CytomX Therapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 7, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Condensed Financial Statements (Unaudited)
- Description of the Business
CytomX Therapeutics, Inc. (the “Company”) is a clinical-stage, oncology-focused biopharmaceutical company developing potent biologics designed to remain masked and inactive in healthy tissue and to be unmasked and preferentially activated in the tumor microenvironment. The Company aims to build a commercial enterprise to maximize its impact on the treatment of cancer. The Company is advancing potential first-in-class and best-in-class therapeutics created using its PROBODY® therapeutic technology platform that could meaningfully improve outcomes for cancer patients. Its proprietary and unique PROBODY technology platform is designed to enable “conditional activation” of masked antibody-based drugs in the tumor microenvironment across multiple therapeutic modalities. The Company is located in South San Francisco, California and was incorporated in the state of Delaware in September 2010.
- Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation
The accompanying interim condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) regarding interim financial reporting.
Unaudited Interim Financial Information
The accompanying interim condensed financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the results of operations for the periods presented.
The condensed results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. The accompanying condensed financial statements should be read in conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC.
Use of Estimates
The preparation of the financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
Cash, Cash Equivalents and Restricted Cash
The Company considers all highly liquid investments purchased with original maturities of three months or less at the date of purchase to be cash equivalents. Restricted cash represents a standby letter of credit issued pursuant to an office lease and value added tax return.
Revenue Recognition
The Company’s revenues are primarily derived through its license, research, development and commercialization agreements. The terms of these types of agreements may include (i) licenses for the Company’s technology or programs, (ii) research and development services, and (iii) services or obligations in connection with participation in research or steering committees. Payments to the Company under these arrangements typically include one or more of the following: non-refundable upfront and license fees, research funding, milestone and other contingent payments to the Company for the achievement of defined collaboration objectives and certain preclinical, clinical, regulatory and sales-based events, as well as royalties on sales of any commercialized products.
The Company assesses whether the promises in its arrangements with customers are distinct performance obligations that should be accounted for separately. Judgment is required to determine whether the license to the Company’s intellectual property is distinct from the research and development services or participation on steering committees.
The Company’s collaboration and license agreements may include contingent payments related to specified research, development and regulatory milestones. Such milestone payments are typically payable under the collaborations when the collaboration partner claims or selects a target, or initiates or advances a covered product candidate in preclinical or clinical development, upon submission for marketing approval of a covered product with regulatory authorities, or upon receipt of actual marketing approvals of a covered product or for additional indications. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At each reporting date, the Company re-evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price by using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price in such period of determination.
The Company’s collaboration and license agreements may also include contingent payments related to sales-based milestones. Sales-based milestones are typically payable when annual sales of a covered product reach specified levels. Sales-based milestones are recognized at the later of when the associated performance obligation has been satisfied or when the sales occur. Unlike other contingency payments, such as regulatory milestones, sales-based milestones are not included in the transaction price based on estimates at the inception of the contract; instead, they are included when the sales or usage occur.
Due to the early stage of the Company’s licensed technology, the license of such technology is typically combined with research and development services and steering committee participation as one performance obligation. Under the collaboration and license agreements, each collaboration target or program is generally considered to be a separate combined performance obligation. The transaction price in each arrangement is allocated to the identified performance obligations based on the relative standalone selling price (“SSP”) of each distinct performance obligation, which requires judgment. In instances where SSP is not directly observable, such as when a license or service is not sold separately, SSP is determined using information that may include market conditions and other observable inputs. Variable consideration is allocated to certain performance obligations if it is triggered by the Company’s efforts to satisfy or a specific outcome from satisfying these performance obligations. In the event that the Company receives non-cash consideration such as consideration in the form of a research license and research support services from the counterparty, the transaction price of a non-monetary exchange that has commercial substance is estimated based on the fair value of the non-cash consideration received, which may be determined through a valuation analysis. The Company recognizes revenue from upfront payments over the estimated period of performance under the agreement using an input method for the performance obligation. In applying the input method of revenue recognition, the Company uses actual full-time equivalent (FTE) hours incurred relative to estimated total FTE hours expected to be incurred for each combined performance obligation over the estimated research service period of each collaboration target.
In certain cases, the Company’s performance creates an asset that does not have an alternative use to the customer and the Company has an enforceable right to payment at all times for performance completed to date. In these cases, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Any consideration payable to the Company’s customers is treated as a reduction to the transaction price and revenue, unless the payment to the customer is in exchange for distinct good and services.
Contract Balances
Customer payments are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company satisfies its performance obligations under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional.
Segment
The Company derives revenues through its collaboration and license agreements and determined that it operates as a single reportable segment which primarily focus on clinical and pre-clinical research programs. The Chief Operating Decision Maker ("CODM") primarily reviews the Company’s financial information on an aggregate basis. All long-lived assets are maintained in the United States of America.
Recent Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting - Improvements to Reportable Segment Disclosures ("ASU 2023-07"), which enhances transparency in income tax disclosures. ASU 2023-07 requires entities to provide incremental disclosures, if applicable, related to a public entity's reportable segments but does not change the definition of a segment, the method for determining segments, or the criteria for aggregating operating segments into reportable segment. ASU 2023-07 improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses, which enable users of financial statements to better understand the entity's measurement and assessment of segment performance and resource allocation. The new guidance is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024. The Company will adopt the ASU for its 2024 Form 10-K. The ASU is required to be applied on a retrospective basis. The Company is evaluating the impact on its financial statements.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures ("ASU 2023-09"), which enhances transparency in income tax disclosures. ASU 2023-09 require entities to disclose (1) specific categories in the rate reconciliation, (2) the income or loss from continuing operations before income tax expense or benefit (separated between domestic and foreign) and (3) income tax expense or benefit from continuing operations (separated by federal, state and foreign). ASU 2023-09 also requires entities to disclose their income tax payments to international, federal, state and local jurisdictions, among other changes. The Company will adopt the ASU for its 2025 Form 10-K on a prospective basis. The Company is evaluating the impact on its financial statements.
