New clinical data from biotechnology company IMV Inc (IMV Stock Quote, Charts, News, Analysts, Financials NASDAQ:IMV) has Leede Jones Gable analyst Douglas W. Loe staying the course as far as the stock goes. In an update to clients on Tuesday, Loe reiterated his “Speculative Buy” rating and $6.00 target for IMV, which at the time of publication represented a projected one-year return of 341 per cent.
Dartmouth, Nova Scotia-based IMV is a clinical stage biotech company whose main technology is the Depovax lipid-based water-free antigen delivery platform, with the company currently focused on oncology and infectious disease with its lead candidates DPX-Survivac and DPX-RSV.
The company announced on April 8 that it will be presenting safety and preliminary efficacy data at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans from April 8-13. The data is from a Phase 2 study on the combination of the Company’s lead immunotherapy candidate, maveropepimut-S (MVP-S), with pembrolizumab involving patients with advanced, metastatic bladder cancer. IMV says the preliminary results of the study (involving 17 patients who on average had two prior lines of therapy) “suggest that IMV’s therapy may provide a well-tolerated therapeutic alternative for advanced, metastatic bladder cancer patients in need of new treatment options,” according to the company.
“The basket trial was designed to identify signals of clinical benefit for the combination of MVP-S/ CPA and pembrolizumab,” said Jeremy Graff, Ph.D., Chief Scientific Officer at IMV Inc, in a press release. “We are very encouraged to see such positive clinical results, particularly in advanced, metastatic bladder cancer patients that had already been treated with immune checkpoint inhibitors. We are now meeting with top key opinion leaders in the field to design follow-on trials to deepen our understanding of this clinical benefit.”
IMV said five of the 17 subjects showed a response, two of which confirmed complete responses and three confirmed additional partial responses, and that long-term clinical benefit was observed in several subjects along with an increase in detectable suvivin-specific T cells in peripheral blood. IMV said the combination treatment was well-tolerated and that the majority of adverse events were of grade 1 or grade 2.
Looking at the results, Loe said while the response rate data may seem modest (with a cumulative tumour response rate of 29 per cent), they are positive for DPX-Survivac’s prospects in metastatic bladder cancer as all patients in the study had failed at least three prior courses of chemotherapy.
“We await final Phase II Basket data from all enrolled bladder cancer patients in the trial before determining if this underserved cancer market merits further attention from IMV/DPX-Survivac. However, a 29 per cent overall response rate for this advanced cancer form is strong in our view, at least to the limits of study design, and we are optimistic that more advanced bladder cancer clinical testing could be relevant in the firm’s R&D priorities in future quarters,” Loe said.
Loe said his model on IMV and its royalty revenues from DPX-Survivac doesn’t currently include market value ascribed to advanced bladder cancer as a target indication, with projections currently based on expectations for FDA-approved usage for recurrent, refractory ovarian cancer and diffuse large B-cell lymphoma.
“For now, we are maintaining our Speculative BUY rating and one-year price target of $6.00 on IMV, with our valuation still based on NPV (25 per cent discount rate) and multiples of our F2026 EBITDA/EPS forecasts. Our EV calculation incorporates FQ421 balance sheet data (cash of $38.6 million, total debt of $18.0 million) even though we are mindful that the firm has incurred another quarter of operating cash losses since end-of-F2021,” Loe wrote.
By the numbers, Loe is calling for IMV to deliver 2024 revenue and EBITDA of $5.0 million and negative $23.4 million, respectively, 2025 revenue and EBITDA of $11.2 million and negative $15.3 million, respectively, and 2026 revenue and EBITDA of $93.7 million and $69.7 million, respectively. (All figures in US dollars.)
“[The] competitive landscape in bladder cancer therapeutics is dominated by checkpoint inhibitor antibody drugs, many of which are already approved for various stages of bladder cancer but are exploring broader clinical utility across the entire continuum-of- disease,” Loe wrote.
“There are a few advanced Phase III-stage bladder cancer programs that we are closely monitoring for comparison to DPX-Survivac’s current and future market potential in this broad indication. Many of these are follow-on studies for already- approved checkpoint inhibitor mAbs that we would see as being more complementary to DPX-Survivac than competitive to it, as we believe that any positive clinical data that DPX-Survivac generates in combination with pembrolizumab could be replicated with alternative anti-PD-1 mAbs either approved or in development,” he said.