Rezolute, Inc. - Quarter Report: 2014 March (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q |
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the quarterly period ended March 31, 2014 | ||
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: 000-54495 |
ANTRIABIO, INC
(Exact Name of Registrant as Specified in its Charter)
Delaware | 27-3440894 | |
(State of other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
890 Santa Cruz Avenue, Menlo Park CA | 94025 | |
(Address of Principal Executive Offices) | (Zip Code) |
(650)-241-9330 |
(Registrant’s Telephone Number, including Area Code) |
(Former name, former address and former fiscal year, if changed since last report) |
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. x Yes ¨ 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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
x Yes ¨ No
Indicate by check mark whether the Registrant is ¨ a large accelerated filer, ¨ an accelerated file, ¨ a non-accelerated filer, or x a smaller reporting company (as defined in Rule 12b-2 of the Exchange Act)
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)
¨ Yes x No
Number of shares of issuer’s common stock outstanding as of May 13, 2014: 17,723,989
TABLE OF CONTENTS
i |
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains statements reflecting assumptions, expectations, projections, intentions or beliefs about future events that are intended as “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements included or incorporated by reference in this report, other than statements of historical fact, that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. These statements appear in a number of places, including, but not limited to “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These statements represent our reasonable judgment of the future based on various factors and using numerous assumptions and are subject to known and unknown risks, uncertainties and other factors that could cause our actual results and financial position to differ materially from those contemplated by the statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts, and use words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “may,” “should,” “plan,” “project” and other words of similar meaning. In particular, these include, but are not limited to, statements relating to the following:
• | projected operating or financial results, including anticipated cash flows used in operations; |
• | expectations regarding capital expenditures, research and development expense and other payments; |
• | our beliefs and assumptions relating to our liquidity position, including our ability to obtain additional financing; |
• | our ability to obtain regulatory approvals for our pharmaceutical drugs and diagnostics; and |
• | our future dependence on third party manufacturers or strategic partners to manufacture any of our pharmaceutical drugs and diagnostics that receive regulatory approval, and our ability to identify strategic partners and enter into license, co-development, collaboration or similar arrangements. |
Any or all of our forward-looking statements may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks, uncertainties and other factors including, among others:
• | the loss of key management personnel or sponsored research partners on whom we depend; |
• | the progress and results of clinical trials for our product candidates; |
• | our ability to navigate the regulatory approval process in the U.S. and other countries, and our success in obtaining required regulatory approvals for our product candidates; |
• | commercial developments for products that compete with our product candidates; |
• | the actual and perceived effectiveness of our product candidates, and how those product candidates compare to competitive products; |
• | the strength of our intellectual property protection, and our success in avoiding infringing the intellectual property rights of others; |
• | adverse developments in our research and development activities; |
• | potential liability if our product candidates cause illness, injury or death, or adverse publicity from any such events; |
• | our ability to operate our business efficiently, manage capital expenditures and costs (including general and administrative expenses) and obtain financing when required; |
• | our expectations with respect to our acquisition activity. |
In addition, there may be other factors that could cause our actual results to be materially different from the results referenced in the forward-looking statements, some of which are included elsewhere in this Quarterly Report on Form 10-Q, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Many of these factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual future results may vary materially from those expressed or implied in any forward-looking statements. All forward-looking statements contained in this Quarterly Report of Form 10-Q are qualified in their entirety by this cautionary statement. Forward-looking statements speak only as of the date they are made, and we disclaim any obligation to update any forward-looking statements to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q, except as otherwise required by applicable law.
1 |
AntriaBio, Inc.
(A Development Stage Enterprise)
PART I - FINANCIAL INFORMATION
March 31, 2014 | June 30, 2013 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets | ||||||||
Cash | $ | 5,641,627 | $ | 527 | ||||
Note receivable - related party | - | 163,829 | ||||||
Interest receivable - related party | - | 3,341 | ||||||
Inventory | 223,000 | 223,000 | ||||||
Due from related party | - | 183,346 | ||||||
Deferred financing, net | - | 146,037 | ||||||
Other current assets | 119,800 | 95,469 | ||||||
Total current assets | 5,984,427 | 815,549 | ||||||
Non-current assets | ||||||||
Fixed assets, idle | 275,717 | 275,717 | ||||||
Intangibile assets, net | 10,047 | 12,705 | ||||||
Total non-current assets | 285,764 | 288,422 | ||||||
Total Assets | $ | 6,270,191 | $ | 1,103,971 | ||||
Liabilities and Stockholders' Equity (Deficit) | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses | $ | 645,696 | $ | 188,346 | ||||
Accounts payable and accrued expenses - related party | 1,122,839 | 807,001 | ||||||
Convertible notes payable | 657,500 | 3,732,500 | ||||||
Note payable - related party | 234,700 | - | ||||||
Interest payable | 98,718 | 380,575 | ||||||
Warrant derivative liability | 102,917 | 157,761 | ||||||
Total current liabilities | 2,862,370 | 5,266,183 | ||||||
Commitments and Contingencies (Note 10) | ||||||||
Stockholders' equity (deficit): | ||||||||
Preferred stock, $0.001 par value; 20,000,000 shares authorized; none issued and outstanding | - | - | ||||||
Common stock, $0.001 par value, 200,000,000 shares authorized; 14,617,629 and 6,666,667 shares issued and outstanding, March 31, 2014 and June 30, 2013 | 14,617 | 6,667 | ||||||
Additional paid-in capital | 19,134,897 | 3,847,591 | ||||||
Deficit accumulated during the development stage | (15,741,693 | ) | (8,016,470 | ) | ||||
Total stockholders' equity (deficit) | 3,407,821 | (4,162,212 | ) | |||||
Total Liabilities and Stockholders' Equity (Deficit) | $ | 6,270,191 | $ | 1,103,971 |
See accompanying notes to consolidated financial statements
2 |
(A Development Stage Enterprise)
Consolidated Statements of Operations
Three Monts | Nine Months | From March 24, 2010 | ||||||||||||||||||
Ended March 31, | Ended March 31, | (Inception) to | ||||||||||||||||||
2014 | 2013 | 2014 | 2013 | March 31, 2014 | ||||||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||||||
Operating expenses | ||||||||||||||||||||
Consulting fees | $ | 221,263 | $ | 266,164 | $ | 383,288 | $ | 494,319 | $ | 1,283,792 | ||||||||||
Compensation and benefits | 591,023 | 3,473,499 | 1,361,355 | 3,867,370 | 5,997,232 | |||||||||||||||
Research and development | 2,246 | 3,025 | 2,246 | 3,025 | 5,740 | |||||||||||||||
Insurance | 33,645 | 44,146 | 122,722 | 52,762 | 241,592 | |||||||||||||||
Professional fees | 228,308 | 198,368 | 470,926 | 486,747 | 1,273,869 | |||||||||||||||
Rent | 23,001 | 16,038 | 61,750 | 50,362 | 193,702 | |||||||||||||||
Travel | 44,219 | 22,629 | 51,616 | 77,840 | 290,749 | |||||||||||||||
Amortization | 886 | - | 2,658 | - | 2,953 | |||||||||||||||
General and administrative | 450,788 | 30,412 | 489,759 | 60,301 | 622,827 | |||||||||||||||
Total operating expenses | 1,595,379 | 4,054,281 | 2,946,320 | 5,092,726 | 9,912,456 | |||||||||||||||
