UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM10-Q

 

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended SeptemberJune 30, 20162017

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:0-21990

 

 

Mateon Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 13-3679168

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

701 Gateway Blvd, Suite 210

South San Francisco, CA 94080

(Address of principal executive offices, including zip code)

(650) 635-7000

(Registrant’s telephone number, including area code)

Not applicable

(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.    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 ofRegulation S-T (§232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit and post such files).    Yes  ☒    No  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, anon-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer” and, “smaller reporting company” and “emerging growth company” in Rule12b-2 of the Exchange Act inRule 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 
Emerging Growth Company

Indicate by check mark whether the registrant is a shell company (as defined inRule 12b-2 of the Exchange Act).    Yes  ☐    No  ☒

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 13(a) of the Exchange Act.  ☐

As of November 10, 2016,July 31, 2017, there were 26,544,934 shares of the Registrant’s Common Stock issued and outstanding.

 

 

 


Mateon Therapeutics, Inc.

Cautionary Factors that May Affect Future Results

This report contains “forward-looking statements,” which give management’s current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historic or current facts. They use words, such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seek,” “indicate,” or “continue” or the negative of these terms and other words and terms of similar meaning.

Any or all of our forward-looking statements in this report may turn out to be wrong. They can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. Consequently, no forward-looking statement can be guaranteed. Actual results may vary materially from those set forth in forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future, such as those relating to our cash resources and our need and ability to raise additional capital in the near term in order to continue operations; our estimates regarding the initiation, timing, progress and results of our preclinical and clinical trials; anticipated operating losses, future performance future revenues and projected expenses; our liquidity and our expectations regarding our needs for and ability to raise additional capital; our ability to select and capitalize on commercially desirable product opportunities as a result of limited financial resources; our ability to manage our expenses effectively and raise the funds needed to continue our business; our ability to maintain the listing of our common stock on The NASDAQ Capital Market;effectively; our ability to retain the services of our current executive officers, directors and principal consultants; the competitive nature of our industry and the possibility that our product candidates may become obsolete; our ability to obtain and maintain regulatory approval of our product candidates and any future products we may develop; the clinical development of and the process of commercializing CA4P, (combretastatin A4 phosphatewhich is also known as combretastatinA4-phosphate, fosbretabulin or fosbretabulin) and OXi4503,fosbretabulin tromethamine; the initiation, timing, progress and resultsefficacy of our preclinical and clinical trials,the combination of CA4P with bevacizumab; research and development programs;programs including preclinical studies; regulatory and legislative developments in the United States and foreign countries; the timing, costs and other limitations involved in obtaining regulatory approval for any product candidate; the further preclinical or clinical development and commercialization of our product candidates; our ability to obtain and maintain orphan drug exclusivity for some of our product candidates; the potential benefits of our product candidates over other therapies; our ability to enter into and maintain any collaboration with respect to product candidates; our ability to continue to develop or commercialize our product candidates in the event any license agreements in place with third parties expire or are terminated; the performance and conduct of third parties;parties, including our third-party manufacturers and third party service providers used in our clinical trials; our ability to obtain and maintain intellectual property protection for our product candidates and any future products we may develop and operate our business without infringing upon the intellectual property rights of others; the potential liability exposure related to our product candidates and any future products we may develop and our insurance coverage for such exposure; the size and growth of the potential markets for our products and our ability to serve those markets; the rate and degree of market acceptance of any future products; the sufficiency of potential proceeds from any financing; the volatility of the price of our common stock; the ability to achieve secondary trading of our stock in certain states; the dilutive effects of potential future equity issuances; our expectation that no dividends will be declared on our common stock in the foreseeable future; our ability to maintain an effective system of internal controls; the payment and reimbursement methods used by private or governmental third-party payers,payers; our ability to retain adequate staffing levels; unfavorable global economic conditions; a failure of our internal computer systems or those of our contractors and consultants; potential misconduct or other improper activities by our employees, contractors or consultants; the ability of our business continuity and disaster recovery plans to protect us in the event of a natural disaster, and other factors discussed in our Annual Report on Form10-K for the year ended December 31, 20152016 filed with the Securities and Exchange Commission (the SEC) on March 25, 201630, 2017 or any document incorporated by reference herein or therein.

We will not update forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law. You are advised to consult any further disclosures we make in our reports to the SEC, including our reports on Form 10-Q, 8-K10-Q,8-K and10-K. Our filings list various important factors that could cause actual results to differ materially from expected results. We note these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. You should understand that it is not possible to predict or identify all such factors. Consequently, you should not consider any such list to be a complete set of all potential risks or uncertainties.

INDEX

 

   Page
No.
 

PART I—FINANCIAL INFORMATION

  

Item 1. Financial Statements

   4 

Condensed Balance Sheets

   4 

Condensed Statements of Comprehensive Loss

   5 

Condensed Statements of Cash Flows

   6 

Notes to Condensed Financial Statements

   7 

Item  2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

   10 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

   1413 

Item 4. Controls and Procedures

   1413 

PART II—OTHER INFORMATION

  

Item 1. Legal Proceedings

   1514 

Item 1A. Risk Factors

   1514 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

   1514 

Item 3. Defaults Upon Senior Securities

   1514 

Item 4. Mine Safety Disclosures

   1514 

Item 5. Other Information

   1514 

Item 6. Exhibits

   1614 

SIGNATURES

   1715 

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

Mateon Therapeutics, Inc.

Condensed Balance Sheets

(in thousands, except per share data)

 

  September 30, 2016 December 31, 2015   June 30, 2017 December 31, 2016 
  (Unaudited) (See Note 1)   (Unaudited) (See Note 1) 
ASSETS      

Current assets:

      

Cash and cash equivalents

  $5,167   $27,285    $5,004  $3,535 

Short-term investments

   11,113    —       —    8,512 

Prepaid expenses and other current assets

   934   105  

Prepaid clinical trial expenses

   1,162  1,946 

Other prepaid expenses and current assets

   324  77 
  

 

  

 

   

 

  

 

 

Total current assets

   17,214   27,390     6,490  14,070 

Property and equipment, net

   14   30     6  11 

Other assets

   33   33     33  33 
  

 

  

 

   

 

  

 

 

Total assets

  $17,261   $27,453    $6,529  $14,114 
  

 

  

 

   

 

  

 

 
LIABILITIES AND STOCKHOLDERS’ EQUITY      

Current liabilities:

      

Accounts payable

  $532   $287    $401  $310 

Accrued compensation and employee benefits

   497   636     483  842 

Accrued clinical trial expenses

   46   918     120  64 

Other accrued liabilities

   410   262     421  398 
  

 

  

 

   

 

  

 

 

Total current liabilities

   1,485   2,103     1,425  1,614 
  

 

  

 

   

 

  

 

 

Commitments and contingencies

      

Stockholders’ equity:

      

Preferred stock, $0.01 par value, 15,000 shares authorized; No shares issued and outstanding

   —      —       —     —   

Common stock, $0.01 par value, 70,000 shares authorized; 26,545 shares issued and outstanding

   265   265     265  265 

Additional paid-in capital

   290,521   289,894     291,144  290,698 

Accumulated deficit

   (275,010 (264,809   (286,305 (278,463
  

 

  

 

   

 

  

 

 

Total stockholders’ equity

   15,776   25,350     5,104  12,500 
  

 

  

 

   

 

  

 

 

Total liabilities and stockholders’ equity

  $17,261   $27,453    $6,529  $14,114 
  

 

  

 

   

 

  

 

 

See accompanying notes .notes.

Mateon Therapeutics, Inc.

