Microvast Holdings announces departure of chief financial officer
On Monday, H.C. Wainwright maintained its Buy rating and $4.00 stock price target for Actinium Pharma (NYSE:ATNM) following the company's third-quarter financial report on November 14.
The earnings per share (EPS) were reported at a loss of ($0.37), which was slightly below the firm's expectation of ($0.36) and below the consensus estimate of ($0.30). Actinium ended the quarter with $78.7 million in cash, which is anticipated to sustain the company's operations for at least the next year.
Actinium is advancing its radio-therapeutic portfolio, with several key milestones on the horizon. For Iomab-B, after the FDA required a new trial design for a Biologics License Application (BLA), Actinium has been in discussions with the agency to outline the parameters of a head-to-head clinical trial.
The company has reported an agreement with the FDA on the patient criteria for a Phase 3 trial, which will compare allogeneic Bone Marrow Transplant (BMT) with Iomab-B plus Flu/TBI to BMT with cyclophosphamide plus Flu/TBI in adults with active Acute Myeloid Leukemia (AML).
Additionally, for Actimab-A, Actinium has aligned with the FDA on a randomized Phase 2/3 trial design, which will begin with a Phase 2 segment to fine-tune the dosage of Actimab-A combined with CLAG-M for relapsed or refractory AML. This approach is designed to save time and resources by avoiding separate studies.
Lastly, the company announced in May 2024 the FDA clearance for an Investigational New Drug (IND) application to study Iomab-ACT as a targeted conditioning treatment before CAR-T therapy. Patient enrollment for this study is expected to begin in the first quarter of 2025, with proof of concept data anticipated by the end of that year. The firm's reiteration of the Buy rating and price target reflects confidence in Actinium's ongoing development and upcoming clinical milestones.
In other recent news, Actinium Pharmaceuticals (NYSE:ATNM) has reported significant results from its Phase 3 SIERRA trial for Iomab-B, a targeted radiotherapy for patients with relapsed or refractory Acute Myeloid Leukemia. The trial demonstrated that Iomab-B led to an increase in durable Complete Remission and Event-Free Survival among patients aged 55 and above.
However, the FDA has requested a new trial to demonstrate an overall survival benefit for Iomab-B before considering a Biologics License Application, as the SIERRA trial was deemed inadequate.
In response, Actinium is planning a new trial and is currently seeking a strategic partner for Iomab-B in the U.S. Meanwhile, the company's Iomab-ACT program has received FDA clearance for an Investigational New Drug application to study its effect on patients with sickle cell disease undergoing bone marrow transplant, in collaboration with Columbia University.
These are among the recent developments at Actinium Pharmaceuticals, which continues to make strides in its pursuit to improve outcomes for patients with advanced blood cancers. The company's portfolio includes other targeted radiotherapy candidates and maintains a strong financial position, with a reported first-quarter cash balance of $84.05 million.
InvestingPro Insights
Recent InvestingPro data provides additional context to Actinium Pharma's (NYSE:ATNM) financial situation and market performance. The company's revenue for the last twelve months as of Q3 2024 stood at $0.08 million, with a gross profit of the same amount, indicating a 100% gross profit margin. However, the operating income was negative at -$44.96 million, reflecting the company's current focus on research and development rather than profitability.
InvestingPro Tips highlight that Actinium is not profitable over the last twelve months, which aligns with the reported financial results and the company's stage in drug development. The stock has also taken a significant hit, with a -84.69% price return over the past six months and a -22.28% return in just the last week. These figures underscore the volatility and risks associated with investing in early-stage biopharmaceutical companies.
Despite these challenges, InvestingPro Tips note that Actinium operates with a moderate level of debt and its liquid assets exceed short-term obligations. This financial position supports the H.C. Wainwright analyst's observation that the company has sufficient cash to fund operations for at least the next year, which is crucial as Actinium advances its clinical trials.
For investors seeking a more comprehensive analysis, InvestingPro offers 5 additional tips for Actinium Pharma, providing deeper insights into the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.