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EX-32.2 - EXHIBIT 32.2 - Medisun Precision Medicine Ltd.ex32_2apg.htm
EX-32.1 - EXHIBIT 32.1 - Medisun Precision Medicine Ltd.ex32_1apg.htm
EX-31.2 - EXHIBIT 31.2 - Medisun Precision Medicine Ltd.ex31_2apg.htm
EX-31.1 - EXHIBIT 31.1 - Medisun Precision Medicine Ltd.ex31_1apg.htm



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, 2017


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: 000-54907


ACCUREXA INC.

(Exact name of registrant as specified in its charter)


Marshall Islands

47-2999657

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification No.)

Trust Company Complex, Ajeltake Road

Majuro, Marshall Islands MH 96960

(Address of principal executive offices, including Zip Code)

 

(929) 314-3718

(Registrant’s telephone number, including area code)


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 (§ 229.405 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, or a smaller reporting company.  See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer

[   ]

Accelerated filer

[   ]

Non-accelerated filer

[   ] (Do not check if a smaller reporting company)

Smaller reporting company

[X]



Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).

[   ] Yes

[X] No


APPLICABLE ONLY TO CORPORATE ISSUERS:


Indicate the number of shares outstanding of each of the issuer’s classes of stock, as of the latest practicable date.


Class

Outstanding as of May 12, 2017

Common stock, $0.0001 par value

19,398,954

Convertible preferred stock, $0.0001 par value

1,625





2




 

TABLE OF CONTENTS


PART I – FINANCIAL INFORMATION

 

4

Item 1.

Financial Statements

 

4

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

13

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

15

Item 4.

Controls and Procedures

 

16

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.

Exhibits

 

19

SIGNATURES

 

 

20




3







PART I – FINANCIAL INFORMATION


ITEM 1. FINANCIAL STATEMENTS


ACCUREXA INC.

 

 

 

 

 

 

 

 

 

INDEX TO INTERIM FINANCIAL STATEMENTS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Page

 

 

 

 

 

 

 

 

 

Index to Interim Financial Statements

 

 

 

 

4

 

 

 

 

 

 

 

 

 

Condensed Interim Balance Sheets at March 31, 2017 and December 31, 2016

5

 

 

 

 

 

 

 

 

 

Condensed Interim Statements of Operations for the three months ended March 31, 2017 and 2016

6

 

 

 

 

 

 

 

 

 

Condensed Interim Statements of Cash Flows for the three months ended March 31, 2017 and 2016

7

 

 

 

 

 

 

 

 

 

Notes to Condensed Interim Financial Statements

8




4








ACCUREXA INC.

Condensed Interim Balance Sheets

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

March 31,

2017

 

December 31,

2016

 

 

 

 

 

 

 

 

ASSETS

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

544,530 

$

1,336,937 

 

    Total current assets

 

 

544,530 

 

1,336,937 

Prepaid assets

 

 

152,131 

 

260,086 

Intangible assets

 

 

1,006,560 

 

1,025,393 

Fixed assets, net

 

 

112,776 

 

123,445 

 

    Total assets

 

$

1,815,998 

$

2,745,861 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

Accounts payable and other accruals

 

$

$

39,784 

 

Convertible notes - current, net of unamortized debt discount

 

 

18,079 

 

498,820 

 

    Total current liabilities

 

 

18,079 

 

538,604 

 

    Total liabilities

 

 

18,079 

 

538,604 

Commitments and contingencies

 

 

 

 

 

STOCKHOLDERS' EQUITY

 

 

 

 

 

 

Convertible preferred stock

 

 

 

 

 

 

 

Authorized 2,000,000 shares at par value of $0.0001 and with a stated value of $1,000

 

 

 

 

 

 

 

Issued and outstanding 1,625 shares as of March 31, 2017 and as of December 31, 2016

 

 

 

 

Common stock

 

 

 

 

 

 

 

Authorized 20,000,000 shares at par value of $ 0.0001 each

 

 

 

 

 

 

 

Issued and outstanding 9,398,954 shares as of March 31, 2017 and 9,198,954 shares as of December 31, 2016

 

 

940 

 

920 

 

Additional paid-in capital

 

 

14,228,466 

 

14,172,486 

 

Accumulated deficit

 

 

(12,431,488)

 

(11,966,149)

 

 

Total stockholders' equity

 

 

1,797,918 

 

2,207,256 

 

 

 

 

 

 

 

 

 

Total liabilities and stockholders' equity

 

$

1,815,998 

$

2,745,861 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these financial statements.





5








ACCUREXA INC.

