UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended September 30, 2016
OR
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 001-37587
CytomX Therapeutics, Inc.
(Exact name of Registrant as Specified in its Charter)
Delaware |
|
27-3521219 |
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification No.) |
151 Oyster Point Blvd., Suite 400 South San Francisco, CA 94080 (650) 515-3185 (Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices) |
Indicate by check mark whether the issuer (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 website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). 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. (Check one)
Large accelerated filer |
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☐ |
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Accelerated filer |
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☐ |
Non-accelerated filer |
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☒ (Do not check if a smaller reporting company) |
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Smaller reporting company |
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☐ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of November 1, 2016, 36,402,346 shares of the registrant’s common stock were outstanding.
FORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 2016
TABLE OF CONTENTS
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PART I – FINANCIAL INFORMATION |
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Item 1. |
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5 |
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5 |
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6 |
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7 |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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26 |
Item 3. |
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32 |
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Item 4 |
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32 |
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PART II – OTHER INFORMATION |
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Item 1. |
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33 |
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Item 1A. |
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33 |
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Item 2. |
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63 |
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Item 3. |
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64 |
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Item 4. |
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64 |
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Item 5. |
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64 |
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Item 6. |
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64 |
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65 |
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66 |
2
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains certain forward-looking statements that involve risks and uncertainties. These forward-looking statements reflect our current views with respect to, among other things, future events and our financial performance. These statements are often, but not always, made through the use of words or phrases such as “may,” “might,” “should,” “could,” “predict,” “potential,” “believe,” “expect,” “continue,” “will,” “anticipate,” “seek,” “estimate,” “intend,” “plan,” “projection,” “would,” “annualized” and “outlook,” or the negative version of those words or other comparable words or phrases of a future or forward-looking nature. These forward-looking statements are not historical facts, and are based on current expectations, estimates and projections about our industry, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond our control. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions, estimates and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.
A number of important factors could cause our actual results to differ materially from those indicated in these forward-looking statements, including those factors identified in “Risk Factors” or “Management’s Discussion and Analysis of Financial Condition and Results of Operations” or the following:
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the initiation, timing, progress and results of our research and development programs, preclinical studies, any clinical trials and Investigational New Drug application (“IND”), Clinical Trial Application, New Drug Application (“NDA”), Biologics License Application (“BLA”) and other regulatory submissions; |
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our receipt and timing of any milestone payments or royalties under any existing or future research collaboration and license agreements or arrangements; |
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our expectations regarding the activity of our product candidates once administered in a human subject; |
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our expectations and beliefs regarding the evolution of the market for cancer therapies and development of the immuno-oncology industry; |
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our ability to identify and develop products for novel cancer targets; |
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our dependence on existing and future collaborators for developing, obtaining regulatory approval for and commercializing product candidates in such collaborations; |
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our ability to identify and develop product candidates for treatment of additional disease indications; |
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our or an existing or future collaborator’s ability to obtain and maintain regulatory approval of any of our or such collaborator’s product candidates; |
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the rate and degree of market acceptance of any approved products candidates; |
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the commercialization of any approved product candidates; |
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our ability to establish and maintain collaborations and retain commercial rights for our product candidates in the collaborations; |
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the implementation of our business model and strategic plans for our business, technologies and product candidates; |
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our estimates of our expenses, ongoing losses, future revenue and capital requirements; |
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our ability to obtain additional funds for our operations; |
3
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rights of others; |
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our reliance on third parties to conduct our preclinical studies or any future clinical trials; |
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our reliance on third-party supply and manufacturing partners to supply the materials and components for, and manufacture, our research and development, preclinical and clinical trial product supplies; |
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our ability to attract and retain qualified key management and technical personnel; |
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our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012; |
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our financial performance; and |
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developments relating to our competitors or our industry. |
Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part II, Item 1A. Risk Factors and discussed elsewhere in this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
This Quarterly Report on Form 10-Q also contains estimates, projections and other information concerning our industry, our business and the markets for certain drugs and therapeutic biologics, including data regarding the estimated size of those markets, their projected growth rates and the incidence of certain medical conditions. Information that is based on estimates, forecasts, projections or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained these industry, business, market and other data from reports, research surveys, studies and similar data prepared by third parties, industry, medical and general publications, government data and similar sources. In some cases, we do not expressly refer to the sources from which these data are derived.
Except where the context otherwise requires, in this Quarterly Report on Form 10-Q, “we,” “us,” “our” and the “Company” refer to CytomX Therapeutics, Inc., a Delaware corporation.
Trademarks
This Quarterly Report on Form 10-Q includes trademarks, service marks and trade names owned by us or other companies. All trademarks, service marks and trade names included in this Quarterly Report on Form 10-Q are the property of their respective owners.
4
PART I – FINANCIAL INFORMATION
CYTOMX THERAPEUTICS, INC.
(in thousands, except share and per share data)
(unaudited)
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September 30, |
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December 31, |
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2016 |
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2015 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
59,758 |
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$ |
59,822 |
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Short-term investments |
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118,707 |
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126,889 |
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Accounts receivable |
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240 |
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372 |
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Related party accounts receivable |
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207 |
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372 |
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Prepaid expenses and other current assets |
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4,401 |
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2,299 |
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Total current assets |
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183,313 |
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189,754 |
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Long-term investments |
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2,025 |
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— |
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Property and equipment, net |
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3,701 |
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3,481 |
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Intangible assets |
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1,750 |
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1,750 |
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Goodwill |
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949 |
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949 |
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Restricted cash |
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917 |
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917 |
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Other assets |
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226 |
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364 |
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Total assets |
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$ |
192,881 |
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$ |
197,215 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ |
517 |
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$ |
4,697 |
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Accrued liabilities |
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9,041 |
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4,912 |
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Deferred revenues, current portion |
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14,124 |
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6,130 |
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Total current liabilities |
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23,682 |
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15,739 |
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Deferred revenue, net of current portion |
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79,110 |
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54,703 |
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Deferred tax liability |
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513 |
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507 |
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Other long-term liabilities |
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154 |
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198 |
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Total liabilities |
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103,459 |
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71,147 |
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Commitments and contingencies (Note 11) |
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Preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued and outstanding at September 30, 2016 and December 31, 2015. |
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— |
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— |
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Common stock, $0.00001 par value; 75,000,000 shares authorized; 36,392,821 and 36,033,209 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively |
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1 |
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1 |
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Stockholders notes receivable |
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— |
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(78 |
) |
Additional paid-in capital |
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251,748 |
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243,687 |
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Accumulated other comprehensive income / (loss) |
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6 |
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(76 |
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Accumulated deficit |
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(162,333 |
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(117,466 |
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Total stockholders' equity |
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89,422 |
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126,068 |
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Total liabilities and stockholders' equity |
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$ |
192,881 |
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$ |
197,215 |
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See accompanying notes to condensed financial statements.
