GAITHERSBURG, Md., Aug. 14 /PRNewswire-FirstCall/ -- Iomai Corporation today reported financial results and corporate progress for second quarter ended June 30, 2006.
“During the second quarter of 2006, we continued to make significant strides toward our goal of commercializing our unique and powerful transcutaneous immunization (TCI) technology for new and improved vaccines and immunostimulants,” said Stanley C. Erck, President and Chief Executive Officer of Iomai. “We responded to a U.S. government request for proposal (RFP) seeking to fund dose-sparing vaccination technologies to aid in combating pandemic influenza, and we received a key patent protecting our core technology. We also are incorporating our dry patch into a series of Phase 2 studies for our travelers’ diarrhea vaccine to be conducted over the course of 2006. Preliminary results from one of those trials completed in the second quarter indicate that our travelers’ diarrhea vaccine patch can be self- applied by individuals, not just by healthcare providers. We also showed that Iomai’s influenza vaccine and immunostimulant adjuvant patches are stable for 6 months at room temperature. All this data could also have important implications for our other programs, particularly our influenza programs, and could form the basis for our development of vaccine patches that could be stockpiled, mailed and self-applied -- all important considerations particularly in the event of a pandemic influenza outbreak.”
Second Quarter 2006 Financial Results
For the second quarter of 2006, Iomai reported a net loss available to common stockholders of $7.5 million, or $0.45 loss per share (based on a weighted average number of shares outstanding of 16,908,231), compared to a net loss available to common stockholders in the second quarter of 2005 of $5.1 million, or $6.57 loss per share (based on a weighted average number of shares outstanding of 773,523). The lower net loss per share in the second quarter of 2006 was attributable to the increase in the weighted average number of shares outstanding due to the Company’s initial public offering in the first quarter of 2006. As of June 30, 2006, Iomai had common stock outstanding of 16,908,231 shares.
Iomai reported revenues of $408,000 in the second quarter of 2006, compared to $856,000 in the second quarter of 2005. Revenues reflect reimbursement of expenses under federal government grants, primarily with the National Institutes of Health (NIH). For the second quarters of 2006 and 2005, Iomai’s grant revenues were derived primarily from an NIH grant for development of Iomai’s immunostimulant (IS) technology for pandemic flu applications. This grant was originally awarded in January 2005 to fund up to $2.9 million over two years, and the NIH awarded the remaining $1.4 million available for the last year of this grant during the first quarter of 2006.
Total operating expenses were $8.2 million in the second quarter of 2006, compared to operating expenses of $4.5 million in the second quarter of 2005. The increase in operating expenses was primarily due to increased development costs for our skin preparation system; higher payroll costs associated with a year-to-year increase in headcount and expensing of stock options; and increased clinical trial costs for Iomai’s needle-free vaccine patch for the prevention of travelers’ diarrhea.
As of June 30, 2006, Iomai had unrestricted cash and cash equivalents and marketable securities of $24.0 million compared to $29.5 million at March 31, 2006. The Company expects to be able to fund its capital expenditures and growing operations with its current working capital through early 2007.
Six-Month 2006 Financial Results
Iomai also reported its financial results for the six months ended June 30, 2006. The net loss for the six months ended June 30, 2006 was $13.0 million, or $0.92 per share, compared to a net loss of $10.1 million, or $13.10 per share, for the six months ended June 30, 2005. The lower net loss per share in the first six months of 2006 was attributable to the increase in the weighted average number of shares outstanding due to the Company’s initial public offering in the first quarter of 2006.
Corporate Milestone Guidance
“Over the rest of 2006, we expect to see results of the travelers’ diarrhea patch studies that are now in progress and also launch the trial comparing Iomai’s needle-free flu vaccine to the currently available injectable version, a trial we believe could set the stage for significant future growth opportunities using our TCI patch technology,” continued Erck.
