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Trimeris Announces Fourth Quarter and Year-End 1997 Results; Company Also Reports Phase II Trial Progress
February 3, 1998 8:30 AM EST
DURHAM, N.C.--(BUSINESS WIRE)--Feb. 3, 1998--Trimeris, Inc. (NASDAQ: TRMS) today announced results for the fourth quarter and year-end 1997, ended December 31, 1997.
For the fourth quarter, the company reported a loss of $4.6 million, or $0.45 per share, compared with a loss of $1.9 million ($0.36 per share) in the 1996 period. The increase in net loss is due to expenses incurred in the quarter to purchase drug material and raw materials for drug production to supply the clinical trials.
For the 1997 full year, net loss totaled $11.4 million, or $1.55 per share, compared with $7.0 million ($1.48 per share), for the 1996 period.
"Since we initiated Phase II clinical trials of T-20 against HIV infection, the Institutional Review Boards at the University of North Carolina and the University of Alabama at Birmingham have now given their approval of the clinical protocol, an important first step toward enrolling patients," M. Ross Johnson, president and chief executive officer of Trimeris, said. "The Phase I/II trials, administered intravenously, reduced patients ' viral loads below the limits of detection without drug-related adverse effects. In the Phase II trial, we will shift the administration of T-20 to a pump that delivers the drug by continuous subcutaneous infusion to HIV-1-infected individuals because we believe that this method of continuous dosing offers both patient compliance and therapeutic benefits."
"We are in discussion with the U.S. Food and Drug Administration regarding their request that we conduct additional nonclinical safety studies regarding potential hypersensitivity to subcutaneous infusion as an extra margin of safety prior to dosing patients during the Phase II trial," Johnson explained.
The dosing period of the Phase II study is expected to last approximately 21 days in each patient. Patients who demonstrate a significant viral load decrease will be eligible for a six-month extension of the protocol. The results of the Phase II study, expected in mid-1998, will form the basis of a pivotal trial in triple-drug-combination resistant patients.
Trimeris is a development stage biopharmaceutical company engaged in the discovery and development of novel therapeutic agents that block viral infection by inhibiting viral fusion with host cells. The company's lead product candidate is T-20, which inhibits fusion of the human immunodeficiency virus (HIV) with host cells.
Note: Except for any historical information presented herein, matters presented in this release are forward-looking statements that involve risks and uncertainties. The results of the company's previous clinical trials are not necessarily indicative of future clinical trials, and future results could differ materially from the results presented herein. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the "Risk Factors" section included in the company's Registration Statement on Form S-1 as declared effective by the Securities and Exchange Commission on October 6, 1997, and those discussed from time to time in Trimeris' filings with the Securities and Exchange Commission.
Trimeris, Inc.
(A Development Stage Company)
Statements of Operations
[$ in thousands, except per share amounts]
Three Months Year
Ended Dec. 31 Ended Dec. 31
------------------------------------------------
1997 1996 1997 1996
------------------------------------------------
Revenue $ 90 $ 55 $ 431 $ 55
---------- ---------- ---------- ------------
Operating expenses
Research and
development 4,220 1,361 9,734 5,146
General and
administrative 935 535 2,596 1,761
-------- --- -------- -----
Total operating expenses 5,155 1,896 12,330 6,907
------- ----- --------- -----
Operating loss (5,065) (1,841) (11,899) (6,852)
-------- ------- -------- -------
Other income (expense)
Interest income 475 8 584 47
Interest expense (7) (38) (113) (167)
-------- ---- -------- -----
468 (30) 471 (120)
-------- ------ ------ -----
Basic net loss $ (4,597) $ (1,871) $(11,428) $ (6,972)
========= ========= ========= ==========
Basic net loss per share $ (0.45) $ (0.36) $ (1.55) $ (1.48)
========== ========== ========== ===========
Weighted average
shares outstanding 10,302 5,186 7,395 4,705
========= ===== ======== =====
Trimeris, Inc.
(A Development Stage Company)
Balance Sheets
($ in thousands)
December 31, 1997 December 31, 1996
------------------- ------------------
Assets
Total current assets $37,527 $ 213
Property, furniture and equipment - net 756 897
Total other assets 561 574
------- -------
Total assets $38,844 $ 1,684
======= =======
Liabilities and Stockholders'
Equity (Deficit)
Total current liabilities $ 2,794 $ 1,518
Notes payable -- 259
Capital lease obligations, less
current installments 240 316
------- -------
Total liabilities 3,034 2,093
------- -------
Net stockholders' equity (deficit) 35,810 (409)
------- -------
Total liabilities and
stockholders' equity $38,844 $ 1,684
======= =======
c Business Wire. All rights reserved.