Condensed Statements of Comprehensive Loss

(in thousands, except per share data)

(unaudited)

 

  Three months ended Nine months ended 
  September 30, September 30,   Three months ended June 30, Six months ended June 30, 
  2016 2015 2016 2015   2017 2016 2017 2016 

Operating expenses:

          

Research and development

  $2,075   $2,457   $6,429   $6,107    $3,019  $2,374  $5,867  $4,354 

General and administrative

   1,187   1,142   3,855   3,597     877  1,296  1,999  2,668 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Total operating expenses

   3,262   3,599   10,284   9,704     3,896  3,670  7,866  7,022 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Loss from operations

   (3,262 (3,599 (10,284 (9,704   (3,896 (3,670 (7,866 (7,022

Interest income

   26   7   84   15     12  29  26  57 

Other income (expense), net

   —      —     (1 1  

Other expense

   —     —    (2 (1
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Net loss and comprehensive loss

  $(3,236 $(3,592 $(10,201 $(9,688  $(3,884 $(3,641 $(7,842 $(6,966
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Basic and diluted net loss per share attributable to common stock

  $(0.12 $(0.14 $(0.38 $(0.39  $(0.15 $(0.14 $(0.30 $(0.26
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Weighted-average number of common shares outstanding

   26,545   26,545   26,545   24,748     26,545  26,545  26,545  26,545 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

See accompanying notes .notes.

Mateon Therapeutics, Inc.

Condensed Statements of Cash Flows

(in thousands)

(unaudited)

 

  Nine months ended September 30,   Six months ended
June 30,
 
  2016 2015   2017 2016 

Operating activities:

      

Net loss

  $(10,201 $(9,688  $(7,842 $(6,966

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

      

Depreciation

   16   15     5  11 

Stock-based compensation

   627   527     446  427 

Changes in operating assets and liabilities:

      

Prepaid expenses and other current assets

   (829 (94   537  (930

Accounts payable and accrued expenses

   (618 279     (189 (486
  

 

  

 

   

 

  

 

 

Net cash used in operating activities

   (11,005 (8,961   (7,043 (7,944
  

 

  

 

   

 

  

 

 

Investing activities:

      

Purchase of short-term investments

   (18,915  —       —    (15,604

Sale of short-term investments

   7,802    —       8,512  4,202 

Purchase of property and equipment

   —     (14
  

 

  

 

   

 

  

 

 

Net cash used in investing activities

   (11,113 (14

Net cash provided by (used in) investing activities

   8,512  (11,402
  

 

  

 

   

 

  

 

 

Financing activities:

   

Proceeds from issuance of common stock, net of issuance costs

   —     9,195  

Increase (decrease) in cash and cash equivalents

   1,469  (19,346
  

 

  

 

 

Net cash provided by financing activities

   —     9,195  
  

 

  

 

 

(Decrease) increase in cash and cash equivalents

   (22,118 220  

Cash and cash equivalents at beginning of period

   27,285   30,031     3,535  27,285 
  

 

  

 

   

 

  

 

 

Cash and cash equivalents at end of period

  $5,167   $30,251    $5,004  $7,939 
  

 

  

 

   

 

  

 

 

See accompanying notes .notes.

Mateon Therapeutics, Inc.

Notes to Condensed Financial Statements

SeptemberJune 30, 20162017

(Unaudited)

 

1.Summary of Significant Accounting Policies

Description of Business

Mateon Therapeutics, Inc. (“Mateon” or the “Company”) is a clinical-stage biopharmaceutical company seeking to realize the full potential of vascular targeted therapy in oncology. Vascular targeted therapy includes vascular disrupting agents (VDAs), such as the investigational drugs that Mateon is developing, and anti-angiogenic agents (AAs), a number of which are approved and widely used in oncology indications. Mateon’s VDAs selectively obstruct a tumor’s blood supply without obstructing the blood supply to normal tissues, and treatment with Mateon’s VDAs has been shown to lead to significant central tumor necrosis. The Company believes that the treatment of cancer would be significantly improved if VDAs and AAs were used together, due to their complementary mechanisms of action. In combination, the VDA would occlude the blood vessels in the interior of a tumor while the AA would prevent the formation of new tumor blood vessels. The Company has two VDA drug candidates currently being tested in clinical trials, CA4P (combretastatin A4 phosphate, or fosbretabulin) and OXi4503. The Company was originally incorporated under the name OXiGENE, Inc. in 1988 in the state of New York, and reincorporated in 1992 in the state of Delaware. Effective June 17, 2016, the Company amended its Certificate of Incorporation to changeDelaware and changed its name to Mateon Therapeutics, Inc. and, in connection with the name change, on June 20, 2016, the trading symbol for the Company’s common stock changed from “OXGN” to “MATN”.17, 2016.

Basis of Presentation

The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with the instructions to Form10-Q and Article 10 ofRegulation S-X. The financial statements do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In the opinion of management, however, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and ninesix months ended SeptemberJune 30, 20162017 are not necessarily indicative of the results that may be expected for any other interim period or for the year ending December 31, 2016.2017.

The balance sheet at December 31, 20152016 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. For further information, refer to the financial statements and footnotes thereto included in the Annual Report on Form10-K for the Company for the year ended December 31, 2015.2016.

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 of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period. Actual results could differ from those estimates.

Cash Equivalents

Highly liquid investments with original maturities of three months or less at the date of purchase are considered to be cash equivalents. Cash equivalents are stated at fair value.

Short-term Investments

All marketable securities have been classified as “available for sale” and are carried at fair value, based upon quoted market prices. The Company considers itsavailable-for-sale portfolio to be available for use in current operations. Accordingly, the Company classifies certain investments as short-term marketable securities, even though the stated maturity date may be one year or more beyond the current balance sheet date. Unrealized gains and losses, net of any related tax effects, are excluded from earnings and are included in other comprehensive income and reported as a separate component of stockholders’ deficit until realized. Realized gains and losses and declines in value judged to be other than temporary, if any, onavailable-for-sale securities are included in other income (expense), net. The cost of securities sold is based on the specific-identification method.

Recent Accounting Pronouncements

    In August 2014,Going Concern Evaluation

The principal source of the Financial Accounting Standards Board (the “FASB”), issued ASU No. 2014-15, “DisclosureCompany’s working capital to date has been the proceeds from the sale of Uncertainties aboutequity. The Company has experienced net losses every year since inception and, as of June 30, 2017, had cash and cash equivalents of $5.0 million and an Entity’s Abilityaccumulated deficit of over $286 million. The Company’s net loss was $3.9 million and $7.8 million for the three and six month periods ended June 30, 2017, respectively. The Company has no source of revenue and does not expect to Continuereceive any product revenue in the near future. If the Company remains in operation, the Company expects to incur significant additional operating losses over at least the next several years, principally as a Going Concern.” This ASU requires managementresult of the Company’s continuing clinical trials for its investigational drugs. Based on the Company’s planned operations, Management expects the Company’s existing cash and cash equivalents to evaluate whethersupport its operations only into October 2017. Prior to this time, the Company will need to secure additional funding or it could be forced to curtail or terminate its drug development programs and its operations. Because the Company does not currently have a source of working capital that will sustain its planned operations past October 2017, Management has determined that there is substantial doubt about an entity’sthe Company’s ability to continue as a going concernconcern.

Any additional equity financing, if available, may not be available on favorable terms and expands footnote disclosures relatedwould most likely be dilutive to going concern matters. This ASU willcurrent stockholders. Any debt financing, if available, would likely involve restrictive covenants and may also result in dilution to current stockholders. If the Company accesses funds through collaborative or licensing arrangements, it may be effective forrequired to relinquish rights to some of its technologies or product candidates that it would otherwise seek to develop or commercialize on its own, on terms that are not favorable to the Company. The Company’s ability to access capital in any form is not assured and is likely to be dependent on upcoming clinical trial results, which are not under the control of the Company. If access to additional capital is not achieved on a timely basis, it would materially harm the Company’s 2016 year-endbusiness, financial statementscondition and management plans to include ASU No. 2014-15 disclosures to the extent that they are applicable.results of operations.

