Overview

Curis is a biotechnology company focused on the development of first-in-class and innovative therapeutics for the treatment of cancer.1

The symbol included above the ‘i’ in Curis is known as a fermata. A fermata is used in written notes of musical pieces to indicate the prolongation of a note, a rest of indefinite duration, or the closing of a piece.

At Curis, the company apply this meaning to cancer, by developing novel therapies for slowing or preventing the progression of cancer and prolonging life – or closing and curi͒ng cancer.

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Product Development Programs

Curis is a biotechnology company focused on the development of first-in-class and innovative therapeutics for the treatment of cancer. The company's 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 Protein 88, or MYD88 alterations. The company reported preliminary clinical data from the study in December 2019. Curis is currently planning to initiate a separate Phase 1 trial for acute myeloid leukemia and myelodysplastic syndromes patients in the first half of 2020.
  • CI-8993, a monoclonal antibody designed to antagonize the V-domain Ig suppressor of T cell activation, or VISTA signaling pathway, which the company plan to begin clinical testing in a Phase 1a/1b trial in 2020.
  • Fimepinostat, which is currently being explored in clinical studies in patients with MYC-altered diffuse large B-cell lymphoma, or DLBCL and solid tumors and has been granted Orphan Drug Designation and Fast Track Designation for the treatment of DLBCL by the U.S. Food and Drug Administration, or FDA in April 2015 and May 2018, respectively. The company 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. The company reported preliminary clinical data from this combination study in December 2019. In March 2020, the company announced that although the company observed no significant drug-drug interaction in its Phase 1 study of fimepinostat in combination with venetoclax, the company did not see an efficacy signal that would warrant continuation of the study. Accordingly, no further patients will be enrolled in this study. Curis is currently evaluating future studies for fimepinostat.
  • The company's pipeline includes CA-170 for which the company announced initial data from a clinical study in patients with mesothelioma in conjunction with the Society of lmmunotherapy of Cancer conference in November 2019. Based on this data, no further patients will be enrolled in the study. Curis is currently evaluating future studies for CA-170. In February 2020, the company and Aurigene further amended its collaboration agreement. Under the terms of the amended agreement, Aurigene will fund and conduct a Phase 2b/3 randomized study evaluating CA-170, in combination with chemoradiation, in approximately 240 patients with non-squamous non-small cell lung cancer, or nsNSCLC. In turn, Aurigene receives rights to develop and commercialize CA-170 in Asia, in addition to its existing rights in India and Russia, based on the terms of the original agreement. The company retain U.S., European Union, and rest of world rights to CA-170, and are entitled to receive royalty payments on potential future sales of CA-170 in Asia.
  • The company's pipeline also includes CA-327, which is a pre-Investigational New Drug, or IND stage oncology drug candidate.

On January 18, 2015 the company entered into a collaboration agreement with Aurigene Discovery Technologies Limited, or Aurigene, a specialized, discovery-stage biotechnology company and wholly owned subsidiary of Dr. Reddy’s Laboratories for the discovery, development and commercialization of small molecule compounds in the areas of immuno-oncology and precision oncology, which the company refer to as the Aurigene agreement, which was amended in September 2016 and February 2020

The following graphic outlines the current status of its programs:

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CA-4948

CA-4948 is an oral small molecule drug candidate that is designed to inhibit the IRAK4 kinase, which is an important transducer of toll-like receptor or certain interleukin receptor signaling pathways. These signaling pathways are shown to be involved in certain human cancers and inflammatory diseases.2

CA-4948 is a potent inhibitor of IRAK4 in biochemical and cell based assays, as well as in an in vivo tumor model of diffuse large B cell lymphoma that harbors mutation in the IRAK4 pathway. Lead compounds from this program were also shown to be effective in an in vivo preclinical model of acute inflammation, suggesting that CA-4948 and other program compounds have the potential for use in the treatment of cancer and inflammatory diseases. CA-4948 has been shown to be

active in in vivo xenograft models of human lymphoma, and demonstrates activity in ex-vivo models of acute myeloid leukemia, or AML, and myelodysplastic syndromes, or MDS. In January 2018 the company initiated a Phase 1 dose escalating clinical trial in patients with non-Hodgkin lymphomas including those with MYD88 alterations. The company reported preliminary clinical data from the study in the fourth quarter of 2019. Curis is currently planning to initiate a separate Phase 1 trial for acute myeloid leukemia and myelodysplastic syndromes patients in the first half of 2020.

