The following discussion of our financial condition and results of operations should be read in conjunction with the Condensed Consolidated Financial Statements and the related notes appearing elsewhere in this report. Some of the information contained in this discussion and analysis and set forth elsewhere in this report, including information with respect to our plans and strategy for our business, includes forward-looking statements, based on current expectations and related to future events and our future financial and operational performance, that involve risks and uncertainties. You should review the section titled "Risk Factors" in Part II, Item 1A of this Quarterly Report on Form 10-Q, or Form 10-Q, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. As used throughout this report, the terms "the Company," "we," "us," and "our" refer to the business ofCuris, Inc. and its wholly owned subsidiaries, except where the context otherwise requires, and the term "Curis" refers toCuris, Inc. Overview We are a biotechnology company focused on the development of first-in-class and innovative therapeutics for the treatment of cancer. Our clinical stage drug candidates are: •CA-4948, which is being tested in a Phase 1 dose escalating clinical trial in patients with non-Hodgkin lymphomas, including those with Myeloid Differentiation Primary Response 88, or MYD88 alterations. We reported preliminary clinical data from the study inDecember 2019 . We are also conducting a separate Phase 1 trial for acute myeloid leukemia and myelodysplastic syndromes and announced inJuly 2020 that the first patient had been dosed. We are planning a combination study of CA-4948 and ibrutinib, a BTK inhibitor, in non-Hodgkin lymphomas with planned enrollment commencing in the second half of 2020. •CI-8993, a monoclonal antibody designed to antagonize the V-domain Ig suppressor of T cell activation, or VISTA signaling pathway. InJune 2020 , we announced theU.S. Food and Drug Administration , or FDA, had cleared our Investigational New Drug, or IND, application for CI-8993. We plan to begin clinical testing in a Phase 1a/1b trial in patients with solid tumors in the second half of 2020. 24 -------------------------------------------------------------------------------- Table of Contents •Fimepinostat, which has been granted Orphan Drug Designation and Fast Track Designation for the treatment of DLBCL by the FDA inApril 2015 andMay 2018 , respectively. We began enrollment in a Phase 1 combination study with venetoclax in DLBCL patients, including patients with translocations in both MYC and the BCL2 gene, also referred to as double-hit lymphoma, or high-grade B-cell lymphoma, or HGBL. InMarch 2020 , we announced that although we observed no significant drug-drug interaction in our Phase 1 study of fimepinostat in combination with venetoclax, we did not see an efficacy signal that would warrant continuation of the study. Accordingly, no further patients will be enrolled in this study. We are currently evaluating future studies for fimepinostat. Our pipeline includes CA-170 for which we announced initial data from a clinical study in patients with mesothelioma in conjunction with the Society of lmmunotherapy of Cancer conference inNovember 2019 . Based on this data, no further patients will be enrolled in the study. We are currently evaluating future studies for CA-170. Our pipeline also includes CA-327, which is a pre-IND, stage oncology drug candidate. We are party to a collaboration withGenentech Inc. , orGenentech , a member of the Roche Group, under whichF. Hoffmann-La Roche Ltd , or Roche andGenentech are commercializing Erivedge® (vismodegib), a first-in-class orally administered small molecule Hedgehog signaling pathway inhibitor. Erivedge is approved for the treatment of advanced basal cell carcinoma, or BCC. InJanuary 2015 , we entered into a collaboration agreement focused on immuno-oncology and selected precision oncology targets withAurigene Discovery Technologies Limited , orAurigene , which was amended inSeptember 2016 andFebruary 2020 . As ofJune 30, 2020 , we have licensed four programs under theAurigene collaboration. 1.IRAK4 Program - a precision oncology program of small molecule inhibitors of IRAK4. The development candidate is CA-4948, an orally available small molecule inhibitor of IRAK4. 2.PD1/VISTA Program - an immuno-oncology program of small molecule antagonists of PD1 and VISTA immune checkpoint pathways. The development candidate is CA-170, an orally available small molecule antagonist of VISTA and PDL1. 3.PD1/TIM3 Program - an immuno-oncology program of small molecule antagonists of PD1 and TIM3 immune checkpoint pathways. The development candidate is CA-327, an orally available small molecule antagonist of PDL1 and TIM3. 4.InMarch 2018 , we exercised our option to license a fourth program, which is an immuno-oncology program. In addition, we are party to an option and license agreement withImmuNext, Inc. , or ImmuNext. Pursuant to the terms of the option and license agreement, we have an option, exercisable for a specified period as set forth in the option and license agreement to obtain an exclusive license to develop and commercialize certain VISTA antagonizing compounds, including ImmuNext's lead compound, CI-8993, and products containing these compounds in the field of oncology. Based on our clinical development plans for our pipeline, we intend to predominantly focus our available resources on the continued development of CA-4948, in collaboration withAurigene , and CI-8993, in collaboration with ImmuNext, in the near term. As ofJune 30, 2020 , we believe our$23.6 million of existing cash, cash equivalents and investments should enable us to maintain our planned operations into the first half of 2021. We have based this assessment on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Based on our available cash resources, recurring losses and cash outflows from operations since inception, an expectation of continuing operating losses and cash outflows from operations for the foreseeable future and the need to raise additional capital to finance our future operations, we concluded we do not have sufficient cash on hand to support current operations within the next 12 months from the date of filing this Quarterly Report on Form 10-Q. These factors raise substantial doubt regarding our ability to continue as a going concern. We expect to finance our operations through our common stock purchase agreement withAspire Capital Fund LLC , orAspire Capital , and potential future sales of common stock through our at-the-market sales agreement withJonesTrading Institutional Services LLC , or JonesTrading, or other potential equity financings, debt financings or other capital sources. However, we may not be successful in securing additional financing on acceptable terms, or at all. Furthermore, high volatility in the capital markets resulting from the COVID-19 pandemic has had, and could continue to have, a negative impact on the price of our common stock, and could adversely impact our ability to raise additional funds. If sufficient funds are not available, we will have to delay, reduce the scope of, or eliminate some of our research and development programs, including related clinical trials and operating expenses, potentially delaying the time to market for or preventing the marketing of any of our product candidates, which could adversely affect our business prospects and our ability to continue our operations, and would have a negative impact on our financial condition and ability to pursue our business