GAITHERSBURG, Md., May 14 /PRNewswire-FirstCall/ -- Iomai Corporation today reported financial results and corporate progress for the first quarter ended March 31, 2007.
“This has been a productive quarter for us, highlighted by the government’s decision to award Iomai a $128 million contract for the development of a dose-sparing booster patch that can be used to cut the amount of influenza vaccine required for protection in the event of a flu pandemic. We have already achieved the first milestone under that contract, which was the submission of a product development plan, on time,” said Stanley C. Erck, President and Chief Executive Officer of Iomai. “We further validated our core technology -- transcutaneous immunization (TCI) -- with clinical trial results that showed that our patch-based vaccine for travelers’ diarrhea could prompt an immune reaction even at a low dose. These results should prove useful in designing not only the Phase 2 final formulation study of our travelers’ diarrhea vaccine, but also upcoming studies of our pandemic booster patch and trials of our booster patch for use with the injected seasonal flu vaccine in the elderly. Lastly, we have also improved our financial position by raising more than $30 million in a private placement in March.”
First Quarter 2007 Financial Results
For the first quarter ended March 31, 2007, Iomai reported a net loss available to common stockholders of $9.2 million, or $0.44 per share, compared to a net loss of $5.5 million, or $0.49 per share, for the first quarter ended March 31, 2006. The lower net loss per share in the first quarter of 2007 was attributable to the increase in the weighted average number of shares outstanding due to the Company’s private placements completed in October 2006 and March 2007. As of March 31, 2007, Iomai had approximately 25.5 million common shares outstanding.
Iomai reported revenues of $1.6 million in the first quarter of 2007, compared to $1.0 million in the first quarter of 2006. Revenue in the first quarter of 2007 was largely due to the Department of Health and Human Services contract for the development of a booster patch for use with pandemic influenza vaccines awarded in January. Under that contract, Iomai is reimbursed for costs, plus a fixed fee.
Total operating expenses were $11.0 million in the first quarter of 2007, compared to operating expenses of $6.1 million in the first quarter of 2006. The increase in operating expenses was primarily due to increased clinical trial costs for Iomai’s needle-free vaccine patches for the prevention of travelers’ diarrhea and influenza, increased development costs for our skin preparation system, and higher payroll costs associated with a year-to-year increase in headcount and expensing of stock options.
As of March 31, 2007, Iomai had unrestricted cash and cash equivalents and marketable securities of $34.6 million compared to $15.3 million on Dec. 31, 2006. On March 2, the Company raised an additional $30.3 million in net proceeds from the private placement of approximately 6.29 million units, each unit consisting of one share of common stock and two warrants to purchase, in total, 0.7 shares of common stock.
Iomai expects to be able to fund its capital expenditures and growing operations with its current working capital and reimbursement of expenses under our existing government grants and contracts through the second quarter of 2008.
Corporate Milestone Guidance
“In the second quarter, we will report the results from our head-to-head immunogenicity study comparing injected influenza vaccine to our needle-free flu vaccine patch, and we continue to seek a partner to assist in the commercialization of that promising technology,” said Mr. Erck. “We plan to host a conference call when the immunogenicity data is available to provide both an analysis of that trial as well as an update on our various programs.”
Iomai expects to achieve the following milestones in 2007: -- Announcement of results from our 300-patient Phase 1 study comparing the Iomai patch to an injected influenza vaccine expected in the second quarter of 2007; -- Announcement of results from our Phase 2 field study designed to evaluate how to best conduct a pivotal Phase 3 field study for our travelers’ diarrhea vaccine during the third quarter of 2007; -- Continued negotiations for a corporate partnership for our needle-free influenza program; and -- Initiation of our first clinical safety and immunogenicity study of our immunostimulant (IS), or booster patch, for pandemic influenza expected in the second half of 2007.
