Procyon BioPharma (TSX-PBP)
The last three months have been very much maintaining the status quo for Procyon Biopharma. A pharmaceutical company focused on the development of products for the detection and treatment of various cancers and a topical scar management cream, the Company seems to be in about the same position it was last quarter. The current lack of developments has certainly been felt in the performance of the Company’s stock price, but we are hopeful that the fourth quarter will see several developments that will support the current stock price.
Procyon currently has four products that are either in clinical or preclinical development . Three targeting the treatment and detection of various forms of cancer and a topical cream for the management of scarring after surgery or burning.
The Prostate Secretory Protein, or PSP94, is a protein that the Company has identified that may be beneficial in the identification and treatment of prostate cancer. A synthetic peptide of the protein, PCK3145, is currently in Phase IIa clinical trials in the United Kingdom , trials which should be finishing shortly. The larger near term potential for this compound to the Company is its current discussions with Chiron Corp. (CHIR-NASDAQ). The two companies have been officially in discussions since December of 2001 in search of a worldwide developmental and licensing deal, but the agreement has already been extended once before. The current agreement is set to expire on September 30th, 2002 , and as of the publishing of this report, no further information was available.
During the last quarter, the only announcement made regarding the Company’s developmental pipeline was with respect to Fibrostat, the scar management cream. Procyon announced the results of its Phase II clinical trials, and while being less encouraging than hoped, the safety profile of the cream has now been confirmed. The Company is now preparing a Phase IIb clinical trial, which should begin in the first quarter of 2003. A European patent on the cream has also been granted on Fibrostat, adding to the ones already granted in Canada and the United States . Once trials are complete, the Company feels very confident that it will be well positioned to commercialise the product, or license it to a development partner. Biovail (BVF-TSX) has licensed the North American rights to the cream, and Procyon is reportedly in discussions with a potential European partner, for licensing rights to the EU.
IMI International Medical Innovators (IMI-TSX) is in a development and licensing agreement with Procyon for Colopath, a point-of-care test for colorectal cancer. IMI is developing the test in tandem with its own test for the disease and plans to market the tests as a joint product for doctors to use as part of their patient screening. Current plans to commercialise IMI’s ColorectAlert are still on track for a 2004 commercialisation, according to IMI’s most recent mention, at which time Procyon will receive royalty payments on the sale of either Colopath or ColorectAlert. Development of the test is largely out of the Company’s hands at this time, but IMI is working towards bringing the tests to market.
The fourth technology being developed by Procyon is a platform technology targeting the treatment of several forms of cancer by binding itself to the cancerous cells, preventing their replication. Although still officially in preclinical testing, the Company is hopeful that Phase I clinical trials will begin in 2003. Recent animal tests using the ANA technology have been very positive and Procyon is excited about the possibilities that this technology holds for the treatment of cancer.
Procyon is also completing its due diligence on a technology from Stanford University . The eighteen month agreement allows the Company to review the technology and decide whether it is something which it would like to bring in-house. No mentioned has been made as to what the technology is, only that it will potentially utilise several natural hormone receptors for the treatment of breast, prostate and thyroid cancers.
Financially, Procyon is in a relatively strong financial position. A recent $10 million bought deal financing has given the Company an estimated $14 million in cash at the end of September, which will be needed as we foresee that the Company will not have any meaningful revenue from the sale of its products until 2004, at the earliest, when Colopath / ColorectAlert is commercialised. In the recent second quarter report, R&D expenses were lower than estimated due to a timing difference from the current trials in the UK . The third quarter will see a comparative increase over the recent average R&D expenses, and therefore a greater than normal quarterly loss. At this time we have estimated that losses for the year ending December 31st will be fifteen cents in both 2002 and 2003.
Over the next three to six months investors could expect to see several milestones met:
1) The completion and results of the PSP trials in the UK
2) Potential announcement of an agreement with Chiron for PSP
3) Initiation of Phase IIb trials for Fibrostat
4) A potential European licensing agreement for Fibrostat
5) The initiation of Phase I trials for the ANA platform technology.
Therefore, we are going to maintain our $2.50 target price on Procyon Biopharma and our Speculative Buy recommendation.
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