strategies. In addition, in light of our limited cash resources, we may seek to engage in one or more strategic alternatives, such as a strategic partnership with one or more parties, the licensing, sale or divestiture of some of our assets or proprietary technologies or the sale of our company, but 25 -------------------------------------------------------------------------------- Table of Contents there can be no assurance that we would be able to enter into such a transaction or transactions on a timely basis or on terms favorable to us, or at all. COVID-19 Pandemic InDecember 2019 , an outbreak of respiratory illness caused by a strain of novel coronavirus, COVID-19, began inChina . That outbreak has led to millions of confirmed cases worldwide, including in the Unites States and other countries where we are conducting clinical trials or activities in support thereof. TheWorld Health Organization declared the outbreak a global public health emergency onJanuary 30, 2020 and declared it a pandemic onMarch 11, 2020 . In addition to thosewho have been directly affected, billions more have been affected by governmental efforts around the world to slow the spread of the outbreak. The outbreak and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce. We have enrolled, and will seek to enroll, cancer patients in our clinical trials at sites located both inthe United States and internationally, including inGermany . Many of our clinical trial sites have imposed restrictions on entry as a result of the COVID-19 pandemic, which have had and may continue to have a negative impact on our ability to conduct our clinical trials. We have had and may continue to face difficulties recruiting and retaining patients in our ongoing and planned clinical trials to the extent patients are affected by the virus or are fearful of visiting or traveling to our clinical trial sites because of the outbreak. For example, all of our clinical trial sites for our ongoing Phase 1 clinical trial for CA-4948 in patients with non-Hodgkin lymphomas, including those with MYD88 alterations, are at large academic research hospitals that have imposed restrictions on entry which, have in some instances prohibited and could potentially prohibit in the future, clinical trial monitors and patients from entering the trial sites. We are actively working with our clinical trial sites, to follow FDA guidelines for conducting clinical trials during the COVID-19 pandemic, including performing remote monitoring to the extent possible and to arrange for the shipment of medicine directly from the clinical trial site to patientswho are enrolled in our trials, if required, however, there is no assurance such arrangements will be successful. As a result, further enrollment in our ongoing clinical trial for CA-4948 in patients with non-Hodgkin lymphomas, including those with MYD88 alterations, may be delayed and patients currently enrolled in the trial may cease treatment due to the restrictions described above or fear of visiting or inability to visit our trial sites or other necessary medical facilities. In addition, we do not currently know the duration or to what degree medical facilities, including our clinical trial sites, will continue to be impacted by the pandemic. As a result, enrollment in this trial has been slower than expected and the timeline of this clinical trial may be delayed. In addition, inJuly 2020 we commenced enrollment for our planned Phase 1 clinical trial in CA-4948 in patients with acute myeloid leukemia and myelodysplastic syndromes. Clinical trial sites for this study have also imposed and may continue to impose restrictions similar to those described above. As a result, enrollment in this trial has been slower than expected and we may not be able to enroll this trial on its planned timeline, which would cause a delay in the overall timeline for this trial. Similarly, we have not initiated our planned Phase 1 clinical trial for CI-8993, and initiation and enrollment of this study may be delayed due to the factors discussed above. We and our collaborators, third-party contract manufacturers, contract research organizations and clinical sites may experience delays or disruptions in supply and release of product candidates and/or procuring items that are essential for our research and development activities, including, for example, raw materials used in the manufacturing of our product candidates, basic medical and laboratory supplies used in our clinical trials or preclinical studies, or animals that are used for preclinical testing, in each case, for which there may be shortages because of ongoing efforts to address the outbreak. While we believe that we currently have sufficient supply of our product candidates to continue our ongoing clinical trials, some of our product candidates, or materials contained therein, come from facilities located in areas impacted by COVID-19, includingIndia ,China , andEurope . In addition, any disruptions could impact the supply, manufacturing or distribution of Erivedge, and sales of Erivedge may be negatively impacted by a decrease in new prescriptions as a result of a decline in patient medical visits due to the COVID-19 pandemic, which could negatively impact the amount and timing of any royalty revenue we may receive fromGenentech related to Erivedge. We are also experiencing delays in closing down our clinical trial sites related to our fimepinostat and CA-170 trials due to restrictions on non-essential workers imposed at those sites in response to COVID-19, which has delayed the winding down of these trials and may result in additional costs and expenses. Additionally, the pandemic has already caused significant disruptions in the financial markets, and may continue to cause such disruptions, which could impact our ability to raise additional funds. We cannot be certain what the overall impact of the COVID-19 pandemic will be on our business and it has had and may continue to have an adverse effect on our business, financial condition, results of operations, and prospects. 26 -------------------------------------------------------------------------------- Table of Contents Our Collaborations and License Agreements For information regarding our collaboration and license agreements, refer to Note 9, Research and Development Collaborations, in the accompanying Notes to the Condensed Consolidated Financial Statements included in Item 1 of Part I of this Quarterly Report on Form 10-Q and Note 10, Research and Development Collaborations, in Item 8 of our Annual Report on Form 10-K for the year endedDecember 31, 2019 as filed with theSecurities and Exchange Commission , orSEC onMarch 19, 2020 . Liquidity Since our inception, we have funded our operations primarily through private and public placements of our equity securities, license fees, contingent cash payments, research and development funding from our corporate collaborators, debt financings and the monetization of certain royalty rights. We have never been profitable on an annual basis and have an accumulated deficit of$1.0 billion as ofJune 30, 2020 . For the six months endedJune 30, 2020 we incurred a loss of$16.4 million and used$14.1 million of cash in operations. We expect that our cash, cash equivalents and short term investments as ofJune 30, 2020 should enable us to maintain our planned operations into the first half of 2021. We have based this assessment on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Based on our available cash resources, we do not have sufficient cash on hand to support current operations within the next 12 months