Iomai Corporation (Nasdaq: IOMI) today reported financial results and corporate progress for the first quarter ended March 31, 2006.
"The first quarter of 2006 marked substantial progress in establishing the clinical foundation required to commercialize our transcutaneous immunization (TCI) technology, which we believe will enhance current vaccines and will be the basis for the development of new vaccines with improved efficacy and utility," said Stanley C. Erck, President and Chief Executive Officer of Iomai. "Important accomplishments in the first quarter of 2006 included the completion of our initial public offering and the second year renewal of our $2.9 million grant from the National Institutes of Health to develop our technology to expand vaccine supplies for pandemic influenza. With respect to clinical development, we achieved high immune responses from a new dry formulation of our travelers' diarrhea vaccine, and recently initiated two additional clinical trials for this program, in line with our product development plan for 2006."
First Quarter 2006 Financial Results
For the first quarter of 2006, Iomai reported a net loss available to common stockholders of $5.5 million, or $0.49 loss per share (based on a weighted average number of shares outstanding of 11,179,355), compared to a net loss available to common stockholders in the first quarter of 2005 of $5.0 million, or $6.53 loss per share (based on a weighted average number of shares outstanding of 771,991). The lower net loss per share in the first 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 March 31, 2006, Iomai had common stock outstanding of 16,908,231 shares.
Iomai reported revenues of $1.0 million in the first quarter of 2006, compared to $1.0 million in the first quarter of 2005. Revenues to date reflect reimbursement of expenses under federal government grants, primarily with the National Institutes of Health (NIH). For the first 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 $6.1 million in the first quarter of 2006, compared to operating expenses of $4.6 million in the first 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 March 31, 2006, Iomai had unrestricted cash and cash equivalents and marketable securities of $29.5 million compared to $5.2 million at December 31, 2005. On February 6, 2006, the Company closed its initial public offering in which it raised net proceeds, after expenses, of $31.0 million. The Company expects to be able to fund its capital expenditures and growing operations with its current working capital through early 2007.
Corporate Milestone Guidance
"Recently we responded to a request for proposal (RFP) for further development of our IS patch for use with pandemic influenza vaccines. We believe our technology is uniquely responsive to the government's RFP, which seeks novel approaches for using fewer or smaller doses to extend the supply of pandemic influenza vaccines. Our IS patch is designed to enhance the immune response to any manufactured influenza vaccine, an advantage that may allow the public health service to employ a universal dose-sparing strategy to extend the supply of vaccine," 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
with interim results expected before the end 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
-- Completion of interim data from 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 10:00 a.m. Eastern to discuss these results and business progress. To access the live conference call via phone, please dial 866-543-6408 from the United States and Canada or 617-213-8899 internationally. The conference ID is 17143037. 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 May 22, 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 72384493.
To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the Company's website at http://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 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. All statements contained in this report other than statements of historical fact are forward-looking statements. Forward- looking statements include statements regarding our future financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations. 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. These forward-looking statements include, among other things, statements about the implementation of our corporate strategy; broad applicability of our TCI technology to improve efficacy and utility of current and new vaccines, including the ability of Iomai's patches to stimulate stronger immune responses and to function as a dose-sparing approach to vaccination for pandemic influenza; our future financial performance and projected cash requirements to fund operations; our ability to obtain funding from government agencies to further develop our pandemic influenza program; the likelihood that our proposal was responsive to government's RFP on dose- sparing strategies for pandemic influenza vaccines; our product research and development activities, including the timing and progress of our clinical trials and meetings with regulatory authorities, and projected expenditures.