CI-8993

CI-8993 is a human IgG1 kappa monoclonal antibody directed against the VISTA protein. VISTA shares homology with other immune checkpoint proteins, including PD-1 and PD-L1, and is an important negative regulator in the immune suppression induced by cancer. Recent studies suggest VISTA is strongly upregulated in response to treatment with other cancer immunotherapy agents. VISTA is strongly expressed in several tumor types including pancreatic cancer, mesothelioma, and prostate cancer. VISTA creates an immune blocking signal that is independent of, and complementary to, PD-1 and CTLA-4.

CI-8993 was originally developed as part of a license and collaboration agreement between ImmuNext and Janssen Biotech, Inc., or Janssen. In 2016, Janssen initiated clinical development of CI-8993 in a Phase 1 study evaluating safety, pharmacokinetics and pharmacodynamics of ascending doses of CI-8993 in patients with advanced solid tumors. The study enrolled 12 patients, in which one patient experienced dose-limiting side effects related to cytokine release syndrome. Janssen opted to close the study and ImmuNext regained control of the asset.

In January 2020, the company announced plans to develop CI-8993, leveraging its clinical and non-clinical experience with a VISTA-focused program (CA-170).

Fimepinostat

Fimepinostat was invented by its scientists and is an oral, dual inhibitor of HDAC and PI3K enzymes. Specifically, fimepinostat inhibits HDACs 1, 2, 3, 6 and 10 and PI3K-alpha, delta and beta isoforms. Inhibitors of HDAC enzymes can affect a number of cell functions and cancer cell viability by regulating the acetylation of both histone and non-histone substrates. Multiple inhibitors of HDACs have been approved by the FDA for treatment of hematologic malignancies. PI3 kinases are frequently activated through mutations or by receptor tyrosine kinases in many cancer types. Two PI3K inhibitors are currently approved by the FDA for treatment of patients with B cell malignancies. Fimepinostat has shown potent antitumor activity in a variety of hematologic tumor models such as non-Hodgkin’s lymphoma, including some with alterations in MYC oncogene, and multiple myeloma.

Non-clinical results indicate that at the mechanistic level, fimepinostat effectively downregulates MYC protein levels in MYC-altered and MYC-dependent cells and tumor models, consistent with the roles of HDAC and PI3K in MYC regulation. These results provide a mechanistic rationale for the clinical development of fimepinostat in MYC-driven malignancies.

Clinical development of fimepinostat began in January 2013. Based on examination of multiple dose and schedules of administration in the Phase 1 trial, the recommended dose of fimepinostat was determined to be once daily oral administration of 60 mg dose using a 5 days “on”/2 days “off” schedule in 21-day cycles.  The most common drug related adverse events, or AEs reported in the Phase 1 trial were low grade, meaning Grade 1 and 2, diarrhea, fatigue and nausea.  Dose limiting toxicities, or DLTs have consisted of diarrhea and hyperglycemia, however no DLTs occurred at the recommended dose and schedule.  Other drug-related Grade 3 or Grade 4 AEs reported in three or more patients included thrombocytopenia and neutrophil decrease, which are hematologic AEs, as well as diarrhea, hyperglycemia and fatigue, which are non-hematologic AEs. In the expansion stage of the Phase 1 trial, fimepinostat was tested as monotherapy or in combination with rituximab in patients with relapsed or refractory DLBCL, a type of non-Hodgkin’s Lymphoma.

