Tekmira this week reported a 70 percent increase in first-quarter revenues, driven by a US government contract to develop an RNAi therapeutic to treat Ebola virus infection.
Officials said in a conference call to discuss the company's first-quarter financial results that under the Ebola contract, Tekmira has been able to scale up its lipid nanoparticle technology to support late clinical development and therapeutic manufacturing.
Tekmira reported revenue of $4.3 million for the quarter, of which $3.4 million, or 80 percent, was derived from the Ebola contract. The balance of first-quarter revenues, $900,000, came from Tekmira's ongoing manufacturing services agreement with Alnylam.
In the year-ago period, Tekmira reported $2.5 million in revenue, of which $900,000 came from the Alnylam manufacturing agreement and the remainder came from a collaboration with Roche. While the pharmaceutical firm pulled out of the RNAi space in late 2010 (GSN 11/18/2010), Tekmira CFO Ian Mortimer noted during this week's call that the reduction in Roche revenue in Q1 was "more than offset" by the Ebola contract revenue.
Regarding the company's ongoing litigation with Alnylam, CEO Mark Murray said Tekmira is "confident that we have taken appropriate steps to ensure that we can pursue this lawsuit without interruption to our core business activities, and we intend to fulfill all of our manufacturing obligations to Alnylam." He declined to comment further.
Tekmira sued Alnylam in March, claiming that its partner had misappropriated trade secrets and other information related to its LNP technology (GSN 3/17/2011). Alnylam countersued in April (GSN 4/7/2011).
Murray reiterated previously disclosed timelines for the company's pipeline programs — TKM-PLK1, an siRNA-based cancer drug currently in phase I testing; and TKM-Ebola, the Ebola treatment it is developing under the US Department of Defense Chemical and Biological Defense Program. Interim data on TKM-PLK1 is expected before the end of 2011, while an investigational new drug application filing on TKM-Ebola is planned for the second half of the year.
"Importantly, Tekmira's work on TKM-Ebola also supports continued lipid nanoparticle technology development, innovations around process development, manufacturing scale-up, and lyophilization," Murray said.
He noted that the company has completed pilot studies in which it has scaled up its manufacturing capabilities from 10-gram batches to 1-kilogram batches, "which will support late clinical development and commercialization of LNP product candidates."
He noted that LNP specifications "are consistent and reproducible with this 100-fold increase in batch size."
In addition, the company "has successfully completed a pilot project on LNP lyophilization, which will provide a number of platform-wide benefits, including long-term product stability and reliable transport," Murray said.
Murray did not shed further light on an effort to develop a next-generation version of the LNP technology, which he disclosed in March (GSN 3/31/2011).
At the time, he said the company planned to add antibody-based targeting moieties to the LNP molecules and to enable respiratory administration. In early results, he said the improved LNPs were shown to “achieve therapeutic indices superior to any currently available."
Tekmira narrowed its first-quarter net loss to $3.1 million, or $0.30 per common share, from $4.2 million, or $0.40 per common share, in the first quarter of 2010.
First-quarter R&D expenses were flat at $5.6 million, compared to $5.5 million in the year-ago quarter, while general and administrative expenses increased to $1.5 million from $1 million, largely due to legal expenses related to the Alnylam suit.
As of March 31, Tekmira had cash and cash equivalents of approximately $9.2 million.
Mortimer said the company believes this is sufficient to continue the company's product-development efforts into the second quarter of 2012.
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