Condensed Interim Statements of Operations

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months

Ended

March 31, 2017

 

Three Months

Ended

March 31, 2016

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

$

 

 

 

 

 

 

 

 

 

 

Operating Expenses

 

 

 

 

 

 

 

Depreciation and Amortization Expense

 

 

29,502 

 

10,668 

 

 

Research & Development

 

 

439,930 

 

163,806 

 

 

General and Administrative

 

 

145,224 

 

141,534 

 

Total Operating Expenses

 

 

614,656 

 

316,008 

 

 

 

 

 

 

 

 

 

 

Loss from Operations

 

 

(614,656)

 

(316,008)

 

 

 

 

 

 

 

 

 

 

Interest Income (Expense)

 

 

(35,758)

 

(25,274)

 

Gain from extinguishment of debt

 

 

185,076 

 

 

Loss before provisions for income taxes

 

 

(465,338)

 

(341,282)

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

 

 

 

Net Loss

 

$

(465,338)

$

(341,282)

 

 

 

 

 

 

 

 

 

 

Loss per common share - basic and fully diluted:

 

$

(0.05)

$

(0.04)

 

 

 

 

 

 

 

 

 

 

Weighted average number of basic and fully diluted common shares outstanding

 

 

9,349,516 

 

8,101,272 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these financial statements.




6








ACCUREXA INC.

Condensed Interim Statements of Cash Flows

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

Three Months

Ended

 March 31, 2017

 

Three Months

Ended

March 31, 2016

 

 

 

 

 

 

 

Cash flows from operations:

 

 

 

 

 

Loss from continuing operations

$

(465,338)

$

(341,282)

 

Adjustment to reconcile net loss to net cash used in operating activities:

 

 

 

 

Depreciation and amortization

 

29,502 

 

10,668 

 

 

Amortization of non-cash expenses

 

156,840 

 

234,458 

 

 

Amortization of discount on convertible notes

 

34,335 

 

18,329 

 

 

Gain on debt extinguishment

 

(185,076)

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts payable and other accruals

 

(19,785)

 

14,802 

 

 

Prepaid assets

 

7,115 

 

 

 

 

 

 

 

 

Net cash used in operations

 

(442,407)

 

(63,024)

 

 

 

 

 

 

 

Investment activities:

 

 

 

 

 

Investment in fixed assets

 

 

Net cash used in investment activities

 

 

 

 

 

 

 

 

 

Financing activities:

 

 

 

 

 

Repayment of convertible note

 

(350,000)

 

Net cash provided by financing activities

 

(350,000)

 

 

 

 

 

 

 

 

Net (decrease) / increase in cash

 

(792,407)

 

(63,024)

 

 

 

 

 

 

 

Cash, beginning of period

 

1,336,937 

 

1,811,871 

Cash, end of period

$

544,530 

$

1,748,847 

 

 

 

 

 

 

 

Non-cash investing and financing activities:

 

 

 

 

Debt settlement

 

200,000 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these financial statements.





7




ACCUREXA INC.

Notes To Interim Financial Statements

 (Unaudited)




1 - INTERIM FINANCIAL STATEMENTS


The accompanying interim financial statements have been prepared by the Company without audit.  In the opinion of management, all adjustments (which include only normal recurring adjustments) necessary to present fairly the financial position, results of operations, and cash flows at March 31, 2017, and for all periods presented herein, have been made.


Certain information and 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.  It is suggested that these interim financial statements be read in conjunction with the financial statements and notes thereto included in the Company's December 31, 2016 audited financial statements. The results of operations for the period ended March 31, 2017 are not necessarily indicative of the operating results for the full year.


2 - GOING CONCERN


The Company's financial statements are prepared using generally accepted accounting principles in the United States of America applicable to a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company has not yet established an ongoing source of revenues sufficient to cover its operating costs and allow it to continue as a going concern. The ability of the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund operating losses until it becomes profitable. If the Company is unable to obtain adequate capital, it could be forced to cease operations.


In order to continue as a going concern, the Company will need, among other things, additional capital resources. Management's plan is to obtain such resources for the Company by obtaining capital from management and significant shareholders sufficient to meet its minimal operating expenses and seeking equity and/or debt financing. However, management cannot provide any assurances that the Company will be successful in accomplishing any of its plans.


The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish the plans described in the preceding paragraph and eventually secure other sources of financing and attain profitable operations. The accompanying financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.


3 – SIGNIFICANT ACCOUNTING POLICIES


Use of Estimates

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  Actual results could differ from those estimates.


Recent Accounting Pronouncements

Management has considered all recent accounting pronouncements issued since the last audit of our financial statements. The Company’s management believes that these recent pronouncements will not have a material effect on the Company’s financial statements.