The Phase 2 study of monotherapy fimepinostat in patients with relapsed or refractory DLBCL, including those whose tumor harbors alterations of the MYC oncogene is ongoing, and is designed to enroll up to 100 patients with DLBCL with MYC alteration. Study objectives include measurement of objective response rate, progression-free survival, overall survival, duration of response, incidence and severity of adverse events and other safety parameters, and characterization of the pharmacokinetics of fimepinostat.

CA-170

CA-170 is an oral small molecule drug candidate that is designed to selectively target VISTA and PDL1 immune checkpoint proteins, both of which independently function as negative regulators of immune activation. CA-170 is being developed by it under its collaboration with Aurigene.

CA-170 can potently rescue effector functions of T cells, such as cytokine secretion and proliferation, which are inhibited in the presence of VISTA and PDL1/L2 checkpoint proteins. CA-170 has demonstrated high selectivity, and is unable to rescue T cells functions in the presence of other checkpoint protein molecules such as TIM3, CTLA4, LAG-3 and BTLA. Additionally, in multiple syngeneic mouse tumor models (such as melanoma and colon cancer), oral administration of CA-170 was demonstrated to result in anti-tumor activity but no such activity was observed in immune deficient mice, suggesting that the in vivo anti-cancer effects of CA-170 require an intact immune system.

In June 2016, the company dosed the first patient in a Phase 1 trial of CA-170 being conducted in patients with solid tumors and lymphomas. In November 2018, the company presented preliminary clinical data from the ongoing dose escalation stage of CA-170's Phase 1 trial at the Society for Immunotherapy of Cancer, or SITC Meeting. The data demonstrated that CA-170 has a dose proportional and predictable PK profile in patients treated orally at various doses in the ongoing dose escalation stage of the study. Additionally, evaluation of patient blood samples demonstrated that CA-170 appears to be biologically active in modulating the immune system, with a several-fold increase in percentage of circulating CD8+ T cells expressing activation markers within 24 hours of oral dosing. As compared to pre-dosing, there was a marked increase in the population of CD8+ T cells detected in the post treatment tumor biopsy samples in multiple patients. The data presented also demonstrated that multiple patients experienced tumor shrinkages, including two patients each with non-small cell lung cancer and melanoma, and one patient each with follicular lymphoma, esophageal, squamous carcinoma of the head and neck, and Hodgkin lymphoma. CA-170 was well tolerated up to the highest dose tested, 1200 mg twice daily oral administration, as of December 2018. The company announced initial data in conjunction with the Society for lmmunotherapy of Cancer conference in November 2019. Based on this data, no further patients will be enrolled in the study. Curis is currently evaluating future studies for CA-170.

The company's collaboration partner, Aurigene, initiated a Phase 2 trial for CA-170 in India in the first quarter of 2018. In 2019, Aurigene presented clinical data from a Phase 2a basket study of CA-170 in patients with multiple tumor types, including those with non-squamous non-small cell lung cancer, or nsNSCLC. In the study, CA-170 demonstrated promising signs of safety and activity in nsNSCLC patients compared to various anti-PD-1/PD-L1 antibodies. In February 2020 the company amended its collaboration, license and option agreement with Aurigene. Under the terms of the amended agreement, Aurigene will fund and conduct a Phase 2b/3 randomized study evaluating CA-170 in combination with chemoradiation, in approximately 240 patients with nsNSCLC. Aurigene has rights to develop and commercialize CA-170 in Asia, in addition to its existing rights in India and Russia, based on the terms of the original agreement. Curis is entitled to receive royalty payments on potential future sales of CA-170 in Asia, and the company retain rights in the U.S., European Union and rest of the world.

CA-327

In October 2016, the company exercised its option within the collaboration with Aurigene to license the PDL1/TIM3 program. CA-327 is an oral small molecule drug candidate that is designed to selectively target PDL1 and TIM3 immune checkpoint proteins, both of which independently function as negative regulators of immune activation. CA-327 has demonstrated anti-tumor activity in multiple syngeneic mouse tumor models in an immune-dependent manner.

For a further discussion of its collaboration agreement with Aurigene, see “Business—The company's Collaborations and License Agreements—Aurigene.”

