UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
| x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30,
2015
OR
| ¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _______
to _______
Commission file number: 001-35610
ATOSSA GENETICS INC.
(Exact name of registrant as specified in
its charter)
Delaware |
|
26-4753208 |
(State or other jurisdiction of |
|
(I.R.S. Employer |
incorporation or organization) |
|
Identification No.) |
|
|
|
2345 Eastlake Ave. East, Suite 201 |
|
98102 |
Seattle, WA |
|
(Zip Code) |
(Address of principal executive offices) |
|
|
Registrant’s telephone number, including
area code: (206) 325-6086
Indicate by check mark whether the registrant: (1) has filed
all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes þ No
¨
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was
required to submit and post such files). Yes þ No
¨
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definition of “large accelerated
filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large accelerated filer ¨ |
Accelerated filer ¨ |
Non-accelerated filer ¨ |
Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No
þ
The number of shares of the registrant’s common stock,
$0.001 par value per share, outstanding at August 6, 2015 was 29,046,260.
ATOSSA GENETICS INC.
FORM 10-Q
QUARTERLY REPORT
INDEX
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| |
June 30, | | |
December 31, | |
| |
2015 | | |
2014 | |
| |
(Unaudited) | | |
| |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 11,402,935 | | |
$ | 8,500,718 | |
Accounts receivable, net | |
| 2,012,153 | | |
| 297,958 | |
Prepaid expenses | |
| 239,092 | | |
| 247,207 | |
Inventory, net | |
| 101,339 | | |
| 39,788 | |
Total current assets | |
| 13,755,519 | | |
| 9,085,671 | |
| |
| | | |
| | |
Furniture and equipment, net | |
| 360,206 | | |
| 357,532 | |
Intangible assets, net | |
| 1,822,328 | | |
| 1,920,645 | |
Deferred financing costs | |
| 570,500 | | |
| 351,961 | |
Other assets | |
| 52,647 | | |
| 48,193 | |
Total assets | |
$ | 16,561,200 | | |
$ | 11,764,002 | |
| |
| | | |
| | |
Liabilities and Stockholders' Equity | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 580,541 | | |
$ | 594,357 | |
Accrued expenses | |
| 1,900,284 | | |
| 444,861 | |
Payroll liabilities | |
| 840,228 | | |
| 1,056,705 | |
Short-term lease obligations | |
| 72,338 | | |
| 76,025 | |
Other current liabilities | |
| 20,272 | | |
| 42,228 | |
Total current liabilities | |
| 3,413,663 | | |
| 2,214,176 | |
| |
| | | |
| | |
Deferred rent, net of current portion | |
| 10,019 | | |
| 2,483 | |
Long-term lease obligations | |
| 12,531 | | |
| 49,216 | |
Total liabilities | |
| 3,436,213 | | |
| 2,265,875 | |
| |
| | | |
| | |
Commitments and contingencies (note 13) | |
| | | |
| | |
| |
| | | |
| | |
Stockholders' equity | |
| | | |
| | |
Preferred stock - $.001 par value; 10,000,000 shares authorized, 0 shares issued and outstanding | |
| - | | |
| - | |
Common stock - $.001 par value; 75,000,000 shares authorized, 29,046,260 and 24,564,058 shares issued and outstanding | |
| 29,046 | | |
| 24,564 | |
Additional paid-in capital | |
| 54,751,098 | | |
| 44,648,103 | |
Accumulated deficit | |
| (41,655,157 | ) | |
| (35,174,540 | ) |
Total stockholders' equity | |
| 13,124,987 | | |
| 9,498,127 | |
| |
| | | |
| | |
Total liabilities and stockholders' equity | |
$ | 16,561,200 | | |
$ | 11,764,002 | |
The accompanying notes are an integral
part of these condensed consolidated financial statements
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(UNAUDITED)
| |
For the Three Months Ended June 30, | | |
For The Six Months Ended June 30, | |
| |
2015 | | |
2014 | | |
2015 | | |
2014 | |
Net revenue | |
$ | 2,694,157 | | |
$ | 9,875 | | |
$ | 4,567,425 | | |
$ | 33,999 | |
Cost of revenue | |
| 1,854,711 | | |
| - | | |
| 3,062,665 | | |
| - | |
Gross profit | |
| 839,446 | | |
| 9,875 | | |
| 1,504,760 | | |
| 33,999 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Selling | |
| 732,061 | | |
| 223,385 | | |
| 1,278,915 | | |
| 461,223 | |
Research and development | |
| 510,458 | | |
| 510,767 | | |
| 1,307,683 | | |
| 933,270 | |
General and administrative | |
| 2,790,872 | | |
| 2,462,256 | | |
| 5,395,983 | | |
| 4,236,964 | |
Total operating expenses | |
| 4,033,391 | | |
| 3,196,408 | | |
| 7,982,581 | | |
| 5,631,457 | |
Operating loss | |
| (3,193,945 | ) | |
| (3,186,533 | ) | |
| (6,477,821 | ) | |
| (5,597,458 | ) |
Other income (expense) | |
| 48,619 | | |
| (1,443 | ) | |
| (2,796 | ) | |
| (2,049 | ) |
Loss before income taxes | |
| (3,145,326 | ) | |
| (3,187,976 | ) | |
| (6,480,617 | ) | |
| (5,599,507 | ) |
Income taxes | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
$ | (3,145,326 | ) | |
$ | (3,187,976 | ) | |
$ | (6,480,617 | ) | |
$ | (5,599,507 | ) |
Loss per common share - basic and diluted | |
$ | (0.11 | ) | |
$ | (0.13 | ) | |
$ | (0.25 | ) | |
$ | (0.24 | ) |
Weighted average shares outstanding, basic & diluted | |
| 27,686,202 | | |
| 24,430,346 | | |
| 25,805,293 | | |
| 23,515,576 | |
The accompanying
notes are an integral part of these condensed consolidated financial statements.
ATOSSA GENETICS, INC.
CONSOLIDATED STATEMENT OF
STOCKHOLDERS' EQUITY
| |
Common Stock | | |
| | |
| | |
| |
| |
Shares | | |
Amount | | |
Additional Paid-in Capital | | |
Accumulated Deficit | | |
Total Stockholders’ Equity | |
| |
| | |
| | |
| | |
| | |
| |
Balance at December 31, 2014 | |
| 24,564,058 | | |
$ | 24,564 | | |
$ | 44,648,103 | | |
$ | (35,174,540 | ) | |
$ | 9,498,127 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common shares for cash | |
| 4,107,202 | | |
| 4,107 | | |
| 5,960,344 | | |
| - | | |
| 5,964,451 | |
Deferred financing costs net of amortization | |
| 375,000 | | |
| 375 | | |
| 218,164 | | |
| - | | |
| 218,539 | |
Financing fees from the public offering | |
| - | | |
| - | | |
| (577,790 | ) | |
| - | | |
| (577,790 | ) |
Issuance of prefunded warrants | |
| - | | |
| - | | |
| 4,116,537 | | |
| - | | |
| 4,116,537 | |
Compensation cost for stock options granted to executives and employees | |
| - | | |
| - | | |
| 385,740 | | |
| - | | |
| 385,740 | |
Net loss for the six months ended June 30, 2015 | |
| - | | |
| - | | |
| - | | |
| (6,480,617 | ) | |
| (6,480,617 | ) |
Balance at June 30, 2015 | |
| 29,046,260 | | |
$ | 29,046 | | |
$ | 54,751,098 | | |
$ | (41,655,157 | ) | |
$ | 13,124,987 | |
The accompanying notes are an integral
part of these condensed consolidated financial statements.
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS
(UNAUDITED)
|
|
For the Six Months
Ended
June 30, |
|
|
|
2015 |
|
|
2014 |
|
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,480,617 |
) |
|
$ |
(5,599,507 |
) |
Compensation cost for stock options granted |
|
|
385,740 |
|
|
|
397,715 |
|
Depreciation and amortization |
|
|
170,775 |
|
|
|
252,924 |
|
Loss on disposal of intangible assets |
|
|
6,533 |
|
|
|
- |
|
Bad debt expense |
|
|
562,694 |
|
|
|
64,759 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(2,276,889 |
) |
|
|
26,158 |
|
Inventory |
|
|
(61,551 |
) |
|
|
(1,910 |
) |
Prepaid expenses |
|
|
8,115 |
|
|
|
(129,719 |
) |
Other assets |
|
|
(4,454 |
) |
|
|
(24,863 |
) |
Accounts payable |
|
|
(13,816 |
) |
|
|
542,042 |
|
Payroll liabilities |
|
|
(216,477 |
) |
|
|
32,169 |
|
Deferred rent |
|
|
8,736 |
|
|
|
(26,785 |
) |
Accrued expenses |
|
|
1,415,051 |
|
|
|
(172,836 |
) |
Product recall liabilities |
|
|
- |
|
|
|
(199,465 |
) |
Other current liabilities |
|
|
(23,156 |
) |
|
|
(19,027 |
) |
Net cash used in operating activities |
|
|
(6,519,316 |
) |
|
|
(4,858,345 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Purchase of furniture and equipment |
|
|
(66,112 |
) |
|
|
(20,629 |
) |
Purchase of intangible assets |
|
|
(15,553 |
) |
|
|
(170,441 |
) |
Net cash used in investing activities |
|
|
(81,665 |
) |
|
|
(191,070 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
Net proceeds from issuance of common stock and warrants |
|
|
9,503,198 |
|
|
|
13,005,745 |
|
Net cash provided by financing activities |
|
|
9,503,198 |
|
|
|
13,005,745 |
|
|
|
|
|
|
|
|
|
|
NET INCREASE IN CASH AND CASH EQUIVALENTS |
|
|
2,902,217 |
|
|
|
7,956,330 |
|
CASH AND CASH EQUIVALENTS, BEGINNING BALANCE |
|
|
8,500,718 |
|
|
|
6,342,161 |
|
CASH AND CASH EQUIVALENTS, ENDING BALANCE |
|
$ |
11,402,935 |
|
|
$ |
14,298,491 |
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURES: |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
3,311 |
|
|
$ |
2,192 |
|
NONCASH INVESTING AND FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Noncash reclassification of prepaid license fees |
|
$ |
- |
|
|
|
15,000 |
|
Amortization of commitment shares |
|
$ |
392,711 |
|
|
$ |
- |
|
The accompanying notes are an integral
part of these condensed consolidated financial statements.
ATOSSA GENETICS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 1: NATURE OF OPERATIONS
Atossa Genetics Inc. (the “Company”)
was incorporated on April 30, 2009 in the State of Delaware. The Company’s operations began in December 2008 with the negotiations
for the acquisition of the Mammary Aspirate Specimen Cytology Test System, or the MASCT System, patent rights and assignments and
the FDA clearance for marketing, which acquisition was completed in January 2009. The Company was formed to develop and market
the MASCT System, which is a medical device that collects specimens of nipple aspirate fluid (NAF). The Company’s fiscal
year ends on December 31st.
In December 2011,
the Company established The National Reference Laboratory for Breast Health, Inc., the NRLBH, as a wholly-owned subsidiary
which performs the Company’s NAF cytology test on NAF specimens including those collected with the MASCT System. The
NRLBH is certified by College of American Pathologists (CAP) and by Clinical Laboratory Improvement Amendments (CLIA). The
current version of the MASCT System is called the ForeCYTE Breast Aspirator. The NRLBH is providing other test services,
including the pharmacogenomics test which provides physicians with genetic information that can be used to guide therapeutic
decisions and may mitigate the incidence of costly adverse drug reactions and improve efficiencies.
Since its inception, the Company has been
dependent upon the receipt of capital investment to fund its continuing activities. In addition to the normal risks associated
with a new business venture, there can be no assurance that the Company’s business plan will be successfully executed. The
Company’s ability to execute its business plan will depend on its ability to obtain additional financing and achieve a profitable
level of operations. There can be no assurance that sufficient financing will be obtained. Further, the Company cannot give any
assurance that it will generate substantial revenue or that its business operations will prove to be profitable.
NOTE 2: GOING CONCERN
The Company’s consolidated financial
statements are prepared using generally accepted accounting principles in the United States of America (“GAAP”) applicable
to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
The Company has incurred net losses and negative operating cash flows since inception. For the six months ended June 30, 2015,
the Company recorded a net loss of approximately $6.5 million and used approximately $6.5 million of cash in operating activities.