8




ACCUREXA INC.

Notes To Interim Financial Statements

 (Unaudited)




Cash and Cash Equivalents

Cash equivalents comprise of certain highly liquid instruments with a maturity of three months or less when purchased.  


4 – PREPAID ASSETS


On February 18, 2015, the Company entered into a consulting agreement (“Agreement”) with the Capital Communications Group (“Consultant”) under which the Consultant assists the Company in its efforts to gain greater recognition and awareness among relevant investors in the public capital markets on a non-exclusive basis.  In connection with the Agreement, the Company issued a four-year Warrant (“Warrant”) to the Consultant under which the Consultant is entitled to purchase from the Company up to 200,000 shares of the Company’s Common Stock (“Warrant Shares”) at an exercise price of $0.50 per Share (“Exercise Price”).  The Warrant is exercisable, in whole or in part, during the term commencing on the issuance date of the Warrant on February 18, 2015 and ending on February 18, 2019 (the “Exercise Period”).  The 200,000 Warrant Shares are valued at $527,500 based on the Black-Scholes formula and are amortized on a straight-line basis over the 24-month term of the Agreement.


5 – INTANGIBLE ASSETS


On August 11, 2015 (“Effective Date”), the Company entered into an exclusive license agreement (“ACL License”) with Accelerating Combination Therapies LLC (“ACL”) in regards to the exclusive licensing of the issued U.S. Patent No. 8,895,597 B2 Combination of Local Temozolomide with Local BCNU (“Patent Rights”).  Under the ACL License, the Company paid ACL a license issue fee of 1,000,000 shares of the Company’s common stock. The 1,000,000 shares of common stock are valued at $1.13 per share, equal to the publicly traded share price on the Effective Date, are capitalized in the amount of $1,130,000, and amortized over an expected patent life of 15 years.


6 – FIXED ASSETS


The Company has purchased equipment to support the development of its prototype device which are capitalized in the amount of $112,776 as fixed assets on the Company’s balance sheet.  The equipment is amortized on a straight-line basis over 5 years.


7- CONVERTIBLE NOTES


On July 25, 2013, the Company entered into a secured convertible note (“Note”) under which the Company received $350,000 from the convertible note holder (“Holder”) and is obligated to pay to the Holder the full principal amount after 36 months from the date of the Note, plus an interest at the rate of 10.0% per year payable at the end of each year from the date of the Note.  The Note was extended for 12 months on July 25, 2016.  The Holder has the right to convert the Note, in whole or in part, into shares of common stock of the Company (“Common Stock”) at a fixed rate of $0.50 per share (the “Conversion Price”) at any time.  The Company may prepay the Note in whole or in part at any time for cash.  The Company prepaid the Note in whole on January 24, 2017.  The Note agreement was filed on August 14, 2013 as an exhibit to Form 10-Q for the three months ended June 30, 2013.


On July 15, 2014, the Company entered into a secured convertible note (“Note”) under which the Company received $20,000 from the convertible note holder (“Holder”) and is obligated to pay to the Holder the full principal amount after 36 months from the date of the Note.  The Holder has the right to convert the Note, in whole or in part, into shares of common stock of the Company (“Common Stock”) at



9




ACCUREXA INC.

Notes To Interim Financial Statements

 (Unaudited)




a "Variable Conversion Price" of 50% multiplied by the Market Price (representing a discount rate of 50%). “Market Price” means the average of the Closing Trading Prices for the Common Stock during the ten (10) Trading Day period ending on the latest complete Trading Day prior to the Conversion Date. The Company may prepay the Note in whole or in part at any time for cash on 15 business days’ prior written notice, subject to the right of the Holder to convert into shares of Common Stock of the Company prior to any prepayment. The Company has determined the value associated with the beneficial conversion feature in connection with the notes to be $20,000. The aggregate beneficial conversion feature was accreted and charged to interest expense in the amount of $1,667 as of March 31, 2017, and will be amortized until July 15, 2017.  


On January 12, 2015, the Company and the Lim Development Group (“Consultant”) entered into a consulting agreement (“Agreement”).  Under the Agreement, the Company also issued a promissory note (“Note”) in the amount of $200,000 and at an interest rate of 5.00% per annum to the Consultant.  The Note was fully assumed by CNMRGS Inc. under the sublicense agreement that the Company entered with CNMRGS Inc. on January 31, 2017.  A full description of the sublicense agreement was filed as exhibit 10.21 to the Form 8-K as of February 3, 2017.


