Hansoh Pharma’s AMEILE (almonertinib) Receives Marketing Authorization in China for Second-line Treatment for Patients With EGFR T790m-mutation Non-small Cell Lung Cancer

On March 19, 2020 Hansoh Pharmaceutical Group Company Limited ("Hansoh Pharma"), a leading biopharmaceutical company in China, reported that the National Medical Products Administration (NMPA) has granted marketing authorization for AMEILE (almonertinib, previously also known as HS-10296) once daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after other EGFR tyrosine kinase inhibitor (TKI) therapy (Press release, Jiangsu Hansoh Pharmaceutical, MAR 19, 2020, View Source [SID1234555712]).

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AMEILE is the second 3rd generation EGFR TKI to be approved for metastatic NSCLC patients with EGFR T790M. The approval of AMEILE provides a highly efficacious treatment option with favorable safety profile for advanced NSCLC patients.

Lung cancer remains the leading cause of cancer-related deaths worldwide and in China. EGFR mutation is the most common mutation and accounts for about 40% of NSCLC patients in China. Approximately 50% of NSCLC patients will develop drug-resistant T790M mutation following treatment with first or second generation EGFR TKI. In its registrational study, APOLLO (n=244), patients taking AMEILE has shown a median progression-free-survival (mPFS) of greater than a year, the longest in its class as a monotherapy in second line therapy. AMEILE provides a new option with favorable safety profile and high efficacy for NSCLC patients in China, and is another illustration of Hansoh Pharma’s steadfast commitment in developing life-changing medicines to help patients and families in need around the world.

The NMPA’s approval of AMEILE was supported by clinical results from APOLLO study, a multicenter, open-label, single-arm Phase 2 study conducted in patients with recurrent NSCLC harboring EGFR T790M mutations. In this study, a total of 244 patients were treated with 110mg of almonertinib. The primary endpoint was objective response rate (ORR) as determined by blinded independent central review (ICR). Key secondary endpoints include PFS assessed by ICR, disease control rate (DCR), duration of response (DoR), and overall survival (OS). In APOLLO trial, ORR was 68.9%, DCR was 93.4%, mPFS was 12.3 months, and ORR in patients with CNS metastasis was 61.5%.[1,2] Further, almonertinib was well tolerated, where most common AEs were grade 1 or 2, with less than three percent patients discontinued treatment with almonertinib due to drug-related AEs. There was no interstitial lung disease reported during this study while neither grade 3 rash nor QT prolongation was observed. The most commonly observed adverse events, regardless of attribution, were blood creatine phosphokinase increased, rash, pruritus, aspartate aminotransferase increased, and alanine aminotransferase increased. [1,2]

"AMEILE has demonstrated a compelling efficacy and tolerability in NSCLC patients with EGFR mutations," said Professor Shun Lu, the Principal Investigator of APOLLO trial and Professor of Shanghai Chest Hospital, Affiliated Hospital of Shanghai Jiao Tong University. "AMEILE provides a new targeted-therapy option for NSCLC patients with EGFR-mutations, especially for patients with brain metastasis."

"Almonertinib serves as a promising option for NSCLC patients, which is supported by the efficacy and safety data from APOLLO as well as other studies," said Professor James Chih-Hsin Yang of Graduate institute of Oncology at National Taiwan University College of Medicine.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer deaths among both men and women globally and in China. In 2018, there were approximately 867,500 new diagnoses of lung cancer in China, of which 737,400, or approximately 85%, were recorded as NSCLC in 2018, with a five-year survival rate of only 19.3%. About 40% of these are EGFR mutation-positive and approximately 50% of patients treated with first- or second-generation EGFR TKI therapy will acquire resistance related to the T790M mutation. [3]

About Almonertinib

Almonertinib 110mg once-daily tablet is a medicine indicated for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an NMPA-approved test, who have progressed on or after prior EGFR TKI therapy. Almonertinib has high, nanomolar inhibitory activity against common EGFR mutations as well as drug-resistant T790M mutations in preclinical studies.

Celsion Corporation to Hold Year-End 2019 Financial Results Conference Call on Thursday, March 26, 2020

On March 19, 2020 Celsion Corporation (NASDAQ: CLSN) reported that the Company will host a conference call to discuss financial results for the year ended December 31, 2019 and provide an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA plasmid vector formulated into a nanoparticle with a non-viral delivery system at 11:00 a.m. EDT on Thursday, March 26, 2020 (Press release, Celsion, MAR 19, 2020, View Source [SID1234555711]).