As of June 30, 2015, the Company had approximately $11.4 million in cash and cash equivalents and working capital of approximately
$10.3 million. The Company has not yet established an ongoing source of revenue sufficient to cover its operating costs and allow
it to continue as a going concern. The ability of the Company to continue as a going concern is dependent on the Company obtaining
adequate capital to fund operating losses until it becomes profitable. The Company can give no assurances that any additional capital
that it is able to obtain, if any, will be sufficient to meet its needs, or that any such financing will be obtainable on acceptable
terms. If the Company is unable to obtain adequate capital, it could be forced to cease operations or substantially curtail is
commercial activities. These conditions raise substantial doubt as to the Company’s ability to continue as a going concern.
The accompanying consolidated financial statements do not include any adjustments relating to the recoverability and classification
of recorded asset amounts and classification of liabilities should the Company be unable to continue as a going concern.
Management’s Plan to Continue as
a Going Concern
In order to continue as a going concern,
the Company will need, among other things, additional capital resources. Management’s plans to obtain such resources for
the Company include (1) obtaining capital from the sale of its equity securities during 2015, (2) sales of the ForeCYTE and FullCYTE
Breast Aspirators and laboratory service revenue in 2015, and (3) short-term borrowings from the banks, stockholders or related
party(ies), if needed. However, management cannot provide any assurance that the Company will be successful in accomplishing any
of its plans.
The ability of the Company to continue
as a going concern is dependent upon its ability to successfully accomplish the plans described in the preceding paragraph and
eventually to secure other sources of financing and attain profitable operations.
NOTE 3: SUMMARY OF ACCOUNTING POLICIES
Basis of Presentation:
The accompanying condensed consolidated
financial statements have been prepared pursuant to the rules of the Securities and Exchange Commission (“SEC”). Certain
information and footnote disclosures, normally included in annual financial statements prepared in accordance with U.S. generally
accepted accounting principles (“GAAP”), have been condensed or omitted pursuant to those rules and regulations. The
Company believes disclosures made are adequate to make the information presented not misleading. In the opinion of management,
all adjustments which consist only of normal recurring adjustments necessary to fairly state the financial position, results of
operations and cash flows with respect to the interim condensed consolidated financial statements have been included. The results
of operations for the interim periods are not necessarily indicative of the results of operations for the entire fiscal year. Reference
is made to the Company’s audited annual financial statements included in its Annual Report on Form 10-K for the year ended
December 31, 2014, which contain information useful to understanding the Company's business and financial statement presentations.
The Condensed Consolidated Balance Sheet as of December 31, 2014 was derived from the Company's most recent audited financial statements,
but does not include all disclosures required by GAAP for a year-end balance sheet. The Company’s significant accounting
policies and practices are presented as Note 3 to the consolidated financial statements included in the Annual Report. The accompanying
condensed consolidated financial statements include the financial statements of Atossa Genetics Inc. and its wholly-owned subsidiary,
NRLBH. All significant intercompany account balances and transactions have been eliminated in consolidation. These condensed consolidated
financial statements have been prepared in accordance with GAAP.
Use of Estimates:
The preparation of financial statements
in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses
during the reporting period. Actual results could differ from those estimates.
Revenue Recognition
The Company recognizes product and service
revenue in accordance with GAAP when the following overall fundamental criteria are met: (i) persuasive evidence of an arrangement
exists, (ii) delivery has occurred or the service has been performed, (iii) the Company’s price to the customer is fixed
or determinable, and (iv) collection of the resulting accounts receivable is reasonably assured.
Service Revenue
Diagnostic testing revenue is recognized
upon completion of the test, communication of results to the patient’s physician, and when collectability is reasonably assured.
Patient requisition forms and/or contracts are generally used to determine the existence of an arrangement.
Services are provided to self-pay patients
or patients covered by various commercial insurance plans and Medicare programs. Revenue for services under insurance plans are
recognized net of allowances for contractual discounts and allowances for differences between the amounts we bill and expected
payment amounts. The Company records revenue for diagnostic testing on an accrual basis based on the amount expected to be collected
based on historical benefit allowed for Medicare and non-Medicare payors. The assumptions used to determine the expected benefits
allowed are reasonable considering known facts and circumstances and may change as we develop more history. If the actual amount
received from the payors or patients are different than the original accrual amount, revenue is subsequently adjusted.
Recently Issued Accounting Pronouncements:
In May 2014, the Financial Accounting Standards
Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with
Customers: Topic 606 (“ASU 2014-09”), to supersede nearly all existing revenue recognition guidance under GAAP.
The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount
that reflects the consideration that is expected to be received for those goods or services. ASU 2014-09 defines a five step process
to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue
recognition process than required under existing GAAP including identifying performance obligations in the contract, estimating
the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate
performance obligation. ASU 2014-09 is effective for the Company in the first quarter of 2017 using either of two methods: (i)
retrospective to each prior reporting period presented with the option to elect certain practical expedients as defined within
ASU 2014-09; or (ii) retrospective with the cumulative effect of initially applying ASU 2014-09 recognized at the date of initial
application and providing certain additional disclosures as defined per ASU 2014-09. The Company is currently evaluating the impact
of its pending adoption of ASU 2014-09 on its consolidated financial statements.
In August, 2014, FASB issued ASU 2014-15,
Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. This ASU requires management
to determine whether substantial doubt exists regarding the entity’s going concern presumption, which generally refers to
an entity’s ability to meet its obligations as they become due. If substantial doubt exists but is not alleviated by management’s
plan, the footnotes must specifically state that “there is substantial doubt about the entity’s ability to continue
as a going concern within one year after the financial statements are issued.” In addition, if substantial doubt exists,
regardless of whether such doubt was alleviated, entities must disclose: (a) principal conditions or events that raise substantial
doubt about the entity’s ability to continue as a going concern (before consideration of management’s plans, if any);
(b) management’s evaluation of the significance of those conditions or events in relation to the entity’s ability to
meet its obligations; and (c) management’s plans that are intended to mitigate the conditions or events that raise substantial
doubt, or that did alleviate substantial doubt, about the entity’s ability to continue as a going concern. If substantial
doubt has not been alleviated, these disclosures should become more extensive in subsequent reporting periods as additional information
becomes available. In the period that substantial doubt no longer exists (before or after considering management’s
plans), management should disclose how the principal conditions and events that originally gave rise to substantial doubt have
been resolved. The ASU applies prospectively to all entities for annual periods ending after December 15, 2016, and to annual
and interim periods thereafter. Early adoption is permitted. The Company has not yet adopted the provisions of ASU 2014-15.
NOTE 4: PREPAID EXPENSES
Prepaid expenses consisted of the following:
| |
June 30, 2015 | | |
December 31, 2014 | |
Prepaid insurance | |
| 119,886 | | |
| 87,633 | |
Retainer and security deposits | |
| 39,821 | | |
| 25,000 | |
Prepaid hardware and software | |
| 32,691 | | |
| 38,268 | |
Lab supplies | |
| 7,499 | | |
| 14,976 | |
Tradeshow and other marketing events | |
| - | | |
| 50,000 | |
Other | |
| 39,195 | | |
| 31,330 | |
Total prepaid expenses | |
$ | 239,092 | | |
$ | 247,207 | |
NOTE 5: FURNITURE AND EQUIPMENT
Furniture and equipment consisted of the
following:
| |
June 30, 2015 | | |
December 31, 2014 | |
Machinery and equipment | |
$ | 586,100 | | |
$ | 522,813 | |
Leasehold improvements | |
| 96,491 | | |
| 93,665 | |
Furniture and equipment | |
| 682,591 | | |
| 616,478 | |
Less: Accumulated depreciation | |
| (322,385 | ) | |
| (258,946 | ) |
Total furniture and equipment | |
$ | 360,206 | | |
$ | 357,532 | |
Depreciation and amortization
expense for the three months ended June 30, 2015 and 2014 was $32,844 and $19,864, respectively, and $63,438 and $41,035 for the
six months then ended.
NOTE 6: INTANGIBLE ASSETS
Intangible assets consisted of the following:
| |
June 30, | | |
December 31, | |
| |
2015 | | |
2014 | |
Patents | |
$ | 1,630,000 | | |
$ | 1,630,000 | |
Capitalized license costs | |
| 200,000 | | |
| 200,000 | |
Software | |
| 203,890 | | |
| 203,038 | |
Intangible assets | |
| 2,033,890 | | |
| 2,033,038 | |
Less: Accumulated amortization | |
| (211,562 | ) | |
| (112,393 | ) |
Total intangible assets, net | |
$ | 1,822,328 | | |
$ | 1,920,645 | |
Intangible assets amounted to $1,822,328
and $1,920,645 as of June 30, 2015 and December 31, 2014, respectively, and consisted of patents, capitalized license costs and
software acquired. The amortization period for the purchased software is 3 years. Amortization expense related to software for
the three months ended June 30, 2015 and 2014 was $11,018 and $9,466, respectively, and $22,829 and $18,227 for the six months
ended June 30, 2015 and June 30, 2014, respectively.
Patents amounted to $1,630,000 as of June
30, 2015 and December 31, 2014, and mainly consisted of patents acquired from Acueity on September 30, 2012 in an asset purchase
transaction. Patent assets are amortized based on their determined useful life, and tested annually for impairment. The amortization
period was from 7 to 12 years. Amortization expense related to patents was $37,254 and $93,498 for the three months ended June
30, 2015 and 2014, respectively, and $74,508 and $186,995 for the six months ended June 30, 2015 and 2014, respectively.
Capitalized license costs consist of fees
paid to A5 Genetics KFT, Corporation, pursuant to which the Company received the world-wide (other than the European Union) exclusive
license to use the software in the NextCYTE test. Amortization expense related to license costs was $5,000 and $4,999 for the three
months ended June 30, 2015 and 2014, respectively, and $10,000 and $6,667 for the six months ended June 30, 2015 and 2014,
respectively.
Future estimated amortization expenses as
of June 30, 2015 for the five succeeding years are as follows:
For the Year Ending December 31, | |
Amounts | |
2015 (includes the remainder of the year) | |
$ | 107,030 | |
2016 | |
| 227,130 | |
2017 | |
| 198,628 | |
2018 | |
| 169,934 | |
2019 | |
| 169,015 | |
Thereafter | |
| 950,591 | |
| |
$ | 1,822,328 | |
NOTE 7: PAYROLL LIABILITIES:
Payroll liabilities consisted of the following:
| |
June 30, 2015 | | |
December 31, 2014 | |
Accrued bonus payable | |
$ | 459,592 | | |
$ | 752,828 | |
Accrued payroll liabilities | |
| 169,854 | | |
| 109,653 | |
Accrued payroll tax liabilities | |
| 210,782 | | |
| 194,224 | |
Total payroll liabilities | |
$ | 840,228 | | |
$ | 1,056,705 | |
NOTE 8: ACCRUED EXPENSES:
Accrued expenses consisted of the following:
| |
June 30, 2015 | | |
December 31, 2014 | |
Accrued commissions | |
$ | 1,502,759 | | |
$ | 174,398 | |
Accrued expenses | |
| 279,030 | | |
| 254,126 | |
Accrued royalties | |
| 118,495 | | |
| 16,337 | |
Total accrued expenses | |
$ | 1,900,284 | | |
$ | 444,861 | |
NOTE 9: STOCKHOLDERS’ EQUITY
The Company is authorized to issue a total
of 85,000,000 shares of stock consisting of 75,000,000 shares of common stock, par value $0.001 per share, and 10,000,000 shares
of preferred stock, par value $0.001 per share. The Company has designated 750,000 shares of Series A Junior Participating Preferred
Stock, par value $0.001 per share through the filing of a certificate of designation with the Delaware Secretary of State.
On May 19, 2014, the Company adopted a stockholder
rights agreement which provided that all stockholders of record on May 26, 2014 received a non-taxable distribution of one preferred
stock purchase right for each share of the Company’s common stock held by such stockholder. Each right is attached to and
trades with the associated share of common stock. The rights will become exercisable only if one of the following occurs: (1) a
person becomes an “Acquiring Person” by acquiring beneficial ownership of 15% or more of the Company’s common
stock (or, in the case of a person who beneficially owned 15% or more of the Company’s common stock on the date the stockholder
rights agreement was executed, by acquiring beneficial ownership of additional shares representing 2.0% of the Company’s
common stock then outstanding (excluding compensatory arrangements) or (2) a person commences a tender offer that, if consummated,
would result in such person becoming an Acquiring Person. If a person becomes an Acquiring Person, each right will entitle the
holder, other than the Acquiring Person and certain related parties, to purchase a number of shares of the Company’s common
stock with a market value that equals twice the exercise price of the right. The initial exercise price of each right is $15.00,
so each holder (other than the Acquiring Person and certain related parties) exercising a right would be entitled to receive $30.00
worth of the Company’s common stock. If the Company is acquired in a merger or similar business combination transaction at
any time after a person has become an Acquiring Person, each holder of a right (other than the Acquiring Person and certain related
parties) will be entitled to purchase a similar amount of stock of the acquiring entity.