Recent Accounting Pronouncements

In February 2016, the Financial Accounting Standards Board, or FASB, issued ASUNo. 2016-2, “Leases.” This ASU requires substantially all leases, including operating leases, to be recognized by lessees on their balance sheet as aright-of-use asset and corresponding lease liability. This ASU is effective for the Company’s interim and annual reporting periods beginning January 1, 2019 and early adoption is permitted. The Company is currently evaluating the impact that the adoption of this ASU will have on its financial statements.

In March 2016, the FASB issued ASUNo. 2016-09, “Improvements to Employee Share-Based Payment Accounting,” which simplifiessimplified several aspects of the accounting for share-based payments, including immediate recognition of all excess tax benefits and deficiencies in the income statement, changing the threshold to qualify for equity classification up to the employees’ maximum statutory tax rates, allowing an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures as they occur, and clarifying the classification on the statement of cash flows for the excess tax benefit and employee taxes paid when an employer withholds shares fortax-withholding purposes. This ASU isbecame effective for the Company’sMateon’s interim and annual reporting periods beginning January 1, 2017, and earlythe adoption of this standard did not have a material impact on the Company’s financial statements. As part of the adoption of this standard, the Company elected to continue estimating the expected option forfeiture rate.

In August 2016, the FASB issued ASUNo. 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments,” addressing several specific cash flow issues to reduce diversity in practice. The amended guidance is permitted.effective for fiscal years beginning after December 31, 2017, and for interim periods within those years. The Company is currently evaluating the impact thatdoes not expect the adoption of this ASU willto have a material impact on its financial statements.

 

2.Cash, Cash Equivalents and Short-Term Investments

Cash, cash equivalents and short-term investments consisted of the following (in thousands):

 

   September 30, 2016 
   Amortized
Cost
   Unrealized
Gain
   Unrealized
(Loss)
   Estimated Fair
Value
 

Cash

  $1,326    $—      $—      $1,326  

Money market funds

   3,341     —       —       3,341  

U.S. government treasury bills

   3,606     —       —       3,606  

Corporate bonds and commercial paper

   8,007     —       —       8,007  
  

 

 

   

 

 

   

 

 

   

 

 

 
  $16,280    $—      $—      $16,280  
  

 

 

   

 

 

   

 

 

   

 

 

 

Reported as:

        

Cash and cash equivalents

        $5,167  

Short-term investments

         11,113  
        

 

 

 

Total cash, cash equivalents and short-term investments

        $16,280  
        

 

 

 
   June 30, 2017 
   Amortized
Cost
   Unrealized
Gain
   Unrealized
(Loss)
   Estimated Fair
Value
 

Cash

  $304   $—     $—     $304 

Money market funds

   4,700    —      —      4,700 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total cash and cash equivalents

  $5,004   $—     $—     $5,004 
  

 

 

   

 

 

   

 

 

   

 

 

 

As of September 30, 2016, the Company’s cash equivalents and short-term investments had a weighted-average time to maturity of less than one year, and the Company has the ability to hold its investments through their maturity dates. There have been no significant realized gains or losses on investments for the period presented.

   December 31, 2016 
   Amortized
Cost
   Unrealized
Gain
   Unrealized
(Loss)
   Estimated Fair
Value
 

Cash

  $671   $—     $—     $671 

Money market funds

   2,864    —      —      2,864 

U.S. government treasury bills

   3,008    —      —      3,008 

Corporate bonds and commercial paper

   5,504    —      —      5,504 
  

 

 

   

 

 

   

 

 

   

 

 

 
  $12,047   $—     $—     $12,047 
  

 

 

   

 

 

   

 

 

   

 

 

 

Reported as:

  

Cash and cash equivalents

  $3,535 

Short-term investments

   8,512 
  

 

 

 

Total cash, cash equivalents and short-term investments

  $12,047 
  

 

 

 

 

3.Fair Value Measurements

Fair value is defined as the price at which an asset could be exchanged or a liability transferred in a transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or parameters are not available, valuation models are applied.

Assets and liabilities recorded at fair value are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities, are as follows:

Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets at the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide reasonably accurate pricing information on an ongoing basis.

Level 2—Inputs, other than quoted prices included in Level 1, that are either directly or indirectly observable for the asset or liability through correlation with market data at the reporting date and for the duration of the instrument’s anticipated life.

The Company utilizes third party pricing services in developing fair value measurements where fair value is based on observable market inputs, including benchmark yields, reported trades, broker/dealer quotes, bids, offers and other reference data. The Company uses quotes from external pricing service providers and otheron-line quotation systems to verify the fair value of investments provided by third party pricing service providers.

Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities reflect management’s best estimate of what market participants would use in pricing the asset or liability at the reporting date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.

Financial assets measured at fair value on a recurring basis are categorized in the tables below based upon the lowest level of significant input to the valuations (in thousands):

 

  September 30, 2016   June 30, 2017 
  Level 1   Level 2   Level 3   Total   Level 1   Level 2   Level 3   Total 

Money market funds

  $3,341    $—      $—      $3,341     4,700    —      —      4,700 

U.S. government treasury bills

   —       3,606     —       3,606  

Corporate bonds and commercial paper

   —       8,007     —       8,007  
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total

  $3,341    $11,613    $—      $14,954    $4,700   $—     $—     $4,700 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

   December 31, 2016 
   Level 1   Level 2   Level 3   Total 

Money market funds

  $2,864   $—     $—     $2,864 

U.S. government treasury bills

   —      3,008    —      3,008 

Corporate bonds and commercial paper

   —      5,504    —      5,504 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $2,864   $8,512   $—     $11,376 
  

 

 

   

 

 

   

 

 

   

 

 

 

 

4.Stockholders’ Equity

The following is a summary of the Company’s outstanding common stock warrants:

 

   Exercise   September 30, 2016   December 31, 2015 

Expiration Date

  Price   (in thousands) 

04/16/18

  $3.40     1,460     1,460  

09/23/18

  $2.80     147     147  

02/18/19

  $2.75     1,872     1,872  

02/11/19

  $2.56     293     293  

08/28/19

  $2.90     2,700     2,700  

06/14/17

  $3.70     216     216  

03/25/20

  $1.71     2,920     2,920  

03/20/20

  $2.13     234     234  
    

 

 

   

 

 

 

Total Warrants Outstanding

  

   9,842     9,842  
    

 

 

   

 

 

 

Expiration Date

  Exercise
Price
   June 30, 2017   December 31, 2016 
       (in thousands) 
6/14/2017  $ 3.70    —      216
4/16/2018  $ 3.40    1,460   1,460
9/23/2018  $ 2.80    147   147
2/11/2019  $ 2.56    293   293
2/18/2019  $ 2.75    1,872   1,872
8/28/2019  $ 2.90    2,700   2,700
3/20/2020  $ 2.13    234   234
3/25/2020  $ 1.71    2,920   2,920
    

 

 

   

 

 

 
   9,626   9,842
  

 

 

   

 

 

 

The following is a summary of the Company’s stock option activity under its equity incentive plans:

 

   Options
Available
for Grant
  Options
Outstanding
  Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Life
   Aggregate
Intrinsic
Value
 
   (in thousands)      (years)   (in thousands) 

Balance at December 31, 2015

   2,695    2,031   $2.01     8.44    

Options granted

   (2,238  2,238   $0.72      

Options forfeited

   220    (220 $2.14      
  

 

 

  

 

 

      

Balance at September 30, 2016

   677    4,049   $1.54     8.36    $—    
  

 

 

  

 

 

      

Vested and exercisable at September 30, 2016

    1,043   $2.26     6.87    $—    

Vested and expected to vest at September 30, 2016

    3,048   $1.40     8.15    $—    

Unvested at September 30, 2016

    3,006   $1.29      
   Options
Available
for Grant
  Options
Outstanding
  Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Life
   Aggregate
Intrinsic
Value
 
   (in thousands)      (years)   (in thousands) 

Balance at December 31, 2016

   549   4,177  $1.47    8.14   

Options authorized

   2,000       

Options granted

   (2,484  2,484  $0.42     

Options forfeited

   720   (720 $1.66     
  

 

 

  

 

 

      

Balance at June 30, 2017

   785   5,941  $1.01    8.30   $—   
  

 

 

  

 

 

      

Vested and exercisable at June 30, 2017

 

  1,722  $1.29    7.73   $—   

Vested and expected to vest at June 30, 2017

 

  4,540  $0.90    8.17   $—   

Unvested at June 30, 2017

    4,219  $0.89     

As of SeptemberJune 30, 2016,2017, there was approximately $1.3 million of unrecognized compensation cost related to stock option awards that is expected to be recognized as expense over a weighted average period of approximately 2.72.4 years.