Erivedge

Erivedge is an orally bioavailable small molecule which is designed to selectively inhibit the Hedgehog signaling pathway by targeting a protein called Smoothened. The Hedgehog signaling pathway is normally active during embryonic development and unregulated activation of the pathway is believed to play a central role in allowing the proliferation and survival of cancer cells and leading to formation and maintenance of certain cancers. Genetic mutations that lead to unregulated activation of Hedgehog signaling are found in BCC and medulloblastoma. Aberrant signaling in the Hedgehog signaling pathway is implicated in over 90% of BCC cases.

Erivedge is FDA approved for treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation and is being developed under a collaboration agreement with Genentech. Genentech and Roche are responsible for the clinical development and global commercialization of Erivedge. Erivedge is currently marketed and sold in the U.S. by Genentech and in the European Union, Australia and several other countries by Roche.

Collaborations and License Agreements

Aurigene

In January 2015, the company entered into an exclusive collaboration agreement with Aurigene for the discovery, development and commercialization of small molecule compounds in the areas of immuno-oncology and selected precision oncology targets. Under the collaboration agreement, Aurigene granted it an option to obtain exclusive, royalty-bearing licenses to relevant Aurigene technology to develop, manufacture and commercialize products containing certain of such compounds anywhere in the world, except for India and Russia, which are territories retained by Aurigene.

In connection with the collaboration agreement, the company issued to Aurigene 3,424,026 shares of its common stock valued at $24.3 million at the time of issuance in partial consideration for the rights granted to it under the collaboration agreement which the company recognized as expense during the year ended December 31, 2015. The shares were issued pursuant to a stock purchase agreement with Aurigene dated January 18, 2015.

In September 2016, the company and Aurigene entered into an amendment to the collaboration agreement. Under the terms of the amendment, in exchange for the issuance by it to Aurigene of 2,041,666 shares of its common stock, Aurigene waived payment of up to a total of $24.5 million in potential milestones and other payments associated with the first four programs in the collaboration that may have become due from it under the collaboration agreement. To the extent any of these waived milestones or other payments are not payable by it, for example in the event one or more of the milestone events do not occur, the company will have the right to deduct the unused waived amount from any one or more of the milestone payment obligations tied to achievement of commercial milestone events. The amendment also provides that, in the event supplemental program activities are performed by Aurigene, the company will provide up to $2.0 million of additional funding for each of the third and fourth licensed program. The shares were issued pursuant to a stock purchase agreement with Aurigene dated September 7, 2016.

ImmuNext

In January 2020, the company entered into an option and license agreement with ImmuNext, or the ImmuNext Agreement Under the terms of the ImmuNext Agreement, the company agreed to engage in a collaborative effort with ImmuNext, and to conduct a Phase 1a/1b clinical trial of CI-8993. In exchange, ImmuNext granted it an exclusive option, exercisable until the earlier of (a) four years after January 6, 2020 and (b) 90 days after database lock for the first Phase 1a/1b trial in which the endpoints are satisfied, or the Option Period, to obtain an exclusive, worldwide license to develop and commercialize certain VISTA antagonizing compounds and products containing these compounds in the field of oncology.

A joint steering committee composed of representatives from each of the parties will manage the non-clinical and clinical

development of the VISTA compounds and products during the Option Period, including, but not limited to, the approval of

the plan for the Phase 1a/1b trial.

During the Option Period, the company will conduct the Phase 1a/1b trial and ImmuNext will conduct certain agreed upon non-clinical research activities to support the Phase 1a/1b trial. During the Option Period, the company will assign to ImmuNext all right, title and interest in and to, inventions made by it alone or jointly with ImmuNext in conducting clinical and non-clinical activities under the ImmuNext Agreement during the Option Period and any patent rights covering those inventions. Effective as of the option exercise date (if any), ImmuNext will assign to it information all such inventions that were made solely by it and any patent rights covering those inventions that were assigned by it to ImmuNext during the Option Period and (ii) a joint ownership interest in all such inventions that were made jointly by it and ImmuNext and patent rights covering those inventions that the company assigned to ImmuNext during the option period, except for any of those inventions that relates to compounds as to which ImmuNext has retained exclusive rights.

