UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number:
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(Address of Principal Executive Offices) | (Zip Code) |
(
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class: |
| Trading Symbol |
| Name of each exchange on which registered: |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13 (a) of the Exchange Act. ◻
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934). Yes
Indicate the number of shares of each of the issuer’s classes of common stock, as of the latest practicable date:
Class | Outstanding at July 30, 2020 | |
Common stock, $0.01 par value |
Xencor, Inc.
Quarterly Report on FORM 10-Q for the Quarter Ended June 30, 2020
Table of Contents
In this report, unless otherwise stated or the context otherwise indicates, references to “Xencor,” “the Company,” “we,” “us,” “our” and similar references refer to Xencor, Inc. The Xencor logo is a registered trademark of Xencor, Inc. This report also contains registered marks, trademarks and trade names of other companies. All other trademarks, registered marks and trade names appearing in this report are the property of their respective holders.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of federal securities laws. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time those statements are made and/or management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth below under Part II, Item 1A, “Risk Factors” in this Quarterly Report. These statements, which represent our current expectations or beliefs concerning various future events, may contain words such as “may,” “will,” “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate” or other words indicating future results. Such statements may include, but are not limited to, statements concerning the following:
These forward-looking statements should, therefore, be considered in light of various important factors, including but not limited to, the following:
| ● | the effects of the ongoing COVID-19 pandemic on our financial condition, results of operations, cash flows and performance; |
| ● | our plans to research, develop and commercialize our product candidates; |
| ● | our ongoing and planned clinical trials; |
| ● | the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; |
| ● | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
| ● | our ability to identify additional products or product candidates with significant commercial potential that are consistent with our business objectives; |
| ● | the rate and degree of market acceptance and clinical utility of our products; |
| ● | the capabilities and strategy of our suppliers and vendors including key manufacturers of our clinical drug supplies; |
| ● | significant competition in our industry; |
| ● | costs of litigation and the failure to successfully defend lawsuits and other claims against us; |
| ● | our partners’ ability to advance drug candidates into, and successfully complete, clinical trials; |
| ● | our ability to receive research funding and achieve anticipated milestones under our collaborations; |
| ● | our intellectual property position; |
| ● | loss or retirement of key members of management; |
| ● | costs of compliance and our failure to comply with new and existing governmental regulations; |
| ● | failure to successfully execute our growth strategy, including any delays in our planned future growth; and |
| ● | our failure to maintain effective internal controls. |
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The factors, risks and uncertainties referred to above and others are more fully described under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and this Quarterly Report on Form 10-Q. Forward-looking statements should be regarded solely as our current plans, estimates and beliefs. We cannot guarantee future results, events, levels of activity, performance or achievements. We do not undertake and specifically decline any obligation to update, republish or revise forward-looking statements to reflect future events or circumstances or to reflect the occurrences of unanticipated events.
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PART I — FINANCIAL INFORMATION
Item1. Financial Statements
Xencor, Inc.
Balance Sheets
(In thousands, except share amounts)
| June 30, |
| December 31, | |||
2020 | 2019 | |||||
(unaudited) | ||||||
Assets | ||||||
Current assets | ||||||
Cash and cash equivalents | $ | | $ | | ||
Marketable securities | | | ||||
Equity securities | | — | ||||
Accounts receivable | |
| | |||
Income tax receivable | | | ||||
Prepaid expenses and other current assets | |
| | |||
Total current assets | |
| | |||
Property and equipment, net |
| |
| | ||
Patents, licenses, and other intangible assets, net | |
| | |||
Marketable securities - long term | | | ||||
Income tax receivable | — | | ||||
Other assets |
| |
| | ||
Total assets | $ | | $ | | ||
Liabilities and stockholders’ equity | ||||||
Current liabilities | ||||||
Accounts payable | $ | | $ | | ||
Accrued expenses | |
| | |||
Lease liabilities | | | ||||
Deferred revenue | |
| | |||
Total current liabilities | |
| | |||
Lease liabilities, net of current portion | | | ||||
Deferred revenue, net of current portion | — | | ||||
Total liabilities | |
| | |||
Commitments and contingencies | ||||||
Stockholders’ equity | ||||||
Preferred stock, $ | ||||||
Common stock, $ | |
| | |||
Additional paid-in capital | |
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Accumulated other comprehensive income | |
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Accumulated deficit |
| ( |
| ( | ||
Total stockholders’ equity |
| |
| | ||
Total liabilities and stockholders’ equity | $ | | $ | | ||
See accompanying notes.
5
Xencor, Inc.
Statements of Comprehensive Income (Loss)
(unaudited)
(In thousands, except share and per share data)
Three Months Ended |
| Six Months Ended | ||||||||||
June 30, |
| June 30, | ||||||||||
| 2020 |
| 2019 |
| 2020 |
| 2019 | |||||
Revenue | ||||||||||||
Collaborations, licenses, milestones, and royalties | $ | | $ | | $ | | $ | | ||||
Operating expenses | ||||||||||||
Research and development |
| |
| |
| |
| | ||||
General and administrative |
| |
| |
| |
| | ||||
Total operating expenses |
| |
| |
| |
| | ||||
Income (loss) from operations |
| ( |
| ( |
| ( |
| | ||||
Other income (expenses) | ||||||||||||
Interest income, net |
| |
| |
| |
| | ||||
Other income (expense), net | | ( | ( | ( | ||||||||
Total other income, net |
| |
| |
| |
| | ||||
Net income (loss) before income tax expense | ( | ( | ( | | ||||||||
Income tax expense | — | | — | | ||||||||
Net income (loss) | ( | ( | ( | | ||||||||
Other comprehensive income | ||||||||||||
Net unrealized gain on marketable securities | | | | | ||||||||
Comprehensive income (loss) | $ | ( | $ | ( | $ | ( | $ | | ||||
Basic net income (loss) per common share | $ | ( | $ | ( | $ | ( | $ | | ||||
Diluted net income (loss) per common share | $ | ( | $ | ( | $ | ( | $ | | ||||
Basic weighted average common shares outstanding | | | | | ||||||||
Diluted weighted average common shares outstanding | | | | | ||||||||
See accompanying notes.
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Xencor, Inc.
Statement of Stockholders’ Equity
(in thousands, except share data)
Accumulated | |||||||||||||||||
Additional | Other | Total | |||||||||||||||
Common Stock | Paid-in | Comprehensive | Accumulated | Stockholders’ | |||||||||||||
Stockholders’ Equity | Shares | Amount | Capital | Income (Loss) | Deficit | Equity | |||||||||||
Balance, December 31, 2019 | | | | | ( | | |||||||||||
Issuance of common stock upon exercise of stock awards | | | | — | — | | |||||||||||
Issuance of restricted stock units | | — | — | — | — | — | |||||||||||
Comprehensive loss | — | — | — | ( | ( | ( | |||||||||||
Stock-based compensation | — | — | | — | — | | |||||||||||
Balance, March 31, 2020 | | $ | | $ | | $ | | $ | ( | $ | | ||||||
Issuance of common stock upon exercise of stock awards | | | | — | — | | |||||||||||
Issuance of restricted stock units | | — | — | — | — | — | |||||||||||
Issuance of common stock under the Employee Stock Purchase Plan | | — | | — | — | | |||||||||||
Comprehensive income (loss) | — | — | | ( | ( | ||||||||||||
Stock-based compensation | — | — | | — | — | | |||||||||||
Balance, June 30, 2020 | | $ | | $ | | $ | | $ | ( | $ | | ||||||
Accumulated | |||||||||||||||||
Additional | Other | Total | |||||||||||||||
Common Stock | Paid-in | Comprehensive | Accumulated | Stockholders’ | |||||||||||||
Stockholders’ Equity | Shares | Amount | Capital | Income (Loss) | Deficit | Equity | |||||||||||
Balance, December 31, 2018 | | | | ( | ( | | |||||||||||
Issuance of common stock upon exercise of stock awards | | | | — | — | | |||||||||||
Issuance of restricted stock units | | — | — | — | — | — | |||||||||||
Comprehensive income | — | — | — | | | | |||||||||||
Stock-based compensation | — | — | | — | — | | |||||||||||
Balance, March 31, 2019 | | $ | | $ | | $ | | $ | ( | $ | | ||||||
Issuance of common stock upon exercise of stock awards | | | | — | — | | |||||||||||
Issuance of common stock under the Employee Stock Purchase Plan | | — | | — | — | | |||||||||||
Comprehensive income (loss) | — | — | — | | ( | ( | |||||||||||
Stock-based compensation | — | — | | — | — | | |||||||||||
Balance, June 30, 2019 | | $ | | $ | | $ | | $ | ( | $ | | ||||||
See accompanying notes.
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Xencor, Inc.
Statements of Cash Flows
(unaudited)
(in thousands)
Six Months Ended | ||||||
June 30, | ||||||
| 2020 |
| 2019 | |||
Cash flows from operating activities | ||||||
Net income (loss) | $ | ( | $ | | ||
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||||||
Depreciation and amortization |
| |
| | ||
Accretion of discount on marketable securities |
| ( |
| ( | ||
Stock-based compensation |
| |
| | ||
Abandonment of capitalized intangible assets |
| |
| | ||
Equity received in connection with license agreement | ( | — | ||||
Change in fair value of equity security | | — | ||||
Loss on disposal of assets | | | ||||
Gain on sale of marketable securities available for sale | ( | — | ||||
Changes in operating assets and liabilities: | ||||||
Accounts receivable |
| |
| | ||
Interest receivable | | ( | ||||
Prepaid expenses and other assets |
| ( |
| ( | ||
Accounts payable |
| |
| | ||
Accrued expenses |
| |
| ( | ||
Income taxes | | | ||||
Lease liabilities and right of use (ROU) assets | ( | ( | ||||
Deferred revenue |
| ( |
| | ||
Net cash provided by (used in) operating activities |
| ( |
| | ||
Cash flows from investing activities | ||||||
Purchase of marketable securities |
| ( |
| ( | ||
Purchase of intangible assets |
| ( |
| ( | ||
Purchase of property and equipment |
| ( |
| ( | ||
Proceeds from maturities of marketable securities | | | ||||
Net cash provided by (used in) investing activities |
| |
| ( | ||
Cash flows from financing activities | ||||||
Proceeds from issuance of common stock upon exercise of stock awards |
| |
| | ||
Proceeds from issuance of common stock under the Employee Stock Purchase Plan | | | ||||
Net cash provided by financing activities |
| |
| | ||
Net increase in cash and cash equivalents |
| |
| | ||
Cash and cash equivalents, beginning of period |
| |
| | ||
Cash and cash equivalents, end of period | $ | | $ | | ||
Supplemental disclosure of cash flow information | ||||||
Cash paid during the period for: | ||||||
Interest | $ | | $ | | ||
Income taxes | $ | — | $ | | ||
Supplemental disclosures of non-cash investing activities | ||||||
Unrealized gain on marketable securities | $ | | $ | | ||
See accompanying notes.