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To participate in the call, interested parties may dial 1-800-367-2403 (Toll-Free/North America) or 1-334-777-6978 (International/Toll) and ask for the Celsion Corporation Fourth Quarter and Year-End 2019 Earnings Call (Conference Code: 8257530) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay on Friday, March 27, 2020 and will remain available until April 10, 2020. The replay can be accessed at 1-719-457-0820 or 1-888-203-1112 using Conference ID: 8257530. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT Thursday, March 26, 2020.

NantKwest Doses First Patient in Phase 2 Single-Arm Trial of Metastatic Merkel Cell Carcinoma Therapy With Off-the-Shelf CD16 Natural Killer Cells

On March 19, 2020 NantKwest, Inc. (Nasdaq: NK), a next-generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer and infectious diseases, reported dosing of the first patient in a Phase 2 trial for second- and third-line Merkel cell carcinoma (MCC) in patients who are refractory to immune checkpoint inhibitors (Press release, NantKwest, MAR 19, 2020, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-doses-first-patient-phase-2-single-arm-trial?field_nir_news_date_value[min]= [SID1234555710]). The trial will evaluate the Company’s first-in-class, off-the-shelf CD16-targeted natural killer (haNK) cells in combination with ImmunityBio’s IL-15 superagonist N-803 and Avelumab.

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MCC is a rare and aggressive skin cancer that arises from uncontrolled growth of cells in the skin. Increasing in incidence, approximately 2,500 new cases are reported in the U.S. each year. Patients with metastatic or locally advanced MCC have an extremely poor prognosis, with less than 20% of patients surviving longer than five years. Typically, these patients are treated with a range of drugs, including chemotherapy, which can result in significant side effects. Although new immune therapies have the potential to improve survival, Merkel cell carcinoma is still fatal for a majority of patients who have progressed on or after treatment with a checkpoint inhibitor and represents an unmet medical need.

"With over 70% of patients failing checkpoint inhibitors in solid tumors, it is vital to develop novel and effective therapeutic options," said Patrick Soon-Shiong, M.D., chairman and CEO of NantKwest and ImmunityBio. "Checkpoint and CAR-T therapies only target the T cell, which is a small portion of effector killer cells, and often result in substantial side effects. These side effects make those therapies unusable for many patients. Our combination therapy is designed to activate the innate immune system to create an immunological memory against tumors, resulting in immunogenic cell death."

"We have now established the first-in-class, cryopreserved CD16 NK-92 cell line, which can be manufactured under GMP conditions at scale. Having accomplished this development and manufacturing milestone in the field of NK cell therapy, we are actively pursuing pivotal trials for our CD16 NK-92 products haNK and PD-L1 t-haNK," continued Soon-Shiong.

The single-arm study will involve 43 patients who failed all standard of care treatments for MCC, including checkpoint therapy (QUILT-3.063; NCT03853317). Clinical trial sites are currently being activated.

"Single-arm studies allow us to offer patients who have no other approved treatment options the opportunity to participate in a potential treatment for this rare and deadly disease without fear of receiving a placebo drug," said John Lee, M.D., senior vice president of adult medical affairs at NantKwest. "Our past study using our non-targeted aNK cells showed clinical responses either alone or in combination with N-803. The current study builds on this approach using a PD-L1 antibody that will bind to the high affinity CD16 receptor on haNK cells to potentially help target PD-L1 tumor cells. The N-803 superagonist has been shown to enhance the body’s NK and T cells to also help attack the tumor cells. The goal of this work is to provide real hope for these patients using the power of our combination therapies."

Curis Reports Fourth Quarter and Year-End 2019 Financial Results and Provides Business Update

On March 19, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the fourth quarter and year ended December 31, 2019 (Press release, Curis, MAR 19, 2020, View Source [SID1234555705]).

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"Our mission at Curis is to develop the next generation of targeted cancer therapies that improve the lives of patients. In 2019, we made significant clinical progress across our pipeline, including reporting preliminary data for CA-4948 that demonstrates anti-cancer activity," said James Dentzer, President and Chief Executive Officer of Curis. "We look forward to reporting additional clinical data on CA-4948 later this year. In 2019, we also reported initial data in our Phase 1 study of fimepinostat in combination with venetoclax, in which we observed no significant drug-drug interaction. Since then, we have enrolled additional patients and have not seen an efficacy signal that would warrant further development in this indication. Given current market conditions, we have made the decision to discontinue the study and focus our resources on CA-4948 and CI-8993. We would like to thank the patients and their families who participated in this study as well as our investigators and employees for their commitment and support."