2014 Public Offering of Common Stock
and Warrants
On January 29, 2014, the Company closed
a public offering of 5,834,234 units at the price of $2.40 per unit for total gross proceeds of approximately $14.0 million. Each
unit consists of one share of common stock and a warrant to purchase 0.20 of a share of common stock (the “2014 Investor
Warrants”). The 2014 Investor Warrants are exercisable at $3.00 per share and callable by the Company at $6.00 per share
if certain conditions are met.
Placement Agent Fees
In connection with
the 2014 Public Offering, the Company paid Dawson James Securities, Inc. (the “Placement Agent”), a cash fee equal
to 7% of the gross proceeds from sale of the units, which resulted in a payment to the Placement Agent of an aggregate of $980,151
(the “Placement Agent Fee”). In addition, the Company entered into Warrant Agreements with the Placement Agent pursuant
to which the Placement Agent received 175,027 warrants, or 3% of the aggregate number of shares sold in the offering (the “2014
Placement Agent Warrants” and together with the 2014 Investor Warrants, the “2014 Warrants”). Each 2014 Placement
Agent Warrant entitles the Placement Agent to purchase one share of the Company’s common stock at $3.00 per share. The cash
payment of the $980,151 2014 Placement Agent Fee and the $121,707 aggregated initial fair value of the 2014 Placement Agent Warrants
were directly attributable to an actual offering and were charged through additional paid-in capital in accordance with the SEC
Staff Accounting Bulletin (SAB) Topic 5A.
Warrants
The 2014 Warrants are exercisable at any
time commencing after January 29, 2014. Subject to the call right described above, the 2014 Warrants shall expire and no longer
be exercisable on November 29, 2018. The 2014 Warrants cannot be exercised on a cashless basis. There are no redemption features
embodied in the 2014 Warrants and they have met the conditions provided in current GAAP accounting standards for equity classification.
2015 Issuance of Additional Shares
to Aspire
During the first quarter of 2015, we sold
a total of 2,653,199 shares of common stock to Aspire Capital Fund LLC under the stock purchase agreement dated November 8, 2013
with aggregate gross proceeds to us of $4,292,349. No shares remain available for sale to Aspire under the terms of the November
8, 2013 agreement with them.
2015 Offering of Common Stock and Pre-Funded
Warrants
In June 2015, the Company
entered into a Placement Agent Agreement with Roth Capital Partners, LLC. and Dawson James Securities, Inc. (the “2015 Placement
Agents”), pursuant to which the Company issued and sold an aggregate of 1,454,003 shares of common stock at the purchase
price of $1.15 per share and pre-funded warrants to purchase 3,610,997 shares of common stock (the “Pre-Funded Warrants”)
at a purchase price of $1.14 per share for net proceeds of $5.2 million after deducting $577,790 of offering expenses (the “2015
Offering”). Each Pre-Funded Warrant is exercisable for $0.01 per share, subject to adjustments from time to time and certain
limits on each holder’s beneficial ownership of common stock of the Company. Each Pre-Funded Warrant is perpetual in duration.
Placement Agent and Other Fees
In connection with the 2015 Offering, the Company paid the 2015 Placement Agents a cash fee of $463,091,
including reimbursement of the legal fees incurred by the 2015 Placement Agents of $57,886, and incurred legal fees of $114,699.
Outstanding Warrants
As of June 30, 2015, warrants to purchase
9,644,423 shares of common stock are outstanding including:
|
|
Outstanding
Warrants to
Purchase Shares |
|
|
Exercise
Price |
|
|
Expiration Date |
|
|
|
|
|
|
|
|
|
2011 private placement |
|
|
4,252,050 |
|
|
$ |
1.25 - 1.60 |
|
|
June 23, 2016 |
Acueity warrants |
|
|
325,000 |
|
|
|
5.00 |
|
|
September 30, 2017 |
2014 public offering |
|
|
1,166,849 |
|
|
|
3.00 |
|
|
January 29, 2019 |
2015 offering prefunded warrants |
|
|
3,610,997 |
|
|
|
0.01 |
|
|
Perpetual |
Placement agent fees for Company’s offerings |
|
|
242,027 |
|
|
|
2.12 – 12.43 |
|
|
March - November, 2018 |
Outside consulting |
|
|
47,500 |
|
|
$ |
4.24 |
|
|
January 14, 2018 |
|
|
|
9,644,423 |
|
|
|
|
|
|
|
NOTE 10: NET LOSS PER SHARE
The Company accounts for and discloses net
loss per common share in accordance with FASB Accounting Standards Codification (“ASC”) Topic 260, Earnings per
Share. Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted
average number of common shares outstanding. Diluted net loss per common share is computed by dividing net loss attributable to
common stockholders by the weighted average number of common shares that would have been outstanding during the period assuming
the issuance of common shares for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable
upon the exercise of stock options and warrants. Because the inclusion of potential common shares would be anti-dilutive for all
periods presented, diluted net loss per common share is the same as basic net loss per common share.
The following table sets forth the number
of potential common shares excluded from the calculation of net loss per diluted share for the three and six months ended June
30, 2015 and 2014 because the effect of them would be anti-dilutive since the Company recorded net losses for both periods:
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2015 | | |
2014 | | |
2015 | | |
2014 | |
Options to purchase common stock | |
| 4,312,409 | | |
| 3,610,152 | | |
| 4,312,409 | | |
| 3,610,152 | |
Warrants to purchase common stock | |
| 9,644,423 | | |
| 6,033,426 | | |
| 9,644,423 | | |
| 6,033,426 | |
| |
| 13,956,832 | | |
| 9,643,578 | | |
| 13,956,832 | | |
| 9,643,578 | |
NOTE 11: INCOME TAXES
Deferred income tax assets and liabilities
are recognized for the estimated future tax consequences attributable to differences between the financial reporting and tax bases
of assets and liabilities and are measured using enacted tax rates in effect for the year in which those temporary differences
are expected to be recovered or settled. A valuation allowance is provided for the amount of deferred tax assets that, based on
available evidence, are not expected to be realized.
As a result of the Company’s cumulative
losses, management has concluded that a full valuation allowance against the Company’s net deferred tax assets is appropriate.
No income tax liabilities existed as of June 30, 2015 and December 31, 2014 due to the Company’s continuing operating losses.
NOTE 12: CONCENTRATION OF CREDIT RISK
Financial instruments that potentially subject
the Company to concentration of credit risk consist principally of cash deposits. Accounts at each institution are insured by the
Federal Deposit Insurance Corporation (“FDIC”) up to $250,000. At June 30, 2015 and December 31, 2014, the Company
had $11,152,935 and $8,250,718 in excess of the FDIC insured limit, respectively.
NOTE 13: COMMITMENTS AND CONTINGENCIES
Affymetrix Purchase
Commitment
On September
1, 2013, in connection with the development of the NextCYTE test by the NRLBH, the NRLBH entered into an “OwnerChip
Program Agreement” with Affymetrix, Inc. (“Affymetrix”), a manufacturer of GeneChip Systems, where
Affymetrix has agreed to loan a GeneChip System 3000Dx v.2 (“instrument”) to the Company if it purchases and
takes delivery of a minimum thirty GeneChip Human Genome U133 Plus 2.0 (30-pack) arrays at $21,590 per 30-pack for the next
three years for a total purchase obligation of $647,700 with a minimum purchase of ten 30-pack arrays per contract
year. At the end of the three-year contract, upon fulfillment of the purchase commitment, the instrument title and
ownership transfer to the NRLBH at no additional cost. Because the Company takes ownership of the equipment at the
completion of the three-year contract, the Company determined that the arrangement represents a capital lease for the
equipment. The Company recorded $206,702 as a capital lease for the equipment and began amortizing the equipment on a
straight line basis over five years. In addition to the GeneChip Human Genome, the NRLBH must purchase a two-year service
contract for $51,600 to cover maintenance of the instrument during the contract period. The NRLBH placed an initial
order for four 30-pack arrays during 2013 for $94,723. In September 2014, the NRLBH purchased six additional 30-pack arrays
for $142,005.
The future minimum payments for the Affymetrix
capital lease are as follows:
Year Ending December 31, | |
Amount | |
2015 | |
$ | 35,645
| |
2016 | |
| 49,224 | |
Total minimum lease payments | |
$ | 84,869
| |
A5 Software Development Commitment
On June 10, 2013, the Company entered into
an irrevocable license and service agreement with A5 Genetics KFT, Corporation (“A5 Genetics”), pursuant to which the
Company received the worldwide (other than the European Union) exclusive license to the software used in the NextCYTE test.
The Company has the right to prosecute patents related to this software, two of which the Company has filed in the United States.
The patent applications have been assigned to the Company. The Company paid a one-time fee of $100,000 to A5 Genetics in 2013
and in March 2014 the Company completed software validation and paid an additional $100,000 to A5 Genetics. The Company is
obligated to pay up to an additional $1.2 million to A5 Genetics upon receiving the regulatory clearance for the NextCYTE test.
The Company must also pay a royalty of $50 for each NextCYTE test performed and a service fee of $65 for each NextCYTE test performed.
The NextCYTE test is still in validation stage and no royalty or service fees have been paid as of June 30, 2015. The agreement
terminates on the later of June 10, 2023 or the expiration of the latest patents covering the software.
Luminex Reagent
Rental Agreement and Assay License Agreement
On
September 2, 2014, in connection with the development of a pharmacogenomics test by the NRLBH, the NRLBH entered into a three-year
rental agreement with Luminex Corporation (Luminex), which provides that the NRLBH acquires the right to use Luminex instruments,
including accessories, peripherals and options (the “System”) at no cost if the NRLBH purchases goods (the “Products”)
at agreed upon quantities and prices for the next three years. The minimum purchases of Products under the agreement are $452,408
per year. The title to the System remains with Luminex and the NRLBH is required to return the System to Luminex at the end of
the three-year rental agreement.
Targeted Medical Education (TME)
Master Service Agreement
On September 1, 2014, the NRLBH entered
into a three year agreement with TME Research LLC (TME) which requires TME to provide to the NRLBH 100 tissue specimens in connection
with the development of the NextCYTE test. Fees payable to TME under the agreement includes $99,600 up front, $31,500 upon supplying
the first 25 specimens and $31,500 at the time of final delivery of all specimens. The agreement is terminable with 60 days prior
written notice or immediately upon a material breach. As of June 30, 2015, the Company has paid $162,600 in fees, which were recorded
as R&D expenses.
Besins Healthcare Luxembourg SARL
Agreement
On May 14, 2015, the Company entered
into an Intellectual Property License Agreement with Besins Healthcare Luxembourg SARL (“Besins”). The agreement provides
the Company with an exclusive worldwide license to develop and commercialize Besins’ patented gel formulation of 4-Hydroxytamoxifen,
or Afimoxifene Gel, for the potential treatment and prevention of hyperplasia of the breast.
The agreement requires that the Company
pay a royalty of 8% to 9% of net sales for the first 15 years of commercialization. The Company has the non-exclusive right to
also develop Afimoxifene Gel for breast cancer and other breast diseases, subject to the payment of the following milestone payments
for these additional indications: (i) $5,000,000 for the exclusive right to review, access, and reference a Besins investigational
new drug application (IND) for each additional indication; and (ii) $20,000,000 when the Company commences a Phase 3 clinical trial
for each additional indication. If and when Atossa decides to sublicense its rights to commercialize the Afimoxifene Gel in a country
in the territory, Besins has the right of first refusal to commercialize the Afimoxifene Gel on a country-by-country basis in countries
where Besins has a marketing presence.
The agreement automatically expires on
a country-by-country basis fifteen years after the first commercial sale of Afimoxifene Gel in the particular country. The Agreement
may be terminated (i) by either party upon a material breach of the agreement that is not cured by the breaching party, (ii) by
mutual agreement of the parties, (iii) by the Company at its discretion if it elects to stop developing or commercializing Afimoxifene
Gel, (iv) by Besins on a country-by-country basis or indication-by-indication basis if the Company fails to commercialize or commence
commercial sales within a specified time, or (v) by Besins if Atossa fails to accomplish any aspect of the development plan within
six months of target date set forth in the development plan. The development plan covers an 18-month period and is required to
be updated by the Company every six months during the term of the agreement.