- Net Income (Loss) Per Share
Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of shares of common stock outstanding for the period. Diluted net income (loss) per share is calculated using the weighted-average number of common shares outstanding, plus potential dilutive common stock during the period. Diluted net loss per share is the same as basic net loss per share in the period when the effect of the potentially dilutive securities is anti-dilutive. The pre-funded warrants are included in both the basic and diluted EPS calculation.
The following table presents the calculation of basic and diluted net income (loss) per share:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| (in thousands, except share and per share data) | ||||
| Numerator: | ||||
| Net income (loss) | $5,736 | $2,992 | $12,993 | $(1,406) |
| Denominator: | ||||
| Basic | ||||
| Weighted-average common shares outstanding | 78,170,101 | 66,779,192 | 77,081,967 | 66,523,404 |
| Weighted-average pre-funded warrants | 6,923,126 | 13,952,759 | 6,923,126 | 4,702,029 |
| Weighted-average common shares outstanding used to calculate basic net income (loss) per share | 85,093,227 | 80,731,951 | 84,005,093 | 71,225,433 |
| Diluted | ||||
| Weighted-average common shares outstanding used to calculate basic net income (loss) per share | 85,093,227 | 80,731,951 | 84,005,093 | 71,225,433 |
| Effect of potentially dilutive securities: | ||||
| Stock options, ESPP & RSUs | 111,482 | 259,771 | 423,750 | — |
| Weighted-average common shares outstanding used to calculate diluted net income (loss) per share | 85,204,709 | 80,991,722 | 84,428,843 | 71,225,433 |
| Net income (loss) per share | ||||
| Basic | $0.07 | $0.04 | $0.15 | $(0.02) |
| Diluted | $0.07 | $0.04 | $0.15 | $(0.02) |
The following weighted-average outstanding shares of potentially dilutive securities are excluded from the computation ofdiluted net income (loss) per share for the periods presented, because including them would have been anti-dilutive:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| Options and ESPP to purchase common stock | 14,583,619 | 13,863,671 | 14,262,791 | 14,046,593 |
| Common stock warrants | 11,538,462 | 11,162,208 | 11,538,462 | 3,720,736 |
| RSUs | 1,738,213 | 884,232 | 217,727 | 1,659,636 |
| Total | 27,860,294 | 25,910,111 | 26,018,980 | 19,426,965 |
- Fair Value Measurements and Investments
In accordance with Accounting Standards Codification (“ASC”) 820-10, Fair Value Measurements and Disclosures, the Company determines the fair value of financial and non-financial assets and liabilities using the fair value hierarchy, which establishes three levels of inputs that may be used to measure fair value, as follows:
Level I: Inputs which include quoted prices in active markets for identical assets and liabilities.
Level II: Inputs other than Level I that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level III: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The carrying amounts of the Company’s financial instruments, including restricted cash, accounts receivable, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. The Company’s financial instruments consist of Level I and Level II assets which consist primarily of highly liquid money market funds, some of which are included in restricted cash and U.S. Treasury securities that are included in cash equivalents or short-term investments.
The following tables set forth the fair value of the Company’s investments subject to fair value measurements on a recurring basis and the level of inputs used in such measurements:
| ValuationHierarchy | AmortizedCost | GrossUnrealizedGains | AggregateFair Value | |
|---|---|---|---|---|
| (in thousands) | ||||
| Assets | ||||
| Money market funds | Level I | $28,212 | $— | $28,212 |
| Restricted cash (money market funds) | Level I | 1,027 | — | 1,027 |
| U.S. Treasury Securities | Level II | 89,349 | 40 | 89,389 |
| Total | $118,588 | $40 | $118,628 | |
| ValuationHierarchy | AmortizedCost | GrossUnrealizedGains | AggregateFair Value | |
|---|---|---|---|---|
| (in thousands) | ||||
| Assets | ||||
| Money market funds | Level I | $17,109 | $— | $17,109 |
| Restricted cash (money market funds) | Level I | 917 | — | 917 |
| U.S. Treasury Securities | Level II | 157,243 | 95 | 157,338 |
| Total | $175,269 | $95 | $175,364 | |
As of September 30, 2024, the remaining contractual terms of those investments are less than a year.
