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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 10-Q
 
(Mark One)
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2023
 
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from             to            
 
COMMISSION FILE NUMBER 001-35558
 
CARDIFF ONCOLOGY, INC.
(Exact Name of registrant as specified in its charter)
Delaware27-2004382
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)
11055 Flintkote Avenue, San Diego, California
92121
(Address of principal executive offices)(Zip Code)
(858) 952-7570
(Registrant’s telephone number, including area code)
Title of each class: Trading Symbol(s) Name of each exchange on which registered:
Common Stock CRDF Nasdaq Capital Market
 
Indicate by check mark whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes    No 
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes    No 
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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.
Large accelerated filer 
Accelerated filer  
Non-accelerated filer

Smaller reporting company 
Emerging growth company
  
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes    No 
 
As of August 3, 2023, the issuer had 44,677,169 shares of Common Stock issued and outstanding.


CARDIFF ONCOLOGY, INC.
 
Table of Contents
 
Page

2

PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

CARDIFF ONCOLOGY, INC. 
CONDENSED BALANCE SHEETS
(in thousands, except par value)
(Unaudited)
 
June 30,
2023
December 31,
2022
Assets
Current assets:
Cash and cash equivalents$19,369 $16,347 
Short-term investments70,059 88,920 
Accounts receivable and unbilled receivable161 771 
Prepaid expenses and other current assets3,142 5,246 
Total current assets92,731 111,284 
Property and equipment, net1,356 1,269 
Operating lease right-of-use assets1,978 2,251 
Other assets1,390 1,387 
Total Assets$97,455 $116,191 
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable$2,939 $1,956 
Accrued liabilities5,501 5,177 
Operating lease liabilities683 675 
Total current liabilities9,123 7,808 
Operating lease liabilities, net of current portion1,753 2,040 
Total Liabilities10,876 9,848 
Commitments and contingencies (Note 7)
Stockholders’ equity
Preferred stock, 20,000 shares authorized; Series A Convertible Preferred Stock liquidation preference $1,056 and $1,044 at June 30, 2023 and December 31, 2022, respectively (Note 6)
  
Common stock, $0.0001 par value, 150,000 shares authorized; 44,677 shares issued and outstanding at June 30, 2023 and December 31, 2022
4 4 
Additional paid-in capital407,479 404,834 
Accumulated other comprehensive loss(431)(395)
Accumulated deficit(320,473)(298,100)
Total stockholders’ equity86,579 106,343 
Total liabilities and stockholders’ equity$97,455 $116,191 
 
See accompanying notes to the unaudited condensed financial statements.
3

CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
 
Three Months Ended June 30,Six Months Ended June 30,
2023202220232022
Royalty revenues$108 $91 $191 $165 
Costs and expenses:
Research and development8,020 7,448 17,072 14,656 
Selling, general and administrative4,296 3,086 7,379 7,026 
Total operating expenses12,316 10,534 24,451 21,682 
Loss from operations(12,208)(10,443)(24,260)(21,517)
Other income (expense), net:
Interest income, net1,053 253 1,993 383 
Other income (expense), net5 (253)(106)(302)
Total other income (expense), net1,058  1,887 81 
Net loss (11,150)(10,443)(22,373)(21,436)
Preferred stock dividend payable on Series A Convertible Preferred Stock(6)(6)(12)(12)
Net loss attributable to common stockholders$(11,156)$(10,449)$(22,385)$(21,448)
Net loss per common share — basic and diluted$(0.25)$(0.24)$(0.50)$(0.50)
Weighted-average shares outstanding — basic and diluted44,677 43,306 44,677 43,269 
 
See accompanying notes to the unaudited condensed financial statements.
4


CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
(Unaudited)

Three Months Ended June 30,Six Months Ended June 30,
2023202220232022
Net loss$(11,150)$(10,443)$(22,373)$(21,436)
Other comprehensive loss:
  Unrealized loss on securities available-for-sale(355)(234)(36)(840)
Total comprehensive loss(11,505)(10,677)(22,409)(22,276)
Preferred stock dividend payable on Series A Convertible Preferred Stock(6)(6)(12)(12)
Comprehensive loss attributable to common stockholders$(11,511)$(10,683)$(22,421)$(22,288)

See accompanying notes to the unaudited condensed financial statements.
5

CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
(Unaudited)

 Preferred Stock
Shares
Preferred Stock
Amount
Common Stock
Shares
Common Stock
Amount
Additional
Paid-In Capital
Accumulated Other Comprehensive LossAccumulated DeficitTotal
Stockholders’ Equity
Balance, January 1, 202361 $ 44,677 $4 $404,834 $(395)$(298,100)$106,343 
Stock-based compensation— — — — 1,064 — — 1,064 
Other comprehensive gain— — — — — 319 — 319 
Net loss— — — — — — (11,223)(11,223)
Balance, March 31, 202361 $ 44,677 $4 $405,898 $(76)$(309,323)$96,503 
Stock-based compensation— — — — 1,581 — — 1,581 
Other comprehensive loss— — — — — (355)— (355)
Net loss— — — — — — (11,150)(11,150)
Balance, June 30, 202361 $ 44,677 $4 $407,479 $(431)$(320,473)$86,579 


 Preferred Stock
Shares
Preferred Stock
Amount
Common Stock
Shares
Common Stock
Amount
Additional
Paid-In Capital
Service ReceivableAccumulated Other Comprehensive LossAccumulated DeficitTotal
Stockholders’ Equity
Balance, January 1, 2022716 $1 41,964 $4 $400,503 $(139)$(142)$(259,810)$140,417 
Stock-based compensation— — — — 1,152 — — — 1,152 
Other comprehensive loss— — — — — — (606)— (606)
Issuance of common stock upon conversion of Series E Convertible Preferred Stock(328)(1)1,342 — — — — — (1)
Preferred stock dividend— — — — — — — (6)(6)
Release of clinical trial funding commitment— — — — — 139 — — 139 
Net loss— — — — — — — (10,993)(10,993)
Balance, March 31, 2022388 $ 43,306 $4 $401,655 $ $(748)$(270,809)$130,102 
Stock-based compensation— — — — 1,055 — — — 1,055 
Other comprehensive loss— — — — — — (234)— (234)
Preferred stock dividend— — — — — — — (6)(6)
Net loss— — — — — — — (10,443)(10,443)
Balance, June 30, 2022388 $ 43,306 $4 $402,710 $ $(982)$(281,258)$120,474 

See accompanying notes to the unaudited condensed financial statements.
6

CARDIFF ONCOLOGY, INC. 
CONDENSED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
Six Months Ended June 30,
20232022
Operating activities
Net loss$(22,373)$(21,436)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation188 69 
Stock-based compensation expense2,645 2,207 
Amortization of premiums (discounts) on short-term investments(405)557 
Release of clinical trial funding commitment 139 
Changes in operating assets and liabilities:
Other assets(3)54 
Accounts receivable and unbilled receivable610 (16)
Prepaid expenses and other assets2,260 18 
Operating lease right-of-use assets273 272 
Accounts payable and accrued expenses1,293 1,367 
Operating lease liabilities(279)(143)
Other liabilities (32)
Net cash used in operating activities(15,791)(16,944)
Investing activities:
Capital expenditures(259)(483)
Insurance proceeds from casualty loss— 71 
Maturities of short-term investments68,265 48,801 
Purchases of short-term investments(50,868)(57,309)
Sales of short-term investments1,675 34,886 
Net cash provided by investing activities18,813 25,966 
Financing activities:
Net cash provided by financing activities  
Net change in cash and cash equivalents3,022 9,022 
Cash and cash equivalents—Beginning of period16,347 11,943 
Cash and cash equivalents—End of period$19,369 $20,965 
Supplementary disclosure of cash flow activity:
Cash paid for taxes$1 $1 
Supplemental disclosure of non-cash investing and financing activities:
Acquisition of property and equipment included in accounts payable and accrued expenses$16 $456 
Acquisition of property and equipment included in insurance proceeds receivable$— $43 
 
See accompanying notes to the unaudited condensed financial statements.
7

CARDIFF ONCOLOGY, INC. 
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
 
1. Organization and Basis of Presentation
 
Business Organization and Overview
 
Cardiff Oncology, Inc. (“Cardiff Oncology” or the “Company”) headquartered in San Diego, California, is a clinical-stage biotechnology company leveraging Polo-like Kinase 1 (“PLK1”) inhibition to develop novel therapies across a range of cancers. The Company’s lead asset is onvansertib, a PLK1 inhibitor that is being evaluated in combination with standard-of-care therapies in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer, metastatic pancreatic cancer, as well as investigator-initiated trials in triple negative breast cancer and small cell lung cancer. These programs and the Company’s broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the standard-of-care alone. The Company's common stock is listed on the Nasdaq Capital Market under the ticker symbol "CRDF".
 
Basis of Presentation
 
The accompanying unaudited interim condensed financial statements of Cardiff Oncology have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The unaudited interim condensed financial statements reflect all adjustments consisting of normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and the results of its operations and cash flows for the periods presented. The unaudited condensed balance sheet at December 31, 2022, has been derived from the audited financial statements at that date but does not include all of the information and disclosures required by GAAP for annual financial statements. The operating results presented in these unaudited interim condensed financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2022, included in the Company’s annual report on Form 10-K filed with the SEC on March 2, 2023.

Liquidity

The Company has incurred net losses since its inception and has negative operating cash flows. As of June 30, 2023, the Company had $89.4 million in cash, cash equivalents and short-term investments and believes it has sufficient cash to meet its funding requirements for at least the next 12 months following the issuance date of these financial statements.

For the foreseeable future, the Company expects to continue to incur losses and require additional capital to further advance its clinical trial programs and support its other operations. The Company cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that the Company can raise additional funds by issuing equity securities, the Company’s stockholders may experience additional dilution.

2. Summary of Significant Accounting Policies
 
During the six months ended June 30, 2023, there have been no changes to the Company’s significant accounting policies as described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2022.

Net Loss Per Share
 
Basic and diluted net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. Preferred dividends are included in net loss attributable to common stockholders in the computation of basic and diluted earnings per share.

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The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their effect was anti-dilutive:
 
June 30,
20232022
Options to purchase Common Stock6,603,661 5,131,195 
Warrants to purchase Common Stock2,807,948 4,490,159 
Series A Convertible Preferred Stock877 877 
Series E Convertible Preferred Stock 1,342,250 
9,412,486 10,964,481 

Recent Accounting Pronouncement Not Yet Adopted

In August 2020, the FASB issued ASU No. 2020-06 ("ASU 2020-06"), Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2021 (or December 15, 2023, for companies who meet the SEC definition of Smaller Reporting Companies), and interim periods within those fiscal years. The amendment is to be adopted through either a fully retrospective or modified retrospective method of transition. Early adoption is permitted. The Company is currently evaluating the impact of this standard on its financial statements and related disclosures, and will adopt this standard on January 1, 2024.