8 – CONVERTIBLE PREFERRED STOCK


On June 22, 2015, the Company closed a private placement of 2,250 shares of the Company's convertible preferred stock for gross proceeds to the Company of $2,250,000 and net proceeds of $1,993,500.  The convertible preferred stock is convertible into shares of common stock of the Company at a conversion price of $1.25 per share. The Preferred Stock has no dividend rights or liquidation preference. If dividends are declared on the Common Stock, the holders of the Preferred Stock shall be entitled to participate in such dividends on an as-converted-to-common stock basis. The Company recorded a beneficial conversion feature of $1,980,000 based on the fair value of the common stock and the conversion rate as of the date of the offering.  This amount was recorded as a deemed distribution during the period of the offering.  


9 - WARRANTS


In connection with the private placement of 2,250 shares of the Company's convertible preferred stock on June 22, 2015, we issued to the investors warrants to purchase up to 1,800,000 shares of common stock. The warrants have an exercise price of $1.50 per share and are exercisable for 4 years. We also issued an aggregate of 162,000 warrants that were similar to the warrants issued to investors and are exercisable at $1.50 per share for 4 years, to our placement agent and its designees.


The following is a summary of the status of all of the Company’s stock warrants as of March 31, 2017 and changes during the periods ended on that date:


 

Number

of Warrants

 

Weighted-Average

Exercise Price

Outstanding at January 1, 2017

2,162,000

 

$     1.41

Granted

-

 

$     0.00

Exercised

-

 

$     0.00

Cancelled

-

 

$     0.00

Outstanding at March 31, 2017

2,162,000

 

$     1.41

Warrants exercisable at March 31, 2017

2,162,000

 

$     1.41



10




ACCUREXA INC.

Notes To Interim Financial Statements

 (Unaudited)







10 - FORM S-1 REGISTRATION STATEMENT


On July 6, 2015, the Company filed a Form S-1 registration statement that relates to the offer and resale of up to 3,762,000 shares of the Company’s common stock, par value $0.0001 per share, by the selling stockholders (“Selling Stockholders”) listed in the Form S-1 registration statement (“Selling Stockholders”), issuable to such stockholders upon the conversion of shares of the Company’s preferred stock or exercise of an aggregate of 1,800,000 warrants which the Company sold to investors in a private placement, or exercise of an aggregate of 162,000 warrants which the Company issued to its placement agent. In that private placement the Company sold an aggregate of 2,250 shares of its Series A convertible preferred stock, par value $0.0001 per share (“Preferred Stock”) for gross proceeds to the Company of $2,250,000. Each share of the Preferred Stock is convertible into 800 shares of the Company’s common stock (“Common Stock”) which results in an effective conversion price of $1.25 per share. The Preferred Stock has no dividend rights or liquidation preference. If dividends are declared on the Common Stock, the holders of the Preferred Stock shall be entitled to participate in such dividends on an as-converted-to-common stock basis. In addition, in the private placement the Company issued to the investors warrants (“Investor Warrants”) to purchase up to 1,800,000 shares of Common Stock. The Warrants have an exercise price of $1.50 per share and are exercisable through June 21, 2019. The shares of the Company’s common stock issuable on exercise of the Investor Warrants are registered under the Company’s Form S-1. H.C. Wainwright & Co., LLC (“Placement Agent”) acted as the exclusive placement agent for the placement of the Company’s Preferred Stock and Investor Warrants.  The Placement Agent purchased securities in the offering on the same terms and conditions as the other investors.  In addition, the Placement Agent and its designees received an aggregate of 162,000 warrants to purchase the Company’s common stock at a price of $1.50 per share through June 21, 2019 (“Agent Warrants”).  The shares underlying the Agent Warrants are registered under the Company’s Form S-1. The Company will not receive any proceeds from the sale of shares sold by the Selling Stockholders or from the conversion of Preferred Stock.  However, the Company will receive proceeds of $1.50 per share upon the exercise of any Investor Warrants or Agent Warrants.  The Company’s Form S-1 registration statement became effective on August 10, 2015.


On August 11, 2015, the Selling Stockholders converted an aggregate of 375 convertible preferred stock into 300,000 shares of common stock that were issued by the Company to the Selling Stockholders.


On September 1, 2015, the Placement Agent converted an aggregate of 250 convertible preferred stock into 200,000 shares of common stock that were issued by the Company to the Placement Agent.


11 - SUBSEQUENT EVENTS


Resignations


On April 18, 2017, Bryan Lee, PhD resigned as President & Chief Executive Officer, and Director of the Company’s Board, effective immediately.  Mr. Lee’s resignation does not arise from any disagreement on any matter relating to the Company’s operations, policies or practices, or regarding the general direction of the Company.