- Accrued Liabilities
Accrued liabilities consisted of the following:
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Research and clinical expenses | $7,366 | $8,435 |
| Payroll and related expenses | 7,410 | 8,160 |
| Legal and professional expenses | 1,674 | 690 |
| Other accrued expenses | 292 | 314 |
| Total | $16,742 | $17,599 |
- Collaboration and License Agreements
The following table summarizes the revenue by collaboration partner:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| (in thousands) · (in thousands) | ||||
| AbbVie | $— | $— | $— | $3,988 |
| Amgen | (783) | 1,627 | 1,491 | 5,124 |
| Astellas | 2,553 | 4,630 | 23,497 | 18,685 |
| Bristol Myers Squibb | 22,977 | 14,028 | 56,042 | 35,630 |
| Regeneron | 2,896 | 2,913 | 7,925 | 5,249 |
| Moderna | 5,789 | 3,186 | 11,055 | 5,931 |
| Total revenue | $33,432 | $26,384 | $100,010 | $74,607 |
AbbVie Ireland Unlimited Company
In April 2016, the Company and AbbVie entered intotwo agreements, a CD71 Co-Development and Licensing Agreement (the “CD71 Agreement”) and a Discovery Collaboration and Licensing Agreement (as amended and restated in June 2019, the “Discovery Agreement” and together with the CD71 Agreement the “AbbVie Agreements”). Under the terms of the CD71 Agreement, the Company and AbbVie were co-developing a conditionally activated antibody-drug conjugate (“ADC”), CX-2029, against CD71, with the Company being responsible for preclinical and early clinical development. AbbVie was to be responsible for later development and commercialization, with global late-stage development costs shared between the two companies. Under the CD71 Agreement, the Company has received in aggregate $100.0 million in upfront and milestone payments. AbbVie had entered into a license agreement with Seattle Genetics, Inc. (“SGEN”) to license certain intellectual property rights pursuant to which the Company was required to pay SGEN sublicense fees for certain milestone achievements and an annual maintenance fee. These sublicense fees were treated as reductions to the transaction price and combined with the performance obligation to which they relate.
In March 2023, the Company announced that it would evaluate the potential next steps for CX-2029 following the decision from AbbVie, to not advance CX-2029 into additional clinical studies. As a result of AbbVie’s decision, the 2016 CD71 License and Collaboration Agreement was terminated in May 2023 and the Company re-acquired full rights to CX-2029. The Company has completed the performance obligation under the CD71 Agreement as of March 31, 2023, and recognized the related remaining deferred revenue of $4.0 million in the first quarter of 2023.
In December 2022, the research on the two discovery targets under the Discovery Agreement concluded with no plans to advance the discovery targets into clinical studies or to pursue new programs. The Discovery Agreement was also terminated and all target rights have reverted back to CytomX.
In August 2023, the Company entered into a Transition Agreement (the “Transition Agreement”) with AbbVie Global Enterprises Ltd. ("AbbVie Global", an affiliate entity of AbbVie), pursuant to which the Company regained exclusive worldwide rights to develop CX-2029, a CD71-targeting conditionally activated antibody drug conjugate. The Transition Agreement supersedes the CD71 Agreement that was terminated in May 2023, and grants certain intellectual property rights from AbbVie Global to enable the continued development of CX-2029 by the Company for all human and nonhuman diagnostic, prophylactic, and therapeutic uses. Pursuant to the Transition Agreement, AbbVie
Global is eligible to receive tiered sales royalties for CX-2029 ranging from the low-to-mid single digit percentages. In the fourth quarter of 2023, the Company decided to not to make any further substantial investments in the CX-2029 program in the near-term but continues to view CD71 as a target of strategic interest, including novel next-generation strategies.
Amgen, Inc.
On September 29, 2017, the Company and Amgen, Inc. (“Amgen”) entered into a Collaboration and License Agreement (the “Amgen Agreement”). Pursuant to the Amgen Agreement, the Company received an upfront payment of $40.0 million in October 2017. Concurrent with the Amgen Agreement, the Company and Amgen entered into a Share Purchase Agreement pursuant to which Amgen purchased 1,156,069 shares of the Company’s common stock at a price of $17.30 per share for total proceeds of $20.0 million.
In October 2021, CytomX and Amgen executed an amendment to the Amgen Agreement primarily to (1) extend the target selection date for Amgen to select its additional targets for research and development, and (2) reduce the total number of milestone events and increase the total amount of milestone payments for EGFR Products. In each of May 2023 and March 2024, CytomX and Amgen executed an amendment to the Amgen Agreement to extend the target selection period for Amgen to select its additional targets for research and development as further discussed below.
Under the terms of the Amgen Agreement, as amended, the Company and Amgen will co-develop a conditionally activated T-cell engager (“TCE”) targeting epidermal growth factor receptor (the “EGFR Products”). The Company is responsible for early-stage development of EGFR Products and Amgen will be responsible for late-stage development and commercialization of EGFR Products. Following early-stage development, the Company will have the right to elect to participate financially in the global co-development of EGFR Products with Amgen, during which the Company would bear a certain percentage of the worldwide development costs for EGFR Products and Amgen would bear the rest of such costs (the “EGFR Co-Development Option”). If the Company exercises its EGFR Co-Development Option, the Company will share in somewhat less than 50% of the profit and losses from sales of such EGFR Products in the U.S., subject to certain caps, offsets, and deferrals. If the Company chooses not to exercise its EGFR Co-Development Option, the Company will not bear any costs of later stage development. The Company is also eligible to receive up to $460.0 million in development, regulatory, and commercial milestone payments for EGFR Products, and royalties in the low-double-digit to mid-teen percentage of worldwide commercial sales, provided that if the Company exercises its EGFR Co-Development option, it shall receive a profit and loss split of sales in the United States and royalties in the low-double-digit to mid-teen percentage of commercial sales outside of the United States. In January 2022, the IND for the EGFR product (CX-904) was allowed to proceed by the U.S. Food and Drug Administration (“FDA”) and the program continues in an ongoing Phase 1 study.