Loss from operations | (1,595,379 | ) | (4,054,281 | ) | (2,946,320 | ) | (5,092,726 | ) | (9,912,456 | ) | ||||||||||
Other income (expense) | ||||||||||||||||||||
Interest income | 3,667 | 13,801 | 10,500 | 102,703 | 148,091 | |||||||||||||||
Interest expense | (3,441,448 | ) | (181,703 | ) | (4,229,612 | ) | (396,022 | ) | (5,259,776 | ) | ||||||||||
Derivative expense | (53,970 | ) | (311,794 | ) | (559,791 | ) | (311,794 | ) | (717,552 | ) | ||||||||||
Total other income (expense) | (3,491,751 | ) | (479,696 | ) | (4,778,903 | ) | (605,113 | ) | (5,829,237 | ) | ||||||||||
Net loss | $ | (5,087,130 | ) | $ | (4,533,977 | ) | $ | (7,725,223 | ) | $ | (5,697,839 | ) | $ | (15,741,693 | ) | |||||
Net loss per common share - basic and diluted | $ | (0.76 | ) | $ | (0.71 | ) | $ | (1.16 | ) | $ | (0.94 | ) | $ | (2.58 | ) | |||||
Weighted average number of common shares outstanding - basic and diluted | 6,671,537 | 6,401,723 | 6,669,896 | 6,050,535 | 6,106,136 |
See accompanying notes to consolidated financial statements
3 |
(A Development Stage Enterprise)
Consolidated Statement of Stockholders' Equity (Deficit)
From March 24, 2010 (Inception) to March 31, 2014 (Unaudited)
Deficit | ||||||||||||||||||||||||
Accumulated | ||||||||||||||||||||||||
Common | Additional | During the | Total | |||||||||||||||||||||
Common Stock, $0.001 Par Value | Stock | Paid-in | Development | Stockholders' | ||||||||||||||||||||
Shares | Amount | Subscribed | Capital | Stage | Equity (Deficit) | |||||||||||||||||||
Balance at March 10, 2010 (Inception) | - | $ | - | $ | - | $ | 100 | $ | - | $ | 100 | |||||||||||||
Issuance of common stock | 5,880,667 | 5,881 | (5,881 | ) | - | - | - | |||||||||||||||||
Net loss for the period from March 24, 2010 (Inception) to June 30, 2011 | - | - | - | - | (505,630 | ) | (505,630 | ) | ||||||||||||||||
Balance at June 30, 2011 | 5,880,667 | 5,881 | (5,881 | ) | 100 | (505,630 | ) | (505,530 | ) | |||||||||||||||
Net loss for the year ended June 30, 2012 | - | - | - | - | (783,383 | ) | (783,383 | ) | ||||||||||||||||
Balance at June 30, 2012 | 5,880,667 | 5,881 | (5,881 | ) | 100 | (1,289,013 | ) | (1,288,913 | ) | |||||||||||||||
Stock-based compensation | - | - | - | 3,687,502 | - | 3,687,502 | ||||||||||||||||||
Warrant expense | - | - | - | 191,126 | - | 191,126 | ||||||||||||||||||
Conversion of equity in reverse merger acquisition | 786,000 | 786 | 5,881 | (31,137 | ) | - | (24,470 | ) | ||||||||||||||||
Net loss for the year ended June 30, 2013 | - | - | - | - | (6,727,457 | ) | (6,727,457 | ) | ||||||||||||||||
Balance at June 30, 2013 | 6,666,667 | 6,667 | - | 3,847,591 | (8,016,470 | ) | (4,162,212 | ) | ||||||||||||||||
Stock-based compensation (Unaudited) | - | - | - | 495,120 | - | 495,120 | ||||||||||||||||||
Beneficial conversion feature (Unaudited) | - | - | - | 2,922,938 | - | 2,922,938 | ||||||||||||||||||
Fair value of warrants for financing and conversion (Unaudited) | - | - | - | 4,863,979 | - | 4,863,979 | ||||||||||||||||||
Issuance of common stock, net of issuance costs of $849,858 (Unaudited) | 3,186,222 | 3,186 | - | 2,303,090 | - | 2,306,276 | ||||||||||||||||||
Issuance of common stock for note conversions (Unaudited) | 4,588,457 | 4,588 | - | 4,427,355 | - | 4,431,943 | ||||||||||||||||||
Issuance of common stock as repayment of related party balance (Unaudited) | 176,283 | 176 | - | 274,824 | - | 275,000 | ||||||||||||||||||
Net loss for the nine months ended March 31, 2014 (Unaudited) | - | - | - | - | (7,725,223 | ) | (7,725,223 | ) | ||||||||||||||||
Balance at March 31, 2014 (Unaudited) | 14,617,629 | $ | 14,617 | $ | - | $ | 19,134,897 | $ | (15,741,693 | ) | $ | 3,407,821 |
See accompanying notes to consolidated financial statements
4 |
(A Development Stage Enterprise)
Consolidated Statements of Cash Flows
(Unaudited)
Nine Months | From March 24, 2010 | |||||||||||
Ended March 31, | (Inception) to | |||||||||||
2014 | 2013 | March 31, 2014 | ||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||||||
Net loss | $ | (7,725,223 | ) | $ | (5,697,839 | ) | $ | (15,741,693 | ) | |||
Amortization of notes payable discount | 3,356,000 | 19,312 | 3,643,500 | |||||||||
Amortization of deferred financing costs | 416,337 | 188,511 | 778,426 | |||||||||
Amortization of intangible asset | 2,658 | - | 2,953 | |||||||||
Stock-based compensation expense | 495,120 | 3,269,893 | 4,182,622 | |||||||||
Warrant expense | 76,064 | - | 76,064 | |||||||||
Derivative expense | 559,791 | 311,794 | 717,552 | |||||||||
Bad debt expense | 341,780 | - | 341,780 | |||||||||
Changes in operating assets and liabilities: | ||||||||||||
Increase in other assets | (24,331 | ) | (188,444 | ) | (194,800 | ) | ||||||
Increase in due from related parties | 18,948 | (151,809 | ) | (187,661 | ) | |||||||
Increase in accounts payable and accrued expenses | 457,350 | 142,067 | 646,729 | |||||||||
Increase in accounts payable and accrued expenses - related party | 590,838 | 522,893 | 1,395,699 | |||||||||
Increase in interest payable | 365,485 | 188,399 | 746,060 | |||||||||
Net Cash Used In Operating Activities | (1,069,183 | ) | (1,395,223 | ) | (3,592,769 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||||||
Purchase of fixed assets | - | (11,717 | ) | (11,717 | ) | |||||||
Acquisition of assets | - | (500,000 | ) | (500,000 | ) | |||||||
(Increase) decrease in interest receivable - related party | (10,212 | ) | 31,547 | (13,553 | ) | |||||||
Issuance of note receivable - related party | - | (305,603 | ) | (1,138,057 | ) | |||||||
Payments on note receivable - related party | - | 974,228 | 974,228 | |||||||||
Net Cash Provided by (Used In) Investing Activities | (10,212 | ) | 188,455 | (689,099 | ) | |||||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||||||
Payments of financing costs | (270,300 | ) | - | (512,300 | ) | |||||||
Proceeds from issuance of convertible notes payable | 2,703,000 | 1,575,000 | 6,183,500 | |||||||||
Repayments of convertible notes payable | (67,500 | ) | - | (103,000 | ) | |||||||
Proceeds from issuance of notes payable - related party | 234,700 | - | 234,700 | |||||||||
Proceeds from issuance of equity financing | 4,970,453 | - | 4,970,453 | |||||||||
Payment of placement agent compensation and issuance costs | $ | (849,858 | ) | $ | - | $ | (849,858 | ) | ||||
Net Cash Provided By Financing Activities | 6,720,495 | 1,575,000 | 9,923,495 | |||||||||
Net increase in cash | 5,641,100 | 368,232 | 5,641,627 | |||||||||
Cash - Beginning of Period | 527 | 25,878 | - | |||||||||
Cash - End of Period | $ | 5,641,627 | $ | 394,110 | $ | 5,641,627 | ||||||
SUPPLEMENTARY CASH FLOW INFORMATION: | ||||||||||||
Cash Paid During the Period for: | ||||||||||||
Taxes | $ | - | $ | - | $ | - | ||||||
Interest | $ | - | $ | - | $ | - | ||||||
Non-Cash Transactions: | ||||||||||||
Assumption of accrued expenses in reverse merger | $ | - | $ | 1,207 | $ | 1,207 | ||||||
Assumption of due to/from related party in reverse merger | $ | - | $ | 23,263 | $ | 23,263 | ||||||
Conversion of convertible notes payable to common stock | $ | 5,710,500 | $ | - | $ | 5,710,500 | ||||||
Conversion of interest payable to common stock | $ | 647,342 | $ | - | $ | 647,342 | ||||||
Conversion of accounts payable and accrued expense - related party | ||||||||||||
to common stock | $ | 275,000 | $ | - | $ | 275,000 | ||||||
Beneficial conversion feature recorded as a debt discount | $ | 2,922,938 | $ | - | $ | 2,922,938 | ||||||
Warrant value recorded as a debt discount | $ | 433,062 | $ | - | $ | 433,062 | ||||||
Assets acquired in asset acquisition: | ||||||||||||
Inventory | $ | - | $ | 223,000 | $ | 223,000 | ||||||
Fixed assets | - | 264,000 | 264,000 | |||||||||
Intangible assets | - | 13,000 | 13,000 | |||||||||
Cash paid for asset acquisition | $ | - | $ | 500,000 | $ | 500,000 |
See accompanying notes to consolidated financial statements
5 |
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements
March 31, 2014
(Unaudited)
Note 1 Nature of Operations
These financial statements represent the consolidated financial statements of AntriaBio, Inc. (“AntriaBio”), formerly known as Fits My Style, Inc., and its wholly owned operating subsidiary, AntriaBio Delaware, Inc. (“Antria Delaware”). AntriaBio and Antria Delaware are collectively referred to herein as the “Company”. The Company is a development stage company in which the strategy is to develop sustained release products for the diabetes market.