5
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2016 |
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2015 |
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2016 |
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2015 |
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Revenues |
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$ |
2,829 |
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$ |
1,471 |
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$ |
7,151 |
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$ |
4,422 |
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Revenues from related parties |
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625 |
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468 |
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1,620 |
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1,302 |
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Total revenues |
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3,454 |
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1,939 |
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8,771 |
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5,724 |
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Operating expenses: |
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Research and development |
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13,337 |
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9,157 |
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39,407 |
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18,854 |
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General and administrative |
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5,033 |
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4,051 |
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14,720 |
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8,549 |
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Total operating expenses |
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18,370 |
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13,208 |
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54,127 |
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27,403 |
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Loss from operations |
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(14,916 |
) |
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(11,269 |
) |
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(45,356 |
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(21,679 |
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Interest income |
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692 |
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407 |
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1,842 |
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874 |
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Interest expense |
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(482 |
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(718 |
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(1,300 |
) |
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(1,356 |
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Other income (expense), net |
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45 |
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(287 |
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(46 |
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(1,718 |
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Loss before provision for income taxes |
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(14,661 |
) |
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(11,867 |
) |
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(44,860 |
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(23,879 |
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Provision for income taxes |
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1 |
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3 |
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7 |
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8 |
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Net loss |
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(14,662 |
) |
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(11,870 |
) |
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(44,867 |
) |
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(23,887 |
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Accretion to redemption value and cumulative dividends on preferred stock |
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— |
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(2,958 |
) |
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— |
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(6,147 |
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Net loss attributable to common stockholders |
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$ |
(14,662 |
) |
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$ |
(14,828 |
) |
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$ |
(44,867 |
) |
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$ |
(30,034 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.40 |
) |
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$ |
(14.26 |
) |
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$ |
(1.24 |
) |
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$ |
(29.66 |
) |
Shares used to compute net loss per share attributable to common stockholders, basic and diluted |
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36,324,805 |
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1,039,567 |
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36,168,026 |
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1,012,534 |
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Other comprehensive loss: |
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|
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|
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Changes in unrealized gains / (losses) on investments |
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(72 |
) |
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(7 |
) |
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82 |
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(8 |
) |
Total other comprehensive income / (loss) |
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(72 |
) |
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(7 |
) |
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82 |
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(8 |
) |
Comprehensive loss |
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$ |
(14,734 |
) |
|
$ |
(11,877 |
) |
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$ |
(44,785 |
) |
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$ |
(23,895 |
) |
See accompanying notes to condensed financial statements.
6
CONDENSED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Nine Months Ended |
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September 30, |
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2016 |
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2015 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(44,867 |
) |
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$ |
(23,887 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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1,243 |
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|
877 |
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Amortization of debt discount |
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— |
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80 |
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Accretion of discount on investments |
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1,256 |
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|
816 |
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Stock-based compensation expense |
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7,473 |
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2,065 |
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Issuance of stock in connection with services |
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159 |
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— |
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Change in fair value of convertible preferred stock liability |
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— |
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1,114 |
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Change in fair value of convertible preferred stock warrant liability |
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— |
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|
602 |
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Deferred income taxes |
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6 |
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8 |
|
Changes in operating assets and liabilities |
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|
|
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Accounts receivable |
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132 |
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|
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(73 |
) |
Related party accounts receivable |
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|
165 |
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|
1,542 |
|
Prepaid expenses and other current assets |
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|
(2,102 |
) |
|
|
(396 |
) |
Other assets |
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|
138 |
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|
121 |
|
Accounts payable |
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|
(4,059 |
) |
|
|
749 |
|
Accrued liabilities and other long-term liabilities |
|
|
4,087 |
|
|
|
1,733 |
|
Deferred revenue |
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|
32,401 |
|
|
|
(4,597 |
) |
Net cash used in operating activities |
|
|
(3,968 |
) |
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|
(19,246 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
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Purchases of property and equipment |
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|
(1,574 |
) |
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|
(1,412 |
) |
Purchases of investments |
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|
(121,517 |
) |
|
|
(129,553 |
) |
Maturities of investments |
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|
126,500 |
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|
|
51,250 |
|
Net cash provided by / (used in) investing activities |
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|
3,409 |
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|
|
(79,715 |
) |
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs |
|
|
— |
|
|
|
74,430 |
|
Proceeds from exercise of stock options |
|
|
429 |
|
|
|
128 |
|
Proceeds from stockholder notes |
|
|
78 |
|
|
|
326 |
|
Repayment of notes payable |
|
|
— |
|
|
|
(3,027 |
) |
Payment of deferred offering costs |
|
|
(12 |
) |
|
|
(1,101 |
) |
Net cash provided by financing activities |
|
|
495 |
|
|
|
70,756 |
|
Net decrease in cash and cash equivalents |
|
|
(64 |
) |
|
|
(28,205 |
) |
Cash and cash equivalents, beginning of period |
|
|
59,822 |
|
|
|
64,396 |
|
Cash and cash equivalents, end of period |
|
$ |
59,758 |
|
|
$ |
36,191 |
|
Supplemental disclosures of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
— |
|
|
$ |
220 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of noncash investing and financing items: |
|
|
|
|
|
|
|
|
Net change in acquisition of property and equipment in accounts payable and accrued liabilities |
|
|
(111 |
) |
|
|
114 |
|
Accretion to redemption value and cumulative dividends on preferred stock |
|
|
— |
|
|
|
6,147 |
|
Convertible preferred stock liability recorded in connection with redeemable convertible preferred stock, net |
|
|
— |
|
|
|
1,509 |
|
Issuance costs in accounts payable and accrued liabilities |
|
|
— |
|
|
|
283 |
|
Deferred offering costs in accounts payable and accrued liabilities |
|
|
— |
|
|
|
1,862 |
|
See accompanying notes to condensed financial statements.
7
Notes to Condensed Financial Statements (Unaudited)
1. Description of the Business
CytomX Therapeutics, Inc. (the “Company”) is an oncology-focused biopharmaceutical company developing Probody therapeutics for the treatment of cancer. Probody therapeutics are masked antibodies that remain inert in healthy tissue but are activated specifically in the disease microenvironment. The Company is located in South San Francisco, California and was incorporated in the state of Delaware in September 2010.
Initial Public Offering
On October 7, 2015, the Company’s registration statement on Form S-1 (File No. 333-206658) relating to its initial public offering (“IPO”) of its common stock was declared effective by the Securities and Exchange Commission (“SEC”) and the shares of its common stock began trading on The NASDAQ Global Select Market on October 8, 2015. The public offering price of the shares sold in the IPO was $12.00 per share. The IPO closed on October 14, 2015, pursuant to which the Company sold 7,666,667 shares of common stock, including the sale of 1,000,000 shares of common stock to the underwriters upon their exercise of their option to purchase additional shares. The Company received net proceeds of approximately $81.8 million, after underwriting discounts, commissions and offering expenses. Immediately prior to the consummation of the IPO, all outstanding shares of convertible preferred stock and redeemable convertible preferred stock converted into common stock.
Reverse Stock Split
On October 2, 2015, the Company effected a one-for-62.997 reverse stock split of the Company’s issued and outstanding shares of common stock, redeemable convertible preferred stock and convertible preferred stock. The par values of the common stock, redeemable convertible preferred stock and convertible preferred stock were not adjusted as a result of the reverse split. All authorized and issued and outstanding shares of common stock, redeemable convertible preferred stock and convertible preferred stock and per share amounts contained in the accompanying condensed financial statements have been retroactively adjusted to reflect this reverse stock split for all periods presented.
2. Liquidity
Since inception, the Company has incurred recurring net operating losses. As of September 30, 2016 and December 31, 2015, the Company had an accumulated deficit of $162.3 million and $117.5 million, respectively, and expects to incur losses for the foreseeable future. To date, the Company has financed its operations primarily through sales of its common stock in conjunction with the IPO, sales of its convertible preferred securities and payments received under its collaboration agreements. As of September 30, 2016 and December 31, 2015, the Company had cash, cash equivalents, short-term and long-term investments of $180.5 million and $186.7 million, respectively. In May and June 2015, the Company received aggregate net proceeds of $73.2 million from the issuance of its Series C and Series D redeemable convertible preferred stock. In October 2015, the Company consummated its IPO and raised net proceeds of approximately $81.8 million, after deducting underwriting discounts and commissions and offering expenses.
3. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. The Company’s functional and reporting currency is the U.S. dollar.
Unaudited Interim Financial Information
The accompanying interim condensed financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the results of operations for the periods presented.
The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. The condensed results of operations for the three and nine months ended September 30, 2016 are not necessarily
8
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
indicative of the results to be expected for the full year or for any other future year or interim period. The accompanying condensed financial statements should be read in conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC.
Use of Estimates
The preparation of the financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
Concentration of Credit Risk and Other Risks and Uncertainties
The Company is subject to a number of risks similar to other biopharmaceutical companies in the early stage, including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s products, and protection of proprietary technology. If the Company does not successfully obtain regulatory approval, commercialize or partner any of its product candidates, it will be unable to generate revenue from product sales or achieve profitability.
Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents, short-term investments, long-term investments and accounts receivable. Substantially all the Company’s cash is held by one financial institution that management believes is of high credit quality. Such deposits may, at times, exceed federally insured limits. The Company invests its cash equivalents in highly rated money market funds and its investments in U.S. Government Bonds.
Customers who represent 10% of more of the Company’s total revenue during each period presented or net accounts receivable balance at each respective balance sheet date are as follows:
|
|
Revenue |
|
|
Accounts Receivable, net |
|
||||||||||||||||||
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
September 30, |
|
|
December 31, |
|
||||||||||||
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
||||||
Customer A |
|
|
52 |
% |
|
|
76 |
% |
|
|
61 |
% |
|
|
77 |
% |
|
|
54 |
% |
|
|
50 |
% |
Customer B |
|
|
30 |
% |
|
|
0 |
% |
|
|
21 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Customer C |
|
|
18 |
% |
|
|
24 |
% |
|
|
18 |
% |
|
|
23 |
% |
|
|
46 |
% |
|
|
50 |
% |
|
All of the Company’s customers are located in the United States of America.
Segments
Management has determined that it has one business activity and operates as one operating segment as it only reports financial information on an aggregate basis to its chief executive officer, who is the Company’s chief operating decision maker. All long-lived assets are maintained in the United States of America.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with original maturities of three months or less at the date of purchase to be cash equivalents.
Restricted Cash
Restricted cash represents a standby letter of credit issued pursuant to an office lease entered in December 2015.
9
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
Long-term Investments and Short-term Investments
All investments have been classified as “available-for-sale” and are carried at fair value as determined based upon quoted market prices or pricing models for similar securities at period end. Investments with contractual maturities less than 12 months at the date of purchase are considered short-term investments. Those investments with contractual maturities greater than 12 months at the date of purchase are considered long-term investments. Unrealized gains and losses, deemed temporary in nature, are reported as a component of accumulated other comprehensive income (loss), net of tax.
A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the security. Premiums (discounts) are amortized (accreted) over the life of the related security as an adjustment to yield using the straight-line interest method. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of securities sold.
Property and Equipment, net
Property and equipment are recorded at cost net of accumulated depreciation and amortization. Depreciation is provided using the straight-line method over the estimated useful lives of the respective assets. The useful lives of property and equipment are as follows:
Machinery and equipment |
|
5 years |
Computer equipment and software |
|
3 years |
Furniture and fixtures |
|
3 years |
Leasehold improvements |
|
Shorter of remaining |
|
|
lease term or estimated life of the assets |
Maintenance and repairs that do not extend the life or improve the asset are expensed when incurred.
Goodwill and Intangible Assets
Goodwill represents the excess of the purchase price paid over the fair value of tangible and identifiable intangible assets acquired in business combinations. Goodwill and other intangible assets with indefinite lives are not amortized, but are assigned to reporting units and tested for impairment annually, or whenever there is an impairment indicator. Intangible assets are comprised of in-process research and development (“IPR&D”), which is accounted for as an indefinite-lived intangible asset until the underlying projects are completed or abandoned. The Company assesses impairment indicators annually or more frequently, if a change in circumstances or the occurrence of events suggests the remaining value may not be recoverable. Intangible assets that are not deemed to have an indefinite life are amortized over their estimated useful lives. There was no impairment of goodwill or intangible assets identified during the nine months ended September 30, 2016 and the year ended December 31, 2015.
Impairment of Long-Lived Assets
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset (or asset group) may not be recoverable and prior to any goodwill impairment test. An impairment loss is recognized when the total of estimated undiscounted future cash flows expected to result from the use of the asset (or asset group) and its eventual disposition is less than its carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. There was no impairment of long-lived assets during the periods presented in these condensed financial statements.
Convertible Preferred Stock Warrant Liability
Freestanding warrants for shares that are contingently redeemable are classified as liabilities on the balance sheet at their estimated fair value because the shares underlying the warrants may obligate the Company to transfer assets to the holders at a future date under certain circumstances such as a deemed liquidation event. The warrants are subject to re-measurement at each balance sheet date and the change in fair value, if any, is included in other income (expense), net. The Company adjusted the liability for changes in fair value until the consummation of its IPO in October 2015, at which time all convertible preferred stock warrants were net exercised into shares of common stock and the related convertible preferred stock warrant liability was reclassified to additional paid-in capital.
10
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
Convertible Preferred Stock Liability
The obligation to issue additional shares of Series B-1 and Series C redeemable convertible preferred stock at a future date was determined to be a freestanding instrument that should be accounted for as a liability. At initial recognition, the Company recorded the convertible preferred stock liability on the balance sheets at its estimated fair value. The liability is subject to remeasurement at each balance sheet date, with changes in fair value recognized as a component of other income (expense), net. At the time of each funding, the Company remeasured the liability, with the change in fair value recognized as a component of other income (expense), net and then reclassifies the fair value associated with the convertible preferred stock liability to the applicable series of redeemable convertible preferred stock. Immediately prior to the consummation of the Company’s IPO in October 2015, the convertible preferred stock converted to 27,135,453 shares of common stock.
Comprehensive Income (Loss)
Comprehensive income (loss) represents all changes in stockholders’ equity except those resulting from distributions to stockholders. The Company’s unrealized gains and losses on investments represent the only component of other comprehensive loss that is excluded from the reported net loss.
Revenue Recognition
The Company recognizes revenue when all of the following criteria are met: persuasive evidence that an arrangement exists; transfer of technology has been completed or services have been rendered; the price to the customer is fixed or determinable; and collectability is reasonably assured.
The Company’s revenues are primarily derived through its license, research, development and commercialization agreements. The terms of these types of agreements may include (i) licenses for the Company’s technology, (ii) research and development services, and (iii) services or obligations in connection with participation in research or steering committees. Payments to the Company under these arrangements typically include one or more of the following: nonrefundable upfront and license fees, research funding, milestone and other contingent payments to the Company for the achievement of defined collaboration objectives and certain preclinical, clinical, regulatory and sales-based events, as well as royalties on sales of any commercialized products.
In arrangements involving the delivery of more than one element, each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting. The determination is based on whether the deliverable has “standalone value” to the customer. If a deliverable does not qualify as a separate unit of accounting, it is combined with the other applicable undelivered item(s) within the arrangement and these combined deliverables are treated as a single unit of accounting.
The arrangement’s consideration that is fixed or determinable is allocated to each separate unit of accounting based on the relative selling price methodology in accordance with the selling price hierarchy, which includes vendor-specific objective evidence (“VSOE”) of selling price, if available, or third-party evidence of selling price if VSOE is not available, or the best estimate of selling price, if neither VSOE nor third-party evidence is available.
Payments or reimbursements for the Company’s research and development efforts for the arrangements where such efforts are considered as deliverables are recognized as the services are performed and are presented on a gross basis. When upfront payments are received and if there is no discernible pattern of performance and/or objectively measurable performance measures do not exist, the Company recognizes revenue ratably over the associated period of performance.
