IMCR - Immunocore: First Half Of 2024 IMC-F106C Data Expected

2023-11-01 17:42:17 ET

Summary

• Immunocore Holdings plc had net KIMMTRAK product revenues of $57.8 million generated in Q2 2023.
• Release of results from phase 1/2 study, using IMC-F106C for the treatment of various cancers, expected in the first half of 2024.
• Initiation of phase 3 study using IMC-F106C for first-line cutaneous melanoma patients expected to begin in Q1 2024.
• Immunocore had $435.1 million in cash as of June 30th 2023, enough to fund its operations for at least the next 12 months from the date of its 6-K SEC filing.

Immunocore Holdings plc ( IMCR ) has been making great progress to advance its pipeline. That's because it has already been selling a drug from its pipeline known as KIMMTRAK, which has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in several territories such as the United States, European Union, Canada, Australia and United Kingdom. In Q2 of 2023 , it reported that it earned approximately $57.8 million in net revenues for KIMMTRAK. I believe that there is potential with this biotech, because it has already launched this drug for several other territories. The expansion of this drug towards several of these other territories should help it to see an increase in revenues for this particular drug.

However, I believe that it is important to go over this biotech for another reason, which is the fact that it has a major data readout that is rapidly approaching. It is expected that Immunocore will be releasing data from its phase 1/2 study, using IMC-F106C for the treatment of patients with several types of cancers, in the 1st half of 2024. It is also already expected to initiate a new phase 3 study, which is specifically going to use IMC-F106C for the treatment of patients with first-line cutaneous melanoma. The first patient for this study is expected to be randomized by Q1 of 2024.

Phase 1/2 Study Data In First Half Of 2024 With IMC-F106C For Treatment Of Several Tumor Types

The thing about this biotech is that it has a major catalyst opportunity for investors to look forward to. That is, it is expected that it is going to release data from a phase 1/2 study using IMC-F106C for the treatment of patients with solid tumors in the 1st half of 2024. This is a study that is using IMC-F106C to treat patients with several types of cancers. Such cancers being targeted with the use of this drug for this early-stage study are: non-small cell lung cancer, melanoma, endometrial, and ovarian cancers. Preliminary data showed that the use of this drug candidate to target these patients was highly active. That's because this was the breakdown of the cancer patient populations that were being targeted with respect to durable partial responses that were achieved:

• 2 out of 6 patients with cutaneous melanoma.
• 2 out of 4 patients with ovarian cancer.
• 3 out of 6 patients with tebentafusp-naive uveal melanoma.

IMC-F106C was shown to be safe/tolerable and the treatment-related adverse events that did occur were highly manageable. For instance, the most frequent one was cytokine release syndrome [CRS], but that was mostly grade 1, and there were no CRS events that were Grade ?3. In terms of the safety data, the most important thing to highlight is that there were no treatment discontinuations or patient deaths. Hopefully, the next set of data to be released in the first part of next year ends up showing improvement in multiple solid tumor types.

Regardless of what happens with the other solid tumor data to be released from the phase 1/2 study, Immunocore is already gearing up to initiate a phase 3 registrational trial. Such a trial is going to recruit patients with previously untreated HLA-A*02:01 positive advanced melanoma. Patients for this late-stage study are going to be randomized into one these three arms:

• IMC-F106C + Opdivo [nivolumab].
• Opdivo.
• Opdivo + Opdualag [relatlimab].

However, one important item to point out is that the goal is to incorporate two doses of IMC-F106C, which are 40 mcg and 60 mcg respectively. One of these doses is going to be discontinued after this biotech is able to review the first 60 patients randomized to the two experimental arms. The primary efficacy outcome measure of this phase 3 study is going to be progression-free survival [PFS] by BICR. The first patient will be randomized to this late-stage registrational trial in Q1 of 2024.

Financials

According to the 6-K SEC Filing , Immunocore had cash and cash equivalents of $435.1 million as of June 30, 2023. This biotech is generating some sales of a drug, which has been approved for several territories, known as KIMMTRAK. Net revenues of this drug came in at $57.8 million in Q2 of 2023. However, I believe that there is potential for revenues to increase in the coming quarters and that is because of the expansion it has been able to achieve. It has been able to launch KIMMTRAK in several other territories such as Austria, Italy, Israel, and Finland.

Not only that, but it expects additional launches in other European territories by the end of 2023 as well. In terms of cash on hand , it believes that it has enough to fund its operations for at least the next 12 months from the date of the 6-K SEC Filing, which was filed on August 10th, 2023. In order to raise such cash, it could deploy the use of public/private equity offerings, debt financing, collaboration agreements or licensing agreements. Either way, it is going to have to find a way to raise additional cash by at least early 2024.

Risks To Business

There are several risks that investors should be aware of before investing in Immunocore. The first risk to consider would be with respect to the upcoming release of results from the phase 1/2 study, which is using IMC-F106C for the treatment of patients with several types of cancers. That's because such results are expected to be released in the 1st half of 2024 and there is no guarantee that data to be released from study will turn out to be positive. While preliminary data showed that IMC-F106C was able to generate durable partial responses [PRs] for several types of cancers, it is not known whether or not such responses continued on for an extended period of time.

The second risk to consider would be with respect to the initiation of the phase 3 registrational study, which is using IMC-F106C for patients with previously untreated HLA-A*02:01 positive advanced melanoma. Upon completion of this late-stage trial, there is no assurance that the primary endpoint of progression-free survival [PFS] by BICR will be obtained.

The third and final risk to consider would be with respect to the financial position that this biotech is in. That's because it states in its 6-K SEC Filing that it only has enough cash to fund its operations for at least the next 12 months. This means that it will likely need to start looking to find ways to raise additional funds by the early part of 2024.

Conclusion

Immunocore Holdings plc has made great progress in being able to advance its pipeline. That's because it is already generating revenues through sales of its regulatory-approved drug KIMMTRAK. This drug has been approved in multiple territories for the treatment of patients with metastatic uveal melanoma. It reported that it generated total net product revenues of KIMMTRAK of $57.8 million for Q2 of 2023. As I stated above, I believe that it has the ability to increase net product revenues of this drug because of its ability to expand its use towards several other territories. It even expects to be able to launch this drug in several other European territories by the end of 2023.

One could consider another expansion opportunity as it relates to this specific program. This company is already in the process of exploring KIMMTRAK in HLA-A*02:01 positive patients with 2nd line or later cutaneous melanoma, in a phase 2/3 study. The only downside is that the completion of trial randomization for this trial is not anticipated until the 2nd half of 2024. IMC-F106C offers PRAME A02 targeting, which gives Immunocore the ability to target other types of solid tumors, besides the target of only uveal melanoma with respect to KIMMTRAK.

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