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Closing $1.5M Financing Round, Mirna Still Seeks More Cash and Delays First Phase I to 2013

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By Doug Macron

Mirna Therapeutics, a developer of therapeutic microRNA mimics, this week announced that it has closed a $1.5 million internal round of financing.

The company said the capital would be sufficient to pay for the investigational new drug application-enabling studies necessary to move its lead drug candidate into phase I testing in early 2013 — two years later than originally planned.

Additionally, CEO Paul Lammers said the firm is still intent on finalizing a $25 million Series B round that was supposed to have closed in 2010. He now said it will likely close sometime next year.

Lammers said that the new round was completed with investments from “a few high net-worth individuals” who had previously invested in the company.

He also stressed that the new capital, together with a $10.3 million grant Mirna received last July from the Cancer Prevention and Research Institute of Texas, will give the shop some breathing room to prep for the phase I study. Lammers said the trial will be for the miR-34 mimic, which the company has chosen as its lead drug candidate.

“Our burn is in check … and [the new funding] allows us to do the preclinical development programs we want to run,” Lammers said. “Right now, we are well funded up to an IND submission at the end of next year and getting into the clinic” in early 2013.

“We still want to go out and do a bigger [financing] toward the end of this year,” Lammers added. “The good thing is that between this money … [and] the State of Texas funding, we are very well financed at the moment. [This] allows us to be a bit critical about the valuation for our technology.”

He confirmed that Mirna is still targeting a Series B of around $25 million.

Last July, when Mirna disclosed that it was receiving the $10.3 million CPRIT grant, Lammers told Gene Silencing News that it was also aiming to wrap up the Series B before the end of that summer (GSN 6/24/2010).

Also at the time, he projected that Mirna would file the IND — the company's first — sometime in 2011.

But by early this year, Mirna had failed to close the Series B, which caused it to push back until 2012 the expected IND filing date. Lammers attributed the setback to general investor concerns over decisions by key pharmaceutical companies operating in the RNAi space (GSN 1/20/2011).

At the time, he said discussions with potential investors were still ongoing and noted that potential backers remained “very committed to Mirna, our approach, and our targets." The financing round "will just take a bit longer to complete.”

Meantime, to stay on track with its updated IND plans, Mirna is working to select a delivery vehicle for the miR-34 mimic. Previously, that process had involved concurrently evaluating technologies from outside companies as well as an internal neutral lipid-emulsion approach.

Recently, however, the company concluded that the lipid-emulsion technology “needed quite a bit of optimization before it would be IND-ready,” Lammers said. As such, Mirna has decided that its first clinical candidate would use a delivery vehicle from another company.

About half of the technologies under consideration are already in the clinic, he noted, which would reduce the amount of pre-IND toxicology work Mirna would need to conduct. The company expects to select a delivery approach by the end of this year.

Still, work continues on the lipid-emulsion technology, which “could still be a great second- or third-generation delivery system,” he said. “But we really want to get data on the microRNA-replacement therapy approach we pursue because that could be a great value-driver. I think it makes sense, then, to move forward with one of the [external delivery technologies] that show promise.”


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