8
Xencor, Inc.
Notes to Financial Statements
(unaudited)
June 30, 2020
1. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited interim financial statements for Xencor, Inc. (the Company, Xencor, we or us) have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that the management of the Company believes are necessary for a fair presentation of the periods presented. The preparation of interim financial statements requires the use of management’s estimates and assumptions that affect reported amounts of assets and liabilities at the date of the interim financial statements and the reported revenues and expenditures during the reported periods. These interim financial results are not necessarily indicative of the results expected for the full fiscal year or for any subsequent interim period.
The accompanying unaudited interim financial statements and related notes should be read in conjunction with the audited financial statements and notes thereto included in the Company’s 2019 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 25, 2020.
Use of Estimates
The preparation of interim financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, other comprehensive gain (loss) and the related disclosures. On an ongoing basis, management evaluates its estimates, including estimates related to its accrued clinical trial and manufacturing development expenses, stock-based compensation expense, intangible assets and related amortization. Significant estimates in these interim financial statements include estimates made for royalties and accrued research and development expenses, stock-based compensation expenses, intangible assets and related amortization, estimated standalone selling price of performance obligations, the likelihood of recognizing variable consideration, and recoverability of deferred tax assets.
Intangible Assets
The Company maintains definite-lived intangible assets related to certain capitalized costs of acquired licenses and third-party costs incurred in establishing and maintaining its intellectual property rights to its platform technologies and development candidates. These assets are amortized over their useful lives, which are estimated to be the remaining patent life or the contractual term of the license. The straight-line method is used to record amortization expense. The Company assesses its intangible assets for impairment if indicators are present or changes in circumstances suggest that impairment may exist. There were
The Company capitalizes certain in-process intangible assets that are then abandoned when they are no longer pursued or used in current research activities. There was no material abandonment of in-process intangible assets during the three and six months ended June 30, 2020 and 2019.
Marketable and Equity Securities
The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification. The Company invests its excess cash primarily in marketable debt securities issued by investment grade institutions.
9
The Company considers its marketable debt securities to be available-for-sale and does not intend to sell these securities, and it is not more likely than not that the Company will be required to sell the securities before recovery of the amortized cost basis. These assets are carried at fair value and any impairment losses and recoveries related to the underlying issuer’s credit standing are recognized within other income (expense), while non-credit related impairment losses and recoveries are recognized within accumulated other comprehensive income (loss). There were
The Company also has an investment in an equity security that is carried at fair value with changes in fair value recognized within other income (expense). For equity securities with a readily determinable fair value, the Company remeasures these equity investments at each reporting period until such time that the investment is sold or disposed. If the Company sells an investment, any realized gains and losses on the sale of the securities will be recognized within other income (expense) in the Statement of Comprehensive Income (Loss) in the period of sale.
Recent Accounting Pronouncements
Pronouncements Adopted in 2020
Effective January 1, 2020, the Company adopted ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, as well as ASU No, 2018-19, Codification Improvements to Topic 326, Financial Instruments – Credit Losses. The standard amends guidance on reporting credit losses for assets held at amortized cost basis and also provides an available-for-sale (AFS) debt security impairment model that is a modified version of the other-than-temporary-impairment (OTTI) model. The AFS debt security impairment model no longer allows consideration of the length of time during which the fair value has been less than its amortized cost when determining whether a credit loss exists. The adoption of this standard did not have any impact on the Company’s financial statements.
Effective January 1, 2020, the Company adopted ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosures for transfers between Level 1 and Level 2 of the fair value hierarchy, modifies the Level 3 disclosure requirements for non-public entities and requires additional disclosure for Level 3 fair value hierarchy. The adoption of this standard did not have any impact on the Company’s financial statements.
Effective January 1, 2020, the Company adopted ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606, which provides guidance on how to assess whether certain transactions between collaborative arrangement participants should be accounted for within the revenue recognition standard. The adoption of this standard did not have any impact on the Company’s financial statements.
Pronouncements Not Yet Effective
In December 2019, the Financial Accounting Standards Board (FASB) issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which is effective for fiscal years beginning on and after December 15, 2020, and interim periods within those fiscal years. The standard removes specific exceptions to the general principles in Topic 740 and simplifies the accounting for income taxes. The Company does not anticipate that the standard will have a significant impact on its financial statements.
10
In January 2020, the FASB issued ASU No. 2020-01, which clarifies that a company should consider observable transactions that require a company to either apply or discontinue the equity method of accounting under Topic 323, Investment – Equity Method and Joint Ventures, for the purposes of applying the measurement alternative in accordance with Topic 321 immediately before applying or upon discontinuing the equity method. The amendment is effective for fiscal years beginning after December 15, 2020. The Company does not anticipate that the standard will have a significant impact on its financial statements.
There have been no other material changes to the significant accounting policies previously disclosed in the Company’s 2019 Annual Report on Form 10-K.
2. Fair Value of Financial Instruments
Financial instruments included in the financial statements include cash equivalents, marketable securities, accounts receivable, accounts payable and accrued expenses. Marketable securities and cash equivalents are carried at fair value. The fair value of the other financial instruments closely approximates their fair value due to their short-term maturities.
The Company accounts for recurring and non-recurring fair value measurements in accordance with FASB Accounting Standards Codification ASC 820, Fair Value Measurements and Disclosures (ASC 820). ASC 820 defines fair value, establishes a fair value hierarchy for assets and liabilities measured at fair value, and requires expanded disclosure about fair value measurements. The ASC 820 hierarchy ranks the quality of reliable inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories:
Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets or liabilities.
Level 2—Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets or liabilities in active markets or quoted prices for identical assets or liabilities in markets that are not active. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data.
Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by the reporting entity – e.g. determining an appropriate discount factor for illiquidity associated with a given security.
The Company measures the fair value of financial assets using the highest level of inputs that are reasonably available as of the measurement date. The assets recorded at fair value are classified within the hierarchy as follows for the periods reported (in thousands):
June 30, 2020 | December 31, 2019 | |||||||||||||||||
| Total |
|
|
| Total |
|
| |||||||||||
Fair Value | Level 1 | Level 2 | Fair Value | Level 1 | Level 2 | |||||||||||||
Money Market Funds | $ | | $ | | $ | — | $ | | $ | | $ | — | ||||||
Corporate Securities | | — | | | — | | ||||||||||||
Government Securities | | — | |
| | — | | |||||||||||
Equity Securities with Readily Determinable Fair Value | | | — | — | — | — | ||||||||||||
$ | | $ | | $ | | $ | | $ | | $ | | |||||||
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Our policy is to record transfers of assets between Level 1 and Level 2 at their fair values as of the end of each reporting period, consistent with the date of the determination of fair value. During the three and six months ended June 30, 2020 and 2019, there were
3. Net Income (Loss) Per Share
We compute basic net income (loss) per common share by dividing the net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period without consideration of common stock equivalents. Diluted net income (loss) per share is computed by dividing the net income (loss) attributable to common stockholders by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants, employee stock purchase plan (ESPP) and restricted stock units (RSUs). Potentially dilutive securities consisting of stock issuable under options, ESPP and RSUs are not included in the per common share calculation in periods when the inclusion of such shares would have an antidilutive effect.
Basic and diluted net income (loss) per common share is computed as follows (in thousands except share and per share data):
Three Months Ended |
| Six Months Ended | ||||||||||
June 30, | June 30, | |||||||||||
| 2020 |
| 2019 |
| 2020 |
| 2019 | |||||
(in thousands, except share and per share data) | ||||||||||||
Numerator: | ||||||||||||
Net income (loss) attributable to common stockholders | $ | ( | $ | ( | $ | ( | $ | | ||||
Denominator: | ||||||||||||
Weighted-average common shares outstanding used in computing basic net income (loss) |
| |
| | | | ||||||
Effect of dilutive securities | — | — | — | | ||||||||
Weighted-average common shares outstanding used in computing diluted net income (loss) | | | | | ||||||||
Basic net income (loss) per common share | $ | ( | $ | ( | $ | ( | $ | | ||||
Diluted net income (loss) per common share | $ | ( | $ | ( | $ | ( | $ | | ||||
For the three and six months ended June 30, 2020, and the three months ended June 30, 2019, all outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per common share as the effect of including such securities would have been antidilutive. For the six months ended June 30, 2019, potentially dilutive securities consisting of
4. Comprehensive Income
Comprehensive income is comprised of net income (loss) and other comprehensive income (loss). For the three and six months ended June 30, 2020 and 2019, the only component of other comprehensive income is net unrealized gain on marketable securities. There were no material reclassifications out of accumulated other comprehensive income (loss) during the three and six months ended June 30, 2020 and 2019.
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5. Marketable and Equity Securities
The Company’s marketable debt securities held as of June 30, 2020 and December 31, 2019 are summarized below:
Gross | Gross | |||||||||||
| Amortized |
| Unrealized | Unrealized |
| |||||||
June 30, 2020 | Cost | Gains | Losses | Fair Value | ||||||||
(in thousands) | ||||||||||||
Money Market Funds | $ | | $ | — | $ | — | $ | | ||||
Corporate Securities | | | — | | ||||||||
Government Securities | | | ( | | ||||||||
$ | | $ | | $ | ( | $ | | |||||
Reported as | ||||||||||||
Cash and cash equivalents | $ | | ||||||||||
Marketable securities | | |||||||||||
Total investments | $ | | ||||||||||
Gross | Gross | |||||||||||
| Amortized |
| Unrealized | Unrealized |
| |||||||
December 31, 2019 | Cost | Gains | Losses | Fair Value | ||||||||
(in thousands) | ||||||||||||
Money Market Funds | $ | | $ | — | $ | — | $ | | ||||
Corporate Securities | | | ( | | ||||||||
Government Securities | | | — | | ||||||||
$ | | $ | | $ | ( | $ | | |||||
Reported as | ||||||||||||
Cash and cash equivalents | $ | | ||||||||||
Marketable securities | | |||||||||||
Total investments | $ | | ||||||||||
The maturities of the Company’s marketable debt securities are as follows:
Amortized |
| Estimated | ||||
June 30, 2020 | Cost | Fair Value | ||||
(in thousands) | ||||||
Mature in one year or less | $ | | $ | | ||
Mature within two years | | | ||||
$ | | $ | | |||
13
The unrealized losses on available-for-sale investments and their related fair values as of June 30, 2020 and December 31, 2019 are as follows:
Less than 12 months | 12 months or greater | |||||||||||
Unrealized | Unrealized | |||||||||||
June 30, 2020 | Fair value | losses | Fair value | losses | ||||||||
(in thousands) | ||||||||||||
Government Securities | | ( | — | — | ||||||||
Less than 12 months | 12 months or greater | |||||||||||
Unrealized | Unrealized | |||||||||||
December 31, 2019 | Fair value | losses | Fair value | losses | ||||||||
(in thousands) | ||||||||||||
Corporate Securities | $ | | $ | ( | $ | | $ | ( | ||||
The unrealized losses from the listed securities are primarily due to a change in the interest rate environment and not a change in the credit quality of the securities.
