POTP Point Therapeutics (MM)

Point Therapeutics, Inc. (NASDAQ: POTP) today reported financial results for the fiscal quarter ended March 31, 2005. Point reported a net loss of $4,915,000 or $0.25 per share, in the first quarter of 2005, compared with a net loss of $3,135,000, or $0.21 per share, in the first quarter of 2004. During the first quarter of 2005, the Company achieved several important milestones: -- Completed the first stage of a two-stage study in the Company's Phase 2 single-agent trial of talabostat in patients with advanced metastatic melanoma -- Raised $16.4 million though a registered direct placement of 3,650,000 shares of the Company's common stock -- Announced that Thomas F. Gajewski, MD, PhD, Associate Professor in the Department of Pathology and Medicine at the Ben May Institute and leader of the Immunology and Cancer Program at University of Chicago Cancer Research Center, joined Point's Clinical Advisory Board "The first quarter of 2005 was an important one for the Company," said Donald R. Kiepert, Jr., President and Chief Executive Officer. "We achieved the first stage of a two-stage study in our Phase 2 single-agent trial of talabostat in patients with advanced metastatic melanoma, allowing us to move this trial forward to its next stage. We were also successful in raising $16.4 million, positioning the Company solidly to further our clinical program. Currently, we are conducting four Phase 2 clinical trials in advanced metastatic melanoma, non-small cell lung cancer and chronic lymphocytic leukemia, and we expect to initiate a fifth Phase 2 study in pancreatic cancer by the end of the second quarter. Importantly, we also recently announced that we intend to initiate a Phase 3 pivotal program in non-small cell lung cancer later this year." Research and development expenses increased to $3,553,000 in the first quarter of 2005, from $2,026,000 in the first quarter of 2004. The increase in research and development costs resulted primarily from increased clinical and related manufacturing costs pertaining to the Company's four ongoing Phase 2 clinical trials. General and administrative expenses increased to $1,444,000 in the first quarter of 2005 from $1,128,000 in the first quarter of 2004. The increase in general and administrative expenses resulted primarily from increased salaries, annual bonuses and related costs for three new hires. Point's cash and investment balance as of March 31, 2005 was $25,224,000. On March 4, 2005, Point received $16,425,000 in gross proceeds relating to the sale of 3,650,000 shares of common stock in a registered direct placement of securities. Offsetting these proceeds were costs totaling approximately $1,400,000 relating to the sale and registration of the shares, resulting in net proceeds from the private placement of approximately $15,000,000. Interest income was $81,000 in the first quarter of 2005 compared to $19,000 in the first quarter of 2004. The increase in interest income was principally due to a higher average cash balance and slightly higher interest rates in 2005 compared to 2004. On April 28, 2005, the Company announced that it achieved the desired tumor response criteria with its lead compound, talabostat, in combination with docetaxel, in its Phase 2 Stage IIIb/IV non-small cell lung cancer (NSCLC) clinical trial. These results allow Point to move forward in planning its Phase 3 pivotal program for NSCLC, which the Company intends to initiate later this year. About Point Therapeutics, Inc.: Point is a Boston-based biopharmaceutical company developing a family of dipeptidyl peptidase (DPP) inhibitors for a variety of cancers, certain hematopoietic disorders, type 2 diabetes and as vaccine adjuvants. Their lead product candidate, talabostat (PT-100), is a small molecule drug in Phase 2 clinical trials. Talabostat is orally-active and, through a novel mechanism of action, has the potential to inhibit the growth of malignant tumors and to accelerate the reconstitution of the hematopoietic system. In 2004, Point initiated four Phase 2 clinical trials of talabostat. The trials are studying talabostat in combination with Taxotere(R) for the treatment of advanced NSCLC, talabostat as a single agent to treat advanced metastatic melanoma, talabostat in combination with cisplatin also to treat advanced metastatic melanoma, and talabostat in combination with rituximab to treat advanced chronic lymphocytic leukemia (CLL). The Company is also studying talabostat in clinical trials to potentially prevent both neutropenia and anemia. In addition, their portfolio includes two other DPP inhibitors in preclinical development--PT-630 for type 2 diabetes, and PT-510 as a vaccine adjuvant. Certain statements contained herein are not strictly historical and are "forward looking" statements as defined in the Private Securities Litigation Reform Act of 1995. This information includes statements on the prospects for our drug development activities and results of operations based on our current expectations, such as statements regarding certain milestones with respect to our clinical program and our product candidates. Forward-looking statements are statements that are not historical facts, and can be identified by, among other things, the use of forward-looking language, such as "believes," "expects," "may," "will," "should," "seeks," "plans," "schedule to," "anticipates" or "intends" or the negative of those terms, or other variations of those terms of comparable language, or by discussions of strategy or intentions. A number of important factors could cause actual results to differ materially from those projected or suggested in the forward looking statement, including, but not limited to, the ability of Point to (i) successfully develop and manufacture products, (ii) obtain external funding to finance the operations, (iii) obtain the necessary regulatory approvals, and (iv) obtain and enforce intellectual property rights, as well as the risk factors described in Point's 10-K, filed with the Securities and Exchange Commission on March 15, 2005, and from time to time in Point's other reports filed with the Securities and Exchange Commission. -0- *T POINT THERAPEUTICS, INC. (A Development Stage Company) CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) Period from September 3, 1996 (date of inception) Three months ended through March 31, March 31, 2005 2004 2005 ------------ ------------ ---------------- REVENUES License revenue $ - $ - $ 5,115,041 Sponsored research revenue - - 2,400,000 ------------ ------------ -------------- Total revenues - - 7,515,041 ------------ ------------ -------------- OPERATING EXPENSES Research and development 3,552,984 2,025,617 35,776,379 General and administrative 1,443,632 1,127,681 17,486,408 ------------ ------------ -------------- Total operating expenses 4,996,616 3,153,298 53,262,787 ------------ ------------ -------------- Net loss from operations (4,996,616) (3,153,298) (45,747,746) Interest income 81,271 18,786 1,220,623 Interest expense - - (82,652) ------------ ------------ -------------- Net loss $ (4,915,345) $(3,134,512) $ (44,609,775) ============ ============ ============== Basic and diluted net loss per common share $ (0.25) $ (0.21) ============ ============ Basis and diluted weighted average common shares outstanding 19,439,848 15,168,907 ============ ============ POINT THERAPEUTICS, INC. (A Development Stage Company) CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) March 31, December 31, 2005 2004 ------------ ------------ ASSETS Cash, cash equivalents and marketable securities $25,223,841 $13,991,994 Property and equipment, net 193,270 205,323 Other assets 827,716 298,758 ----------- ----------- Total assets $26,244,827 $14,496,075 =========== =========== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities $ 3,052,080 $ 2,397,814 Other liabilities 47,604 47,604 Total stockholders' equity 23,145,143 12,050,657 ----------- ----------- Total liabilities and stockholders' equity $26,244,827 $14,496,075 =========== =========== *T