’s earnings call highlighted a year of notable achievements and strategic planning, despite facing financial challenges and leadership changes. The company’s strong pipeline progress and financial position suggest a promising outlook, with key milestones on the horizon that could significantly impact its future trajectory.