The fair values for the stock options granted were estimated at the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions for the periods indicated:

  Nine months ended September 30,   Six months ended June 30, 
  2016 2015   2017 2016 

Risk-free interest rate

   1.5 1.7   2.0 1.5

Expected life (years)

   6.0   6.0     6.0  6.0 

Expected volatility

   89 92   88 89

Dividend yield

   0 0   0 0

 

5.Net Loss Per Share

Basic and diluted net loss per share was calculated by dividing the net loss per share attributed to the Company’s common shares by the weighted-average number of common shares outstanding during the period. Diluted net loss per share includes the effect of all dilutive, potentially issuable common equivalent shares as defined using the treasury stock method. All of the Company’s common stock equivalents are anti-dilutive due to the Company’s net loss position for all periods presented. Accordingly, common stock equivalents of approximately 4,049,0005,941,000 stock options and 9,626,000 warrants at June 30, 2017 and 4,139,000 stock options and 9,842,000 warrants at SeptemberJune 30, 2016, and 2,192,000 stock options and 9,842,000 warrants at September 30, 2015, were excluded from the calculation of weighted average shares for diluted net loss per share.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis should be read together with the audited financial statements and notes, as well as our “Management’s Discussion and Analysis of Financial Condition and Results of Operations” that are included in our Annual Report on Form10-K for the year ended December 31, 2015,2016, and also with the unaudited financial statements set forth in Part I, Item 1 of this Quarterly Report on Form10-Q.

Overview

We are a biopharmaceutical company seeking to realizefocused on the full potentialdevelopment of vascular targeted therapy in oncology. Vascular targeted therapy includes vascular disrupting agents, or VDAs, such asfor the investigational drugs that we are developing, and anti-angiogenic agents, or AAs, a numbertreatment of which are approved and widely used in oncology indications. Ourcancer. VDAs selectively target the vasculature of cancer tumors and obstruct a tumor’s blood supply without obstructingdisrupting the blood supply to normal tissues, and treatmenttissues. Treatment with our VDAs has been shown to lead to significant central tumor necrosis. We believe thatnecrosis, which refers to the death of cancer cells. Unlike most other drugs used for the treatment of certain typescancer, our investigational drugs have consistently shown a stronger treatment effect in larger tumors than in smaller tumors.

VDAs are in a class of cancer would be significantly improved ifdrugs called vascular targeted therapies, or VTTs, which also includes anti-angiogenic agents, or AAs. Bevacizumab (marketed under the brand name Avastin® by Roche/Genentech) and other currently-approved AA drugs work by preventing the growth of new blood vessels which can supply nutrients to tumor cells. We are seeking to realize the full potential of VTTs in oncology by using the combination of VDAs and AAs were used together, due to their complementary mechanismstreat cancer tumors. The aim of action. Inusing a VDA and an AA in combination is for the VDA would occludeto directly cut off the blood vessels insupply to the interiormajority of athe tumor, while the AA indirectly inhibits angiogenesis, which is the process by which new blood vessels form andre-vascularize the tumor. Our current VDA development plans are focused on this combination so that the mechanism of action of each drug would preventcomplement that of the formation of newother – disrupting tumor blood vessels. supply in two different ways instead of just one.

We have two VDA drug candidatesclinical stage investigational drugs, both VDAs, that we are currently being tested indeveloping – CA4P and OXi4503. Our most advanced compound is CA4P. The largest clinical trials, CA4P (combretastatin A4 phosphate, or fosbretabulin) and OXi4503.

Recent Developments

On June 17, 2016, we changed our name from OXiGENE, Inc. to Mateon Therapeutics, Inc. OXiGENE was named for our original founding technology of oxygen-mediated radiosensitizers. The new company name is derived from our location in San Mateo County, the birthplace of biotechnology.

On June 20, 2016, we announced new analyses from the GOG-0186I Study in recurrent ovarian cancer. This study compared the combinationtrial of CA4P and bevacizumab (CA4P-treated patients)conducted to bevacizumab (control patients). Key new analyses, with an updated dataset as of November 2015, included median overall survival (OS), in the intent-to-treat (ITT) population of 3.2 months longer for the CA4P-treated patients compared to the control patients (25.2 vs. 22.0 months, respectively; HR=0.83, not statistically significant). The GOG-0186I Study included 81 patients (75.7% of study patients) with recurrent ovarian cancer that was deemed “measurable”, a pre-specified covariate defined by RECIST criteria, and 26 patients (24.3%) with tumors deemed “non-measurable.” Measurable disease is generally defined as primary tumor sizes greater than 1 cm in diameter, while non-measurable tumors are generally identified and monitored by increased serum CA-125 antigen levels, ascites, or other clinical signs of disease. Patients with measurable disease treated with CA4P had a 5.6 month improvement in median OS (26.8 vs. 21.2 months; 22% reduction in the risk of death; HR=0.78, not statistically significant), and a 3.7 month improvement in progression free survival, or PFS (9.8 vs. 6.1 months; HR=0.60, p=0.027), compared to control patients with measurable disease.

CA4P

Our lead investigational drug, CA4P, is a reversible tubulin binding agent that selectively targets endothelial cells that make up the blood vessel walls in most solid cancer tumors, causing the endothelial cells to swell and thus obstruct the flow of blood to the tumor, which starves the tumor of vital nutrients including oxygen. This deprivation, also known as tumor hypoxia, results in rapid downstream tumor cell death.

Our primary focus for 2016 is the development of CA4P for platinum-resistant ovarian cancer. Approximately 22,000 women in the U.S. are diagnosed with ovarian cancer each year. More than 60% of women diagnosed with ovarian cancer are in stage III or IV at the time of their diagnosis, making ovarian cancer difficult to treat and often fatal, with a five-year survival rate of approximately 45% — a rate which is largely unchanged since the 1990s. Overall, approximately 80% of patients diagnosed with ovarian cancer will relapse after first-line platinum-based and taxane-based chemotherapy. One quarter of those who relapse after initial treatment, or more than 4,300 women, will have platinum-resistant cancer, the most difficult-to-treat form of the disease. Additionally, a majority of patients who are not initially platinum-resistant and who may achieve a full remission following first-line therapy will also develop recurrent disease. There are relatively few cancer therapies that have been approved for the treatment of ovarian cancer, including platinum-resistant ovarian cancer, and new treatments are needed. We have been granted orphan drug designation in both the U.S. and the European Union for the use of CA4P in the treatment of ovarian cancer and have received Fast Track designation in the U.S. for use in the treatment of platinum-resistant ovarian cancer.

CA4P in Combination with Bevacizumab – Completed Phase 2 Clinical Trial with Positive Results

Genentech’s bevacizumab (Avastin®) is an anti-vascular endothelial growth factor, or VEGF, monoclonal antibody which has been approved for the treatment of ovarian cancer in the United States and elsewhere. The approval of bevacizumab in the United States in combination with chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan) for the treatment of women with platinum-resistant ovarian cancer was based in part upon results from the phase 3 AURELIA trial, which had a primary endpoint of PFS. Bevacizumab is also currently approved in the EU in combination with different chemotherapy regimens for platinum-resistant and platinum-sensitive ovarian cancer. These EU approvals were also based primarily upon PFS.

