SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
|x||QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934|
For the quarterly period ended September 30, 2017
|¨||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|
|(Exact Name of Registrant as Specified in its Charter)|
|(State of other jurisdiction of incorporation or organization)||(I.R.S. Employer Identification No.)|
|1450 Infinite Drive, Louisville, Colorado||80027|
|(Address of Principal Executive Offices)||(Zip Code)|
|(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 filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
|Large accelerated filer ¨||Accelerated filer ¨|
|Non-accelerated filer ¨||Smaller reporting company x|
|(Do not check if a smaller reporting company)|
|Emerging Growth Company ¨|
If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 17(a)(2)(B) of the Securities 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 November 14, 2017: 53,728,640
TABLE OF CONTENTS
|PART I - FINANCIAL INFORMATION||2|
|ITEM 1. FINANCIAL STATEMENTS||2|
|Consolidated Balance Sheets – September 30, 2017 (unaudited) and June 30, 2017||2|
|Consolidated Statements of Operations - Three months ended September 30, 2017 (unaudited) and 2016 (unaudited)||3|
|Consolidated Statements of Stockholders’ Equity - From June 30, 2017 to September 30, 2017 (unaudited)||4|
|Consolidated Statements of Cash Flows - Three months ended September 30, 2017 (unaudited) and 2016 (unaudited)||5|
|Notes to Consolidated Financial Statements||6|
|ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS||15|
|ITEM 3. QUALITATIVE AND QUANTITATIVE DISCUSSION ABOUT MARKET RISK||17|
|ITEM 4. CONTROLS AND PROCEDURES||17|
|PART II – OTHER INFORMATION||18|
|ITEM 1. LEGAL PROCEEDINGS||18|
|ITEM 1A. RISK FACTORS||18|
|ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS||18|
|ITEM 3. DEFAULTS UPON SENIOR SECURITIES||18|
|ITEM 4. MINE SAFETY DISCLOSURE||18|
|ITEM 5. OTHER INFORMATION||18|
|ITEM 6. EXHIBITS||18|
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.
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS.
Consolidated Balance Sheets
|September 30, 2017||June 30, 2017|
|Other current assets||349,170||442,015|
|Total current assets||4,364,885||4,928,553|
|Fixed assets, net||5,064,604||5,325,401|
|Intangible assets, net||42,499||44,322|
|Deferred lease asset||80,562||86,293|
|Total non-current assets||5,432,006||5,700,357|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||1,568,041||$||1,652,677|
|Convertible notes payable||10,000||10,000|
|Deferred lease liability, current portion||110,765||105,295|
|Warrant derivative liability||246||588|
|Total current liabilities||1,691,814||1,771,322|
|Deferred lease liability, less current portion||274,130||304,575|
|Total non-current liabilities||299,176||329,621|
|Commitments and Contingencies (Note 10)|
|Preferred stock, $0.001 par value; 20,000,000 shares authorized; none issued and outstanding||-||-|
|Common stock, $0.001 par value, 200,000,000 shares authorized; 53,728,640 and 49,228,640 shares issued and outstanding, September 30, 2017 and June 30, 2017||53,730||49,230|
|Additional paid-in capital||78,758,745||72,800,699|
|Total stockholders’ equity||7,805,901||8,527,967|
|Total Liabilities and Stockholders’ Equity||$||9,796,891||$||10,628,910|
See accompanying notes to consolidated financial statements
Consolidated Statements of Operations
|Ended September 30,|
|Research and development|
|Compensation and benefits||$||1,500,864||$||1,303,840|
|Consultants and outside costs||130,361||271,475|
|Material manufacturing costs||426,089||511,707|
|Clinical trial costs||979,766||-|
|Facilities and other costs||502,657||398,907|
|General and administrative|
|Compensation and benefits||1,795,427||866,901|
|General and administrative||327,600||256,596|
|Total operating expenses||6,717,129||3,823,684|
|Loss from operations||(6,717,129||)||(3,823,684||)|
|Other income (expense)|
|Total other income||32,517||7,817|
|Net loss per common share - basic and diluted||$||(0.13||)||$||(0.11||)|
|Weighted average number of common shares outstanding - basic and diluted||52,887,981||35,400,427|
See accompanying notes to consolidated financial statements
Consolidated Statements of Stockholders’ Equity
From June 30, 2017 to September 30, 2017 (Unaudited)
|Common Stock, $0.001 Par Value||Paid-in||Accumulated||Stockholders’|
|Balance at June 30, 2017||49,228,640||$||49,230||$||72,800,699||$||(64,321,962||)||$||8,527,967|
|Stock-based compensation (Unaudited)||-||-||1,507,699||-||1,507,699|
|Fair value of warrants issued (Unaudited)||-||-||14,847||-||14,847|