from the date of filing this Quarterly Report on Form 10-Q. See "Funding Requirements" and Note 1 to the Condensed Consolidated Financial Statements appearing in this Quarterly Report on Form 10-Q for a further discussion of our liquidity and the conditions and events that raise substantial doubt regarding our ability to continue as a going concern. We will need to generate significant revenues to achieve profitability, and do not expect to achieve profitability in the foreseeable future, if at all. See "--Liquidity and Capital Resources--Funding Requirements" and Note 1 to the Condensed Consolidated Financial Statements appearing in this Quarterly Report on Form 10-Q for a further discussion of our liquidity and the conditions and events that raise substantial doubt regarding our ability to continue as a going concern.Key Drivers We believe that near term key drivers to our success will include: •our ability to successfully plan, finance and complete current and planned clinical trials for CA-4948 and CI-8993 as well as for such clinical trials to generate favorable data; •our ability to raise the substantial additional financing required to fund our operations through our common stock purchase agreement withAspire Capital and potential future sales of common stock through our at-the-market sales agreement with JonesTrading or other potential financing. In the longer term, a key driver to our success will be our ability, and the ability of any current or future collaborator or licensee, to successfully develop and commercialize drug candidates. Financial Operations Overview General. Our future operating results will largely depend on the progress of drug candidates currently in our research and development pipeline. The results of our operations will vary significantly from year to year and quarter to quarter and depend on, among other factors, the cost and outcome of any preclinical development or clinical trials then being conducted. For a discussion of our liquidity and funding requirements, see "- Liquidity" and "- Liquidity and Capital Resources - Funding Requirements". Liability Related to the Sale of Future Royalties. In connection with the termination and repayment in full of our prior loan withHealthCare Royalty Partners ,III, L.P. , or HealthCare Royalty, we and Curis Royalty entered into the royalty interest purchase agreement, or Oberland Purchase Agreement, with entities managed byOberland Capital Management, LLC , or the Purchasers. Upon closing of the Oberland Purchase Agreement, Curis Royalty received an upfront purchase price of$65.0 million from the Purchasers, approximately$33.8 million of which was used to pay off the remaining loan principal to HealthCare Royalty, and$3.7 million of which was used to pay transaction costs, including$3.4 million to HealthCare Royalty in accrued and unpaid interest and prepayment fees under the loan, resulting in net proceeds of$27.5 million . Curis Royalty will also be entitled to receive milestone payments of (i)$17.2 million if the Purchasers and Curis Royalty receive aggregate royalty payments pursuant to the Oberland Purchase Agreement in excess of$18.0 million during the calendar year 2021, subject to certain exceptions, and (ii)$53.5 million if the Purchasers receive payments pursuant to the Oberland Purchase Agreement in excess of$117.0 million on or prior toDecember 31, 2026 , which milestone payments may each be paid, at the option of the Purchasers, in a lump sum in cash or out of the Purchaser's portion of future payments under the Oberland 27 -------------------------------------------------------------------------------- Table of Contents Purchase Agreement. For a discussion of the Oberland Purchase Agreement, see "Liquidity and Capital Resources - Royalty Interest Purchase Agreement". Revenue. We do not expect to generate any revenues from our direct sale of products for several years, if ever. Substantially all of our revenues to date have been derived from license fees, research and development payments, and other amounts that we have received from our strategic collaborators and licensees, including royalty payments. Since the first quarter of 2012, we have recognized royalty revenues related toGenentech's sales of Erivedge and we expect to continue to recognize royalty revenue in future quarters fromGenentech's sales of Erivedge in theU.S. and Roche's sales of Erivedge outside of theU.S. However, a portion of our royalty and royalty related revenues under our collaboration withGenentech will be paid to the Purchasers, pursuant to the Oberland Purchase Agreement. The Oberland Purchase Agreement will terminate upon the earlier to occur of (i) the date on which Curis Royalty's rights to receive a portion of certain royalty and royalty related payments, excluding a portion of nonU.S. royalties retained by Curis Royalty, referred to as the Purchased Receivables, owed byGenentech under theGenentech collaboration agreement have terminated in their entirety and (ii) the date on which payment in full of the price, referred to as the Put/Call Price, equal to a percentage, beginning at a low triple digit percentage and increasing over time up to a low mid triple digit percentage of the sum of the upfront purchase price and any portion of the milestone payments paid in a lump sum by the Purchasers, if any, minus certain payments previously received by the Purchasers with respect to the Purchased Receivables, is received by the Purchasers pursuant to the Purchasers' exercise of their put option or Curis Royalty's exercise of its call right as described in Note 8, Liability Related to the Sale of Future Royalties, in the accompanying Notes to the Condensed Consolidated Financial Statements included in Item 1 of Part I of this Quarterly Report on Form 10-Q. We could receive additional milestone payments fromGenentech , provided that contractually specified development and regulatory objectives are met. Also, we could receive milestone payments from the Purchasers, provided that contractually specified royalty payment amounts are met within applicable time periods. Our only source of revenues and/or cash flows from operations for the foreseeable future will be royalty payments that are contingent upon the continued commercialization of Erivedge under our existing collaboration withGenentech , and contingent cash payments for the achievement of clinical, development and regulatory objectives, if any, that are met under such collaboration. Our receipt of additional payments under our existing collaboration withGenentech cannot be assured, nor can we predict the timing of any such payments, as the case may be. Cost of Royalty Revenues. Cost of royalty revenues consists of all expenses incurred that are associated with royalty revenues that we record as revenues in our Condensed Consolidated Statements of Operations and Comprehensive Loss. These costs currently consist of payments we are obligated to make to university licensors on royalties that Curis Royalty receives fromGenentech on net sales of Erivedge. In all territories other thanAustralia , our obligation is equal to 5% of the royalty payments that we receive fromGenentech for a period of 10 years from the first commercial sale of Erivedge, which occurred inFebruary 2012 in theU.S. In addition, for royalties that Curis Royalty receives from Roche's sales of Erivedge inAustralia , we were obligated to make payments to university licensors of 2% of Roche's direct net sales inAustralia until expiration of the patent inApril 2019 . FollowingApril 2019 , the amount we are obligated to pay has decreased to 5% of the royalty payments that Curis Royalty receives fromGenentech . Research and Development. Research and development expense consists of costs incurred to develop our drug candidates. These expenses consist primarily of: •salaries and related expenses for personnel, including stock based compensation expense; •costs of conducting clinical trials, including amounts paid to clinical centers, clinical research organizations and consultants, among others; •other outside service costs, including costs of contract manufacturing; •sublicense payments; •the costs of supplies and reagents; •occupancy and depreciation charges; •certain payments that we make toAurigene under our collaboration agreement, including, for example, option exercise fees and milestone payments; and •payments that we are obligated to make to certain third party university licensors upon our receipt of payments fromGenentech related to the achievement of clinical development and regulatory objectives under our collaboration agreement. 