3. Fair Value Measurements
 
The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of June 30, 2023, and December 31, 2022:
 
Fair Value Measurements at
June 30, 2023
(in thousands)Quoted Prices in Active Markets for Identical Assets and Liabilities
(Level 1)
Significant Other Observable Inputs
(Level 2)
Significant Unobservable Inputs
(Level 3)
Total
Assets:
Money market fund$18,792 $ $ $18,792 
Total included in cash and cash equivalents18,792   18,792 
Available for sale investments:
Certificate of deposit 7,991  7,991 
Corporate debt securities 23,062  23,062 
    Commercial paper 11,089  11,089 
U.S. government agencies 7,802 7,802 
U.S. treasury securities20,115   20,115 
Total available for sale investments20,115 49,944  70,059 
Total assets measured at fair value on a recurring basis$38,907 $49,944 $ $88,851 

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Fair Value Measurements at
December 31, 2022
(in thousands)Quoted Prices in Active Markets for Identical Assets and Liabilities
(Level 1)
Significant Other Observable Inputs
(Level 2)
Significant Unobservable Inputs
(Level 3)
Total
Assets:
Money market fund$15,722 $ $ $15,722 
Total included in cash and cash equivalents15,722   15,722 
Available for sale investments:
Certificate of deposit 16,023  16,023 
Corporate debt securities 49,535  49,535 
    Commercial paper 13,187  13,187 
U.S. government agencies 2,288  2,288 
U.S. treasury securities7,887   7,887 
Total available for sale investments7,887 81,033  88,920 
Total assets measured at fair value on a recurring basis$23,609 $81,033 $ $104,642 

The Company’s policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 3 during the six months ended June 30, 2023.

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4. Supplementary Balance Sheet Information

Investments available for sale

Investments available for sale consist of the following:

As of June 30, 2023
(in thousands)Amortized CostGross Unrealized GainsGross Unrealized LossesFair Market Value
Maturity less than 1 year:
Certificate of deposit$8,005 $ $(14)$7,991 
Corporate debt securities14,465 5 (53)14,417 
Commercial paper11,102  (13)11,089 
U.S. government agencies7,841  (39)7,802 
Total maturity less than 1 year41,413 5 (119)41,299 
Maturity 1 to 2 years:
Corporate debt securities8,711 16 (82)8,645 
U.S. treasury securities20,366  (251)20,115 
Total maturity 1 to 2 years29,077 16 (333)28,760 
Total short-term investments$70,490 $21 $(452)$70,059 


As of December 31, 2022
(in thousands)Amortized CostGross Unrealized GainsGross Unrealized LossesFair Market Value
Maturity less than 1 year:
Certificate of deposit$16,101 $3 $(81)$16,023 
Corporate debt securities44,806 8 (275)44,539 
Commercial paper13,203 4 (20)13,187 
Non U.S. government2,284 4  2,288 
U.S. treasury securities7,905  (18)7,887 
Total maturity less than 1 year84,299 19 (394)83,924 
Maturity 1 to 2 years:
Corporate debt securities5,016 1 (21)4,996 
Total maturity 1 to 2 years5,016 1 (21)4,996 
Total short-term investments$89,315 $20 $(415)$88,920 

We periodically review our portfolio of debt securities to determine if any investment is impaired due to credit loss or other potential valuation concerns. For debt securities where the fair value of the investment is less than the amortized cost basis, we have assessed at the individual security level for various quantitative factors including, but not limited to, the nature of the investments, changes in credit ratings, interest rate fluctuations, industry analyst reports, and the severity of impairment. Unrealized losses in investments available for sale debt securities at June 30, 2023, were substantially due to increases in interest rates, not due to increased credit risks associated with specific securities. Accordingly, we have not recorded an allowance for credit losses. It is not more likely than not that we will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity.


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Investments available for sale that have been in a continuous unrealized loss position for greater than one-year consist of the following:
As of June 30, 2023
(in thousands)Fair Market ValueGross Unrealized Loss
Corporate debt securities$2,963 $(24)

Property and equipment

Property and equipment consist of the following:
 
(in thousands)As of June 30,
2023
As of December 31,
2022
Furniture and office equipment$1,081 $1,066 
Leasehold improvements2,568 2,560 
Laboratory equipment1,264 1,056 
4,913 4,682 
Less—accumulated depreciation and amortization(3,557)(3,413)
Property and equipment, net$1,356 $1,269 

Accrued Liabilities

Accrued liabilities consisted of the following:

(in thousands)As of June 30,
2023
As of December 31,
2022
Accrued compensation$2,175 $1,849 
Clinical trials2,364 2,333 
Research agreements and services543 509 
Director fees125 125 
Patent, license and other fees83 24 
Other accrued liabilities211 337 
Total accrued liabilities$5,501 $5,177 
 
5. Leases

 As a lessee, the Company’s current leases include its master facility lease and immaterial equipment leases, all of which are considered operating leases.

Master Facility Lease

The Company currently leases office and lab space in San Diego that expires on February 28, 2027. The lease currently requires monthly payments of approximately $61,000 per month with 3% annual escalation.

The components of lease expense were as follows:
Three Months Ended June 30,Six Months Ended June 30,
(in thousands)2023202220232022
Operating lease cost$180 $190 $363 $381 

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Supplemental balance sheet information related to leases was as follows:
(in thousands)As of June 30,
2023
As of December 31,
2022
Operating lease ROU assets$1,978 $2,251 
Current operating lease liabilities$683 $675 
Non-current operating lease liabilities1,753 2,040 
Total operating lease liabilities$2,436 $2,715 
Weighted-average remaining lease term–operating leases3.7 years4.2 years
Weighted-average discount rate–operating leases7.0 %7.0 %

Supplemental cash flow and other information related to leases was as follows:
Three Months Ended June 30,Six Months Ended June 30,
(in thousands)2023202220232022
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases$183 $180 $368 $251 

Total remaining annual commitments under non-cancelable lease agreements for each of the years ended December 31 are as follows:
(in thousands)
Year Ending December 31, Operating Leases
2023 (excluding the six months ended June 30, 2023)
$306 
2024754 
2025775 
2026796 
Thereafter136 
Total future minimum lease payments2,767 
Less imputed interest(331)
Total$2,436 

6. Stockholders’ Equity
 
Stock Options
 
Stock-based compensation expense related to Cardiff Oncology equity awards have been recognized in operating results as follows:
 
Three Months Ended June 30,Six Months Ended June 30,
(in thousands)2023202220232022
Included in research and development expense$297 $126 $691 $460 
Included in selling, general and administrative expense1,284 929 1,954 1,747 
Total stock-based compensation expense$1,581 $1,055 $2,645 $2,207 
 
The unrecognized compensation cost related to non-vested stock options outstanding at June 30, 2023, net of estimated forfeitures, was $8.4 million, which is expected to be recognized over a weighted-average remaining vesting period of 2.5 years. The weighted-average remaining contractual term of outstanding options as of June 30, 2023, was approximately 8.4
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years. The total fair value of stock options vested during the six months ended June 30, 2023 and 2022, were $3.2 million and $3.0 million, respectively.

The estimated fair value of stock option awards was determined on the date of grant using the Black-Scholes option valuation model with the following weighted-average assumptions during the following periods indicated:
 
Six Months Ended June 30,
20232022
Risk-free interest rate3.61 %1.87 %
Dividend yield0 %0 %
Expected volatility of Cardiff Oncology common stock109 %106 %
Expected term(1)
5.3 years6.0 years
(1)The expected term for options granted after January 1, 2023 is estimated based on the Company's historical employee data. Prior to January 1, 2023, the Company used the "simplified method" to estimate expected term.

A summary of stock option activity and changes in stock options outstanding is presented below:
 
Total OptionsWeighted-Average
Exercise Price
Per Share
Intrinsic
Value
Balance outstanding, December 31, 20225,069,458 $5.92 $19,322 
Granted2,088,608 $1.71  
Forfeited and expired(554,405)$7.12  
Balance outstanding, June 30, 20236,603,661 $4.49 $23,351 
Exercisable at June 30, 20232,766,027 $6.16 $21,713 
Vested and expected to vest at June 30, 20236,410,335 $4.55 $23,269 
 
2021 Equity Incentive Plan

In June 2021 the Company's stockholders approved the 2021 Omnibus Equity Incentive Plan ("2021 Plan"). The number of authorized shares in the 2021 Plan is equal to the sum of (i) 3,150,000 shares, plus (ii) the number of shares of Common Stock reserved, but unissued under the 2014 Plan; and (iii) the number of shares of Common Stock underlying forfeited awards under the 2014 Plan. On June 9, 2022, the shareholders approved an increase of shares authorized in the 2021 Plan to 5,150,000 from 3,150,000. As of June 30, 2023, there were 2,013,871 shares available for issuance under the 2021 Plan.

2014 Equity Incentive Plan

Subsequent to the adoption of the 2021 Plan, no additional equity awards can be made under the terms of the 2014 Plan.

Inducement Grants

The Company issues equity awards to certain new employees as inducement grants outside of its 2021 Plan. As of June 30, 2023, an aggregate of 1,385,240 shares were issuable upon the exercise of inducement grant stock options approved by the Company.

Modification of Stock Options

In June 2023 the Company modified stock options for a departing employee. The modification resulted in an incremental stock-based compensation expense of $0.6 million during the three month period ended June 30, 2023.

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Warrants
 
A summary of warrant activity and changes in warrants outstanding, including both liability and equity classifications is presented below:
 
Total WarrantsWeighted-Average
Exercise Price
Per Share
Weighted-Average
Remaining Contractual
Term
Balance outstanding, December 31, 20224,360,968 $5.33 2.1 years
Expired(1,553,020)$10.54  
Balance outstanding, June 30, 20232,807,948 $2.45 2.5 years


Preferred Stock

A summary of our Company's classes of preferred stock is presented below:
Shares outstanding
ClassPar valueShares designatedAs of June 30,
2023
As of December 31,
2022
Series A Convertible Preferred Stock$0.001 277,100 60,600 60,600 
Series B Convertible Preferred Stock$0.001 8,860   
Series C Convertible Preferred Stock$0.001 200,000   
Series D Convertible Preferred Stock$0.0001 154,670   
Series E Convertible Preferred Stock$0.001 865,824   

Subsequent to quarter-end the Company filed a certificate of elimination and the Series B, C, D & E preferred stock have been eliminated from authorized series of preferred stock.


7. Commitments and Contingencies
 
Executive Agreements
 
Certain executive agreements provide for severance payments in case of terminations without cause or certain change of control scenarios.
 