Litigation and Contingencies
On October 10, 2013, a putative securities
class action complaint, captioned Cook v. Atossa Genetics, Inc., et al., No. 2:13-cv-01836-RSM, was filed in the United States
District Court for the Western District of Washington against us, certain of the Company’s directors and officers and the
underwriters of the Company’s November 2012 initial public offering. The complaint alleges that all defendants violated
Sections 11 and 12(a)(2), and that the Company and certain of its directors and officers violated Section 15, of the Securities
Act by making material false and misleading statements and omissions in the offering’s registration statement, and that we
and certain of our directors and officers violated Sections 10(b) and 20A of the Exchange Act and SEC Rule 10b-5 promulgated thereunder
by making false and misleading statements and omissions in the registration statement and in certain of the Company’s subsequent
press releases and SEC filings with respect to its NAF specimen collection process, its ForeCYTE Breast Health Test and its MASCT
device. This action seeks, on behalf of persons who purchased the Company’s common stock between November 8, 2012 and
October 4, 2013, inclusive, damages of an unspecific amount.
On February 14, 2014, the Court appointed
plaintiffs Miko Levi, Bandar Almosa and Gregory Harrison (collectively, the “Levi Group”) as lead plaintiffs, and approved
their selection of co-lead counsel and liaison counsel. The Court also amended the caption of the case to read In re Atossa
Genetics, Inc. Securities Litigation. No. 2:13-cv-01836-RSM. An amended complaint was filed on April 15, 2014. The
Company and other defendants filed motions to dismiss the amended complaint on May 30, 2014. On October 6, 2014 the Court granted
defendants’ motion dismissing all claims against the Company and all other defendants. On October 30, 2014, the Court entered
a final order of dismissal. On November 3, 2014, plaintiffs filed a notice of appeal with the Court and have appealed the Court’s
dismissal order to the U.S. Court of Appeals for the Ninth Circuit. On February 11, 2015, plaintiffs filed their opening appellate
brief. Defendants filed an answer on April 13, 2015. On May 18, 2015, Plaintiffs filed a reply brief in support of their appeal.
A hearing for the appeal has not been set.
The Company believes this lawsuit is without
merit and plans to defend itself vigorously; however, failure by the Company to obtain a favorable resolution of the claims set
forth in the complaint could have a material adverse effect on the Company’s business, results of operations and financial
condition. Currently, the amount of such material adverse effect cannot be reasonably estimated, and no provision or liability
has been recorded for these claims as of June 30, 2015. The costs associated with defending and resolving the lawsuit and ultimate
outcome cannot be predicted. These matters are subject to inherent uncertainties and the actual cost, as well as the distraction
from the conduct of the Company’s business, will depend upon many unknown factors and management’s view of these may
change in the future.
NOTE 14: STOCK BASED COMPENSATION
Stock Options and Incentive Plan:
On September 28, 2010, the Board of Directors
approved the adoption of the 2010 Stock Option and Incentive Plan, or the 2010 Plan, to provide for the grant of equity-based awards
to employees, officers, non-employee directors and other key persons providing services to the Company. Awards of incentive options
may be granted under the 2010 Plan until September 2020. No other awards may be granted under the 2010 Plan after the date that
is 10 years from the date of stockholder approval. An aggregate of 1,000,000 shares were initially reserved for issuance in connection
with awards granted under the 2010 Plan, such number of shares to be subject to adjustment as provided in the plan and in any award
agreements entered into by the Company under the plan, and upon the exercise or conversion of any awards granted under the plan.
The following table presents the additions
to the 2010 Plan since inception:
January 1,
| |
Number of shares | |
2012 | |
| 450,275 | |
2013 | |
| 516,774 | |
2014 | |
| 742,973 | |
2015 | |
| 983,362 | |
Total additional shares | |
| 2,693,384 | |
The Company granted options to
purchase 845,822 shares of common stock from the 2010 Plan to employees and directors during the six months ended June 30,
2015. There are 666,466 options available for grant under the 2010 Plan as of June 30, 2015.
Compensation costs associated with the
Company’s stock options are recognized, based on the grant-date fair values of these options, over the requisite service
period, or vesting period. Accordingly, the Company recognized stock based compensation expense of $205,112 and $385,740 for the
three months and six months ended June 30, 2015. The stock based compensation expense for the three months and six months ended
2014 was $167,534 and $397,715, respectively.
Stock-based compensation expense was included
in the following captions in the condensed consolidated statements of operations for the periods shown:
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2015 | | |
2014 | | |
2015 | | |
2014 | |
Selling expenses | |
$ | 13,100 | | |
$ | 25,911 | | |
$ | 45,399 | | |
$ | 41,837 | |
Research and development expenses | |
| 24,820 | | |
| 10,139 | | |
| 43,790 | | |
| 14,766 | |
General and administrative expenses | |
| 167,192 | | |
| 131,484 | | |
| 296,551 | | |
| 341,112 | |
| |
$ | 205,112 | | |
$ | 167,534 | | |
$ | 385,740 | | |
$ | 397,715 | |
The following table presents information
concerning stock option grants for the six months ended June 30, 2015:
|
|
Employees |
|
|
Executives &
Officers |
|
Date of Grant |
|
January – June 2015 |
|
|
January –
June 2015 |
|
|
|
|
|
|
|
|
Fair value of common stock on date of grant |
|
$ |
1.19 – 1.59 |
|
|
$ |
1.21 – 1.59 |
|
Exercise price of the options |
|
$ |
1.40 – 1.88 |
|
|
$ |
1.44 – 1.88 |
|
Expected life of the options (years) |
|
|
6.03 – 6.13 |
|
|
|
6.06 – 6.11 |
|
Dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
Expected volatility |
|
|
110.8 – 115.0 |
% |
|
|
111.3 – 113.5 |
% |
Risk-free interest rate |
|
|
1.64 – 1.79 |
% |
|
|
1.72 – 1.74 |
% |
Expected forfeiture per year (%) |
|
|
10.00 |
% |
|
|
10.00 |
% |
Weighted average fair value of the options per unit |
|
$ |
1.50 |
|
|
$ |
1.46 |
|
Options issued and outstanding as of June
30, 2015 and their activities during the six months then ended are as follows:
| |
Number of Underlying Shares | | |
Weighted- Average Exercise Price Per Share | | |
Weighted- Average Contractual Life Remaining in Years | | |
Aggregate Intrinsic Value | |
Outstanding as of January 1, 2015 | |
| 3,675,634 | | |
$ | 2.86 | | |
| | | |
$ | 344,000 | |
Granted | |
| 1,145,822 | | |
| 1.71 | | |
| | | |
| - | |
Forfeited | |
| (509,047 | ) | |
| 2.06 | | |
| | | |
| 63,223 | |
Exercised | |
| - | | |
| - | | |
| | | |
| - | |
Outstanding as of June 30, 2015 | |
| 4,312,409 | | |
| 2.65 | | |
| 8.03 | | |
$ | 39,400 | |
Exercisable as of June 30, 2015 | |
| 1,734,948 | | |
| 3.89 | | |
| 6.37 | | |
$ | - | |
Vested and expected to vest (1) | |
| 3,929,771 | | |
$ | 2.74 | | |
| 7.90 | | |
$ | 33,255 | |
(1) vested shares and unvested
shares after a forfeiture rate is applied
As of June 30, 2015, there were 2,577,461
unvested options outstanding and the related unrecognized total compensation cost associated with these options was $2,057,210.
This expense is expected to be recognized over a weighted average period of 3.16 years.
NOTE 15: SUBSEQUENT EVENTS
All subsequent events requiring recognition
as of June 30, 2015 have been incorporated into these consolidated financial statements and there are no subsequent events that
require disclosure in accordance with FASB ASC Topic 855, “Subsequent Events.”
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of the financial
condition and results of operations should be read in conjunction with the financial statements and the related notes included
elsewhere in this report. This discussion contains forward-looking statements, which are based on assumptions about the future
of the Company's business. The actual results could differ materially from those contained in the forward-looking statements. Please
read “Forward-Looking Statements” included below for additional information regarding forward-looking statements.
Forward-Looking Statements
This report contains, in addition to historical
information, certain information, assumptions and discussions that may constitute forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”). We have made these statements in reliance on the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties,
which could cause actual results to differ materially from those projected or anticipated. Although we believe our assumptions
underlying our forward-looking statements are reasonable as of the date of this report, we cannot assure you that the forward-looking
statements set out in this report will prove to be accurate. We typically identify these forward-looking statements by the use
of forward-looking words such as “expect,” “potential,” “continue,” “may,” “will,”
“should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,”
“anticipate,” or the negative version of those words or other comparable words. Forward-looking statements contained
in this report include, but are not limited to, statements about:
| • | whether we maintain our clearances from the U.S. Food and Drug Administration, or FDA, and foreign regulatory bodies, and the
CE Certificates of Conformity granted by our notified body, to sell, market and distribute our medical devices; |
| • | whether we can achieve our revenue forecast and other financial projections for 2015; |
| • | our ability to successfully launch and commercialize the FullCYTE Breast Aspirator in the United States and our ForeCYTE Breast
Aspirator outside the United States; |
| • | our ability to successfully continue selling and servicing pharmacogenomics and NAF cytology testing in our laboratory; |
| • | our ability to successfully sell our products and services at currently expected prices or otherwise at prices acceptable to
us; |
| • | our ability to successfully develop and commercialize our pharmaceutical candidates, including Afimoxifene Gel and our ability
to manufacture sufficient quantities of the active ingredients, enroll and successfully complete clinical studies and obtain necessary
approvals from the FDA and other regulatory authorities; |
| • | our ability to successfully develop and commercialize new tests, tools and treatments currently in development and in the time
frames currently expected; |
| • | our ability to maintain our business relationships, including with our distributors, suppliers and customers, while we launch
and commercialize the FullCYTE Breast Aspirator in the United States and ForeCYTE Breast Aspirator and laboratory tests outside
the United States; |
| • | our ability to engage third party suppliers to manufacture the ForeCYTE Breast Aspirator, FullCYTE Breast Aspirator, FullCYTE
Microcatheter, other devices under development and their components at quantities and costs acceptable to us; |
| • | our ability to satisfy ongoing FDA, European Union (EU) and foreign requirements for manufacturing, distributing, and
promoting the FullCYTE Breast Aspirator, ForeCYTE Breast Aspirator, NAF cytology test and FullCYTE
Microcatheter and to obtain regulatory approvals, clearances and CE Certificate of Conformity for our other products and
services in development; |
| • | our ability to successfully defend ongoing litigation, including the securities class action law suit filed against us on October
10, 2013, and other similar complaints that may be brought in the future, in a timely manner and within the coverage, scope and
limits of our insurance policies; |
| • | the benefits and clinical accuracy of our laboratory tests, including the NAF cytology and pharmacogenomics tests; |
| • | our ability to establish and maintain intellectual property rights covering our products and services; |
| • | the willingness of health insurance companies, including those who are members of the MultiPlan, FedMed and HealthSmart networks,
and other third party payors to approve our products and services for coverage and reimbursement; |
| • | our ability to establish and maintain an independent sales representative force, including with our current and future distributors
and their sub-distributors, to market our current products and services and those that we may develop; |
| • | our expectations regarding, and our ability to satisfy, federal, state and foreign regulatory requirements; |
| • | the accuracy of our estimates of the size and characteristics of the markets that our products and services may address; |
| • | our expectations as to future financial performance, expense levels and liquidity sources; |
| • | our ability to attract and retain key personnel; |
| • | our ability to sell additional shares of our common stock to Aspire Capital under the terms of our purchase agreement with
them; and |
| • | our ability to obtain, maintain and defend our intellectual property rights covering our devices, specimens, collection kits,
diagnostic tests and compositions. |
These
and other forward-looking statements made in this report are presented as of the date on which the statements are made. We have
included important factors in the cautionary statements included in this report, particularly in the section titled “ITEM
1A. RISK FACTORS,” that we believe could cause actual results or events to differ materially from the anticipated results
as set forth in the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact
of any new information, future events or circumstances that may affect our business after the date of this report. Except as required
by law, we do not intend to update any forward-looking statements after the date on which the statement is made, whether as a
result of new information, future events or circumstances or otherwise.