|Issuance of common stock, net of issuance costs of $60,000 (Unaudited)||4,500,000||4,500||4,435,500||-||4,440,000|
|Net loss for the three months ended September 30, 2017 (Unaudited)||-||-||-||(6,684,612||)||(6,684,612||)|
|Balance at September 30, 2017 (Unaudited)||53,728,640||$||53,730||$||78,758,745||$||(71,006,574||)||$||7,805,901|
See accompanying notes to consolidated financial statements
Consolidated Statements of Cash Flows
|Ended September 30,|
|CASH FLOWS FROM OPERATING ACTIVITIES:|
|Amortization of intangible asset||1,823||1,823|
|Stock-based compensation expense||1,507,699||889,028|
|Changes in operating assets and liabilities:|
|Decrease in other assets||92,845||362|
|Decrease in deferred lease asset||5,731||-|
|Decrease in accounts payable and accrued expenses||(84,636||)||(273,637||)|
|Increase in interest payable||-||500|
|Decrease in deferred lease liability||(24,975||)||(29,462||)|
|Net Cash Used In Operating Activities||(4,905,007||)||(2,968,310||)|
|CASH FLOWS FROM INVESTING ACTIVITIES:|
|Purchase of fixed assets||(5,816||)||(126,956||)|
|Return of security deposit||-||65,933|
|Net Cash Used In Investing Activities||(5,816||)||(61,023||)|
|CASH FLOWS FROM FINANCING ACTIVITIES:|
|Payments on lease payable||-||(23,128||)|
|Proceeds from issuance of equity financing||4,500,000||2,692,399|
|Payment of placement agent compensation and issuance costs||(60,000||)||(336,211||)|
|Net Cash Provided by Financing Activities||4,440,000||2,333,060|
|Net decrease in cash||(470,823||)||(696,273||)|
|Cash - Beginning of Period||4,486,538||4,062,013|
|Cash - End of Period||$||4,015,715||$||3,365,740|
|SUPPLEMENTARY CASH FLOW INFORMATION:|
|Cash Paid During the Period for:|
|Fixed assets acquired through accounts payable and accrued expenses||$||-||$||59,028|
See accompanying notes to consolidated financial statements
Notes to Consolidated Financial Statements
September 30, 2017
Note 1 Nature of Operations
These financial statements represent the consolidated financial statements of AntriaBio, Inc. (“AntriaBio”), 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 clinical stage biopharmaceutical Company.
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 22, 2017, 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, 2017.
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 September 30, 2017 are not necessarily indicative of results for the full fiscal year.
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 impairment of depreciable assets, the fair value of share-based payments and warrants, fair value of derivative instruments, 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. Actual results could differ from those estimates.
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 clinical stage company, including the potential risk of business failure. See Note 3 regarding going concern matters.
Fixed assets are carried at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives.
Research and Development Costs
Research and development costs are expensed as incurred and include salaries, benefits and other staff-related costs; consultants and outside costs; material manufacturing costs, clinical trial costs, license and development payments under third party agreements; and facilities and other costs. These costs relate to research and development costs without an allocation of general and administrative expenses.
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 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 convertible notes payable approximated fair value as of September 30, 2017 and June 30, 2017 due to the relatively short maturity of the respective instruments.
The warrant derivative liability recorded as of September 30, 2017 and June 30, 2017 is recorded at an estimated fair value based on a Black-Scholes pricing model. The warrant derivative liability is a level 3 fair value measurement with the entire change in the balance recorded through earnings. 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, 2017||$||(588||)|
|Total unrealized gains (losses):|
|Included in earnings||342|
|Balance as of September 30, 2017||$||(246||)|
Recent Accounting Pronouncements
In January 2016, the FASB issued ASU 2016-01, Financial Instruments – Overall: Recognition and Measurement of Financial Assets and Financial Liabilities, which addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. ASU 2016-01 will be effective for us starting on July 1, 2018, and early adoption is not permitted. We are currently evaluating the impact that the standard will have on our consolidated financial statements.
