Radiopharm Theranostics Ltd (ASX:RAD) has received a share price valuation of A$0.70 per share from Diamond Equity Research, with the analyst maintaining its previous valuation riding on the back of the company’s extensive and innovative cancer pipeline.
The analyst foresees two important potential value-driving catalysts in the coming months being IND approval and initiation of Phase 2b/3 clinical trial imaging brain metastasis and topline data from the RAD 301 Phase 1 safety study.
RAD shares are currently trading at A$0.14 with a market cap of approximately A$32.3 million.
Following are the excerpts from Diamond Equity’s research report:
IND application approval imminent
Radiopharm Theranostics has successfully concluded a pre-IND meeting with the US FDA receiving positive guidance to initiate F18-pivalate (RAD 101) clinical trial imaging brain metastasis.
The company expects to file an IND during the third quarter of 2023 and anticipates the initiation of the multi-centre Phase 2b/3 trial by the end of the year.
RAD101, composed of F18 radioisotope and pivalate (a small molecule targeting fatty acid synthetase), is a novel radiotracer used to detect and monitor the progression of glioblastoma and brain metastasis.
The company had previously reported positive data from the Phase 2 brain metastasis clinical trial. The imaging trial results showed high tumour uptake regardless of the origin of the tumour.
The positive pre-IND meeting solidifying the pathway toward clinical trial is a significant milestone toward potentially progressing the lead pipeline candidate to late-stage clinical trials.
Orphan drug designation for RAD 301
The company recently announced the receipt of a second FDA Orphan Drug Designation relating to RAD301 (68Ga-Trivehexin), a novel radiopharmaceutical technology for imaging patients with pancreatic ductal adenocarcinoma.
Trivehexin, a unique peptide-based compound, when labelled with 68Ga radionuclide, targets αvβ6-integrin, a cell marker indicative of tumour invasion and metastatic expansion.
The αvβ6integrin receptor is abundantly present in most pancreatic carcinoma cells, which makes it a promising target for both diagnosis and treatment.
The company has also previously received an IND approval allowing it to begin a Phase 1 imaging trial in patients with pancreatic cancer.
The phase 1 safety study, as listed on clinicaltrials.gov, is estimated to enrol 9nineparticipants, including healthy human volunteers and patients with pancreatic cancer.
Participants will be intravenously administered radioisotope, RAD301, and radiation absorption will be assessed in internal organs.
Valuation
The company's pipeline is extensive, as evidenced by the development of innovative radiopharmaceuticals aimed at treating several types of difficult-to-treat cancers.
These developments hold significant potential in terms of market size across both the diagnostics and therapeutics space.
Moreover, we foresee two important potential value-driving catalysts in the coming months being the IND approval and initiation of Phase 2b/3 clinical trial imaging brain metastasis and topline data from the RAD 301 Phase 1 safety study.
These milestones remain crucial in shaping the trajectory of the company's clinical development pipeline.
We have updated our valuation model, reflecting the latest cash balance and outstanding shares. Furthermore, we have updated the comparable company analysis, maintaining our previous valuation of A$0.70 per share contingent on successful execution by the company.