Trimeris Inc. entered into agreements to sell approximately 1.27 million shares of newly issued common stock, a private placement expected to net $41 million.
The Durham, N.C.-based company is focused on drug candidates for HIV and has fast-track status from the FDA for two peptides, T-20 and T-1249, now in clinical trials in conjunction with its partner, Hoffmann-La Roche Inc., of Nutley, N.J., for HIV-infected patients. (See BioWorld Today, June 20, 2001.)
“It gives [us] about a year and a half of cash,” Dick Ellis, executive vice president and chief business officer, told BioWorld Today. “It clearly takes us through some very significant milestones, which is through Phase III data in the second quarter, with an NDA [new drug application] filing planned for the second half of this year.”
Ellis said Trimeris has been “somewhat opportunistic” about its financing strategy.
“Given the events of 9-11, some of us have recalibrated,” Ellis said, noting that while the opportunity exists, companies may feel the need to raise money.
As of Sept. 30, Trimeris, which has 108 employees, had $90.2 million in cash, with a burn rate of about $7 million per month, Ellis said. The company had 17.5 million shares outstanding prior to the financing. It did not disclose the gross proceeds or share price of the new placement.
T-20 and T-1249 are part of a broad category of investigational drugs called entry inhibitors, which work to block a virus before it enters and takes over a host cell. There are three types of entry inhibitors: attachment inhibitors, co-receptor inhibitors and fusion inhibitors. T-20 and T-1249 are fusion inhibitors.
Trimeris has said that there is a growing population of HIV-infected patients who are resistant to current therapies, and therein lies the urgency to offer new therapies to them.
T-20 is a peptide drug made up of 36 amino acids and is the most advanced in Trimeris’ pipeline. It is in Phase III trials, the results of which are expected during the second quarter. There are two Phase III trials, one with 500 patients in the United States and an exact replica with 500 patients in Europe, Ellis said.
T-20 is administered as a twice-daily subcutaneous injection. The most frequent side effect shown to date is mild to moderate skin reaction at the site of injection.
T-1249 is in Phase I/II trials. In the lab, it showed activity against virus that has developed resistance to T-20.
Roche and Trimeris are sharing equally in worldwide research, development and commercialization costs. They would share equally in profits from sales of new HIV fusion inhibitor peptides discovered after July 1, 1999.
Trimeris also has programs in the preclinical stage.
“The technology platform that Trimeris is founded on enables us to move into other viral diseases that are medically important and virally significant,” Ellis said.
For example, the company is looking at fusion inhibitors for respiratory syncytial virus, which is a major cause of lower respiratory tract infection in children.
Trimeris and Array BioPharma Inc., of Boulder, Colo., signed an agreement in August to discover small-molecule fusion inhibitors of HIV and RSV. Trimeris initially is screening a library of small-molecule compounds provided by Array against HIV and RSV fusion protein targets. Array will optimize lead compounds and receive payments and royalties based on achievement of specific development milestones.
Trimeris’ stock (NASDAQ:TRMS) fell 86 cents Friday to close at $37.14.