During the remainder of the year, Iomai expects to achieve the following milestones:
-- Initiation of a Phase 1/2 trial comparing Iomai’s needle-free influenza patch to traditional intramuscular vaccines in the second half of 2006;
-- Signing of a corporate partnership for our needle-free influenza program during the second half of 2006;
-- Initiation of a Phase 2 study of our IS patch to enhance the immune response to traditional influenza vaccination in the elderly in the second half of 2006; and
-- Continuation of a series of Phase 2 studies for the prevention of E. coli-related travelers’ diarrhea.
Conference Call Details
Iomai management will host a conference call today at 11 a.m. Eastern to discuss these results and business progress. To access the live conference call via phone, please dial 800-659-2037 from the United States and Canada or 617-614-2713 internationally. The conference ID is 80957702. Please dial in approximately ten minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through August 21, 2006 and may be accessed by dialing 888-286-8010 from the United States and Canada or 617-801-6888 internationally. The replay passcode is 20759259.
To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the Company’s website at www.iomai.com. Please connect to the web site at least 15 minutes prior to the call to allow for any software download that may be necessary.
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 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. All statements contained in this report other than statements of historical fact are forward-looking statements. The words “may,” “continue,” “estimate,” “intend,” “plan,” “will,” “believe,” “project,” “expect,” “seek,” “anticipate” and similar expressions may identify forward- looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Forward- looking statements include statements regarding potential commercialization of our product candidates; future benefits from patent protection; potential for additional new government funding; sufficiency of existing cash to fund operations into early 2007; timing for initiating new clinical trials, completing ongoing clinical trials, and announcing results from completed clinical trials; future growth opportunities; and entering into a partnership for the needle-free flu program. Applicable risks and uncertainties include, among others, that results in future clinical trials may fail to demonstrate improved efficacy and utility from our TCI technology; that Iomai may not be able to enroll sufficient numbers of patients in future clinical trials or enroll them on targeted timelines; that Iomai may be unable to retain or obtain the regulatory approvals necessary to complete or conduct additional clinical trials; that Iomai’s operating costs may exceed expectations; that Iomai may fail to adequately protect its intellectual property; that potential collaborators may determine to wait for addition clinical data prior to entering into a collaboration or may be unwilling to collaborate on terms Iomai deems acceptable; 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 June 30, 2006, 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 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.
~financial statements follow~ IOMAI CORPORATION STATEMENTS OF OPERATIONS (in thousands, except share and per share data) Three Months Ended Six Months Ended June 30, June 30, 2006 2005 2006 2005 (Unaudited) (Unaudited) Revenues $408 $856 $1,405 $1,826 Cost and expenses: Research and development 6,801 3,747 11,730 7,485 General and administrative 1,370 790 2,589 1,671 Total costs and expenses 8,171 4,537 14,319 9,156 Loss from operations (7,763) (3,681) (12,914) (7,330) Other income (expense) Interest income 155 109 295 224 Interest expense (98) (115) (195) (240) Other income (expense), net 162 (8) 234 (18) Total other income (expense), net 219 (14) 334 (34) Net loss before cumulative effect of a change in accounting principle (7,544) (3,695) (12,580) (7,364) Cumulative effect of change in accounting principle -- -- 17 -- Net loss (7,544) (3,695) (12,563) (7,364) Dividends on and accretion of convertible redeemable preferred stock -- (1,387) (434) (2,760) Net loss available to common stockholders $(7,544) $(5,082) $(12,997) $(10,124) Net loss available to common stockholders per share of common stock-basic and