Trimeris Announces Fourth Quarter and Year-End 1997 Results; Company Also Reports Phase II Trial Progress
February 3, 1998 8:30 AM EST
DURHAM, N.C.--(BUSINESS WIRE)--Feb. 3, 1998--Trimeris, Inc. (NASDAQ: TRMS) today announced results for the fourth quarter and year-end 1997, ended December 31, 1997.
For the fourth quarter, the company reported a loss of $4.6 million, or $0.45 per share, compared with a loss of $1.9 million ($0.36 per share) in the 1996 period. The increase in net loss is due to expenses incurred in the quarter to purchase drug material and raw materials for drug production to supply the clinical trials.
For the 1997 full year, net loss totaled $11.4 million, or $1.55 per share, compared with $7.0 million ($1.48 per share), for the 1996 period.
"Since we initiated Phase II clinical trials of T-20 against HIV infection, the Institutional Review Boards at the University of North Carolina and the University of Alabama at Birmingham have now given their approval of the clinical protocol, an important first step toward enrolling patients," M. Ross Johnson, president and chief executive officer of Trimeris, said. "The Phase I/II trials, administered intravenously, reduced patients ' viral loads below the limits of detection without drug-related adverse effects. In the Phase II trial, we will shift the administration of T-20 to a pump that delivers the drug by continuous subcutaneous infusion to HIV-1-infected individuals because we believe that this method of continuous dosing offers both patient compliance and therapeutic benefits."
"We are in discussion with the U.S. Food and Drug Administration regarding their request that we conduct additional nonclinical safety studies regarding potential hypersensitivity to subcutaneous infusion as an extra margin of safety prior to dosing patients during the Phase II trial," Johnson explained.
The dosing period of the Phase II study is expected to last approximately 21 days in each patient. Patients who demonstrate a significant viral load decrease will be eligible for a six-month extension of the protocol. The results of the Phase II study, expected in mid-1998, will form the basis of a pivotal trial in triple-drug-combination resistant patients.
Trimeris is a development stage biopharmaceutical company engaged in the discovery and development of novel therapeutic agents that block viral infection by inhibiting viral fusion with host cells. The company's lead product candidate is T-20, which inhibits fusion of the human immunodeficiency virus (HIV) with host cells.
Note: Except for any historical information presented herein, matters presented in this release are forward-looking statements that involve risks and uncertainties. The results of the company's previous clinical trials are not necessarily indicative of future clinical trials, and future results could differ materially from the results presented herein. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the "Risk Factors" section included in the company's Registration Statement on Form S-1 as declared effective by the Securities and Exchange Commission on October 6, 1997, and those discussed from time to time in Trimeris' filings with the Securities and Exchange Commission.
Trimeris, Inc.
(A Development Stage Company)
Statements of Operations
[$ in thousands, except per share amounts]
Three Months Year
Ended Dec. 31 Ended Dec. 31
------------------------------------------------
1997 1996 1997 1996
------------------------------------------------
Revenue $ 90 $ 55 $ 431 $ 55
---------- ---------- ---------- ------------
Operating expenses
Research and
development 4,220 1,361 9,734 5,146
General and
administrative 935 535 2,596 1,761
-------- --- -------- -----
Total operating expenses 5,155 1,896 12,330 6,907
------- ----- --------- -----
Operating loss (5,065) (1,841) (11,899) (6,852)
-------- ------- -------- -------
Other income (expense)
Interest income 475 8 584 47
Interest expense (7) (38) (113) (167)
-------- ---- -------- -----
468 (30) 471 (120)
-------- ------ ------ -----
Basic net loss $ (4,597) $ (1,871) $(11,428) $ (6,972)
========= ========= ========= ==========
Basic net loss per share $ (0.45) $ (0.36) $ (1.55) $ (1.48)
========== ========== ========== ===========
Weighted average
shares outstanding 10,302 5,186 7,395 4,705
========= ===== ======== =====
Trimeris, Inc.
(A Development Stage Company)
Balance Sheets
($ in thousands)
December 31, 1997 December 31, 1996
------------------- ------------------
Assets
Total current assets $37,527 $ 213
Property, furniture and equipment - net 756 897
Total other assets 561 574
------- -------
Total assets $38,844 $ 1,684
======= =======
Liabilities and Stockholders'
Equity (Deficit)
Total current liabilities $ 2,794 $ 1,518
Notes payable -- 259
Capital lease obligations, less
current installments 240 316
------- -------
Total liabilities 3,034 2,093
------- -------
Net stockholders' equity (deficit) 35,810 (409)
------- -------
Total liabilities and
stockholders' equity $38,844 $ 1,684
======= =======
c Business Wire. All rights reserved. |