The Company’s collaboration and license agreements may include contingent payments related to specified research, development and regulatory milestones and sales-based milestones. Such payments are typically payable under the collaborations when the collaboration partner claims or selects a target, or initiates or advances a covered product candidate in preclinical or clinical development, upon submission for marketing approval of a covered product with regulatory authorities, upon receipt of actual marketing approvals of a covered product or for additional indications, or upon the first commercial sale of a covered product. Sales-based milestones are typically payable when annual sales of a covered product reach specified levels. Each contingent and milestone payment is evaluated to determine whether it is substantive and at risk to both parties. The Company recognizes any payment that is contingent upon the achievement of a substantive milestone entirely in the period in which the milestone is achieved. Any payments that are contingent upon achievement of a non-substantive milestone are recognized as revenue prospectively, when such payments become due and collectible, over the remaining expected performance period under the arrangement, which is generally the remaining period over which the research and development services are expected to be provided.
11
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
Research and Development Expenses
Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, depreciation on and maintenance of research equipment, the cost of services provided by outside contractors, and the allocated portions of facility costs, such as rent, utilities, insurance, repairs and maintenance, depreciation, and general support services. All costs associated with research and development are expensed as incurred.
Stock-Based Compensation
The Company measures its stock-based awards made to employees based on the fair values of the awards as of the grant date using the Black-Scholes option-pricing model. Stock-based compensation expense is recognized over the requisite service period using the straight-line method and is based on the value of the portion of stock-based payment awards that is ultimately expected to vest. As such, the Company’s stock-based compensation is reduced for the estimated forfeitures at the date of grant and revised in subsequent periods if actual forfeitures differ from those estimates.
Stock-based compensation expense for options granted to non-employees as consideration for services received is measured on the date of performance at the fair value of the consideration received or the fair value of the equity instruments issued, using the Black-Scholes option-pricing model, whichever can be more reliably measured. Compensation expense for options granted to non- employees is periodically remeasured as the underlying options vest.
Income Taxes
The Company accounts for income taxes under the liability method which requires, among other things, that deferred income taxes be provided for temporary differences between the tax basis of the Company’s assets and liabilities and their financial statement reported amounts. In addition, deferred tax assets are recorded for the future benefit of utilizing net operating losses and research and development credit carryforwards. A valuation allowance is provided against deferred tax assets unless it is more likely than not that they will be realized.
The Company recognizes benefits of uncertain tax positions if it is more likely than not that such positions will be sustained upon examination based solely on their technical merits, as the largest amount of benefit that is more likely than not to be realized upon the ultimate settlement. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits.
Net Loss per Share Attributable to Common Stockholders
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period, without consideration of potentially dilutive securities. Diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since the effect of potentially dilutive securities is anti-dilutive.
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers, which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. The new standard will be effective for the Company on January 1, 2018, which is the effective date for public companies. Early application is permitted as of January 1, 2017. The standard permits the use of either the retrospective or cumulative effect transition method. Additionally, in March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net), which clarifies the implementation guidance on principal versus agent considerations in ASU No. 2014-09. In April 2016, the FASB issued ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, which clarifies certain aspects of identifying performance obligations and licensing implementation guidance. In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients, which relates to disclosures of remaining performance obligations, as well as other amendments to guidance on collectability, non-cash consideration and the presentation of sales and other similar taxes collected from customers. These standards have the same effective
12
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
date and transition date of January 1, 2018. The Company is evaluating the effect that ASU 2014-09 will have on its financial statements and related disclosures. The Company has not yet selected a transition method nor has it determined the effect of the standard on its ongoing financial reporting.
In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern. This standard update provides guidance around management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. The new guidance is effective for all annual and interim periods ending after December 15, 2016. The Company does not believe that adopting ASU 2014-15 will have a material impact on its financial statements.
In November 2015, the FASB issued ASU No 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes. This standard amends the accounting for income taxes and requires that all deferred tax assets and liabilities be classified as noncurrent in a classified statement of financial position. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016, with early adoption permitted. As the Company’s deferred tax balance is already classified as noncurrent, the adoption of this new guidance is not expected to have a financial statement impact.
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). Under ASU 2016-2, an entity will be required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. ASU 2016-02 offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. For public companies, ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2018, including interim periods within that reporting period, and requires a modified retrospective adoption, with early adoption permitted. The Company plans to adopt this guidance beginning with its first quarter ending March 31, 2019. The Company is in the process of evaluating the future impact of ASU 2016-02 on its financial statements.
In March 2016, the FASB issued ASU No. 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. ASU 2016-09 simplifies several aspects of accounting for share-based payment award transactions, including income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. ASU 2016-09 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016, with early adoption permitted. The Company is in the process of assessing the impact of adoption of ASU 2016-09 of its financial statements.
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The new standard changes the impairment model for most financial assets and certain other instruments. Under the new standard, entities holding financial assets and net investment in leases that are not accounted for at fair value through net income are to be presented at the net amount expected to be collected. An allowance for credit losses will be a valuation account that will be deducted from the amortized cost basis of the financial asset to present the net carrying value at the amount expected to be collected on the financial asset. The new standard will be effective for us on January 1, 2020. The adoption of this standard is not expected to have a material impact on our financial position or results of operations.
In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. The new standard addresses the classification of certain specific cash flow issues including debt prepayment or extinguishment costs, settlement of certain debt instruments, contingent consideration payments made after a business combination, proceeds from the settlement of certain insurance claims and distributions received from equity method investees. The new standard is effective for fiscal years beginning after December 15, 2017 and interim periods within those fiscal years, with early adoption permitted. An entity that elects early adoption must adopt all of the amendments in the same period. The Company is currently evaluating the effect this ASU will have on its statement of cash flows.
13
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
4. Fair Value Measurements and Investments
The Company records its financial assets and liabilities at fair value. The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:
|
• |
Level I: Inputs which include unadjusted quoted prices in active markets for identical assets or liabilities. |
|
• |
Level II: Inputs other than Level I that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets or liabilities; unadjusted quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
|
• |
Level III: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
The carrying amounts of the Company’s financial instruments, including restricted cash, accounts receivable, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. The Company’s financial instruments consist of Level I and II assets. Level I assets consist primarily of highly liquid money market funds, some of which are included in restricted cash. The Company’s Level II assets consist of U.S. government bonds that are included in short-term and long-term investments.