Mr. Dentzer continued: "On the corporate side, we are pleased to have entered into a common stock purchase agreement with Aspire Capital, which provides us with a flexible and efficient source of capital to advance our clinical programs. We are also excited about the recent execution of several collaborations and partnerships, including the option and license agreement for CI-8993, our clinical anti-VISTA candidate. We look forward to initiating a Phase 1a/1b study of CI-8993 and reporting data from our ongoing study of CA-4948 later this year."

Full Year 2019 and Recent Operational Highlights

Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

In December 2019, Curis announced updated preliminary data from its ongoing Phase 1 dose escalation study of CA-4948, an IRAK4 kinase inhibitor, for the treatment of patients with R/R non-Hodgkin’s lymphoma (NHL), including patients with DLBCL, Waldenström’s macroglobulinemia (WM) and oncogenic MYD88 mutations. The data demonstrated anti-cancer activity and a favorable safety profile for CA-4948, establishing that targeting IRAK4 may be a viable clinical strategy. Curis plans to continue dose escalation in this Phase 1 study until the maximum tolerated dose and/or recommended Phase 2 dose of CA-4948 is determined.
Precision oncology, fimepinostat (HDAC/PI3K inhibitor):

Today, Curis announced that it is discontinuing its Phase 1 study of fimepinostat, in combination with venetoclax, a BCL-2 inhibitor, in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including double-hit/double-expressor (DH/DE) lymphoma. Ongoing analytical research with DarwinHealth to characterize biomarkers and tumor subtype alignments will help guide any future clinical development opportunities with fimepinostat.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

In January 2020, Curis announced it entered into an option and license agreement to acquire exclusive, worldwide rights from ImmuNext Inc. (ImmuNext) to develop and commercialize anti-VISTA antibodies for the treatment of cancer, including ImmuNext’s lead compound, CI-8993. CI-8993 is a clinical-stage monoclonal antibody designed to antagonize the V-domain Ig suppressor of T-cell activation (VISTA) signaling pathway.
Corporate:

In February 2020, Curis entered into a common stock purchase agreement of up to $30 million with Aspire Capital Fund, LLC (Aspire Capital). Under the terms of the Agreement, Aspire Capital made an initial investment via purchase of $3 million of common shares of Curis. In addition, Aspire committed to purchasing up to an additional $27 million of common shares of Curis at Curis’ 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 certain limits.
In February 2020, Curis entered into an amendment of its collaboration, license and option agreement with Aurigene Discovery Technologies, Ltd. (Aurigene), under which Aurigene will fund and conduct a Phase 2b/3 randomized study evaluating CA-170, an orally available, dual inhibitor of VISTA and PDL1, in combination with chemoradiation, in approximately 240 patients with non-squamous non-small cell lung cancer. In turn, Aurigene received rights to develop and commercialize CA-170 in Asia, in addition to its existing rights in India and Russia. Curis retained U.S., E.U., and rest of world rights to CA-170, and is entitled to receive royalty payments on potential future sales of CA-170 in Asia.
In January 2020, Curis and DarwinHealth, Inc. announced a multi-year scientific research collaboration to characterize biomarkers and tumor subtype alignments to identify potential additional therapeutic opportunities for fimepinostat.
Upcoming 2020 Planned Milestones

Continue dose escalation of CA-4948 in the ongoing Phase 1 study to determine the recommended Phase 2 dose and report updated efficacy data from the study in 2020
Initiate a Phase 1 study of CA-4948 in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), including patients with spliceosome mutations that encode oncogenic IRAK4-L in the first half of 2020
Initiate a Phase 1a/1b dose escalation study of CI-8993 in in the second half of 2020.
Full Year and Fourth Quarter 2019 Financial Results

For the year ended December 31, 2019, Curis reported a net loss of $32.1 million, or $0.97 per share on both a basic and diluted basis, as compared to a net loss of $32.6 million, or $0.98 per share on both a basic and diluted basis in 2018. For the fourth quarter of 2019, Curis reported a net loss of $8.6 million or $0.26 per share on both a basic and diluted basis, as compared to a net loss of $5.9 million, or $0.18 per share on both a basic and diluted basis for the same period in 2018.

Revenues for the year ended December 31, 2019, were $10.0 million as compared to $10.4 million for the same period in 2018. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2019 and 2018 were $3.3 million and $2.8 million, respectively.

Operating expenses for the year ended December 31, 2019 were $34.4 million as compared to $39.8 million for the same period in 2018. Operating expenses for the fourth quarter of 2019 were $10.6 million, as compared to $7.9 million for the same period in 2018, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.5 million for the year ended December 31, 2019 as compared to $0.6 million for the same period in 2018. Cost of royalty revenues were $0.2 million for the fourth quarter of 2019, as compared to $0.1 million for the same period in 2018.