On January 31, 2013, AntriaBio, a public company, acquired Antria Delaware pursuant to a share exchange agreement in which the existing stockholders of Antria Delaware exchanged all of their issued and outstanding shares of common stock of Antria Delaware for 5,880,667 shares of common stock of AntriaBio (the “Reverse Merger”). After the consummation of the Reverse Merger, stockholders of Antria Delaware owned 88.2% of AntriaBio’s outstanding common stock.
As a result of the Reverse Merger, Antria Delaware became a wholly owned subsidiary of AntriaBio. For accounting purposes, the Reverse Merger was treated as a reverse acquisition with Antria Delaware as the acquirer and AntriaBio as the acquired party. As a result, the business and financial information included in this Quarterly Report on Form 10-Q is the business and financial information of Antria Delaware. The accumulated deficit of AntriaBio has been included in additional paid-in-capital. Pro-forma information has not been presented as the financial information of AntriaBio was insignificant.
Effective May 1, 2014, the Company effected a 6 to 1 reverse stock split of the Company’s common stock, in which for every six (6) shares of common combined into one (1) share of common stock. All share and per share amounts in this Quarterly Report on Form 10-Q have been retroactively restated to reflect the forward split.
Note 2 Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America and the rules and regulations of the United States Securities and Exchange Commission for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X.
The unaudited interim financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K filed on September 11, 2013, which contains the audited financial statements and notes thereto, together with the Management’s Discussion and Analysis of Financial Condition and Results of Operations, for the year ended June 30, 2013.
Certain information or footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted, pursuant to the rules and regulations of the Securities and Exchange Commission for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a comprehensive presentation of financial position, results of operations, or cash flows. It is management's opinion, however, that all material adjustments (consisting of normal recurring adjustments) have been made which are necessary for a fair financial statement presentation. The interim results for the period ended March 31, 2014 are not necessarily indicative of results for the full fiscal year.
6 |
Development Stage
The Company's financial statements are presented as those of a development stage enterprise. Activities during the development stage primarily include equity and debt based financing and the development of the business plan.
Use of Estimates
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts in the financial statements and the accompanying notes. Such estimates and assumptions impact, among others, the following: estimated useful lives and potential impairment of intangible assets, the fair value of share-based payments, estimates of the probability and potential magnitude of contingent liabilities and the valuation allowance for deferred tax assets due to continuing and expected future operating losses.
Risks and Uncertainties
The Company's operations may be subject to significant risk and uncertainties including financial, operational, regulatory and other risks associated with a development stage company, including the potential risk of business failure. See Note 3 regarding going concern matters.
Fixed Assets
Fixed assets are carried at cost less accumulated depreciation and amortization. The fixed assets primarily consist of lab and manufacturing equipment. Depreciation is computed using the straight-line method over the estimated useful lives. The fixed assets have not been placed in service as of March 31, 2014 as they are being stored until a lab facility has been established at which time the assets can be installed and placed in service. As the assets have not been placed into service they have not begun depreciating.
Beneficial Conversion Feature of Convertible Notes Payable
The Company accounts for convertible notes payable in accordance with the guidelines established by the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) Topic 470-20, Debt with Conversion and Other Options, Emerging Issues Task Force ("EITF") 98-5, Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios, and EITF 00-27, Application of Issue No 98-5 To Certain Convertible Instruments. The Beneficial Conversion Feature ("BCF") of a convertible note is normally characterized as the convertible portion or feature of certain notes payable that provide a rate of conversion that is below market value or in-the-money when issued. The Company records a BCF related to the issuance of a convertible note when issued and also records the estimated fair value of any warrants issued with those convertible notes. Beneficial conversion features that are contingent upon the occurrence of a future event are recorded when the contingency is resolved.
The BCF of a convertible note is measured by allocating a portion of the note's proceeds to the warrants, if applicable, and as a reduction of the carrying amount of the convertible note equal to the intrinsic value of the conversion feature, both of which are credited to additional paid-in-capital. The value of the proceeds received from a convertible note is then allocated between the conversion features and warrants on an allocated fair value basis. The allocated fair value is recorded in the financial statements as a debt discount (premium) from the face amount of the note and such discount is amortized over the expected term of the convertible note (or to the conversion date of the note, if sooner) and is charged to interest expense.
7 |
Fair Value of Financial Instruments
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The standard also expands disclosures about instruments measured at fair value and establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company has consistently applied the valuation techniques discussed below in all periods presented. The standard describes three levels of inputs that may be used to measure fair value:
· | Level 1: Quoted prices for identical assets and liabilities in active markets; |
· | Level 2: Quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets; and |
· | Level 3: Valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. |
The carrying amounts of financial instruments including cash, accounts payable and accrued expenses, and notes payable approximated fair value as of March 31, 2014 and June 30, 2013 due to the relatively short maturity of the respective instruments. The warrant derivative liability recorded as of March 31, 2014 and June 30, 2013 is recorded at an estimated fair value based on a Black-Scholes pricing model. The warrant derivative liability is a level 3 fair value instrument. See significant assumptions in Note 8. The following table sets forth a reconciliation of changes in the fair value of financial instruments classified as level 3 in the fair value hierarchy:
Balance as of June 30, 2013 | $ | (157,761 | ) | |
Total unrealized gains (losses): | ||||
Included in earnings | (559,791 | ) | ||
Warrant reclassified to equity | 614,635 | |||
Balance as of March 31, 2014 | $ | (102,917 | ) |
Recent Accounting Pronouncements
There are no recent accounting pronouncements that are expected to have an effect on the Company’s financial statements.
Note 3 Going Concern
As reflected in the accompanying financial statements, the Company has a net loss of $7,725,223 and net cash used in operations of $1,069,183 for the nine months ended March 31, 2014, and working capital equity of $3,122,057 and stockholders’ equity of $3,407,821 and a deficit accumulated during the development stage of $15,741,693 at March 31, 2014. In addition, the Company is in the development stage and has not yet generated any revenues. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
The Company expects that its current cash resources as well as expected lack of operating cash flows will not be sufficient to sustain operations for a period greater than one year.
The ability of the Company to continue its operations is dependent on Management's plans, which include continuing to raise capital through equity and debt based financings.
8 |
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. These consolidated financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern.
Note 4 Acquisition of Assets
On January 30, 2013, the Company closed on an asset purchase agreement with the Chapter 7 Estate of PR Pharmaceuticals, Inc. (“PRP”). Pursuant to the asset purchase agreement, the Company has acquired certain tangible and intangible assets in exchange for $400,000 in cash plus an initial deposit of $100,000 paid to the Chapter 11 Trustee of PRP which is included in the purchase price, plus contingent consideration up to a maximum amount of $44,000,000.