Company Overview
We are a healthcare
company focused on the development of locally-administered pharmaceuticals for the treatment of proliferative breast diseases (PBD)
or hyperplasia. Our leading pharmaceutical under development is Afimoxifene Gel, which is in Phase II clinical trials. We have
also developed and are commercializing proprietary laboratory tests and medical devices which, subject to receiving regulatory
approvals, we also intend to develop for use in diagnosing PBD and to act as companions to our pharmaceuticals. Our laboratory
tests are being developed and performed by our wholly owned subsidiary, The National Reference Laboratory for Breast Health, Inc.,
or the “NRLBH.” The NRLBH has developed and is currently marketing nipple aspirate fluid, or NAF, cytology tests and
pharmacogenomics tests.
In May 2015, we acquired
the world-wide exclusive rights to develop and commercialize Afimoxifene Gel for the potential treatment of hyperplasia of the
breast and, subject to the payment of milestones, the non-exclusive rights for other indications including breast cancer. We intend
to commence a Phase II clinical trial using our breast aspirator devices and laboratory tests as companions to Afimoxifene Gel
in the detection and treatment of breast hyperplasia. Afimoxifene Gel has been used in 16 Phase I and Phase II studies conducted
in a variety of indications with over 450 patients.
We also intend to develop
a pharmaceutical for targeted delivery directly to the site of a breast lesion using our patented intraductal microcatheters. We
plan to identify a pharmaceutical candidate and begin a clinical study using our intraductal microcatheters for the potential treatment
of ductal carcinoma in-situ (DCIS) or other serious breast health condition. This program is in the early pre-clinical stage and
will require pre-clinical and clinical studies and regulatory approvals prior to commercialization.
Our medical devices
currently being marketed include the ForeCYTE Breast Aspirator for distribution outside the United States and the FullCYTE Breast
Aspirator for the U.S. market. These devices are intended for the collection of NAF for cytological testing at a laboratory. The
current version of the ForeCYTE Breast Aspirator is not cleared by the FDA for marketing in the United States; however, this device
is CE-marked and is therefore being commercialized in the European Union and the countries of the European Free Trade Association
(EFTA). The FullCYTE Breast Aspirator has been cleared by the FDA for the collection of NAF for cytological purposes and is being
commercialized for the U.S. market. Other devices under development include intraductal microcatheters for the collection of ductal
lavage fluid and for the potential administration of a targeted pharmaceutical, and various tools for potential use by breast surgeons.
Our 2015 key objectives
are:
(1) Launch and commercialize
the FullCYTE Breast Aspirator in the United States: We began the launch of our FullCYTE Breast Aspirator in the United States
in March 2015. We have engaged Thermo Fisher Scientific and Henry Schein Medical as our initial U.S. distributors and we plan to
build our own specialty sales force.
(2) Launch and commercialize
the ForeCYTE Breast Aspirator in the EU: We received CE Certificate of Conformity from our notified body for the ForeCYTE Breast
Aspirator and Collection Kits in October 2014 and in March 2015 began the launch of this device in the EU and the countries of
the European Free Trade Association (EFTA), focusing initially on the Netherlands, Germany, Switzerland, and the United Kingdom.
(3) Maximize total
gross revenue from our products and services: We plan to grow our revenue by selling our products and promoting the tests currently
being offered by the NRLBH, including NAF cytology tests and pharmacogenomics tests, and by developing and commercializing additional
laboratory tests. We project 2015 total gross revenues of $8 million and in the first six months of 2015 reported total gross revenue
of $4.6 million, substantially all of which was from pharmacogenomics testing. The NRLBH has in-network arrangements with Meridian Health Plan of Michigan and Washington Medicaid.
(4) Begin one or
more clinical studies using our devices and potential pharmaceutical therapy: We plan to begin a Phase II clinical study using our tests and devices as companions to Afimoxifene Gel for the potential treatment of hyperplasia.
We have contracted with a manufacturing source for the active pharmaceutical ingredient in Afimoxifene Gel which we plan to use in a clinical trial starting in 2016.
We are also planning to commence a clinical study in the next six to nine months using our intraductal microcatheter for targeted delivery of a pharmaceutical to potentially treat a serious breast health condition, such as DCIS.
The ForeCYTE Breast
Aspirator will not be launched in the United States unless and until we receive additional regulatory clearance from the FDA. Our
planned pharmaceuticals and our devices and laboratory tests under development, either separately or in combination, will require
clearance and/or approval from the FDA prior to commercialization. No assurance can be given that such approvals and/or clearances
will be obtained in a timely manner.
Our common stock is
currently quoted on The NASDAQ Capital Market under the symbol “ATOS.”
Intellectual Property
As of June 22, 2015, and based on a recent periodic review of our patent estate, we own 147 issued patents
(45 in the United States and at least 102 in foreign countries), and 21 pending patent applications (9 in the United States, and
12 pending international applications) directed to our products, services, and technologies. Our patent estate consists primarily
of the following:
|
|
United States |
|
|
Foreign/PCT |
Description |
|
|
Issued(1) |
|
|
Expiration |
|
|
Pending(1) |
|
|
|
Issued(1) |
|
|
Expiration |
|
|
Pending |
ForeCYTE Breast Aspirator Program |
|
|
7 |
|
|
2016 – 2031 |
|
|
4 |
|
|
|
12 |
|
|
2016 – 2031 |
|
|
8 |
FullCYTE Microcatheters & FullCYTE Breast Aspirators Program |
|
|
20 |
|
|
2019 – 2031 |
|
|
5 |
|
|
|
53 |
|
|
2019 – 2031 |
|
|
4 |
NextCYTE Test Program |
|
|
0 |
|
|
2031 |
|
|
1 |
|
|
|
0 |
|
|
2031 |
|
|
1 |
Intraductal Treatment Program |
|
|
12 |
|
|
2030 |
|
|
3 |
|
|
|
47 |
|
|
2030 |
|
|
1 |
Carbohydrate Biomarkers Program |
|
|
2 |
|
|
2022 |
|
|
0 |
|
|
|
3 |
|
|
2022 |
|
|
0 |
Acueity Tools |
|
|
12 |
|
|
2015 – 2024 |
|
|
0 |
|
|
|
2 |
|
|
2015 – 2024 |
|
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
The total number of patents issued or pending, as applicable, in the respective descriptive columns exceed the totals because some patents and applications contain more than one type of claim directed to methods, kits, compositions, devices and/or technology and the patent counts disclosed herein are subject to change. |
Atossa, Atossa Genetics (stylized), MASCT, ArgusCYTE, and National Reference Laboratory for Breast Health
(stylized) are our registered trademarks. We have pending allowed applications with the United States Patent and Trademark Office
for registration of the use of the marks FullCYTE, and NextCYTE.
Summary of Our Products and Services
Our products and services currently being
offered and currently under development consist primarily of the following:
|
|
Product or Service |
|
Regulatory Status |
|
Primary Market |
|
Commercialization Status |
Laboratory Tests
Offered or Being
Developed by the
NRLBH |
|
Pharmacogenomics Test |
|
Laboratory Developed Test (LDT); not FDA approved or cleared |
|
United States |
|
Launched October 2014 |
|
|
NAF Cytology Test |
|
LDT |
|
United States |
|
Launched December 2012 |
|
|
NextCYTE Breast Cancer Test |
|
LDT |
|
United States |
|
Validation stage |
|
|
ArgusCYTE Breast Health Test |
|
LDT |
|
United States |
|
Validation stage |
|
|
Other Tests |
|
Under development |
|
Various |
|
N/A |
|
|
|
|
|
|
|
|
|
Medical Devices |
|
FullCYTE Breast Aspirator |
|
FDA cleared |
|
United States |
|
Launched March 2015 |
|
|
ForeCYTE Breast Aspirator |
|
CE marked |
|
EU and countries of EFTA |
|
Launched March 2015 |
|
|
FullCYTE Microcatheter to Collect Ductal Lavage Fluid for Cytology and/or Deliver Therapeutics |
|
Additional FDA clearance to be sought |
|
United States |
|
Validation Stage |
|
|
Various Diagnostic Tools Including Microendoscopes |
|
FDA cleared; additional clearances may be required |
|
United States |
|
Pre-launch; evaluating commercial opportunities |
|
|
|
|
|
|
|
|
|
Pharmaceuticals |
|
Afimoxifene Gel to Treat Ductal Hyperplasia |
|
Phase II; not approved by the FDA or any other foreign competent authorities |
|
United States; Europe |
|
Licensed from Besins in May 2015; Phase II Trial planned for 2016 |
|
|
Therapeutic Delivered via our Microcatheter to Treat DCIS |
|
Pre-clinical; not approved by the FDA or any other foreign competent authorities |
|
United States; Europe |
|
Pre-clinical |
We have not yet established an ongoing
source of revenue sufficient to cover our operating costs and allow us to continue as a going concern. Our ability to continue
as a going concern is dependent on obtaining adequate capital to fund operating losses until we become profitable. We plan to obtain
additional capital resources by: selling our equity securities; selling the FullCYTE Breast Aspirator in the United States and
the ForeCYTE Breast Aspirator outside the United States; generating laboratory service revenue from our services performed by the
NRLBH; and borrowing from stockholders or others when needed. However, we cannot assure you that we will be successful in accomplishing
any of these plans and, if we are unable to obtain adequate capital, we could be forced to cease operations. In 2013, substantially
all of our revenue was from sales of the MASCT System and patient collection kits and from NAF cytology testing services performed
by the NRLBH and substantially all of our revenue in 2014 and 2015 has been from pharmacogenomics testing performed by the NRLBH.
As a result of the recall of the MASCT System and patient collection kits in October 2013, we did not generate revenue from October
2013 through the third quarter of 2014 when we launched and began generating revenue from the pharmacogenomics test offered by
the NRLBH.
We will incur additional sales and marketing
expenses as we commercialize the FullCYTE Breast Aspirator in the United States and the ForeCYTE Breast Aspirator in the EU and
EFTA and as we continue to promote our pharmacogenomics test. We will need to revise our sales and marketing materials, continue
hiring direct sales employees and engage new distributors. We also expect to continue to hire clinical consultants to assist
in the sales of our NAF cytology tests. The FullCYTE Breast Aspirator may not gain adoption as quickly as the ForeCYTE Breast Aspirator
and it may sell at lower margins. If so, our potential sales and revenues will be negatively impacted.
Recent Capital Raising Transactions
Our New Common Stock Purchase Agreements
with Aspire Capital Fund, LLC
During the first quarter of 2015, we sold
a total of 2,653,199 shares of common stock to Aspire Capital Fund LLC under the stock purchase agreement dated November 8, 2013
with aggregate gross proceeds to us of $4,292,349. No shares remain available for sale to Aspire under the terms of the November
8, 2013 agreement with them.
On May 26, 2015, we
entered into a new common stock purchase agreement with Aspire Capital Fund, LLC, which provides that, upon the terms and subject
to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $25.0 million
of shares of our common stock over the 30-month term of the purchase agreement. Concurrently with entering into the purchase agreement,
we also entered into a registration rights agreement with Aspire Capital, in which we agreed to file one or more registration statements,
as permissible and necessary to register under the Securities Act of 1933, registering the sale of the shares of our common stock
that have been and may be issued to Aspire Capital under the purchase agreement.
Under the new purchase
agreement, we have the right to present Aspire Capital with a purchase notice, directing Aspire Capital to purchase up to 150,000
shares of our common stock per business day, up to $25.0 million of the Company’s common stock in the aggregate at a per
share price equal to the lesser of: (i) the lowest sale price of our common stock on the purchase date; or (ii) the arithmetic
average of the three (3) lowest closing sale prices for our common stock during the twelve (12) consecutive trading days ending
on the trading day immediately preceding the purchase date.
In addition, on any
date on which we submit a purchase notice to Aspire Capital in an amount equal to 150,000 shares and our stock price is not less
than $0.50 per share, we also have the right, in our sole discretion, to present Aspire Capital with a volume-weighted average
price purchase notice (each, a “VWAP Purchase Notice”) directing Aspire Capital to purchase an amount of stock equal
to up to 30% of the aggregate shares of our common stock traded on its principal market on the next trading day (the “VWAP
Purchase Date”), subject to a maximum number of shares we may determine. The purchase price per share pursuant to such VWAP
purchase notice is generally 95% of the volume-weighted average price for our common stock traded on its principal
market on the VWAP purchase date.
The purchase price
will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction occurring
during the period(s) used to compute the purchase price. We may deliver multiple purchase notices and VWAP purchase notices to
Aspire Capital from time to time during the term of the purchase agreement, so long as the most recent purchase has been completed.