The following tables set forth the fair value of the Company’s financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements (in thousands):
|
|
September 30, 2016 |
|
|||||||||||||
|
|
Level I |
|
|
Level II |
|
|
Level III |
|
|
Total |
|
||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
57,684 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
57,684 |
|
Restricted cash (money market funds) |
|
|
917 |
|
|
|
— |
|
|
|
— |
|
|
|
917 |
|
U.S. Government bonds |
|
|
— |
|
|
|
120,732 |
|
|
|
— |
|
|
|
120,732 |
|
Total |
|
$ |
58,601 |
|
|
$ |
120,732 |
|
|
$ |
— |
|
|
$ |
179,333 |
|
|
|
December 31, 2015 |
|
|||||||||||||
|
|
Level I |
|
|
Level II |
|
|
Level III |
|
|
Total |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
44,714 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
44,714 |
|
Restricted cash (money market funds) |
|
|
917 |
|
|
|
— |
|
|
|
— |
|
|
|
917 |
|
U.S. Government bonds |
|
|
— |
|
|
|
140,392 |
|
|
|
|
|
|
|
140,392 |
|
Total |
|
$ |
45,631 |
|
|
$ |
140,392 |
|
|
$ |
— |
|
|
$ |
186,023 |
|
The following tables set forth the gross unrealized gains and losses on the Company’s investments (in thousands):
|
|
September 30, 2016 |
|
|||||||||||||
|
|
Amortized Cost |
|
|
Gross Unrealized Holding Gains |
|
|
Gross Unrealized Holding Losses |
|
|
Aggregate Fair Value |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Investment Securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Government bonds |
|
$ |
120,684 |
|
|
$ |
48 |
|
|
$ |
— |
|
|
$ |
120,732 |
|
Total securities |
|
$ |
120,684 |
|
|
$ |
48 |
|
|
$ |
— |
|
|
$ |
120,732 |
|
14
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
|
December 31, 2015 |
|
||||||||||||||
|
|
Amortized Cost |
|
|
Gross Unrealized Holding Gains |
|
|
Gross Unrealized Holding Losses |
|
|
Aggregate Fair Value |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Investment Securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Government bonds |
|
$ |
126,965 |
|
|
$ |
— |
|
|
$ |
(76 |
) |
|
$ |
126,889 |
|
Total securities |
|
$ |
126,965 |
|
|
$ |
— |
|
|
$ |
(76 |
) |
|
$ |
126,889 |
|
The following tables set forth the contractual maturities of securities classified as available-for-sale (in thousands):
|
|
September 30, 2016 |
|
|
Due within one year |
|
$ |
118,707 |
|
Due after one year |
|
|
2,025 |
|
Total |
|
$ |
120,732 |
|
|
|
December 31, 2015 |
|
|
Due within one year |
|
$ |
126,889 |
|
Total |
|
$ |
126,889 |
|
5. Property and Equipment
Property and equipment, net consisted of the following (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2016 |
|
|
2015 |
|
||
|
|
|
|
|
|
|
|
|
Machinery and equipment |
|
$ |
5,315 |
|
|
$ |
4,910 |
|
Computer equipment and software |
|
|
506 |
|
|
|
452 |
|
Furniture and fixtures |
|
|
51 |
|
|
|
51 |
|
Leasehold improvements |
|
|
720 |
|
|
|
720 |
|
Construction in progress |
|
|
1,173 |
|
|
|
169 |
|
Total property and equipment |
|
|
7,765 |
|
|
|
6,302 |
|
Less: accumulated depreciation and amortization |
|
|
(4,064 |
) |
|
|
(2,821 |
) |
Property and equipment, net |
|
$ |
3,701 |
|
|
$ |
3,481 |
|
Depreciation and amortization expense was $443,000 and $307,000 for three months ended September 30, 2016 and 2015, respectively, and $1.2 million and $877,000 for the nine months ended September 30, 2016 and 2015, respectively.
6. Goodwill and Intangible Assets
Goodwill and in-process research and development assets resulted from a series of integrated financing transactions in 2010 that was accounted for as a business combination. The in-process research and development relates to the Company’s proprietary Probody technology platform and is accounted for as an indefinite-lived intangible asset until the underlying project is completed or abandoned.
Goodwill and intangible assets consisted of the following (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2016 |
|
|
2015 |
|
||
Goodwill |
|
$ |
949 |
|
|
$ |
949 |
|
In-process research and development |
|
|
1,750 |
|
|
|
1,750 |
|
15
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
7. Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2016 |
|
|
2015 |
|
||
Research and clinical expenses |
|
$ |
4,364 |
|
|
$ |
1,562 |
|
Payroll and related expenses |
|
|
3,179 |
|
|
|
2,839 |
|
Legal and professional expenses |
|
|
1,346 |
|
|
|
296 |
|
Other accrued expenses |
|
|
152 |
|
|
|
215 |
|
Total |
|
$ |
9,041 |
|
|
$ |
4,912 |
|
8. Research and Collaboration Agreements
Pfizer Inc.
In May 2013, the Company and Pfizer Inc. (“Pfizer”) entered into a Research Collaboration, Option and License Agreement (the “Pfizer Agreement”) to collaborate on the discovery and preclinical research activities related to Probody therapeutics, and Probody drug conjugates (“PDCs”) for research project targets nominated by Pfizer. Pfizer nominated two research targets in 2013 and, pursuant to the Pfizer Agreement, had the option of nominating two additional research targets. In December 2014, Pfizer selected an additional research target. The option to select a fourth target lapsed in May 2016 without a selection.
The Pfizer Agreement provides Pfizer with an option to acquire an exclusive development and commercialization license for each research project target. Upon exercise of the option, Pfizer (1) will receive an exclusive development and commercialization license for use of the Probody therapeutic during the development, manufacturing and commercialization of the potential product, and (2) will be responsible for the development, manufacturing and commercialization of such potential products.
Pursuant to the Pfizer Agreement, the Company received an upfront payment of $6.0 million and was initially entitled to receive contingent payments of up to an aggregate of $626.5 million as follows: (i) $1.5 million for each of the two additional targets; (ii) up to $12.0 million upon exercise of the license options; (iii) up to $25.0 million from the achievement of development milestones for each research target program, or up to $82.0 million if the maximum of four research targets are selected by Pfizer; (iv) up to $98.0 million in milestone payments for the first commercial sale in various territories for up to three indications per research target program, or up to $249.5 million if the maximum of four research targets are selected; and (v) up to $100.0 million in sales milestones payments per research target program, or up to $280.0 million if the maximum of four research targets are selected by Pfizer. The Company is entitled to receive royalties in the mid-single digits to low teens on initial targets and mid-single digit royalties on additional targets from potential future sales of product candidates. The Company will also receive research and development service fees based on a prescribed full-time employee (“FTE”) rate per year that is capped.
In accordance with ASC 605-25, the Company identified the following deliverables at the inception of the Pfizer Agreement: (1) the research license, (2) the research services and (3) the obligation to participate in the joint research committee. The Company determined that the research license does not have stand-alone value to Pfizer due to the specialized nature of the research services to be provided by the Company, and accordingly, this deliverable was combined with the research services and participation in the joint research committee as a single unit of accounting. The Company concluded that, at the inception of the agreement, Pfizer’s options to obtain an exclusive development and commercialization license for each research project target do not represent deliverables of the agreement because they are substantive options and do not contain a significant or incremental discount.
The upfront payment of $6.0 million was recorded as deferred revenue and is being recognized on a ratable basis over the estimated performance period of seven years. In December 2014, Pfizer selected an additional target and paid $1.5 million, which was recorded as deferred revenue and is being recognized over the remaining performance period. Following the lapse of the Pfizer’s option to select a fourth target in May 2016, the amortization period of deferred revenue was adjusted to five and a half years. In addition, the contingent payments to which the Company was initially entitled were reduced by $133.5 million.
The Company recognized revenue of $0.6 million and $0.5 million for the three months ended September 30, 2016 and 2015, respectively and $1.6 million and $1.3 million for the nine months ended September 30, 2016 and 2015, respectively. As of September 30, 2016 and December 31, 2015, deferred revenue relating to the Pfizer Agreement was $3.8 million and $4.9 million, respectively.
16
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
The amount due from Pfizer under the Agreement was $0.2 million and $0.4 million as of September 30, 2016 and December 31, 2015, respectively.
ImmunoGen, Inc.