As the purchase was treated as an asset acquisition, the value assigned for the assets acquired was based on the estimated fair value of the assets and liabilities. The allocation of the price paid in cash is as follows:
Material inventory | $ | 223,000 | ||
Fixed assets | 264,000 | |||
Intangible assets | 13,000 | |||
$ | 500,000 |
The contingent consideration is payable in the following amounts, upon the occurrence of the following events:
· | Two million dollars ($2,000,000) related to the initiation of Phase 2b clinical studies for a multi-day injectable insulin, payable 30 days after the first dosing of a patient in a formal Phase 2b clinical study; |
· | Two million dollars ($2,000,000) to be paid within 30 days after the exclusive license of the multi-day injectable insulin in the United States to a commercial pharmaceutical company. |
· | Five million dollars ($5,000,000) after the initiation of Phase 3 clinical studies for the multi-day injectable insulin by the Company or a licensee of the Company, payable 30 days after the first dosing of a patient in a formal Phase 3 clinical study. |
· | Ten million dollars ($10,000,000) upon the approval by the FDA or EMEA to allow the marketing and sales of the multi-day injectable insulin by the Company or a licensee of the Company, payable 30 days after the receipt of the approval letter or notice from the FDA or EMEA. |
· | Twenty five million dollars ($25,000,000) if the twelve month cumulative sales of the multi-day injectable insulin by the Company or a licensee of the Company reaches five hundred million dollars ($500,000,000) in any one given twelve consecutive month period, so long as such period occurs during the life of the patents included in the purchased assets, payable 90 days after the twelfth month in which sales equaled or exceeded five hundred million dollars. |
All contingent consideration events must occur within five years of the closing of the asset purchase agreement. If an event is not reached within five years, no remaining contingent consideration would be required to be paid. No contingent events have occurred through the report date.
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Note 5 Related Party Transactions
Effective September 1, 2011, the Company issued a $1,000,000 line of credit to a related party, which has common ownership with the Company. The line of credit was issued in order for the Company to obtain a higher interest rate on excess cash. The balance due on the line of credit as of March 31, 2014 and June 30, 2013 was zero and $163,829, respectively, plus accrued interest of zero and $3,341, respectively. The line of credit bears interest equal to the lower of 10%, or the Wall Street Journal Prime Rate (3.25% at March 31, 2014) plus 5%. The interest rate at March 31, 2014 was 8.25%. The line of credit matured on August 31, 2012 and the Company has no further obligations to fund the credit line. A late charge of 5% of the outstanding balance was charged on the line of credit on December 31, 2012. The line of credit is secured by one million shares of the related party’s common stock. As of March 31, 2014, the Company wrote off the entire balance due from the related party of $163,829 for the receivable balance and $13,553 for the accrued interest balance.
During the three and nine months ended March 31, 2014, the Company incurred consulting expenses of $172,530 and $334,205, respectively and professional expenses of none and $51,000, respectively, for services performed by related parties of the Company and included in the statements of operations. As of March 31, 2014 and June 30, 2013, $1,122,839 and $807,001, respectively, of related party expenses are recorded in accounts payable and accrued expense – related party.
During the three and nine months ended March 31, 2013, the Company incurred consulting expenses of $266,164 and $445,389, respectively, and professional expenses of $25,500 and $109,500, respectively, for services performed by related parties of the Company and included in the statements of operations.
As of March 31, 2014 and June 30, 2013, the due from related party was zero and $183,346 for expenses paid on behalf of related parties. As of March 31, 2014, $164,398 of the due from related party balance is amounts due from a company owned by a Director of the Company on a non-interest bearing basis. On January 31, 2014, the Board of Directors ratified the amount lent to the Company owned by the Director with a repayment term of six months. On March 31, 2014, the Company wrote off the entire balance due from the related party.
Note 6 Convertible Notes Payable
2010 Notes (See (A) below.) - During 2010 and 2011, the Company issued 8% convertible notes payable for which principal and interest is due two years after date of issuance. The Company is required to pay a loan fee equal to 100% of the notes principal balance, which is recorded as a loan discount and being amortized on the effective yield method over the term of the notes.
Upon the close of a “Financing”, which means any third party capital investment in the Company, in cash, that is two million, five hundred thousand dollars ($2,500,000) or greater, the outstanding principal balance and at the option of the Lender, the unpaid accrued interest on these convertible notes shall convert in whole into the number of whole shares of common stock obtained by dividing the outstanding principal balance and unpaid accrued interest on these convertible notes at the time of such Financing, by the Conversion Price. The “Conversion Price” under these notes shall initially be 65% of the common share price of the Financing, subject to adjustment as provided herein. If the Company elects to pay the accrued interest on these convertible notes in cash, the accrued interest payment shall be due on the date the principal amount is converted to common stock. These terms were modified as disclosed below.
2011 Notes (See (B) below.) – During June 2011, the Company issued 8% convertible notes payable via Private Placement Memorandum (“PPM”). The PPM authorizes the issuance of up to $2,000,000 of convertible notes payable for which principal and interest is due one year after date of issuance. Pursuant to the terms of the PPM, upon an offering by the Company of common stock totalling at least $5 million (a “Qualified Offering”) the notes will automatically and on a mandatory basis convert (the “Mandatory Conversion”) into common shares of the Company and the right to receive warrants. On the date of closing of a Qualified Financing of common shares, the Notes will convert into common shares of the Company at a price equal to 65% of the price per common share of the Qualified Financing (the “Mandatory Conversion Price”), subject to a maximum conversion pre-money valuation of $20 million, and the right to receive Warrants. The conversion will include the face amount of the Notes and include any accrued and unpaid interest. For each common share received as a result of the Mandatory Conversion, the Investor will receive one (1) warrant to purchase one (1) common share of the Company at an exercise price equal to 135% of the price per common share at which the Notes are converted pursuant to the Mandatory Conversion. The warrants will be exercisable at any time for a period of five years from the date of the Qualified Offering. These terms were modified as disclosed below.
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2011 Notes (See (C) below) – In September 2011, the Company amended its 2011 PPM (above) to remove the mandatory conversion feature and to permit conversion of the notes payable at the option of the lender. The remaining terms remain essentially the same as the 2011 Notes described above.
On July 1, 2012, the Company amended its June 15, 2011 PPM on its twelve month, 8% convertible notes payable to issue up to an additional $2,000,000 in convertible notes and to extend it offering termination date to October 1, 2012. In addition, the amended PPM changes the definition of a “Qualified Financing” from $5 million to $2.5 million. On the maturity date of the convertible notes, or the closing of a Sale of the Company, whichever occurs first, the lenders are permitted an elective conversion option to convert the outstanding principal and interest on the convertible notes at the lower of 65% of the price per share of common stock in the Qualified Financing or 65% of the common stock price using a pre-money valuation of the Company of $20 million. With each share of common stock received, the investor will also receive a warrant to purchase two shares of common stock at 135% of the price per common stock at the time the note was converted. The Company reserved the right to withdraw the offering at any time.
2012 Notes (See (D) below) - In December 2012, the Company amended its PPM on its twelve month, 8% convertible notes payable to issue up to an additional $1,000,000 in convertible notes and to extend the offering termination to December 31, 2012. On the date of a Qualified Financing, the lenders are permitted an elective conversion option to convert the outstanding principal and interest at the lower of 50% of the price per share of common stock in the Qualified Financing or $4.50 per share. With each share of common stock received, the investor will also receive a warrant to purchase one share of common stock at 150% of the price per common stock at the time the note was converted.
In the second fiscal quarter, the Company sent letters to the holders of the 2010, 2011 and 2012 notes requesting amendment of their convertible notes payable. The convertible notes payable were amended to: (i) fix the conversion price of the notes into common stock at $1.50 per share, (ii) require mandatory conversion of principal and interest, and (iii) change the definition of a qualified financing to an equity financing of at least three million dollars. Through March 31, 2014, $3,007,500 of the convertible notes payable balances outstanding had signed and returned the amendment letter. Based on the fixed conversion price, the intrinsic value of the beneficial conversion feature of $653,000 was calculated and recorded as a discount to the notes payable. As of March 31, 2014, $653,000 of the debt discount has been amortized into interest expense as these all amortized as part of the conversion.