The GOG-0186I clinical trial was conducted by Gynecologic Oncology Group (GOG), part of NRG Oncology, under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI), anddate was a randomized,two-armphase 2 clinical trial evaluating CA4P plus bevacizumab compared to bevacizumab alone in patients with recurrent ovarian cancer.

The GOG-0186I clinical trial enrolled a total of 107 patients with both platinum-sensitive and platinum-resistant recurrent ovarian cancer at 67 clinical sites in the United States. The results indicated a statistically significant increase in progression-free survival (PFS) in the combination arm, which was the primary endpoint of the trial, with a p-value of 0.049 (pre-specified analysis using a one-sided test; 10% level of significance). The hazard ratio was 0.685, with a 90% 2-sided confidence interval (CI) of 0.47 ~1.00. Median PFS was 7.3 months for CA4P plus bevacizumab (n=54), compared to 4.8 months for bevacizumab alone (n= 53). Patients in both arms were treated until disease progression or adverse effects prohibited further therapy.

In a post-hoc subgroup analysis, data showed that patients who were platinum-resistant had an even greater improvement in PFS with the combination. Among the 27 patients who were platinum-resistant, median PFS was 6.7 months for those receiving CA4P plus bevacizumab compared to 3.4 months for those receiving bevacizumab alone, and the results were statistically significant with a p-value of 0.01 and a hazard ratio of 0.57. These findings suggest that adding CA4P to bevacizumab has a greater effect in the difficult-to-treat platinum-resistant patient group than it does for platinum-sensitive patients. Although the results were stronger for the platinum-resistant patients, a post-hoc subgroup analysis among the 80 patients who were platinum-sensitive still showed a numerical improvement in PFS for the combination therapy, with a median PFS of 7.6 months for those receiving CA4P plus bevacizumab compared to 6.1 months for those receiving bevacizumab alone, although the results were not statistically significant, with a p-value of 0.139 and a hazard ratio of 0.67.

In the clinical trial, patients with measurable disease who received the combination of CA4P and bevacizumab also achieved a higher objective response rate, or ORR, a secondary endpoint in the clinical trial, measured according to RECIST criteria. Although not a statistically significant result, patients receiving the combination had an ORR of 35.7% (n=42; CI 90% 23.5 ~ 49.5%) compared to 28.2% for patients on bevacizumab alone (n=39; CI 90% 16.7 ~ 42.3%). In the subgroup of platinum-resistant patients, the addition of CA4P to bevacizumab increased ORR to 40.0% (n=10) compared to 12.5% (n=8) for bevacizumab alone.

All adverse events in the clinical trial were manageable, with one Grade 4 event occurring in each treatment arm. Consistent with prior clinical experience with CA4P, patients in the combination arm experienced an increased incidence of Grade 3 hypertension compared to the control arm (18 cases for the combination compared to 10 cases for bevacizumab alone). One patient on the combination regimen had a Grade 3 thromboembolic event. All cases of hypertension were managed with anti-hypertensive treatments, as specified in the clinical trial protocol.

Follow-up data on OS was collected by the GOG through November 2015. Among all patients enrolled in the study(Intent-to-Treat group, or ITT), the median overall survival was 3.2 months longer for the CA4P and bevacizumab treated group than for the bevacizumab only treated group (25.2 months vs. 22.0 months, respectively; HR=0.83, not statistically significant).

The GOG-0186I clinical trial included 81 patients (75.7% of study patients) with recurrent ovarian cancer that was deemed “measurable”, a pre-specified covariate defined by RECIST criteria, and 26 patients (24.3%) deemed “non-measurable.” Measurable disease is generally defined as primary tumor sizes greater than 1 cm in diameter, while non-measurable tumors are generally identified and monitored by increased serum CA-125 antigen levels, ascites, or other clinical signs of disease.

Patients with measurable disease treated with CA4P had a 5.6 month improvement in median OS (26.8 vs. 21.2 months; 22% reduction in the risk of death; HR=0.78, not statistically significant), and a 3.7 month improvement in PFS (9.8 vs. 6.1 months; HR=0.60, p=0.027) compared to control patients with measurable disease.

Additional analyses were conducted on patients with measurable disease whose tumors were larger than the median baseline tumor size (tumor size>5.7 cm; n=41). CA4P-treated patients with these tumor sizes experienced a 48% reduction in the risk of death (HR=0.52; p=0.095) and a 6.2 month improvement in median PFS (10.5 vs. 4.3 months; HR=0.55, p=0.071) compared to control patients.

CA4P in Combination with Bevacizumab and Physician’s Choice Chemotherapy – Current Phase 2/3 Clinical Trial

Based on the positive overall results from the GOG-0186I clinical trial in recurrent ovarian cancer sponsored by the Gynecologic Oncology Group, or GOG, which was completed in 2014 and alsomet its primary endpoint by demonstrating an improvement in progression-free survival for the statistically significantpatients who received CA4P. This trial, referred to asGOG-0186I, compared treatment with CA4P plus bevacizumab to treatment with bevacizumab alone. Based on the positive results among the subgroup of platinum-resistant patients,this clinical trial, we have initiatedare conducting the FOCUS Study, which is atwo-stage, phase 2/3 clinical trial in platinum-resistant ovarian cancer. FOCUS is comparing treatment with the three-drug combination of CA4P, seekingbevacizumab and chemotherapy, or the active treatment arm, to demonstrate whether CA4P improvestreatment with the current standard of care, for platinum-resistant ovarian cancer. The current standardthetwo-drug combination of care for platinum-resistant ovarian cancer is treatment with bevacizumab and chemotherapy. The clinical trial is designed with two stages – inchemotherapy, or the first stage we plan to enroll up to 80 patients and conduct regular interim analyses in order to verify efficacy and confirm powering assumptions for the second stage. In the second stage, we plan to enroll up to 356 additional patients and do not plan to conduct any interim analyses. The primary endpoint of our phase 2/3 clinical trial will be PFS, and we will also evaluate objective response rate, OS and other parameters. If results from the second stage of the clinical study meet the primary endpoint, we intend to submit a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA. We began enrolling patients into this clinical trial in June 2016.

control arm. CA4P in Combination with Pazopanib – Current Phase 2 Clinical Trial

Pazopanib is an anti-angiogenic oral tyrosine kinase inhibitor that is currently approved by the FDA for the treatment of renal cell carcinoma (RCC) and soft tissue sarcoma (STS). Pazopanib is also approved for ovarian and other cancers in the European Union, and was initially developed by GlaxoSmithKline, then sold to Novartis in 2015. We believe that using CA4Pbeing studied in combination with pazopanib may provide a clinically active yet potentially better tolerated alternative to the current standard of care, cytotoxic chemotherapy, for relapsed ovarian cancer.

In October 2014, the first patient was enrolled in aanon-going phase 1b/2 clinical trial of pazopanib with and without CA4P in advanced recurrent ovarian cancer. We will incur limited costs for this trial, whichcancer that is sponsored by The Christie Hospital NHS Foundation Trust (the Christie NHS Trust) in the United Kingdom and coordinateda phase 1 study in combination with everolimus in neuroendocrine tumors that is sponsored by the Manchester Academic Health Science Centre, Trials Coordination Unit, or MAHSC-CTU, with additional support from TheMarkey Cancer Center at the University of Manchester, the Royal Marsden NHS Foundation Trust and Mount Vernon Cancer Centre (part of the East and North Hertfordshire NHS Trust).

The trial design consists ofKentucky. Our second compound, OXi4503, is being studied in combination with cytarabine in a phase 1b dose escalation portion with1/2 clinical trial in the combination of pazopanib and CA4P, which has been completed, and then a randomized phase 2 portion comparing pazopanib alone versus pazopanib plus CA4PUnited States in patients with relapsed ovarian cancer. The clinical trial is expected to enroll approximately 128 patients at sites in the U.K. The primary endpoint of the trial is PFS, and secondary endpoints include safety, OS, objective response rate, and CA125 response rate. The phase 2 portion began enrolling patients in July 2016.