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This update requires organizations to recognize lease assets and lease liabilities on the balance sheet and also disclose key information about leasing arrangements. This ASU is effective for annual reporting periods beginning on or after December 15, 2018, and interim periods within those annual periods. Earlier application is permitted for all entities as of the beginning of an interim or annual period. We will be required to adopt ASU 2016-02 starting on July 1, 2019. We are currently evaluating the impact the adoption of this ASU will have on our consolidated financial statements.
In March 2016, the FASB issued ASU 2016-09. Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. The update will affect all entities that issue share-based payment awards to their employees and is effective for annual periods beginning after December 15, 2016 for public entities. The areas for simplification in ASU 2016-09 involve several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. We adopted the ASU starting on July 1, 2017 and there is a minimal impact on our consolidated financial statements.
In May 2017, the FASB issued ASU 2017-9. Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting. The update includes guidance on what changes to share-based payment awards would require modification accounting and is effective for annual periods after December 15, 2017. We expect to adopt the ASU 2017-9 on July 1, 2018. We do not expect the adoption of the new provisions to have a material impact on our financial condition or results of operations.
Note 3 Going Concern
As reflected in the accompanying financial statements, the Company has a net loss of $6,684,612 and net cash used in operations of $4,905,007 for the three months ended September 30, 2017, working capital of $2,673,071 and stockholders’ equity of $7,805,901 and an accumulated deficit of $71,006,574 at September 30, 2017. In addition, the Company is in the clinical stage and has not yet generated any revenues. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
The Company expects that its current cash resources as well as expected lack of operating cash flows will not be sufficient to sustain operations for a period greater than one year from the date these financial statements were available for issuance. The ability of the Company to continue its operations is dependent on Management’s plans, which include continuing to raise capital through equity or debt based financings. There can be no assurances that such capital will be available to us on acceptable terms, or at all.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. These financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern.
Note 4 Fixed Assets
The following is a summary of fixed assets and accumulated depreciation:
|Life||September 30, 2017||June 30, 2017|
|Furniture and fixtures||5 - 7 years||$||118,450||$||118,450|
|Lab equipment||3 - 15 years||3,951,855||3,946,040|
|Leasehold Improvements||5 - 7 years||3,247,038||3,247,038|
|Less: accumulated depreciation and amortization||(2,252,739||)||(1,986,127||)|
Depreciation expense was $266,613 and $268,355 for the three months ended September 30, 2017 and 2016, respectively.
Note 5 Related Party Transactions
During the three months ended September 30, 2017, the Company incurred no related party transactions. During the three months ended September 30, 2016, the Company incurred investor relation expenses of $36,225 for services performed by a related party. As of September 30, 2017 and June 30, 2017, there were none and $25,200, respectively, related party expenses recorded in accounts payable and accrued expense – related party.
Note 6 Convertible Notes Payable
As of September 30, 2017 and June 30, 2017, the convertible note outstanding balance was $10,000 and $10,000, respectively. As of September 30, 2017, the outstanding convertible note has matured and payment is due. The convertible note which has not been repaid or converted continues to accrue interest at a rate of 8%.
Note 7 Shareholders’ Equity
During the year ended June 30, 2017, the Company closed private placement transactions in which the Company issued 5,783,184 units to accredited investors. Each investor was issued either Class A Units or Class B units of the Company. Each Class A Unit received one share of common stock and one-half of one common share purchase warrant. If the investor had previously invested in the Company they were eligible for a Class B Unit which received one share of common stock and one common share purchase warrant. Each common share purchase warrant is exercisable at $1.65 per share and will expire 60 months following the issuance. As of June 30, 2017, the Company received net proceeds of approximately $5.2 million after the placement agent compensation and issuance costs paid of $683,194 and $516,550 of warrant expense recorded as issuance costs.
The Company also entered into a private placement transaction in which the Company issued common stock to accredited investors at an offering price of $1.00 per share. As of June 30, 2017, the Company received net proceeds of approximately $8.1 million after the placement agent compensation of $186,671 of warrant expense recorded as issuance costs, as there was no placement agent compensation.
During the three months ended September 30, 2017, the Company closed an additional private placement transaction in which the Company issued common stock to accredited investors at an offering price of $1.00 per share. The Company received net proceeds of $4.44 million after the placement agent compensation of $60,000.