In January 2020, the company paid $1.3 million in an upfront fee to ImmuNext. In addition, if the company exercise the option, the company will pay ImmuNext an option exercise fee of $20.0 million. ImmuNext will be eligible to receive up to $4.6 million in potential development milestones, up to $84.3 million in potential regulatory approval milestones, and up to $125.0 million in potential sales milestone payments from it. ImmuNext is also eligible to receive tiered royalties on annual net sales on a product-by-product and country-by-country basis, at percentage rates ranging from high single digits to low double digits, subject to specified adjustments.

Genentech

In 2003, the company entered into a collaborative research, development and license agreement with Genentech, which the company refer to as the collaboration agreement.

Under the terms of its collaboration agreement with Genentech, the company granted Genentech an exclusive, global, royalty-bearing license, with the right to sublicense, to make, use, sell and import molecules capable of inhibiting the Hedgehog signaling pathway (including small molecules, proteins and antibodies) for human therapeutic applications, including cancer therapy. Genentech subsequently granted a sublicense to Roche for non-U.S. rights to Erivedge other than in Japan where such rights are held by Chugai. Genentech and Roche are responsible for worldwide clinical development, regulatory affairs, manufacturing and supply, formulation, and sales and marketing.

Curis is eligible to receive up to an aggregate of $115.0 million in contingent cash milestone payments, exclusive of royalty payments, in connection with the development of Erivedge or another small molecule Hedgehog pathway inhibitor, assuming the successful achievement by Genentech and Roche of specified clinical development and regulatory objectives. Of this amount, Curis has received $59.0 million to date.

In addition to the contingent cash milestone payments, its wholly owned subsidiary, Curis Royalty, LLC, or Curis Royalty, is entitled to a royalty on net sales of Erivedge that ranges from 5% to 7.5% based upon global Erivedge sales by Roche and Genentech. The royalty rate applicable to Erivedge may be decreased by 2% on a country-by-country basis in certain specified circumstances, including when a competing product that binds to the same molecular target as Erivedge is approved by the applicable country’s regulatory authority in another country and is being sold in such country by a third-party for use in the same indication as Erivedge, or, when there is no issued intellectual property covering Erivedge in a territory in which sales are recorded. During the third quarter of 2015, the FDA and the European Medicine Agency’s Committee for Medicinal Products for Human Use, or CHMP approved another Hedgehog signaling pathway inhibitor, Odomzo® (sonidegib), which is marketed by Sun Pharmaceutical Industries Ltd., for use in locally advanced BCC. Accordingly, Genentech reduced royalties to Curis Royalty on its net sales in the United States of Erivedge by 2% since the fourth quarter of 2015, and the company anticipate that Genentech will reduce by 2% royalties on net sales of Erivedge outside of the United States on a country-by-country basis to the extent that sonidegib is approved by the applicable country’s regulatory authority and is being sold in such country. However, pursuant to the Oberland Purchase Agreement described below, Curis has retained its rights with respect to the 2% of royalties that are subject to such reduction in countries where such reduction may or has occurred, subject to the terms and conditions of the Oberland Purchase Agreement, which the company refer to as the “Retained Royalty Amounts”.

As a result of its licensing agreements with various universities, Curis is also obligated to make payments to university licensors on royalties that Curis Royalty earns in all territories (other than Australia) in an amount that is equal to 5% of the royalty payments received from Genentech. This obligation endures on a country-by-country basis for a period of 10 years from the first commercial sale of Erivedge, which occurred in February 2012 in the U.S. For royalties that the company earn from Roche’s sales of Erivedge in Australia, the company were obligated to make payments to university licensors of 2% of Roche’s direct net sales in Australia until the expiration of the Australian patent in April 2019, after which the amount has decreased to 5% of the royalty payments that the company receive from Genentech for the remainder of the period ending 10 years from the first commercial sale of Erivedge.

