RE:RE:RE:RE:RE:RE:RE:RE:Amy Levin is ONCY's VP Clinical Operations & NOT on the BOD
I would suggest that the more options on the table, the better the end result.
Since large private equity firms like Caryle and its new entity LaunchTx are becoming partners with late stage biopharma companies, this new development provides ONCY a promising option for the funding a Phase 3/4 clinical trial, if required. This nothwithstanding, the preference would be to have Big Pharma acquire ONCY and then have Big Pharma file for an Accelerated Approval and then run a Phase 4 confirmatory clinical trial in both pancreatic and breast cancer.
However the benefits of engaging with a large private enquiry firm like Caryle includes being able to access the fundraising machinery that this large private equity house runs, as well as the broader geographic footprint. Carlyle has a significant team in China, which analysts see as holding potential for both early-stage investments and opportunities for LaunchTx, given the FDA’s wariness about China-only data.
https://www.evaluate.com/vantage/articles/news/policy-and-regulation-snippets/china-backed-us-approvals-continue-hang
Furthermore the US Inflation Reduction Act favors US based biologic drug companies with the FDA extending a longer period of market exclusivity extending to 13 years from the time of marketing approval, than would be the case with small molecules. This recent development has introduced the certainty of investing in late-stage development companies that large private equity seem to have been seeking.
Consequently large private equity firms are now looking to become players in this high-value space.
“We see a strong market need for a clinical development company that can bring access to capital, global resources, and deep operational expertise to biotech and biopharma companies looking to advance therapeutic candidates through clinical trials and regulatory approval,” said Anshul Thakral, CEO of Launch Tx.
That said, one example of such a co-development agreement that happened in January 2023 with the late-stage non-biological biopharma company Pathalys announced the raise of $150 million through a combination of secured product financing and equity to support three major late tage develoment activities those being: (1) two phase 3 clinical trials, (2) registration efforts and (3) pre-commercialization activities for the company’s lead product upacicalcet. Abingworth led both financings and was joined by Carlyle and OrbiMed, along with Pathalys’ founding investors Catalys Pacific and DaVita Venture Group. Pathalys retains worldwide commercial rights to upacicalcet, outside Japan and Asia, and has the option to prepay its obligations in full at any time.
https://launchtx.com/media-center-jan-18-2023/