The purchase agreement
provides that we and Aspire Capital shall not affect any sales under the purchase agreement on any purchase date where the closing
sale price of our common stock is less than $0.25. There are no trading volume requirements or restrictions under the purchase
agreement, and we will control the timing and amount of sales of our common stock to Aspire Capital. Aspire Capital has no right
to require any sales by us, but is obligated to make purchases from us as directed by us in accordance with the purchase agreement.
There are no limitations on use of proceeds, financial or business covenants, restrictions on future funding, rights of first refusal,
participation rights, penalties or liquidated damages in the purchase agreement.
In consideration for
entering into the purchase agreement, concurrently with the execution of the purchase agreement, we issued to Aspire Capital 375,000
shares of our common stock (the “Commitment Shares”). The purchase agreement may be terminated by us at any time, at
our discretion and without any cost to us. Aspire Capital has agreed that neither it nor any of its agents, representatives and
affiliates shall engage in any direct or indirect short-selling or hedging of our common stock during any time prior to the termination
of the purchase agreement. Any proceeds we receive under the purchase agreement are expected to be used for working
capital and general corporate purposes.
The purchase
agreement provides that on the date of its execution, that certain Purchase Agreement, dated as of November 8, 2013, as amended,
by and between us and Aspire Capital, was terminated.
June 2015 Offering
In June 2015, we sold 1,454,003 shares of
common stock at the purchase price of $1.15 per share and pre-funded warrants to purchase 3,610,997 shares of common stock (the
“Pre-Funded Warrants”) at a purchase price of $1.14 per share for total gross proceeds of $5.8 million (the “2015
Offering”). Each Pre-Funded Warrant is exercisable for $0.01 per share, subject to adjustments from time to time and certain
limits on each holder’s beneficial ownership of common stock of the Company. Each Pre-Funded Warrant is perpetual in duration.
Revenue Sources
Our business provides us with two potential
revenue sources: (i) sales-based revenue from the sale of our medical devices, such as our ForeCYTE Breast Aspirator and FullCYTE
Breast Aspirator and patient kits to distributors, physicians, breast health clinics, and mammography clinics; and (ii) service,
or use-based, revenue from laboratory services performed by the NRLBH, such as preparation and interpretation of the NAF samples
sent to our laboratory for analysis, pharmacogenomics tests and other tests that may be developed and commercialized by the NRLBH.
Our main source of revenue beginning in October 2014 has been from pharmacogenomics testing and we anticipate generating additional
revenue from other resources when we develop and launch new laboratory tests and/or when we further commercialize the FullCYTE
Breast Aspirator in the United States and the ForeCYTE Breast Aspirator outside the United States. We plan to initially sell the
breast aspirators and our laboratory services through regional and national specialty product distributors, with independent sales
representatives specializing in women’s health, and through our own direct sale force.
Critical Accounting Policies and Estimates
In our Annual Report on Form 10-K for the
year ended December 31, 2014, we disclosed our critical accounting policies and estimates upon which our financial statements are
derived. There have been no changes to these policies since December 31, 2014. Readers are encouraged to review these disclosures
in conjunction with the review of this report.
Revenue Recognition
Overview
The Company recognizes product and service
revenue in accordance with GAAP when the following overall fundamental criteria are met: (i) persuasive evidence of an arrangement
exists, (ii) delivery has occurred or the service has been performed, (iii) the Company’s price to the customer is fixed
or determinable and (iv) collection of the resulting accounts receivable is reasonably assured.
Service Revenue
Diagnostic testing revenue is recognized
upon completion of the test, communication of results to the patient’s physician, and when collectability is reasonably assured.
Patient requisition forms and/or contracts are generally used to determine the existence of an arrangement.
Services are provided to self-pay patients
or patients covered by various commercial insurance plans and Medicare programs. Revenue for services under insurance plans are
recognized net of allowances for contractual discounts and allowances for differences between the amounts we bill and expected
payment amounts. The Company records revenue for diagnostic testing on an accrual basis based on the amount expected to be collected
based on historical benefits allowed for Medicare and non-Medicare payors. The assumptions used to determine the expected benefits
allowed are reasonable considering known facts and circumstances and may change as we develop more history. If the actual amount
received from the payors or patients are different than the original accrual amount, revenue is subsequently adjusted.
Cost of Revenue
Cost of revenue consists of cost of diagnostic
testing services and cost of product sales. Cost of diagnostic testing services primarily includes direct cost of material,
direct labor, equipment, commissions, royalty and shipping costs to process the patient samples (including pathology, quality control
analysis, and shipping charges to transport tissue sample) in our laboratory. Costs associated with performing the Company's tests
are recorded as tests are processed. Costs recorded for tissue sample processing and shipping charges represent the cost of all
the tests processed during the period regardless of whether revenue was recognized with respect to that test. Cost of product sales
primarily includes manufacturing cost of our ForeCYTE and FullCYTE devices for sales to distributors, which is recorded upon transfer
of ownership of the goods.
Accounts Receivable
Accounts receivable are recorded at net
realizable value consisting of the carrying amount less allowance for doubtful accounts, as needed. The Company assesses the collectability
of accounts receivable based primarily upon the creditworthiness of the customer or as determined by credit checks and analysis,
as well as the customer’s payment history. Management reviews the composition of accounts receivable and analyzes historical
bad debts, customer concentrations, customer credit-worthiness, current economic trends, and changes in customer payment patterns
to evaluate the adequacy of these reserves. The Company’s allowance for doubtful accounts as of June 30, 2015 and December
31, 2014 was $563,818 and $564,456, respectively. Bad debt expense is included in general and administrative expense on the Company’s
consolidated statements of operations. Bad debt expense was $562,694 and $64,759 for the six months ended June 30, 2015 and 2014,
respectively.
Results of Operations
Three Months and Six Months Ended June 30, 2015 and 2014
Revenue and
Cost of Revenue: For the three months and six months ended June 30, 2015, we had total net revenue of $2,694,157 and
$4,567,425, respectively, consisting of pharmacogenomics testing, compared to $9,875 and $33,999 of revenue in the same
periods in 2014, which consisted of additional cash collections on NAF cytology tests performed in 2013. We ceased generating
any revenue from October 2013 through October 2014 due to our voluntary product recall. In March 2015, we began the launch of
the FullCYTE Breast Aspirator in the U.S. and the ForeCYTE Breast Aspirator in the EU, focusing initially on the Netherlands,
Germany, Switzerland, and the United Kingdom; however, we have not generated any revenue in 2015 from product sales since the
launch of these products.
Total cost of revenue for the three months
and six months ended June 30, 2015 was $1,854,711 and $3,062,665, respectively, consisting of costs relating to pharmacogenomics
testing services; there was no cost of revenue during the same periods in 2014 as the only revenue generated during those periods
was from additional cash collections on NAF cytology tests performed in 2013. Gross profit for the three months and six months
ended June 30, 2015 was $839,446 and $1,504,760, respectively, which was attributable to pharmacogenomics testing.
Operating Expenses:
| |
Three Months Ended | | |
Percentage | | |
Six Months Ended | | |
Percentage | |
| |
June 30, | | |
Change | | |
June 30, | | |
Change | |
| |
2015 | | |
2014 | | |
| | |
2015 | | |
2014 | | |
| |
Selling | |
$ | 732,061 | | |
$ | 223,385 | | |
| 228 | % | |
$ | 1,278,915 | | |
$ | 461,223 | | |
| 177 | % |
Research and development | |
$ | 510,458 | | |
$ | 510,767 | | |
| 0 | % | |
$ | 1,307,683 | | |
$ | 933,270 | | |
| 40 | % |
General and administrative | |
$ | 2,790,872 | | |
$ | 2,462,256 | | |
| 13 | % | |
$ | 5,395,983 | | |
$ | 4,236,964 | | |
| 27 | % |
Total operating expenses | |
$ | 4,033,391 | | |
$ | 3,196,408 | | |
| 26 | % | |
$ | 7,982,581 | | |
$ | 5,631,457 | | |
| 42 | % |
Selling Expenses: The increase in
selling expenses is mainly due to increases in compensation expenses, travel, and advertisement as a result of the ForeCYTE and
FullCYTE launch and commercialization in Europe and the United States. We expect that our selling expenses will continue to increase
during 2015, as we build a sales force within and outside of the United States to support the launch and commercialization of these
products and our related laboratory service offerings. Selling expenses may also increase as we market and sell the services offered
by the NRLBH, including NAF cytology tests, pharmacogenomics tests and potentially other tests.
General and Administrative Expenses:
G&A expenses consist primarily of personnel and related benefit costs, facilities, professional services, insurance, and public
company related expenses. The increase in G&A expenses is mainly due to an increase in compensation expenses, professional
fees, and recruiting fees as we increased our headcount to support the launch of our new products. The increase also reflects an
increase in bad debt expenses as a result of significant increases in revenue.
We expect our G&A and selling expenses
to continue to grow throughout 2015 as we hire additional administrative and manufacturing personnel to support the increased
sales and operating activities as we commercialize the ForeCYTE Breast Aspirator and FullCYTE Breast Aspirator, pharmacogenomics
testing and our other products and services under development. We also expect to incur additional costs associated with being a
publicly traded company.
Research and Development Expenses:
The increase in R&D expenses is attributed to additional R&D expenditures on the launch and development of ForeCYTE and
FullCYTE in the first quarter of 2015. We expect that our R&D expenditures will continue to grow as we develop our new products
and tests in the pipeline, including Afimoxifene Gel, our NextCYTE test and other laboratory tests we may develop. We will add
additional full-time employees and incur additional costs to continue the development of our products and services under development,
including the development of Afimoxifene Gel and other potential pharmaceuticals and conducting one or more clinical studies.
Liquidity and Capital Resources
We have a history of operating losses as
we have focused our efforts on raising capital and building the MASCT System. The Company’s consolidated financial statements
are prepared using generally accepted accounting principles in the United States of America applicable to a going concern, which
contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred
net losses and negative operating cash flows since inception. For the six months ended June 30, 2015, the Company recorded a net
loss of approximately $6.5 million and used approximately $6.5 million of cash in operating activities. As of June 30, 2015, the
Company had approximately $11.4 million in cash and cash equivalents and working capital of approximately $10.3 million. The Company
has not yet established an ongoing source of revenue sufficient to cover its operating costs and allow it to continue as a going
concern. The ability of the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund
operating losses until it becomes profitable. The Company can give no assurances that any additional capital that it is able to
obtain, if any, will be sufficient to meet its needs, or that any such financing will be obtainable on acceptable terms. If the
Company is unable to obtain adequate capital, it could be forced to cease operations or substantially curtail is commercial activities.
These conditions raise substantial doubt as to the Company’s ability to continue as a going concern. The accompanying consolidated
financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts
and classification of liabilities should the Company be unable to continue as a going concern.
On March 27, 2013, we entered into a stock
purchase agreement with Aspire Capital Fund, LLC, pursuant to which we sold common stock to Aspire from March 2013 through October
2013 for a total aggregate purchase price of $11,303,745. On November 8, 2013, we terminated this stock purchase agreement
and entered into a new agreement with Aspire for the sale of our common stock to Aspire under the terms and subject to the conditions
and limitations set forth therein. Under the November agreement, Aspire was committed to purchase up to an aggregate of $25
million of shares of our common stock over the 30-month term of the agreement. On December 23, 2013, we sold $1 million of common
stock to Aspire under this agreement. During the first quarter of 2015, we sold a total of 2,653,199 shares of common stock to
Aspire Capital with aggregate gross proceeds to us of $4,292,349. No shares remain available for sale to Aspire under the terms
of the November 8, 2013 agreement.
On January 29, 2014, we closed a public offering
of 5,834,234 units at the price of $2.40 per unit, with each unit consisting of one share of common stock and a warrant to purchase
0.20 of a share of common stock, for gross proceeds of approximately $14.0 million. The warrants are exercisable at $3.00 per share
and are callable by us if and when the trading price of our common stock is $6.00 per share over a defined period and subject to
a daily volume minimum.
In May 2015, we entered into another agreement with Aspire Capital which provides that we may sell common
stock to Aspire under the terms and subject to the conditions and limitations set forth therein. Under the new agreement, Aspire
is committed to purchase up to $25 million of the Company’s common stock over the 30-month term of the new agreement. We
have the right to present Aspire Capital with a purchase notice, directing
Aspire Capital to purchase up to 150,000 shares of the Company’s common stock per business day, up to $25.0 million of the
Company’s common stock in the aggregate at a per share price equal to the lesser of: i) the lowest sale price of the Company’s
common stock on the purchase date; or ii) the arithmetic average of the three lowest closing sale prices for the Company’s
common stock during the twelve consecutive trading days ending on the trading day immediately preceding the purchase date. Because
of limitations imposed by the NASDAQ rules, we may not be able to sell shares of stock to Aspire until November 2015.