Research and Development Agreements

In March 2017, the Company entered into a license agreement with Nerviano which granted the Company development and commercialization rights to NMS-1286937, which Cardiff Oncology refers to as onvansertib. Terms of the agreement also provide for the Company to pay development and commercial milestones, and royalties based on sales volume. These potential development milestones include: (a) dosing of the first subject in the first Phase III Clinical Trial for the first Product, a registration enabling Phase II Clinical Trial, or after completion of a Phase II Clinical Trial that is used as the basis for an NDA submission; and (b) upon filing of the first NDA or equivalent for the first product candidate. During the six months ended June 30, 2023 and 2022 no milestone or royalty payments were made.
 
The Company is a party to various agreements under which it licenses technology on an exclusive basis in the field of oncology therapeutics. These agreements include License fees, Royalties and Milestone payments. The Company also has a legacy license agreement in the field of oncology diagnostics under which royalty payments are due. These royalty payments are calculated as a percent of revenue. For the six months ended June 30, 2023 and 2022, payments have not been material.

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Litigation

Cardiff Oncology does not believe that it has legal liabilities that are probable or reasonably possible that require either accrual or disclosure. From time to time, the Company may become involved in various lawsuits and legal proceedings that arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in matters may arise from time to time that may harm the Company’s business. As of the date of this report, management believes that there are no claims against the Company, which it believes will result in a material adverse effect on the Company’s business or financial condition.

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
Forward-Looking Statements
 
This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding the future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions.
 
In addition, our business and financial performance may be affected by the factors that are discussed under “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2022, filed on March 2, 2023. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for us to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
 
You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
 
The following discussion and analysis is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the financial statements and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q. This discussion should not be construed to imply that the results discussed herein will necessarily continue into the future, or that any conclusion reached herein will necessarily be indicative of actual operating results in the future. Such discussion represents only the best present assessment of our management.
 
Overview

We are a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers with the greatest unmet medical need. Our goal is to target tumor vulnerabilities with treatment combinations of onvansertib, our oral and highly selective PLK1 inhibitor, and standard-of-care ("SoC") therapeutics. We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC") and metastatic pancreatic ductal adenocarcinoma ("mPDAC"), as well as in investigator-initiated trials in triple negative breast cancer ("TNBC") and small cell lung cancer ("SCLC"). Our clinical development programs incorporate tumor genomics and biomarker assays to refine assessment of patient response to treatment.

Our Lead Drug Candidate, Onvansertib

Onvansertib is an oral, small molecule drug candidate that is highly specific for PLK1 inhibition with a 24-hour half-life.

We believe the attributes of onvansertib described below, as well as clinical evidence of favorable safety and efficacy, with expected on-target, easy to manage and reversible side effects, may prove beneficial in addressing clinical therapeutic needs across a variety of cancers:

Onvansertib is highly potent and highly selective against the PLK1 enzyme (IC50 = 2nM; IC50 is the concentration for 50% inhibition), compared to prior PLK1 inhibitors that were pan-inhibitors of several PLK targets. Low or no activity of onvansertib was observed on a panel of 63 kinases (IC50>500 nM), including the PLK members PLK2 and PLK3 (IC50>10,000 nM);

Onvansertib is orally bioavailable, allowing for relative ease and flexibility of dosing.
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Onvansertib has a relatively short drug half-life of 24 hours, allowing for flexible dosing and scheduling which has shown favorable safety and tolerability across multiple clinical trials;

In vitro studies have shown synergistic effects when onvansertib was administered in combination with different cytotoxic agents including microtubule-targeting agents, topoisomerase 1 inhibitors, antimetabolites, alkylating agents, proteasome inhibitors, kinase inhibitors, PARP inhibitors, BCL-2 inhibitors, and androgen biosynthesis inhibitors.

In addition, in vivo combination studies have confirmed the positive results obtained in vitro and synergistic effects have been observed in xenograft models of onvansertib in combination with irinotecan, 5-fluorouracil ("5-FU"), abiraterone, PARP inhibitors, venetoclax, and paclitaxel, while additive effects in combination with cytarabine or bevacizumab have been demonstrated. Combining onvansertib with standard-of-care cancer agents provides opportunities for synergy with many cancer therapies.

There are five ongoing and planned clinical trials of onvansertib: one trial (CRDF-004) in first line treatment in patients with RAS-mutated mCRC, one trial (TROV-054) in second line treatment in patients with KRAS-mutated Metastatic Colorectal Cancer ("mCRC"), one trial in second line treatment in patients with Metastatic Pancreatic Ductal Adenocarcinoma ("mPDAC"), and two investigator-initiated trials in patients with locally advanced or metastatic Triple Negative Breast Cancer ("TNBC") and relapsed Small Cell Lung Cancer ("SCLC").

CRDF-004 Clinical Trial in RAS-mutated mCRC

CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial of onvansertib in combination with standard-of-care FOLFIRI and bevacizumab or FOLFOX and bevacizumab for the first line treatment of patients with RAS-mutated mCRC. The primary objectives of the CRDF-004 trial are to evaluate onvansertib’s safety and efficacy in combination with the standard-of-care, as well as to evaluate two doses of onvansertib, 20mg and 30mg given in combination with standard-of-care, against standard-of-care alone. The primary endpoint of the trial is objective response rate. Progression-free survival and duration of response will be secondary endpoints. We expect to begin enrollment during the second half of 2023, with initial data anticipated in mid-2024. The trial is expected to enroll approximately 90 patients.

Phase 1b/2 Clinical Trial in KRAS-mutated mCRC

TROV-054 is a Phase 1b/2 open-label multi-center clinical trial of onvansertib in combination with standard-of-care FOLFIRI and bevacizumab for the second line treatment of patients with KRAS-mutated mCRC. This trial completed enrollment in October 2022.

The primary objectives of this trial are to evaluate the Dose-Limiting Toxicities ("DLTs"), maximum tolerated dose ("MTD") and recommended Phase 2 dose ("RP2D") of onvansertib in combination with FOLFIRI and bevacizumab (Phase 1b) and to continue to assess the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab patients with KRAS-mutated mCRC (Phase 2).

The scientific rationale for this clinical trial is based on the two key principles of synthetic lethality and synergy, with the objective of demonstrating a proof-of-concept of clinical benefit within this Phase 1b/2 trial. Synthetic lethality refers to a critical vulnerability to tumor cell death by way of PLK1 inhibition within CRC tumor cells harboring KRAS mutations versus KRAS wild-type isogenic cells. Synergy occurs when the combination of multiple drugs results in an unexpected greater activity than an expected additive effect of the individual drugs. Onvansertib in combination with two DNA-damaging agents, irinotecan and 5-FU (two components of FOLFIRI), demonstrated synergy in colorectal cancer cell lines and both combinations have demonstrated significantly greater tumor growth inhibition than either drug alone in CRC in vivo models. We believe this synergy occurs because PLK1 can promote the repair of DNA damage caused by chemotherapeutic agents and by inhibiting PLK1, onvansertib leaves damaged tumor cells unable to repair DNA damage from chemotherapy and then replicate. For more information, please visit NCT03829410 at www.clinicialtrials.gov.

Data presented on August 7, 2023, provided an update of the ongoing TROV-054 Phase 1b/2 single arm clinical trial in KRAS-mutated metastatic colorectal cancer:

Objective response rate ("ORR") across all evaluable patients was 29%, with 19 of 66 evaluable patients achieving an objective response. Responses have been observed across multiple KRAS variants;

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Median duration of response ("mDoR") across all evaluable patients was 12.0 months (95% confidence interval ("CI"): 8.9 – not reached);

Median progression free survival ("mPFS") across all evaluable patients was 9.3 months (95% CI: 7.8 – 14). Historical control trials of different drug combinations, including the standard-of-care ("SOC") of FOLFIRI with bevacizumab, in similar patient populations have shown ORR and mPFS of 5 – 13% and ~4.5 – 6.7 months, respectively.

A subgroup analysis of patients who were bevacizumab naïve when they entered 2nd line therapy vs patients who had received prior bevacizumab in 1st line therapy showed that patients who were bevacizumab naïve (n=15) had an ORR of 73% and mPFS of 15 months, which is well above historical controls. In contrast, patients previously treated with bevacizumab (n=51) had an ORR of 16% and mPFS of 7.8 months.

In reviewing the TROV-054 clinical data, we originally designed the ONSEMBLE trial (CRDF-003) as the next phase of our mCRC program. Upon review of the clinical data from the bev naïve subgroup (those patients who did not receive bev in their 1st line therapy), the preclinical data on the mechanism of action and the feedback from the FDA on our clinical development strategy, we made the decision to discontinue enrollment in the ONSEMBLE trial and to initiate CRDF-004.

Phase 2 Clinical Trial in mPDAC

CRDF-001 is a Phase 2 open-label multi-center clinical trial of onvansertib in combination with nanoliposomal irinotecan (Onivyde®), leucovorin, and fluorouracil for second line treatment of patients with mPDAC, which is being conducted at six clinical trial sites across the U.S. – The Mayo Clinic Cancer Centers (Arizona, Minnesota, and Florida), Kansas University Medical Center, Inova Schar Cancer Institute, and the University of Nebraska Medical Center. The first patient was dosed in June 2021.

The objective of this trial is to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide®), 5-FU and leucovorin as a second-line treatment in patients with mPDAC who have failed 1st line gemcitabine-based therapy. The trial is expected to enroll approximately 45 patients. For more information, please visit NCT04752696 at www.clinicialtrials.gov.

Preliminary data presented on September 12, 2022 provided an update of the ongoing CRDF-001 Phase 2 open label clinical trial in mPDAC:

Preliminary data from 5 evaluable patients showed 1 patient achieving an initial partial response ("PR") and 3 patients achieving stable disease ("SD");

The 4 patients achieving SD or PR remain on study; the fifth evaluable patient discontinued treatment due to disease progression and an additional 3 patients remain on study awaiting their first post-baseline scan;

Additional data is expected in mid-2023.

Phase 1b/2 Investigator-Initiated Clinical Trial in TNBC

A single-arm, Phase 1b/2 trial of onvansertib in combination with paclitaxel in patients with unresectable locally advanced or metastatic TNBC is open for enrollment at Dana Farber Cancer Institute ("DFCI"). In Phase 1b, approximately 14-16 patients will be treated with different doses of onvansertib in combination with a fixed dose of paclitaxel to determine the maximum tolerated dose and RP2D of onvansertib. In Phase 2, approximately 34 patients will be treated with the selected onvansertib RP2D in combination with paclitaxel.

The primary endpoint of Phase 2 of the trial is ORR, with PFS included as a secondary endpoint. Preliminary data from the trial are expected in the fourth-quarter of 2023 or first-quarter of 2024. For more information, please visit NCT05383196 at www.clinicialtrials.gov.