28 -------------------------------------------------------------------------------- Table of Contents We expense research and development costs as incurred. We are currently incurring research and development costs under our Hedgehog signaling pathway inhibitor collaboration withGenentech related to the maintenance of third-party licenses to certain background technologies. Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later stage clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next several years as we conduct our clinical trials of CA-4948 and CI-8993; prepare regulatory filings for our product candidates; continue to develop additional product candidates; and potentially advance our product candidates into later stages of clinical development. The successful development and commercialization of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates. This uncertainty is due to the numerous risks and uncertainties associated with product development and commercialization, including the uncertainty of: •our ability to successfully enroll our current and future clinical trials and our ability to initiate future clinical trials, which has been and may continue to be negatively impacted by the COVID-19 pandemic and responsive measures relating thereto; •the scope, quality of data, rate of progress and cost of clinical trials and other research and development activities undertaken by us or our collaborators; •the results of future preclinical studies and clinical trials; •the cost and timing of regulatory approvals and maintaining compliance with regulatory requirements; •the cost and timing of establishing sales, marketing and distribution capabilities; •the cost of establishing clinical and commercial supplies of our drug candidates and any products that we may develop; •the effect of competing technological and market developments; and •the cost and effectiveness of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights. Any changes in the outcome of any of these variables with respect to the development of our product candidates could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the FDA or another regulatory authority were to delay our clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time to complete clinical development of that product candidate. We may never obtain regulatory approval for any of our product candidates. Drug commercialization will take several years and millions of dollars in development costs. A further discussion of some of the risks and uncertainties associated with completing our research and development programs on schedule, or at all, and some consequences of failing to do so, are set forth under "Part II, Item 1A. Risk Factors" of this Quarterly Report on Form 10-Q. General and Administrative. General and administrative expense consists primarily of salaries, stock based compensation expense and other related costs for personnel in executive, finance, accounting, business development, legal, information technology, corporate communications and human resource functions. Other costs include facility costs not otherwise included in research and development expense, insurance, and professional fees for legal, patent and accounting services. Patent costs include certain patents covered under collaborations, a portion of which is reimbursed by collaborators and a portion of which is borne by us. Critical Accounting Policies and Estimates The preparation of our Condensed Consolidated Financial Statements in conformity with accounting principles generally accepted in theU.S. requires that we make estimates and assumptions that affect the reported amounts and disclosure of certain assets and liabilities at our balance sheet date. Such estimates and judgments include the carrying value of property and equipment and intangible assets, revenue recognition, the value of certain liabilities, debt classification and stock-based compensation. We base our estimates on historical experience and on various other factors that we believe to be appropriate under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and 29 -------------------------------------------------------------------------------- Table of Contents liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. During the three months endedJune 30, 2020 , there were no material changes to our critical accounting policies and estimates as reported in our Annual Report on Form 10-K for the year endedDecember 31, 2019 , which was filed with theSEC onMarch 19, 2020 . Results of Operations Three and Six Months EndedJune 30, 2020 andJune 30, 2019
The following table summarizes our results of operations for the three and six
months ended
For the Three Months Ended Percentage For the Six Months Ended Percentage June 30, Increase June 30, Increase 2020 2019 (Decrease) 2020 2019 (Decrease) (in thousands) (in thousands) Revenues, net:$ 2,360 $ 2,094 13 %$ 5,068 $ 3,861 31 % Costs and expenses: Cost of royalty revenues 122 89 37 % 247 197 25 % Research and development 5,282 5,620 (6) % 12,754 9,694 32 % General and administrative 2,386 2,526 (6) % 5,980 5,669 5 % Other expense, net 1,278 1,072 19 % 2,504 5,398 (54) % Net loss$ (6,708) $ (7,213) (7) %$ (16,417) $ (17,097) (4) %
Revenues. Total revenues are summarized as follows:
For the Three Months Ended Percentage For the Six Months Ended Percentage June 30, Increase June 30, Increase 2020 2019 (Decrease) 2020 2019
(Decrease) (in thousands) (in thousands) Revenues, net: Royalties$ 2,446 $ 2,142 14 %$ 4,961 $ 4,279 16 % Other revenue - - N/A 211 - N/A Contra revenue, net (86) (48) 79 % (104) (418) 75 % Total revenues, net$ 2,360 $ 2,094 13 %$ 5,068 $ 3,861 31 % Total revenues increased to$2.4 million for the three months endedJune 30, 2020 as compared to$2.1 million for the same period in 2019, primarily related to an increase in royalty revenues arising fromGenentech and Roche's net sales of Erivedge during the three months endedJune 30, 2020 as compared to the prior year period. Total revenues increased to$5.1 million for the six months endedJune 30, 2020 as compared to$3.9 million for the same period in 2019, primarily related to an increase in royalty revenues arising fromGenentech and Roche's net sales of Erivedge during the six months endedJune 30, 2020 as compared to the prior year period. In addition to the revenues received fromGenentech , we received a milestone payment from a previously out-licensed technology in the first quarter of 2020. Cost of Royalty Revenues. Cost of royalty revenues increased by 37% for the three months endedJune 30, 2020 as compared to the same period in 2019. Cost of royalty revenues increased by 25% for the six months endedJune 30, 2020 as compared to the same period in 2019. We are obligated to make payments to two university licensors on royalties that Curis Royalty earns fromGenentech on net sales of Erivedge. 