On April 18, 2017, Mr. Stefan Moll resigned as Chief Financial Officer, effective immediately. Mr. Moll’s resignation does not arise from any disagreement on any matter relating to the Company’s operations, policies or practices, or regarding the general direction of the Company.



11




ACCUREXA INC.

Notes To Interim Financial Statements

 (Unaudited)




On April 18, 2017, Mr. Oliver Jackson resigned as Director of the Company’s Board, effective immediately.  Mr. Jackson’s resignation does not arise from any disagreement on any matter relating to the Company’s operations, policies or practices, or regarding the general direction of the Company.


Appointments


On April 18, 2017, the Board of Directors of the Company appointed Ms. Sophia Yaqi Sun as President & Chief Executive Officer, Chief Principal Officer and Director of the Company’s Board, effective immediately.  Ms. Sun (age 35) is the Senior Vice President of Medisun Holdings Limited (“Medisun”, together with its subsidiaries and its affiliated companies, collectively, the “Medisun Group”), and the Vice President of National Investments Fund Limited (“NIF”).  The Medisun Group is a group of companies principally engaged in medical and healthcare related businesses, and is committed to stem cell regenerative and precision medicine industry investments and the commercialization of regenerative and precision medicine technologies.  NIF is a company incorporated in the Cayman Islands, the shares of which are listed on the Main Board of The Stock Exchange of Hong Kong Limited.  Prior to joining Medisun and NIF, Ms. Sun has worked for Ernest & Young LLP in Beijing and San Francisco, leading audit teams in financial auditing, bad debt evaluation, merger acquisition due diligence for commercial banks.  Ms. Sun has obtained her Bachelor’s degree at University of International Business and Economics in the People’s Republic of China, and her Master of Business Administration degree at the University of Illinois.


On April 18, 2017, the Board of Directors of the Company appointed Ms. Lisha Huang as Director of the Company’s Board, effective immediately.  Ms. Huang (age 57) has been a Director of Medisun Holdings Limited and Medisun Group companies since 2014. Prior, Ms. Huang was an Excutive Director of New Sakai Hong Kong Limited, a company incorporated in Hong Kong.


Entry into a Material Definitive Agreement


On April 18, 2017, the Company entered into a license agreement under which Medisun Holdings Limited (“Medisun”) granted a non-exclusive licence (the “Licence”) (including access to Medisun’s clinical network facilities in the Greater China) to use Medisun’s NK (Natural Killer) cell technology to Accurexa for 10 years (the “Term”) in the United States and the Greater China (People’s Republic of China, Hong Kong, the Macau Special Administrative Region and Taiwan). Medisun has developed its NK cell technology for the treatment of cancer. The NK cell technology is currently clinically used to treat cancer patients at Medisun’s network clinical facilities. The Licence includes Medisun’s provision of relevant technical advice and support from time to time required by Accurexa during the Term. In exchange for the License, Accurexa issued 10,000,000 shares of the Company’s common stock to Medisun. These shares were issued pursuant to Regulation D under the Securities Act of 1933, as amended, are exempt from registration by reason of Section 4(2) of the Securities Act of 1933, as amended (the “Act”), and bear an appropriate restrictive legend.




12







ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION


Forward Looking Statements


This quarterly report on Form 10-Q and other reports that we file with the SEC contain statements that are considered forward-looking statements.  Forward-looking statements give the Company’s current expectations, plans, objectives, assumptions or forecasts of future events.  All statements other than statements of current or historical fact contained in this quarterly report, including statements regarding the Company’s future financial position, business strategy, budgets, projected costs and plans and objectives of management for future operations, are forward-looking statements.  In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “plans,” “potential,” “projects,” “ongoing,” “expects,” “management believes,” “we believe,” “we intend,” and similar expressions.  These statements are based on the Company’s current plans and are subject to risks and uncertainties, and as such the Company’s actual future activities and results of operations may be materially different from those set forth in the forward-looking statements.  Any or all of the forward-looking statements in this periodic report may turn out to be inaccurate and as such, you should not place undue reliance on these forward-looking statements.  The Company has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs.  The forward-looking statements can be affected by inaccurate assumptions or by known or unknown risks, uncertainties and assumptions due to a number of factors, including:


·

dependence on key personnel;

·

competitive factors;

·

degree of success of clinical trials and research and development programs;

·

the operation of our business; and

·

general economic conditions in the United States and Worldwide.


These forward-looking statements speak only as of the date on which they are made, and except to the extent required by federal securities laws, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events.  In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.  All subsequent written and oral forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by the cautionary statements contained in this periodic report.