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Phase 2 Investigator-Initiated Clinical Trial in SCLC

A single-arm, two-stage, Phase 2 trial of onvansertib monotherapy in patients with relapsed SCLC is open for enrollment at the University of Pittsburgh Medical Center ("UPMC"). The trial is designed to enroll 15 patients in Stage 1, with the study proceeding to Stage 2 if 2 or more Stage 1 patients achieve an objective response. Stage 2 is designed to enroll an additional 20 patients. The primary endpoint of the trial is ORR, while key secondary endpoints include PFS and overall survival. Preliminary data from the trial are expected in mid-2023. For more information, please visit NCT05450965 at www.clinicialtrials.gov.

Recent Updates

Pfizer Ignite to Conduct CRDF-004 Clinical Trial

Pfizer Ignite will conduct the clinical activities of our new CRDF-004 trial in 1st line RAS-mutated mCRC, which expands the relationship established in November 2021 when Pfizer made an investment in Cardiff Oncology through its Pfizer Breakthrough Growth Initiative. Pfizer VP and Development head Adam Schayowitz sits on the Cardiff Oncology Scientific Advisory Board.

Critical Accounting Policies
 
Our accounting policies are described in ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS of our Annual Report on Form 10-K as of and for the year ended December 31, 2022, filed with the SEC on March 2, 2023. There have been no changes to our critical accounting policies since December 31, 2022.

RESULTS OF OPERATIONS
 
Three Months Ended June 30, 2023 and 2022
 
Revenues
 
Total revenues were $108,000 for the three months ended June 30, 2023, as compared to $91,000 for the prior period. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib. Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees.
 
Research and Development Expenses
 
Research and development expenses consisted of the following:
 
Three Months Ended June 30,
(in thousands)20232022Increase (Decrease)
Salaries and staff costs$1,487 $1,069 $418 
Stock-based compensation297 126 171 
Clinical trials, outside services, and lab supplies5,670 5,903 (233)
Facilities and other566 350 216 
Total research and development$8,020 $7,448 $572 
 
Research and development expenses increased by $0.6 million for the three months ended June 30, 2023, compared to the same period in 2022. The overall increase in expenses was primarily related to salaries and staff costs from additional hires in senior management and our clinical operations team (research and development average headcount grew by 35% over the comparative period). The increase in facilities and other is primarily due to increased allocation of facilities cost resulting from headcount growth compared to the prior period. The decrease in clinical trials, outside services, and lab supplies was primarily related to costs incurred in the prior period related to CMC and clinical pharmacology for studies to support the development of our lead drug candidate, onvansertib.

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Selling, General and Administrative Expenses
 
Selling, general and administrative expenses consisted of the following:
 
Three Months Ended June 30,
(in thousands)20232022Increase (Decrease)
Salaries and staff costs$1,358 $792 $566 
Stock-based compensation1,284 929 355 
Outside services and professional fees1,070 673 397 
Facilities and other584 692 (108)
Total selling, general and administrative$4,296 $3,086 $1,210 
 
Selling, general and administrative expenses increased by $1.2 million for the three months ended June 30, 2023, compared to the same period in 2022. Salaries and staff costs increased due to an employee severance agreement. The increase in outside services and professional fees was due to additional contract review legal fees, public relations and external accounting fees.

Interest Income, Net

Interest income, net was $1.1 million for the three months ended June 30, 2023 as compared to $0.3 million for the same period of 2022. The increase in interest income was primarily due to higher interest rates on our short-term investments portfolio for the three months ended June 30, 2023 as compared to the same period of 2022.

Six Months Ended June 30, 2023 and 2022

Revenues
 
Total revenues were $191,000 for the six months ended June 30, 2023, as compared to $165,000 for the same period in 2022. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib. Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees.
 
Research and Development Expenses
 
Research and development expenses consisted of the following:
 
Six Months Ended June 30,
(in thousands)20232022Increase (Decrease)
Salaries and staff costs$2,860 $2,130 $730 
Stock-based compensation691 460 231 
Clinical trials, outside services, and lab supplies12,515 11,419 1,096 
Facilities and other1,006 647 359 
Total research and development$17,072 $14,656 $2,416 
 
Research and development expenses increased by $2.4 million for the six months ended June 30, 2023, compared to the same period in 2022. The overall increase in expenses was primarily due to costs associated with clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib. Salaries and staff costs increased primarily from additional hires in senior management and our clinical operations team (research and development average headcount grew by 30% over the comparative period). The increase in facilities and other is primarily due to increased allocation of facilities cost resulting from headcount growth compared to the prior period.

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Selling, General and Administrative Expenses
 
Selling, general and administrative expenses consisted of the following:
 
Six Months Ended June 30,
(in thousands)20232022Increase (Decrease)
Salaries and staff costs$2,157 $1,652 $505 
Stock-based compensation1,954 1,747 207 
Outside services and professional fees2,091 2,279 (188)
Facilities and other1,177 1,348 (171)
Total selling, general and administrative$7,379 $7,026 $353 
 
Selling, general and administrative expenses increased by $0.4 million for the six months ended June 30, 2023, compared to the same period in 2022. Salaries and staff costs increased due to an employee severance agreement.

Interest Income, Net

Interest income, net was $2.0 million for the six months ended June 30, 2023 as compared to $0.4 million for the same period of 2022. The increase in interest income was primarily due to higher interest rates on our short-term investments portfolio for the six months ended June 30, 2023 as compared to the same period of 2022.

LIQUIDITY AND CAPITAL RESOURCES

Net cash used in operating activities for the six months ended June 30, 2023, was $15.8 million, compared to $16.9 million for the six months ended June 30, 2022. Our use of cash was primarily a result of the net loss of $22.4 million for the six months ended June 30, 2023, adjusted for non-cash items related to stock-based compensation of $2.6 million. The net change in our operating assets and liabilities decreased cash used in operations by $4.2 million. At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years.

Net cash provided by investing activities was $18.8 million primarily related to sales and maturities in excess of purchases of marketable securities for the six months ended June 30, 2023, compared to net cash provided by investing activities of $26.0 million primarily related to sales and maturities in excess of purchases of marketable securities during the same period in 2022.

Net cash provided in financing activities was $0 for the six months ended June 30, 2023, and 2022.

As of June 30, 2023, and December 31, 2022, we had working capital of $83.6 million and $103.5 million, respectively.

We have incurred net losses since our inception and have negative operating cash flows. As of June 30, 2023, we had $89.4 million in cash, cash equivalents and short-term investments and we believe we have sufficient cash to meet our funding requirements for at least the next 12 months following the issuance date of this Quarterly Report on Form 10-Q. Based on our current projections we expect that our capital resources are sufficient to fund our operations into 2025.

Our drug development efforts are in their early stages, and we cannot make estimates of the costs or the time that our development efforts will take to complete, or the timing and amount of revenues related to the sale of our drug candidates. The risk of completion of any program is high because of the many uncertainties involved in developing new drug candidates to market, including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of research and development expenses, and competing technologies being developed by organizations with significantly greater resources.

For the foreseeable future, we expect to continue to incur losses and require additional capital to further advance our clinical trial programs and support our other operations. We cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that we can raise additional funds by issuing equity securities, our stockholders may experience additional dilution.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

ITEM 4. CONTROLS AND PROCEDURES
 
Evaluation of Disclosure Controls and Procedures
 
We have performed an evaluation under the supervision and with the participation of our management, including our principal executive officer (CEO) and principal financial officer (CFO), of the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of June 30, 2023, to provide reasonable assurance that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives as specified above. Management does not expect, however, that our disclosure controls and procedures will prevent or detect all errors and fraud. Any control system, no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable, not absolute, assurance that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within our company have been detected.
 
Changes in Internal Control over Financial Reporting
 
There was no change in our internal control over financial reporting during the three months ended June 30, 2023, that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II.  OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS
 
None.

ITEM 1A. RISK FACTORS
 
There have been no material changes from the risk factors disclosed in our Form 10-K for the year ended December 31, 2022.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

None.

ITEM 6. EXHIBITS
 
Exhibit
Number
Description of Exhibit
10.1#
31.1
31.2
32.1
32.2
101.INSInline XBRL Instance Document
101.SCHInline XBRL Taxonomy Extension Schema
101.CALInline XBRL Taxonomy Extension Calculation Linkbase
101.LABInline XBRL Taxonomy Extension Labels Linkbase
101.PREInline XBRL Taxonomy Extension Presentation Linkbase
101.DEFInline XBRL Taxonomy Extension Definition Linkbase
104
Cover Page Interactive Data File - the cover page from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, is formatted in Inline XBRL
#    Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10)(iv).
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SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
CARDIFF ONCOLOGY, INC.
August 9, 2023By:/s/ Mark Erlander
Mark Erlander
Chief Executive Officer
CARDIFF ONCOLOGY, INC.
August 9, 2023By:/s/ James Levine
James Levine
Chief Financial Officer

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Document
Confidential
[*]
Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would
be competitively harmful if publicly disclosed.