2013 Notes – In December 2013 and January 2014, the Company issued $2,703,000 of 8% convertible promissory notes payable for which principal and interest is due six months after the date of issuance. Pursuant to the note agreements, if the Company issues equity securities in a transaction resulting in gross proceeds of at least $3 million, the promissory note and accrued interest will automatically convert to common stock at a conversion price of $1.26 per share. The notes also allow the investor to convert at any time prior to maturity at $1.26 per share at their option. With the promissory note, the investor will also receive a warrant to purchase common stock equal to one-half of the principal amount of the promissory note. The warrant will have an exercise price of $1.89 per share and will be exercisable for three years from date of issuance.
The value of the proceeds of the notes was allocated to the warrants as discussed in Note 8 and the remaining balance was allocated to the beneficial conversion feature as the intrinsic value of the beneficial conversion feature is greater than the remaining value of the notes. The discount on the notes is being amortized into interest expense over the remaining life of the notes.
On March 31, 2014, the Company closed on an equity transaction which qualified as a “qualified financing”. As such the $2,703,000 in 2013 Notes and the accrued interest was converted into 2,186,847 shares of our common stock. The Company also converted $3,007,500 of the 2010, 2011 and 2012 Notes and accrued interest into 2,401,610 shares of our common stock. The remaining $1,458,417 of debt discounts on the notes converted was recorded into interest expense at the time of the conversion.
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The convertible notes outstanding as of March 31, 2014 and June 30, 2013 are:
March 31, 2014 | June 30, 2013 | |||||||
2010 Notes (A) | $ | 407,500 | $ | 562,500 | ||||
2011 Notes (B) | - | 645,000 | ||||||
2011 Notes (C) | 50,000 | 1,700,000 | ||||||
2012 Notes (D) | 200,000 | 825,000 | ||||||
$ | 657,500 | $ | 3,732,500 |
The notes originated at various dates from April 2010 through December 2013 and mature at various dates from February 2012 to January 2014.
As of March 31, 2014, all of the outstanding convertible notes have matured and payments were due. The convertible notes were not repaid or converted continue to accrue interest at a rate of 8% for the 2010 notes and 12% for the 2011 notes that had matured. Since March 31, 2014, the remaining note holders have agreed to convert all but $211,966 of the remaining principal and interest into shares of the Company’s common stock.
Note Payable – Related Party – On November 14, 2013, the Company issued a 14% promissory note with a related party. The note allows funds to be borrowed until March 1, 2014 up to $250,000. The note matures on the earlier of November 1, 2014 or when the Company closes on an equity financing of at least $3 million. The Company also issued a warrant for one share of common stock for each dollar of principal loaned. The warrant was issued on March 1, 2014 for option to purchase up to 39,117 shares of common stock. The warrant exercise price will be $7.50 per share and will be exercisable for five years. As of March 31, 2014, the outstanding balance on the note is $234,700 and the accrued interest is $12,895 as of March 31, 2014. The warrants were issued on March 26, 2014 for a fair value of $76,062. The total principal and interest balance was paid in full on April 1, 2014.
Note 7 Shareholders’ Equity (Deficit)
On March 31, 2014, the Company completed an initial close of a private placement transaction in which the Company issued 3,186,222 units to accredited investors. Each unit consists of one share of our common stock and one common share purchase warrant. Each warrant entitles the holder to purchase one share of common stock at a price of $2.34 per share and the warrant will expire 36 months following the issuance. The Company received net proceeds of $4.1 million after the placement agent compensation and issuance costs of $849,858.
In addition to the units issued, the Company also issued 530,300 additional warrants to investors who invested in the 2013 Notes and also in the private placement. For each dollar that was invested in the 2013 Notes, the Company would issue one-half of one common share purchase warrant for their investment in the private placement transaction for up to 150% of their investment in the 2013 Notes. The warrants will be exercisable at $2.34 per share and will expire 36 months after they were issued.
In April 2014, the Company completed its final close of the private placement in which the Company issued an additional 2,539,136 units to accredited investors for net proceeds of approximately $3.4 million after placement agent compensation of $515,226.
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The Company issued no shares of preferred stock during the nine month period ended March 31, 2014. The Company has not declared or paid any dividends or returned any capital to shareholders as of March 31, 2014.
On July 3, 2012 the Company issued warrants to a placement agent to purchase 233,334 shares of common stock from the date of issuance through five years when the warrants expire. On August 15, 2012 the Company issued warrants to two placement agents to purchase up to 41,424 shares of common stock from the date of issuance through five years when the warrants expire. On February 2, 2013, the Company issued warrants to a placement agent to purchase up to 18,334 shares of common stock from the date of issuance through five years when the warrants expire. In December 2013 and January 2014, the Company issued warrants in connection with the convertible notes to purchase up to 225,259 shares of common stock from the date of issuance through three years when the warrants expire. On March 31, 2014, the Company issued warrants to Konus Advisory Group, Inc. in connection with their debt agreement to purchase up to 39,117 shares of common stock from the issue date through five years when the warrants expire. On March 31, 2014, the Company issued warrants in connection with the private placement and the additional incentive warrants. The Company issued warrants to purchase up to 3,716,522 shares of commons stock from the date of issuance through three years when the warrants expire.
Equity Incentive Plan - The Company granted 1,508,334 stock options to four officers and/or directors of the Company and to two contractors of the Company. On March 26, 2014, the Company adopted the AntriaBio, Inc. 2014 Stock and Incentive Plan which allows the Company to issue up to 3,750,000 of common stock in the form of stock options, incentive options or common stock. On March 31, 2014, subject to the effectiveness of stockholder approval pursuant to Rule 14c-2 of the Exchange Act which occurred on April 30, 2014, the Company granted 2,680,000 of these shares to current employees and directors of the Company.
Note 8 Stock-Based Compensation
Options - AntriaBio adopted individual stock option plans in January 2013 for four officers and/or directors of the Company. The stock option plans granted 1,500,000 option shares with an exercise price of $4.50 per share. Options to purchase 819,445 shares vested immediately, options to purchase 541,667 shares vest monthly over 3 years and 138,888 shares vest on May 31, 2013.
In June 2013, AntriaBio adopted individual stock option plans for two consultants of the Company. The stock option plans granted 8,334 shares with an exercise price of $4.50 per share. Option to purchase 2,084 shares vested immediately with the remaining shares vesting at various dates through October 2014.
On March 26, 2014, the Company adopted the AntriaBio, Inc. 2014 Stock and Incentive Plan which allows the Company to issue up to 3,750,000 of common stock in the form of stock options, incentive options or common stock. On March 31, 2014, subject to the effectiveness of stockholder approval pursuant to Rule 14c-2 of the Exchange Act which occurred on April 30, 2014, the Company granted 2,680,000 of these shares to current employees and directors of the Company. The options have an exercise price of $3.12 per share. The options vest monthly over 4 years.
AntriaBio has computed the fair value of all options granted using the Black-Scholes option pricing model. In order to calculate the fair value of the options, certain assumptions are made regarding components of the model, including the estimated fair value of the underlying common stock, risk-free interest rate, volatility, expected dividend yield and expected option life. Changes to the assumptions could cause significant adjustments to valuation. AntriaBio estimated a volatility factor utilizing a comparable published volatility of a peer company. Due to the small number of option holders and all options being to officers and/or directors, AntriaBio has estimated a forfeiture rate of zero. AntriaBio estimates the expected term based on the average of the vesting term and the contractual term of the options. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securities of similar maturity.
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Stock option activity is as follows:
Weighted | Weighted Average | |||||||||||
Number of | Average | Remaining | ||||||||||
Options | Exercise Price | Contractual Life | ||||||||||
Outstanding, June 30, 2012 | - | $ | - | - | ||||||||
Granted | 1,508,334 | $ | 4.50 | |||||||||
Outstanding, June 30, 2013 | 1,508,334 | $ | 4.50 | 4.6 | ||||||||
Granted | 2,680,000 | $ | 3.12 | |||||||||
Outstanding, March 31, 2014 | 4,188,334 | $ | 3.62 | 4.6 | ||||||||
Exercisable at March 31, 2014 | 1,174,190 | $ | 4.50 | 3.9 |
Stock-based compensation expense related to the fair value of stock options was included in the statement of operations as payroll expense of $164,484 and $495,120 for the three and nine months ended March 31, 2014, respectively. The unrecognized stock-based compensation expense at March 31, 2014 is $6,887,183. AntriaBio determined the fair value as of the date of grant using the Black-Scholes option pricing method and expenses the fair value ratably over the vesting period.