Applicable risks and uncertainties include, among others, that results in future clinical trials may not replicate results seen in the trials described in this press release; that Iomai may not be able to enroll sufficient numbers of patients in future clinical trials; that the results from future clinical trials may not demonstrate improved efficacy and utility of vaccines using our TCI technology and may impact the timing of meetings with regulatory authorities to discuss product development plans; that Iomai may be unable to obtain the regulatory approvals necessary to conduct additional clinical trials; that Iomai may encounter substantial difficulties in attempting to scale-up its manufacturing capacity; that development costs may exceed expectations; that Iomai may not be able to find adequate sources of capital in the future; 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, 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 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,
2006 2005
(Unaudited)
Revenues $997 $971
Cost and expenses:
Research and development 4,929 3,739
General and administrative 1,219 881
Total costs and expenses 6,148 4,620
Loss from operations (5,151) (3,649)
Other income (expense)
Interest income 139 115
Interest expense (97) (125)
Other expense, net 72 (10)
Total other income (expense), net 114 (20)
Net loss before cumulative effect of a change
in accounting principle (5,037) (3,669)
Cumulative effect of change in accounting
principle 17 --
Net loss (5,020) (3,669)
Dividends on and accretion of convertible
redeemable preferred stock (434) (1,373)
Net loss available to common stockholders $(5,454) $(5,042)
Net loss available to common stockholders
per share of common stock-basic and diluted $(0.49) $(6.53)
Weighted-average number of shares of common
stock-basic and diluted 11,179,355 771,991
IOMAI CORPORATION
BALANCE SHEETS
(in thousands, except share and per share data)
March 31, December 31,
2006 2005
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $22,554 $5,190
Marketable securities 6,934 --
Accounts receivable 1,008 12
Prepaid expenses and other current assets 980 258
Total current assets 31,476 5,460
Property and equipment, net 5,296 4,465
Restricted cash 49 49
Restricted marketable securities 596 590
Deferred financing costs -- 1,108
Other noncurrent assets 217 189
Total assets $37,634 $11,861
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable $2,256 $2,012
Accrued expenses 993 1,611
Notes payable, current portion 1,365 1,333
Notes payable to related party, current portion 197 229
Capital lease obligation, current portion 5 5
Total current liabilities 4,816 5,190
Notes payable, long-term portion 1,044 1,397
Notes payable to related party, long-term portion 1,485 1,264
Capital lease obligation, long-term portion -- 1
Deferred rent 256 122
Total liabilities 7,601 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 March 31, 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 March 31, 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 March 31, 2006; and 220,000,000 shares
authorized; 795,519 shares issued and
outstanding at December 31, 2005 169 8
Additional paid-in capital 103,886 --
Accumulated other comprehensive income 2 1
Accumulated deficit (74,024) (68,614)
Total stockholders' equity (deficit) 30,033 (68,458)
Total liabilities and stockholders'
equity (deficit) $37,634 $11,861
IOMAI CORPORATION
STATEMENTS OF CASH FLOWS
(in thousands)
Three Months Ended
March 31,
2006 2005
(Unaudited)
Cash flows from operating activities
Net loss $(5,020) $(3,669)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 270 701
Stock-based compensation expense 170 13
Non-cash interest expense and amortization
of premium/discount of marketable securities (16) 10
Deferred rent 110 (11)
Loss on disposal of property and equipment 5 1
Changes in operating assets and liabilities:
Accounts receivable (996) (561)
Prepaid expenses and other current assets (739) (59)
Other noncurrent assets (29) 4
Accounts payable (158) 332
Accrued expenses (418) (181)
Net cash used in operating activities (6,821) (3,420)
Cash flows from investing activities
Purchases of property and equipment (619) (412)
Sales of property and equipment 3 --
Sales/maturities of marketable securities -- 7,000
Purchases of marketable securities (6,906) (4,526)
Net cash (used in) provided by
investing activities (7,522) 2,062
Cash flows from financing activities
Proceeds from the exercise of stock options 7 --
Proceeds from initial public offering, net
of underwriting commissions 32,854 --
Stock issuance costs (1,020) --
Proceeds from notes payable -- 96
Principal payments on notes payable (322) (273)
Proceeds from notes payable to related party 279 --
Principal payments on notes payable to
related party (90) (80)
Payments under capital lease obligations (1) (5)
Net cash provided by (used in) financing
activities 31,707 (262)
Net increase (decrease) in cash and cash
equivalents 17,364 (1,620)
Cash and cash equivalents at beginning
of period 5,190 6,942
Cash and cash equivalents at end of period $22,554 $5,322
Supplemental schedule of noncash investing
and financing activities
Cash paid for interest $107 $133