The Company has not declared or paid any dividends or returned any capital to common stockholders as of September 30, 2017, nor do we intend to do so in the foreseeable future.
Note 8 Stock-Based Compensation
Options – 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. The Company had granted 3,295,000 of these shares to current employees and directors of the Company as of June 30, 2016 and no additional grants as of September 30, 2017. The options have an exercise price from $1.29 to $3.44 per share. The options vest monthly over four years, with some options subject to a one year cliff before options begin to vest monthly.
On February 23, 2015, the Company adopted the AntriaBio, Inc. 2015 Non Qualified Stock Option Plan which allows the Company to issue up to 6,850,000 of common stock in the form of stock options. The Company had granted 4,487,000 of these shares to current employees and directors of the Company as of June 30, 2017 and no additional grants as of September 30, 2017. The options have an exercise price of from $1.00 to $2.06 per share. The options vest monthly over 4 years with some options subject to a one year cliff before options begin to vest monthly.
On October 31, 2016, the Board adopted the AntriaBio, Inc. 2016 Non Qualified Stock Option Plan which allows the Company to issue up to 35,000,000 shares of common stock in the form of stock options. The 2016 Non Qualified Stock Option Plan was amended on August 21, 2017 to reduce the number of shares to be issued to 15,000,000 shares of common stock in the form of stock options. The Board had issued options to purchase 28,995,000 of these shares to current employees and directors as of June 30, 2017, of which 4,360,000 were cancelled before their terms were established and 11,090,000 were additionally cancelled by the Board during the year ended June 30, 2017. The Company had 1,550,000 of the cancelled stock options that had begun vesting prior to the cancellation and with the cancellation the Company recorded $1,199,847 of unrecognized stock compensation expense. The Company had granted 135,000 of these shares to current employees and directors of the Company as of September 30, 2017. The options have an exercise price from $1.00 to $1.20 per share. The options expire no later than ten years from the date of the grant. The options vest on a monthly basis over 48 months, except for 100,000 of the options which do not begin to vest until specific events have occurred and then begin to vest over 48 months and 50,000 of the options that all vest at the end of a consulting contract. Some options are subject to a one year cliff and all options have an exercise price based on the fair value of the common stock on the date of grant.
AntriaBio has computed the fair value of all options granted that have begun vesting using the Black-Scholes option pricing model. The options that require specific events before they begin to vest are not valued until the specific event has occurred. 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 comparable published volatility of several peer companies. Due to the small number of option holders and all options being to officers, directors or high level employees, AntriaBio has estimated a forfeiture rate of zero as the value of each option holder is calculated individually. 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.
AntriaBio has computed the fair value of all options granted during the three months ended September 30, 2017 using the following assumptions:
|Risk free interest rate||2.00%|
|Expected term (years)||7|
Stock option activity is as follows:
|Options||Exercise Price||Contractual Life|
|Outstanding, June 30, 2017||21,290,751||$||1.65||7.7|
|Outstanding, September 30, 2017||21,400,751||$||1.65||7.5|
|Exercisable at September 30, 2017||7,815,876||$||2.21||6.3|
Stock-based compensation expense related to the fair value of stock options was included in the statement of operations as research and development – compensation and benefits expense of $298,955 and $304,969 and as general and administrative – compensation and benefits expense of $1,208,744 and $584,059 for the three months ended September 30, 2017 and 2016, respectively. The unrecognized stock-based compensation expense at September 30, 2017 is $10,268,075. AntriaBio determined the fair value as of the date of grant using the Black-Scholes option pricing method and expenses the fair value ratably over the vesting period.
Warrants – AntriaBio issued warrants to agents in conjunction with the closing of various financings and issued warrants in private placements as follows:
|Warrants||Exercise Price||Contractual Life|
|Outstanding, June 30, 2017||32,796,448||$||1.71||3.7|
|Outstanding, September 30, 2017||32,771,448||$||1.71||3.5|
For the Three Months Ended September 30, 2017: The Company had warrants to purchase 25,000 shares of common stock expire as of September 30, 2017.
The warrants exercisable for 16,667 shares of common stock at September 30, 2017 are accounted for under liability accounting. The fair value as of September 30, 2017 and June 30, 2017 were $246 and $588, respectively which is reflected as a liability with the fair value adjustment recorded as derivative gains or losses on the consolidated statements of operations.