In connection with the Aimmune Agreement (as defined below) which we entered in February 2020, the Company received shares of Aimmune common stock which are classified as equity securities with a readily determinable fair value as of June 30, 2020. The Company recorded $
6. Stock Based Compensation
Our Board of Directors (the Board) and the requisite stockholders previously approved the 2010 Equity Incentive Plan (the 2010 Plan). In October 2013, the Board approved the 2013 Equity Incentive Plan (the 2013 Plan) and in November 2013 our stockholders approved the 2013 Plan which became effective as of December 3, 2013. As of December 2, 2013, we suspended the 2010 Plan and
As of June 30, 2020, the total number of shares of common stock available for issuance under the 2013 Plan is
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In November 2013, the Board and our stockholders approved the 2013 Employee Stock Purchase Plan (ESPP), which became effective as of December 5, 2013. We have reserved a total of
During the six months ended June 30, 2020, the Company awarded
Total employee, director and non-employee stock-based compensation expense recognized for the three and six months ended June 30, 2020 and 2019 are as follows (in thousands):
Three Months Ended |
| Six Months Ended | ||||||||||
June 30, |
| June 30, | ||||||||||
| 2020 |
| 2019 |
| 2020 |
| 2019 | |||||
General and administrative | $ | | $ | | $ | | $ | | ||||
Research and development |
| |
| |
| |
| | ||||
$ | | $ | | $ | | $ | | |||||
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2020 |
| 2019 | 2020 |
| 2019 | |||||||
Stock options | $ | | $ | | $ | | $ | | ||||
ESPP | | | | | ||||||||
Restricted stock units | | | | | ||||||||
$ | | $ | | $ | | $ | | |||||
The following table summarizes option activity under our stock plans and related information:
|
|
| Weighted |
| Weighted | ||||||
Average |
| Average | |||||||||
Number of | Exercise |
| Remaining | Aggregate | |||||||
Shares Subject | Price |
| Contractual | Intrinsic | |||||||
to Outstanding | (Per |
| Term | Value | |||||||
Options | Share) |
| (in years) | (in thousands) | |||||||
Balances at December 31, 2019 |
| | $ | | |||||||
Options granted |
| | $ | | |||||||
Options forfeited |
| ( | $ | | |||||||
Options exercised |
| ( | $ | | |||||||
Balances at June 30, 2020 |
| | $ | | $ | | |||||
Exercisable | | $ | | $ | | ||||||
We calculate the intrinsic value as the difference between the exercise price of the options and the closing price of common stock of $
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Weighted-average fair value of options granted during the six-month periods ended June 30, 2020 and 2019 were $
Options | Options |
| |||||||
Three Months Ended | Six Months Ended | ||||||||
June 30, | June 30, |
| |||||||
| 2020 |
| 2019 |
| 2020 |
| 2019 |
| |
Expected term (years) |
|
| |||||||
Expected volatility | | % | | % | | % | | % | |
Risk-free interest rate | | % | | % | | % | | % | |
Expected dividend yield | — | % | — | % | — | % | — | % | |
ESPP | ESPP |
| |||||||
Three Months Ended | Six Months Ended |
| |||||||
June 30, | June 30, |
| |||||||
| 2020 |
| 2019 |
| 2020 |
| 2019 |
| |
Expected term (years) |
|
|
| ||||||
Expected volatility | % | % | % | % | |||||
Risk-free interest rate |
| % | % | % | % | ||||
Expected dividend yield | — | % | — | % | — | % | — | % | |
As of June 30, 2020, the unamortized compensation expense related to unvested stock options was $
The following table summarizes the RSU activity for the six-month period ended June 30, 2020:
Weighted | |||||
Restricted | Average Grant | ||||
Stock | Date Fair Value | ||||
Units | (Per unit) | ||||
Unvested at December 31, 2019 |
| | $ | | |
Granted |
| | | ||
Vested |
| ( | | ||
Forfeited |
| ( | | ||
Unvested at June 30, 2020 |
| | $ | | |
As of June 30, 2020, the unamortized compensation expense related to unvested RSUs was $
7. Leases
The Company leases office and laboratory space in Monrovia, CA under a lease that expires September 30, 2020; the original lease was a
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The Company also leases office space in San Diego, CA that expired July 2020. The lease includes an option to renew for an additional
The Company leases additional office space in San Diego, CA through August 2022, with an option to extend for an additional
The Company’s lease agreements do not contain any residual value guarantees or restrictive covenants. As of June 30, 2020, the Company did not have additional operating leases that have not yet commenced.
The following table reconciles the undiscounted cash flows for the operating leases at June 30, 2020 to the operating lease liabilities recorded on the balance sheet (in thousands):
Years ending December 31, | |||
For the remainder of 2020 | $ | | |
2021 |
| | |
2022 | | ||
2023 | | ||
2024 | | ||
2025 | | ||
Thereafter | | ||
Total undiscounted lease payments | | ||
Less: Imputed interest | ( | ||
Present value of lease payments | $ | | |
Lease liabilities - short-term | $ | | |
Lease liabilities - long-term | | ||
Total lease liabilities | $ | | |
The following table summarizes lease costs and cash disclosures for the three and six months ended June 30, 2020 (in thousands):
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2020 |
| 2019 | 2020 |
| 2019 | |||||||
Operating lease cost | $ | | $ | | $ | | $ | | ||||
Variable lease cost | | | | | ||||||||
Total lease costs | $ | | $ | | $ | | $ | | ||||
Cash paid for amounts included in | ||||||||||||
the measurement of lease liabilities | $ | | $ | | $ | | $ | | ||||
The amendment to the Monrovia, CA lease is a lease modification. Non-cash activities involving ROU assets related to the lease modification were $
At June 30, 2020, the weighted-average remaining lease term for operating leases was
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8. Commitments and Contingencies
From time to time, the Company may be subject to various litigation and related matters arising in the ordinary course of business. The Company does not believe it is currently subject to any material matters where there is at least a reasonable possibility that a material loss may be incurred.
The Company is obligated to make future payments to third parties under in-license agreements, including sublicense fees, royalties, and payments that become due and payable on the achievement of certain development and commercialization milestones. As the amount and timing of sublicense fees and the achievement and timing of these milestones are not probable and estimable, such commitments have not been included on the Company’s balance sheet. The Company has also entered into agreements with third-party vendors which will require us to make future payments upon the delivery of goods and services in future periods.
9. Collaboration and Licensing Agreements
The following is a summary description of the material revenue arrangements, including arrangements that generated revenue in the three and six months ended June 30, 2020 and 2019.
Genentech
In February 2019, the Company entered into a collaboration and license agreement (the Genentech Agreement) with Genentech, Inc. and F. Hoffman-La Roche Ltd (collectively, Genentech) for the development and commercialization of novel IL-15 collaboration products (Collaboration Products), including XmAb24306 (also named RG6323), the Company’s IL-15/IL-15Ra candidate. The Genentech Agreement became effective March 8, 2019.
Under the terms of the Genentech Agreement, Genentech received an exclusive worldwide license to XmAb24306 and other Collaboration Products, including any new IL-15 programs identified during the joint research collaboration. Genentech and the Company will jointly collaborate on worldwide development of XmAb24306 and potentially other Collaboration Products with Genentech maintaining all worldwide commercialization rights, subject to the Company having an option to co-promote in the United States. The Company has the right to perform clinical studies of Collaboration Products in combination with other therapeutic agents at its own cost, subject to certain requirements.
The Company received a $
Pursuant to the Genentech Agreement, XmAb24306 is designated as a development program and all costs incurred for developing XmAb24306 from March 8, 2019, the effective date of the Genentech Agreement, are being shared with Genentech under the initial cost-sharing percentage of
Pursuant to the Genentech Agreement, the Company and Genentech will conduct joint research activities for a two-year period to identify and discover additional IL-15 candidates developed from the Company’s cytokine and bispecific technologies. The
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The Company recognized the $
For the three months ended June 30, 2020 and 2019, the Company recognized $
Astellas
Effective March 29, 2019, the Company entered into a Research and License Agreement (Astellas Agreement) with Astellas Pharma Inc. (Astellas) pursuant to which the Company and Astellas will conduct a discovery program to characterize compounds and products for development and commercialization. Under the Astellas Agreement, Astellas was granted a worldwide exclusive license, with the right to sublicense products in the field created by the research activities.
Pursuant to the Astellas Agreement, the Company will apply its bispecific Fc technology to research antibodies provided by Astellas to generate bispecific antibody candidates and will conduct limited testing and characterization of the bispecific candidates and return the candidates to Astellas for development and commercialization. The activities will be conducted under a research plan agreed to by both parties to the Astellas Agreement. Astellas will assume full responsibility for development and commercialization of the antibody candidate. Pursuant to the Astellas Agreement, the Company received an upfront payment of $
The Company recognized the $
For the three months ended June 30, 2020 and 2019, the Company recognized $
Novartis
In June 2016, the Company entered into a Collaboration and License Agreement (Novartis Agreement) with Novartis Institutes for BioMedical Research, Inc. (Novartis), to develop and commercialize bispecific and other Fc engineered antibody drug candidates using the Company’s proprietary XmAb technologies and drug candidates. The Company received an upfront payment of $
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Pursuant to the Novartis Agreement:
| ● | The Company granted Novartis certain exclusive rights to research, develop and commercialize vibecotamab (XmAb14045) and plamotamab (XmAb13676), |
| ● | The Company will apply its bispecific technology in up to |
| ● | The Company will provide Novartis with a non-exclusive license to certain of its Fc technologies to apply against up to |
Under the Novartis Agreement, the Company and Novartis are co-developing vibecotamab worldwide and sharing development costs.
In December 2018, Novartis notified the Company it was terminating its rights with respect to the plamotamab program, which became effective June 2019.
The Company has completed delivery of
Amgen Inc.
In September 2015, the Company entered into a research and license agreement (the Amgen Agreement) with Amgen Inc. (Amgen) to develop and commercialize bispecific antibody product candidates using the Company’s proprietary XmAb bispecific Fc technology. Under the Amgen Agreement, the Company granted an exclusive license to Amgen to the rights to our CD38 x CD3 preclinical program and developed AMG 424. Amgen also applied our bispecific Fc technology to create AMG 509, a STEAP1 x CD3 XmAb 2+1 bispecific antibody. The Company has received a total of $
In May 2020, Amgen notified the Company that it was terminating its rights with respect to the CD38 x CD3 program, including AMG 424, which termination became effective July 2020. Under the terms of the Agreement, the rights to the AMG 424 program revert to the Company in connection with the termination.