Amgen also has the right to select a total of up tothree targets, including the two additional targets discussed below. The Company and Amgen collaborate in the research and development of conditionally activated T-cell engaging bispecifics therapies directed against such targets. Amgen has selectedone such target (the “Amgen Other Product”). If Amgen exercises its option within a specified period of time, it can selecttwo such additional targets (the “Amgen Option Products” and, together with the Amgen Other Product, the “Amgen Products”). Except with respect to preclinical activities to be conducted by CytomX, Amgen will be responsible, at its expense, for the development, manufacture, and commercialization of all Amgen Products. If Amgen exercises all of its options and advances all three of the Amgen Products, CytomX is eligible to receive up to $950.0 million in upfront, development, regulatory, and commercial milestones and tiered high single-digit to low-teen percentage royalties. The Company concluded that, at the inception of the agreement and subsequent amendments, Amgen’s option to select the two additional targets is not a material right and does not represent a performance obligation of the agreement.
At the initiation of the collaboration, CytomX had the option to select from programs specified in the Amgen Agreement, an existing preclinical stage TCE product from the Amgen preclinical pipeline. In March 2018, CytomX selected the programand this program is currently in preclinical development. CytomX is responsible, at its expense, for converting this program to a conditionally activated TCE product, and thereafter, will be responsible for development, manufacturing, and commercialization of the product (“CytomX Product”). Amgen is eligible to receive up to $203.0 million in development, regulatory, and commercial milestone payments for the CytomX Product, and tiered mid-single digit to low double-digit percentage royalties.
As of September 30, 2024 and December 31, 2023, deferred revenue related to the EGFR Products performance obligation was$11.3 million and $12.8 million, respectively. Revenue is recognized over the estimated research period using an input measure based on our actual full-time employee ("FTE") hours incurred as a percentage of projected FTE hours for completing the performance obligation. We evaluate the measure of progress each reporting period and, if necessary, we adjust the measure of performance and related revenue recognition. In the three months ended September 30, 2024, we revised the estimated FTE hours-to-completion for the EGFR Products performance obligation which resulted in a cumulative adjustment to revenue which was a$0.8 million reduction of revenue in the period. Such adjustments have impacted and will continue to impact the amounts and timing of our revenue recognized. Deferred revenue related to the Amgen Other Products performance obligation was immaterial as of September 30, 2024 and December 31, 2023.
Astellas Pharma Inc.
The Company and Astellas Pharma, Inc. (“Astellas”) entered into a Collaboration and License Agreement (the “Astellas Agreement”) on March 23, 2020, the effective date, to collaborate on preclinical research activities to discover and develop certain antibody compounds for the treatment of cancer using the Company’s PROBODY therapeutic technology.
Under the terms of the Astellas Agreement, the Company granted Astellas an exclusive, worldwide right to develop and commercialize PROBODY therapeutics for up tofour collaboration targets includingone initial target andthree additional targets (“Additional Targets”). In addition, Astellas had the right to expand the number of Additional Targets from three up tofive (the “Expansion Option”) before the third anniversary of the effective date. Furthermore, for a specified number of targets, at a pre-specified time prior to the initiation of the first pivotal study of a product against such target, the Company may elect to participate in certain development costs and share in the profits generated in the United States with respect to such product (“Cost Share Option”). The Cost Share Option, if exercised, will also provide the option for the Company to co-commercialize such product in the United States. The Company does not consider the Cost Share Option as a performance obligation at the inception of the agreement as participation is at the Company’s discretion.
Pursuant to the Astellas Agreement, the consideration from Astellas is comprised of an upfront fee of $80.0 million and contingent payments for development, regulatory and sales milestones of up to an aggregate of approximately $1.6 billion. The Company is also entitled to tiered royalties from high-single digit to mid-teen percentage royalties from potential future sales. Astellas is responsible for all preclinical research costs incurred by either party as set forth in the preclinical research plan and the Company will receive research and development service fees based on a prescribed full-time employee ("FTE") rate.
In January 2023, the Company announced that it achieved a clinical candidate milestone under the Astellas Agreement which triggered a $5.0 million milestone payment to the Company. The $5.0 million milestone payment was fully recognized in the first quarter of 2023 as the Company had completed its related performance obligation of the collaboration target which resulted in the clinical candidate nomination for further development. In March 2024, the Company announced that it achieved the good laboratory practices ("GLPs") toxicology milestone for this candidate which triggered a $5.0 million milestone payment to the Company. The $5.0 million milestone payment was fully recognized in the first quarter of 2024 as the Company had completed its related performance obligation of the collaboration target. Also, in March 2024, the Company announced that it achieved a clinical candidate milestone for a second collaboration target under the Astellas Agreement which triggered an additional $5.0 million milestone payment to the Company. The $5.0 million milestone payment was fully recognized in the first quarter of 2024 as the Company had completed its related performance obligation of the collaboration target which resulted in the clinical candidate nomination for further development.
As of September 30, 2024 and December 31, 2023, deferred revenue relating to the Astellas Agreement was$22.2 million and $31.0 million, respectively. The amount due from Astellas under the Astellas Agreement was $1.1 million as of September 30, 2024 and $2.2 million as of December 31, 2023.
Bristol Myers Squibb Company
On May 23, 2014, the Company and Bristol Myers Squibb Company (“Bristol Myers Squibb”) entered into a Collaboration and License Agreement (the “BMS Agreement”) to discover and develop compounds for use in human therapeutics aimed at multiple immuno-oncology targets using the Company’s PROBODY therapeutic technology, including the target CTLA-4. The effective date of the BMS Agreement was July 7, 2014.