In June
2015, we sold 1,454,003 shares of common stock at the purchase price of $1.15 per share and pre-funded warrants to purchase 3,610,997
shares of common stock (the “Pre-Funded Warrants”) at a purchase price of $1.14 per share for total gross proceeds
of $5.8 million (the “2015 Offering”). Each Pre-Funded Warrant is exercisable for $0.01 per share, subject to adjustments
from time to time and certain limits on each holder’s beneficial ownership of common stock of the Company.
Our ability to continue as a going concern
is dependent on our obtaining additional adequate capital to fund additional operating losses until we become profitable. If we
are unable to obtain adequate capital, we could be forced to cease operations.
Medicare Reimbursement
The majority of the pharmacogenomics tests
performed by the NRLBH to date have been for Medicare patients and at an average Medicare rate of approximately $1,100 per test.
On May 7, 2015, the Medicare Administrative Contractor covering the region in which the NRLBH operates issued a local coverage
determination (or “LCD”), effective June 22, 2015, that affects the Medicare reimbursement we expect to receive for
our pharmacogenomics tests performed on or after. The LCD provides that Medicare reimbursement will be provided for pharmacogenomics
tests only for patients on a few specific drugs or for specific conditions at the reimbursement rate of $243 to $669 per test,
depending on the drug and condition, which is lower than our historic average reimbursement. Most of the pharmacogenomics tests
previously performed by the NRLBH have been for drugs and conditions that are not reimbursable under the new LCD. In response to
this LCD, we have focused our pharmacogenomics sales and marketing efforts on commercial payors, rather than Medicare, though we
also plan to focus on the drugs and conditions for which Medicare reimbursement is available.
Since April 2015, in response to the anticipated
impact of the LCD, our payer mix has changed to 64% non-Medicare payers and 36% Medicare, which reflects a significant change from
the first quarter of 2015, during which Medicare payers comprised approximately 82% of testing recipients. We expect this trend
to continue.
Cash Flows
As of June 30, 2015, we had cash and cash
equivalents of $11,402,935.
Net Cash Flows from Operating Activities: Net
cash used in operating activities was approximately $6,519,316 for the six months ended June 30, 2015, compared with $4,858,345
for the same period in 2014. The increase in cash used in operating activities of $1,660,971 resulted primarily from an increase
in R&D activities related to our new product developments and additional salaries to support the operations.
Net Cash Flows from Investing Activities:
Net cash used in investing activities was $81,665 for the six months ended June 30, 2015, compared with $191,070 for the six months
ended June 30, 2014. The decrease was primarily attributable to the reduction in purchases of fixed asset equipment in 2015 as
compared to 2014.
Net Cash Flows from Financing Activities:
Net cash provided by financing activities was $9,503,198 for the six months ended June 30, 2015, compared with $13,005,745 for
the six months ended June 31, 2014. In both years, we recognized financing cash flows from the sale of our common stock to Aspire
and the offering in 2015 or the 2014 public offering. The decrease in net cash flows from financing activities is due to the 2015
proceeds from the offering of common stock being lower than the proceeds from the 2014 public offering.
Funding Requirements
We expect to incur substantial expenses
and generate ongoing operating losses for the foreseeable future as we continue to: commercialize the ForeCYTE Breast Aspirator
outside the United States and the FullCYTE Breast Aspirator in the United States; continue to launch our laboratory tests including
the pharmacogenomics and NAF cytology tests; complete the development of and potentially launch the ArgusCYTE test, NextCYTE test,
and potentially other devices in the pipeline; continue the development of Afimoxifene Gel; and start the development of other
therapeutics including related clinical studies. We expect that our existing resources as of June 30, 2015 will be sufficient to
fund our planned operations through the first quarter of 2016. In addition to our cash and cash equivalents at June 30, 2015 of
approximately $11.4 million, additional potential sources of capital include selling securities that are registered on our Form
S-3 registration statement and seeking to raise capital through sales of securities to third parties and existing stockholders.
If we are unable to raise additional capital when needed, however, we could be forced to curtail or cease operations. Our future
capital uses and requirements depend on numerous factors, which include the following:
| • | the time and expense needed to continue the launch and commercialization of the ForeCYTE and FullCYTE Breast Aspirators; |
| • | the expense associated with building a network of independent sales representatives to market the ForeCYTE and FullCYTE Breast
Aspirators, pharmacogenomics tests, and NAF cytology tests; |
| • | time, expense and timing associated with the development of Afimoxifene Gel and our other planned therapeutic programs; and |
| • | the degree and speed of patient and physician acceptance of our products and the degree to which third party payors approve
the tests for reimbursement. |
Additional funding may not be available
to us on acceptable terms or at all. In addition, the terms of any financing may adversely affect the holdings or the rights of
our stockholders. For example, if we raise additional funds by issuing equity securities or by selling debt securities, if convertible,
further dilution to our existing stockholders would result. To the extent our capital resources are insufficient to meet our future
capital requirements, we will need to finance our future cash needs through public or private equity offerings, collaboration agreements,
debt financings or licensing arrangements.
If adequate funds are not available, we
may be required to terminate, significantly modify or delay our development programs, reduce our planned commercialization efforts,
or obtain funds through collaborators that may require us to relinquish rights to our technologies or product candidates that we
might otherwise seek to develop or commercialize independently. Further, we may elect to raise additional funds even before we
need them if we believe the conditions for raising capital are favorable.
Off-Balance Sheet Arrangements
We do not currently have, nor have we ever
had, any relationships with unconsolidated entities or financial partnerships, such as structured finance or special purpose entities,
established for the purpose of facilitating off-balance sheet arrangements or limited purposes. In addition, we do not engage in
trading activities involving non-exchange traded contracts.
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards
Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with
Customers: Topic 606 (“ASU 2014-09”), to supersede nearly all existing revenue recognition guidance under U.S.
GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in
an amount that reflects the consideration that is expected to be received for those goods or services. ASU 2014-09 defines a five
step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within
the revenue recognition process than required under existing GAAP including identifying performance obligations in the contract,
estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each
separate performance obligation. ASU 2014-09 is effective in the first quarter of 2017 using either of two methods: (i) retrospective
to each prior reporting period presented with the option to elect certain practical expedients as defined within ASU 2014-09; or
(ii) retrospective with the cumulative effect of initially applying ASU 2014-09 recognized at the date of initial application and
providing certain additional disclosures as defined per ASU 2014-09. We are currently evaluating the impact of our pending adoption
of ASU 2014-09 on our consolidated financial statements.
In August 29, 2014, FASB issued ASU No.
2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. This ASU requires management
to determine whether substantial doubt exists regarding the entity’s going concern presumption, which generally refers to
an entity’s ability to meet its obligations as they become due. If substantial doubt exists but is not alleviated by management’s
plan, the footnotes must specifically state that “there is substantial doubt about the entity’s ability to continue
as a going concern within one year after the financial statements are issued”. In addition, if substantial doubt exists,
regardless of whether such doubt was alleviated, entities must disclose: (a) principal conditions or events that raise substantial
doubt about the entity’s ability to continue as a going concern (before consideration of management’s plans, if any);
(b) management’s evaluation of the significance of those conditions or events in relation to the entity’s ability to
meet its obligations; and (c) management’s plans that are intended to mitigate the conditions or events that raise substantial
doubt, or that did alleviate substantial doubt, about the entity’s ability to continue as a going concern. If substantial
doubt has not been alleviated, these disclosures should become more extensive in subsequent reporting periods as additional information
becomes available. In the period that substantial doubt no longer exists (before or after considering management’s plans),
management should disclose how the principal conditions and events that originally gave rise to substantial doubt have been resolved. The
ASU applies prospectively to all entities for annual periods ending after December 15, 2016, and to annual and interim periods
thereafter. Early adoption is permitted. We have not yet adopted the provisions of ASU No. 2014-15.
ITEM 3. QUANTATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK.
Not applicable.
ITEM 4. CONTROLS AND PROCEDURES
Our management, with the participation
of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and
procedures as of June 30, 2015. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and
15d-15(e) under the Securities Exchange Act, means controls and other procedures of a company that are designed to ensure that
information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed,
summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure
controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be
disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s
management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding
required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June
30, 2015, our principal executive officer and principal financial officer concluded that, as of such date, the Company’s
disclosure controls and procedures were effective at the reasonable assurance level.
No change in our internal control over
financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the quarter ended June
30, 2015 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
On October 10,
2013, a putative securities class action complaint, captioned Cook v. Atossa Genetics, Inc., et al., No. 2:13-cv-01836-RSM,
was filed in the United States District Court for the Western District of Washington against us, certain of our directors and
officers and the underwriters of our November 2012 initial public offering. The complaint alleges that all defendants
violated Sections 11 and 12(a)(2), and that we and certain of our directors and officers violated Section 15, of the
Securities Act by making material false and misleading statements and omissions in the offering’s registration
statement, and that we and certain of our directors and officers violated Sections 10(b) and 20A of the Exchange Act and SEC
Rule 10b-5 promulgated thereunder by making false and misleading statements and omissions in the registration statement and
in certain of our subsequent press releases and SEC filings with respect to our NAF specimen collection process, our ForeCYTE
Aspirator Breast Health Test and our MASCT device. This action seeks, on behalf of persons who purchased our common
stock between November 8, 2012 and October 4, 2013, inclusive, damages of an unspecific amount.
On February 14,
2014, the Court appointed plaintiffs Miko Levi, Bandar Almosa and Gregory Harrison (collectively, the “Levi
Group”) as lead plaintiffs, and approved their selection of co-lead counsel and liaison counsel. The Court also
amended the caption of the case to read In re Atossa Genetics, Inc. Securities Litigation. No.
2:13-cv-01836-RSM. An amended complaint was filed on April 15, 2014. The Company and other defendants filed motions
to dismiss the amended complaint on May 30, 2014. On October 6, 2014 the Court granted defendants’ motion dismissing
all claims against Atossa and all other defendants. On October 30, 2014, the Court entered a final order of dismissal. On
November 3, 2014, plaintiffs filed a notice of appeal with the Court and have appealed the Court’s dismissal order to
the U.S. Court of Appeals for the Ninth Circuit. On February 11, 2015, plaintiffs filed their opening appellate brief.
Defendants filed an answering brief on April 13, 2015. On May 18, 2015, plaintiffs filed a reply brief in support of
their appeal. A hearing for the appeal has not been set.
The Company believes this complaint is
without merit and plans to defend ourselves vigorously; however failure to obtain a favorable resolution of the claims set
forth in the complaint could have a material adverse effect on the Company’s business, results of operations and financial
condition. Currently, the amount of such material adverse effect cannot be reasonably estimated, and no provision or liability
has been recorded for these claims as of June 30, 2015. The costs associated with defending and resolving the complaint and ultimate
outcome cannot be predicted. These matters are subject to inherent uncertainties and the actual cost, as well as the distraction
from the conduct of our business, will depend upon many unknown factors and management’s view of these may change in the
future.
ITEM 1A. RISK FACTORS
RISK FACTORS
A purchase of our shares of Common Stock
is an investment in our securities and involves a high degree of risk. You should carefully consider the following information
about these risks, together with the other information contained in this report, before purchasing our securities. If any of the
following risks actually occur, our business, financial condition and results of operations would likely suffer. In that case,
the market price of the Common Stock could decline, and you may lose part or all of your investment in our Company. Additional
risks of which we are not presently aware or that we currently believe are immaterial may also harm our business and results of
operations.
There have been no material changes to
the risk factors described in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 30, 2015, except for
the following items, which have been updated.
Anticipated liquidity issues in the next six to twelve
months.
For the six months ended June 30, 2015,
we generated $4,567,425 in revenue and we incurred a net loss of $6,480,617. Through June 30, 2015, we had an accumulated deficit
of approximately $41.7 million. We expect that our existing resources will be sufficient to fund our planned operations through
the first quarter of 2016. We have not yet established an ongoing source of revenue sufficient to cover our operating costs and
allow us to continue as a going concern. Our ability to continue as a going concern is dependent on obtaining adequate capital
to fund operating losses until we become profitable. We may not be successful in launch of ForeCYTE and FullCYTE Breast Aspirators
and other sources of capital may not be available when we need them or on acceptable terms. If we are unable to raise in a timely
fashion the amount of capital we anticipate needing, from Aspire or otherwise, we would be forced to curtail or cease operations.
