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RegeneRx Reports 2004 Year-End Results RegeneRx Reports 2004 Year-End Results March 31, 2005 — Bethesda, Md RegeneRx Biopharmaceuticals, Inc. (AMEX: RGN), announced today the results of its year ended December 31, 2004. The Company had a net loss of $3,326,399 or $0.10 per share for the year ended December 31, 2004, compared with net loss of $1,659,875 or $0.06 per share for the year ended December 31, 2003. The net loss for 2004 resulted primarily from the continued research and development expenditures related to the initiation of Phase II clinical trials to study the Company's product, Thymosin beta 4 (Tß4) for the treatment of chronic dermal wounds, research and development efforts related to its technology, scale-up manufacturing and formulation efforts, and the administrative costs associated with managing the Company's projects. The approximately $2.9 million cash position at December 31, 2004 includes $1.25 million from the first closing of a private placement in December of 2004, but does not include the $4.6 million raised in the second closing completed the first week in January 2005. At January 10, 2005, RegeneRx had approximately $7.5 million of cash. Highlights for 2004, and subsequently, included:
"We were very pleased with our progress in 2004 as we expanded clinical development of our Tß4 platform, received clearance for our first three Phase II trials by the FDA, and achieved numerous other important milestones. We continue to be encouraged with the growing and significant body of scientific data emanating from independent researchers that not only supports the scientific rationale behind our clinical work, but also helps us identify additional ways Tß4 may be used therapeutically, as was the case in the cardiovascular area in 2004," said J.J. Finkelstein, President and CEO. "I think our stock appreciation reflected our achievements this past year and we look forward to continuing with similar successes in 2005," he went on to say. Finkelstein also noted, "Outsourcing key aspects of our product development efforts continues to be an effective way in which to move our technology forward without substantial investment in infrastructure and overhead. With our current cash position we have sufficient capital to implement our business plan for the next 18-24 months and look forward to the results of our clinical trials in the U.S. and Europe during this period. Additionally, we are keenly focused on the cardiovascular potential for our technology and we intend to meet with the FDA to discuss filing an IND for a cardiovascular indication as soon as possible." About RegeneRx Biopharmaceuticals, Inc. Safe Harbor Statement BALANCE SHEETS December 31, 2004 and 2003 December 31, 2004 2003 ASSETS Current assets Cash and cash equivalents $ 2,874,260 $ 1,019,889 Due from related parties 12,357 26,897 Deferred offering costs 75,884 — Other current assets 30,338 36,428 Total current assets 2,992,839 1,083,214 Fixed assets, net of accumulated depreciation of $10,001 and $7,613 2,587 3,377 Proprietary rights, net of accumulated amortization of $4,760 and $2,973 21,440 23,227 Deferred patent costs 271,635 — Total assets 3,288,501 $ 1,109,818 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $ 405,997 $ 81,268 Accrued expenses 153,879 91,734 Letter agreements with vendors 20,046 20,046 Total current liabilities 579,922 193,048 Commitments — — Stockholders’ equity Preferred stock, $.001 par value per share, 1,000,000 authorized; no shares issued — — Common stock, par value $.001 per share, 100,000,000 shares authorized; 34,577,356 and 30,098,968 issued and outstanding 34,577 30,099 Additional paid-in capital 45,179,591 40,065,861 Accumulated deficit (42,505,589) (39,179,190) Total stockholders’ equity 2,708,579 916,770 Total liabilities and stockholders’ equity $ 3,288,501 $ 1,109,818 STATEMENTS OF OPERATIONS Years ended December 31, 2004 and 2003 Years ended December 31, 2004 2003 Revenue $ — $ — Expenses Research and development 2,184,314 775,752 General and administrative 1,158,450 848,743 Total expenses 3,342,764 1,624,495 Operating loss (3,342,764) (1,624,495) Other income (expense) Interest income 16,435 7,571 Interest expense (70) (42,951) Total other income (expense) 16,365 (35,380) Net loss $ (3,326,399) $ (1,659,875) Basic and diluted net loss per common share $ (0.10) $ (0.06) Weighted average number of common shares outstanding 32,909,753 28,522,042 STATEMENTS OF STOCKHOLDERS’ EQUITY Years ended December 31, 2004 and 2003 Common stock Total Additional Accumulated Stock stockholders’ Shares Amount paid-in capital deficit subscriptions equity Balance, December 31, 2002 26,965,479 $ 26,966 $38,102,136 $(37,519,315) $(300,000) $309,787 Issuance of common stock 3,184,713 3,185 1,986,815 — — 1,990,000 Issuance of warrants — — 40,648 — — 40,648 Exercise of options and warrants 306,500 306 30,345 — — 30,651 Repayment and modification of subscription receivable (357,724) (358) (109,642) — 300,000 190,000 Stock option compensation — — 15,559 — — 15,559 Net loss — — — (1,659,875) — (1,659,875) Balance, December 31, 2003 30,098,968 30,099 40,065,861 (39,179,190) — 916,770 Issuance of common stock 2,778,197 2,778 3,428,646 — — 3,431,424 Exercise of warrants 1,675,191 1,675 1,574,676 — — 1,576,351 Exercise of options 25,000 25 2,100 — — 2,125 Stock option compensation — — 108,308 — — 108,308 Net loss — — (3,326,399) — (3,326,399) Balance, December 31, 2004 34,577,356 $34,577 $45,179,591 $(42,505,589) $ — $2,708,579 |