MorphoSys AG
In June 2010, the Company entered into a Collaboration and License Agreement with MorphoSys AG (MorphoSys), which was subsequently amended. Under the agreement, we granted MorphoSys an exclusive worldwide license to the Company’s patents and know-how to research, develop and commercialize the XmAb5574 product candidate (subsequently renamed MOR208 and tafasitamab) with the right to sublicense under certain conditions. If certain developmental, regulatory and sales milestones are achieved, the Company is eligible to receive future milestone payments and royalties.
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In February 2020, the U.S. Food and Drug Administration (FDA) accepted MorphoSys’ Biologics License Application (BLA) for tafasitamab and the Company received a milestone payment of $
On July 31, 2020, the FDA approved MorphoSys’ BLA for tafasitamab (now Monjuvi®). In connection with the approval, the Company will receive a milestone payment of $
Alexion Pharmaceuticals, Inc.
In January 2013, the Company entered into an option and license agreement with Alexion Pharmaceuticals, Inc. (Alexion). Under the terms of the agreement, the Company granted to Alexion an exclusive research license, with limited sublicensing rights, to make and use the Company’s Xtend technology to evaluate and advance compounds. Alexion exercised its rights to
The Company is eligible to receive contractual milestones for certain commercial achievements and is also entitled to receive royalties based on a percentage of net sales of Ultomiris sold by Alexion, its affiliates or its sublicensees, which percentage is in the low single digits. Alexion’s royalty obligations continue on a product-by-product and country-by-country basis until the expiration of the last-to-expire valid claim in a licensed patent covering the applicable product in such country.
Under ASC 606, the Company recognizes revenue for sales-based royalties upon the subsequent sale of the product. We began earning royalty revenue from the sale of Ultomiris in 2019.
The Company recognized $
INmune Bio, Inc.
In October 2017, the Company entered into a License Agreement (Agreement) with INmune Bio, Inc. (INmune). Under the terms of the agreement, the Company provided INmune with an exclusive license to certain rights to a proprietary protein, XPRO1595. Under the agreement the Company received an upfront payment of $
The option has a
The Company did not recognize any revenue related to the agreement for the three and six months ended June 30, 2020 and 2019. There is
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Vir Biotechnology, Inc.
In the third quarter of 2019, the Company entered into a Patent License Agreement (the VirBio Agreement) with Vir Biotechnology (VirBio) pursuant to which the Company provided a non-exclusive license to its Xtend technology for up to
The Company evaluated the VirBio Agreement and determined that the single performance obligation was access to a non-exclusive license to certain patents of the Company which were transferred to VirBio upon execution of the VirBio Agreement in July 2019.
VirBio initiated a Phase 1 study with a licensed antibody in 2019 and in the second quarter of 2020 it initiated a Phase 1 study with a second licensed antibody.
In March 2020, the Company entered into a second Patent License Agreement (the Second VirBio Agreement) with VirBio pursuant to which the Company provided a non-exclusive license to its Xtend technology to extend the half-life of novel antibodies VirBio is investigating as potential treatments for patients with SARS-CoV-2, which causes COVID-19. Under the terms of the Second VirBio Agreement, VirBio is responsible for all research, development, regulatory and commercial activities for the antibody, and the Company is eligible to receive royalties on the net sales of approved products in the mid-single digit percent range.
The Company determined that the Second VirBio Agreement was a modification of the original agreement and the transfer of the license occurred at inception of the VirBio Agreement. The total consideration under the arrangement did not change with the Second VirBio Agreement as the Company will potentially receive additional royalty revenue which is variable consideration and is not included in the transaction price.
The Company recognized $
Aimmune Therapeutics, Inc.
On February 4, 2020, the Company entered into a License, Development and Commercialization Agreement (the Aimmune Agreement) with Aimmune Therapeutics, Inc. (Aimmune) pursuant to which the Company granted Aimmune an exclusive worldwide license to XmAb7195, which was renamed AIMab7195. Under the Aimmune Agreement, Aimmune will be responsible for all further development and commercialization activities for XmAb7195. The Company received an upfront payment of $
Under the Aimmune Agreement, Aimmune received exclusive worldwide rights to manufacture, develop and commercialize XmAb7195. They also received the rights to all data, information and research materials related to the XmAb7195 program.
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The Company evaluated the Aimmune Agreement under the revenue recognition standard ASC 606 and identified the following performance obligations that it deemed to be distinct at the inception of the contract:
| ● | License to the rights to the XmAb7195 drug candidate; and |
| ● | Rights to material, data and information that the Company had accumulated in connection with manufacturing, testing and conducting clinical trials for the XmAb7195 program and intellectual property filings and information (XmAb7195 data). |
The Company considered the licenses as functional intellectual property as Aimmune has the right to use XmAb7195 at the time that the Company transfers such rights. The rights to the XmAb7195 data are not considered to be separate from the license to XmAb7195 as Aimmune cannot benefit from the license without the supporting data and documentation.
The Company determined the transaction price at inception is $
The Company determined the transaction price at inception of the Aimmune Agreement and allocated it to the performance obligation, delivery of the XmAb7195 license.
The Company completed delivery of its performance obligations in March 2020. The license to XmAb7195 was transferred to Aimmune at inception of the Aimmune Agreement, and the XmAb7195 data was transferred to Aimmune in March 2020.
Gilead Sciences, Inc.
In January 2020, the Company entered into a Technology License Agreement (the Gilead Agreement) with Gilead Sciences, Inc. (Gilead), in which the Company provided an exclusive license to its Cytotoxic Fc and Xtend Fc technologies for an initial identified antibody and options for up to
In March 2020, Gilead exercised options on
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The Company evaluated the Gilead Agreement under the revenue recognition standard ASC 606 and identified the following performance obligations that it deemed to be distinct at the inception of the contract:
| ● | Non-exclusive license to its Cytotoxic Fc and Xtend Fc technologies; and, |
| ● | Options for |
The Company considered the licenses as functional intellectual property as Gilead has the right to use the technologies at the time that the Company transfers such rights. Each of the
The total transaction price is $
The Company allocated $
The Company recognized $
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Revenue earned
The revenues recorded for the three and six months ended June 30, 2020 were earned principally from the following licensees (in millions):
Three Months Ended |
| Six Months Ended | ||||||||||
June 30, |
| June 30, | ||||||||||
2020 | 2019 |
| 2020 | 2019 | ||||||||
Aimmune | $ | — |
| $ | — | $ | | $ | — | |||
Alexion |
| | | |
| | ||||||
Astellas | | | | | ||||||||
Genentech | | | | | ||||||||
Gilead | | — | | — | ||||||||
MorphoSys | — | — | | — | ||||||||
Vir Biotechnology | |
| — | |
| — | ||||||
Total | $ | | $ | | $ | | $ | | ||||
The table below summarizes the disaggregation of revenue recorded for the three and six months ended June 30, 2020 (in millions):
Three Months Ended |
| Six Months Ended | ||||||||||
June 30, |
| June 30, | ||||||||||
2020 | 2019 |
| 2020 | 2019 | ||||||||
Research collaboration |
| $ | |
| $ | | $ | |
| $ | | |
Milestone | |
| | |
| | ||||||
Licensing | |
| — | |
| | ||||||
Royalties | | | | | ||||||||
Total | $ | | $ | | $ | | $ | | ||||
Remaining Performance Obligations and Deferred Revenue
The Company’s remaining performance obligations are delivery of
10. Income taxes
On March 27, 2020, the president signed the Coronavirus Aid, Relief and Economic Security (CARES) Act. The legislation provides several changes to corporation income taxes including:
| ● | Modification of the rules applicable to the deductibility of net operation losses (NOLs) incurred in tax years beginning in 2018, 2019 and 2020, and |
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| ● | Acceleration of the corporate minimum tax credit. |
The Company reviewed the new legislation and determined that certain provisions would provide income tax benefits:
| ● | The Company has NOL and income tax credit carryforwards which are subject to a valuation allowance, due to uncertainty about the ability to utilize such losses and credits in future periods. Accordingly, the Company does not expect the changes in the NOL provisions in the legislation to provide any benefit in the near-term. |
| ● | As of December 31, 2019, the Company had recorded a receivable of $ |
There was no provision for income taxes for the three and six months ended June 30, 2020. The provision for income taxes of million for the six months ended June 30, 2019 represents the interim period tax allocation of the state alternative minimum tax based on the Company’s projected year-end effective income tax rates which cannot be offset by the Company’s net operating loss carryforwards. The Company has a federal income tax receivable of $
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the financial statements and accompanying notes thereto for the fiscal year ended December 31, 2019 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year ended December 31, 2019. See also “Special Note Regarding Forward-Looking Statements” included in this Quarterly Report on Form 10-Q.
Company Overview
We are a clinical-stage biopharmaceutical company focused on discovering and developing engineered monoclonal antibody and cytokine therapeutics to treat patients with cancer and autoimmune diseases who have unmet medical needs. We are developing a suite of clinical-stage drug candidates from our proprietary XmAb® technology platforms. In contrast to conventional approaches to antibody design, which focus on the segment of antibodies that interact with target antigens, our protein engineering efforts and the XmAb technologies are focused on the Fc domain, the part of an antibody that interacts with multiple segments of the immune system and controls antibody structure. The Fc domain is constant and interchangeable among antibodies, and our engineered Fc domains, the XmAb technology, can be readily substituted for natural Fc domains. We use our protein engineering capabilities to increase our understanding of protein structure and interactions and to design new XmAb technologies and development candidates with improved properties.
Our business strategy is based on the plug-and-play nature of the XmAb technology, allowing us to create new antibody and cytokine drug candidates for our internal development or licensing, or to selectively license access to one or more of our XmAb technologies to pharmaceutical or biotechnology companies to use in developing their own proprietary antibodies with improved properties.
COVID-19
We are closely monitoring the pandemic caused by the novel coronavirus SARS-CoV-2 which causes the disease COVID-19, and are evaluating its impact on all aspects of our business including how it will affect our partners, collaborations, and our research and development operations. While the pandemic did not significantly disrupt our
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business during the six months ended June 30, 2020, the evolving nature of the pandemic prevents us from reasonably predicting how the pandemic will affect our financial condition, results of operations and cash flows due to numerous uncertainties. These uncertainties include the scope, severity and duration of the pandemic, the actions taken to contain the pandemic or mitigate its impacts and the direct and indirect economic effects of the pandemic
and containment measures, among others. Many states, including California, where we are headquartered and where our principal place of business is located, and cities therein have instituted quarantines, restrictions, rules and guidelines that affect the continued operation of businesses. Other countries and states where we conduct manufacturing of our drug product, testing activities and clinical sites where patients are enrolled in our clinical trials have enacted similar restrictions that could affect our ability to conduct our drug candidate development and clinical operations.