DEVELOPMENT AGREEMENT
This Development Agreement (“Agreement”) is made as of this 30th day of June, 2023 (the “Effective Date”) by and between Cardiff Oncology, Inc., a corporation formed under the laws of Delaware and having a principal place of business at 11055 Flintkote Avenue, San Diego, CA 92121 (“Company”) and Pfizer Inc., a Corporation formed under the laws of Delaware and having a principal place of business at 66 Hudson Boulevard East, New York, NY 10001-2192, on behalf of itself and any one or more of its Affiliates that conducts activities hereunder (collectively, “Pfizer” and along with Company, the “Parties” and each, a “Party”).
A.    Company is in the business of developing therapeutic products; and
B.    Company and Pfizer desire that Pfizer assist Company in the development of the Products (as defined in the applicable Statement of Work (as defined in Section 1.2)) on the terms set forth in this Agreement and that certain Information Rights Agreement dated November 17, 2021 by and between the Parties or their designated Affiliates, as amended by that certain Amendment to the Information Rights Agreement, dated on or around the date hereof (such agreement, as may be amended from time to time, the “Information Rights Agreement”) as part of Pfizer’s Ignite Program.
NOW, THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Pfizer and Company agree as follows:
1.Agreement and Statements of Work.
1.1.Scope of Agreement. As a master form of contract, this Agreement allows the Parties to contract for one or more projects (each, a “Project”) by executing one or more Statements of Work without having to re-negotiate the basic terms and conditions contained herein. Pfizer will perform, or will cause an Affiliate (as defined in Section 1.4) to perform, the services described in this Agreement and the Statements of Work (collectively, the “Services”), including the delivery of any deliverables described in any Statement of Work (the “Deliverables”), subject to the terms and conditions herein. Neither Party is obligated to enter into any Statement of Work.
1.2.Statements of Work. The specific details of the Services for each Project will be set forth in a Statement of Work signed by the Parties or their respective Affiliates in the form attached hereto as Exhibit A-1 (each such “Statement of Work” executed by the Parties, a “Statement of Work”). The initial Statement of Work is attached as Exhibit A hereto as of the Effective Date. Each Statement of Work will include the scope of Services, schedule, budget, and payment terms for a particular Project. Each Statement of Work will be subject to all terms and conditions of this Agreement, in addition to the specific details set forth in such Statement of Work. The terms of each Statement of Work will only apply to the Project set forth therein. To the extent any terms or provisions of a Statement of Work conflict with the terms and provisions of this Agreement, the terms and provisions of this Agreement will control, unless the Statement of Work expressly provides that the Parties intend to override a provision of this Agreement. Any amendment to this Agreement will apply to all Statements of Work. Any amendment or modification to a specific Statement of Work will apply solely to that Statement of Work.
1.3.Change Orders. To the extent any change in the details of a Statement of Work or the assumptions upon which the Statement of Work is based require changes in the budget or schedule of a Project, Pfizer and Company will negotiate such changes diligently and in good faith, and execute a written amendment to such Statement of Work on a form substantially similar to Exhibit B (each, a “Change Order”). Neither Party will have an obligation to amend a Statement of Work until and unless the Parties agree to and execute the corresponding Change Order.
1.4.Relationship with Affiliates and Subcontractors. Pfizer may use the services of its Affiliates or, upon prior written notice to Company, the services of Third Party subcontractors to fulfill Pfizer’s obligations under this Agreement or any Statement of Work. Without limiting the foregoing, and notwithstanding anything in this Agreement to the contrary, Pfizer may use Pfizer’s staff augmentation services (i.e., a certain pool of