Warrants- AntriaBio issued warrants to agents and note holders in conjunction with the closing of its convertible notes payable as follows:
Weighted | Weighted Average | |||||||||||
Number of | Average | Remaining | ||||||||||
Warrants | Exercise Price | Contractual Life | ||||||||||
Outstanding, June 30, 2012 | - | $ | - | - | ||||||||
Warrants issued to placement agents | 41,424 | $ | 1.98 | |||||||||
Warrants issued to placement agent | 233,334 | $ | 1.50 | |||||||||
Warrants issued to placement agent | 18,334 | $ | 4.95 | |||||||||
Outstanding, June 30, 2013 | 293,092 | $ | 1.80 | 4.1 | ||||||||
Warrants issued to note holders | 225,259 | $ | 1.89 | |||||||||
Warrants issued to note holders | 3,657,205 | $ | 2.04 | |||||||||
Warrants issued to related party | 39,117 | $ | 7.50 | |||||||||
Warrants issued in private placement | 3,716,522 | $ | 2.34 | |||||||||
Outstanding, March 31, 2014 | 7,931,195 | $ | 2.19 | 3.0 |
The Company issued warrants to purchase 41,424 shares of common stock at a price of $1.98 per share, exercisable from August 2012 through August 2017 in connection with the closing of convertible notes payable on specific PPMs. The Company issued a warrant to purchase 233,334 shares of common stock at a price of $1.50 per share, exercisable from August 2012 through August 2017 in connection with the closing of over one million dollars in convertible notes payable. The Company issued warrants to purchase 18,334 shares of common stock at a price of $4.95 per share, exercisable from February 2013 through February 2018 in connection with the closing of convertible notes payable on specific PPMs. The Company issued warrants to purchase 225,259 shares of common stock at a price of $1.89 per share, exercisable from December 2013 through January 2017 in connection with the issuance of convertible notes. The Company issued warrants to a related party to purchase 39,117 shares of common stock at a price of $7.50 per share, exercisable from March 2014 through March 2019. The Company issued warrants to purchase 3,657,205 shares of common stock at an average price of $2.04 per share of common stock, exercisable through March 2017 in connection with the conversion of convertible notes payable into equity. The Company issued warrants to purchase 3,716,522 shares of common stock at a price of $2.34 per share, exercisable through March 2017 in connection with the issuance of units in the private placement that was closed in March.
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The warrants exercisable for the 41,424 shares of common stock are accounted for under liability accounting and are fair valued at each reporting period. The warrants to purchase 41,424 shares value as of March 31, 2014 and June 30, 2013 was $102,917 and $157,761, respectively and is recorded as a liability on the consolidated balance sheets with the fair value adjustment recorded as derivative expense on the consolidated statements of operations. The warrants exercisable for the 233,334 shares of common stock were accounted for under liability accounting and were fair valued at each reporting period until March 31, 2014 when the warrants were recorded under equity treatment as the exercise price became fixed. The value of the warrants to purchase 233,334 shares as of March 31, 2014 was $614,635, which was recorded as additional paid-in-capital, and was not valued as of June 30, 2013 as the value could not be determined as an exercise price had not yet been fixed.
The warrants exercisable for the 18,334 shares of common stock are accounted for under equity treatment and fair valued as of the date of issuance. The fair value of the warrants was valued at $191,126 and recorded as additional paid-in-capital and deferred financing fees. The deferred financing fees are being amortized over the term of the notes associated with the warrants. The warrants for the 225,259 shares of common stock are accounted for under equity treatment and were recorded at the allocated fair value as of the date of issuance. The fair value of the warrants was $524,594 and the allocated fair value of $433,062 was recorded into additional paid-in capital and as a discount to the note payable balance.
The warrants exercisable for the 3,657,205 shares of common stock are accounted for under equity treatment and were recorded at the allocated fair value as of the date of issuance. The fair value of the warrants was $8,621,881 and the allocated fair value of $1,814,319 was recorded into additional paid-in capital. The warrants for the 3,716,522 shares of common stock are accounted for under the equity treatment and were recorded at the allocated fair value as of the date of issuance. The fair value of the warrants was $9,951,620 and the allocated fair value of $1,925,901 was recorded into additional paid-in capital. The warrants for the 39,117 was accounted for under the equity treatment and fair valued as of the date of issuance. The fair value of the warrants was valued at $76,062 and recorded as additional paid-in capital and interest expense.
These warrants were valued using the Black-Scholes option pricing model on the date of issuance. In order to calculate the fair value of the warrants, certain assumptions were made regarding components of the model, including the closing price of the underlying common stock, risk-free interest rate, volatility, expected dividend yield, and warrant term. Changes to the assumptions could cause significant adjustments to valuation. AntriaBio estimated a volatility factor utilizing a comparable published volatility of a peer company. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securities of similar maturity. The Black-Scholes valuation methodology was used because that model embodies all of the relevant assumptions that address the features underlying these instruments. Significant assumptions were as follows:
Expected volatility | 93% - 97 | % | ||
Risk free interest rate | 0.78% - 1.46 | % | ||
Warrant term (years) | 3 - 5 | |||
Dividend yield | 0 | % |
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Note 9 Income Taxes
Income tax expense during interim periods is based on applying an estimated annual effective income tax rate to year-to-date income, plus any significant unusual or infrequently occurring items which are recorded in the interim period. The computation of the annual estimated effective tax rate at each interim period requires certain estimates and significant judgment including, but not limited to, the expected operating income for the year, projections of the proportion of income earned and taxed in various jurisdictions, permanent and temporary differences, and the likelihood of recovering deferred tax assets generated in the current year. The accounting estimates used to compute the provision for income taxes may change as new events occur, more experience is obtained, additional information becomes known or as the tax environment changes.
In the nine months ended March 31, 2014, the Company did not record any income tax provision due to continuing the expected future losses and full valuation allowance on its deferred tax assets.
Note 10 Commitments and Contingencies
Employment Agreements - The Company entered into employment agreements with the officers of the Company.
On April 1, 2012, the Company entered into an employment agreement with its Chief Scientific Officer. This agreement provides for an initial salary of $275,000 through December 31, 2012 and a base salary $295,000 thereafter. The Chief Scientific Officer is also entitled to one-time bonuses totaling $275,000 upon achieving certain clinical testing milestones. Furthermore, the Chief Scientific Officer is entitled to an annual performance bonus equal to 40% of his base salary beginning in calendar 2013 based on criteria set by the Board of Directors in its sole discretion. Termination benefits for base salary and certain other benefits are provided for a period of twelve months. On March 26, 2014, we entered into an amended and restated employment agreement which removed the pension benefit owed to the Chief Scientific Officer.
On June 18, 2012, the Company entered into an employment agreement with its Chief Executive Officer. This agreement provides for an initial salary of $230,000 from the effective date of the agreement until the executive commits full time to the Company’s business and his base salary increases to $350,000. The Chief Executive Officer is entitled to one- time bonus of $40,000 upon the close of a Company financing of at least $5,000,000. Furthermore, the Chief Executive Officer is entitled to an annual performance bonus equal to 40% of his base salary beginning in calendar 2013 based on criteria set by the Board of Directors in its sole discretion. The agreement also provides for stock options to purchase 3,500,000 shares of common stock of the Company at an exercise price equal to the fair value of these shares on the date of grant. These options will vest 50% on December 31, 2012 and the remaining shares vest equally over the following thirty-six months of service. Termination benefits for base salary and certain other benefits are provided for a period of six months.
On March 26, 2014, we entered into an amended and restated employment agreement with our Chief Executive Officer. The Amended and Restated Employment Agreement provides, among other things, for: (i) an increase in Mr. Elam’s base salary from $230,000 to $390,000; (ii) a termination of the bonus due to Mr. Elam under the Employment Agreement upon the Company raising at least $5,000,000 in an equity financing; and (iii) a termination of the car allowance granted to Mr. Elam under the Employment Agreement.
