Is it Time for Pharma to Fish or Cut Bait?In my opinion parties interested in ONC/Y are shareholders, analysts, and potential pharma purchasers/partners. I think at this point the group that ONC/Y is most interested in influencing is potential pharma purchasers/partners.
What has ONC/Y communicated to pharma through their year end releases and conference call?
1. No more exclusivity period for BRACELET-1. Now all comers willing to sign a confidentiality agreement are able to recieve all up-to-date data. This applies to "quite a few" pharmas who have shown an interest. This signals to pharma that a competative auction for ONC/Y has begun.
2. The BRACELET-1 ORR and PFS data, if positive, will be sufficient to support a registration trial. Heineman said clearly there is no need to wait for finalized OS results. That said, over time (an estimated another 1 to1 1/2 years) a median OS will likely be able to be fixed. Until then parties with confidentiality agreements will see the OS trend as the OS data matures. Everyone, public included, gets a readout of the data at the ASCO conference in early June. One message to pharma would be to make a partnership or buyout offer soon or risk losing out to others. If the purchase of ONC/Y is similar to acquisitions of many sizeable businesses, once multiple interested parties have been given access to complete information ONC/Y many give a deadline for interested parties to submit partnership or buyout proposals. This could lead to a shortlisting of purchaser/partner candidates and then a further period of due dilegence with a deadline for a final purchase/partnership offer. I've been through a process like this in a business I was involved with. There are brokers and investment banks and established procedures for facilitating the sale of large companies. I strongly suspect ONCY will not be reinventing the wheel. I expect they will utilize highend assistance and established procedures with the process. The process is not chaotic or serendipidous. It is deliberate and methodical. There are often timelines involved, making clear to potential partners/purchasers that it is time to fish or cut bait. ONC/Y, if they are following this route, are in control of the deadlines they set.
3. ONC/Y has established that they will not be vulnerable to financial stresses that a potential purchaser could exploit. The are continuing the measured use of the ATM to maintain a perpetual one-year cash runway.
4. ONC/Y continues to communicate their confidence in the utility of Pela for HR+/HER2- breast cancer and pancreatic cancer. Matt also clearly expressed his hope/expectation for registration trials starting in 2023. That could be hyperbolye, but it communicates that he wants a quick start to registration trials That could only happen if ONC has a partner (or has been bought out). They do not have the capacity financially, personnelwise, or experiencially to run one, let alone two, large registrsation trials on their own. Again, I think this sends the message that ONC/Y is going to find a partner or purchaser soon (say within the next 4-5 months) so interested parties have to act now or miss out.
All the above is in my opinion and open to correction as new facts and better understanding becomes available. Getting at the truth is not insisting on a particular narrative come hell or high water. It involves putting forward hypothesises (predictive models) that are then shot down or validated.