The warrants exercisable for the 250,000 shares of common stock are accounted for under the equity method of accounting and are fair valued monthly at the date that the warrants vest. As of June 30, 2017, warrants to purchase 15,624 shares of common stock had vested and $12,564 had been recorded into equity and investor relations expense. As of September 30, 2017, warrants to purchase an additional 15,624 shares of common stock had vested and $14,847 had been recorded into equity and investor relations 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 comparable published volatilities of several peer companies. 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 for the warrant values calculated for the three months ended September 30, 2017 were as follows:
|Expected volatility||52% - 84%|
|Risk free interest rate||1.47% - 2.35%|
|Warrant term (years)||2 - 10|
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 three months ended September 30, 2017, the Company did not record any income tax provision due to expected future losses and full valuation allowance on its deferred tax assets.
Note 10 Commitments and Contingencies
Lease Commitments – In May 2014, the Company entered into a lease of approximately 27,000 square feet of office, laboratory and clean room space to be leased for seventy-two months. The lease requires monthly payments of $28,939 adjusted annually by approximately 3% plus triple net expenses monthly of $34,381 adjusted annually. The Company also made a security deposit of $750,000 which is held by the landlord, of which $375,000 has been returned to the Company and the remaining balance will be returned gradually over the next several years.
On March 17, 2017, the Company entered into a lease of approximately 20,000 square feet of office space to be leased for eighty-two months. The lease requires monthly payments of $28,425 adjusted annually plus triple net expenses monthly of $28,410 adjusted annually. The Company also made a security deposit of $56,851 which will be returned at the end of the lease.
On March 17, 2017, the Company sub-leased their original approximately 10,000 square feet of office space to another company. The sublease is for eighty-two months unless the Company is unable to extend our current lease then the sub-lease will expire on March 31, 2020. The Company is to receive monthly payments of $12,523 adjusted annually plus triple net expenses monthly of $12,828 adjusted annually. The Company also received a security deposit of $25,046 which will be returned at the end of the lease.
As of September 30, 2017, the minimum rental commitment under the leases are as follows:
|Operating Leases||Sub-lease Income||Total|
|Year Ending June 30,|
License Agreements – On August 4, 2017, the Company entered into a Development and License Agreement (“License Agreement”) with ActiveSite Pharmaceuticals, Inc. (“ActiveSite”) pursuant to which the Company acquired the rights to ActiveSite’s Plasma Kallikrein Inhibitor program (“PKI Program”). The Company desires to use the PKI Program to develop, file, manufacture, market and sell products for diabetic macular edema and other human therapeutic indications. The Company was required to make an upfront payment of $750,000 payable within five (5) days of the date of the parties executed the License Agreement. The Company is required to pay up to an additional aggregate of $36.5 million in development and regulatory milestone payments if certain clinical study objectives and regulatory filings, acceptances and approvals are achieved. In addition, we are required to pay up to an aggregate of $10.0 million in sales milestone payments if certain annual sales targets are achieved.
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 September 30, 2017, 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.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
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.
It is imperative that we raise capital in Q4 of calendar year 2017 or early in 2018 in order to sustain our operations including continuing our ongoing Phase 1 first-in-human clinical study of our lead product candidate, AB101, a once-weekly injectable basal insulin for patients with Type 1 and Type 2 diabetes mellitus (“Study”). The Study is a first-in-human single ascending dose study to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of AB101 in patients with Type 1 Diabetes Mellitus. In Q4 of calendar year 2017, we completed the first of up to five potential cohorts of the Study and having conducted the interim safety and dose escalation review meeting from that cohort, we plan on proceeding to a higher dose in the second cohort as planned per protocol. However, we will not begin dosing patients in the second cohort until we have raised additional capital. Further, as our clinical study is ongoing and we have not dose escalated beyond the first cohort, we do not anticipate announcing any results with respect to the Study until next year. We anticipate that our capital raising activities may include the issuance of equity or debt securities, obtaining credit facilities, or other financing mechanisms.
Our next strategic objective is to advance potential clinical candidates from our kallikrein inhibitor portfolio. Specifically, on October 17, 2017 we announced two preclinical kallikrein programs including AB402 to treat diabetic macular edema and AB602 to treat hereditary angioedema. We are currently taking steps to prepare both programs for clinical studies with the objective of filing an IND for AB402 in Q4 of calendar year 2018 and in Q1 of calendar year 2019 for AB602.