About Iomai Corporation
Iomai Corporation discovers and develops vaccines and immune system stimulants, delivered via a novel, needle-free technology called transcutaneous immunization (TCI). TCI taps into the unique benefits of a major group of antigen-presenting cells found in the outer layers of the skin (Langerhans cells) to generate an enhanced immune response. Iomai is leveraging TCI to enhance the efficacy of existing vaccines, develop new vaccines that are viable only through transcutaneous administration and expand the global vaccine market. Iomai currently has four product candidates in development: three targeting influenza and pandemic flu and one to prevent E. coli-related travelers’ diarrhea. For more information on Iomai, please visit http://www.iomai.com .
Some matters discussed in this press release constitute “forward-looking statements” that involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Such forward-looking statements include statements about the ability of Iomai’s travelers’ diarrhea patch vaccine to stimulate robust immune responses, the use of these results to determine doses for future studies of Iomai’s vaccine candidates for travelers’ diarrhea and pandemic and seasonal influenza, expected government funding; sufficiency of existing cash and government contract revenues to fund operations through the second quarter of 2008; next steps following up on reported data and results; timing for initiating new clinical trials and completing ongoing clinical trials; 2007 milestones; and entering into a partnership for the needle-free flu program. Applicable risks and uncertainties include, among others, that the clinical results described in this press release may not provide the needed information necessary to conduct future trials, that Iomai may not be able to enroll sufficient numbers of patients in future clinical trials; that future clinical trials may not replicate results seen in previous trials; that potential collaborators may determine to wait for additional clinical data prior to entering into a collaboration or may be unwilling to collaborate on terms Iomai deems acceptable; that Iomai may be unable to obtain the regulatory approvals necessary to conduct additional clinical trials or to market any product candidates for travelers’ diarrhea, pandemic and seasonal influenza; that development costs may exceed expectations; that Iomai may fail to adequately protect its intellectual property or may be determined to infringe on the intellectual property of others; and the risks identified under the heading “Factors That May Impact Future Results” in Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Quarterly Report on Form 10-Q for the three months ended March 31, 2007, and filed with the Securities and Exchange Commission. Iomai cautions investors and others not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read the Company’s filings for a discussion of these and other risks and uncertainties which are filed with the U.S. Securities and Exchange Commission, available at http://www.sec.gov .
These statements speak only as of the date of this document, and Iomai undertakes no obligation to update or revise the statements.
IOMAI CORPORATION STATEMENTS OF OPERATIONS (in thousands, except share and per share data) Three Months Ended March 31, 2007 2006 (Unaudited) Revenues $1,588 $997 Cost and expenses: Research and development 8,860 4,929 General and administrative 2,122 1,219 Total costs and expenses 10,982 6,148 Loss from operations (9,394) (5,151) Other income (expense) Interest income 263 139 Interest expense (86) (97) Other expense, net (5) 72 Total other income (expense), net 172 114 Net loss before cumulative effect of a change in accounting principle (9,222) (5,037) Cumulative effect of change in accounting principle - 17 Net loss (9,222) (5,020) Dividends on and accretion of convertible redeemable preferred stock - (434) Net loss available to common stockholders $(9,222) $(5,454) Net loss available to common stockholders per share of common stock - basic and diluted $(0.44) $(0.49) Weighted-average number of shares of common stock - basic and diluted 20,958,806 11,179,355 IOMAI CORPORATION SELECTED BALANCE SHEET DATA (in thousands) March 31, December 31, 2007 2006 (unaudited) Cash and cash equivalents and unrestricted marketable securities $34,587 $15,336 Accounts receivable 1,650 62 Total assets 44,925 23,085 Total debt and capitalized lease obligations 4,266 4,759 Total liabilities 9,276 9,050 Accumulated deficit (110,010) (100,788) Total stockholders’ equity 35,649 14,035
Iomai Corporation
CONTACT: Russell P. Wilson, Senior Vice President, Chief Financial Officerand General Counsel of Iomai Corporation, +1-301-556-4478,investors@iomai.com , or Brian Reid of WeissComm Partners, Inc.,+1-703-402-3626, breid@weisscommpartners.com
Web site: http://www.iomai.com/