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Third Party professionals who are integrated into Pfizer’s systems and trained on Pfizer protocols, work flows, and processes) to fulfill Pfizer’s obligations under this Agreement or any Statement of Work, without requiring notice to, or the consent of, Company. In any case, Pfizer will ensure that any Third Party subcontractors engaged by Pfizer to perform Services shall comply with the terms of this Agreement. Any Affiliate of either Party may enter into a Statement of Work directly with the other Party or its Affiliate; provided, however that each Party will remain responsible and retain primary liability for all of its obligations and activities under any Statement of Work entered into by its Affiliate or Third Party subcontractor. “Affiliate” means, with respect to a Party, all entities or individuals Controlling, Controlled by or under common Control with a Party. “Control” means the possession, directly or indirectly, of 50% or more of the share capital or voting rights of a Party, or of the power to direct or cause the direction of the management and policies of a Party, whether through the ownership of voting securities, by contract or otherwise. “Third Party” means any individual or entity other than a Party or its Affiliate.
1.5.Clinical Trial Agreements. Pfizer shall be responsible for the negotiation and administration of all clinical trial agreements with Third Party clinical trial sites or investigators.
2.Project Management.
2.1.Project Teams; Project Manager. On a Project-by-Project basis, Pfizer and Company will each designate, and identify in the applicable Statement of Work, such of their respective employees from product development, quality assurance, manufacturing, and project management to form a team (“Project Team”) to direct the activities to be carried out under such Statement of Work. Further, on a Project-by-Project basis, each Party will also designate, and identify in the applicable Statement of Work, one of its employees to act as its project manager (each, a “Project Manager”), who will be primarily responsible for communicating all instructions and information concerning the applicable Project to the members of the applicable Project Team. The applicable Project Team and Project Managers will consult periodically during the performance of each Project, through face-to-face meetings, telephone conferences, or videoconferences, at times to be mutually agreed upon by the applicable Project Managers. Either Party may replace a Project Manager or one or more members of each Project Team at any time. Neither the Project Managers nor the Project Teams will have the right to modify, amend, or waive any provision of this Agreement.
2.2.Advisory Committee. Upon mutual agreement of the Parties, Pfizer and Company will jointly constitute a team (“Advisory Committee”) comprised of an equal number of members designated by each Party but, in any event, not less than two members from each Party (or such number as the Parties mutually agree). The Advisory Committee will promptly meet upon mutual agreement of the Parties to address any relevant issue such Party wishes to call to the attention of the Advisory Committee, including any unresolved dispute referred by the Project Managers, to review past performance on mutually agreed upon metrics, discuss future partnership objectives, and to oversee the relationship between Company and Pfizer. For clarity, the Parties agree that all day-to-day issues will be brought before the applicable Project Team. The Advisory Committee will be considered an advisory committee, without the ability to modify, amend, or waive any provision of this Agreement, and will have as its goal to facilitate prompt and mutually agreeable resolution of any financial, technical, or quality issues that may arise in order to advance and preserve a harmonious relationship established by and between Pfizer and Company. Either Party may change its representatives on the Advisory Committee at any time by written notice to the other Party.
3.Performance of Services.
3.1.Performance Standard. Pfizer will use reasonable efforts to conduct its obligations with respect to each Project as set forth in the applicable Statement of Work. However, the Parties acknowledge and agree that neither of them can guarantee that a Project will be successful, nor guarantee any specific scientific results or outcomes, nor warrant that a marketable Product will result from any Project. Pfizer will conduct the Services (a) in a good and workmanlike manner in material compliance with all applicable federal, state, local, and international equivalent laws, rules, guidances, policies, regulations, industry standards, and administrative requirements (including applicable cGLP, cGCP, and cGMP standards) (“Applicable Law”) in the territory set forth in the applicable Statement of Work and (b) with a reasonable standard of care customary for Pfizer and in accordance with the standard operating procedures of Pfizer, and in accordance with Applicable Law and professional standards consistent with Good Clinical Practices and with the generally accepted professional standards of care customary in the performance of clinical research. The Parties will reasonably cooperate with each other to conduct any technology transfer from Company to Pfizer in connection with the initiation of any Services. Notwithstanding the foregoing or any provision to the contrary herein or in any Statement of Work, Pfizer will not have an obligation to perform a Service if
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Pfizer reasonably believes that providing such Service would (x) result in a breach of this Agreement or a failure to comply with Applicable Law, (y) result in a safety issue affecting those conducting the Services or patients, or (z) infringe, misappropriate, or otherwise violate a Third Party’s intellectual property rights; provided, that Pfizer shall promptly, but within no less than * business days for any safety-related issues and * business days in all other cases, notify the Advisory Committee (if it is then in place) and Company of its concerns and discuss with the Company potential resolutions for any issues preventing Pfizer from performing a Service. Pfizer will be responsible for its personnel obtaining all professional licenses, consents, authorizations, permits and certificates as required by Applicable Law for its performance of the Services.
3.2.Project Materials. Company will be responsible for providing Pfizer with all Project Materials (as defined in this Section 3.2) set forth in the applicable Statement of Work for use in the conduct of the Services, except as otherwise set forth in such Statement of Work. Company will, at its cost, deliver Project Materials DDP (Incoterms 2020) to the applicable Pfizer facility at such times and in such quantities and conforming to such criteria as specified in the applicable Statement of Work or otherwise reasonably requested in advance and in writing by Pfizer. Company will provide to Pfizer, prior to delivering any Project Materials, all applicable safety data sheets, environmental and safety information, handling instructions, and other documentation necessary to safely handle and maintain the Project Materials. Pfizer will not be responsible for any delays arising out of Company’s failure to timely provide to Pfizer all Project Materials or other information or materials reasonably required to perform the Services, and Company will be responsible for additional costs and expenses arising out of such delay. Company hereby grants to Pfizer, during the Term, a non-exclusive, fully paid up, royalty-free, non-transferable (except in connection with an assignment of this Agreement), worldwide license, with the right to grant sublicenses through multiple tiers, under all rights, title, and interests in and to the Project Materials and all intellectual property rights therein, solely to perform the Services. “Project Materials” means any and all materials to be provided by or on behalf of Company under a Statement of Work, including the “Key Project Materials” that are specified in the applicable Statement of Work.
3.3.Storage. In the event that any Project Materials remain in Pfizer’s possession after the expiration or earlier termination of all Statements of Work for which they are provided, then, unless the Parties mutually agree otherwise within * days following such expiration or earlier termination, Pfizer may elect, upon notice to Company, to (a) return such Project Materials at Company’s expense, (b) destroy such Project Materials at Company’s expense, or (c) continue to store such Project Materials subject to payment by Company of Pfizer’s then-applicable rates for such storage.
3.4.Regulatory Matters. As between the Parties, Company will be responsible for obtaining, at its expense, all regulatory and governmental approvals and permits necessary for Company’s use of any Product developed or manufactured in the conduct of Services, including investigational new drug application, biologics license application, new drug application, and abbreviated new drug application submissions, and any analogous submissions filed with a regulatory authority outside the United States.
3.5.Deliverables; Records. Subject to Company’s compliance with its payment obligations in Article 5 of this Agreement and the applicable Statement of Work, Pfizer will deliver to Company all Deliverables in accordance with the terms and conditions of this Agreement, and each applicable Statement of Work and quality agreement.
3.6.Privacy and Information Security. The Parties will negotiate and enter into an appropriate data protection addendum promptly following the Effective Date and to be incorporated into this Agreement as Exhibit C.
4.Audits; Regulatory Inspections.
4.1.General Company Audits. During the Term, Pfizer will permit Company’s employees and consultants (collectively, “Representatives”), other than any Third Party Representative that is a competitor of Pfizer or any of its Affiliates, to examine or audit the Services and the facilities at which the Services are conducted during regular business hours solely to determine whether all Projects are being conducted in accordance with this Agreement and the applicable Statement of Work and quality agreement between the Parties and whether the facilities utilized are in compliance with Applicable Law. Prior to any such audit, all Representatives conducting such audit, other than Company’s employees, will enter into a confidentiality agreement with Pfizer on terms at least as stringent as the confidentiality terms herein. Subject to Pfizer’s obligations of confidentiality to other customers and Third Parties, Pfizer will reasonably cooperate with Company’s audits by making relevant resources available to Company for audit, including Pfizer’s relevant physical facilities and a reasonable number of Pfizer’s employees as mutually agreed on by the Parties.
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Such audits (a) will require at least four days’ prior written notice to Pfizer for For-Cause Audits (defined below) and otherwise at least * days’ prior written notice to Pfizer, (b) will be limited to not more than * auditors in toto designated by or representing Company, (c) will last for not more than * days for For-Cause Audits and otherwise * days, (d) may be conducted not more than * time per every * calendar months unless such audit is a For-Cause Audit, and (e) may be conducted remotely. A “For-Cause Audit” is a “for-cause” audit to address significant product or safety concerns as discovered through product failures or otherwise, and related to Pfizer’s manufacture of a Product or the conduct of activities or performance of Services under a Statement of Work or quality agreement between the Parties. Product failures include issues related to stability, out of specification, sterility, labeling, or container integrity.
4.2.Audit Reports. Notwithstanding any provision of this Agreement to the contrary, all reports and financial information of Pfizer, its Affiliates or subcontractors which are provided to or subject to review by Company or its Representative under Section 4.1 or Section 5.6 will be deemed to be Pfizer’s Confidential Information and subject to the provisions of Section 11. Company agrees it will not share any such reports or financial information with a Third Party without Pfizer’s prior written consent. Pfizer and its Affiliates and subcontractors will have no obligation to provide reports or financial information to Company or its Representatives except as required by this Agreement.
4.3.Regulatory Inspections. Pfizer will allow the U.S. Food and Drug Administration (“FDA) and any other applicable regulatory authority to conduct any Pre-Approval Inspection (PAI) or any other inspection relating to the Services of the Pfizer facility in which any Services are conducted, and Pfizer agrees to cooperate with the FDA and any other relevant regulatory authority in connection with such inspection. Pfizer will provide Company with notice of any PAI or other inspection to the extent relating to the Services immediately upon receipt of such notice from FDA or any other applicable regulatory authority. Pfizer shall promptly notify Company if the FDA or any other relevant regulatory agency requests to inspect any books, records, data or other information of Company relating to the Services, and, unless prohibited by Applicable Law, shall promptly share the results and all relevant documentation and findings of any such inspection with Company.
5.Payments.
5.1.Service Fees. Company will pay Pfizer for all Services performed under this Agreement and any Statement of Work in accordance with the budget and payment schedule for such Services set forth in each applicable Statement of Work, including any reasonable out-of-pocket expenses actually incurred by Pfizer as identified in a Statement of Work if applicable (“Service Fees”). All out-of-pocket expenses incurred by Pfizer must be accompanied by appropriate documentary evidence, such as receipts or other documentation as requested by Company. The Service Fees for Services performed a Statement of Work will be set forth in the applicable Statement of Work and may only be amended through a mutually agreed written amendment to the Statement of Work or a Change Order.
5.2.Invoices. Pfizer will invoice Company for Service Fees in accordance with the budget and payment schedule set forth in the applicable Statement of Work. Company will pay all undisputed invoice amounts to Pfizer within * days of receipt. In the event of a good faith dispute between the Parties as to the amount due, Company will pay the undisputed amount when due and the Parties will attempt to resolve the disputed payment within * days of the due date. If Company fails to pay any undisputed sum due under this Agreement in full by the due date for payment then, save where there is a good faith dispute over the amount owed, Pfizer may charge interest on any outstanding amount at a rate equivalent to the lower of (a) * per cent (*%) per annum and (b) the maximum rate allowed by Applicable Law. Such interest shall accrue on a daily basis from the date when payment was due until the date of actual payment of the overdue amount, whether before or after judgment.
5.3.Taxes.
(a)General. It is understood and agreed between the Parties that any payments made under this Agreement are exclusive of any value added or similar tax (“VAT”), which shall be added thereon as applicable. In the event any payments made by one Party to the other Party pursuant to this Agreement become subject to withholding taxes under the laws or regulation of any jurisdiction, the paying Party shall deduct and withhold the amount of such taxes for the account of the receiving Party to the extent required by Applicable Law and such amounts payable to the receiving Party shall be reduced by the amount of taxes deducted and withheld, which shall be treated as paid to the receiving Party in accordance with this Agreement. To the extent that the paying Party is required to deduct and withhold taxes on any payments under this Agreement, the