Use of Terms


Except as otherwise indicated by the context and for the purposes of this report only, references in this report to:


·

“Accurexa”, “the “Company,” “we,” “us,” or “our,” are to the business of Accurexa Inc., a Delaware corporation;

·

“SEC” are to the Securities and Exchange Commission;

·

“Securities Act” are to the Securities Act of 1933, as amended;

·

“Exchange Act” are to the Securities Exchange Act of 1934, as amended;

·

 “U.S. dollars,” “dollars” and “$” are to the legal currency of the United States.


You should read the following plan of operation together with our financial statements and related notes appearing elsewhere in this quarterly report and the most recent Form 10-K. This plan of operation contains forward-looking statements that involve risks, uncertainties, and assumptions. The actual results



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may differ materially from those anticipated in these forward-looking statements as a result of certain factors.


Overview


We are a development stage company and are focused on delivering targeted, precision medicine therapies. We are developing our ACX-31 program to deliver two chemotherapy drugs, temozolomide in combination with BCNU, locally to brain tumor sites. Our ACX-31 program is based on an issued patent licensed from Accelerating Combination Therapies LLC which is co-owned by Dr. Henry Brem, Director of the Neurosurgery Department at Johns Hopkins University (“ACL License”). We are collaborating in the development of our ACX-31 program with Dr. Henry Brem who built one of the largest brain tumor research and treatment centers in the world at Johns Hopkins University.  Dr. Brem is a pioneer in the development of local drug delivery treatments, and invented and developed Gliadel® which is a FDA approved, local chemotherapy for the treatment of glioblastoma multiforme.  We entered into an agreement with the Yissum Research Development Company of The Hebrew University of Jerusalem Ltd. (“Yissum”) to develop and supply a polymeric formulation of a combination of temozolomide and BCNU.  Professor Avi Domb of The Hebrew University of Jerusalem had previously worked on the formulation of Gliadel® and leads the development efforts provided by Yissum. We are also developing other cancer therapies combining our ACX-31 polymer wafer formulation with other drugs, such as a PARP inhibitor. We cannot assure you that we will be successful with our development activities.


Recent Developments


On January 10, 2017, we filed a new patent application related to the combination therapy of a PARP inhibitor and our ACX-31 local temozolomide slow-release wafer polymer formulation for the treatment of solid tumors. PARP (Poly ADP Ribose Polymerase) is a family of proteins that can repair the DNA damage to cancer cells caused by the chemotherapy drug temozolomide. Inhibiting PARP can, therefore, potentially increase the effectiveness of temozolomide in damaging cancer cells.


On April 18, 2017, we entered into a license agreement under which Medisun Holdings Limited (“Medisun”) granted a non-exclusive licence (the “Licence”) (including access to Medisun’s clinical network facilities in the Greater China) to use Medisun’s NK (Natural Killer) cell technology to our Company for 10 years (the “Term”) in the United States and the Greater China (People’s Republic of China, Hong Kong, the Macau Special Administrative Region and Taiwan). Medisun has developed its NK cell technology for the treatment of cancer. The NK cell technology is currently clinically used to treat cancer patients at Medisun’s network clinical facilities. The Licence includes Medisun’s provision of relevant technical advice and support from time to time required by our Company during the Term.


Liquidity and Capital Resources and Plan of Operation


The reader is referred to our financial statements included elsewhere herein. As of March 31, 2017 we had $544,530 in cash and cash equivalents.


As a development stage company, we are focused on developing targeted, precision medicine therapies. We are developing our ACX-31 program to deliver two chemotherapy drugs, temozolomide in combination with BCNU, locally to brain tumor sites.  Temozolomide is a generic, approved chemotherapy drug that is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.  Local delivery of temozolomide has been demonstrated to be superior to oral administration in animal models.  


We are also developing other cancer therapies combining our ACX-31 polymer wafer formulation with other drugs.  After the filing of a new patent application related to the combination therapy of a PARP inhibitor and our ACX-31 local temozolomide slow-release wafer polymer formulation for the treatment of solid tumors, we are formulating and studying such a combination therapy.



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Medisun’s NK cell technology provides us with another treatment of cancer. The NK cell technology is currently clinically used to treat cancer patients at Medisun’s network clinical facilities.


The development of our programs is estimated to cost approximately $5-7 million over 4-5 years as a standalone company. However, we may seek to pursue a strategic collaboration partnership which may accelerate the development timeline, share expenses, and also provide access to ex-US markets.  The development of our programs may also cost substantially more than $5-7 million and may require a substantially longer development timeline than 4-5 years.  Higher development expenses and delays may be caused by but are not limited to sub-optimal product performance and continued product optimization cycles, adverse clinical results and repeat of clinical trials, or delays of a regulatory approval.  In such a scenario, we may not be able to secure sufficient funding or a strategic collaboration partnership and could cease operations under such circumstances.