The Company is targeting another total raise of at least $15 million, which will allow us to sustain operations through the end of calendar year 2018. In addition to funding the ongoing Study, the additional funding will allow us to advance our pipeline and cover general and administrative expenses. The Company has also been actively conducting animal studies to screen potential new product candidates as we seek to evolve our drug pipeline.
No assurance can be given that the Company will be successful in its efforts in raising additional capital. Further, if the Company is unsuccessful, the lack of funding will materially and adversely impact the Company’s business and prospects. In particular, our ability to raise additional capital is substantially dependent upon results from the Study and in the event that such results fail to meet or exceed expectations, we may not be able to attract additional capital to support the continuation of the program or overall operations.
Even if we are able to raise additional capital, it is possible that we could incur unexpected costs and expenses or experience unexpected cash requirements that would force us to seek alternative financing. Furthermore, if we issue additional equity or debt securities, existing holders of our securities may experience additional dilution or the new equity securities may have rights, preferences or privileges senior to those of existing holders of our securities.
Significant Accounting Policies and Estimates
Our consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. On an on-going basis, management evaluates its estimates and judgments, including those related to the estimated useful lives and impairment of depreciable assets, the fair value of share-based payments and warrants, fair value of derivative instruments, income tax valuation allowances and contingencies. Management bases its estimates and judgments on historical experience and on various factors that are believed to be reasonable under the circumstance, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The methods, estimates, and judgments used by us in applying these most critical accounting policies have a significant impact on the results we report in our consolidated financial statements.
Results of Operations
For Three Months Ended September 30, 2017 and 2016
Results of operations for the three months ended September 30, 2017 (the “2018 quarter”) and the three months ended September 30, 2016 (the “2017 quarter”) reflected losses of approximately $6,685,000 and $3,816,000, respectively.
We are a clinical stage company and have not generated any revenues since inception.
Research and development costs include salaries, benefits and other staff-related costs; consultants and outside costs; material manufacturing costs; and facilities and other costs. Research and development costs were approximately $4,311,000 in the 2018 quarter compared to $2,486,000 in the 2017 quarter. The main increase is due to the Company acquiring the license from ActiveSite as well as the costs related to our clinical study that has begun for AB101.
General and administrative costs were approximately $2,406,000 in the 2018 quarter compared to $1,338,000 in the 2017 quarter. The general and administrative costs have remained fairly consistent in the 2018 quarter except for compensation and benefits which has increased for the additional stock options that have been granted.
Liquidity and Capital Resources
As of September 30, 2017, we have approximately $4.0 million in cash on hand and working capital of approximately $2.7 million. During the year ended June 30, 2017, we closed on an equity transaction in which we issued units consisting of one share of common stock and a warrant to purchase either one-half or one share of common stock. During the year ended June 30, 2017, we also closed on an equity transaction in which we issued straight shares of common stock. During the three months ended September 30, 2017, we had an additional close on an equity transaction in which we issued straight shares of common stock.
The Company received net proceeds of approximately $14 million from the transactions above. While we do have cash on hand, we anticipate that we will need an additional $15 million to cover operating expenses, continuing clinical trials of AB101 and continuing research and development of our product pipeline through the calendar year end 2018. We are currently evaluating raising additional capital to fund our current and future operations.
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
See Note 2 to the consolidated financial statements included in this Form 10-Q regarding the impact of certain accounting pronouncements on our 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.
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 Chief Accounting Officer (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 September 30, 2017 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, a need for a stronger internal control environment, and minimal review of complex accounting issues. 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.
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
ITEM 1A. RISK FACTORS.
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 22, 2017 (the “Form 10-K”).
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
ITEM 4. MINE SAFETY DISCLOSURES.
ITEM 5. OTHER INFORMATION.
ITEM 6. EXHIBITS.
|Description of Exhibits|
|31.1||Certification of Chief Executive Officer as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*|
|31.2||Certification of Chief Accounting Officer as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*|
|32.1||Certification of Chief Executive Officer as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*|
|32.2||Certification of Chief Accounting 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 September 30, 2017 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*|
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.
|Date: November 14, 2017||By:||/s/ Nevan Elam|
|Chief Executive Officer|
|(Principal Executive Officer)|
|Date: November 14, 2017||By:||/s/ Morgan Fields|
|Chief Accounting Officer|
|(Principal Accounting Officer)|