Research and Development Expenses. Research and development expenses were $22.3 million for the year ended December 31, 2019, as compared to $24.4 million for the same period in 2018. The decrease was primarily due to lower employee related expenses which resulted from a headcount reduction in the fourth quarter of 2018. This decrease was partially offset by increased clinical, manufacturing and consulting costs for the Company’s ongoing Phase 1 clinical trials. Research and development expenses were $7.5 million for the fourth quarter of 2019 as compared to $4.7 million for the same period in 2018. The increase was primarily due to increased costs related to clinical activities and manufacturing costs for fimepinostat and CA-4948.

General and Administrative Expenses. General and administrative expenses were $11.6 million for the year ended December 31, 2019, as compared to $14.8 million for the same period in 2018. The decrease was primarily due to lower personnel and stock-based compensation expense combined with lower legal and professional service expense. General and administrative expenses were $3.0 million for both the fourth quarter of 2019 and 2018 respectively.

Other expense, net. Net other expense was $7.8 million for the year ended December 31, 2019, as compared to $3.2 million for the same period in 2018. Net other expense primarily consisted of the $3.5 million loss on extinguishment of debt in conjunction with the March 2019 repayment of the loan obligation to HealthCare Royalty Partners, and imputed interest of $4.1 million resulting from the previously announced sale of a portion of Erivedge royalties to Oberland Capital Management. For the fourth quarter of 2019 and 2018, net other expense was $1.3 million and $0.8 million respectively.

As of December 31, 2019, Curis’s cash, cash equivalents, marketable securities and investments totaled $20.5 million and there were approximately 33.2 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into the second half of 2020.

Conference Call Information

Curis management will host a conference call today, March 19, 2020, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

Curis Reports Fourth Quarter and Year-End 2019 Financial Results and Provides Business Update

On March 19, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the fourth quarter and year ended December 31, 2019 (Press release, Curis, MAR 19, 2020, View Source [SID1234555704]).

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"Our mission at Curis is to develop the next generation of targeted cancer therapies that improve the lives of patients. In 2019, we made significant clinical progress across our pipeline, including reporting preliminary data for CA-4948 that demonstrates anti-cancer activity," said James Dentzer, President and Chief Executive Officer of Curis. "We look forward to reporting additional clinical data on CA-4948 later this year. In 2019, we also reported initial data in our Phase 1 study of fimepinostat in combination with venetoclax, in which we observed no significant drug-drug interaction. Since then, we have enrolled additional patients and have not seen an efficacy signal that would warrant further development in this indication. Given current market conditions, we have made the decision to discontinue the study and focus our resources on CA-4948 and CI-8993. We would like to thank the patients and their families who participated in this study as well as our investigators and employees for their commitment and support."

Mr. Dentzer continued: "On the corporate side, we are pleased to have entered into a common stock purchase agreement with Aspire Capital, which provides us with a flexible and efficient source of capital to advance our clinical programs. We are also excited about the recent execution of several collaborations and partnerships, including the option and license agreement for CI-8993, our clinical anti-VISTA candidate. We look forward to initiating a Phase 1a/1b study of CI-8993 and reporting data from our ongoing study of CA-4948 later this year."

Full Year 2019 and Recent Operational Highlights

Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

In December 2019, Curis announced updated preliminary data from its ongoing Phase 1 dose escalation study of CA-4948, an IRAK4 kinase inhibitor, for the treatment of patients with R/R non-Hodgkin’s lymphoma (NHL), including patients with DLBCL, Waldenström’s macroglobulinemia (WM) and oncogenic MYD88 mutations. The data demonstrated anti-cancer activity and a favorable safety profile for CA-4948, establishing that targeting IRAK4 may be a viable clinical strategy. Curis plans to continue dose escalation in this Phase 1 study until the maximum tolerated dose and/or recommended Phase 2 dose of CA-4948 is determined.
Precision oncology, fimepinostat (HDAC/PI3K inhibitor):

Today, Curis announced that it is discontinuing its Phase 1 study of fimepinostat, in combination with venetoclax, a BCL-2 inhibitor, in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including double-hit/double-expressor (DH/DE) lymphoma. Ongoing analytical research with DarwinHealth to characterize biomarkers and tumor subtype alignments will help guide any future clinical development opportunities with fimepinostat.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

In January 2020, Curis announced it entered into an option and license agreement to acquire exclusive, worldwide rights from ImmuNext Inc. (ImmuNext) to develop and commercialize anti-VISTA antibodies for the treatment of cancer, including ImmuNext’s lead compound, CI-8993. CI-8993 is a clinical-stage monoclonal antibody designed to antagonize the V-domain Ig suppressor of T-cell activation (VISTA) signaling pathway.
Corporate:

In February 2020, Curis entered into a common stock purchase agreement of up to $30 million with Aspire Capital Fund, LLC (Aspire Capital). Under the terms of the Agreement, Aspire Capital made an initial investment via purchase of $3 million of common shares of Curis. In addition, Aspire committed to purchasing up to an additional $27 million of common shares of Curis at Curis’ 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 certain limits.
In February 2020, Curis entered into an amendment of its collaboration, license and option agreement with Aurigene Discovery Technologies, Ltd. (Aurigene), under which Aurigene will fund and conduct a Phase 2b/3 randomized study evaluating CA-170, an orally available, dual inhibitor of VISTA and PDL1, in combination with chemoradiation, in approximately 240 patients with non-squamous non-small cell lung cancer. In turn, Aurigene received rights to develop and commercialize CA-170 in Asia, in addition to its existing rights in India and Russia. Curis retained U.S., E.U., and rest of world rights to CA-170, and is entitled to receive royalty payments on potential future sales of CA-170 in Asia.
In January 2020, Curis and DarwinHealth, Inc. announced a multi-year scientific research collaboration to characterize biomarkers and tumor subtype alignments to identify potential additional therapeutic opportunities for fimepinostat.
Upcoming 2020 Planned Milestones

Continue dose escalation of CA-4948 in the ongoing Phase 1 study to determine the recommended Phase 2 dose and report updated efficacy data from the study in 2020
Initiate a Phase 1 study of CA-4948 in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), including patients with spliceosome mutations that encode oncogenic IRAK4-L in the first half of 2020
Initiate a Phase 1a/1b dose escalation study of CI-8993 in in the second half of 2020.
Full Year and Fourth Quarter 2019 Financial Results

For the year ended December 31, 2019, Curis reported a net loss of $32.1 million, or $0.97 per share on both a basic and diluted basis, as compared to a net loss of $32.6 million, or $0.98 per share on both a basic and diluted basis in 2018. For the fourth quarter of 2019, Curis reported a net loss of $8.6 million or $0.26 per share on both a basic and diluted basis, as compared to a net loss of $5.9 million, or $0.18 per share on both a basic and diluted basis for the same period in 2018.

Revenues for the year ended December 31, 2019, were $10.0 million as compared to $10.4 million for the same period in 2018. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2019 and 2018 were $3.3 million and $2.8 million, respectively.

Operating expenses for the year ended December 31, 2019 were $34.4 million as compared to $39.8 million for the same period in 2018. Operating expenses for the fourth quarter of 2019 were $10.6 million, as compared to $7.9 million for the same period in 2018, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.5 million for the year ended December 31, 2019 as compared to $0.6 million for the same period in 2018. Cost of royalty revenues were $0.2 million for the fourth quarter of 2019, as compared to $0.1 million for the same period in 2018.

Research and Development Expenses. Research and development expenses were $22.3 million for the year ended December 31, 2019, as compared to $24.4 million for the same period in 2018. The decrease was primarily due to lower employee related expenses which resulted from a headcount reduction in the fourth quarter of 2018. This decrease was partially offset by increased clinical, manufacturing and consulting costs for the Company’s ongoing Phase 1 clinical trials. Research and development expenses were $7.5 million for the fourth quarter of 2019 as compared to $4.7 million for the same period in 2018. The increase was primarily due to increased costs related to clinical activities and manufacturing costs for fimepinostat and CA-4948.

General and Administrative Expenses. General and administrative expenses were $11.6 million for the year ended December 31, 2019, as compared to $14.8 million for the same period in 2018. The decrease was primarily due to lower personnel and stock-based compensation expense combined with lower legal and professional service expense. General and administrative expenses were $3.0 million for both the fourth quarter of 2019 and 2018 respectively.

Other expense, net. Net other expense was $7.8 million for the year ended December 31, 2019, as compared to $3.2 million for the same period in 2018. Net other expense primarily consisted of the $3.5 million loss on extinguishment of debt in conjunction with the March 2019 repayment of the loan obligation to HealthCare Royalty Partners, and imputed interest of $4.1 million resulting from the previously announced sale of a portion of Erivedge royalties to Oberland Capital Management. For the fourth quarter of 2019 and 2018, net other expense was $1.3 million and $0.8 million respectively.

As of December 31, 2019, Curis’s cash, cash equivalents, marketable securities and investments totaled $20.5 million and there were approximately 33.2 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into the second half of 2020.

Conference Call Information

Curis management will host a conference call today, March 19, 2020, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.