We are actively seeking additional capital investment.  We cannot assure you that we will have access to the necessary funding or that if available it will be available on terms that are not dilutive to our present shareholders. If the funding is not available, we may have to severely curtail or cease operations.


Results of Operations


Revenues


We had no revenues as a development stage company for the three months ended March 31, 2017 and 2016, respectively.


Operating Expenses


Depreciation and Amortization Expenses:  Depreciation and Amortization expenses were $29,502 and $10,668 for the three months ended March 31, 2017 and 2016, respectively. The increase is due to the reclassification of our ACL License as an intangible asset that is amortized.


Research and Development:  Research and development expenses were $439,930 and $163,806 for the three months ended March 31, 2017 and 2016, respectively. The increase was due to the development and patent costs related to our new patent application regarding the combination of a PARP inhibitor with our ACX-31 formulation.


General and Administrative:  General and administrative expenses were $145,224 and $141,534 for the three months ended March 31, 2017 and 2016, respectively. The costs are primarily incurred by professional fees and salaries.


Net Losses


We had net losses of $465,338 and $341,282 for the three months ended March 31, 2017 and 2016, respectively. The increase was due to higher research and development costs.


Off-Balance Sheet Arrangements


We do not have any off balance sheet arrangements that are reasonably likely to have a current or future effect on our financial condition, revenues, and results of operations, liquidity or capital expenditures.


ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK


As a smaller reporting company” (as defined by §229.10(f)(1)), the Company is not required to provide the information required by this Item.



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ITEM 4.  CONTROLS AND PROCEDURES


Regulations under the Securities Exchange Act of 1934 (the “Exchange Act”) require public companies to maintain “disclosure controls and procedures,” which are defined as controls and other procedures that are designed to ensure that information required to be disclosed by the issuer in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission's rules and forms.  Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act 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.


We conducted an evaluation, with the participation of our Chief Executive Officer who is also our Principal Financial Officer, of the effectiveness of our disclosure controls and procedures as of March 31, 2017.  Based on that evaluation, our Chief Executive Officer and Principal Financial Officer has concluded that as of March 31, 2017, our disclosure controls and procedures were not effective at the reasonable assurance level due to the material weaknesses described below.


In light of the material weaknesses described below, we performed additional analysis and other post-closing procedures to ensure our financial statements were prepared in accordance with generally accepted accounting principles.  Accordingly, we believe that the financial statements included in this report fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented.


A material weakness is a control deficiency (within the meaning of the Public Company Accounting Oversight Board (PCAOB) Auditing Standard No. 2) or combination of control deficiencies that result in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected.  Management has identified the following two material weaknesses which have caused management to conclude that, as of March 31, 2017, our disclosure controls and procedures were not effective at the reasonable assurance level:


1.  We do not have written documentation of our internal control policies and procedures.  Written documentation of key internal controls over financial reporting is a requirement of Section 404 of the Sarbanes-Oxley Act which is applicable to us for the quarter ending March 31, 2017.  Management evaluated the impact of our failure to have written documentation of our internal controls and procedures on our assessment of our disclosure controls and procedures and has concluded that the control deficiency that resulted represented a material weakness.


2.  We do not have sufficient segregation of duties within accounting functions, which is a basic internal control.  Due to our size and nature, segregation of all conflicting duties may not always be possible and may not be economically feasible.  However, to the extent possible, the initiation of transactions, the custody of assets and the recording of transactions should be performed by separate individuals.  Management evaluated the impact of our failure to have segregation of duties on our assessment of our disclosure controls and procedures and has concluded that the control deficiency that resulted represented a material weakness.


To address these material weaknesses, management performed additional analyses and other procedures to ensure that the financial statements included herein fairly present, in all material respects, our financial position, results of operations and cash flows for the periods presented.


Management's Report on Internal Control Over Financial Reporting




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Our management is responsible for establishing and maintaining adequate internal control over financial reporting.  Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, the issuer’s principal executive and principal financial officers and effected by the issuer’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America and includes those policies and procedures that:


 

1.

Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the issuer;

 

 

 

 

2.

Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with accounting principles generally accepted in the United States of America and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the issuer; and

 

 

 

 

3.

Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the issuer’s assets that could have a material effect on the financial statements.


Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.  Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.  All internal control systems, no matter how well designed, have inherent limitations.  Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.  Because of the inherent limitations of internal control, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting.  However, these inherent limitations are known features of the financial reporting process.  Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.