The potential impacts on our business, revenue, clinical studies and research and development activities of the COVID-19 pandemic include:
| ● | Business: Our broad protein engineering capabilities and technologies are uniquely suited to provide us with opportunities to identify and enhance compounds that may target the novel coronavirus and potentially treat patients with COVID-19. Two companies are advancing antibodies that incorporate our Xtend Fc technology: |
| o | Alexion Pharmaceuticals, Inc.: Our partner, Alexion announced the initiation of a Phase 3 clinical trial evaluating Ultomiris® in treating patients with severe COVID-19 symptoms. We are eligible to receive sales milestones and a continued low-single digit percent royalty on the sales of Ultomiris®. |
| o | Vir Biotechnology, Inc.: Our partner VirBio, announced that it is initiating a Phase 2/3 clinical trial evaluating VIR-7831, an antibody drug candidate that targets the SARS-CoV-2 virus. We are eligible to receive a mid-single digit royalty on the net sales of approved products for this candidate. |
| ● | Revenue: We receive upfront payments, milestone payments, royalties and cost-sharing payments from licensing our XmAb technologies and drug candidates and from our co-development arrangements. The COVID-19 pandemic has not adversely affected our revenues for the quarter ended June 30, 2020. During the quarter, we continued to generate revenue from our existing partnerships, including Alexion and Gilead, recognizing $3.8 million and $7.5 million of revenue, respectively. |
Our ability to continue to earn revenue from these and other partnerships is dependent on the partners’ ability to generate sales of products, such as our royalties from Ultomiris, and the ability of our partners to continue to advancing their programs through regulatory approval and the ability of our partners to advance our partnered programs into later stages of development, which provide us with potential milestone payments. If the COVID-19 pandemic continues for an extended period and adversely affect the sales or clinical, development and regulatory progress of partnered programs, the amount of revenue we could earn would be adversely affected.
| ● | Clinical studies: We are currently enrolling patients in six clinical programs, and our partner Genentech is enrolling patients in the Phase 1 study of XmAb24306 (also known as RG6323), our co-development program with Genentech. Many of our partners are also enrolling patients in clinical trials with drug candidates that incorporate one or more of our XmAb technologies. Although the COVID-19 pandemic has not materially affected our clinical development for the period ended June 30, 2020, some of our clinical programs have experienced slower patient enrollment, and the initiation of a new study of vibecotamab has been delayed as a result of the COVID-19 pandemic. These delays have not broadly affected the status of our portfolio programs and have been limited to specific trials and specific sites. While clinical studies in oncology are still a high priority for patients, their families and their physicians, our planned study initiations and our ongoing studies have been affected, as many clinical sites have delayed starting new clinical trials and others have postponed enrollment to address the COVID-19 pandemic. |
| ● | Research and development activities: In connection with the COVID-19 pandemic we required all of our non-laboratory employees to begin working remotely, and we have implemented additional health, safety |
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| and environmental procedures for all onsite laboratory research employees. We provide a safe and healthy environment for our onsite employees who have been able to continue research operations, following an initial period of reduced onsite activities while new policies and procedures were developed and implemented. Our development activities include manufacturing, and conducting Investigational New Drug application (IND) enabling studies for XmAb27564, our IL-2-Fc cytokine candidate, XmAb30819, our initial 2+1 bispecific antibody candidate, and other bispecific and cytokine antibody candidates in early stages of development. As of June 30, 2020, these activities have continued remotely without interruption from the COVID-19 pandemic. However, the conduct of all our development activities rely on our employees and on third party vendors. If the COVID-19 pandemic affects our employees, our vendors or other parties in the supply chain required to continue research and development activities, the research and development activities and our expected timelines for completing such activities, including submission of INDs will be adversely affected. |
Wholly Owned and Co-Developed Drug Candidates
There are currently 17 antibody and cytokine drug candidates that are being advanced in clinical trials, by us or by our partners, that have been engineered with our XmAb technologies, and we expect additional candidates currently in later stages of preclinical development to enter the clinic within the next year. The most recent expansion of our platform is the XmAb bispecific Fc domains, which enable the rapid design and simplified development of antibodies, and other protein structures, that can bind two or more different targets simultaneously. We recently expanded the functionality, selectivity and potency tuning of the bispecific platform with the design of our 2+1 bispecific format. These bispecific Fc domains are used to generate a broad array of novel drug candidates.
CD3 candidates: The initial bispecific antibody candidates that we designed contain an anti-tumor associated antigen binding domain and a second binding domain targeted to CD3, an activating receptor on T cells. The goal of the “CD3 bispecific” is to recruit or activate T cells against tumor cells expressing the antigen target.
We are currently conducting Phase 1 studies for three CD3 bispecific antibody candidates: vibecotamab, plamotamab and tidutamab.
| ● | Vibecotamab (XmAb14045) is a bispecific antibody that targets CD123, an antigen on acute myeloid leukemia (AML) cells and leukemic stem cells, and CD3, an activating receptor on T cells. It is being developed in collaboration with our partner, Novartis. We continue enrolling patients with AML in an ongoing Phase 1 study, and we plan to initiate additional clinical studies evaluating vibecotamab in 2021. |
| ● | Plamotamab (XmAb13676) is a bispecific antibody that targets CD20, an antigen on B-cell tumors, and CD3 for the treatment of B-cell malignancies. We continue to enroll patients with B-cell malignancies in an ongoing Phase 1 study, and we plan to initiate additional clinical studies evaluating plamotamab in 2021. |
| ● | Tidutamab (XmAb18087) is a bispecific antibody that targets somatostatin receptor 2 (SSTR2), a target on neuroendocrine tumors (NET) and gastrointestinal stromal tumors (GIST), and CD3. We continue to enroll patients with NET or GIST in the Phase 1 study, and we expect to provide initial data from NET patients in this study in the second half of 2020. |
XmAb 2+1 bispecific antibodies. We use the modularity of our XmAb Fc technology to build bispecific antibodies in a variety of formats to best suit therapeutic uses. Recently we created CD3 bispecific antibodies with 2 binding domains to the tumor target (bivalent binding) and 1 binding domain to CD3, a format called 2+1 bispecific antibody. The 2+1 bispecific antibodies can be more tumor specific, because bivalent binding preferentially targets tumor cells with high density target expression, potentially sparing any normal tissue expressing the target at low density. Also, bivalent binding broadens the range of potency tuning for improving efficacy and tolerability. We believe that the selectivity of the 2 +1 format is particularly useful for antibodies against solid tumor targets, which can have poor tolerability because such targets are often expressed on a range of normal tissues, including critical organs.
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The 2+1 format was used for the design of AMG509, a bispecific antibody that we developed under our Amgen collaboration. AMG509 is a STEAP1 x CD3 XmAb 2+1 bispecific antibody for which Amgen is currently enrolling a Phase 1 trial and is being developed for patients with prostate cancer and Ewing sarcoma.
At the American Association for Cancer Research (AACR) Virtual Annual Meeting in June, we presented preclinical data from three 2+1 bispecific programs targeting renal cell carcinoma, prostate cancer and ovarian cancer which included XmAb30819, ENPP3 x CD3, our initial bispecific development program using the 2+1 format and targeting ENPP3 x CD3.
| ● | XmAb30819, ENPP3 x CD3 is a bispecific antibody that targets ENPP3, an antigen in renal cell carcinomas (RCC) tumors, and CD3. RCC is the most common form of kidney cancer and in 2020 the National Cancer Institute estimated that there are 73,750 new cases each year and 14,830 deaths from this cancer. |
ENPP3 is an underexplored tumor antigen overexpressed on RCCs. In preclinical models, XmAb30819 bound preferentially to tumor cells compared to normal cells and selectively and effectively recruited T cells to kill tumor cells. Additional data demonstrated a strong reversal of tumor growth in human-cell engrafted mouse models of disease. A study in non-human primates demonstrated XmAb30819 was well-tolerated with expected pharmacodynamics and an antibody like half-life. We are conducting IND-enabling studies with XmAb30819 and expect to file an IND and initiate Phase 1 studies for this candidate in 2021.
TME activator candidates: We are also advancing a suite of tumor microenvironment (TME) activators that have been designed to promote tumor-selective T cell activation by targeting multiple checkpoint or co-stimulatory receptors. These TME activator candidates use our bispecific Fc domain and incorporate our Xtend technology for longer half-life. We are currently conducting Phase 1 studies for three TME activator candidates: XmAb20717, XmAb22841 and XmAb23104:
| ● | XmAb20717 targets PD-1 and CTLA-4, two immune checkpoint receptors, to activate the tumor microenvironment selectively, and is being developed in broad oncology indications including solid tumors. We are currently enrolling patients with RCC, prostate cancer and other cancers without approved checkpoint therapies to expansion cohorts in an ongoing Phase 1 study, and the study continues to enroll patients in additional dose-escalation cohorts. Expansion cohorts for patients with melanoma and advanced non-small cell lung cancer are fully enrolled. |
In May 2020, we presented initial dose-escalation data from the study. In the first six dose-escalation cohorts, XmAb20717 was generally well-tolerated in heavily pretreated patients with advanced solid tumors. We observed dose-dependent increases in T cell activation biomarkers, and within the highest dose cohort (10 mg/kg), a patient with melanoma, who was treated previously with checkpoint therapy (pembrolizumab), achieved a confirmed complete response. Additionally, a patient at the 6 mg/kg dose level with microsatellite instability-high (MSI-H) colorectal cancer, who had progressive disease after 10 months of treatment with pembrolizumab and prior treatment with both nivolumab and ipilimumab, achieved stable disease, and as of the presentation of data, had continued on treatment at cycle 14 (392 days).
| ● | XmAb23104 targets PD-1 and ICOS, an immune co-stimulatory receptor, and is being developed for multiple oncology indications. We continue to enroll patients with selected solid tumors in the Phase 1 dose-escalation study. |
| ● | XmAb22841 targets CTLA-4 and LAG-3, also an immune checkpoint receptor, and is being developed for multiple indications. We are advancing XmAb22841 in combination with pembrolizumab, an inhibitor of the PD1 checkpoint receptor to create a triple checkpoint blockade. We continue to enroll patients with select solid tumors in the Phase 1 single-agent dose-escalation portion of the study and have begun to dose patients with the pembrolizumab combination. |
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Cytokine candidates: Our cytokine drug candidates are built on our bispecific Fc domain and have their potency tuned to improve therapeutic index. These candidates also incorporate our Xtend technology for longer half-life.
| ● | XmAb24306 (also known as RG6323) is an IL15/IL15-receptor alpha complex fused to a bispecific Fc domain (IL15/IL15Ra-Fc). In February 2019, we entered into the Genentech Agreement to develop and commercialize novel IL-15 cytokine therapeutics, whereby the companies will co-develop XmAb24306 and other potential IL-15 programs. In March 2020, Genentech dosed the first patient in a Phase 1 dose-escalation study with XmAb24306. The study is designed to determine initial safety and potential efficacy of XmAb24306, as a single agent and in combination with atezolizumab, before advancing it into further clinical studies in combination with other agents. |
| ● | XmAb27564 is an IL-2 Fc fusion protein with our bispecific Fc domain that we intend to develop for the treatment of patients with autoimmune diseases. We are currently conducting IND-enabling studies for XmAb27564 and plan to submit an IND and initiate Phase 1 studies for this candidate in 2021. |
Licensing Partnerships
An important part of our business strategy is to leverage the value of our Fc technologies and drug candidates with partnerships and collaborations. We have eleven partnerships for the licensing of our XmAb technologies and drug candidates. These arrangements provide upfront payments, annual licensing fees, potential milestone payments and royalties as our partners advance XmAb technologies and drug candidates through clinical development and commercialize products that gain regulatory approval. These payments provide us with multiple revenue streams that help fund development of our product candidates, and the partnerships usually require limited resources or efforts from us. Where possible, we structure such transactions to retain long-term value in the drug candidates through profit-split arrangements or retaining U.S. commercial rights.