Under the terms of the BMS Agreement, the Company granted Bristol Myers Squibb exclusive worldwide rights to develop and commercialize PROBODY therapeutics for up tofour oncology targets. Bristol Myers Squibb had additional rights to substitute up totwo collaboration targets within three years of the effective date of the BMS Agreement. These rights expired in May 2017. Each collaboration target had atwo-year research term and thetwo additional targets had to be nominated by Bristol Myers Squibb within five years of the effective date of the BMS Agreement. The research term for each collaboration target could be extended inone year increments up tothree times.
Pursuant to the BMS Agreement, the financial consideration from Bristol Myers Squibb was comprised of an upfront payment of $50.0 millionand estimated research and development service fees, and the Company was initially entitled to receive contingent payments of up to
$25.0 million for additional targets and contingent payments for development, regulatory and sales milestones. In addition, the Company was entitled to royalty payments in the mid-single digits to low double-digit percentages from potential future sales.
On March 17, 2017, the Company and Bristol Myers Squibb amended the BMS agreement and entered into Amendment Number 1 to Extend Collaboration and License Agreement (“Amendment 1”). Amendment 1 granted Bristol Myers Squibb exclusive worldwide rights to develop and commercialize PROBODY therapeutics for up toeight additional targets. The effective date of Amendment 1 was April 25, 2017 (“Amendment Effective Date”). Under the terms of Amendment 1, the Company continued to have obligations to Bristol Myers Squibb to discover and conduct preclinical development of PROBODY therapeutics against any targets they chose to select during the research period under the terms of Amendment 1.
Pursuant to Amendment 1, the financial consideration from Bristol Myers Squibb was comprised of an upfront payment of $200.0 million, estimated research and development service fees, and contingent payments for development, regulatory and sales milestones for theeight targets. The Company was also entitled to tiered mid-single to low double-digit percentage royalties from potential future sales. Amendment 1 did not change the term of Bristol Myers Squibb’s royalty obligation under the BMS Agreement. Bristol Myers Squibb’s royalty obligation continues on a licensed-product by licensed-product basis until the later of (i) the expiration of the last claim of the licensed patents covering the licensed products in the country, (ii) the twelfth anniversary of the first commercial sale of a licensed product in a country, or (iii) the expiration of any applicable regulatory, pediatric, orphan drug or data exclusivity with respect to such product.
The initial transaction price for the BMS Agreement and Amendment 1, collectively, was $304.7 million consisting of the upfront fees of $250.0 million, target selection fees for the third and fourth targets of $25.0 million, estimated research and development service fees of $17.7 million and milestone payments received up to January 1, 2018, of $12.0 million. The Company determined that the remaining potential milestone payments were probable of significant revenue reversal as their achievement was highly dependent on factors outside the Company’s control. Therefore, these payments were fully constrained and were not included in the transaction price upon the adoption of ASC 606 on January 1, 2018. The initial transaction pricefor the combined obligation for each collaboration target is recognized using an input measure.
In February 2021, the Company and Bristol Myers Squibb amended the BMS agreement and entered into Amendment Number 2 to amend the Collaboration and License Agreement (“Amendment 2”), as previously amended by Amendment 1. Subsequent to Amendment 2, in addition to Bristol Myers Squibb’s ongoing development of the CTLA-4 program, Bristol Myers Squibb also had the exclusive worldwide rights to develop and commercialize PROBODY therapeutics for up to five oncology targets. Under the terms of Amendment 2, the period for target selection was extended and in 2022, all remaining targets were selected. The Company will continue to collaborate with Bristol Myers Squibb to discover and conduct preclinical development of PROBODY therapeutics against targets selected by Bristol Myers Squibb over the estimated research period, which is projected to end in April 2025. Pursuant to Amendment 2, the Company was eligible to receive contingent payments for development, regulatory and sales milestones. It is also entitled to tiered mid-single to low double-digit percentage of royalties from potential future sales. The Company accounted for Amendment 2 as a modification and reallocated the remaining unrecognized transaction price to the remaining performance obligations.
In October 2022, the Company and Bristol Myers Squibb amended the BMS Agreement and entered into Amendment Number 3 (“Amendment 3”), as previously amended by Amendment 1 and Amendment 2, to clarify the rights and restrictions of certain new proprietary antibodies that the parties exchanged. There were no substantive changes to each party's performance obligations.
In March 2024, following a Bristol Myers Squibb corporate portfolio prioritization process, Bristol Myers Squibb notified CytomX that it does not intend to continue the development of BMS-986288 beyond the current Phase 2 study and terminated its collaboration license on the CTLA-4 target under the collaboration. BMS-986288 was Bristol Myers Squibb’s leading next generation PROBODY CTLA-4 program that it had previously prioritized over BMS-986249, which was a PROBODY version of ipilumamab.
In June 2024, Bristol Myers Squibb prioritized its pre-clinical research activities under the collaboration and revised the research scope by one collaboration target. The Company determined that it has no further obligations related to the target that was deprioritized and accounted for the reduction of the target as a modification and the related remaining unrecognized transaction price was reallocated to the remaining performance obligations. The Company continues to be obligated to perform research work under Amendment 2 executed in February 2021 for multiple ongoing research programs.
As of September 30, 2024, the Company is eligible to receive approximately $1.3 billion in contingent payments for development, regulatory and sales milestones for the ongoing collaboration programs.