diluted $(0.45) $(6.57) $(0.92) $(13.10) Weighted-average number of shares of common stock-basic and diluted 16,908,231 773,523 14,059,619 772,762 IOMAI CORPORATION BALANCE SHEETS (in thousands, except share and per share data) June 30, December 31, 2006 2005 (Unaudited) ASSETS Current assets: Cash and cash equivalents $10,734 $5,190 Marketable securities 13,256 -- Accounts receivable 109 12 Prepaid expenses and other current assets 637 258 Total current assets 24,736 5,460 Property and equipment, net 5,866 4,465 Restricted cash 49 49 Restricted marketable securities 265 590 Deferred financing costs -- 1,108 Other noncurrent assets 136 189 Total assets $31,052 $11,861 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $2,635 $2,012 Accrued expenses 1,089 1,611 Notes payable, current portion 1,435 1,333 Notes payable to related party, current portion 167 229 Capital lease obligation, current portion 4 5 Total current liabilities 5,330 5,190 Notes payable, long-term portion 1,320 1,397 Notes payable to related party, long-term portion 1,437 1,264 Capital lease obligation, long-term portion -- 1 Deferred rent 243 122 Total liabilities 8,330 7,974 Common stock subject to put right -- 1,959 Warrant to purchase Series C preferred stock -- 23 Series C convertible redeemable preferred stock, $0.01 par value; 0 shares authorized, issued and outstanding at June 30, 2006; and 150,000,000 shares authorized; 129,590,034 shares issued and outstanding at December 31, 2005 -- 70,363 Stockholders’ equity (deficit): Series B convertible preferred stock; $0.01 par value; 0 shares authorized, issued and outstanding at June 30, 2006; and 15,200,000 shares authorized; 14,734,578 shares issued and outstanding at December 31, 2005 -- 147 Common stock, $0.01 par value; 200,000,000 shares authorized and 16,908,231 shares outstanding at June 30, 2006; and 220,000,000 shares authorized; 795,519 shares issued and outstanding at December 31, 2005 169 8 Additional paid-in capital 104,123 -- Accumulated other comprehensive (loss) income (3) 1 Accumulated deficit (81,567) (68,614) Total stockholders’ equity (deficit) 22,722 (68,458) Total liabilities and stockholders’ equity (deficit) $31,052 $11,861 IOMAI CORPORATION STATEMENTS OF CASH FLOWS (in thousands) Six Months Ended June 30, 2006 2005 (Unaudited) Cash flows from operating activities Net loss $(12,563) $(7,364) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 587 1,413 Stock-based compensation expense 452 169 Non-cash interest expense and amortization of premium/discount of marketable securities (126) 21 Deferred rent 97 (23) Loss on disposal of property and equipment 5 1 Changes in operating assets and liabilities: Accounts receivable (97) (583) Prepaid expenses and other current assets (479) 49 Other noncurrent assets 51 5 Accounts payable 675 (73) Accrued expenses (323) (248) Net cash used in operating activities (11,721) (6,633) Cash flows from investing activities Purchases of property and equipment (1,639) (748) Restricted cash and marketable securities 335 10 Sales of property and equipment 3 -- Sales/maturities of marketable securities 2,000 11,900 Purchases of marketable securities (15,043) (6,790) Net cash (used in) provided by investing activities (14,344) 4,372 Cash flows from financing activities Proceeds from the exercise of stock options 7 2 Proceeds from initial public offering, net of underwriting commissions 32,854 -- Stock issuance costs (1,385) -- Proceeds from notes payable 695 96 Principal payments on notes payable (670) (553) Proceeds from notes payable to related party 279 -- Principal payments on notes payable to related party (169) (162) Payments under capital lease obligations (2) (9) Net cash provided by (used in) financing activities 31,609 (626) Net increase (decrease) in cash and cash equivalents 5,544 (2,887) Cash and cash equivalents at beginning of period 5,190 6,942 Cash and cash equivalents at end of period $10,734 $4,055 Supplemental schedule of noncash investing and financing activities Cash paid for interest $677 $260
Iomai Corporation
CONTACT: Russell P. Wilson, Senior Vice President, Chief Financial Officerand General Counsel of Iomai Corporation, +1-301-556-4478, orinvestors@iomai.com; or Jennifer Larson of WeissComm Partners, Inc.,+1-415-409-2729, or jlarson@weisscommpartners.com, for Iomai Corporation
Web site: http://www.iomai.com/