OXi4503 Development Program

In addition to pursuing development of CA4P, we are also pursuing the development of a second product candidate, OXi4503, a novel, dual-mechanism VDA, which has not only been shown to reduce tumor blood flow but which also forms a potentially anti-proliferative metabolite. We believe that this dual mechanism of OXi4503 may result in enhanced anti-tumor activity in certain tumor types. Based on preclinical data, we believe that OXi4503 may be particularly active in hepatocellular carcinoma, melanoma, and leukemias of the myeloid lineage, all of which have relatively high levels of the enzymes that facilitate the conversion of OXi4503 into a metabolite that directly kills tumor cells. Similar to CA4P, OXi4503 has shown potent anti-tumor activity in preclinical studies of solid tumors andor refractory acute myelogenous leukemia (AML) or AML, and in two clinical studies in advanced solid tumors and liver tumors, both as a single agent and in combination with other anti-proliferative agents.myelodysplastic syndromes (MDS).

AML is a relatively rare cancerRecent Developments

On April 18, 2017, we announced results from the first scheduled interim analysis of the myeloid blood cells, with approximately 10,500 new cases each yearon-going FOCUS Study. The interim analysis was conducted after the first 20 patients enrolled into the trial had been treated for at least two months or had discontinued from the trial. Interim results indicated that no significant CA4P safety issues had been identified in the United States, accounting for approximately 1.2%trial, and that the initial efficacy was in favor of cancer deaths. AML is characterized by the rapid growthCA4P, with 22% (2/9) of abnormal white blood cells that pollute bone marrow and interfere with the production of normal blood cells. We are currently developing OXi4503 for AML and have been granted orphan drug designationpatients in the United States and European Union fortreatment arm responding compared to 9% (1/11) of patients in the use ofcontrol arm.

On June 7, 2017, we announced that the FDA had granted Fast Track designation to our product candidate OXi4503 for the treatment of AML.

PriorOn June 12, 2017, we announced that one patient out of three enrolled in the fourth cohort of our study of OXi4503 in AML experienced a significant AML blast count reduction. In addition, we announced that the Christie NHS Trust has temporarily suspended enrollment in the PAZOFOS Study in order to October 2015, OXi4503evaluate two potential adverse events involving the combination of CA4P and pazopanib.

On July 31, 2017, we announced that two out of four patients in the fifth cohort of Study OX1222 had beenmorphological complete remissions after one cycle of treatment with OXi4503.

On August 1, 2017, we announced that we had completed enrollment in development in an investigator-sponsored phase 1 clinical trial of patients with AML or MDS, a disorderthe first part of the normal blood formation process. In October 2015, the investigator-sponsored clinical trial was closed, and we brought the clinical trial under our direct management and expanded the numberFOCUS Study of sites to four, with the goal of enrolling patients faster than had occurred at the single site. In December 2015, we moved this clinical trial into its second stage, whereby OXi4503 is being used in combination with cytarabine, an FDA-approved drugCA4P for the treatment of AMLplatinum-resistant ovarian cancer.

Results of Operations

Three and NineSix Months Ended SeptemberJune 30, 20162017 and SeptemberJune 30, 20152016

Research and development expenses

Research and development expenses decreasedincreased for both the three and six month periodperiods ended SeptemberJune 30, 20162017 compared to the same periodperiods in 20152016 primarily due to lower consulting and employee costs. For the nine month period ended September 30, 2016, research and development costs increased primarily dueadditional clinical trial activity related to our initiation of the FOCUS Study, a phase 2/3 clinical trial evaluating whether our lead investigational drug, candidate, CA4P, improves upon the standard of care for women with platinum-resistant ovarian cancer.CA4P. The table below summarizes the most significant components of our research and development expenses for the periods indicated in thousands, and provides the amount and percentage change in these components:components (in thousands):

 

   Three months ended,
September 30,
   Change  Nine months ended,
September 30,
   Change 
   2016   2015   Amount  %  2016   2015   Amount  % 

Clinical studies

  $947    $909    $38    4 $3,072    $2,207    $865    39

Employee compensation and related

   663     769     (106  -14  2,005     1,768     237    13

Employee stock-based compensation

   111     78     33    42  299     336     (37  -11

Consulting and professional services

   177     549     (372  -68  568     1,096     (528  -48

Drug manufacturing

   107     70     37    53  270     309     (39  -13

Other

   70     82     (12  -15  215     391     (176  -45
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

   

 

 

   

 

 

  

 

 

 

Total research and development

  $2,075    $2,457    $(382  -16 $6,429    $6,107    $322    5
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

   

 

 

   

 

 

  

 

 

 

   Three months ended
June 30,
   Change  Six months ended
June 30,
   Change 
   2017   2016   Amount  %  2017   2016   Amount   % 

Clinical studies

  $1,764   $1,306   $458   35 $3,025   $2,124   $901    42

Employee compensation and related

   616    633    (17  -3  1,579    1,342    237    18

Employee stock-based compensation

   105    100    5   5  211    188    23    12

Consulting and professional services

   378    162    216   133  575    391    184    47

Drug manufacturing

   75    110    (35  -32  316    163    153    94

Other

   81    63    18   29  161    146    15    10
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

   

 

 

   

 

 

   

 

 

 

Total research and development

  $3,019   $2,374   $645   27 $5,867   $4,354   $1,513    35
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

   

 

 

   

 

 

   

 

 

 

ExpensesHigher expenses were incurred for clinical studies represent the most significant component of our research and development expenses. Forfor the three and ninesix month periods ended SeptemberJune 30, 2016, expenditures on clinical studies of our investigational drugs increased2017 compared to the three and nine monthsame periods ended September 30, 2015, primarilyin 2016 due to our preparation for andthemid-2016 initiation of theour phase 2/3 FOCUS Studystudy of CA4P in platinum-resistant ovarian cancer in 2016. Forcancer. FOCUS represents the three month period,most advanced clinical study for our increasedlead investigational drug. Through June 30, 2017, we had enrolled 69 patients into the trial, and expenses for the 2017 periods include clinical trial costs for these patients, as compared to primarily planning costs for this trial during the 2016 period. The higher clinical study costs in 2017 associated with FOCUS Study were mostlypartially offset by a reduction inlower clinical costs for thea study of CA4P in neuroendocrine tumor (NETs) study, fortumors, or NETs, which patient treatment completed during the second quarter of 2016. The Company also received a vendor credit of $0.2 million recorded in the third quarter of 2016 based on newly renegotiated terms of a service agreement. Clinical study

Employee compensation and related expenses include costs incurred by contract research organizations who conduct clinical trials on our behalf, patient and clinical site costs, laboratory costs and other services directly related to clinical trials. The increased clinical trial activity during 2016 was also related to our increase in employee compensation for the nine month period ended September 30, 2016, because during the second half of 2015 we hired new personnel to support the clinical programs. Following our hiring of new personnel to support the clinical trial activity, we eliminated the positions of certain previous research and development personnel, resulting in lower employee compensation expenseswere similar for the three month period ended SeptemberJune 30, 2016 compared to2017 and the three month period ended SeptemberJune 30, 2015. The changes2016. Employee compensation and related expenses increased for the six month period ended June 30, 2017 compared to the same period in personnel also allowed us2016 due to reduce reliance on outside consultants,severance incurred in early 2017 as a result of a reduction in our development headcount in an area not related to the clinical trials. Employee stock-based compensation was similar for both three month periods, but increased for the six month period ended June 30, 2017 compared to the same period in 2016 due to the 2017 initial cliff vesting of certain stock options granted in March 2016, resulting in a reduction to the estimated forfeiture rates for this tranche, increasing the 2017 expense.