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paying Party shall pay the amounts of such taxes to the proper governmental authority in a timely manner and promptly transmit to the receiving Party an official tax certificate or other evidence of such withholding sufficient to enable the receiving Party to claim such payments of taxes. The receiving Party shall provide any tax forms to the paying Party that may be reasonably necessary in order for the paying Party not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted by Applicable Law, of withholding taxes, VAT, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax or VAT.
(b)Tax Actions. Notwithstanding anything in this Agreement to the contrary, if an action, including but not limited to any assignment or sublicense of its rights or obligations under this Agreement, or any failure to comply with Applicable Laws or filing or record retention requirements (a “Tax Action”) by a Party leads to the imposition of withholding tax liability or VAT on the other Party that would not have been imposed in the absence of a Tax Action or in an increase in such liability above the liability that would have been imposed in the absence of such Tax Action, then (i) the sum payable by the Party that caused the Tax Action (in respect of which such deduction or withholding is required to be made) shall be increased to the extent necessary to ensure that the other Party receives a sum equal to the sum which it would have received had no Tax Action occurred and (ii) the sum payable by the Party that caused a Tax Action (in respect of which such deduction or withholding is required to be made) shall be made to the other Party after deduction of the amount required to be so deducted or withheld, which deducted or withheld amount shall be remitted in accordance with Applicable Law. For the avoidance of doubt, a Party shall only be liable for increased payments pursuant to this Section to the extent such Party engaged in a Tax Action that created or increased a withholding tax or VAT on the other Party.
(c)Cooperation. The Parties agree to cooperate and produce on a timely basis any tax forms or reports, including an IRS Form W-8BEN, reasonably requested by the other Party in connection with any payment made by Company to Pfizer under this Agreement.
5.4.Currency; Blocked Payments. All consideration due to Pfizer will be payable and will be made in United States dollars by wire transfer to an account designated by Pfizer. Company is responsible for all bank or other transfer charges.
5.5.Final Reconciliation. Within * days after the conclusion of the Services for each Statement of Work, or termination of this Agreement or any applicable Statement of Work pursuant to Section 12.3(a), Pfizer will submit to Company a final invoice with a reconciliation of all amounts invoiced by Pfizer and all payments made by Company, with appropriate supporting documentation. Pfizer will refund any overpayment by Company within * days after receipt by Company of such reconciliation, and Company will pay Pfizer any underpayment by Company within * days after receipt by Company of such final invoice.
5.6.Financial Audits. No more than once during any *-month period during the Term, Pfizer will permit an independent certified public accounting firm of nationally recognized standing selected by Company and reasonably acceptable to Pfizer to audit Pfizer’s relevant books and records, at Company’s sole cost and expense (provided, that if the audit reveals an overcharge of more than the greater of *% of audited payments or $*, then the costs of the audit will be borne by Pfizer), solely as required to confirm Pfizer’s compliance with the terms of Article 5. Each such audit may only take place during regular business hours following at least * days’ prior written notice to Pfizer. Prior to conducting any such audit, the applicable auditor will be required to enter into a confidentiality agreement with Pfizer on terms at least as stringent as the confidentiality terms herein. Each such auditor is not permitted to share any portion of Pfizer’s books and records with Company or its Affiliates and may only report to Company whether Pfizer is in compliance with the terms of Article 5. Upon completion of the audit, the accounting firm will provide both Pfizer and Company a written report disclosing any discrepancies in the books and records submitted by Pfizer, and, in each case, the specific details concerning any discrepancies. No other information will be provided to Company.
6.Intellectual Property.
6.1.Ownership. As between the Parties, each Party will own all rights, title, and interests in and to its Background IP. As between the Parties, and in each case subject to the terms of each applicable Statement of Work: (a) Pfizer will own all rights, title, and interests in and to all Foreground Know-How that is an improvement or modification to any of Pfizer’s Background IP (“Pfizer Foreground Know-How”) and all
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Foreground Patent Rights that claim Pfizer Foreground Know-How (“Pfizer Foreground Patent Rights”) and (b) Company will own all rights, title and interests in and to all Foreground Know-How that is not Pfizer Foreground Know-How (“Company Foreground Know-How”), all Foreground Patent Rights that claim Company Foreground Know-How (“Company Foreground Patent Rights”), and all Deliverables. Each Party hereby assigns and agrees to assign, and will ensure that its employees, agents, representatives, Affiliates, and subcontractors assign, to the other Party all of its rights, title, and interests in and to all Foreground Know-How and Foreground Patent Rights that are owned by the other Party pursuant to this Section 6.1 or the relevant terms of the applicable Statement of Work. For clarity, Pfizer hereby assigns and agrees to assign, and will ensure that its employees, agents, representatives, Affiliates, and subcontractors assign, to Company all of its and their rights, title, and interests in and to all Company Foreground Know-How and Company Foreground Patent Rights; and Company hereby assigns and agrees to assign, and will ensure that its employees, agents, representatives, and Affiliates assign, to Pfizer all of its and their rights, title, and interests in and to all Pfizer Foreground Know-How and Pfizer Foreground Patent Rights. Notwithstanding the foregoing, for certain types of Services the ownership of Foreground Know-How and Foreground Patent Rights arising from the conduct of such Services may be subject to different terms, as set forth in the applicable Statement of Work, in which case such terms will control the ownership of such intellectual property rights.
Background IP” means, with respect to a Party, (a) all Know-How, other than Foreground Know-How and (b) all Patent Rights, other than Foreground Patent Rights, that, in each case ((a) and (b)), such Party or any of its Affiliates controls as of the Effective Date or that comes into the control of such Party or any of its Affiliates during the Term as a result of activities outside of a Statement of Work, and includes any Background IP identified in a Statement of Work.
Foreground Know-How” means all Know-How created by or on behalf of either Party or both Parties in the conduct of activities under this Agreement or any Statement of Work, and “Foreground Patent Rights” means any Patent Right that claims any Foreground Know-How.
Know-How” means any (a) proprietary scientific or business information or materials, including records, improvements, modifications, techniques, assays, designs, protocols, formulas, data (including physical data, chemical data, toxicology data, animal data, raw data, clinical data, and analytical and quality control data), dosage regimens, control assays, product specifications, marketing, pricing and distribution costs, inventions, algorithms, technology, forecasts, profiles, strategies, plans, results in any form whatsoever, know-how, and trade secrets (in each case, whether or not patentable, copyrightable, or otherwise protectable), and (b) any information embodied in chemical or biological materials or physical embodiments of any of the foregoing, in each case ((a) and (b)), other than any Patent Rights.
Patent Rights” means any and all (a) patents, (b) patent applications, including all provisional and non-provisional applications, patent cooperation treaty (PCT) applications, substitutions, continuations, continuations-in-part, divisions and renewals, and all patent rights granted thereon, (c) all patents-of-addition, reissues, re-examinations, and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates, patent term extensions, and equivalents thereof, (d) inventor’s certificates, letters patent, or (e) any other substantially equivalent form of government issued right substantially similar to any of the foregoing described in subsections (a) through (d) above, anywhere in the world.
6.2.Licenses. Company hereby grants to Pfizer and its Affiliates, during the Term, a non-exclusive, fully paid up, royalty-free, worldwide, non-transferable (except in connection with an assignment of this Agreement) license, with the right to grant sublicenses through multiple tiers, under Company’s Background IP, Company Foreground Know-How, and Company Foreground Patent Rights solely to conduct Pfizer’s obligations and perform the Services under this Agreement and any Statement of Work. In addition, each Statement of Work may provide for additional licenses from Company to Pfizer. In the event that Pfizer incorporates any Pfizer Foreground Know-How or Pfizer Foreground Patent Rights into any Deliverable provided to Company in accordance with the terms of a Statement of Work, Pfizer will and does hereby grant to Company, solely to the extent Pfizer has the right to grant such license, a non-exclusive, perpetual, fully paid up, royalty-free, worldwide license, with the right to grant sublicenses through multiple tiers, under such Pfizer Foreground Know-How or Pfizer Foreground Patent Rights solely to make, have made, use, have used, sell, have sold, offer for sale, import or otherwise exploit such Deliverable. Neither Company nor Pfizer has granted any right or license to any proprietary technology, Know-How, Patent Right, or other proprietary rights under this Agreement, either expressly or by implication, except those specifically set forth herein.
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6.3.Use of Software. To the extent Company uses, or has access to, any software provided by Pfizer or its Affiliates hereunder, Company will not, and will ensure that its employees, agents, representatives, Affiliates, (sub)licensees, and subcontractors do not, copy, recreate, disassemble, modify, translate, decompile or reverse engineer such software or attempt to do any of the foregoing. Pfizer agrees that it will not copy, share, allow access to or otherwise disseminate any clinical trial data or outputs from the clinical trials conducted pursuant to the Services under this Agreement or any Statement of Work to any person outside of those personnel performing activities under this Agreement on a need-to-know basis.
7.Representations and Warranties; Covenants.
7.1.Representations and Warranties. Each Party hereby represents and warrants to the other Party as of the Effective Date that it (a) has the full right and authority to enter into this Agreement, extend the rights and licenses granted to the other Party in this Agreement, and fully perform its obligations hereunder, and (b) has not made any commitments to others in material conflict with or in material derogation of such rights or this Agreement. Company further represents and warrants that, to the best of its knowledge, use of any Project Materials or other materials that Company instructs Pfizer to use in accordance with the terms of this Agreement (y) do not and will not infringe any issued patent of any Third Party and (z) will not infringe the claims of any published Third Party patent application when and if such claims issue. Neither Party makes any representation or warranty with respect to the development or approval of any Product by any regulatory authority. Except as expressly set forth in this Section 7.1, each Party expressly disclaims any and all warranties of any kind, express or implied, including the warranties of design, merchantability, fitness for a particular purpose, or non-infringement of the intellectual property rights of Third Parties. A Party will promptly notify the other, in writing, of any change to the truth of a representation or warranty herein.
7.2.Debarment. Each Party hereby represents and warrants to the other Party that none of such Party nor any of such Party’s personnel conducting activities under this Agreement and, with respect to Pfizer, none of Pfizer’s Affiliates or its subcontractors nor their personnel conducting activities under this Agreement (a) is under investigation by the FDA, or other equivalent agency for debarment action, or other Applicable Law of any countries under which such Party or its relevant Affiliates is registered and licensed, (b) has a disqualification hearing pending or has been disqualified by the FDA or other applicable agency, including by the FDA under Section 306(a) and (b) of the U.S. Federal Food, Drug and Cosmetic Act, or (c) has been convicted of a crime for which a person or entity can be debarred under Applicable Law. Each Party covenants that it will not knowingly employ any person or entity that has been so debarred to conduct any activities under this Agreement. If during the Term a Party becomes aware that a Party or any personnel retained by it to conduct activities under this Agreement (x) comes under investigation by the FDA, or other applicable agency for debarment or disqualification, (y) is debarred or disqualified, or (z) engages in any conduct or activity which could lead to any of the above mentioned disqualification or debarment actions, such Party will immediately notify the other Party, in writing, of the same.
7.3.Anti-Bribery and Anti-Corruption. Each Party hereby represents, warrants, and covenants that:
(a)It acknowledges that most countries have anti-bribery and anti-corruption laws, including, to the extent applicable, the U.S. Foreign Corrupt Practices Act of 1977 and the U.K. Bribery Act 2010, which forbid the making, offering or promising of any payment or anything of value to government officials, or other persons, when the payment is intended to influence any act or decision to award or retain business and it represents, and warrants it implements policies and procedures consistent with complying with such laws and that it will raise to the other Party any concerns related to a potential violation of anti-bribery and anti-corruption laws.
(b)It is and will remain licensed, registered, or qualified under local law, regulations, policies, and administrative requirements to do business and, to the extent required by Applicable Law, has obtained licenses or completed such registrations as may be necessary or required by law to provide the goods or services described herein, and providing such goods or services is not inconsistent with any other obligation.
(c)It has not and will not in the future directly, or indirectly, offer or pay, or authorize the offer or payment, of any money or anything of value in an effort to influence any government official or any other person in order for the other Party to improperly obtain or retain business or to gain an improper business advantage, and, has not accepted, and will not accept in the future, such a payment.