30 -------------------------------------------------------------------------------- Table of Contents Research and Development Expenses. The following table summarizes our research and development expenses incurred during the periods indicated: For the Three Months Ended Percentage For the Six Months Ended Percentage June 30, Increase June 30, Increase 2020 2019 (Decrease) 2020 2019 (Decrease) (in thousands) (in thousands) Direct research and development$ 3,336 $ 3,578 $ 8,619 $ 5,759 expenses (7) % 50 % Employee related expenses 1,434 1,465 (2) % 3,180 3,067 4 % Facilities, depreciation and other 512 577 955 868 expenses (11) % 10 % Total research and development expenses$ 5,282 $ 5,620 (6) %$ 12,754 $ 9,694 32 % Research and development expenses were$5.3 million for the three months endedJune 30, 2020 as compared to$5.6 million in the same period in 2019, a decrease of approximately$0.3 million , or 6%. Direct research and development expenses decreased by$0.2 million for the three months endedJune 30, 2020 as compared to the same period in 2019. The decrease in direct research and development expenses for the quarter is primarily attributable to reduced clinical trial costs related to CA-170 and fimepinostat. Research and development expenses were$12.8 million for the six months endedJune 30, 2020 as compared to$9.7 million in the same period in 2019, an increase of approximately$3.1 million , or 32%. Direct research and development expenses increased by$2.9 million , or 50%, for the six months endedJune 30, 2020 as compared to the same period in 2019, primarily due to$1.6 million related to our option and license agreement with ImmuNext and increased clinical and manufacturing costs for CA-4948 and CI-8993. We expect that a majority of our research and development expenses for the foreseeable future will be incurred in connection with our efforts to advance our programs, including clinical and preclinical development costs, manufacturing, option exercise fees, and potential milestone payments upon achievement of certain milestones. General and Administrative Expenses. General and administrative expenses are summarized as follows: For the Three Months Ended Percentage For the Six Months Ended Percentage June 30, Increase June 30, Increase 2020 2019 (Decrease) 2020 2019 (Decrease) (in thousands) (in thousands) Personnel$ 992 $ 988 - %$ 2,108 $ 2,023 4 % Legal services 233 389 (40) % 1,415 976 45 % Professional and consulting services 257 405 (37) % 645 858 (25) % Insurance costs 114 106 8 % 220 210 5 % Stock based compensation 400 508 (21) % 855 983 (13) % Other general and administrative expenses 390 130 >100 % 737 619 19 % Total general and administrative expenses$ 2,386 $ 2,526 (6) %$ 5,980 $ 5,669 5 % General and administrative expenses were$2.4 million for the three months endedJune 30, 2020 , as compared to$2.5 million in the same period in 2019, a decrease of$0.1 million , or 6%. The decrease in general administrative expense was driven primarily by lower stock-based compensation costs as well as lower legal and professional services fees, partially offset by higher occupancy costs during the three months endedJune 30, 2020 . General and administrative expenses were$6.0 million for the six months endedJune 30, 2020 , as compared to$5.7 million in the same period in 2019, an increase of$0.3 million , or 5%. The increase in general administrative expense was driven primarily by higher legal services during the period. Other Expense. Other expense increased by$0.2 million , or 19% for the three months endedJune 30, 2020 as compared to the same period in 2019. Net other expense for the second quarters of 2020 and 2019 primarily consisted of imputed interest expense related to future royalty payments. Other expense decreased by$2.9 million , or 54% for the six months endedJune 30, 2020 as compared to the same period in 2019. Net other expense for the second quarter of 2020 primarily consisted of$2.6 million of imputed interest expense 31 -------------------------------------------------------------------------------- Table of Contents related to future royalty payments, whereas in 2019 the expense related to loss on extinguishment of debt of$3.5 million and imputed interest expense of$1.4 million . Liquidity and Capital Resources We have financed our operations primarily through private and public placements of our equity securities, license fees, contingent cash payments and research and development funding from our corporate collaborators, debt financings, and the monetization of certain royalty rights. See "Funding Requirements" and Note 1 to the Condensed Consolidated Financial Statements appearing in this Quarterly Report on Form 10-Q for a further discussion of our liquidity and the conditions and events that raise substantial doubt regarding our ability to continue as a going concern. AtJune 30, 2020 , our principal sources of liquidity consisted of cash, cash equivalents, and investments of$23.6 million , excluding our restricted investments of$1.0 million . Our cash and cash equivalents are highly liquid investments with a maturity of three months or less at date of purchase, and consist of investments in money market funds with commercial banks and financial institutions, as well as short term commercial paper and government obligations. We maintain cash balances with financial institutions in excess of insured limits. Common Stock Purchase Agreement InFebruary 2020 we entered into a common stock purchase agreement, or the purchase agreement, for the sale of up to$30.0 million of our common stock withAspire Capital Fund, LLC , orAspire Capital . Under the terms of the purchase agreement,Aspire Capital made an initial investment of$3.0 million through the purchase of 2,693,965 shares of our common stock. In addition,Aspire Capital committed to purchase up to an additional$27.0 million in shares of our common stock, at our request from time to time during a 30-month period at prices based on the market price at the time of each sale, subject to specified terms and limitations. As consideration forAspire Capital's obligation under the agreement, we issued 646,551 shares of our common stock toAspire Capital as a commitment fee. We also entered into a registration rights agreement withAspire Capital in connection with our entry into the common stock purchase agreement setting forth our obligation to maintain an effective registration statement covering any shares of common stock sold or to be sold toAspire Capital , subject to the terms of the registration rights agreement. Under the terms of the purchase agreement, we have the right to sell up to 150,000 shares of common stock per day toAspire Capital , which total may be increased by mutual agreement up to an additional 2,000,000 shares per day. The extent to which we rely onAspire Capital as a source of funding will depend on a number of factors, including the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources. Pursuant to the terms of the purchase agreement, the aggregate number of shares that we can sell toAspire Capital under the purchase agreement may exceed 6,645,034 shares of our common stock (which is equal to approximately 19.9% of the common stock outstanding on the date of the purchase agreement), including the shares purchased byAspire Capital and