Consulting and these costs decreasedprofessional services increased for both the three and ninesix month periods ended SeptemberJune 30, 20162017 compared to the same periods in 2015.2016 largely due to expenses incurred to assist with recruiting patients into our FOCUS clinical trial.

DrugThe timing of drug manufacturing expenses can be highlycosts is variable and areis impacted by the timing of when drug product is needed for clinical trials, product expiration or re-test requirements, potential regulatory filings and scheduling of production batches based on thebatches. The decrease in drug manufacturer’s generally long lead time requirements. Drug manufacturing expenses did not meaningfully change amongfor the periods presented.three months ended June 30, 2017 compared to the three months ended June 30, 2016 was due to costs incurred during the 2016 period which were associated with supplying and labeling initial drug product for the FOCUS study. The increase in drug manufacturing expenses for the six month period ended June 30, 2017 compared to the six month period ended June 30, 2016 was due to work related to optimization of the manufacturing process for our VDAs.

Other expenses primarily include facility related expenses and licensing fees, which decreased for the nine month period ended September 30, 2016 compared to the same period in 2015 due to lower licensing fees paid for rights to our drug product candidates.

We expectrepresent less than 4% of research and development expenses for all periods presented.

Our FOCUS study of CA4P in platinum-resistant ovarian cancer ison-going and we continue to treat patients that are participating in the clinical study. As a result, research and development expenses may continue to increase in 2017 for the balance of 2016 as compared to 2015 dueclinical studies, subject to our planned additional clinical trial activity, primarily relatedability to the FOCUS Study.secure sufficient funding to continue these studies.

General and administrative expenses

The table below summarizes the most significant components of our general and administrative expenses for the periods indicated, in thousands, and provides the amount and percentage changes in these components:

   Three months ended,
September 30,
   Change  Nine months ended,
September 30,
   Change 
   2016   2015   Amount  %  2016   2015   Amount  % 

Employee compensation and related

  $460    $497    $(37  -7 $1,559    $1,454    $105    7

Stock-based compensation

   90     23     67    291  328     112     216    193

Consulting and professional services

   521     473     48    10  1,608     1,590     18    1

Other

   116     149     (33  -22  360     441     (81  -18
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

   

 

 

   

 

 

  

 

 

 

Total general and administrative

  $1,187    $1,142    $45    4 $3,855    $3,597    $258    7
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

   

 

 

   

 

 

  

 

 

 

   Three months ended
June 30,
   Change  Six months ended
June 30,
   Change 
   2017   2016   Amount  %  2017   2016   Amount  % 

Employee compensation and related

  $394   $511   $(117  -23 $923   $1,099   $(176  -16

Stock-based compensation

   100    135    (35  -26  235    239    (4  -2

Consulting and professional services

   279    509    (230  -45  649    1,086    (437  -40

Other

   104    141    (37  -26  192    244    (52  -21
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

   

 

 

   

 

 

  

 

 

 

Total general and administrative

  $877   $1,296   $(419  -32 $1,999   $2,668   $(669  -25
  

 

 

   

 

 

   

 

 

  

 

 

  

 

 

   

 

 

   

 

 

  

 

 

 

General and administrative expenses increaseddecreased for both the three and six month periods ended SeptemberJune 30, 20162017 compared to the same periods ended September 30, 2015. For the three-month period ended September 30, 2016, stock-based compensation increased as a result of higher option expenses for grants made during mid-2015 and early 2016, while base compensation and consulting and professional services were fairly consistent between the periods. For the nine month period ended September 30, 2016, employeein 2016.

Employee compensation and related costs increased as a result of several positions converting from part time to full timeexpenses decreased for the full 2016 period, asthree month and six month periods ended June 30, 2017 compared to only part of the 2015 period, as well as higher temporary housing costs associated with an employee relocation, partially offset by severance recorded in 2015 due to the departure of a former employee. Stock-based compensation expense also increased for the nine month periodsame periods ended SeptemberJune 30, 2016 due to stock option grants madelower accruals for incentive bonuses in the 2017 periods, reduced headcount in the 2017 period and a lower amount of net vacation earned.

Stock-based compensation decreased for the three month period ended June 30, 2017 compared to the three month period ended June 30, 2016 due to expenses incurred in the 2016 period related to the initial one year cliff vesting of certain options granted in 2015 following stockholder approval of a new stock option plan in mid-2015. the 2015 Equity Incentive Plan. Stock-based compensation expenses were comparable for the six month periods ended June 30, 2017 and 2016.

Consulting and professional services were similardecreased for both the ninethree month periods.and six month periods ended June 30, 2017 compared to the same periods ended June 30, 2016 due to significantly higher market research costs incurred during the first half of 2016 as well as reduced expenses in nearly all external general and administrative services used.

Other expenses, which include facility-relatedfacility related expenses and insurance expenses, decreased for both the three and ninesix month periods ended SeptemberJune 30, 2017 compared to the same periods ended June 30, 2016 due to lower fees paid in several differentcosts across most areas, the most significantnone of which was for lower corporate insurance costs.were individually significant.

We expect general and administrative expenses to increase for 2016 to continue at increased levels compared to 2015 in orderthe balance of 2017 to support our planned increase in research andclinical development activities, as well as for additional business development and investor relations efforts.efforts, subject to our ability to secure sufficient funding to continue these activities.

LIQUIDITY AND CAPITAL RESOURCES

Our business isWe are currently developing two investigational drugs, both VDAs, for the treatment of cancer and we currently have no sources of revenue. Werevenue to support the development costs for these investigational drugs. Accordingly, we measure liquidity by the cash and other capital we have available to fund our operations, which are primarily focused on the advancement of our VDAs.drug candidates. To date, we have financed our operations principally through proceeds received from the sale of equity and at one point through a strategic development arrangement which concluded in 2009.equity. We have experienced net losses in each year since our inception, and negative cash flowflows from operations in nearly every year also.year. As of SeptemberJune 30, 2016,2017, we had an accumulated deficit of $275over $286 million, including a net loss of approximately $10.2$7.8 million for the first nine monthshalf of 20162017 and approximatelya net loss of $13.7 million for the year ended December 31, 2015. At September2016. As of June 30, 2016,2017, we hadheld cash and cash equivalents and short-term investments of approximately $16.3$5 million, which we expect to be sufficient to fund our plannedoperating activities into approximately October 2017. If we are unable to secure additional funding prior to that date, we may be required to scale back or conclude our operations including continued development of our investigational drugs CA4P and OXi4503, into the third quarter of 2017. We expect to continue to incur expenses, resulting in losses and negative cash flows from operations, over at least the next several years as we develop our candidate drugs for the treatment of cancer.

We expect to incur significant additional costs over at least the next several years as a result of our plans to develop VDAs for the treatment of cancer, including continuing our existing clinical trials as well as conducting new, additional clinical trials and anticipated research and development expenditures.altogether.

We will require additional capital before we can complete all planned clinical trials and development of CA4P and OXi4503. Additional funding may not be available to us on acceptable terms, or at all. If we are unable to access additional funds when needed we may not be able to continue the development of our product candidates or we could be required to delay, scale back or eliminate some or all of our development programs and operations. Any additional equity financing, if available, may not be available on favorable terms and would most likely be dilutive to our current stockholders and debtstockholders. Debt financing, if available, may involve restrictive covenants.covenants and could also be dilutive to our current stockholders. If we are able to access funds through collaborative or licensing arrangements, we may be required to relinquish rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize on our own, on terms that are not favorable to us.