In 2020, we entered into licensing transactions with Aimmune and Gilead for which we received total payments of $9.6 million and $13.5 million, respectively. In 2020, we have also extended our licensing partnership with VirBio whereby VirBio will have non-exclusive access to Xtend Fc technology to extend the half-life of antibodies that VirBio is investigating as potential treatments for patients with COVID-19, the disease caused by the novel coronavirus SARS-CoV-2.
In July 2020, we entered into a Collaboration and License Agreement (Atreca Agreement) with Atreca, Inc. (Atreca), to research, develop and commercialize novel CD3 bispecific antibodies as potential therapeutics in oncology. Under the Atreca Agreement, the companies will engage in a three-year research program in which Atreca will provide antibodies against novel tumor targets through its discovery platform from which we will engineer XmAb bispecific antibodies that also bind to the CD3 receptor on T cells. Up to two joint programs are eligible to be mutually selected for further development and commercialization, with each partner sharing 50 percent of costs and profits. Each company has the option to lead development, regulatory and commercialization activities for one of the joint programs. In addition, the agreement allows each partner the option to pursue up to two programs independently, with a mid-to high-single digit percent royalty payable on net sales to the other partner.
The most advanced program where we have licensed our technology is Alexion’s Ultomiris®, a complement inhibitor antibody, to allow for a longer duration of action, less frequent dosing and reduced patient burden of therapy compared to Alexion’s previous generation therapy, Soliris®. Alexion is approved for marketing in the U.S., Europe and Japan for the treatment of adult patients with the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) and is also approved in the U.S. and Europe for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). In March 2020, Alexion announced it was initiating a Phase 3 study of Ultomiris in treating patients with severe COVID-19, adults who are hospitalized with severe pneumonia or acute respiratory distress syndrome (ARDS).
Examples of other partnerships and collaborations in which we have licensed XmAb technologies and candidates to other biopharmaceutical companies for further development include those with MorphoSys, Amgen, Novartis, Gilead and VirBio:
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| ● | MorphoSys AG: In 2010, we licensed exclusive worldwide rights to develop and commercialize tafasitamab (MOR208) to MorphoSys. In February 2020, the FDA accepted MorphoSys’ Biologics License Application (BLA) and granted priority review for tafasitamab in combination with lenalidomide for the treatment of relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL), and we received a milestone payment of $12.5 million. On July 31, 2020, the FDA approved MorphoSys’ Monjuvi (tafasitamab-cxix) in combination with lenalidomide treating patients with relapsed refractory DLBCL. We will receive a $25.0 million milestone payment in connection with the approval and are eligible to receive up to $50.0 million in potential sales milestones and royalties on net sales of Monjuvi in the high-single to low-double digit percent range. |
| ● | Amgen Inc.: In 2015, we entered into a research and license agreement with Amgen to develop and commercialize products using our bispecific technology. Amgen applied our bispecific Fc technology to create, AMG 509, a STEAP1 x CD3 XmAb 2+1 bispecific antibody, which Amgen is developing for patients with prostate cancer and Ewing sarcoma. Preclinical data were presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting I in April 2020. Amgen is currently enrolling patients in a Phase 1 study of AMG 509 in patients with metastatic castration-resistant prostate cancer (mCRPC). |
Amgen also licensed the rights to our CD38 x CD3 preclinical program and developed AMG 424 which was enrolling a Phase 1 study in patients with multiple myeloma. In May 2020, Amgen notified us they were terminating the CD38 x CD3 program, including AMG 424, which termination became effective July 2020. Under the terms of the agreement, the rights to the CD38 program including AMG 424 revert to us. We are working with Amgen to review the AMG 424 development data and determine potential next steps for the program.
| ● | Novartis Institutes for BioMedical Research: In connection with our 2016 Novartis collaboration, we created and licensed to Novartis an undisclosed bispecific antibody candidate. In December 2019, Novartis dosed the first patient in a Phase 1 study for this drug candidate. |
| ● | Gilead Sciences, Inc.: In January 2020, we provided Gilead an exclusive license to our Cytotoxic Fc and Xtend Fc technologies for elipovimab (GS-9722), an anti-HIV antibody that Gilead has advanced in a Phase 1 study. In connection with the license, we provided Gilead with options to three additional antibodies directed to the same molecule target as elipovimab. In March 2020, Gilead exercised two of the remaining options and in April 2020, Gilead exercised the final option. We received an upfront payment of $6.0 million in the first quarter of 2020 and option payments of $7.5 million in April 2020 in connection with the agreement. |
| ● | Vir Biotechnology, Inc.: In August 2019, we provided VirBio a non-exclusive license to use our Xtend Fc technology in developing and commercializing antibodies as potential treatments for patients with influenza A and hepatitis B virus infection. VIR-2482 is being evaluated as a universal prophylactic for influenza A in an ongoing Phase 1/2 clinical study. In May 2020, VirBio initiated a Phase 1 clinical study for a second antibody, VIR-3434, which is being evaluated as a potential treatment for patients with hepatitis B virus infection. |
In March 2020, we entered into a second non-exclusive license with VirBio to use our Xtend technology to extend the half-life of VIR-7831 and VIR-7832, novel antibodies that VirBio is investigating as potential treatments for patients with COVID-19, the disease caused by the novel coronavirus SARS-CoV-2. VirBio plans to commence a Phase 2/3 clinical study for VIR-7831 within the coming months.
We have over 1,000 issued and pending patents worldwide to protect our XmAb technology platform and XmAb drug candidates.
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Since we commenced active operations in 1998, we have devoted substantially all our resources to staffing our company, business planning, raising capital, developing our technology platforms, identifying potential product candidates, undertaking pre-clinical and IND-enabling studies and conducting clinical trials. We have no products approved for commercial sale and have not generated any revenues from product sales, and we continue to incur significant research and development expenses and other expenses related to our ongoing operations. To date, we have funded our operations primarily through the sale of stock and from payments generated from our product development partnerships and licensing arrangements.
As of June 30, 2020, we had an accumulated deficit of $339.5 million. Substantially all of the operating losses that we have incurred resulted from expenses incurred in connection with our product candidate development programs, our research activities and general and administrative costs associated with our operations.
Results of Operations
Comparison of the Three Months Ended June 30, 2020 and 2019
The following table summarizes our results of operations for the three months ended June 30, 2020 and 2019 (in millions):
Three Months Ended |
| |||||||||
June 30, |
| |||||||||
| 2020 |
| 2019 |
| Change |
| ||||
Revenues: | ||||||||||
Research collaboration |
| $ | 1.5 | $ | 14.4 | $ | (12.9) | |||
Milestone | 0.3 | 4.0 | (3.7) | |||||||
Licensing | 7.5 |
| — |
| 7.5 | |||||
Royalties | 3.8 | 1.1 | 2.7 | |||||||
Total revenues |
| 13.1 | 19.5 | (6.4) | ||||||
Operating expenses: | ||||||||||
Research and development | 43.5 |
| 33.3 | 10.2 | ||||||
General and administrative | 7.2 |
| 5.8 | 1.4 | ||||||
Total operating expenses | 50.7 |
| 39.1 | 11.6 | ||||||
Other income, net |
| 2.6 |
| 3.6 | (1.0) | |||||
Loss before income tax expense | (35.0) | (16.0) | (19.0) | |||||||
Income tax expense | — | — | — | |||||||
Net loss | $ | (35.0) | $ | (16.0) | $ | (19.0) | ||||
Revenues
Revenues for the three months ended June 30, 2020 are primarily from royalty revenue from our Alexion collaboration and licensing revenue recognized from our Gilead collaboration. Revenue for the three months ended June 30, 2019 is primarily from our research collaboration revenue from our Genentech and Astellas collaborations and milestone revenue received from our Alexion collaboration.
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Research and Development Expenses
The following table summarizes our research and development expenses for the three months ended June 30, 2020 and 2019 (in millions):
Three Months Ended | |||||||||
June 30, | |||||||||
| 2020 |
| 2019 |
| Change | ||||
Product programs: | |||||||||
Obexelimab (XmAb5871) |
| $ | 1.0 | $ | 5.4 | $ | (4.4) | ||
Bispecific programs: | |||||||||
CD3 programs: | |||||||||
Vibecotamab (XmAb14045)* | 3.1 | 3.7 | (0.6) | ||||||
Plamotamab (XmAb13676) | 9.3 | 3.3 | 6.0 | ||||||
Tidutamab (XmAb18087) | 3.7 | 2.9 | 0.8 | ||||||
XmAb30819, ENPP3 x CD3 | 1.9 | — | 1.9 | ||||||
Total CD3 programs | 18.0 | 9.9 | 8.1 | ||||||
Tumor micro environment (TME) activators: | |||||||||
XmAb20717 | 6.8 | 4.0 | 2.8 | ||||||
XmAb23104 | 3.7 | 2.1 | 1.6 | ||||||
XmAb22841 | 2.2 | 1.9 | 0.3 | ||||||
Total TME activators | 12.7 | 8.0 | 4.7 | ||||||
Cytokine programs: | |||||||||
XmAb24306* | 2.0 | 5.1 | (3.1) | ||||||
XmAb27564 | 4.7 | 1.1 | 3.6 | ||||||
Total cytokine programs | 6.7 | 6.2 | 0.5 | ||||||
Subtotal bispecific programs | 37.4 | 24.1 | 13.3 | ||||||
Other, research and early stage programs | 5.1 | 3.8 |
| 1.3 | |||||
Total research and development expenses |
| $ | 43.5 | $ | 33.3 | $ | 10.2 | ||
*Includes net payments to, and reimbursements from our partners pursuant to agreements that include cost-sharing arrangements.