The Company reevaluated the remaining potential milestone payments and determined that significant revenue reversal was probable as the achievement of such milestones was highly dependent on factors outside the Company’s control. As a result, these payments continued to be fully constrained and were not included in the transaction price as of September 30, 2024.
As of September 30, 2024 and December 31, 2023, deferred revenue relating to the BMS Agreement was$63.9 million and $119.9 million, respectively.
ModernaTX, Inc.
The Company and ModernaTX, Inc. (“Moderna”) entered into a Collaboration and License Agreement (the “Moderna Agreement”) on December 30, 2022, the effective date, to collaborate on discovery and preclinical research and development activities to create investigational messenger RNA (mRNA) based conditionally activated therapies using the Company’s PROBODY therapeutic technology. Moderna is solely responsible for the development (preclinical and clinical), manufacturing, and commercialization of any products under the Moderna Agreement.
Under the terms of the Moderna Agreement, the Company granted Moderna an exclusive, worldwide right to develop and commercialize PROBODY therapeutics for the collaboration programs. In exchange, the Company received an upfront payment of $35.0 million in January 2023, including $5.0 million of prepaid research and development service fees. The Company will continue to receive research and development service fees according to the preclinical research work plans based on a prescribed FTE rate and is eligible to receive up to approximately $1.2 billion in future development, regulatory, and commercial milestone payments. The Company is also eligible to receive tiered royalties from high-single digit to low-teen percentage rates of annual global net sales of any products that are commercialized under the Moderna Agreement.
As of September 30, 2024 and December 31, 2023, deferred revenue relating to the Moderna Agreement was$14.2 million and $24.2 million, respectively. The amount due from Moderna under the Moderna Agreement was $1.1 million as of September 30, 2024 and$0 as of December 31, 2023.
Regeneron Pharmaceuticals, Inc.
The Company and Regeneron Pharmaceuticals Inc. (“Regeneron”) entered into a Collaboration and License Agreement (the “Regeneron Agreement”) on November 16, 2022, to collaborate on creation of conditionally-activated investigational bispecific cancer therapies utilizing the Company’s PROBODY® therapeutic platform and Regeneron’s Veloci-Bi® bispecific antibody development platform. The Company and Regeneron will collaborate on preclinical research and discovery activities for initially agreed upon collaboration programs (“Collaboration Program”) with an option to expand additional Collaboration Programs (“Additional Collaboration Program Option”).
Under the Collaboration and License Agreement, the Company granted Regeneron an exclusive, worldwide, royalty-bearing license under certain Company intellectual property to develop, manufacture, commercialize and otherwise exploit licensed products (“Licensed Products”) for all human and non-human diagnostic, prophylactic and therapeutic uses in oncology. Regeneron is responsible for funding the cost of preclinical research and discovery activities of both parties for all Licensed Products and for funding the cost of development, manufacturing and commercialization of all Licensed Products worldwide.
Pursuant to the Regeneron Agreement, the consideration from Regeneron is comprised of an upfront fee of $30.0 million, contingent payments for development and regulatory milestones and commercial milestone payments of up to an aggregate of approximately $0.8 billion. If Regeneron exercises its Additional Collaboration Program Option, the Company would be eligible to receive additional upfront and milestone payments aggregating up to approximately $1.2 billion. The Company is also entitled to tiered royalties from high-single digit to low-teen percentage royalties from potential future sales. In addition, the Company will receive research and development service fees based on a prescribed FTE rate.
As of September 30, 2024 and December 31, 2023, deferred revenue relating to the Regeneron Agreement was$18.0 million and $24.4 million, respectively. The amount due from Regeneron under the Regeneron Agreement was $1.0 millionand $1.1 million as of September 30, 2024 and December 31, 2023, respectively.
Contract Liabilities
The following table presents changes in the Company’s total contract liabilities during thenine months ended September 30, 2024 and 2023:
| Deferred Revenue | |
|---|---|
| (in thousands) | |
| December 31, 2023 | $212,315 |
| Additions | 6,652 |
| Revenue recognized | (89,348) |
| September 30, 2024 | $129,619 |
| December 31, 2022 | $301,326 |
| Additions | 3,921 |
| Revenue recognized | (68,590) |
| September 30, 2023 | $236,657 |
The Company expects that the$129.6 million of deferred revenue related to the following contracts as of September 30, 2024 will be recognized as revenue based on actual FTE effort and estimated program progress as set forth below. However, the timing of revenue recognition could differ from the estimates depending on facts and circumstances impacting the various contracts, including progress of research and development, resources assigned to the contracts by the Company or its collaboration partners or other factors outside of the Company’s control.
The$11.3 million of deferred revenue related to the Amgen EGFR Products is expected to be recognized until 2027.
The$22.2 million of deferred revenue related to the Astellas Agreement is expected to be recognized until 2026.
The$63.9 million of deferred revenue related to the BMS Agreement is expected to be recognized through the second quarter of 2025.
The$14.2 million of deferred revenue related to the Moderna Agreement, together with research and development service fees, is expected to be recognized until 2027.
The$18.0 million of deferred revenue related to the Regeneron Agreement, together with research and development service fees, is expected to be recognized until 2026.
- Common Stock
In February 2020, the Company entered into the Open Market Sale Agreement (as amended on each of March 4, 2022 and August 9, 2024, the “Sales Agreement”) with Jefferies LLC (“Jefferies”), to sell its common stock, at par value $0.00001 per share, with aggregate gross sales proceeds of up to $75,000,000, from time to time upon the Company’s request, through an at the market offering under which Jefferies will act as sales agent. Pursuant to the Sales Agreement, Jefferies as the sales agent will receive a commission of 3.0% of the gross sales price for shares of common stock sold under the Sales Agreement. In April 2024, under the Sales Agreement, the Company sold 2,270,608 shares at an average price of $2.20 per share and received net proceeds of approximately $4.8 million after deducting the 3.0% sales commission and related issuance cost.