Advisory Agreement - On July 2, 2012, the Company entered into an advisory agreement whereby the Company receives services including, but not limited to finance and strategy, clinical design, project management and portfolio assessment. The Company agreed to pay a monthly retainer in the amount of $9,000 per month to cover general and administrative matters plus an hour fee ranging from $100 to $700 per hour for additional services provided.
Consulting Agreements – On March 31, 2014, the Company entered into a services agreement whereby the Company receives assistance with investor relations relating to digital strategy, website and investor materials, market awareness and other services. The compensation for these services will be 500,000 shares of common stock to be issued over a twelve-month period.
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On April 1, 2014, the Company entered into a services agreement whereby the Company receives assistance with strategic media placement, third –party research, e-mail blasts and media buys to generate awareness of the Company. The Company agreed to pay $20,000 per month plus expenses for these services through March 31, 2015, and can be renewed on a monthly basis at that point in time.
Legal Matters - From time to time, the Company may be involved in litigation relating to claims arising out of operations in the normal course of business. As of March 31, 2014, there were no pending or threatened lawsuits that could reasonably be expected to have a material effect on the results of our operations. There are no proceedings in which any of our directors, officers or affiliates, or any registered or beneficial shareholders, is an adverse party or has a material interest adverse to our interest.
Note 11 Subsequent Events
No events occurred subsequent to March 31, 2014 that would require adjustment to the accompanying financial statements or footnotes other than those disclosed in the notes above and the events listed below:
On May 5, 2014, the Company entered into a lease agreement for approximately 27,000 square feet of office, lab and clean room space in Louisville, Colorado. The lease is for 72 months with a base rent starting at $12.74 per square foot with annual rent escalations.
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Effective May 1, 2014, the Company effected a 6 to1 reverse stock split of the Company’s common stock, in which for every six (6) shares of common stock combined into one (1) share of common stock. All share and per share amounts in this Quarterly Report on Form 10-Q have been retroactively restated to reflect the forward split.
General
This discussion and analysis should be read in conjunction with the accompanying financial statements and related notes. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors.
Overview, Background and Recent Developments
On January 31, 2013, AntriaBio acquired Antria Delaware pursuant to a share exchange in which AntriaBio acquired all of the issued and outstanding shares of common stock of Antria Delaware from the stockholders of Antria Delaware in exchange for 5,880,667 shares of common stock of AntriaBio (the “Reverse Merger”). As a result of the Reverse Merger, Antria Delaware became a wholly owned subsidiary of AntriaBio. For accounting purposes, the Reverse Merger was treated as a reverse acquisition with Antria Delaware as the acquirer and AntriaBio as the acquired party. As a result, the business and financial information included in the report is the business and financial information of Antria Delaware. The accumulated deficit of AntriaBio has been included in additional paid-in-capital. Pro-forma information has not been presented as the financial information of AntriaBio was insignificant.
Antria Delaware was formed as a Delaware corporation in March 2010 under the name “AntriaBio, Inc.” As a condition precedent to the Reverse Merger, Antria Delaware agreed to change its name from “AntriaBio, Inc.” to “AntriaBio Delaware, Inc.” On January 3, 2013, Antria Delaware filed an amendment to its certificate of incorporation with an effective date of January 10, 2013 to change its name from “AntriaBio, Inc.” to “AntriaBio Delaware, Inc.”
Antria Delaware was formed with the express purpose of acquiring the assets of PR Pharmaceuticals, Inc. (“PRP”). PRP was a company that developed proprietary technology to be used with active pharmaceutical ingredients to create sustained release injectable formulations. On October 5, 2012, Antria Delaware entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) to acquire all of PRP’s operating and intellectual property assets out of bankruptcy including, but not limited to, program data and materials, associated inventory, equipment, lab notebooks, patents, patent applications, technology and know-how, electronic data, and regulatory filings/correspondence related to development programs (the “Asset Purchase”). On January 31, 2013, the Asset Purchase closed and upon closing, PRP’s lead product candidate, a potential once-a-week basal insulin injection for the diabetes market, became our lead product candidate (AB101). Our strategy is to develop AB101 and other products for the diabetes market using our proprietary sustained release formulation capabilities with known pharmaceutical agents and United States Food and Drug Administration (“FDA”) approved delivery technologies. We believe that this strategy increases the probability of technical success while reducing safety concerns, approval risks and development costs. We also believe that our approach can result in differentiated, patent-protected products that provide significant benefits to patients and physicians.
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Plan of Operation
We have been focused on raising capital to fund our initial operations including conducting clinical studies for AB101 and developing our product pipeline. Our objective is to demonstrate that AB101 is safe and effective at the intended once weekly subcutaneous dosing frequency, specifically that it is non-inferior to current standard of care basal insulin therapies such as Lantus in controlling blood glucose, without an undue risk of hypoglycemia. After completion of additional IND-enabling work, we plan on filing an IND with the FDA in 2015, followed by the initiation of clinical trials in the second half of 2015. The objectives of the Phase 1 program will be to assess the single and repeat (once weekly) ascending dose safety, pharmacokinetics (PK), and pharmacodynamics (PD) in the target population with type 1 and type 2 diabetes, including confirmation of the time-action profile for glucose lowering (Phase 2a data). Following successful completion of the Phase 1/2a program, Phase 2b trials in both populations will be conducted to obtain proof-of-concept for the intended once weekly dosing regimen, using the accepted biomarker for glucose efficacy (hemoglobin A1c; HbA1c), compared to a standard of care basal insulin such as Lantus. If proof-of-concept trials are successful, we would expand our clinical program to include Phase 3 registration trials in various jurisdictions including the US and Europe, to obtain regulatory and marketing approval. The Phase 3 program would include studies in combination with other injectable and oral glucose lowering therapies, and would be designed to meet regulatory guidelines for the development of therapies for diabetes, while achieving an expanded label at the time of product launch.
This year, as a precursor to our US clinical studies and in order to fulfil FDA requirements for GLP (good laboratory practices) toxicity studies in support of our IND, we plan on conducting necessary IND-enabling pre-clinical studies, including acute and sub-acute toxicity studies in rodents and non-rodents, safety pharmacology, and mutagenicity/genotoxicity studies. Additional work may include further in vitro and in vivo pharmacology. In parallel, we will also conduct CMC work to produce clinical trial material under clinical good manufacturing practices (cGMP) conditions, as well as develop the necessary analytical methods for testing the material. Near term or critical path pre-clinical work will be geared toward enabling the IND and first clinical trial(s), while subsequent non critical path pre-clinical development work will be staged and resourced to meet the needs of continued clinical development.
Part of the assets that we acquired from PR Pharmaceuticals includes bulk product that has been fully characterized for strength, particle size, and sufficiency for injection and stability, but has not been produced in conformance with the FDA cGMP requirements and is therefore not approved for clinical use in the US (the “Existing Material”). Therefore, this Existing Material will be used to facilitate timely conduct of critical path IND-enabling studies. This material could also be used to conduct a preliminary clinical trial outside of the U.S., and this possibility is being evaluated.
In order to provide sterile, cGMP clinical material for our pre-clinical testing and clinical studies in the US, we plan on leasing a facility in the greater Denver, Colorado area where we anticipate making certain leasehold improvements including the addition of a cGMP aseptic suite. In the facility we plan on installing, commissioning and validating the manufacturing and analytical equipment that we acquired from PR Pharmaceuticals, which was previously used to produce AB101. We expect new material for the IND enabling preclinical and stability studies to be available by the end of the calendar year Q3 2014 and we anticipate having new clinical material for our US trials by the end of Q1 2015.
We entered into a lease for office, lab and clean room space in Louisville, Colorado. In order to facilitate commissioning of equipment and manufacturing in the leased facility, we entered into an agreement with a company located in Colorado to utilize their services to carry out simulated runs for manufacturing, to ensure that the analytical equipment is operational, and to produce documentation for analytical methods needed for product release and stability testing. The manufacturing and analytical equipment are assets that the Company acquired from PR Pharmaceuticals.