In January 2014, the Company and ImmunoGen, Inc. (“ImmunoGen”) entered into the Research Collaboration Agreement (the “ImmunoGen Agreement”). The ImmunoGen Agreement provides the Company with the right to use ImmunoGen’s Antibody Drug Conjugate (“ADC”) technology in combination with the Company’s Probody technology to create PDCs directed at one specified target under a research license, and to subsequently obtain an exclusive, worldwide development and commercialization license to use ImmunoGen’s ADC technology to develop and commercialize such PDCs. The Company made no upfront cash payment in connection with the execution of the agreement. Instead, the Company provided ImmunoGen with the rights to CytomX’s Probody technology to create PDCs directed at two targets under the research license and to subsequently obtain exclusive, worldwide development and commercialization licenses to develop and commercialize such PDCs. Under the research licenses, the parties have one replacement right for each target, which needs to be made before the third anniversary of the agreement execution.
Under the terms of the agreement, both the Company and ImmunoGen are required to perform research activities on behalf of the other party for no monetary consideration. The research activities for a particular target will last until January 2018 unless they are terminated by one of the parties or when a development and commercialization license is obtained with respect to that target. Each party is solely responsible for the development, manufacturing and commercialization of any products resulting from the exclusive development and commercialization license obtained by such party under the agreement. Each party may be liable to pay annual maintenance fees to the other party if the licensed product candidate covered under each development and commercialization license has not progressed to the clinical stage of development within six years of the exercise of the development and commercialization license.
In consideration for the exclusive development and commercialization license that may be obtained by ImmunoGen, the Company is entitled to receive up to $30.0 million in development and regulatory milestone payments per the research program target, up to $50.0 million in sales milestone payments per target and royalties in the mid-single digits on the commercial sales of any resulting product. For the development and commercialization license that may be obtained by the Company, ImmunoGen is entitled to receive up to $60.0 million in development and regulatory milestone payments, up to $100.0 million in sales milestone payments and royalties in the mid to high single digits on the commercial sales of any resulting product.
The Company accounted for the ImmunoGen Agreement based on the fair value of the assets and services exchanged. The Company identified the following significant deliverables at the inception of the ImmunoGen Agreement: (1) the research license, (2) the research services, (3) the obligation to participate in the joint research committee, (4) the exclusive research, development and commercialization license and (5) the obligation to provide future technology improvements, when available. The Company determined that the research license, participation in the joint steering committee and the research services do not have stand-alone value from the development and commercialization license and therefore those deliverables were combined into one unit of accounting. The Company considered factors such the limited economic benefits to ImmunoGen if development and commercialization license is not obtained and the lack of sublicensing rights in the research license.
The estimated total fair value of the consideration of $13.2 million was recorded as deferred revenue, of which $13.0 million was allocated to the unit of accounting comprised of the research license, research services, participation in the joint research committee and the development and commercialization license, and $0.2 million was allocated to the future technological improvements. The Company will recognize $13.0 million upon delivery of development and commercialization licenses and will recognize amounts allocated to the future technology improvements over the term of the license.
The estimated fair value of assets and services received was also $13.2 million, of which $12.7 million was allocated to the licenses received and was charged to research and development expense, with the remaining amount of $0.5 million was allocated to the research services, joint research committee participation and technology improvements, which is being expensed over the period of services to be provided.
As of September 30, 2016 and December 31, 2015, deferred revenue relating to the ImmunoGen Agreement was $13.2 million for both periods.
17
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
On May 23, 2014, the Company and Bristol-Myers Squibb Company (“BMS”) entered into a Collaboration and License Agreement (the “BMS Agreement”) to discover and develop compounds for use in human therapeutics aimed at multiple immuno-oncology targets using the Company’s Probody technology. The effective date of the BMS Agreement was July 7, 2014.
Under the terms of the BMS Agreement, the Company granted BMS exclusive worldwide rights to develop and commercialize Probody therapeutics for up to four oncology targets. BMS will have additional rights to substitute up to two collaboration targets. Each collaboration target has a two year research term and the two additional targets must be nominated by BMS within five years of the effective date of the BMS Agreement. The research term for each collaboration target can be extended in one year increments up to three times. In January 2016, BMS selected an additional research target.
Pursuant to the BMS Agreement, the Company received an upfront payment of $50.0 million and was initially entitled to receive contingent payments of up to an aggregate of $1,217.0 million as follows: (i) up to $25.0 million for additional targets; (ii) up to $114.0 million in development milestone payments per research target program or up to $456.0 million if the maximum of four research targets are selected; (iii) up to $124.0 million in milestone payments for the first commercial sale in various territories for up to three indications per research target program or up to $496.0 million if the maximum of four research targets are selected; and (iv) up to $60.0 million in sales milestones payments per research target program or up to $240.0 million if maximum of four research targets are selected. The Company is entitled to royalty payments in the mid to high single digits to low teens from potential future sales. The Company will also receive research and development service fees based on a prescribed FTE rate that is capped.
The BMS Agreement also required BMS to purchase the Company’s common stock upon an IPO if certain conditions were met. In connection with the IPO in October 2015, BMS purchased 833,333 shares of the Company’s common stock at the initial public offering price and on the same terms as other purchasers in the offering.
The Company identified the following deliverables at the inception of the BMS Agreement: (1) the exclusive research, development and commercialization license (“license”), (2) the research and development services and (3) the obligation to participate in the joint research committee. The Company determined that the license does not have stand-alone value to BMS without the Company’s research services and expertise related to the development of the product candidates, and accordingly, it was combined with the research services and participation in the joint research committee as a single unit of accounting.
The Company received an upfront payment of $50.0 million from BMS in July 2014. The upfront payment was recorded as deferred revenue and is being recognized on a ratable basis over the estimated performance period of ten years. The Company determined that the remaining contingent payments under the Agreement do not constitute substantive milestones and will not be accounted for under the milestone method of revenue recognition. The events leading to these payments do not meet the definition of a substantive milestone because the achievement of these events solely depends on BMS’s performance. Accordingly, any revenue from these contingent payments would be subject to an allocation of arrangement consideration and would be recognized over any remaining period of performance obligations, if any, relating to this arrangement. If there are no remaining performance obligations under the arrangement at the time the contingent payment is triggered, the contingent payment will be recognized as revenue in full upon the triggering event.
In January 2016, BMS selected an additional target pursuant to the BMS Agreement. Under the terms of the BMS Agreement, BMS paid the Company a $10.0 million milestone payment. This amount was recorded as deferred revenue and is being recognized over the remaining performance period.
The Company recognized revenue of $1.8 million and $1.4 million for the three months ended September 30, 2016 and 2015, respectively and $5.3 million and $4.4 million for the nine months ended September 30, 2016 and 2015, respectively. As of September 30, 2016 and December 31, 2015, deferred revenue relating to the BMS Agreement was $48.0 million and $42.6 million, respectively. The amount due from BMS under the BMS Agreement was $0.2 million and $0.4 million as of September 30, 2016 and December 31, 2015, respectively.
18
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
In November 2015, the Company entered into a research collaboration agreement with MD Anderson to research Probody-enabled chimeric antigen receptor killer (CAR-NK) cell therapies, known as ProCAR-NK cell therapies. Under this collaboration, MD Anderson will use the Company’s Probody technology to conduct research of ProCAR-NK cell therapies against certain targets selected by the Company in cancer immunotherapy. Under the research collaboration agreement, the Company has the right to exercise an option, during the option period expiring on November 2, 2019 and upon payment of an option exercise fee, to negotiate and acquire a worldwide, exclusive, sublicensable license from MD Anderson for development and commercialization of products directed against any of the selected targets. The research collaboration agreement will continue in effect until the earlier of (i) the date that the Company exercises the option to acquire the license from MD Anderson and (ii) the expiration of the option period. The impact of this agreement was not material for the financial statements for the nine months ended September 30, 2016.