Financial Overview

Debt

In December 2012, Curis Royalty entered into a $30 million credit agreement with BioPharma-II, at an annual interest rate of 12.25% collateralized with certain future Erivedge royalty and royalty-related payment streams.

In March 2017, the company and Curis Royalty, entered into a new credit agreement, referred to as the credit agreement, with HealthCare Royalty, a Delaware limited partnership managed by Healthcare Royalty Management, LLC, for the purpose of refinancing the prior credit agreement from BioPharma-II. On the effective date of the credit agreement with Healthcare Royalty, the prior credit agreement was terminated in its entirety.

Pursuant to the credit agreement, HealthCare Royalty made a $45.0 million loan at an annual interest rate of 9.95% to Curis Royalty, which was used to pay off the approximate $18.4 million in remaining loan obligations to BioPharma-II under the prior loan. The remaining proceeds of the loan of $26.6 million were distributed to it as sole equity holder of Curis Royalty. As of December 31, 2018, the outstanding principal and interest due under the loan was $35.8 million. On March 22, 2019, the company terminated, and repaid in full all amounts outstanding under the loan with HealthCare Royalty. As of December 31, 2019, there is no debt outstanding.

Liability Related to the Sale of Future Royalties.   In connection with the termination and repayment in full of the loan with HealthCare Royalty, the Company and Curis Royalty entered into the Oberland Purchase Agreement. 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 information $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 to December 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 Purchase Agreement.

Revenue

The company do not expect to generate any revenues from its direct sale of products for several years, if ever. Substantially all of its revenues to date have been derived from license fees, research and development payments, and other amounts that Curis has received from its strategic collaborators and licensees, including royalty payments. Since the first quarter of 2012, Curis has recognized royalty revenues related to Genentech’s sales of Erivedge and the company expect to continue to recognize royalty revenue in future quarters from Genentech’s sales of Erivedge in the U.S. and Roche’s sales of Erivedge outside of the U.S. However, a portion of its royalty and royalty-related revenues under its collaboration with Genentech will be paid to the Purchasers, pursuant to the Oberland Purchase Agreement. The Oberland Purchase Agreement will terminate upon the earlier to occur of information the date on which Curis Royalty’s rights to receive the Purchased Receivables owed by Genentech under the Genentech collaboration agreement have terminated in their entirety and (ii) the date on which payment in full of the put/call price is received by the Purchasers pursuant to the Purchasers’ exercise of their put option or Curis Royalty’s exercise of its call right. For additional information regarding the terms and termination provisions of this agreement, see Note 8 “Liability Related to the Sale of Future Royalties.”

The company could receive additional milestone payments from Genentech, provided that contractually specified development and regulatory objectives are met. Also, the company could receive milestone payments from the Purchasers, provided that contractually specified royalty payment amounts are met within applicable time periods. The company's 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 this collaboration, and contingent cash payments for the achievement of clinical, development and regulatory objectives, if any, are met, under its existing collaboration with Genentech. The company's receipt of additional payments under its existing collaboration with Genentech cannot be assured, nor can the company predict the timing of any such payments, as the case may be.

Total revenues decreased by $0.4 million, or 4%, to $10.0 million for the year ended December 31, 2019 as compared to $10.4 million for the year ended December 31, 2018, primarily related to an increase in the reserve for contractual royalty reductions arising from Genentech and Roche’s net sales of Erivedge.

Cost of Royalty Revenues. Cost of royalty revenues decreased by approximately $0.1 million, to $0.5 million for the year ended December 31, 2019 as compared to $0.6 million for the year ended December 31, 2018. The decrease reflects its obligation to make payments to two university licensors on royalties that Curis Royalty earns on Genentech’s net sales of Erivedge, which decreased in 2019 as compared to 2018.