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7.4.Global Trade Controls Laws. Each Party hereby represents, warrants, and covenants that:
(a)It will comply with all Global Trade Control Laws. “Global Trade Control Laws” means the U.S. Export Administration Regulations; the U.S. International Traffic in Arms Regulations; the U.S. economic sanctions rules and regulations implemented under statutory authority or the President's Executive Orders and administered by the U.S. Department of the Treasury Office of Foreign Assets Control; European Union (E.U.) Council Regulations on export controls, including Nos.428/2009, 267/2012; other E.U. Council sanctions regulations, as implemented in E.U. Member States; United Nations sanctions policies; all relevant regulations and legislative instruments made under any of the above; other relevant economic sanctions, export and import control laws, and other laws, regulations, legislation, orders and requirements imposed by a relevant governmental entity.
(b)Activities under this Agreement will not take place in, involve companies, organizations, or governmental entities from, nor involve individuals ordinarily resident in, a Restricted Market. “Restricted Market” means the Crimean Peninsula, Cuba, the Donbass Region, Iran, North Korea, Russia, Belarus, the “Luhansk People’s Republic,” the “Donetsk People’s Republic,” and Syria, or any other country or region sanctioned by the United States, the United Kingdom or European Union.
(c)It is not, and will not be, (i) a Restricted Party or (ii) owned or controlled by a Restricted Party. “Restricted Party” means an individual or entity on the list of sanctioned entities maintained by the United Nations; the Specially Designated Nationals List and the Sectoral Sanctions Identifications List of the U.S. Treasury Department’s Office of Foreign Assets Control; the U.S. Denied Persons List, the U.S. Entity List, and the U.S. Unverified List of the U.S. Department of Commerce; entities subject to restrictive measures and the Consolidated List of Persons, Groups and Entities Subject to E.U. Financial Sanctions, as implemented by the E.U. Common Foreign and Security Policy; the List of Excluded Individuals / Entities published by the U.S. Health and Human Services Office of Inspector General; any lists of prohibited or debarred parties established under the U.S. Federal Food Drug and Cosmetic Act; the list of parties suspended or debarred from contracting with the U.S. government; and similar lists of restricted parties maintained by the governmental entities of the countries that have jurisdiction over the activities conducted under this Agreement.
(d)It will not knowingly transfer any goods, software, technology, or services to the other party that are (i) controlled under the U.S. International Traffic in Arms Regulations or at a level other than EAR99 under the U.S. Export Administration Regulations; or (ii) specifically identified as an E.U. Dual Use Item or on an applicable export control list of another country.
(e)It will not engage or delegate any activities under this Agreement to a Restricted Party.
8.Limitation of Liability.
8.1.NOTWITHSTANDING ANY PROVISION TO THE CONTRARY IN THIS AGREEMENT, OTHER THAN WITH RESPECT TO (I) THE APPLICABLE PARTY’S BREACH OF SECTION 11, (II) THE APPLICABLE PARTY’S INDEMNIFICATION OBLIGATIONS UNDER THIS AGREEMENT, (III) PFIZER’S BREACH OF EXHIBIT C, OR (IV) A SECURITY INCIDENT INVOLVING COMPANY’S DATA, NEITHER PARTY WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE, OR MULTIPLE DAMAGES ARISING IN CONNECTION WITH THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS OR OBLIGATIONS HEREUNDER OR FOR LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY THEREOF, AND REGARDLESS OF THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT, OR OTHERWISE).
8.2.NOTWITHSTANDING ANY PROVISION TO THE CONTRARY IN THIS AGREEMENT, OTHER THAN WITH RESPECT TO (i) PFIZER’S INDEMNIFICATION OBLIGATIONS UNDER THIS AGREEMENT, (ii) PFIZER’S BREACH OF SECTION 11, (iii) PFIZER’S BREACH OF EXHIBIT C, OR (iv) A SECURITY INCIDENT INVOLVING COMPANY’S DATA, IN NO EVENT WILL (I) PFIZER’S LIABILITY FOR DAMAGES FOR ANY CLAIM UNDER THIS AGREEMENT EXCEED AN AMOUNT EQUAL TO THE TOTAL VALUE OF CONSIDERATION PAID TO PFIZER UNDER THE STATEMENT OF WORK APPLICABLE TO SUCH CLAIM PRIOR TO THE DATE ON WHICH
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THE APPLICABLE CLAIM AROSE, (II) PFIZER’S TOTAL AGGREGATE LIABILITY FOR ALL CLAIMS IN CONNECTION WITH A STATEMENT OF WORK EXCEED AN AMOUNT EQUAL TO THE TOTAL VALUE OF ALL CONSIDERATION PAID TO PFIZER UNDER SUCH STATEMENT OF WORK, AND (III) PFIZER’S TOTAL AGGREGATE LIABILITY FOR ALL CLAIMS UNDER THIS AGREEMENT EXCEED AN AMOUNT EQUAL TO THE TOTAL VALUE OF ALL CONSIDERATION PAID TO PFIZER UNDER THIS AGREEMENT.
8.3.NOTWITHSTANDING ANY PROVISION TO THE CONTRARY IN THIS AGREEMENT, OTHER THAN WITH RESPECT TO (i) COMPANY’S INDEMNIFICATION OBLIGATIONS UNDER THIS AGREEMENT, (ii) COMPANY’S BREACH OF SECTION 11 AND (iii) COMPANY’S BREACH OF ITS PAYMENT OBLIGATIONS UNDER THIS AGREEMENT OR ANY STATEMENT OF WORK, IN NO EVENT WILL (I) COMPANY’S LIABILITY FOR DAMAGES FOR ANY CLAIM UNDER THIS AGREEMENT EXCEED AN AMOUNT EQUAL TO * TIMES THE TOTAL VALUE OF CONSIDERATION PAID OR PAYABLE TO PFIZER UNDER THE STATEMENT OF WORK APPLICABLE TO SUCH CLAIM PRIOR TO THE DATE ON WHICH THE APPLICABLE CLAIM AROSE, (II) COMPANY’S TOTAL AGGREGATE LIABILITY FOR ALL CLAIMS IN CONNECTION WITH A STATEMENT OF WORK EXCEED AN AMOUNT EQUAL TO * TIMES THE TOTAL VALUE OF ALL CONSIDERATION PAID OR PAYABLE TO PFIZER UNDER SUCH STATEMENT OF WORK, AND (III) COMPANY’S TOTAL AGGREGATE LIABILITY FOR ALL CLAIMS UNDER THIS AGREEMENT EXCEED AN AMOUNT EQUAL TO * TIMES THE TOTAL VALUE OF ALL CONSIDERATION PAID OR PAYABLE TO PFIZER UNDER THIS AGREEMENT.
8.4.NOTWITHSTANDING ANY PROVISION TO THE CONTRARY IN THIS AGREEMENT, WITH RESPECT TO (i) PFIZER’S INDEMNIFICATION OBLIGATIONS UNDER THIS AGREEMENT, (ii) PFIZER’S BREACH OF SECTION 11, (iii) PFIZER’S BREACH OF EXHIBIT C, AND (iv) A SECURITY INCIDENT INVOLVING COMPANY’S DATA, IN NO EVENT WILL PFIZER’S TOTAL AGGREGATE LIABILITY FOR ALL CLAIMS RELATING TO THE FOREGOING (i)-(iv) EXCEED *. FOR CLARITY, THE FOREGOING * AGGREGATE LIABILITY CAP IS NOT INTENDED TO BE A SEPARATE CAP FOR EACH CATEGORY OF LIABILITY IN THE FOREGOING (i)-(iv), BUT AN AGGREGATE CAP FOR LIABILITY RELATING TO ANY OF THE FOREGOING (i)-(iv).
8.5.THE PARTIES ACKNOWLEDGE AND AGREE THAT THE LIMITATIONS OF LIABILITY SET FORTH IN SECTION 8.1, SECTION 8.2, SECTION 8.3 AND SECTION 8.4 ABOVE ARE A CRITICAL COMPONENT OF THE CONSIDERATION UPON WHICH EACH PARTY RELIED IN ENTERING INTO THIS AGREEMENT AND, BUT FOR AN EXPECTATION AND UNDERSTANDING THAT THESE LIMITATIONS OF LIABILITIES WOULD BE STRICTLY INTERPRETED AND APPLIED IN ALL INSTANCES UNDER THIS AGREEMENT, NEITHER PARTY WOULD HAVE ENTERED INTO THIS AGREEMENT. FOR THE AVOIDANCE OF DOUBT AND NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, SECURITY INCIDENT RELATED DAMAGES ARE CONSIDERED DIRECT DAMAGES AND NOT EXCLUDED UNDER SECTION 8.1. “SECURITY BREACH DAMAGES” INCLUDE (A) THE COST OF PREPARING AND DELIVERING NOTICES TO AFFECTED DATA SUBJECTS AND/OR SUPERVISORY, REGULATORY OR OTHER GOVERNMENTAL AUTHORITIES, (B) THE COST OF PROVIDING TOLL-FREE INFORMATION SERVICES AND CREDIT MONITORING FOR UP TO 12 MONTHS (OR LONGER IF REQUIRED BY APPLICABLE LAW) TO AFFECTED DATA SUBJECTS, (C) AMOUNTS PAYABLE TO THIRD PARTIES, INCLUDING SUPERVISORY, REGULATORY OR OTHER GOVERNMENTAL AUTHORITIES, AS DAMAGES, FINES, AND/OR PENALTIES, AND (D) EXPENSES INCURRED BY COMPANY IN INVESTIGATING AND RESPONDING, INCLUDING EXPENSES FOR FORENSIC, INCIDENT RESPONSE, AND LEGAL EXPERTS AND CONSULTANTS.
9.Indemnification.
9.1.Company Indemnification. Company will indemnify, defend, and hold harmless Pfizer and its Affiliates, and its and their directors, officers, employees, and agents (each, a “Pfizer Indemnified Party”), from and against any and all losses, damages, liabilities, fines, reasonable attorney fees, court costs, and expenses, resulting or arising from any Third Party claims, actions, proceedings, investigations, or litigation relating to or arising from or in connection with this Agreement, any Statement of Work, or the Services contemplated herein (collectively “Losses”) to the extent such Losses arise out of (a) Company’s breach of this Agreement (including its representations and warranties hereunder) or any Statement of Work, (b) the use by Company, its Affiliates, or their respective (sub)licensees or subcontractors of any products, materials, information, or Deliverables provided by or on behalf of Pfizer under this Agreement (including to the extent any of such are contained in other products or processes), including any product liability
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claims arising from such use, (c) any Third Party claim alleging that the use of Company’s Background IP or Project Materials in accordance with the terms of this Agreement infringe or misappropriate any Third Party intellectual property rights, (d) injury to or death of any person or damage to any property caused by or resulting from the use of any of Company’s Background IP, Products or Project Materials in accordance with the terms of this Agreement, (e) any Services conducted by or on behalf of Pfizer in accordance with the terms of this Agreement, the applicable Statement of Work and any applicable clinical study agreement and protocols, and otherwise in accordance with Company’s written instructions to Pfizer; or (f) gross negligence, willful misconduct, or violation of Applicable Law by any Company Indemnified Party (as defined in Section 9.2) in connection with this Agreement or any Statement of Work, except, in each case ((a)-(f)) to the extent such Losses are subject to Pfizer’s indemnification obligations under Section 9.2.
9.2.Pfizer Indemnification. Pfizer will indemnify, defend, and hold harmless Company and its Affiliates, and its and their directors, officers, employees and agents (each, a “Company Indemnified Party”), from and against any and all Losses to the extent such Losses arise out of (a) Pfizer’s breach of this Agreement (including its representations and warranties hereunder) or any Statement of Work, (b) injury to or death of any person or damage to any property caused by or resulting from Pfizer’s performance of Services contrary to the terms of this Agreement, the applicable Statement of Work and any applicable clinical study agreement and protocols, or otherwise contrary to Company’s written instructions to Pfizer, (c) gross negligence, willful misconduct, or violation of Applicable Law by any Pfizer Indemnified Party in connection with this Agreement or any Statement of Work, or (d) a Security Incident (as defined in Exhibit C), except, in each case ((a)-(c)) to the extent such Losses are subject to Company’s indemnification obligations under Section 9.1.
9.3.Indemnification Procedure. A Party seeking indemnification hereunder (the “Indemnified Party”) will give the other Party (the “Indemnifying Party”) prompt notice of any such Third Party claim, action, or lawsuit covered by Section 9.1 or Section 9.2 (“Claim”) served upon the Indemnified Party and will fully cooperate with the Indemnifying Party and its legal representatives in the investigation of any such Claim at the Indemnifying Party’s cost and expense. The Indemnified Party’s failure to provide such prompt notice and cooperation will limit the Indemnified Party’s right to indemnification solely to the extent that such failure prejudices the Indemnifying Party’s ability to defend against such Claim. The Indemnified Party will not unreasonably withhold its approval of the settlement of Claim, will cooperate with counsel of the Indemnifying Party in the defense of the Claim, and reserves the right to engage its own counsel to assist in the defense at its own cost and expense. The Indemnified Party will give the Indemnifying Party sole control over the defense of each Claim, except that the Indemnifying Party will not agree to any settlement of any Claim under terms that would require the Indemnified Party to pay any money, admit any wrongdoing, or otherwise be prejudiced, in each case without the Indemnified Party giving its prior written consent to such settlement.
10.Insurance. Each Party agrees to obtain and maintain, during the Term, commercial general liability insurance, including products liability insurance (or clinical trials insurance, if applicable) with minimum “A-” A.M. Best rated carriers satisfactory in kind and with liability limits appropriate to the circumstances to protect the Parties hereunder against any claims or liabilities that may arise from the performance of Services hereunder. Notwithstanding the foregoing, Pfizer may fulfill its insurance obligations under this Agreement by self-insuring.
11.Confidentiality.
11.1.Confidential Information. “Confidential Information” means all non-public information disclosed by or on behalf of one Party (the “Disclosing Party”) to the other Party (the “Receiving Party”) or otherwise accessed by the Receiving Party, in whatever form (including tangible, intangible, visual, and oral), before, on, or after the Effective Date, including: (a) draft and filed content within patent applications, office action responses, and other communications with patent authorities; (b) manufacturing information, including processes, protocols, and know-how; (c) vendor information and lists; and (d)  other proprietary information, ideas, gene sequences, product applications, formulations, chemical formulas, assays, techniques, drawings, works of authorship, models, inventions, know-how, processes, apparatuses, equipment configurations, and formulae related to the current, future, and proposed products and services of the Disclosing Party, and including such Party’s information concerning research, experimental work, development, design details and specifications, engineering, financial information, procurement requirements, purchasing, manufacturing, customer lists, investors, employees, business and contractual relationships, business forecasts, analyst reports, sales and merchandising reports, and marketing plans. Without limiting the foregoing, (i) Pfizer’s Background IP, Pfizer Foreground Know-How, and Pfizer Foreground Patent Rights will be considered Pfizer’s Confidential Information and (ii) Company’s
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Background IP, Company Foreground Know-How, and Company Foreground Patent Rights, Project Materials and the Deliverables will be considered Company’s Confidential Information. In addition all confidential information of a Party under the *, by and between the Parties (the “Prior CDA”) will be deemed to be such Party’s Confidential Information under this Agreement. The existence and terms of this Agreement will be deemed to be the Confidential Information of both Parties with each Party being deemed a Receiving Party with respect thereto.
11.2.Non-Disclosure. A Receiving Party will not, at any time, directly or indirectly, use for any reason other than activities contemplated under this Agreement or disclose to any Third Party any Confidential Information of the Disclosing Party. Each Receiving Party in possession of Confidential Information of the Disclosing Party will take all appropriate steps to safeguard such information with the same degree of care with which it maintains the confidentiality of its own confidential information, which in no event shall be less than a reasonable standard of care. The Parties further acknowledge that Confidential Information may have been provided by the Parties to each other prior to the Effective Date, including under the Prior CDA. The Parties agree that as of the Effective Date, all such Confidential Information will be protected by the terms and conditions of this Agreement. Confidential Information will not include information that the Receiving Party can show by competent proof: (a) was known to the