In June 2023, the Company entered into an agreement with BVF Partners L.P. (“BVF”) for a private placement and received an aggregate net proceeds of approximately $29.7 million in July 2023, after deducting issuance costs of approximately $0.3 million. In the private placement, CytomX issued pre-funded warrants to BVF to purchase up to 14,423,077 shares of common stock, accompanying Tranche 1 warrants to purchase up to 5,769,231 shares of common stock and accompanying Tranche 2 warrants to purchase up to 5,769,231 shares of common stock, at a combined price of $2.08 per share. On May 1, 2024, BVF exercised its right to purchase 7.5 million shares of common stock through its pre-funded warrants at an exercise price of $0.00001 per share.
The following table summarizes the Company's outstanding warrants as of September 30, 2024:
| Pre-funded Warrants | Tranche 1 Warrants | Tranche 2 Warrants | ||||
|---|---|---|---|---|---|---|
| Number ofwarrants | Weighted-AverageExercise Price Per Share | Number ofwarrants | Weighted-AverageExercise Price Per Share | Number ofwarrants | Weighted-AverageExercise Price Per Share | |
| Warrants Outstanding | 6,923,077 | $0.00001 | 5,769,231 | $4.16 | 5,769,231 | $6.24 |
In the May 2024 annual meeting of stockholders, the Company's authorized shares of common stock were approved to increase from 150,000,000 shares to 300,000,000 shares.
- Stock-Based Compensation
Stock Options
Activities for the Company’s stock option plans for thenine months ended September 30, 2024 were as follows:
| Options Outstanding | ||
|---|---|---|
| Number of Options | Weighted-AverageExercise Price Per Share | |
| Balance at December 31, 2023 | 12,949,612 | $7.16 |
| Options granted | 2,371,000 | 1.70 |
| Options exercised | (132,351) | 1.58 |
| Option forfeited/expired | (618,940) | 10.20 |
| Balance at September 30, 2024 | 14,569,321 | $6.19 |
The Company recorded $1.5 million and $0.5 million of stock-based compensation expense related to the stock options for thethree months ended September 30, 2024 and 2023, respectively.
The Company recorded $4.4 million and $4.1 million of stock-based compensation expense related to the stock option plans for thenine months ended September 30, 2024 and 2023, respectively.
Time-based RSUs ("TRSU")
Activities for the Company’s TRSUs for thenine months ended September 30, 2024 were as follows:
| Number ofShares | Weighted Average Grant Date Fair Value Per Share | |
|---|---|---|
| Balance at December 31, 2023 | 1,400,529 | $2.40 |
| RSU's awarded | 1,195,833 | 1.64 |
| RSU's vested | (706,923) | 2.14 |
| RSU's cancelled | (73,929) | 1.82 |
| Balance at September 30, 2024 | 1,815,510 | $2.02 |
The Company recorded $0.4 million and $0.5 million of stock-based compensation expense related to the TRSUs for thethree months ended September 30, 2024 and 2023, respectively.
The Company recorded $1.1 million and $1.5 million of stock-based compensation expense related to the TRSUs for thenine months ended September 30, 2024 and 2023, respectively.
Performance-based RSUs ("PSUs")
2022 PSU
In August 2022, the Company granted 250,000 PSUs to executive employees with an aggregated grant date fair value of approximately $0.4 million. Vesting for 50% of the PSUs granted was set to occur upon attaining certain specific milestones by December 2023 (“2022-Tranche 1”), and the remaining 50% are set to vest upon attaining certain specific milestones by December 2024 (“2022-Tranche 2”). In December 2023, the Company determined that the performance conditions for 2022-Tranche 1 was satisfied and the award was vested in December 2023. As a result, the Company recorded $55,000 and the remaining $128,000 compensation cost for the 2022-Tranche 1 award for the year ended December 31, 2022 and 2023, respectively. In August 2024, the Company determined that the performance conditions for the 2022-Tranche 2 had been satisfied and the award was vested in August 2024. As a result the Company recorded $38,000 and $77,000 compensation cost for thethree and nine months ended September 30, 2024 and $106,000 for the fiscal year 2023, respectively.
2023 PSU
In February 2023, the Company granted 760,000 PSUs to executive employees with an aggregated grant date fair value of approximately $1.9 million. Vesting for 50% of the PSUs granted will occur upon attaining certain specific milestones by December 2024 (“2023-Tranche 1”), and the remaining 50% will vest upon attaining certain specific milestones by December 2025 (“2023-Tranche 2”). The Company determined that it is not probable that the performance conditions will be satisfied for each of these tranches and hence no compensation cost was recorded for these awards through September 30, 2024.
2024 PSU
In January 2024, the Company granted 810,000 PSUs to executive employees with an aggregated grant date fair value of approximately $1.3 million. Vesting for 50% of the PSUs granted will occur upon attaining certain specific milestones by December 2025 (“2024-Tranche 1”), and the remaining 50% will vest upon attaining certain specific milestones by December 2026 (“2024-Tranche 2”). The Company determined that it is not probable that the performance conditions will be satisfied for each of these tranches and hence no compensation cost was recorded for these awards through September 30, 2024.