The company's total research and development expenses decreased by $2.1 million, or 9%, to $22.3 million for the year ended December 31, 2019, as compared to $24.4 million for the prior year. Direct research and development expenses increased $3.8 million for the year ended December 31, 2019 as compared to the prior year period. These costs included increased clinical site, patient, clinical research organization, manufacturing and consulting costs for its ongoing Phase 1 clinical trials. Employee-related expenses decreased $5.5 million for the year ended December 31, 2019 as compared to the prior year period, which was primarily due to a reduction in headcount which occurred in the fourth quarter of 2018.

General and administrative expenses decreased by $3.2 million, or 22%, during the year ended December 31, 2019 as compared to the prior year. The decrease in general administrative expense was driven primarily by $1.6 million of lower personnel expense primarily attributable to the departure of personnel following a reduction in headcount announced in the fourth quarter of 2018 and the departure of its former Chief Executive Officer in the third quarter of 2018. Legal services decreased $0.9 million as compared to 2018 primarily due to a reduction in intellectual property following a portfolio review of non-essential patents. Stock-based compensation decreased by $0.5 million primarily due to a lower head count in 2019 as compared to 2018, and professional and consulting services decreased by $0.3 million, offset by other general and administrative expenses for the 2019 period.

Other expense, net, was $7.8 million for the year ended December 31, 2019, as compared to $3.2 million for the same period in 2018. Interest expense related to debt was $0.8 million in the current year as compared to $3.9 million in 2018. This decrease was a direct result of the March 22, 2019 payment to HealthCare Royalty in full satisfaction of the debt held by Curis Royalty. In March 2019 the company recorded a $3.5 million loss on extinguishment of debt in conjunction with the repayment of the loan obligation to BioPharma-II. Additionally, imputed interest of $4.1 million resulting from the previously announced sale of a portion of Erivedge royalties to Oberland Capital Management was also recorded. For the years ended December 31, 2019 and 2018, interest income was $0.6 million and $0.7 million, respectively.

The company incurred a net loss applicable to common stockholders of $32.1 million for the year ended December 31, 2019 and $32.6 million for the year ended December 31, 2018.

Recent development

Curis Announces Closing of Public Offering of Common Stock with $169.6 Million in Gross Proceeds, Including Full Exercise of Underwriters' Option to Purchase Additional Shares 3

Dec. 14, 2020; Curis, Inc. (NASDAQ: CRIS), today announced the closing of its underwritten public offering of 29,500,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase up to an additional 3,847,826 shares, at the public offering price of $5.75 per share (the Offering). Curis expects the net proceeds from the Offering to be approximately $159.1 million, after deducting underwriting discounts and commissions and estimated offering expenses.

Cantor Fitzgerald & Co. and JonesTrading Institutional Services LLC acted as joint book-runners for the Offering.  H.C. Wainwright & Co., LLC and Laidlaw & Company (UK) Ltd. acted as co-lead managers.

Curis intends to use the net proceeds from the Offering, together with its existing cash and cash equivalents, to continue development of CA-4948, in collaboration with Aurigene, and CI-8893, in collaboration with ImmuNext, and for general working capital and capital expenditures.  Curis estimates that the net proceeds from the Offering, together with its existing cash and cash equivalents, will enable it to fund its operating expenses and capital expenditure requirements into 2023.

The securities in the Offering were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224627) that was filed with the United States Securities and Exchange Commission ("SEC") on May 3, 2018, and declared effective by the SEC on May 17, 2018 and an additional registration statement on Form S-3 (File No. 333-251211) filed pursuant to Rule 462(b) which became automatically effective on December 9, 2020. The offering was made only by a means of a written prospectus and a prospectus supplement that form a part of the registration statement.

References

  1. ^ https://www.curis.com/about/company-overview/
  2. ^ https://fintel.io/doc/sec-cris-curis-10k-annual-report-2020-march-19-18340
  3. ^ http://investors.curis.com/2020-12-14-Curis-Announces-Closing-of-Public-Offering-of-Common-Stock-with-169-6-Million-in-Gross-Proceeds-Including-Full-Exercise-of-Underwriters-Option-to-Purchase-Additional-Shares
Tags: US:CRIS
Created by Asif Farooqui on 2019/10/14 06:26
     
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