issued toAspire Capital as consideration in connection with entering into the purchase agreement, or the Exchange Cap, only if (i) stockholder approval is obtained to issue more, in which case the Exchange Cap does not apply, or (ii) stockholder approval is not obtained and at any time the Exchange Cap is reached and at all times thereafter the average price paid for all shares issued under the purchase agreement (including the shares issued as consideration toAspire Capital in connection with entering into the purchase agreement) is equal to or greater than$1.34 , or the Minimum Price. InJune 2020 , our stockholders approved the issuance of up to$27.0 million in additional shares of common stock toAspire Capital , resulting in the removal of the Exchange Cap. Pursuant to the purchase agreement, we will control the timing and amount of the further sale of our common stock toAspire Capital . We plan to use the proceeds for general corporate purposes, including research and development, clinical trial activity and working capital. There are no restrictions on future financings and there are no financial covenants, participation rights, rights of first refusal, or penalties in the purchase agreement. We have the right to terminate the purchase agreement at any time without any additional cost or penalty. At-the-Market Offering/Program OnJuly 2, 2015 , we entered into a sales agreement withCowen and Company, LLC , or Cowen, pursuant to which we could sell from time to time up to$30.0 million of our common stock through an "at-the-market" equity offering program, under which Cowen was to act as sales agent. As ofDecember 31, 2019 , we sold an aggregate of 420,796 shares of common stock pursuant to this sales agreement, for net proceeds of$6.2 million . We terminated this sales agreement inMarch 2020 . OnMarch 4, 2020 , we entered into a Capital on Demand™ Sales Agreement, or the sales agreement, withJonesTrading Institutional Services LLC , or JonesTrading, to sell from time to time up to$30.0 million of our common stock through an "at-the-market equity offering" program under which JonesTrading will act as sales agent. Subject to the terms and conditions of the sales agreement, JonesTrading may sell the common stock by methods deemed to be an "at-the-market" offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on the Nasdaq Global 32 -------------------------------------------------------------------------------- Table of Contents Market, on any other existing trading market for the common stock, or to or through a market maker other than on an exchange. In addition, with our written approval, JonesTrading may also sell the common stock by any other method permitted by law, including in privately negotiated transactions. We are not obligated to sell any of the common stock under this sales agreement. Either JonesTrading or we may at any time suspend solicitations and offers under the sales agreement upon notice to the other party. The aggregate compensation payable to JonesTrading shall be equal to 3% of the gross proceeds from sales of the common stock sold by JonesTrading pursuant to the sales agreement. In addition, we agreed to reimburse a portion of the expenses of JonesTrading in connection with the offering up to a maximum of$30.0 thousand . Each party agreed in the sales agreement to provide indemnification and contribution against certain liabilities, including liabilities under the Securities Act, subject to the terms of the sales agreement. The shares to be sold under the sales agreement may be issued and sold pursuant to the currently effective universal shelf registration statement on Form S-3, which was filed with theSEC onMay 3, 2018 and declared effective onMay 17, 2018 (File No. 333-224627), and which we refer to as the universal shelf registration statement on Form S-3. We have also filed with theSEC a prospectus supplement, datedMarch 6, 2020 , related to the sales agreement with JonesTrading, and offerings of our common stock will only be made available by means of the prospectus supplement. We did not sell shares of common stock under this sales agreement during the three and six months endedJune 30, 2020 . As ofJune 30, 2020 , we had not sold any shares of common stock pursuant to this sales agreement. Registered Direct Offering InJune 2020 , we entered into a securities purchase agreement with certain institutional investors, pursuant to which we issued and sold, in a registered direct offering, an aggregate of 14,000,000 shares of our common stock at a purchase price per share of$1.25 . The aggregate gross proceeds were$17.5 million , before deducting fees of approximately$1.0 million paid to the placement agent and other estimated offering expenses of approximately$0.5 million paid by us. JonesTrading acted as the exclusive placement agent for the transaction and we offered the shares pursuant to our universal shelf registration statement on Form S-3, and a prospectus supplement thereunder. Compliance with Nasdaq Global Markets Listing Requirements OnApril 13, 2020 , we received a deficiency letter fromListing Qualifications Department , or the Staff of theNasdaq Stock Market , or Nasdaq notifying us that our Market Value ofListed Securities , or MVLS, had closed for the last 30 consecutive business days below the minimum$50.0 million requirement for continued listing on the Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(b)(2)(A), or the Minimum MVLS Requirement. The Staff also noted in its letter that we are not in compliance with Nasdaq Listing Rule 5450(b)(3)(A), which requires listed companies to have total assets and total revenue of at least$50.0 million each for the most recently completed fiscal year or for two of the three most recently completed fiscal years. In accordance with Nasdaq Listing Rule 5810(c)(3)(C), we had 180 calendar days from our receipt of the deficiency letter, orOctober 12, 2020 , to regain compliance with the Minimum MVLS Requirement, or the MVLS Compliance Period. In order to regain compliance, our MVLS was required to close at$50.0 million or more for a minimum of ten consecutive business days during the MVLS Compliance Period. OnJuly 6, 2020 , we received a notice from Nasdaq indicating that we had regained compliance with Listing Rule 5450(b)(2)(A) as of such date. In addition, onApril 24, 2020 , we received a deficiency letter from the Staff of Nasdaq notifying us that, for the last 30 consecutive business days, the bid price for our common stock had closed below the minimum$1.00 per share requirement for continued inclusion on the Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(a)(1), or the Bid Price Rule. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), or the Compliance Period Rule, we had an initial period of 180 calendar days to regain compliance. However, given the extraordinary market conditions in the financial markets, Nasdaq had determined to toll the compliance period for the bid price requirement throughJune 30, 2020 . The compliance period resumed onJuly 1, 2020 , and we had 180 calendar days, or untilDecember 28, 2020 , or the Compliance Date, to regain compliance with the Bid Price Rule by bid price for our common stock closing at$1.00 or more for a minimum of 10 consecutive business days. OnJune 23, 2020 , we received a notice from Nasdaq indicating that we have regained compliance with Listing Rule 5450(a)(1) as of such date. Royalty Interest Purchase Agreement OnMarch 22, 2019 , we and Curis Royalty entered into the Oberland Purchase Agreement with the Purchasers. We sold to the Purchasers a portion of our rights to receive royalties fromGenentech on potential net sales of Erivedge. As upfront consideration for the purchase of the royalty rights, at closing the Purchasers paid to Curis Royalty$65.0 million less certain transaction expenses. Curis Royalty will also be entitled to receive up to approximately$70.7 million in milestone payments based on sales of Erivedge as follows: (i)$17.2 million if the Purchasers and Curis Royalty receive aggregate royalty payments pursuant to the Oberland Purchase Agreement in excess of$18.0 million during the calendar year 2021, subject to certain exceptions and (ii)$53.5 million if the Purchasers receive payments pursuant to the Oberland Purchase 33 -------------------------------------------------------------------------------- Table of Contents Agreement in excess of$117.0 million on or prior toDecember 31, 2026 . For further discussion please refer to Note 8, Liability Related to the Sale of Future Royalties. Milestone Payments and Monetization of Royalty Rights We have received aggregate milestone payments totaling$59.0 million under our collaboration withGenentech since 2012. In addition, we began receiving royalty revenues in 2012 in connection withGenentech's sales of Erivedge in theU.S. and Roche's sales of Erivedge outside of theU.S. Erivedge royalty revenues received afterDecember 2012 were used to repay Curis Royalty's outstanding principal and interest under the loans due to BioPharma-II and HealthCare Royalty. A portion of Erivedge royalty and royalty related revenue payments will be paid to the Purchasers pursuant to the Oberland Purchase Agreement. We also remain entitled to receive any contingent payments upon achievement of clinical development objectives and royalty payments related to sales of Erivedge pursuant to our collaboration agreement withGenentech and certain contingent payments upon achievement of contractually specified royalty revenue payment amounts related to sales of Erivedge pursuant to the Oberland Purchase Agreement. Upon receipt of any such payments, as well as on royalties received in any territory other thanAustralia , we are required to make payments to certain university licensors totaling 5% of these amounts. In addition, for royalties that Curis Royalty receives from Roche's sales of Erivedge inAustralia , we were obligated to make payments to university licensors of 2% of Roche's direct net sales inAustralia until the expiration of the patent inApril 2019 . FollowingApril 2019 , the amount we are obligated to pay has decreased to 5% of the royalty payments that Curis Royalty receives fromGenentech . CARES Act PPP Loan OnApril 21, 2020 , we entered into a promissory note evidencing an unsecured$0.9 million loan, which we refer to as the PPP Loan, under the Paycheck Protection Program, or the PPP, of the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act. The PPP Loan was made bySilicon Valley Bank , or SVB. The term of the PPP Loan is 24-months. The interest rate on the PPP Loan is 1%, which shall be deferred for the first six months of the term of the loan; however, interest will still accrue during this deferral period. We will begin making monthly principal and interest payments onNovember 21, 2020 . We may prepay the PPP Loan at any time without payment of penalty or premium. The promissory note evidencing the PPP Loan contains customary events of default relating to, among other things, payment defaults, breach of representations and warranties or provisions of the promissory note, and cross-default provisions. The occurrence of an event of default may result in the repayment of all amounts outstanding, collection of all amounts we owe, and/or filing suit and obtaining judgment against us. Under the terms of the CARES Act and the Paycheck Protection Program Flexibility Act of 2020, PPP Loan recipients can apply for and be granted forgiveness for all or a portion of loans granted under the PPP. The PPP Loan may be forgiven in part or in full if the PPP Loan proceeds are used for covered payroll costs, rent and utilities, provided that such amounts are incurred during the 24-week period that commenced onApril 22, 2020 , employee and compensation levels are maintained (subject to certain exceptions), and at least 60% of the PPP Loan proceeds have been used for covered payroll costs. Any forgiveness of the PPP Loan will be made in accordance withU.S. Small Business Administration , or SBA, requirements and subject to approval by SVB. No assurance is provided that we will obtain forgiveness of the PPP Loan in whole or in part. We will remain responsible for amounts due under the promissory note that are not forgiven, together with interest accrued and unpaid thereon at the rate set forth above. Interest payable on the PPP Loan may be forgiven only if the SBA agrees to pay such interest on the forgiven principal amount of the PPP Loan. There is no assurance that any interest payable on the PPP Loan will be forgiven in whole or in part. The CARES Act also includes, among other items, provisions relating to payroll tax credits and deferrals, net operating loss carryback periods, alternative minimum tax credits and technical corrections to tax depreciation methods for qualified improvement property. We are currently evaluating the impact of the provisions of the CARES Act. Cash Flows Cash flows for operations have primarily been used for salaries and wages for our employees, facility and facility related costs for our office and laboratory, fees paid in connection with preclinical and clinical studies, laboratory supplies, consulting fees and legal fees. We expect that costs associated with clinical studies will increase in future periods. Net cash used in operating activities of$14.1 million during the six months endedJune 30, 2020 was primarily the result of our net loss for the period of$16.4 million , offset by non-cash charges consisting of stock based compensation, amortization of debt issuance costs, non-cash lease expense, depreciation, and non-cash imputed interest totaling$1.3 million . Accounts payable and accrued and other liabilities increased$0.1 million , and accounts receivable decreased$0.8 million related to a decrease in Erivedge royalties. Prepaid expenses and other assets decreased$0.1 million . Net cash used in operating activities of$13.9 million during the six months endedJune 30, 2019 was primarily the result of our net loss for the period of$17.1 million , offset by non-cash charges consisting of$3.5 million related to the loss on 34 -------------------------------------------------------------------------------- Table of Contents extinguishment of debt. Additionally, the net loss was offset by stock based compensation, non-cash interest expense, amortization of debt issuance costs and depreciation totaling$1.5 million . Accounts payable and accrued and other liabilities increased$2.6 million , and accounts receivable decreased$0.7 million related to a decrease in Erivedge royalties. We expect to continue to use cash in operations as we seek to advance our drug candidates and our programs under our collaboration agreements withAurigene and ImmuNext. In addition, in the future we may owe royalties and other contingent payments to our licensors based on the achievement of developmental milestones, product sales and other specified objectives. Investing activities provided cash of$4.6 million and used cash of$7.5 million for the six months endedJune 30, 2020 and 2019, respectively, resulting primarily from net investment activity from purchases and sales or maturities of investments for the respective periods. Financing