Tim Moore, CFA an Analyst at EF Hutton has recently published a report citing the opportunities for growth with Cel-Sci Corproation (Nasdaq: CVM) as a pre-surgery immunotherapy candidate for cancer patients and upcoming near-term catalysts for the company.
EF Hutton coverage has initiated a BUY on Cel-Sci Corporation. The analyst buy rating for Cel-Sci comes with a price target of $17.00 per shared based on EF Hutton’s DCF model factory in a 24% discount rate.
The analyst report and price target assume FDA approval of Multikine as a biologic product in 2023, though it should be noted that approval is not guaranteed and has yet to occur.
About Cel-Sci Corporation
Cel-Sci Corporation is a clinical stage immunotherapy company. The Company is engaged in the development of products to treat cancer and infections, or other diseases through the activation or modulation of the immune system.
Multikine is the company’s primary immunotherapy therapy product currently pending FDA approval. Designed treat advanced stages (III & IV) of primary head and neck cancer, if successful Multikine could be administered as a first-line therapy in the period prior to surgery (tumor removal).
The hope is that this therapy will offer a cure for those diagnosed with primary head and neck cancer and a new top-line treatment option for head and neck cancer.
Multikine completed its Phase 3 clinical trial in June 2021 and is awaiting the publication of the complete data from the 10-year study.
The publication of independent peer-reviewed medical journal studies with data analysis could be catalysts for the stock price. Cel-Sci deemed Multikine’s Phase 3 clinical trial a success, and the company is now looking forward to the next steps in their journey.
EF Hutton Analyst Tim Moore Coverage of Cel-Sci
CEL-SCI’s stock looks attractive to Tim Moore of EF Hutton, who has initiated coverage on the company with a buy rating and $17 price target. This is based on the development of Multikine as well as an existing gap in the market for this pre-surgery treatment.
Multikine has the potential to fill this gap and provide a much needed treatment option for patients. Moore believes that the risk-reward profile of CEL-SCI’s stock is favorable at current levels.
The benefit-to-risk analysis of Multikine is interesting because, according to the Phase 3 study, it can extend life without any adverse safety issues. This is a significant advantage that Multikine has over other similar treatments.
Additionally, Moore and the EF Hutton team note that they were recently impressed with the company’s manufacturing facility in Maryland – stating it is clear that they have a well-controlled process in place. This is another positive point in favor of Multikine.
The benefit-to-risk analysis of Multikine is interesting because it can extend life without adverse safety issues according to the Phase 3 study. Separately, we recently toured the company’s manufacturing facility in Maryland and came away impressed with its readiness and controlled process.
CEL-SCI Corporation is expected to submit an application for FDA approval of Multikine in late 2022 with rumors of news coming as early as April 21, 2022.
Multikine is being developed as a treatment for advanced head and neck cancer patients who are planned to receive surgery and radiation therapy as their primary treatments. If approved, this population of patients could be an attractive target market for Multikine.
EF Hutton Key Points for Cel-Sci Success
Moore of EF Hutton cited 4 key points that were factors in the Buy rating and price target of $17.00 for CVM. Those points include:
- Intent to Cure & First-Line Treatment
- Peer-Reviewed Medical Journal Publications & Full Data Analysis Catalysts
- 2023 Multikine FDA Approval Potential
- Fully Capable Manufacturing Facility Ready & Waiting
Cel-Sci’s Multikine First-Line Treatment & Intent to Cure
CEL-SCI’s Multikine therapy is a promising treatment for head and neck cancer patients who are yet to undergo surgery.
Multikine is administered before surgery and is given with the aim of curing the patient, as opposed to other treatments which are only used after a tumor recurrence following surgery, radiation, or chemotherapy. If successful, Multikine could significantly improve the prognosis for head and neck cancer patients.
Other therapies may help to extend survival times in some cases, but they do not always prevent death from cancer recurrence or other complications. This creates a need for new therapies, like Multikine pre-surgery therapy, which could potentially improve outcomes for patients with cancer.
Multikine Peer-Reviewed Medical Journal Publication & Full Data Analysis
Moore & EF Hutton believe that academic and research journal publications could occur this spring and summer as a potential new cancer treatment as Multikine demonstrated a 14% improvement in overall survival rate in a recent clinical trial.
This bodes well for the efficacy of the treatment, which is especially encouraging considering that there were no adverse safety issues reported in the trial population.
If these results are replicated in future trials and research, Multikine could become a major breakthrough in cancer treatment, helping to improve survival rates for patients with this disease.
The 10% improvement in survival seen in the chemotherapy group compared to the 14% seen in the non-chemotherapy group is encouraging, as is the lack of adverse safety issues seen in the overall treated population.
These results suggest that Multikine may be a safe and effective treatment option for patients with this head and neck cancer.
Multikine FDA Approval Potential in Early 2023
The results of the Multikine phase 3 clinical trial showed a statistically significant improvement in survival rates for the radiation-only subgroup after tumor surgery. However, chemotherapy can be an intense treatment that may offset the benefits of Multikine for the chemotherapy subgroup.
Chemotherapy can cause a shock to the immune system, which may make it less effective in fighting cancer. Therefore, it is important to weigh the risks and benefits of both treatments before deciding which is best for each individual patient.
Approximately 40% of advanced primary head and neck cancer cases are treated with radiation, but not chemotherapy. This leaves a large enough target market size for Multikine, if the FDA approves it.
Analysis of the data from participants who did not receive chemotherapy could meet FDA requirements meaning Multikine could be an effective treatment option for many people with head and neck cancer.
Cel-Sci Multikine Manufacturing Facility Fully Up & Operational
Moore and others from EF Hutton recently took a tour the company’s expanded manufacturing facility led by CEL-SCI’s Chief Scientific Officer Eyal Talor, PhD who also serves as Sr. VP Research & Manufacturing.
The team reviewed the labeling room, fill room and quality assurance areas leaving with a positive impression in regards to the readiness, design and closed-loop process controls.
Annual production capacity for Multikine is currently 15,000 treatments. However, with expansion into adjacent areas, production can be doubled to 30,000 treatments.
This increase in production would be enough to meet EF Hutton revenue targets if FDA approval occurs. Therefore, the expansion into adjacent areas is crucial for the company in order to reach its desired financial goals.
Cel-Sci Stock Valuation by EF Hutton
EF Hutton has derived a $17 price target from the company’s DCF model with a discount rate of 24%.
The model takes into account the potential for Multikine to be approved by the FDA with potential revenue based on an estimated addressable market of 630,000 newly diagnosed H&N cancer patients worldwide, of which 40% are treated with surgery alone and would be eligible for Multikine.
Although there are other head and neck cancer treatments on the market, none of them have demonstrated the overall survival benefits that Multikine has shown in clinical trials.
This gives Cel-Sci a strong competitive advantage and creates significant upside potential for the stock price.