Research and development expenses increased by $10.2 million for the three months ended June 30, 2020 over the same period in 2019 primarily due to increased spending on our plamotamab and XmAb20717 programs as we continue to advance these programs in dose escalation clinical studies. Spending also increased on our XmAb27564 and XmAb30819 programs as we initiate manufacturing campaigns and IND enabling studies. Spending also increased in our earlier research stage studies. These increases were partially offset by reduced spending on our XmAb24306 and obexelimab programs.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the three months ended June 30, 2020 and 2019 (in millions):
Three Months Ended |
| |||||||||
June 30, |
| |||||||||
| 2020 |
| 2019 |
| Change |
| ||||
General and administrative |
| $ | 7.2 | $ | 5.8 |
| $ | 1.4 | ||
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General and administrative expenses increased by $1.4 million for the three months ended June 30, 2020 over the same period in 2019 primarily due to increased general and administrative staffing and spending on professional fees.
Other Income, Net
Other income was $2.6 million and $3.6 million for the three months ended June 30, 2020 and 2019, respectively. The decrease in other income was primarily due to lower interest income earned from our marketable securities.
Comparison of the Six Months Ended June 30, 2020 and 2019
The following table summarizes our results of operations for the six months ended June 30, 2020 and 2019 (in millions):
Six Months Ended |
| |||||||||
June 30, |
| |||||||||
| 2020 |
| 2019 |
| Change |
| ||||
Revenues: | ||||||||||
Research collaboration |
| $ | 2.4 | $ | 14.7 | $ | (12.3) | |||
Milestone | 12.8 |
| 4.0 | 8.8 | ||||||
Licensing | 23.1 | 111.6 |
| (88.5) | ||||||
Royalties | 7.2 | 1.1 | 6.1 | |||||||
Total revenues |
| 45.5 | 131.4 | (85.9) | ||||||
Operating expenses: | ||||||||||
Research and development | 77.4 |
| 61.5 |
| 15.9 | |||||
General and administrative | 14.4 |
| 11.3 | 3.1 | ||||||
Total operating expenses | 91.8 |
| 72.8 | 19.0 | ||||||
Other income, net |
| 3.3 |
| 6.3 | (3.0) | |||||
Income (loss) before income tax expense | (43.0) | 64.9 | (107.9) | |||||||
Income tax expense | — | 0.9 | (0.9) | |||||||
Net income (loss) | $ | (43.0) | $ | 64.0 | $ | (107.0) | ||||
Revenues
Revenues for the six months ended June 30, 2020 are primarily from royalty revenue from our Alexion collaboration and licensing revenue recognized from our collaborations with Gilead and Aimmune. Revenues recognized for the six months ended June 30, 2019 are primarily from licensing and collaboration revenue recognized under the Genentech and Astellas arrangements.
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Research and Development Expenses
The following table summarizes our research and development expenses for the six months ended June 30, 2020 and 2019 (in millions):
Six Months Ended | |||||||||
June 30, | |||||||||
| 2020 |
| 2019 |
| Change | ||||
Product programs: | |||||||||
Obexelimab (XmAb5871) |
| $ | 1.9 | $ | 11.9 | $ | (10.0) | ||
Bispecific programs: | |||||||||
CD3 programs: | |||||||||
Vibecotamab (XmAb14045)* | 5.7 | 6.5 | (0.8) | ||||||
Plamotamab (XmAb13676) | 16.4 | 5.2 | 11.2 | ||||||
Tidutamab (XmAb18087) | 6.9 | 5.6 | 1.3 | ||||||
XmAb30819, ENPP3 x CD3 | 2.9 | — | 2.9 | ||||||
Total CD3 programs | 31.9 | 17.3 | 14.6 | ||||||
Tumor micro environment (TME) activators: | |||||||||
XmAb20717 | 12.1 | 6.7 | 5.4 | ||||||
XmAb23104 | 6.5 | 4.1 | 2.4 | ||||||
XmAb22841 | 4.7 | 3.6 | 1.1 | ||||||
Total TME activators | 23.3 | 14.4 | 8.9 | ||||||
Cytokine programs: | |||||||||
XmAb24306* | 4.0 | 9.8 | (5.8) | ||||||
XmAb27564 | 6.6 | 1.2 | 5.4 | ||||||
Total cytokine programs | 10.6 | 11.0 | (0.4) | ||||||
Subtotal bispecific programs | 65.8 | 42.7 | 23.1 | ||||||
Other, research and early stage programs | 9.7 | 6.9 |
| 2.8 | |||||
Total research and development expenses |
| $ | 77.4 | $ | 61.5 | $ | 15.9 | ||
*Includes net payments to, and reimbursements from our partners pursuant to agreements that include cost-sharing arrangements.
Research and development expenses increased by $15.9 million for the six months ended June 30, 2020 over the same period in 2019 primarily due to increased spending on our plamotamab, XmAb20717 and XmAb22841 programs as we continue to advance these programs in dose escalation clinical studies. Spending also increased on our XmAb27564 and XmAb30819 programs as we initiate manufacturing campaigns and IND enabling studies and activities. Spending also increased in our earlier research stage studies. These increases were partially offset by reduced spending on the XmAb24306 and obexelimab programs.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the six months ended June 30, 2020 and 2019 (in millions):
Six Months Ended | |||||||||
June 30, | |||||||||
| 2020 |
| 2019 |
| Change | ||||
General and administrative |
| $ | 14.4 | $ | 11.3 |
| $ | 3.1 | |
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General and administrative expenses increased by $3.1 million for the six months ended June 30, 2020 over the same period in 2019 primarily due to increased general and administrative staffing and spending on professional fees.
Other Income, Net
Other income was $3.3 million and $6.3 million for the six months ended June 30, 2020 and 2019, respectively. The decrease in other income was primarily from the $2.3 million unrealized loss recognized in the first quarter related to our Aimmune common stock and also a reduction in earnings from investments due to lower interest rates during the period.
Cash Flows
The following table sets forth the primary sources and uses of cash for each of the periods presented below (in thousands):
Six Months Ended | |||||||||
June 30, | |||||||||
| 2020 |
| 2019 |
| Change | ||||
Net cash (used in) provided by: | |||||||||
Operating activities | $ | (18,222) | $ | 90,428 | $ | (108,650) | |||
Investing activities |
| 71,973 |
| (88,757) |
| 160,730 | |||
Financing activities | 5,471 |
| 4,640 |
| 831 | ||||
Net increase in cash | $ | 59,222 | $ | 6,311 | $ | 52,911 | |||
Operating Activities
Cash used in operating activities for the six months ended June 30, 2020 was $18.2 million while cash provided by operating activities for the six months ended June 30, 2019 was $90.4 million. This is primarily due to upfront and milestone payments received from collaborations in the six-month period ended June 30, 2019 in excess of operating costs incurred in each period.
Investing Activities
Investing activities consist primarily of investments in marketable securities available-for-sale, purchases of intangible assets, capitalization of patent and licensing costs and purchases of property and equipment.
Financing Activities
Net cash provided by financing activities for the six months ended June 30, 2020 increased by $0.8 million over the same period in 2019 which reflects additional proceeds received from the exercise of stock options.
Liquidity and Capital Resources
We have financed our operations primarily through private placements of our equity and convertible notes, the public offerings of our common stock, and payments received under our product development partnerships and licensing arrangements.
As of June 30, 2020, we had $587.4 million of cash, cash equivalents and marketable and equity securities compared to $601.3 million at December 31, 2019. The investments in marketable securities are further described above in footnote 5 in the Notes to Financial Statements in Item 1 of Part I of this Quarterly Report on Form 10-Q. We expect to continue to receive additional payments from our collaborators for research and development services rendered, additional milestone, opt-in, contingent payments and royalties. Our ability to receive milestone payments and contingent payments from our partners is dependent upon either our ability or our partners’ abilities to achieve certain levels of research and development activities and is therefore uncertain at this time.
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Funding Requirements
We have not generated any revenue from product sales to date and do not expect to do so until we obtain regulatory approval of and commercialize one or more of our product candidates. As we are currently in the clinical stage of development, it will be some time before we expect to achieve this, and it is uncertain that we ever will commercialize one or more of our product candidates. We expect that we will continue to increase our operating expenses in connection with ongoing as well as additional clinical and preclinical development of product candidates in our pipeline.
Although it is difficult to predict our funding requirements, based upon our current operating plan, we expect that our existing cash, cash equivalents and marketable securities and certain potential milestone payments will fund our operating expenses and capital expenditure requirements into 2024. We have based these estimates on assumptions that may prove to be wrong, and the COVID-19 pandemic could materially alter these estimates which would cause us to use our capital resources sooner than we currently expect.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements.
Contractual Obligations and Commitments
There were no material changes outside of the ordinary course of business to our specific contractual obligations during the six months ended June 30, 2020.
Critical Accounting Policies
For a discussion on our material changes in critical accounting policies, see “Recent Accounting Pronouncements” in the notes to the financial statements included in this Quarterly Report on Form 10-Q.
ITEM 3. Quantitative and Qualitative Disclosures about Market Risk
Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. Due to the short-term maturities of our cash equivalents and marketable securities and the low risk profile of our investments, an immediate 10% decrease in interest rates would not have a material effect on the fair market value of our portfolio. In connection with the COVID-19 pandemic the financial markets were materially affected and all classes of public corporate debt were subject to increased risk. We are closely monitoring the changes in the market with our financial advisors and are adjusting our investment holdings in connection with the risk caused by the COVID-19 pandemic.
We do not believe that our cash and cash equivalents have significant risk of default or illiquidity. While we believe our cash and cash equivalents do not contain excessive risk, we cannot provide absolute assurance that in the future our investments will not be subject to adverse changes in market value. In addition, we maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits.
Inflation generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect on our results of operations during the periods presented.
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ITEM 4. Controls and Procedures
Disclosure Controls and Procedures
As required by Rule 13a-15(b) and Rule 15d-15(b) of the Exchange Act, our management, with the supervision of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(b) and 15d-15(e)) as of June 30, 2020. Our disclosure controls and procedures are designed to provide reasonable assurance that the information required to be disclosed in this Quarterly Report on Form 10-Q has been appropriately recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission's rules and forms, and that such information is accumulated and communicated to our management, including our principal executive and principal financial officers, to allow timely decisions regarding required disclosure. Based on that evaluation, our principal executive and principal financial officers have concluded that our disclosure controls and procedures are effective at the reasonable assurance level as of June 30, 2020.
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable assurance, not absolute assurance, that the objectives of our disclosure control system are met and, as set forth above, our principal executive officer and principal financial officer have concluded, that based on their evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective to provide reasonable assurance that the objective of our disclosure control system were met.