AbbVie Ireland Unlimited Company
In April 2016, the Company and AbbVie Ireland Unlimited Company (“AbbVie”) entered into two agreements, a CD71 Co-Development and Licensing Agreement (the “CD71 Agreement”) and a Discovery Collaboration and Licensing Agreement (the “Discovery Agreement” and together with the CD71 Agreement the “AbbVie Agreements”). Under the terms of the CD71 Agreement, the Company and AbbVie will co-develop a PDC against CD71, with the Company responsible for pre-clinical and early clinical development. AbbVie will be responsible for later development and commercialization, with global late-stage development costs shared between the two companies. The Company will assume 35% of the net profits or net losses related to later development unless it opts-out. If the Company opts-out from participation of co-development of the CD71 PDC, AbbVie will have sole right and responsibility for the further development, manufacturing and commercialization of such CD71 PDC. AbbVie, at its sole discretion, may stop development of any CD71 PDC and terminate the CD71 Agreement if the Company does not meet certain preclinical research criteria by the applicable deadline. In such case, the Company and AbbVie may evaluate and approve an alternate CD71 PDC. If such alternate CD71 PDC is approved, then the Company and AbbVie will, in good faith, negotiate amendments to the timelines and, if necessary, the content in the research and development plan and budget and extensions to the deadlines to achieve defined success criteria.
Under the CD71 Agreement, the Company received an upfront payment of $20.0 million in April 2016, and is eligible to receive up to $470.0 million in development, regulatory and commercial milestone payments and royalties on ex-US sales in the high teens to low twenties if the Company participates in the co-development of the CD71 Licensed Product subject to a reduction in such royalties if the Company opts-out from the co-development of the CD71 PDC. The Company’s share of later stage co-development costs for each CD71 PDC are capped, provided that AbbVie may offset the Company’s co-development cost above the capped amounts from future payments such as milestone payments and royalties.
Under the terms of the Discovery Agreement, AbbVie receives exclusive worldwide rights to develop and commercialize Probody drug conjugates against up to two undetermined targets. The Company shall perform research services to discover the Probodies and create PDCs for the nominated collaboration targets. From that point, AbbVie shall have sole right and responsibility for development and commercialization of products comprising or containing such PDCs (“Discovery Licensed Products”).
Under the Discovery Agreement, the Company received an upfront payment of $10.0 million in April 2016 and may receive an additional payment upon the selection by AbbVie of the second target and the satisfaction of certain performance conditions under the CD71 Agreement. AbbVie has not selected the second target, but the performance conditions under the CD71 Agreement were met in September 2016. The Company is also eligible to receive up to $275.0 million in target nomination, development, regulatory and commercial milestone payments and royalties in the high single to low teens from commercial sales of any resulting PDCs.
The Company has determined that the CD71 and Discovery Agreements with AbbVie should be combined and evaluated as a single arrangement in determining revenue recognition, because both agreements were concurrently negotiated and executed.
The Company identified the following deliverables at the inception of the AbbVie Agreements: (1) the research, development and commercialization license for CD71 Probody, (2) the research services related to CD71 Probody, (3) the obligation to participate in the CD71 Agreement joint research committee, (4) the research services related to the first discovery target (5) the research, development and commercialization license for the first discovery target, and (6) the obligation to participate in the Discovery Agreement joint research committee. The Company concluded that, at the inception of the agreement, AbbVie’s option for the second discovery target is substantive and does not represent a deliverable of the agreement.
The Company determined that the research, development and commercialization license for CD71 and discovery targets do not have a standalone value without the Company’s respective research services and expertise. The Company considered factors such as novelty of the Probody and PDC technology and lack of other parties’ expertise in this space, the Company’s rights to technology relating to a proprietary platform to enable the Probody development and AbbVie’s contractual obligation to use the Company’s research services.
19
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
The Company also determined that the CD71 Agreement research, development and commercialization license, related research service and participation in the joint research committee as a single unit of accounting has a standalone value from the Discovery Agreement research, development and commercialization license, related research service and participation in the joint research committee as another single unit of accounting. Therefore, the Company concluded that there are two units of accounting: CD71 Agreement unit of accounting consisting of the CD71 Agreement research, development and commercialization license, related research service and participation in the joint research committee, and the Discovery Agreement unit of accounting consisting of the Discovery Agreement research, development and commercialization license, related research service and participation in the joint research committee.
The upfront payments under the AbbVie Agreements are allocated between two units of accounting based on the estimated relative selling prices of each unit. In order to determine the best estimate of selling price, the Company used the discounted cash flow method by calculating risk-adjusted net present values of estimated cash flows. The Company recognizes the allocated amounts ratably over the estimated research service period of five years. The Company recognized revenue of $1.0 million and $1.8 million for the three and nine months ended September 30, 2016, respectively, related to the AbbVie Agreements. As of September 30, 2016, deferred revenue related to the CD71 unit of accounting was $18.8 million and $9.4 million related to the Discovery Agreement unit of accounting.
9. License Agreement
The Company has an exclusive, worldwide license agreement (the “UC Agreement”) with the Regents of the University of California (the “UC Regents”) relating to the use of certain patents and technology relating to its core technology, including its therapeutic antibodies. Pursuant to the UC Agreement, the Company is obligated to (i) make royalty payments to the UC Regents on net sales of its products covered under the agreement, subject to annual minimum amounts, (ii) make milestone payments to the UC Regents upon the occurrence of certain events, (iii) make a milestone payment to the UC Regents upon occurrence of an IPO or change of control, and (iv) reimburse the UC Regents for prosecution and maintenance of the licensed patents. If the Company sublicenses its rights under the UC Agreement, it is obligated to pay the UC Regents a percentage of the total gross proceeds received in consideration of the grant of the sublicense, which total amount would be first reduced by the aggregate amount of certain research and development related expenses incurred by the Company.
In 2013, the Company amended the UC Agreement to reduce the amounts due to the UC Regents upon receipt by the Company of upfront payments, milestone payments and royalties from sublicensees. In exchange for this amendment, the Company issued to the UC Regents 157,332 shares of common stock. The UC Agreement, as amended, will remain in effect until the expiration or abandonment of the last to expire of the licensed patents.
In the nine months ended September 30, 2016 and 2015, the Company incurred expenses of $1.1 million and $0.3 million, respectively, to the UC Regents under the provisions of the UC Agreement.
Royalty obligations
The Company has future minimum royalty obligations due under the terms of certain exclusive licensed patent rights. These minimum future obligations are as follows (in thousands):
Year ended December 31, |
|
|
|
|
2016 (three months remaining) |
|
$ |
— |
|
2017 |
|
|
150 |
|
Total minimum royalty obligations |
|
$ |
150 |
|
10. Long-term Debt
In May 2012, the Company entered into a Master Loan and Security Agreement (the “Debt Facility”). Under the terms of the agreement, an aggregate of $2.0 million could be drawn down during the initial basic loan term of 42 months. In January and December 2013, the Company amended the Debt Facility to borrow an additional $0.3 million and $3.0 million, respectively, with similar terms. Borrowings under the debt facility bore interest at a rate of 11.74% per annum.
20
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
In connection with the execution and the amendment of the Debt Facility, the Company issued warrants to the lender to purchase an aggregate of 81,620 shares of the Company’s Series B-1 redeemable convertible preferred stock. The warrants were exercisable in cash at an exercise price of $3.084396 per share or through a cashless exercise provision.
In connection with the consummation of the IPO in October 2015, all of the warrants were net exercised, resulting in issuance of an aggregate of 60,640 shares of our common stock.
Upon issuance of the warrants, the Company recorded a preferred stock warrant liability based on its initial fair value estimated using the Black-Scholes model with an offset to debt discount. The debt discount was amortized to interest expense using the effective interest method over the term of the Debt Facility. The warrant liability was subject to remeasurement to fair value at each balance sheet date until the earliest of the exercise or expiration of the convertible preferred stock warrant, and any change in fair value is recognized in other income (expense), net.