Activities for the Company’s PSUs for thenine months ended September 30, 2024, were as follows:
| Number ofShares | Weighted Average Grant Date Fair Value Per Share | |
|---|---|---|
| Balance at December 31, 2023 | 875,000 | $2.41 |
| PSU's awarded | 810,000 | 1.66 |
| PSU's released | (115,000) | 1.59 |
| Balance at September 30, 2024 | 1,570,000 | $2.09 |
Stock-based Compensation
Total stock-based compensation recorded was as follows:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| (in thousands) · (in thousands) | ||||
| Research and development | $691 | $126 | $2,054 | $2,001 |
| General and administrative | 1,304 | 1,100 | 3,730 | 4,005 |
| Total stock-based compensation expense | $1,995 | $1,226 | $5,784 | $6,006 |
- Commitments and Contingencies
Legal Proceedings
On March 4, 2020, Vytacera Bio, LLC (“Vytacera”)filed a patent infringement lawsuit against the Company in the U.S. District Court for the District of Delaware. The lawsuit alleged that the Company's use, offers to sell, and/or sales of the PROBODY® technology platform for basic research applications constituted infringement. The complaint sought unspecified monetary damages. In September 2022, the Company filed a motion to dismiss the case. On October 17, 2024, the Court dismissed the case. Vytacera may appeal. The Company believes that the lawsuit is without merit and intends to vigorously defend itself through any appeal. The Company does not believe a loss is probable and hasnot recorded any amount as a contingent liability for claims associated with this lawsuit as of September 30, 2024.
- License Agreement
UCSB Agreement
In August 2010, the Company entered into an exclusive, worldwide license agreement with University of California, Santa Barbara (“UCSB”), relating to the use of certain patents and technology relating to its core technology, including its therapeutic antibodies, and to certain patent rights the Company co-owns with UCSB covering PROBODY antibodies and other pro-proteins (the “UCSB Agreement”). Pursuant to the UCSB Agreement, the Company is obligated to (i) make royalty payments to UCSB on net sales of its products covered under the agreement, subject to annual minimum amounts, (ii) make milestone payments to UCSB upon the occurrence of certain events, (iii) make a milestone payment to UCSB upon occurrence of an IPO or change of control, and (iv) reimburse UCSB for prosecution and maintenance of the licensed patents. As part of the UCSB Agreement, the Company has annual minimum royalty obligations of $0.2 million under the terms of certain exclusive licensed patent rights. In April 2019, the Company entered into Amendment No.3 to the UCSB Agreement to adjust and clarify certain sublicense terms (“Amendment No.3”). Under the terms of Amendment No.3, the Company and UCSB agreed to modify the determination of sublicense revenues payable by the Company to UCSB on certain existing collaboration agreements and on collaboration agreements executed subsequent to Amendment No.3. In exchange, the Company agreed to make an upfront payment of $1.0 million as well as additional annual license maintenance fees of $0.8 million through 2031.
In March 2024, the Company incurred $0.6 million of sublicense fees triggered by achieving the GLP toxicology studies milestone for the first clinical candidate which was nominated by Astellas in 2023, as well as by achieving the clinical candidate nomination milestone for a second collaboration target under the Astellas Agreement.
For the three and nine months ended September 30, 2024, the Company incurred sublicense expenses of $0 and $1.6 million, respectively, under the provisions of the UCSB Agreement. For the three and nine months ended September 30, 2023, the Company incurred sublicense expenses of $0 and $1.1 million under the provisions of the UCSB Agreement.
ImmunoGen (acquired by AbbVie in 2024)
In December 2019, the Company entered into a License Agreement (the “ImmunoGen 2019 License”) with ImmunoGen, Inc. to obtain an exclusive license with respect to epithelial cell adhesion molecule (“EPCAM”). Under the ImmunoGen 2019 License, ImmunoGen agreed to transfer its know-how, patents, intellectual property rights, and technology transfer materials and information related to its EpCAM program. The license gives the Company the sole ability to develop, manufacture, use and commercialize any licensed product that incorporates, is comprised of, or otherwise derived from PROBODY technology that targets EpCAM in any human therapeutic field on a worldwide basis.
In April 2024, the Company incurred a $5.0 million milestone payment to AbbVie (formerly ImmunoGen) with respect to achieving the milestone of dosing the first patient for CX-2051 under the ImmunoGen 2019 License Agreement.
- Income Taxes
The Company maintains a full valuation allowance against its net deferred tax assets due to the Company’s history of losses through December 31, 2023.
The Company files income taxes in the U.S. federal jurisdiction, the state of California and various other U.S. states. The state of California contested the Company’s tax position on revenue apportionment for upfront and milestone payments resulting from the Company’s collaboration and licensing agreements for the years 2017 and 2018. In September 2023, the Company rece ived Notice of Proposed Assessment (“NOPA”) from the Franchise Tax Board. The Company recorded an uncertain tax position of $4.1 million in long term liabilities for the proposed tax assessment, penalties and interest through September 30, 2024. Of the unrecognized tax benefits as of September 30, 2024, approximately $4.1 million would affect the Company’s effective tax rate if recognized. In addition, utilization of carryforward attributes and indirect federal tax effects of the assessment would result in a reduction in deferred tax assets of $5.1 million. The Company filed a protest to contest the proposed assessment in November 2023. Due to the ongoing nature of the examination and discussions with the state of California, the Company is unable to estimate a date by which this matter will be resolved.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.