We have filed a shelf registration statement on Form S-3 with the SEC, covering the sale from time to time of shares of our common stock and other securities, which may provide us the opportunity to raise funds when we consider it necessary or appropriate, at prices and on terms to be determined at the time of any such offering. However, pursuant to the instructions to Form S-3, we only have the ability to sell shares under the shelf registration statement, during any 12-month period, in an amount less than or equal to one-third of the aggregate market value of our common stock held by non-affiliates. Our ability to access capital when needed is not assured and, if access is not achieved on a timely basis, will materially harm our business, financial condition and results of operations. Our ability

If we are able to raisesecure additional capital could also be further impaired iffunding to continue our common stock is delisted from The NASDAQ Capital Marketoperations, we expect to incur significant additional costs and trades onexpenses over at least the over-the-counter market.

We currently do not comply with the NASDAQ requirement to havenext several years as a minimum $1.00 per share closing bid price. At our annual meeting held on June 1, 2016, our stockholders did not approve a proposal authorizing a reverse splitresult of our common stock. This reverse split could have rectifiedplans to develop VDAs for the treatment of cancer, including continuing our noncompliance with the NASDAQ bid-price requirement.existing clinical trials as well as conducting new, additional clinical trials and anticipated research and development expenditures. We currently have a different reverse split proposal scheduled for stockholder vote on November 11, 2016. If this proposal is not approvedanticipate that our development will include continuing our current clinical trials as well as new clinical trials and our common stock is delisted by NASDAQ,additional research and accordingly no longer trades on a national stock exchange, both the price of our common stock and our ability to raise additional capital are likely to be significantly and negatively impacted. NASDAQ has provided us with a grace period through November 28, 2016 to regain compliance with the minimum bid price requirement.development expenditures.

Critical Accounting Policies and Significant Judgments and Estimates

There have been no changes to our critical accounting policies and significant judgments and estimates from our Annual Report on Form10-K for the year ended December 31, 2015.2016.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

There have been no changes to our market risks from our Annual Report on Form10-K for the year ended December 31, 2015.2016.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

The SEC requires that as of the end of the period covered by this Quarterly Report onForm 10-Q, the Chief Executive Officer (CEO) and the Chief Financial Officer (CFO) evaluate the effectiveness of the design and operation of our disclosure controls and procedures (as defined inRules 13a-15(e) and15d-15(e)) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, and report on the effectiveness of the design and operation of our disclosure controls and procedures. Based upon that evaluation, our CEO and CFO concluded that our disclosure controls and procedures were effective, as of SeptemberJune 30, 20162017, to ensure that we record, process, summarize and report the information we must disclose in reports that we file or submit under the Exchange Act, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our CEO and CFO, as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting, identified in connection with the evaluation of such control that occurred during the last fiscal quarter, which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Important Considerations

The effectiveness of our disclosure controls and procedures and our internal control over financial reporting is subject to various inherent limitations, including cost limitations, judgments used in decision making, assumptions about the likelihood of future events, the soundness of our systems, the possibility of human error, and the risk of fraud. Moreover, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions and the risk that the degree of compliance with policies or procedures may deteriorate over time. Because of these limitations, there can be no assurance that any system of disclosure controls and procedures or internal control over financial reporting will be successful in preventing all errors or fraud or in making all material information known in a timely manner to the appropriate levels of management.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings

Not applicable.

Item 1A. Risk Factors

Except as set forth below, thereThere have been no other material changes to the risk factors as described in our Annual Report on Form10-K for the year ended December 31, 2015.

We currently do not meet the continued listing standards of The NASDAQ Capital Market, which require a minimum closing bid price of $1.00 per share, and on June 1, 2016, our stockholders did not approve a reverse stock split which could have enabled us to regain compliance with these continued listing standards. Our failure to meet NASDAQ’s continued listing standards could result in the delisting of our common stock, negatively impact the price of our common stock and negatively impact our ability to raise additional capital.

Our common stock is listed on The NASDAQ Capital Market. NASDAQ provides various continued listing requirements that a company must meet in order for its stock to continue trading on The NASDAQ Capital Market. Among these requirements is the requirement that the Company’s stock trades at a minimum closing bid price of $1.00 per share. Our stock has recently and consistently traded below $1.00 per share, including closing bid prices below $1.00 per share. On December 1, 2015, we received a deficiency letter from The NASDAQ Stock Market which provided us a grace period of 180 calendar days, or until May 31, 2016, to regain compliance with the minimum bid price requirement, which would require a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days. We did not meet the minimum bid requirement prior to the expiration of the grace period on May 31, 2016.

At our annual stockholders’ meeting held on June 1, 2016, our stockholders failed to approve a proposal authorizing our Board of Directors to consummate a reverse stock split of our common stock in the range of 1:5 and 1:10. On June 1, 2016, we received notice that NASDAQ granted us an additional 180-day grace period (until November 28, 2016) to regain compliance with NASDAQ’s $1.00 per share minimum bid price requirement under Nasdaq Marketplace Listing Rule 5810(c)(3)(A). We may achieve compliance during this additional 180-day period if the closing bid price of our common stock is at least $1.00 per share for a minimum of 10 consecutive business days before November 28, 2016. We are currently seeking stockholder approval for a different reverse stock split proposal, which provides for a reverse split in the range of 1:2 to 1:4, with voting results scheduled for November 11, 2016. We can provide no assurance that our stockholders will approve this proposal. If we fail to regain compliance on or prior to November 28, 2016, our stock will be subject to delisting by NASDAQ. Additionally, if we fail to comply with any other continued listing standards of NASDAQ, our common stock will also be subject to delisting. If that were to occur, our common stock would be subject to rules that impose additional sales practice requirements on broker-dealers who sell our securities. The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from effecting transactions in our common stock. This would significantly negatively affect the ability of investors to trade our securities and would significantly negatively affect the value and liquidity of our common stock. These factors could contribute to lower prices and larger spreads in the bid and ask prices for our common stock.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

None.

Item 5. Other Information

None.

Item 6. Exhibits

 

      Incorporated by Reference    

Exhibit
Number

  

Description

  Form   Filing Date   Exhibit
Number
   Filed
Herewith
10.1  Amended and Restated Employment Agreement, by and between Mateon Therapeutics, Inc. and David J. Chaplin, Ph.D.*   8-K     10/28/2016     10.1    
10.2  Amended and Restated Director Compensation Policy*   8-K     10/28/2016     10.2    
31.1  Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and15d-14(a).        x
31.2  Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and15d-14(a).        x
32.1  Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of theSarbanes-Oxley Act of 2002.        x
101  The following materials from Mateon Therapeutics, Inc.’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Balance Sheets at September 30, 2016 and December 31, 2015, (ii) Condensed Statements of Comprehensive Loss for the three and nine months ended September 30, 2016 and 2015, (iii) Condensed Statements of Cash Flows for the nine months ended September 30, 2016 and 2015, and (iv) Notes to Condensed Financial Statements        x

*Management contract or compensatory plan or arrangement.

Incorporated by Reference

Exhibit
Number

Description

Form

Filing Date

Exhibit
Number

Filed
Herewith
31.1Certification of Chief Executive Officer pursuant toRule 13a-14(a) and15d-14(a).x
31.2Certification of Chief Financial Officer pursuant to Rule13a-14(a) and15d-14(a).x
32.1Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.x
101The following materials from Mateon Therapeutics, Inc.’s Quarterly Report on Form10-Q for the quarter ended June 30, 2017, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Balance Sheets at June 30, 2017 and December 31, 2016, (ii) Condensed Statements of Comprehensive Loss for the three and six months ended June 30, 2017 and 2016, (iii) Condensed Statements of Cash Flows for the six months ended June 30, 2017 and 2016, and (iv) Notes to Condensed Financial Statementsx

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.

 

 

Mateon Therapeutics, Inc.

(Registrant)

Date: November 14, 2016August 2, 2017 By: 

/s/William D. Schwieterman

  William D. Schwieterman
  

Chief Executive Officer

(Principal Executive Officer)

Date: November 14, 2016August 2, 2017 By: 

/s/Matthew M. Loar

  Matthew M. Loar
  

Chief Financial Officer

(Principal Financial Officer)

 

1715