How important was that announcement a couple of days ago about 'cancer indication' or whatever that was? Is this a huge deal that means great things for the future? Or is this some meaningless item to hype the company?
What's the deal?
The PR about ovarian cancer merely further validates the potential multiple indications for the lead candidate. This makes interested parties more likely to take a closer look at other oncology indications if they are interested in licensing or perhaps buying the entire company. Don't forget that the lead candidate is now 10 long years in the making and that is why so many prior investors got burned. Spiro appears aware of what he now needs to do to leverage the pipeline and that means signing deals for the other indications or EU territories.
Pay close attention to the sap in MDS p2 results out in only 2 months. The company may very well already have a good idea of the results. This might be why Spiro speaks of licensing interest.
Another strong possibility is that JNJ will buy rights to sap in Europe as they are the ones with marketing rights in Europe for DACOGEN as their scientists certainly understand the potential of sap in AML especially in combination with DACOGEN. The two drugs in combination so far show outstanding results.
How much would JNJ pay for sap marketing rights? Minimally $50M but easily much more. Mundi paid Allos $50M upfront to Allos for Fotolyn rights in Europe which the EU refused to approve. Fotolyn only has US sales of about $50M. Mundi is a lot smaller than JNJ. $50M is chump change to JNJ and
if sap gains approval the potential income stream is enormous. Their reps would have 2 drugs in the same bag selling the best treatment for AML in many many years.
The recent news out on CYCC I believe has at least raised awareness and gets this small company on the biotech investor radar screens. Once licensing deals are established, you are going to see a lot more interest. Why? Because if large pharma pays for licensing rights it further legitimizes the science behind the pipeline and Wall Street will jump in with both legs. Those who sold into the recent spike will regret having not waited a few more months,
Thanks guys for your responses. Tough to reconcile all of this. Either investors are totally missing this boat ($70 million valuation) or ??? I am long 8,000 shares and I think I'll long-term hold those but I do not have the courage to add to that. Thanks for the info - good luck to all.
You should not get caught up in the short-term moves, unless you are only trading this. Long-term, this has too good of a pipeline to pass up at this low valuation. I am long now 23000 shares and still have an order in today and will have more orders in the future while she stays under $5...Good luck and be patient.....this should play out nicely in the longs hands.
Sentiment: Strong Buy
The Ovarian Cancer news was another piece of the Sapacitabine HR pathway construct. Ovarian Cancer Patients have a significant preponderance of Homologous Recombination Pathway Deficiencies. Knowing this, investigators chose to test the hypothesis that Sapacitabine would be consistent with the previous experience with the drug by yielding "Super Responders" among an Ovarian Cancer cell line population. . Although the tests were in Vitro, they are highly significant because the activity of Sapacitabine and it's metabolite CNDAC have been repeatedly established in vivo. It should be understood that these in vitro tests were conducted side by side with Cisplatin which is the current standard of care for Ovarian Cancer and a multibillion dollar drug. Sapacitabine achieved almost DOUBLE THE RESPONSE of CISPLATIN. Ovarian Cancer currently has a 70% death rate due to poor treatment options. With Sapacitabine's low toxicity and long term maintenance potential, new hope may be found for this dreaded disease. In 2020, Ovarian Cancer is projected to reach $2.5 billion. Without stating the obvious, this could result in Billions in sales for Cyclacel and this is only one of the multiple indications for Sapacitabine in solid and liquid tumors. The continued proof of HRD concept has far reaching implications for treating multiple types of Cancer Patient Populations with a genomic targeted Sapacitabine protocol. ;o)
Sentiment: Strong Buy
"We are encouraged by the activity signal of sapacitabine in ovarian cancer samples," said Judy Chiao, M.D., Vice President, Clinical Development and Regulatory Affairs of Cyclacel. "This observation may be directly related to the drug's mechanism which is enhanced in cancer cells with reduced capacity for DNA repair through the homologous recombination repair or HR pathway. In addition to our ongoing Phase 3 registration trial of sapacitabine in acute myeloid leukemia and Phase 2 studies in myelodysplastic syndromes, we are continuing to evaluate sapacitabine as a potential treatment for patients with solid tumors, and in particular those with BRCA-deficient cancers."
Cyclacel collaborators from the Northern Institute for Cancer Research, Newcastle University, UK led by Nicola Curtin, Professor of Experimental Therapeutics and Richard Edmondson, Professor of Gynaecological Oncology reported that CNDAC, the active metabolite of sapacitabine, was active against 75% (30 of 40) of primary ovarian cancer (POC) samples isolated from patients. In contrast cisplatin was active in less than half of the samples. Over half of the cisplatin-resistant samples were sensitive to CNDAC, indicating that sapacitabine has potential utility for treatment of ovarian cancers, including platinum-resistant disease. The majority, but not all, of the samples tested were from high grade serous ovarian cancers.
Sentiment: Strong Buy