BioCryst Pharmaceuticals is once again left without a dance partner, after its shareholders voted down a proposal to merge with Idera Pharmaceuticals and form a combined rare disease company.
Durham, North Carolina-based BioCryst proposed a $101 million merger deal with Presidio Pharmaceuticals in 2012, which fell through after BioCryst endured an FDA hold and clinical trial failures in the following weeks—including the termination of a late-stage study evaluating flu drug peramivir, for which it received nearly $235 million for development from the federal government. Those setbacks would lead the company to cut half of its staff later that year.
Today, BioCryst said it will soldier on and continue advancing its clinical-stage pipeline and generation of new compounds.
“We are moving forward executing our standalone strategy with a great deal of confidence in our programs, our pipeline and our ability to drive value for our stockholders,” BioCryst President and CEO Jon Stonehouse said in a statement.
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According to SEC filings, of the nearly 83 million voting shares representing BioCryst stockholders, 50.6 million were cast against the deal, or over 60%. Idera’s backers, meanwhile, voted 99.9% to move forward with the merger, amassing 149.7 million shares in favor of the deal, compared to about 2 million against.
First announced in January, the merger would have seen the formation of a new, renamed company led by Idera CEO Vincent Milano and based at Idera’s current headquarters in Exton, Pennsylvania. Stonehouse would serve as a board member, while BioCryst Chairman Robert Ingram would become chairman of the board.
Per the agreement, BioCryst will reimburse Idera $6 million for canceling the deal. BioCryst also revised its financial guidance, expecting its net operating cash use to be in the range of $85 million to $105 million, up from previous estimates of $67 million to $90 million.
In the coming months, BioCryst expects to see trial data from the first cohort of a clinical trial evaluating BCX7353 in acute hereditary angioedema, with data readouts from a separate phase 3 trial in the indication expected in the first half of next year. In addition, the company is planning to launch a phase 1 study of its ALK-2 inhibitor in fibrodysplasia ossificans progressiva in early 2019.
Meanwhile, Idera’s lead candidate, TLR9 agonist tilsotolimod, is being studied in early-phase, proof-of-concept trials in PD-1 refractory melanoma patients in combination with checkpoint inhibitors. A phase 3 trial is currently enrolling patients.
“Our tilsotolimod would have been one of the two centerpiece product opportunities of the combined company,” said Idera’s Milano in a release. “As we move forward independently, we will remain focused on the development of tilsotolimod in anti-PD-1 refractory melanoma, a significant unmet need, as well as begin to explore the role of tilsotolimod in improving outcomes in patients suffering from additional solid tumor cancers. While we remain focused on the development of tilsotolimod, if an opportunity arises to further enhance shareholder value and build our company through business development, we will explore it.”
Date: July 16, 2018
Source: Fierce Biotech