The Company repaid and terminated the Debt Facility in September 2015.
11. Commitments and Contingencies
Operating Lease
New Lease Agreement
On December 10, 2015, the Company entered into a lease (the “New Lease”) with HCP Oyster Point III LLC (the “Landlord”) to lease approximately 76,173 rentable square feet of office and laboratory space located in South San Francisco, California for the Company’s new corporate headquarters.
The term of the New Lease commences on the later of (i) the date that the Landlord’s construction and tenant improvements have been completed pursuant to the New Lease and (ii) October 1, 2016. The New Lease has an initial term of ten years from the commencement date, and the Company has an option to extend the initial term for an additional five years at the then fair rental value as determined pursuant to the New Lease.
The New Lease provides for annual base rent of approximately $3.1 million in the first year of the lease term. The annual base rent for the second twelve months will be approximately $4.3 million, which will increase on an annual basis beginning from the 25th month to approximately $5.5 million for the tenth year of the lease. The Company will be entitled to a one-time improvement allowance of up to $12.6 million.
In addition, the Company obtained a standby letter of credit (the “Letter of Credit”) in an amount of approximately $0.9 million, which may be drawn by the Landlord to be applied for certain purposes upon the Company’s breach of any provisions under the New Lease. The Company has recorded the $0.9 million Letter of Credit in restricted cash as a non-current asset on its balance sheet.
Amendment to Existing/Current Lease
In March 2016, the Company entered into an agreement to terminate its existing/current lease, which was due to expire on January 31, 2019 (“Lease Termination”) with its current landlord. The Lease Termination provides for an early termination of the existing/current lease effective on November 30, 2016. The Company will not be required to pay the landlord a termination payment in connection with the early termination of the existing/current lease.
Rent expense is recognized on a straight-line basis over the term of the lease and accordingly the Company records the difference between cash rent payments and the recognition of rent expense as a deferred rent liability.
21
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
The minimum lease payments for all the Company’s facility leases are as follows (in thousands):
Year Ending December 31: |
|
|
|
|
2016 (three months remaining) |
|
$ |
610 |
|
2017 |
|
|
3,387 |
|
2018 |
|
|
4,374 |
|
2019 |
|
|
4,506 |
|
2020 and beyond |
|
|
34,144 |
|
Total |
|
$ |
47,021 |
|
Rent expense was $255,000 and $236,000 for the three months ended September 30, 2016 and 2015, respectively and $505,000 and $705,000 for the nine months ended September 30, 2016 and 2015, respectively. Rent expense for the nine months ended September 30, 2016 included a one-time adjustment to deferred rent pursuant to the termination of the existing/current lease.
Legal Proceedings
The Company is subject to claims and assessments from time to time in the ordinary course of business but do not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company’s financial position, results of operations or cash flows.
Indemnifications
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions.
Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company has also entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by Delaware corporate law. The Company currently has directors’ and officers’ insurance.
12. Convertible Preferred Stock
In December 2014, the Company granted a second tranche option (“Second Tranche Option”) to one of its investors to purchase 659,209 shares of its Series C redeemable convertible preferred stock upon the achievement of certain milestones. At initial recognition, the Company recorded the Second Tranche Option as a derivative liability on the balance sheet at its estimated fair value of $395,000. In May 2015, the Company achieved the relevant milestones and the investor exercised its right to purchase 659,209 shares of Series C convertible redeemable preferred stock for net proceeds of $3.5 million. Immediately prior to the closing of this tranche, the Company remeasured the preferred stock liability to its then fair value and recorded a loss from remeasurement of $1.1 million in other income (expense), net. The fair value of the preferred stock liability in the amount of $1.5 million was reclassified to redeemable convertible preferred stock.
In connection with the consummation of the IPO in October 2015, all outstanding shares of Series A-1, Series A-2, Series B-1, Series B-2, Series C and Series D were converted into 27,135,453 shares of common stock on a one-for-one basis. As such, no convertible preferred stock shares were outstanding as of September 30, 2016 and December 31, 2015.
13. Common Stock
In October 2015, the Company’s board of directors and stockholders approved the Company’s amended and restated certificate of incorporation. The amended and restated certificate of incorporation was effective as of October 14, 2015, and provides for 75,000,000 authorized shares of common stock with a par value of $0.00001 per share and 10,000,000 shares of preferred stock with a par value of $0.00001 per share.
22
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
Common stockholders are entitled to dividends if and when declared by the Board of Directors subject to the prior rights of the preferred stockholders. As of September 30, 2016 and December 31, 2015, no dividends on common stock had been declared by the Board of Directors.
The Company had reserved shares of common stock for issuance, on an as-converted basis, as follows:
|
|
September 30, 2016 |
|
|
December 31, 2015 |
|
||
Options issued and outstanding |
|
|
6,102,930 |
|
|
|
5,270,751 |
|
Shares available for future stock option grants |
|
|
2,614,788 |
|
|
|
2,401,406 |
|
|
|
|
8,717,718 |
|
|
|
7,672,157 |
|
14. Stock Option Plans
In 2010, the Company adopted its 2010 Stock Incentive Plan (the “2010 Plan”) which provided for the granting of stock options to employees, directors and consultants of the Company. Options granted under the 2010 Plan were either incentive stock options (“ISOs”) or nonqualified stock options (“NSOs”).
In February 2012, the Company adopted its 2011 Stock Incentive Plan (the “2011 Plan”). The 2011 Plan is divided into two separate equity programs, an option and stock appreciation rights grant program and a stock award program. In conjunction with adopting the 2011 Plan, the Company discontinued the 2010 Plan and released the shares reserved and still available under that plan.
In connection with the consummation of the IPO in October 2015, the board of directors adopted the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). In conjunction with adopting the 2015 Plan, the Company discontinued the 2011 Plan with respect to new equity awards.
Options under the 2015 Plan may be granted for periods of up to ten years. All options issued to date have had a 10-year life. Under the terms of the 2015 Plan, options may be granted at an exercise price not less than the estimated fair value of the shares on the date of grant, as determined by the Company’s board of directors. For employees holding more than 10% of the voting rights of all classes of stock, the exercise price of ISOs and NSOs may not be less than 110% of the estimated fair value of the shares on the date of grant, as determined by the board of directors. To date, options granted generally vest over four years and vest at a rate of 25% upon the first anniversary of the issuance date and 1/48th per month thereafter.
Activity under the Company’s stock option plans is set forth below:
|
|
|
|
|||||
|
|
Options Outstanding |
|
|||||
|
|
Number of Options |
|
|
Weighted-Average Exercise Price Per Share |
|
||
Balances at December 31, 2015 |
|
|
5,270,751 |
|
|
$ |
3.694 |
|
Options granted |
|
|
1,234,946 |
|
|
|
13.359 |
|
Options exercised |
|
|
(348,612 |
) |
|
|
1.229 |
|
Option forfeited/expired |
|
|
(54,155 |
) |
|
|
4.578 |
|
Balances at September 30, 2016 |
|
|
6,102,930 |
|
|
$ |
5.783 |
|
Options exercisable at September 30, 2016 |
|
|
2,850,370 |
|
|
$ |
3.444 |
|
23
CYTOMX THERAPEUTICS, INC.
Notes to Condensed Financial Statements (unaudited)—(Continued)
Total stock-based compensation recognized was as follows (in thousands):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
September 30, |
|
|
September 30, |
|
||||||||||
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
||||
Stock-based compensation expense: |
|
|
|
|