Changes in Internal Control
There were no changes in our internal control over financial reporting that occurred during the six months ended June 30, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Beginning March 17, 2020, a majority of our business, accounting and financial reporting employees began working remotely due to the COVID-19 pandemic. Since that time, we have not experienced any material impact to our internal controls over financial reporting. We are continually monitoring and assessing the COVID-19 situation on our internal controls to minimize the impact to their design and operating effectiveness.
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PART II — OTHER INFORMATION
ITEM 1. Legal Proceedings.
None.
ITEM 1A. Risk Factors
You should carefully consider the factors discussed in Part 1, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019, which could materially affect our business, financial position, or future results of operations. See also “Special Note Regarding Forward-Looking Statements” included in this Quarterly Report on Form 10-Q. In addition to the risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially and adversely affect our business. In light of the rapid spread of SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19), we are updating and supplementing our risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2019 to include the following new risk factor.
Risks Relating To Our Business and to the Discovery, Development, Regulatory Approval of Our Product Candidates and other Legal Compliance Matters
The COVID-19 pandemic and the future outbreak of other highly infectious or contagious diseases, could materially and adversely impact or disrupt our business and our financial condition, results of operations, cash flows and performance.
On March 11, 2020, the World Health Organization (WHO) declared the rapid spread of COVID-19 a global pandemic, and on March 19, the Governor of the State of California, where we are headquartered and where our principal place of business is located, implemented a mandatory stay at home order for residents working in non-critical businesses.
An epidemic or pandemic disease outbreak, including the COVID-19 pandemic, could cause significant disruptions to our business operations, business operations of our partners, on whom we rely for potential revenue, and product development collaborations; operations of our third-party manufacturers and contract research organizations (CROs), on which we rely to conduct our clinical trials; and to our clinical trials, including as a result of significant restrictions or bans on travel into and within the countries in which our manufacturers produce our product candidates or where we conduct our clinical trials. Such disruptions could impede, delay, limit or prevent our employees and CROs from continuing research and development activities.
Although the COVID-19 pandemic has not materially affected our clinical development for the period ended June 30, 2020, certain of our clinical programs have seen slower enrollment and there have also been delays in initiating new studies as a result of the COVID-19 pandemic. These delays are not seen across all our trials and is specific to certain trials enrolling at certain sites. In the future, the COVID-19 pandemic could further adversely affect our and our partners’ ability to enroll and recruit patients in current and future clinical trials. Our success is dependent on our ability and the ability of our partners to advance our wholly-owned and partnered development programs into later stages of clinical development. Many pharmaceutical and biotechnology companies have indicated that their clinical trials will be delayed and enrollment of current and ongoing trials will suffer as a result of the COVID-19 pandemic. Completion of our ongoing clinical and preclinical studies or commencement of new clinical trials could be impeded, delayed, limited or prevented by the effects of the COVID-19 pandemic and related restrictions including negative effects on the production, delivery or release of our product candidates to our clinical trial sites, as participation by our clinical trial investigators, patients or other critical staff, which to could delay data collection, analysis and other related activities, any of which could cause delay or denial of regulatory approval of our product candidates. The delay and impact on enrollment cannot be determined at this time and will depend on the length and severity of the COVID-19 pandemic. Continued delays on our clinical and preclinical studies or trials will increase our costs and expenses and seriously harm our operations and financial condition, which will adversely affect our business.
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The COVID-19 pandemic could also potentially affect the business of the FDA as well as other health regulatory authorities, which could result in delays in our communications with these authorities and ultimately in our ability for us and our partners to have drug products approved.
The COVID-19 pandemic and mitigation measures also have had and may continue to have an adverse impact on global economic conditions which could have an adverse effect on our business and financial condition, including impairment of our ability to raise capital when needed. The trading prices for biopharmaceutical companies’ stock, including our common shares have been highly volatile as a result of the COVID-19 pandemic. In addition, a recession, depression or other sustained adverse market event resulting from the COVID-19 pandemic could materially and adversely affect our business and the value of our common shares.
The COVID-19 pandemic could potentially affect our partnerships and collaborations which provide us with revenue and non-dilutive payments in the form of upfront payments, milestone payments, royalties and cost-sharing of co-development programs. If our partners’ and collaborators’ operations are severely affected by the COVID-19 pandemic, it will adversely affect our future potential revenue from such partners and collaborators.
We have required most of our employees, including all of our administrative employees, to work remotely, restricted on-site staff to only those employees that must perform essential activities that must be completed on-site and limited the number of staff allowed in our laboratory and offices. These changes may negatively impact productivity, or disrupt, delay, or otherwise adversely impact our business. In addition, this could increase our cyber security risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which could adversely impact our business operations. When we reopen our facilities, we could encounter delays in connection with implementing precautionary measures to mitigate the risk of exposing our facilities and employees to COVID-19.
The COVID-19 pandemic could adversely affect our supply chain for our research, development and clinical programs. We rely on third party vendors for research supplies, development activities including manufacturing of drug product for our clinical studies and testing of drug material. If any of the vendors in our supply chain of products or services are severely affected from the COVID-19 pandemic, it will adversely affect our ability to continue our research and development activities and also continue our clinical trial activities.
The COVID-19 pandemic continues to rapidly evolve. Its ultimate impact on our business operations is highly uncertain and subject to change that will depend on future developments, which cannot be accurately predicted, including the duration of the COVID-19 pandemic, additional or modified government actions, new information that will emerge concerning the severity and impact of COVID-19 and the actions taken to address its impact in the short and long term, among others. We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems or the global economy. We will continue to monitor the situation closely.
40
ITEM 6. Exhibits
Exhibit | ||
Number |
| Description of Document |
3.1 | ||
3.2 | ||
4.1 | ||
4.2 | ||
10.1 | ||
31.1 | Rule 13a-14(a) Certification of Principal Executive Officer. | |
31.2 | Rule 13a-14(a) Certification of Principal Financial Officer. | |
32.1 | Section 1350 Certification of Principal Executive Officer and Principal Financial Officer. | |
101.INS | Inline XBRL Instance Document – The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the inline XBRL document. | |
101.SCH | Inline XBRL Schema Document | |
101.CAL | Inline XBRL Calculation Linkbase Document | |
101.DEF | Inline XBRL Definition Linkbase Document | |
101.LAB | Inline XBRL Labels Linkbase Document | |
101.PRE | Inline XBRL Presentation Linkbase Document | |
104 | 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | |
41
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
XENCOR, INC. | ||
BY: | /s/ BASSIL I. DAHIYAT | |
Bassil I. Dahiyat, Ph.D. | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) | ||
BY: | /s/ JOHN J. KUCH | |
John J. Kuch | ||
Chief Financial Officer | ||
(Principal Financial Officer) | ||
Dated: August 4, 2020 | ||
42
Exhibit 10.1
THIRD AMENDMENT TO LEASE
This THIRD AMENDMENT TO LEASE (this “Amendment”) is made and effective as of April 30, 2020 (the “Effective Date”) by and between 111 LEMON INVESTORS LLC, a California limited liability company successor-in-interest to BF Monrovia, LLC, a California limited liability company (“Landlord”) and XENCOR, INC., a Delaware corporation successor-in-interest to Xencor, Inc., a California corporation (“Tenant”).
r e c I t a l s:
A.Landlord and Tenant entered into that certain Lease dated as of January 1, 2015 (the “Original Lease”) whereby Landlord leased to Tenant and Tenant leased from Original Landlord that certain space containing approximately 24,573 rentable square feet, comprising the entirety of the second (2nd) floor (the “2nd Floor Premises”) of that certain building located at 111 West Lemon Street, Monrovia, California 91016 (the “Building”).
B.The Original Lease was amended by that certain Amendment to Lease dated as of January 26, 2015, by and between Landlord and Tenant, and further amended by the Second Amendment to Lease, dated as of July 5, 2017, wherein an additional 23,652 comprising the Third Floor was added to the 2nd Floor Premises as an Expansion Space. The term of the Lease for the Expansion Space under the Second Amendment commenced on August 1, 2017 and will terminate 62-months thereafter. (The Original Lease, the First Amendment, and Second Amendment may be referred to herein collectively as the “Lease.”)
C.The parties desire to amend the Lease to extend the term of the Lease as to the 2nd Floor Premises (as defined in the Lease) and to otherwise modify the Lease, all upon the terms and conditions hereinafter set forth.
a g r e e m e n t:
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:
[SIGNATURES APPEAR ON THE FOLLOWING PAGE]
IN WITNESS WHEREOF, this Second Amendment to Lease has been executed as of the Effective Date.
“Landlord” | 111 LEMON INVESTORS LLC, |
By: | Robhana LV1 LLC, |
By:
Robert Hanasab
Its Manager
“Tenant” | XENCOR, INC., |
By:
Printed Name:
Its:
By:
Printed Name:
Its:
Exhibit 31.1
CERTIFICATION OF CHIEF PRINCIPAL OFFICER PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
I, Bassil I. Dahiyat, Ph.D., certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of Xencor, Inc., (the “Company”); |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report; |
| 4. | The Company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act rules 13a-15(f) and 15d-15(f)) for the Company and have: |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities particularly during the period in which this report is being prepared; |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c) | Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d) | Disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the Company’s most recent fiscal quarter (the Company’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting; and |
| 5. | The Company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the equivalent functions): |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting. |
| /s/ BASSIL I. DAHIYAT |
| Bassil I. Dahiyat, Ph.D. |
| President & Chief Executive Officer |
| |
Date: August 4, 2020 | |
Exhibit 31.2
CERTIFICATION OF THE PRINCIPAL FINANCIAL OFFICER PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
I, John J. Kuch, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of Xencor, Inc., (the “Company”); |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report; |
| 4. | The Company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act rules 13a-15(f) and 15d-15(f) for the Company and have: |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c) | Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d) | Disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the Company’s most recent fiscal quarter (the Company’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting; and |
| 5. | The Company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the equivalent functions): |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting. |
| /s/ JOHN J. KUCH |
| John J. Kuch |
| Chief Financial Officer (Principal Financial Officer) |
| |
Date: August 4, 2020 | |
Exhibit 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Bassil I. Dahiyat, Chief Executive Officer of Xencor, Inc. (the “Company”), and John J. Kuch, Chief Financial Officer of the Company, each hereby certifies that, to the best of his or her knowledge:
| 1. | The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2020, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and |
| 2. | The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Dated: August 4, 2020
IN WITNESS WHEREOF, the undersigned have set their hands hereto as of the 4th day of August 2020.
/s/ BASSIL I. DAHIYAT | | /s/ JOHN J. KUCH |
Bassil I. Dahiyat | | John J. Kuch |
Chief Executive Officer | | Chief Financial Officer |
This certification accompanies the Periodic Report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Xencor, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.