While we have preclinical and clinical plans for AB101 as well as plans to develop other product opportunities, we currently do not have sufficient cash to carry out these studies and other Company objectives. We believe that we need to raise as much as $30 million to fund our development and clinical activities through the completion of the initial Phase 1 and Phase 2 AB101 studies in the US. We raised approximately $11.6 million through early 2014 and will potentially raise an additional $10 to 15 million in late 2014 or the first half of 2015. We also anticipate that during this same period, we will hire 30-45 individuals and spend approximately ten million dollars on salaries/benefits, rent and general and administrative matters.
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Significant Accounting Policies and Estimates
The discussion and analysis of the financial condition and results of operations are based upon the financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of any contingent liabilities at the financial statement date and reported amounts of revenue and expenses during the reporting period. On an on-going basis the Company reviews its estimates and assumptions. The estimates were based on historical experience and other assumptions that we believe to be reasonable under the circumstances. Actual results are likely to differ from those estimates under different assumptions or conditions, but the Company does not believe such differences will materially affect our financial position or results of operations.
Results of Operations
For Three and Nine Months Ended March 31, 2014 and 2013
Results of operations for the three months ended March 31, 2014 (the “2014 quarter”) and the three months ended March 31, 2013 (the “2013 quarter”) reflected losses of $5,087,130 and $4,533,977, respectively. These losses include charges related to stock based compensation of $164,484 in the 2014 quarter and $3,269,894 in the 2013 quarter. The losses also include the amortization of the debt discount into interest expense of $2,938,364 in the 2014 quarter and $2,280 in the 2013 quarter as well as a write off of receivable balances of $341,780 in the 2014 quarter.
Results of operations for the nine months ended March 31, 2014 (the “2014 period”) and the nine months ended March 31, 2013 (the “2013 period”) reflected losses of $7,725,223 and $5,697,839 respectively. These losses include charges related to stock based compensation of $495,120 in the 2014 period and $3,269,893 in the 2013 period as well as a derivative expense of $559,791 in the 2014 period and $311,794 in the 2013 period. The losses also include the amortization of the debt discount into interest expense of $3,356,000 in the 2014 period and $19,312 in the 2013 period as well as a write off or receivable balances of $341,780 in the 2014 period.
Revenues
We are a development stage entity and have not generated any revenues since inception.
Expenses
Consulting expenses were approximately $221,000 in the 2014 quarter compared to $266,000 in the 2013 quarter, and $383,000 in the 2014 period compared to $494,000 in the 2013 period. The decrease is primarily due to the decrease in consulting fees that were paid to Konus Advisory Group for director consulting fees and other consulting services.
Payroll expenses were approximately $591,000 in the 2014 quarter compared to $3,473,000 in the 2013 quarter, and $1,361,000 in the 2014 period and $3,867,000 in the 2013 period. The decrease is due to stock-based compensation in the 2013 period for stock options that were granted in January 2013 and had immediately vested.
Professional fees were approximately $228,000 in the 2014 quarter compared to $198,000 in the 2013 quarter, and $471,000 in the 2014 period compared to $487,000 in the 2013 period. Professional fees consist primarily of legal, audit and accounting costs, costs related to public company compliance, and consulting related to capital formation. The increase is due to the increase in legal services as well as other public compliance costs that have been incurred in the 2014 period.
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General and administrative costs were approximately $451,000 in the 2014 quarter compared to $30,000 in the 2013 quarter, and $490,000 in the 2014 period compared to $60,000 in the 2013 period. The increase in the 2014 period is primarily due to the write off of receivable balances in the 2014 quarter as well as increased marketing and investor relations costs in the current period.
Liquidity and Capital Resources
At March 31, 2014, we have approximately $5.6 million of cash on hand. In March and April 2014, the Company completed a private placement transaction in which the Company issued units to accredited investors. Each unit consists of one share of our common stock and one common share purchase warrant. Each warrant entitles the holder to purchase one share of common stock at a price of $2.34 per share and the warrant will expire 36 months following the issuance. The Company received net proceeds of $7.6 million after the placement agent compensation. The private placement above was considered a “qualified financing” which allowed conversion of a significant amount of our convertible bridge note holders to convert into equity. As such the $2,703,000 in 2013 Notes and the accrued interest was converted into 2,186,847 shares of our common stock. The Company also converted $3,007,500 of the 2010, 2011 and 2012 Notes and accrued interest into 2,401,610 shares of our common stock. Since March 31, 2014, the remaining note holders have agreed to convert all but $211,966 of the remaining principal and interest into common stock.
The capital that was received in the private placement will be used to fund our ongoing operations including hiring additional personnel, leasing a manufacturing facility, acquiring certain equipment and commencing clinical trials.
Going Concern
The continuation of our business is dependent upon obtaining further financing and achieving a break even or profitable level of operations in our business. The issuance of additional equity securities by us could result in a significant dilution in the equity interests of our current or future stockholders. Obtaining commercial loans, assuming those loans would be available, will increase our liabilities and future cash commitments. There are no assurances that we will be able to obtain additional financing through either private placements, and/or bank financing or other loans necessary to support our working capital requirements. To the extent that funds generated from operations and any private placements, public offerings and/or bank financing are insufficient, we will have to raise additional working capital. No assurance can be given that additional financing will be available, or if available, will be on terms acceptable to us. These conditions raise substantial doubt about our ability to continue as a going concern.
Recent Accounting Pronouncements
There are no recent accounting pronouncements that are expected to have an effect on the Company’s consolidated financial statements.
Off-Balance Sheet Arrangements
We had no off-balance sheet transactions.
ITEM 3. QUALITATIVE AND QUANTITATIVE DISCUSSION ABOUT MARKET RISK.
Not required for smaller reporting companies.
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ITEM 4. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (our principal executive officer and our principal accounting officer), of the effectiveness of our disclosure controls and procedures as defined in Rule 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (“Exchange Act”). Based on that evaluation and the material weakness described below, our management concluded that we did not maintain effective disclosure controls and procedures as of March 31, 2014 in ensuring that information that we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms and that it is accumulated and communicated to the issuer’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Our management has identified control deficiencies regarding a lack of segregation of duties, and a need for a stronger internal control environment. Our management believes that these deficiencies, which in the aggregate constitute a material weakness, are due to the small size of our staff, which makes it challenging to maintain adequate disclosure controls.
Changes in internal controls over financial reporting
During the period covered by this Quarterly Report on Form 10-Q, there were no changes in our internal control over financial reporting (as defined in Rule 13(a)-15(f) or 15(d)-15(f)) that occurred during the period covered by this quarterly report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
None.
Certain factors exist which may affect the Company’s business and could cause actual results to differ materially from those expressed in any forward-looking statements. The Company has not experienced any material changes from those risk factors as previously disclosed in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on September 11, 2013 (the “Form 10-K”).
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
All unregistered sales of equity securities have previously been disclosed on our Current Reports on Form 8-K.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
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On March 31, 2014, the Company wrote off the related party receivable balance and accrued interest of $163,829 and $13,553 as well as the due from related party balance of $164,398.
Exhibit Number | Description of Exhibits | |
10.1 | Form of Placement Agent Warrant* | |
10.2 | Lease Agreement (incorporated by reference to the Company’s Form 8-K Filing on May 12, 2014) | |
31.1 | Certification of Chief Executive Officer and Chief Financial Officer as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002* | |
32.2 | Certification of Chief Executive Officer and Chief Financial Officer as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002* | |
101 | The following materials from our Quarterly Report on Form 10-Q for the quarter ended December 31, 2013 formatted in XBRL (eXtensible Business Reporting Language): (i) Balance Sheet, (ii) Statement of Operations, (iii) Statements of Cash Flows, (iv) Statements of Stockholders Equity and (v) related notes to these financial statements, tagged as blocks of text.** |
*Filed herewith
**Furnished herewith
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In accordance with Section 12 of the Securities Exchange Act of 1934, the Registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ANTRIABIO, INC. | ||
By: | /s/ Nevan Elam | |
Nevan Elam | ||
Chief Executive Officer | ||
(Principal Executive Officer | ||
and Principal Financial and Accounting Officer) | ||
Date: | May 14, 2014 |
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