Changes in regulations and policies,
including adverse coverage decisions by Medicare Administrative Contractors, or changes in payor mix may adversely affect reimbursement
for laboratory services and could have a material adverse impact on our revenue and profitability.
Most of our services are billed to a party
other than the physician who ordered the test, including for example, Medicare and commercial insurance companies. The majority
of our pharmacogenomics tests have been billed to Medicare. Reimbursement levels for healthcare services are subject to continuous
and often unexpected changes in policies. Changes in governmental and third party reimbursement rates and policies may result from
statutory and regulatory changes, retroactive rate adjustments, administrative rulings, competitive bidding initiatives, and other
policy changes. Uncertainty also exists as to the coverage and reimbursement status of new services, including our pharmacogenomics
test and NAF test both of which are relatively new services.
Government payors and insurance companies
have increased their efforts to control the cost, utilization, and delivery of healthcare services. For example, at least yearly,
Congress has considered and enacted changes in the Medicare fee schedule in conjunction with budgetary legislation. Further reductions
of reimbursement for Medicare services or changes in policy regarding coverage of tests may be implemented from time to time. The
payment amounts under the Medicare fee schedules are often used as a reference for the payment amounts set by other third party
payors. As a result, a reduction in Medicare reimbursement rates could result in a corresponding reduction in the reimbursements
we may receive from such third party payors. Changes in test coverage policies of other third party payors may also occur. Such
reimbursement and coverage changes in the past have resulted in reduced prices, added costs and reduced accession volume, and have
imposed more complex regulatory and administrative burdens. Further changes in federal, state, and local third party payor laws,
regulations, or policies may have a material adverse impact on our business.
Adverse coverage decisions by Medicare
Administrative Contractors could have a material adverse impact on our revenue and operations.
The majority of the pharmacogenomics tests
performed by the NRLBH have been for Medicare patients and at an average Medicare rate of approximately $1,100 per test. On May
7, 2015, the Medicare Administrative Contractor covering the region in which the NRLBH operates issued a local coverage determination,
or LCD, that affects the Medicare reimbursement we expect to receive for our pharmacogenomics tests for tests performed on or after
the effective date of the LCD which is June 22, 2015. The LCD provides that Medicare reimbursement will be provided for pharmacogenomics
tests only for patients on a few specific drugs or for specific conditions at the reimbursement rate of $243 to $669 per test,
depending on the drug and condition, which is lower than our historic average reimbursement. Most of the pharmacogenomics tests
previously performed by the NRLBH have been for drugs and conditions for which Medicare reimbursement will not be available under
the new LCD after it becomes effective. This new LCD could significantly reduce the rate at which the NRLBH is reimbursed and could
reduce the types of pharmaceuticals and conditions for which reimbursement is available, which could have a significant adverse
impact on our revenues and operations.
If we are not able to protect our
proprietary technology, others could compete against us more directly, which would harm our business.
Our commercial success will depend, in
part, on our ability to obtain additional patents and licenses and protect our existing patent position, both in the United States
and in other countries, for devices, kits, diagnostics tests, therapeutics and related technologies, processes, methods, compositions
and other inventions that we believe are patentable. Our ability to preserve our trade secrets and other intellectual property
is also important to our long-term success. If we do not adequately protect our intellectual property, competitors may be able
to use our technologies and erode or negate any competitive advantage we may have, which could harm our business and ability to
maintain profitability. Patents may also issue to third parties which could interfere with our ability to bring our molecular diagnostic
tests or therapeutics to market. The laws of some foreign countries do not protect our proprietary rights to the same extent as
U.S. laws, and we may encounter significant problems in protecting our proprietary rights in these countries. The patent positions
of diagnostic companies and pharmaceutical and biotechnology companies, including our patent position, are generally highly uncertain
and particularly after the Supreme Court decisions, Mayo Collaborative Services v. Prometheus Laboratories, 132 S.
Ct. 1289 (2012), Association for Molecular Pathology v. Myriad, 133 S. Ct. 2107 (2013), and Alice Corp. v.
CLS Bank Int’l, 134 S. Ct. 2347 (2014), and involve complex legal and factual questions, and, therefore, any patents
issued to us may be challenged, deemed unenforceable, invalidated or circumvented. We will be able to protect our proprietary rights
from unauthorized use by third parties only to the extent that our proprietary technologies and any future tests are covered by
valid and enforceable patents or are effectively maintained as trade secrets. Our patent applications may never issue as patents,
and the claims of any issued patents may not afford meaningful protection for our technology or tests. In addition, any patents
issued to us or our licensors may be challenged, and subsequently narrowed, invalidated or circumvented.
The degree of future protection for our
proprietary rights is uncertain, and we cannot ensure that:
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we or our licensors were the first to make the inventions covered by each of our patent applications; |
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we or our licensors were the first to file patent applications for these inventions; |
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others will not independently develop similar or alternative technologies or duplicate any of our technologies; |
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any of our or our licensors’ patent applications will result in issued patents; |
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any of our or our licensors’ patents will be valid or enforceable; |
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any patents issued to us or our licensors and collaborators will provide a basis for commercially viable tests and/or therapeutics, will provide us with any competitive advantages or will not be challenged by third parties; |
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we will develop additional proprietary technologies or tests that are patentable; |
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the patents of others will not have an adverse effect on our business; or |
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our patents or patents that we license from others will survive legal challenges, and remain valid and enforceable. |
If a third party files a patent application
with claims to a biomarker or a drug we have discovered or developed, a derivation proceeding may be initiated regarding competing
patent applications. If a derivation proceeding is initiated, we may not prevail in the derivation proceeding. If the other party
prevails in the derivation proceeding, we may be precluded from commercializing services or tests based on the biomarker or the
drug, or may be required to seek a license. A license may not be available to us on commercially acceptable terms, if at all.
We also rely upon unpatented proprietary
technologies. Although we require employees, consultants and collaborators to sign confidentiality agreements, we may not be able
to adequately protect our rights in such unpatented proprietary technologies, which could have a material adverse effect on our
business. For example, others may independently develop substantially equivalent proprietary information or techniques or otherwise
gain access to our proprietary technologies or disclose our technologies to our competitors.
If we were sued for patent infringement
by third parties, we might incur significant costs and delays in test or drug introduction.
Our tests and drug candidates may also
conflict with patents that have been or may be granted to others. Our industry includes many organizations that have or are seeking
to discern biomarkers and develop genomic, proteomic and other technologies and also develop drugs. To the extent any patents are
issued or have been issued to those organizations, the risk increases that the sale of our molecular diagnostic and companion diagnostic
tests, and drugs under development may give rise to claims of patent infringement. Others may have filed and in the future are
likely to file patent applications covering biomarkers that are similar or identical to our tests and/or drugs that are similar
to our drugs. Any of these patent applications may have priority over our patent applications and these entities or persons could
bring legal proceedings against us seeking damages or seeking to enjoin us from testing or marketing our tests. Patent litigation
is costly, and even if we prevail, the cost of such litigation could have a material adverse effect on us. If the other parties
in any such actions are successful, in addition to any liability for damages, we could be required to cease the infringing activity
or obtain a license. Any license required may not be available to us on commercially acceptable terms, if at all. Our failure to
obtain a license to any technology that we may require to commercialize our tests could have a material adverse effect on our business.
We believe that there may be significant litigation in the industry regarding patent and other intellectual property rights. If
we become involved in this litigation, it could consume a substantial portion of our managerial and financial resources.
If we fail to comply with our obligations
under license or technology agreements with third parties, we could lose license rights that are critical to our business.
We license intellectual property that is
critical to our business, including licenses underlying the technology in our molecular diagnostic and pharmaceutical and clinical
services and therapeutics and in the future we may enter into additional agreements that provide us with licenses to valuable intellectual
property or technology. These licenses impose various royalty payments, milestones, and other obligations on us. If we fail to
comply with any of these obligations, the licensor may have the right to terminate the license. Termination by the licensor would
cause us to lose valuable rights, and could prevent us from distributing our current tests and/or drugs, or inhibit our ability
to commercialize future test and/or therapeutics candidates. Our business would suffer if any current or future licenses terminate,
if the licensors fail to abide by the terms of the license, if the licensors fail to prevent infringement by third parties, if
the licensed patents or other rights are found to be invalid or unenforceable, or if we are unable to enter into necessary licenses
on acceptable terms.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Not applicable.
ITEM 6. EXHIBITS
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Incorporated by Reference Herein |
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Exhibit No. |
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Description |
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Form |
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Date |
10.1 |
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Intellectual Property License Agreement with Besins Healthcare Luxembourg SARL |
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Current Report on Form 8-K, as Exhibit 10.1 |
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May 18, 2015 |
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10.2 |
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Purchase Agreement and Registration Rights Agreement with Aspire Capital |
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Registration Statement on Form S-1 |
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May 26, 2015 |
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10.3 |
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Placement Agent Agreement with Roth Capital partners, LLC and Dawson James Securities, Inc. |
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Current Report on Form 8-K, as Exhibit 10.1 |
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June 10, 2015 |
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10.4 |
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Pre-Funded Warrants to Purchase Common Stock. |
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Current Report on Form 8-K, as Exhibit 4.1 |
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June 10, 2015 |
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10.5 |
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Subscription Agreements to Purchase Shares. |
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Current Report on Form 8-K, as Exhibit 10.2 |
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June 10, 2015 |
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31.1 |
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Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of Steven C. Quay |
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Filed herewith |
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31.2 |
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Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of Kyle Guse |
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Filed herewith |
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32.1 |
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Certification pursuant to 18 U.S.C. Section 1350 of Steven C. Quay |
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Filed herewith |
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32.2 |
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Certification pursuant to 18 U.S.C. Section 1350 of Kyle Guse |
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Filed herewith |
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101
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Interactive Data Files pursuant to Rule 405 of Regulation S-T |
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Filed herewith |
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SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: August 6, 2015
/s/ Steven C. Quay |
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President and Chief Executive Officer |
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(On behalf of the Registrant) |
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/s/ Kyle Guse |
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Kyle Guse |
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Chief Financial Officer, General Counsel and Secretary |
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(As Principal Financial and Accounting Officer) |
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Exhibit 31.1
CERTIFICATION
PURSUANT TO RULE 13a-14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Steven C. Quay, certify that:
1. I
have reviewed this Report of Atossa Genetics Inc.;
2. Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report;
3. Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented
in this report;
4. The
registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its subsidiaries, is made known to us by others within
those entities, particularly during the period in which this report is being prepared;
(b) designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles;
(c) evaluated
the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d) disclosed
in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most
recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or
is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5. The
registrant's other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the
equivalent function):
(a) all
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information;
and
(b) any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal
control over financial reporting.
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Date: August 6, 2015 |
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/s/ Steven C. Quay |
|
Steven C. Quay |
|
Chief Executive Officer and President |
|
(Principal executive officer) |
Exhibit 31.2
CERTIFICATION
PURSUANT TO RULE 13a-14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Kyle Guse, certify that:
1. I
have reviewed this Report of Atossa Genetics Inc.;
2. Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report;
3. Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented
in this report;
4. The
registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its subsidiaries, is made known to us by others within
those entities, particularly during the period in which this report is being prepared;
(b) designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles;
(c) evaluated
the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d) disclosed
in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most
recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or
is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5. The
registrant's other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the
equivalent function):
(a) all
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information;
and
(b) any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal
control over financial reporting.
|
Date: August 6, 2015 |
|
|
|
/s/ Kyle Guse |
|
Kyle Guse |
|
Chief Financial Officer, General Counsel and Secretary |
|
(Principal financial and accounting officer) |
Exhibit 32.1
CERTIFICATION
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with
the Quarterly Report of Atossa Genetics Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2015
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Steven C. Quay, Chief Executive
Officer and President of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley
Act of 2002, that:
(1) The
Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
|
Date: August 6, 2015 |
|
|
|
/s/ Steven C. Quay |
|
Steven C. Quay |
|
Chief Executive Officer and President |
|
(Principal executive officer) |
Exhibit 32.2
CERTIFICATION
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT
TO
SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
In connection with
the Quarterly Report of Atossa Genetics Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2015
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Kyle Guse, Chief Financial
Officer, General Counsel and Secretary of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906
of the Sarbanes-Oxley Act of 2002, that:
(1) The
Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
|
Date: August 6, 2015 |
|
|
|
/s/ Kyle Guse |
|
Kyle Guse |
|
Chief Financial Officer, General Counsel and Secretary |
|
(Principal financial and accounting officer) |
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