activities provided cash of$17.8 million for the six months endedJune 30, 2020 , as a result of the proceeds from our registered direct offering inJune 2020 and the issuance of shares toAspire Capital in the first quarter of 2020, offset by the payment of our liability under the Oberland Purchase Agreement. Financing activities provided cash of$24.9 million for the six months endedJune 30, 2019 . We extinguished our loan to HealthCare Royalty and made payments totaling$39.0 million , which was offset by$65.0 million in proceeds from the sale of future royalties under the Oberland Purchase Agreement less$0.6 million in issuance costs. Funding Requirements We have incurred significant losses since our inception. As ofJune 30, 2020 , we had an accumulated deficit of approximately$1.0 billion . We will require substantial funds to continue our research and development programs and to fulfill our planned operating goals. In particular, our currently planned operating and capital requirements include the need for working capital to support our research and development activities for CA-4948 and CI-8993, and other programs under our collaboration withAurigene , and to fund our general and administrative costs and expenses. Based on our available cash resources, we do not have sufficient cash on hand to support current operations within the next 12 months from the date of filing this Quarterly Report on Form 10-Q and anticipate that our$23.6 million of existing cash, cash equivalents and investments as ofJune 30, 2020 , should enable us to maintain our planned operations into the first half of 2021. Our ability to raise additional funds will depend on financial, economic and market conditions, many of which are outside of our control, and we may be unable to raise financing when needed, or on terms favorable to us, or at all. Furthermore, high volatility in the capital markets resulting from the COVID-19 pandemic has had, and could continue to have, a negative impact on the price of our common stock, and could adversely impact our ability to raise additional funds. In addition, in light of our limited cash resources, we may seek to engage in one or more strategic alternatives, such as a strategic partnership with one or more parties, the licensing, sale or divestiture of some of our assets or proprietary technologies or the sale of our company, but there can be no assurance that we would be able to enter into such a transaction or transactions on a timely basis or on terms favorable to us, or at all. Our failure to raise capital through a financing or strategic alternative as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. Factors that may affect our planned future capital requirements and accelerate our need for additional working capital, and that would have a negative impact on our financial condition and our ability to pursue our business strategies, include the following: •unanticipated costs in our research and development programs; •the timing and cost of obtaining regulatory approvals for our drug candidates and maintaining compliance with regulatory requirements; •the timing and amount of option exercise fees, milestone payments, royalties and other payments, including payments due to licensors, includingAurigene and ImmuNext, for patent rights and technology used in our drug development programs; •the costs of commercialization activities for any of our drug candidates that receive marketing approval, to the extent such costs are our responsibility, including the costs and timing of establishing drug sales, marketing, distribution and manufacturing capabilities; •unplanned costs to prepare, file, prosecute, defend and enforce patent claims and other patent related costs, including litigation costs and technology license fees; •unexpected losses in our cash investments or an inability to otherwise liquidate our cash investments due to unfavorable conditions in the capital markets; •impacts resulting from the COVID-19 pandemic and responsive actions relating thereto; and 35
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Table of Contents •our ability to continue as a going concern. Subject to specified exceptions, we andAurigene agreed to collaborate exclusively with each other on the discovery, research, development and commercialization of programs and compounds within immuno-oncology for an initial period of approximately two years from the effective date of the collaboration agreement. At our option, and subject to specified conditions, we had the right to extend such exclusivity for up to three additional one year periods by paying toAurigene additional exclusivity option fees on an annual basis. We exercised the first one year exclusivity option in 2017. The fee for this exclusivity option exercise was$7.5 million , which we paid in two equal installments in 2017. We elected not to exercise our exclusivity option in 2018 and did not make the$10.0 million payment required for this additional exclusivity in 2018. As a result of this election to not further exercise our exclusivity option, we no longer operate under the broad immuno-oncology exclusivity withAurigene . In 2019, we elected not to further exercise our exclusivity option related to the IRAK4 and PD1/VISTA programs and did not make the$2.0 million payment required for this continued exclusivity. We have historically derived a portion of our operating cash flow from our receipt of milestone payments under collaboration agreements with third parties. However, we cannot predict whether we will receive additional milestone payments under existing or future collaborations. To become and remain profitable, we, either alone or with collaborators, must develop and eventually commercialize one or more drug candidates with significant market potential. This will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of our drug candidates, obtaining marketing approval for these drug candidates, manufacturing, marketing and selling those drugs for which we may obtain marketing approval and satisfying any post marketing requirements. We may never succeed in these activities and, even if we do, may never generate revenues that are significant or large enough to achieve profitability. Other than Erivedge, which is being commercialized byGenentech and Roche, our most advanced drug candidates are currently only in early clinical testing. For the foreseeable future, we will need to spend significant capital in an effort to develop and commercialize products and we expect to incur substantial operating losses. Our failure to become and remain profitable would, among other things, depress the market price of our common stock and could impair our ability to raise capital, expand our business, diversify our research and development programs or continue our operations. New Accounting Pronouncements For detailed information regarding recently issued accounting pronouncements and the expected impact on our Condensed Consolidated Financial Statements, see Note 2g, New Accounting Pronouncements, in the accompanying Notes to Condensed Consolidated Financial Statements included in Item 1 of Part I of this Form 10-Q. Contractual Obligations There have been no material changes to our contractual obligations set forth under the heading "Management's Discussion and Analysis of Financial Condition and Results of Operations - Contractual Obligations" in our Annual Report on Form 10-K for the year endedDecember 31, 2019 . Off-Balance Sheet Arrangements We have no off-balance sheet arrangements as ofJune 30, 2020 .
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