As of the end of our most recent quarter, management assessed the effectiveness of our internal control over financial reporting based on the criteria for effective internal control over financial reporting established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO") and SEC guidance on conducting such assessments.  Based on that evaluation, they concluded that, as of March 31, 2017, such internal control over financial reporting was not effective.  This was due to deficiencies that existed in the design or operation of our internal control over financial reporting that adversely affected our internal controls and that may be considered to be material weaknesses.


The matters involving internal control over financial reporting that our management considered to be material weaknesses under the standards of the Public Company Accounting Oversight Board were: (1) lack of a functioning audit committee due to a lack of a majority of independent members and a lack of a majority of outside directors on our board of directors, resulting in ineffective oversight in the establishment and monitoring of required internal controls and procedures; and (2) inadequate segregation of duties consistent with control objectives of having segregation of the initiation of transactions, the recording of transactions and the custody of assets.  The aforementioned material weaknesses were identified by our Chief Executive Officer in connection with the review of our financial statements as of March 31, 2017.


Management believes that the material weaknesses set forth in items (1) and (2) above did not have an effect on our financial results.  However, management believes that the lack of a functioning audit committee and the lack of a majority of outside directors on our board of directors results in ineffective oversight in the establishment and monitoring of required internal controls and procedures, which could result in a material misstatement in our financial statements in future periods.



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This quarterly report does not include an attestation report of the Company's registered public accounting firm regarding internal control over financial reporting.  Management's report was not subject to attestation by the Company's registered public accounting firm pursuant to temporary rules of the SEC that permit the Company to provide only the management's report in this annual report.


Management's Remediation Initiatives


In an effort to remediate the identified material weaknesses and other deficiencies and enhance our internal controls, we have initiated, or plan to initiate, the following series of measures:


We will increase our personnel resources and technical accounting expertise within the accounting function when funds are available to us. First, we will create a position to segregate duties consistent with control objectives of having separate individuals perform (i) the initiation of transactions, (ii) the recording of transactions and (iii) the custody of assets.  Second, we will create a senior position to focus on financial reporting and standardizing and documenting our accounting procedures with the goal of increasing the effectiveness of the internal controls in preventing and detecting misstatements of accounting information.  Third, we plan to appoint one or more outside directors to our board of directors who shall be appointed to an audit committee resulting in a fully functioning audit committee who will undertake the oversight in the establishment and monitoring of required internal controls and procedures such as reviewing and approving estimates and assumptions made by management when funds are available to us.


Management believes that the appointment of one or more outside directors, who shall be appointed to a fully functioning audit committee, will remedy the lack of a functioning audit committee and a lack of a majority of outside directors on our Board.  Due to our small size and limited resources we could experience delays in implementation.



PART II – OTHER INFORMATION


ITEM 1. LEGAL PROCEEDINGS


We are not currently a defendant in any legal proceeding or governmental proceeding nor are we currently aware of any pending legal proceeding or governmental proceeding proposed to be initiated against us. There are no proceedings in which any of our current directors, executive officers or affiliates, or any registered or beneficial shareholder, is an adverse party or has a material interest adverse to us.


ITEM 1A. RISK FACTORS


The Company, as a “smaller reporting company” (as defined by §229.10(f)(1)), is not required to provide the information required by this Item.


ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES


On April 18, 2017, we issued 10,000,000 shares of the Company’s common stock to Medisun Holdings Limited (“Medisun”) in connection with entering into a license agreement with Medisun under which we were granted a non-exclusive license to use Medisun’s NK (Natural Killer) cell technology for the treatment of cancer. These shares were issued pursuant to Regulation D under the Securities Act of 1933, as amended, are exempt from registration by reason of Section 4(2) of the Securities Act of 1933, as amended (the “Act”), and bear an appropriate restrictive legend.



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ITEM 3. EXHIBITS


Exhibit No.

 

Description

 

 

 

31.1

 

 

 

Certifications of Principal Executive Officer filed pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

31.2

 

Certifications of Principal Financial Officer filed pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

  

32.1

 

Certifications of Principal Executive Officer furnished pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

  

32.2

 

Certifications of Principal Financial Officer furnished pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.



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SIGNATURES


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.



 

ACCUREXA INC.

May 12, 2017

/s/ Sophia Yaqi Sun

Sophia Yaqi Sun

President and Chief Executive Officer

(Principal Executive Officer)




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EXHIBIT INDEX


Exhibit No.

 

Description

 

 

 

31.1

 

 

Certifications of Principal Executive Officer filed pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

31.2

 

Certifications of Principal Financial Officer filed pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

  

32.1

 

Certifications of Principal Executive Officer furnished pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

  

32.2

 

Certifications of Principal Financial Officer furnished pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.




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